WorldWideScience

Sample records for investigator information clinical

  1. Clinical Investigations

    Science.gov (United States)

    1977-09-30

    conducted at WBAV’S is categorized as t basic experimental medicine or trials and testing of clinical medicine pro- cedures using the indigenous population...Unit No. 77/20 (FY77, 0) An Analysis of Ameloblastic Fibro-odontoma ....................... 27 Department of Medicine Nork Unit No, 69/338 (FY69, T...Unit No. 71/38 (FY71, T) Injected Marihuana : Effects of Cannabinol ....................... 71 Department of Pediatrics Wfork Unit No. 74/23 (FY74, T

  2. Clinical Investigation.

    Science.gov (United States)

    1979-09-30

    Zbylski, LaRossa, Cullington: A Simple Method of Rapid Assessment of Malar Depression . Annals of Plastic Surgery, Aug 79. Urology Service Fauver, H.E...J.R.: ST Depression Suggesting Subendocardial Ischemia in Neonates with PDA. Presented: Eighth Annual Army Association of Cardiok yy tt,eting, Tacoma...79/100 Investigation of the Tumor Reduction Effect of Combined Sodium-L-Ascorbate and 5FU Chemotherapy in Transplanted B16 Melanoma of Mice. (O

  3. Investigating the congruence of crowdsourced information with official government data: the case of pediatric clinics.

    Science.gov (United States)

    Kim, Minki; Jung, Yuchul; Jung, Dain; Hur, Cinyoung

    2014-02-03

    Health 2.0 is a benefit to society by helping patients acquire knowledge about health care by harnessing collective intelligence. However, any misleading information can directly affect patients' choices of hospitals and drugs, and potentially exacerbate their health condition. This study investigates the congruence between crowdsourced information and official government data in the health care domain and identifies the determinants of low congruence where it exists. In-line with infodemiology, we suggest measures to help the patients in the regions vulnerable to inaccurate health information. We text-mined multiple online health communities in South Korea to construct the data for crowdsourced information on public health services (173,748 messages). Kendall tau and Spearman rank order correlation coefficients were used to compute the differences in 2 ranking systems of health care quality: actual government evaluations of 779 hospitals and mining results of geospecific online health communities. Then we estimated the effect of sociodemographic characteristics on the level of congruence by using an ordinary least squares regression. The regression results indicated that the standard deviation of married women's education (P=.046), population density (P=.01), number of doctors per pediatric clinic (P=.048), and birthrate (P=.002) have a significant effect on the congruence of crowdsourced data (adjusted R²=.33). Specifically, (1) the higher the birthrate in a given region, (2) the larger the variance in educational attainment, (3) the higher the population density, and (4) the greater the number of doctors per clinic, the more likely that crowdsourced information from online communities is congruent with official government data. To investigate the cause of the spread of misleading health information in the online world, we adopted a unique approach by associating mining results on hospitals from geospecific online health communities with the sociodemographic

  4. SES, Ethnic, and Gender Differences in Young Children's Informal Addition and Subtraction: A Clinical Interview Investigation

    Science.gov (United States)

    Ginsburg, Herbert P.; Pappas, Sandra

    2004-01-01

    The main goal of this study was to examine possible socioeconomic status (SES) differences in 4- and 5-year-old children's informal mathematical knowledge. One hundred and two children, 32 from lower, 39 from middle, and 31 from upper SES families participated in the study. Each participant was given a clinical interview involving several addition…

  5. Clinical Investigator Inspector List (CLIIL)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who...

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

  8. 75 FR 31794 - Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked...

    Science.gov (United States)

    2010-06-04

    ... various blocks within the form, and when the form might need to be updated. In addition, we clarify... outside the United States that may or may not be under an investigational new drug application. This... guidance represents the agency's current thinking on completing the Form FDA 1572. It does not create or...

  9. EDIS Investigation Filing Information

    Data.gov (United States)

    US International Trade Commission — This dataset contains investigation, document and attachment metadata from the USITC's Electronic Document Information System (EDIS), as well as access to attached...

  10. Investigating Music Information Objects

    Science.gov (United States)

    Weissenberger, Lynnsey K.

    2016-01-01

    This dissertation, titled "Investigating Music Information Objects," is a study of the nature, description, representations, and ideas related to music information objects (MIOs). This research study investigates how music practitioners from various traditions describe and conceptualize MIOs, using a theoretical framework to classify…

  11. A Systematic Investigation on Barriers and Critical Success Factors for Clinical Information Systems in Integrated Care Settings.

    Science.gov (United States)

    Hoerbst, A; Schweitzer, M

    2015-08-13

    Clinical Information Systems (CIS) have ever since the introduction of information technology in healthcare played an important role to support healthcare professionals and the process of treatment. With the rise of the concept of integrated care organizational borders, the sole focus on data aggregation or healthcare professionals as users disappear more and more. The manuscript discusses the concept of CISs and investigates critical success factors for CISs in the context of integrated care and in the course of time. In order to identify critical success factors and barriers for CISs a systematic literature review was conducted based on the results from PubMed and Cochrane, using MaxQDA. Search results were thereby limited to reviews or meta-analysis. We have found 1919 references of which 40 met the inclusion criteria. The analysis of the manuscripts resulted in a comprehensive list of success factors and barriers related to CISs in integrated care settings. Most barriers were user-related whereas for the success factors an even distribution of organizational, technical and user-related factors was observed. The vast majority of publications was focused on healthcare professionals. It is important to incorporate experiences made/ collected over time, as the problems encountered seem to remain almost unvaried. In order to support further systematic investigations on the topic it is necessary to rethink existing concepts and definitions to realign them with the ideas of integrated care.

  12. Future requirements. Clinical investigations

    DEFF Research Database (Denmark)

    Qvist, V.

    2002-01-01

    Biocompatability, Cariology, Clinical trials, Dental materials, Helath services research, Human, Pedodontics......Biocompatability, Cariology, Clinical trials, Dental materials, Helath services research, Human, Pedodontics...

  13. Clinical Investigation Program.

    Science.gov (United States)

    1985-10-01

    Tracheoesophageal Fistula: Diagnosis with CT. Pediatr Radiol 15:134-135, 1985 Sueoka BL, Johnson JF, Enzenauer RW, Kolina JS: Infantile Infectious Sacroiliitis...C) Stokes WS: Spontaneous Diabetes Mellitus in a Baboon (Papio anubis). 35th Annual Session, American Association for Laboratory Animal Science...Summary Sheet Prot No: 21H/85 Status: Ongoing TITLE: Efficacy of Cholestyramine in Acute Infantile Diarrhea Principal Investigator: CPT George M. Maher

  14. 75 FR 57472 - Clinical Investigator Training Course

    Science.gov (United States)

    2010-09-21

    ... days in advance. SUPPLEMENTARY INFORMATION: Clinical trial investigators play a critical role in the... toxicological, pharmacological, and manufacturing data to support investigational use in humans; Fundamental issues in the design and conduct of clinical trials; Statistical and analytic considerations in the...

  15. Clinical Information Support System (CISS)

    Data.gov (United States)

    Department of Veterans Affairs — Clinical Information Support System (CISS) is a web-based portal application that provides a framework of services for the VA enterprise and supplies an integration...

  16. Ageing management technical information investigations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-08-15

    In February 2013, there are 50 units of commercial nuclear power plants (NPPs) in Japan. We enter into a period that 20 units of them are operating for more than 30 years. Currently, regulation imposes utilities to conduct ageing technical evaluations of each unit before operation of 30 years from the commissioning, to develop the long term maintenance management policy for next 10 years and to submit to the regulatory authority the policy with the report on ageing management technical evaluation (AMTE) for each NPP. It is necessary for regulatory side to develop technical information bases incorporating latest technical knowledge as operating experiences in domestic and abroad on ageing of the plants necessary to conduct reviews of AMTE for each unit. Based on these standpoints, technical information bases investigations have been conducted from the viewpoints of material degradation of ageing NPPs. In order to develop scientific regulator judgment bases related to ageing management (AM) and long-term operation (LTO), investigations on latest information on ageing management in domestic and abroad are conducted and a set of documents including technical evaluation review manuals necessary to conduct AMTE are prepared. To utilize the results of the investigations for ageing technical evaluation, database including latest information related to AM and LTO are developed, ran and operated. In addition, investigations related to Fugen nuclear plant, under decommissioning plants, investigations on mechanism of stress corrosion cracking (SCC), thermal ageing and preventive technologies for SCC, detection and diagnosis technology for ageing degradation and condition monitoring technology are performed to validate and confirm effectiveness of the technologies. (author)

  17. 77 FR 60440 - Clinical Investigator Training Course

    Science.gov (United States)

    2012-10-03

    ... concerns, adverse event monitoring, compliance with the legal and ethical obligations of clinical research... with knowledge, experience, and commitment to investigational medicine; Promote communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in experimental medicine...

  18. 76 FR 45577 - Clinical Investigator Training Course

    Science.gov (United States)

    2011-07-29

    ... concerns, adverse event monitoring, compliance with the legal and ethical obligations of clinical research... knowledge, experience, and commitment to investigational medicine; Promote communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in experimental medicine; and Improve...

  19. i3b3: Infobuttons for i2b2 as a Mechanism for Investigating the Information Needs of Clinical Researchers.

    Science.gov (United States)

    Kennell, Timothy; Dempsey, Donald M; Cimino, James J

    2016-01-01

    The information needs of clinicians, as they interact with the EHR, are well-studied. Clinical researchers also interact with the EHR and, while they might be expected to have some similar needs, the unique needs that arise due to nature of their work remain largely unstudied. For clinicians, infobuttons (context-aware hyperlinks) provide a mechanism of studying these information needs. Here we describe the integration of infobuttons into i2b2, a popular data warehouse commonly used by clinical researchers, using a plugin. A preliminary survey of i2b2 developers suggests a general interest in infobuttons for i2b2 and indicates good likelihood for their deployment, where they may be used as a tool for further studying these needs in greater detail.

  20. Clinical investigation of thyroid disorders

    International Nuclear Information System (INIS)

    Miller, J.L.

    1981-01-01

    Current investigations of thyroid dysfunction available to the clinician are reviewed and correlated with disease processes. The aim is to provide a simplified guide to the investigation of thyroid disorders

  1. Clinical investigation in Wilson's disease

    International Nuclear Information System (INIS)

    Mizutani, Naoki; Maehara, Mitsuo; Negoro, Tamiko; Watanabe, Kazuyoshi

    1983-01-01

    Wilson's disease of cerebral type with a chief complaint of tremor occurred in 3 brothers and sisters of a certain family line. Treatment with D-penicillamine produced remarkable clinical improvement as shown by the disappearance of tremor and Kayser-Fleischer ring. Cranial CT scans made before the treatment revealed abnormal findings such as low density areas in the (bilateral) thalamus and the lenticular nucleus, atrophy of the cerebral cortex, and enlargement of the ventricles. After the treatment, cranial CT revealed that the low density areas in the thalamus and the lenticular nucleus disappeared corresponding to the clinical improvement. However, the atrophy of the cerebral cortex and the enlargement of the ventricles were not ameliorated. (Ueda, J.)

  2. Investigation Of Information Sources And Communication Channels ...

    African Journals Online (AJOL)

    Investigation Of Information Sources And Communication Channels In Ipm Rice ... the information accessibility of farmer groups seems as empowerment strategy. ... information sources and communication channels, in order of importance, ...

  3. Transcranial magnetic stimulation techniques in clinical investigation.

    Science.gov (United States)

    Currà, A; Modugno, N; Inghilleri, M; Manfredi, M; Hallett, M; Berardelli, A

    2002-12-24

    Transcranial magnetic stimulation (TMS) is a technique that can activate cortical motor areas and the corticospinal tract without causing the subject discomfort. Since TMS was introduced, numerous applications of the technique have been developed for the evaluation of neurologic diseases. Standard TMS applications (central motor conduction time, threshold and amplitude of motor evoked potentials) allow the evaluation of motor conduction in the CNS. Conduction studies provide specific information in neurologic conditions characterized by clinical and subclinical upper motor neuron involvement. In addition, they have proved useful in monitoring motor abnormalities and the recovery of motor function. TMS also gives information on the pathophysiology of the processes underlying the various clinical conditions. More complex TMS applications (paired-pulse stimulation, silent period, ipsilateral silent period, input-output curve, and evaluation of central fatigue) allow investigation into the mechanisms of diseases causing changes in the excitability of cortical motor areas. These techniques are also useful in monitoring the effects of neurotrophic drugs on cortical activity. TMS applications have an important place among the investigative tools to study patients with motor disorders.

  4. 78 FR 63988 - Clinical Investigator Training Course

    Science.gov (United States)

    2013-10-25

    ... communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1214... support regulatory decisions. This course is intended to assist clinical investigators in understanding...

  5. VIOLIN: vaccine investigation and online information network.

    Science.gov (United States)

    Xiang, Zuoshuang; Todd, Thomas; Ku, Kim P; Kovacic, Bethany L; Larson, Charles B; Chen, Fang; Hodges, Andrew P; Tian, Yuying; Olenzek, Elizabeth A; Zhao, Boyang; Colby, Lesley A; Rush, Howard G; Gilsdorf, Janet R; Jourdian, George W; He, Yongqun

    2008-01-01

    Vaccines are among the most efficacious and cost-effective tools for reducing morbidity and mortality caused by infectious diseases. The vaccine investigation and online information network (VIOLIN) is a web-based central resource, allowing easy curation, comparison and analysis of vaccine-related research data across various human pathogens (e.g. Haemophilus influenzae, human immunodeficiency virus (HIV) and Plasmodium falciparum) of medical importance and across humans, other natural hosts and laboratory animals. Vaccine-related peer-reviewed literature data have been downloaded into the database from PubMed and are searchable through various literature search programs. Vaccine data are also annotated, edited and submitted to the database through a web-based interactive system that integrates efficient computational literature mining and accurate manual curation. Curated information includes general microbial pathogenesis and host protective immunity, vaccine preparation and characteristics, stimulated host responses after vaccination and protection efficacy after challenge. Vaccine-related pathogen and host genes are also annotated and available for searching through customized BLAST programs. All VIOLIN data are available for download in an eXtensible Markup Language (XML)-based data exchange format. VIOLIN is expected to become a centralized source of vaccine information and to provide investigators in basic and clinical sciences with curated data and bioinformatics tools for vaccine research and development. VIOLIN is publicly available at http://www.violinet.org.

  6. Annotating temporal information in clinical narratives.

    Science.gov (United States)

    Sun, Weiyi; Rumshisky, Anna; Uzuner, Ozlem

    2013-12-01

    Temporal information in clinical narratives plays an important role in patients' diagnosis, treatment and prognosis. In order to represent narrative information accurately, medical natural language processing (MLP) systems need to correctly identify and interpret temporal information. To promote research in this area, the Informatics for Integrating Biology and the Bedside (i2b2) project developed a temporally annotated corpus of clinical narratives. This corpus contains 310 de-identified discharge summaries, with annotations of clinical events, temporal expressions and temporal relations. This paper describes the process followed for the development of this corpus and discusses annotation guideline development, annotation methodology, and corpus quality. Copyright © 2013 Elsevier Inc. All rights reserved.

  7. Pretherapy Information: An Investigation of Client Responses.

    Science.gov (United States)

    Lewis, Kathleen N.; And Others

    1983-01-01

    Investigated effects of pretherapy information about a feminist therapist's values and therapy orientation. Studied self-identified feminist clients' judgments of similarity to the therapist's values, confidence in the therapist's helpfulness, and willingness to see the therapist. Subjects were not as willing to see the explicitly feminist…

  8. Research Investigation of Information Access Methods

    Science.gov (United States)

    Heinrichs, John H.; Sharkey, Thomas W.; Lim, Jeen-Su

    2006-01-01

    This study investigates the satisfaction of library users at Wayne State University who utilize alternative information access methods. The LibQUAL+[TM] desired and perceived that satisfaction ratings are used to determine the user's "superiority gap." By focusing limited library resources to address "superiority gap" issues identified by each…

  9. Clinical Investigation Program, RCS MED-300 (RI).

    Science.gov (United States)

    1984-10-01

    protocol is a clinical validation study uti - lizing the BIOTRONIK DIPLOS 04 Dual Chamber Pulse Generator. This study is being conducted under an...recurrence-rates, survival-rates, and pattern of recurrence for patients receiving therapy uti - lizing surgery and postoperative radiation vs combined...placed in the treatment qroup or control aroup by the pharmacist . Progress: Terminate. Both the principal and associate investigators have ETS d. 7

  10. 76 FR 20575 - Disqualification of a Clinical Investigator

    Science.gov (United States)

    2011-04-13

    ... research or marketing permit for products regulated by FDA. This proposal is based in part upon.... SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Background III. Description of the Proposed.... References I. Introduction Under current regulations, a clinical investigator disqualified by the...

  11. Clinical investigation of radioallergosorbent test (RAST)

    International Nuclear Information System (INIS)

    Okuda, Minoru; Usami, Atsushi

    1974-01-01

    Relationship of radioallergosorbent test (RAST), intracutaneous reaction, serum IgE determination and RMCD (Rat Mast Cell Degranulation Test) in subjects with tick allergy was compared in order to investigate clinical application for nasal allergy. 1. RAST is suitable for clinical examinations as determination of IgE. Because it is simple in technique, a technical expert can treat many subjects within a short time, and the result can be decleared within 2 days. 2. RAST was high in specificity and was consistent with clinical findings. RAST positive was thought to be allergy by the antigen, but RAST negative could not deny allergy by the antigen. 3. Correlation of some degree was found to exist between RAST and intracutaneous reaction or degree of induced reaction or threshold value of antigen intracutaneous reaction. But degree of intracutaneous reaction and induced reaction and threshold value of intracutaneous reaction could not be determined from the result of RAST. 4. Determination of IgE antibody by RAST was more useful in clinical study than that of IgE or IgE antibody by RMCD. (Oyama, S.)

  12. Clinical Investigation of Benign Asbestos Pleural Effusion

    Directory of Open Access Journals (Sweden)

    Nobukazu Fujimoto

    2015-01-01

    Full Text Available There is no detailed information about benign asbestos pleural effusion (BAPE. The aim of the study was to clarify the clinical features of BAPE. The criteria of enrolled patients were as follows: (1 history of asbestos exposure; (2 presence of pleural effusion determined by chest X-ray, CT, and thoracentesis; and (3 the absence of other causes of effusion. Clinical information was retrospectively analysed and the radiological images were reviewed. There were 110 BAPE patients between 1991 and 2012. All were males and the median age at diagnosis was 74 years. The median duration of asbestos exposure and period of latency for disease onset of BAPE were 31 and 48 years, respectively. Mean values of hyaluronic acid, adenosine deaminase, and carcinoembryonic antigen in the pleural fluid were 39,840 ng/mL, 23.9 IU/L, and 1.8 ng/mL, respectively. Pleural plaques were detected in 98 cases (89.1%. Asbestosis was present in 6 (5.5% cases, rounded atelectasis was detected in 41 (37.3% cases, and diffuse pleural thickening (DPT was detected in 30 (27.3% cases. One case developed lung cancer (LC before and after BAPE. None of the cases developed malignant pleural mesothelioma (MPM during the follow-up.

  13. A clinical and investigational study of donovanosis

    Directory of Open Access Journals (Sweden)

    Veeranna S

    2003-03-01

    Full Text Available A clinical and investigational study of 25 cases of Donovanosis was undertaken. The incidence was found to be 1.53% of all STD cases and 2.9% of GUD. M:F ratio was 2.12:1. Incidence was more in unmarried people. Fleshy exuberant type was seen in 88% of cases. Two patients (8% had extragenital ulcers. Donovan bodies were found in 88%. Pseudo elephantiasis was seen in 8 patients. Biopsy was done in 8 cases and showed ocanthosis, plasma cell infiltration and pseudo epitheliomatous hyperplasia. One patient developed squamous cell carcinoma of vulva.

  14. Investigating antibiotic resistance in non-clinical environments

    Directory of Open Access Journals (Sweden)

    Fiona eWalsh

    2013-02-01

    Full Text Available There have been many calls for more information about the natural resistome and these have also highlighted the importance of understanding the soil resistome in the preservation of antibiotics for the treatment of infections. However, to date there have been few studies which have investigated the culturable soil resistome, which highlights the difficulties faced by microbiologists in designing these experiments to produce meaningful data. The World Health Organization definition of resistance is the most fitting to non-clinical environmental studies: Antimicrobial resistance is resistance of a microorganism to an antimicrobial medicine to which it was previously sensitive. The ideal investigation of non-clinical environments for antibiotic resistance of clinical relevance would be using standardized guidelines and breakpoints. This review outlines different definitions and methodologies used to understand antibiotic resistance and suggests how this can be performed outside of the clinical environment.

  15. Radiation information and informed consent for clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Caon, Martin [School of Nursing and Midwifery, Flinders University, Adelaide (Australia)], E-mail: martin.caon@flinders.edu.au

    2008-09-01

    Examples of the statements about the radiation from medical imaging in the information for participants provided to the Human Research Ethics Committee (HREC) for approval are presented and discussed. There is considerable scope for improvement in the information about radiation that is presented to potential participants in clinical trials. Many radiation statements seem only intended to allay fear and anxiety about radiation rather than providing accurate information. This situation cannot be said to be conducive to allowing the participant to give informed consent to their involvement in a clinical trial in which ionising radiation is used. As many clinical trials are international and conducted at many sites (sometimes over 100), we would expect the same statements to have been seen by members of HRECs in many countries. Few HRECs include a member who is an expert in radiation. Hence, to ensure that the information is sound, those sections of the participant information that refer to radiation should be written or reviewed by a specialist in radiation protection such as a medical physicist, a health physicist or a radiation safety officer. (opinion)

  16. Radiation information and informed consent for clinical trials

    International Nuclear Information System (INIS)

    Caon, Martin

    2008-01-01

    Examples of the statements about the radiation from medical imaging in the information for participants provided to the Human Research Ethics Committee (HREC) for approval are presented and discussed. There is considerable scope for improvement in the information about radiation that is presented to potential participants in clinical trials. Many radiation statements seem only intended to allay fear and anxiety about radiation rather than providing accurate information. This situation cannot be said to be conducive to allowing the participant to give informed consent to their involvement in a clinical trial in which ionising radiation is used. As many clinical trials are international and conducted at many sites (sometimes over 100), we would expect the same statements to have been seen by members of HRECs in many countries. Few HRECs include a member who is an expert in radiation. Hence, to ensure that the information is sound, those sections of the participant information that refer to radiation should be written or reviewed by a specialist in radiation protection such as a medical physicist, a health physicist or a radiation safety officer. (opinion)

  17. Public information about clinical trials and research.

    Science.gov (United States)

    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.

  18. Investigating the Benefits of Information and Communication ...

    African Journals Online (AJOL)

    Information and Communication Technologies (ICTs) are widely used by ... benefits of ICT, outsourcing trends and availability of help and advice on ICT adoption. ... KEYWORDS: Information and Communication Technology (ICT), Nigeria ...

  19. Clinical investigation of proximate exposed group, 1

    International Nuclear Information System (INIS)

    Ito, Chikako; Hasegawa, Kazuyo; Kato, Masafumi; Kumasawa, Toshihiko

    1984-01-01

    In order to investigate effects of the A-bombing on prevalence of diabetes mellitus, follow-up studies were made on 5907 A-bomb survivors who received glucose tolerance test (GTT) during 20 years between 1963 and 1983. The A-bomb survivors were divided into the group A (1899 men and 1165 women exposed within 1.9 km from the hypocenter) and the group B (1725 men and 1118 women exposed 3.0 km or farther from it). Among non-obese survivors, 21.9% and 21.8% were being treated for diabetes mellitus or were evaluated as having diabetic type on GTT in the group A and the group B, respectively; while this was seen in 52.1% of obese survivors in the group A and 49.9% in the group B. There was no difference between the groups. In non-obese survivors, the annual development rate from the normal type to the diabetic type was 0.89% in the group A and 0.65% in the group B; the annual development rate from the borderline type to the diabetic type was 5.73% in the group A and 5.49% in the group B, showing no differences between the groups. The annual development rate from the normal or borderline type to the diabetic type was two times or higher in obese survivors than in non-obese survivors irrespective of exposure status. Regarding the number of diabetic survivors who became non-diabetic type in spite of having no treatment, and prevalence of diabetic complications, no difference was seen between the groups. These results suggest that the A-bombing has scarcely influenced the prevalence of diabetes mellitus and clinical course. (Namekawa, K.)

  20. Informal sources of supervision in clinical training.

    Science.gov (United States)

    Farber, Barry A; Hazanov, Valery

    2014-11-01

    Although formal, assigned supervision is a potent source of learning and guidance for psychotherapy trainees, many beginning psychotherapists use other, informal sources of supervision or consultation for advice and support. Results of an online survey of beginning trainees (N = 146) indicate that other than their formally assigned supervisor, trainees most often consult with colleagues in their program, their own psychotherapist, and their significant other; that they're most likely to seek these other sources of help when they're feeling stuck or feel they've made a clinical mistake; that they do so because they need extra reassurance and suggestions; that they feel the advice given from these sources is helpful; and that they don't especially regret sharing this information. Several case examples are used to illustrate these points. Discussing clinical material with informal sources is, apparently, a great deal more common than typically acknowledged, and as such, has implications for training programs (including discussions of ethics) and formal supervision. © 2014 Wiley Periodicals, Inc.

  1. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Science.gov (United States)

    2011-05-24

    ... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...

  2. Investigation Of Information Sources And Communication Channels ...

    African Journals Online (AJOL)

    Extension of integrated pest management (IPM) as a component of sustainable agricultural development, involves empowering farmers. Facilitating the information accessibility of farmer groups seems as empowerment strategy. This strategy is based on identification of related patterns, including information sources and ...

  3. Clinical trials in orthopaedics and the future direction of clinical investigations for femoroacetabular impingement

    DEFF Research Database (Denmark)

    Clohisy, John C; Kim, Young-Jo; Lurie, Jon

    2013-01-01

    to be further defined. To date, clinical research reports have included primarily surgical case series. Future clinical investigations are needed to establish improved clinical evidence to guide patient care. Most urgent is the need to better understand the potential role of standardized nonsurgical treatment......Femoroacetabular impingement (FAI) represents a heterogeneous group of disorders that affect a diverse patient population. The natural history of the disease, the role of nonsurgical management, the indications for surgery, optimal surgical techniques, and the predictors of treatment outcomes need...... options for FAI and to define the predictors of surgical and nonsurgical outcomes. Future randomized controlled trials and large observational cohort studies targeted at these clinical research deficiencies will strengthen the evidence and improve informed decision making regarding the management...

  4. 337Info - Unfair Import Investigations Information System

    Data.gov (United States)

    US International Trade Commission — The 337Info database contains data relating to Section 337 investigations instituted, or otherwise initiated, by the U.S. International Trade Commission on or after...

  5. Trauma-Informed Forensic Child Maltreatment Investigations

    Science.gov (United States)

    Pence, Donna M.

    2011-01-01

    Trauma-informed child welfare systems (CWSs) are the focus of several recent national and state initiatives. Since 2005 social work publications have focused on systemic and practice changes within CW which seek to identify and reduce trauma to children and families experiencing child maltreatment or other distressing events, as well as to the…

  6. Clinical Investigation Program: Annual Progress Report

    Science.gov (United States)

    1992-09-30

    Diamminedichloroplatinum (II), Methotrexate and Bleomycin in the Treatment of Advanced Epidermoid Carcinoma of the Penis , Phase II...II), Methotrexate and Bleomycin in the Treatment of Advanced Epidermoid Carcinoma of the Penis , Phase II (5) Start Date: (6) Est Compl Date: (7...Associate Investigators (11) Key Words: constitutional delay delayed puberty (12) Accumulative MEDCASE:* (13) Est Accum OKA Cost:* *Refer to Unit Summary

  7. Investigators’ Guide to Sources of Information.

    Science.gov (United States)

    1997-04-01

    pathology, soil science, veterinary medicine , and zoology. A separate listing of book review citations follows the subject entries. Gale Directory of This...federal contracting, state and local government, and directories are listed in the index, subtopics such as counterfeiting , criminal history, income tax...responsible for investigating the counterfeiting of currency and securities; forgery and altering of government checks and bonds; thefts and fraud relating to

  8. Clinical Investigation Program Annual Progress Report

    Science.gov (United States)

    1993-09-30

    The assigned staff of the Molecular Biology Service are Dr. Anthony G. Gutierrez , Chef , GSl3, Ph. D. in Molecular Genetics, and Ms. Judith O’Brien...Node-Negative Breast Cancer Patients Using a Panel of Prognostic Factors. A Companion Protocol to SWOG 8897 ................................ . 103 91...of Prog- nostic Factors. A companion protocol to 8897 (5) Start Date: 1991 (6) Est Compl Date: (7) Principal Investigator: (8) Facility: FAMC Thomas

  9. Clinical Investigation Program Annual Progress Report

    Science.gov (United States)

    1988-10-20

    Presented: Interna- tional Symposium on Orthopedics, Mexico , September 1987. Publications: In preparation. 147 FAMC A.P.R. (RCS MED 300) Detail Summary...Infection: A Prospective Study. Presented: 2nd Annual Symposium of the Rocky Moun- tain Flow Cytometry Users Group, Albuquerque, New Mexico , 10-11...Podgore, COL, MC (9) Dept/ISvc: Pediatrics (10) Associate Investigators (11) Key Words: Myron J. Levin, M.D. varicella vaccine U Co. HSC (12

  10. Measurements of body protein for clinical investigation

    International Nuclear Information System (INIS)

    Mernagh, J.R.; Harrison, J.E.; McNeill, M.G.; Jeejeebhoy, K.N.; Krishnan, S.S.

    1986-01-01

    Body protein (nitrogen) is determined by bilaterally irradiating the body with neutrons using Pu-Be sources and measuring the resultant 10.8 MeV gamma rays from the reaction 14 N(n,8) 15 N. In the authors lab the whole body can be scanned or separate segments of the body can be measured independently. A nitrogen index has been developed based on body size and is used as a predictor of normal total body nitrogen (TBN). They have found that TBN, when normalized to body size in this way, provides a reliable index of protein status which cannot be accurately determined by body weight, anthropometry, or body potassium measurements. Changes in body composition with age were studied by measuring the composition of 56 healthy female volunteers aged 20-80. Measurements were made for K( 40 K), Ca and N. It was shown that protein and bone mineral decrease with age but that this is not reflected in K or anthropometry measurements. Results of other studies to be presented include: body protein measurements pre and post TPN (total parenteral nutrition), nutritional status of patients on long term CAPD (continuous ambulatory peritoneal dialysis) and changes in body composition as a result of TPN in patients with small cell lung cancer receiving chemotherapy. Clinical results show that indirect measurements of body protein based on weight, potassium, or anthropometry, do not give an accurate measure of body protein. For an accurate measurement, direct measurement of body protein is necessary

  11. Patient representatives? views on patient information in clinical cancer trials

    OpenAIRE

    Dellson, Pia; Nilbert, Mef; Carlsson, Christina

    2016-01-01

    Background Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives? views and perceptions on the written trial information used in clinical cancer trials. Methods Written patient information leaflet...

  12. Multichannel optical mapping: investigation of depth information

    Science.gov (United States)

    Sase, Ichiro; Eda, Hideo; Seiyama, Akitoshi; Tanabe, Hiroki C.; Takatsuki, Akira; Yanagida, Toshio

    2001-06-01

    Near infrared (NIR) light has become a powerful tool for non-invasive imaging of human brain activity. Many systems have been developed to capture the changes in regional brain blood flow and hemoglobin oxygenation, which occur in the human cortex in response to neural activity. We have developed a multi-channel reflectance imaging system, which can be used as a `mapping device' and also as a `multi-channel spectrophotometer'. In the present study, we visualized changes in the hemodynamics of the human occipital region in multiple ways. (1) Stimulating left and right primary visual cortex independently by showing sector shaped checkerboards sequentially over the contralateral visual field, resulted in corresponding changes in the hemodynamics observed by `mapping' measurement. (2) Simultaneous measurement of functional-MRI and NIR (changes in total hemoglobin) during visual stimulation showed good spatial and temporal correlation with each other. (3) Placing multiple channels densely over the occipital region demonstrated spatial patterns more precisely, and depth information was also acquired by placing each pair of illumination and detection fibers at various distances. These results indicate that optical method can provide data for 3D analysis of human brain functions.

  13. Sharing information: Mixed-methods investigation of brief experiential interprofessional

    Science.gov (United States)

    Cocksedge, Simon; Barr, Nicky; Deakin, Corinne

    In UK health policy ‘sharing good information is pivotal to improving care quality, safety, and effectiveness. Nevertheless, educators often neglect this vital communication skill. The consequences of brief communication education interventions for healthcare workers are not yet established. This study investigated a three-hour interprofessional experiential workshop (group work, theoretical input, rehearsal) training healthcare staff in sharing information using a clear structure (PARSLEY). Staff in one UK hospital participated. Questionnaires were completed before, immediately after, and eight weeks after training, with semistructured interviews seven weeks after training. Participants (n=76) were from assorted healthcare occupations (26% non-clinical). Knowledge significantly increased immediately after training. Self-efficacy, outcome expectancy, and motivation to use the structure taught were significantly increased immediately following training and at eight weeks. Respondents at eight weeks (n=35) reported their practice in sharing information had changed within seven days of training. Seven weeks after training, most interviewees (n=13) reported confidently using the PARSLEY structure regularly in varied settings. All had re-evaluated their communication practice. Brief training altered self-reported communication behaviour of healthcare staff, with sustained changes in everyday work. As sharing information is central to communication curricula, health policy, and shared decision-making, the effectiveness of brief teaching interventions has economic and educational implications.

  14. [Support Team for Investigator-Initiated Clinical Research].

    Science.gov (United States)

    Fujii, Hisako

    2017-07-01

    Investigator-initiated clinical research is that in which investigators plan and carry out their own clinical research in academia. For large-scale clinical research, a team should be organized and implemented. This team should include investigators and supporting staff, who will promote smooth research performance by fulfilling their respective roles. The supporting staff should include project managers, administrative personnel, billing personnel, data managers, and clinical research coordinators. In this article, I will present the current status of clinical research support and introduce the research organization of the Dominantly Inherited Alzheimer Network (DIAN) study, an investigator-initiated international clinical research study, with particular emphasis on the role of the project management staff and clinical research coordinators.

  15. Clinical investigation of fatty liver by CT

    International Nuclear Information System (INIS)

    Kato, Katsumoto; Takayama, Tetsuo; Sano, Hiroshi; Katada, Naoyuki; Takeichi, Masayuki

    1984-01-01

    CT findings of 56 cases of diffuse fatty infiltration comfirmed by liver biopsy were investigated and compared with those of chronic hepatitis and liver cirrhosis. We found that the diagnosis of severe fatty infiltration (fatty liver) can be specifically possible when the ratios of CT values of liver to those of spleen are less than 0.85 and it is reasonable criterion for diagnosis of fatty liver by CT. This criterion was satisfied by 197 studies (2.9%), 169 cases with fatty liver (diffuse: 141 cases, focal: 28 cases) of 6800 CT studies of liver. Obesity, diabetes and alcohol abuse were main causative factors in both diffuse and focal fatty liver. The percentage of cases showing no abnormal results in blood chemistry tests was great compared with the previous report based on liver biopsy. The changes of CT values of liver faithfully reflected the improvement of each causal factor and reciprocal changes were observed between diffuse and focal fatty liver in repeated CT examination. So, CT is useful in estimating the effect of treatment as well as in diagnosis of fatty liver. Focal fatty liver is temporary manifestation during the proscess of development or improvement of fatty liver. (author)

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

    Science.gov (United States)

    Johnson, Maree; Jefferies, Diana; Nicholls, Daniel

    2012-10-01

    Clinical handover is the primary source of patient information for nurses; however, inadequate information transfer compromises patient safety. We investigated the content and organization of information conveyed at 81 handovers. A structure that captures and presents the information transferred at handover emerged: identification of the patient and clinical risks, clinical history/presentation, clinical status, care plan and outcomes/goals of care (ICCCO). This approach covers essential information while allowing for prioritization of information when required. Further research into the impact of ICCCO on patient safety is in progress. © 2012 Wiley Publishing Asia Pty Ltd.

  17. Evaluation of clinical information modeling tools.

    Science.gov (United States)

    Moreno-Conde, Alberto; Austin, Tony; Moreno-Conde, Jesús; Parra-Calderón, Carlos L; Kalra, Dipak

    2016-11-01

    Clinical information models are formal specifications for representing the structure and semantics of the clinical content within electronic health record systems. This research aims to define, test, and validate evaluation metrics for software tools designed to support the processes associated with the definition, management, and implementation of these models. The proposed framework builds on previous research that focused on obtaining agreement on the essential requirements in this area. A set of 50 conformance criteria were defined based on the 20 functional requirements agreed by that consensus and applied to evaluate the currently available tools. Of the 11 initiative developing tools for clinical information modeling identified, 9 were evaluated according to their performance on the evaluation metrics. Results show that functionalities related to management of data types, specifications, metadata, and terminology or ontology bindings have a good level of adoption. Improvements can be made in other areas focused on information modeling and associated processes. Other criteria related to displaying semantic relationships between concepts and communication with terminology servers had low levels of adoption. The proposed evaluation metrics were successfully tested and validated against a representative sample of existing tools. The results identify the need to improve tool support for information modeling and software development processes, especially in those areas related to governance, clinician involvement, and optimizing the technical validation of testing processes. This research confirmed the potential of these evaluation metrics to support decision makers in identifying the most appropriate tool for their organization. Los Modelos de Información Clínica son especificaciones para representar la estructura y características semánticas del contenido clínico en los sistemas de Historia Clínica Electrónica. Esta investigación define, prueba y valida

  18. An interactive data management and analysis system for clinical investigators.

    Science.gov (United States)

    Groner, G F; Hopwood, M D; Palley, N A; Sibley, W L; Baker, W R; Christopher, T G; Thompson, H K

    1978-09-01

    An interactive minicomputer-based system has been developed that enables the clinical research investigator to personally explore and analyze his research data and, as a consequence of these explorations, to acquire more information. This system, which does not require extensive training or computer programming, enables the investigator to describe his data interactively in his own terms, enter data values while having them checked for validity, store time-oriented patient data in a carefully controlled on-line data base, retrieve data by patient, variable, and time, create subsets of patients with common characteristics, perform statistical analyses, and produce tables and graphs. It also permits data to be transferred to and from other computers. The system is well accepted and is being used by a variety of medical specialists at the three clinical research centers where it is operational. Reported benefits include less elapsed and nonproductive time, more thorough analysis of more data, greater and earlier insight into the meaning of research data, and increased publishable results.

  19. Preferred information sources for clinical decision making: critical care nurses' perceptions of information accessibility and usefulness.

    Science.gov (United States)

    Marshall, Andrea P; West, Sandra H; Aitken, Leanne M

    2011-12-01

    Variability in clinical practice may result from the use of diverse information sources to guide clinical decisions. In routine clinical practice, nurses privilege information from colleagues over more formal information sources. It is not clear whether similar information-seeking behaviour is exhibited when critical care nurses make decisions about a specific clinical practice, where extensive practice variability exists alongside a developing research base. This study explored the preferred sources of information intensive care nurses used and their perceptions of the accessibility and usefulness of this information for making decisions in clinically uncertain situations specific to enteral feeding practice. An instrumental case study design, incorporating concurrent verbal protocols, Q methodology and focus groups, was used to determine intensive care nurses' perspectives of information use in the resolution of clinical uncertainty. A preference for information from colleagues to support clinical decisions was observed. People as information sources were considered most useful and most accessible in the clinical setting. Text and electronic information sources were seen as less accessible, mainly because of the time required to access the information within the documents. When faced with clinical uncertainty, obtaining information from colleagues allows information to be quickly accessed and applied within the context of a specific clinical presentation. Seeking information from others also provides opportunities for shared decision-making and potential validation of clinical judgment, although differing views may exacerbate clinical uncertainty. The social exchange of clinical information may meet the needs of nurses working in a complex, time-pressured environment but the extent of the evidence base for information passed through verbal communication is unclear. The perceived usefulness and accessibility of information is premised on the ease of use and access

  20. Information on blinding in registered records of clinical trials

    Directory of Open Access Journals (Sweden)

    Viergever Roderik F

    2012-11-01

    Full Text Available Abstract Information on blinding is part of the data that should be provided upon registration of a trial at a clinical trials registry. Reporting of blinding is often absent or of low quality in published articles of clinical trials. This study researched the presence and quality of information on blinding in registered records of clinical trials and highlights the important role of data-recording formats at clinical trial registries in ensuring high-quality registration.

  1. Clinical Investigation of Treatment Failure in Type 2 Diabetic ...

    African Journals Online (AJOL)

    Clinical Investigation of Treatment Failure in Type 2 Diabetic Patients ... Purpose: To examine body mass index (BMI), occupation, sex, age, and ... development of secondary failure in type 2 diabetics receiving metformin and glibenclamide.

  2. Patient representatives' views on patient information in clinical cancer trials

    DEFF Research Database (Denmark)

    Dellson, Pia; Nilbert, Mef; Carlsson, Christina

    2016-01-01

    of future simplified and more attractive informed consent forms. CONCLUSIONS: The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language......BACKGROUND: Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed...... consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. METHODS: Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I...

  3. Disclosure of investigators' recruitment performance in multicenter clinical trials

    DEFF Research Database (Denmark)

    Dal-Ré, Rafael; Moher, David; Gluud, Christian

    2011-01-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....

  4. [The informed consent in international clinical trials including developing countries].

    Science.gov (United States)

    Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

    2008-01-01

    The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

  5. Health Management Information System in Private Clinics in Ilorin ...

    African Journals Online (AJOL)

    This descriptive survey was conducted among private clinics located in Ilorin, Kwara State, Nigeria to determine the awareness and level of involvement of private clinic operators towards the National Health Management Information System. A total of 37 functional clinics responded to the survey. Structured questionnaire ...

  6. Clinical investigations for SUS, the Brazilian public health system.

    Science.gov (United States)

    Paula, Ana Patrícia de; Giozza, Silvana Pereira; Pereira, Michelle Zanon; Boaventura, Patrícia Souza; Santos, Leonor Maria Pacheco; Sachetti, Camile Giaretta; Tamayo, César Omar Carranza; Kowalski, Clarissa Campos Guaragna; Elias, Flavia Tavares Silva; Serruya, Suzanne Jacob; Guimarães, Reinaldo

    2012-01-01

    Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa), especially with regard to establishing a National Clinical Research Network. The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.

  7. 59th Medical Wing Clinical Research Division Clinical Investigations Program Pathology Poster

    Science.gov (United States)

    2017-04-28

    59 MDW/SGVU SUBJECT: Professional Presentation Approval 1. Your paper, entitled 59th Medical Wing Clinical Research Division Clinical Investigations...Program Pathology Poster presented at/published to For hanging in a hallway of the 591h Medical Wing Clinical Research Division, Bldg 4430 in...Graduate Health Sciences Education student and your department has told you they cannot fund your publication, the 59th Clinical Research Division may

  8. Informed Consent for Inclusion into Clinical Trials: A Serious Subject ...

    African Journals Online (AJOL)

    Informed Consent for Inclusion into Clinical Trials: A Serious Subject to Note in the Developing World Morteza. ... Review: The process of taking informed consent is wellunderstood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of ...

  9. [Development and clinical evaluation of an anesthesia information management system].

    Science.gov (United States)

    Feng, Jing-yi; Chen, Hua; Zhu, Sheng-mei

    2010-09-21

    To study the design, implementation and clinical evaluation of an anesthesia information management system. To record, process and store peri-operative patient data automatically, all kinds of bedside monitoring equipments are connected into the system based on information integrating technology; after a statistical analysis of those patient data by data mining technology, patient status can be evaluated automatically based on risk prediction standard and decision support system, and then anesthetist could perform reasonable and safe clinical processes; with clinical processes electronically recorded, standard record tables could be generated, and clinical workflow is optimized, as well. With the system, kinds of patient data could be collected, stored, analyzed and archived, kinds of anesthesia documents could be generated, and patient status could be evaluated to support clinic decision. The anesthesia information management system is useful for improving anesthesia quality, decreasing risk of patient and clinician, and aiding to provide clinical proof.

  10. Patient representatives' views on patient information in clinical cancer trials.

    Science.gov (United States)

    Dellson, Pia; Nilbert, Mef; Carlsson, Christina

    2016-02-01

    Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. Two major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms. The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.

  11. Clinical Investigation Program. Annual Progress Report. Volume 1

    Science.gov (United States)

    1994-01-20

    Components Surgical Day, Bethesda, MD, in April 1993. 2. Planned for FY-94 The Department of Clinical Investigation hopes to maintain the essence of the...sclerosing cholangitis after choledochojejun- ostomy : radiographic and biochemical improvement with antibiotic therapN. Am J Gastroenterol 1993;88:1635

  12. [An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials].

    Science.gov (United States)

    Kao, Chi-Yin; Huang, Guey-Shiun; Dai, Yu-Tzu; Pai, Ya-Ying; Hu, Wen-Yu

    2015-06-01

    Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. This study investigates the role responsibilities of CRNs in conducting clinical trials / research. A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p research coordination and management" (p clinical practice.

  13. Health care librarians and information literacy: an investigation.

    Science.gov (United States)

    Kelham, Charlotte

    2014-09-01

    Until relatively recently, the concept of information literacy, and teaching the skills to enable it, was mainly a concern of academic libraries. Now, it is also seen to be of high importance within the context of health care libraries. Health care libraries and librarians can provide crucial support towards the implementation of evidence-based practice in patient care through both information literacy skills training and by conducting mediated searches on behalf of health care practitioners. This article reports the findings from an investigation conducted by Charlotte Kelham as part of her MA in Librarianship from the University of Sheffield. Her dissertation investigated how health care librarians understand the concept of information literacy, the implications of this for their role and their perceptions around how their role is valued. Charlotte graduated from Sheffield in 2013 and is currently job hunting. AM. © 2014 The authors. Health Information and Libraries Journal © 2014 Health Libraries Journal.

  14. Clinical investigations for SUS, the Brazilian public health system

    Directory of Open Access Journals (Sweden)

    Ana Patrícia de Paula

    Full Text Available CONTEXT AND OBJECTIVE: Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. DESIGN AND SETTING: Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. METHODS: The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. RESULTS: The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa, especially with regard to establishing a National Clinical Research Network. CONCLUSION: The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.

  15. Informed Consent for Inclusion into Clinical Trials: A Serious Subject ...

    African Journals Online (AJOL)

    Informed Consent for Inclusion into Clinical Trials: A Serious Subject to Note in the Developing World Morteza. ... Arab Journal of Nephrology and Transplantation ... in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to ...

  16. Collateral Information for Equating in Small Samples: A Preliminary Investigation

    Science.gov (United States)

    Kim, Sooyeon; Livingston, Samuel A.; Lewis, Charles

    2011-01-01

    This article describes a preliminary investigation of an empirical Bayes (EB) procedure for using collateral information to improve equating of scores on test forms taken by small numbers of examinees. Resampling studies were done on two different forms of the same test. In each study, EB and non-EB versions of two equating methods--chained linear…

  17. Clinical information in drug package inserts in India

    Directory of Open Access Journals (Sweden)

    Shivkar Y

    2009-01-01

    Full Text Available Background: It is widely recognized that accurate and reliable product information is essential for the safe and effective use of medications. Pharmaceutical companies are the primary source of most drug information, including package inserts. Package inserts are printed leaflets accompanying marketed drug products and contain information approved by the regulatory agencies. Studies on package inserts in India, in 1996, had shown that crucial information was often missing and they lacked uniformity. Aim: To assess the presentation and completeness of clinically important information provided in the currently available package inserts in India. Materials and Methods: Package inserts accompanying allopathic drug products marketed by pharmaceutical companies in India were collected. These package inserts were analyzed for the content of clinically important information in various sections. Statistical Analysis: The results were expressed as absolute numbers and percentages. Results: Preliminary analyses revealed that most package inserts did contain information under headings, such as, therapeutic indications, contraindications, undesirable effects, etc., listed in the Drugs and Cosmetics Rules 1945. The findings indicated considerable improvement in package inserts since 1996. However, on critical evaluation it was revealed that clinically important information was not well presented and was often incomplete. Information with regard to pediatric and geriatric use was present in only 44% and 13% of the package inserts, respectively. Only five of the inserts had information on the most frequent adverse drug reactions associated with the drug. Also, information on interactions and overdosage was often missing. Conclusion: Although the package inserts appear to have improved over the past decade there is still a definite need to further refine the clinical information contained, to minimize the risks to patients. This could be brought about by self

  18. A history of the American Society for Clinical Investigation

    Science.gov (United States)

    Howell, Joel D.

    2009-01-01

    One hundred years ago, in 1909, the American Society for Clinical Investigation (ASCI) held its first annual meeting. The founding members based this new society on a revolutionary approach to research that emphasized newer physiological methods. In 1924 the ASCI started a new journal, the Journal of Clinical Investigation. The ASCI has also held an annual meeting almost every year. The society has long debated who could be a member, with discussions about whether members must be physicians, what sorts of research they could do, and the role of women within the society. The ASCI has also grappled with what else the society should do, especially whether it ought to take a stand on policy issues. ASCI history has reflected changing social, political, and economic contexts, including several wars, concerns about the ethics of biomedical research, massive increases in federal research funding, and an increasingly large and specialized medical environment. PMID:19348041

  19. Beyond Readability: Investigating Coherence of Clinical Text for Consumers

    Science.gov (United States)

    Hetzel, Scott; Dalrymple, Prudence; Keselman, Alla

    2011-01-01

    between (Original + Dictionary) and Vocabulary (P = .36) nor Coherent and Vocabulary (P = .62). No statistically significant effect of any document transformation was found either in the open-ended questionnaire (clinical trial: P = .86, Visit Note: P = .20) or in the error rate (clinical trial: P = .47, Visit Note: P = .25). However, post hoc power analysis suggested that increasing the sample size by approximately 6 participants per condition would result in a significant difference for the Visit Note, but not for the clinical trial text. Conclusions Statistically, the results of this study attest that improving coherence has a small effect on consumer comprehension of clinical text, but the task is extremely labor intensive and not scalable. Further research is needed using texts from more diverse clinical domains and more heterogeneous participants, including actual patients. Since comprehensibility of clinical text appears difficult to automate, informatics support tools may most productively support the health care professionals tasked with making clinical information understandable to patients. PMID:22138127

  20. Comparative clinical, roentgenological, scintigraphic and thermographic investigations in psoriasis arthropathica

    International Nuclear Information System (INIS)

    Loreck, D.; Lips, H.; Schulze, P.

    1988-01-01

    20 patients with psoriasis arthropatica and different duration of the articular symptoms were examined. Besides clinical investigation radiographs of both hands and feet (central and phalanges), scintigraphy of hands, feet and the sacroiliac joints as well as liquid crystal thermograhy of both hands were performed and the results are compared. The conclusions drawn characterize the diagnostic value of the methods. Scintigraphy as well as thermography are very good means for the early detection of psoriasis arthropathica. (author)

  1. An Investigation into the Clinical Reasoning Development of Veterinary Students.

    Science.gov (United States)

    Vinten, Claire E K; Cobb, Kate A; Freeman, Sarah L; Mossop, Liz H

    Clinical reasoning is a fundamental skill for veterinary clinicians and a competency required of graduates by the Royal College of Veterinary Surgeons. However, it is unknown how veterinary students develop reasoning skills and where strengths and shortcomings of curricula lie. This research aimed to use the University of Nottingham School of Veterinary Medicine and Science (SVMS) as a case study to investigate the development of clinical reasoning among veterinary students. The analysis was framed in consideration of the taught, learned, and declared curricula. Sixteen staff and sixteen students from the SVMS participated separately in a total of four focus groups. In addition, five interviews were conducted with recent SVMS graduates. Audio transcriptions were used to conduct a thematic analysis. A content analysis was performed on all curriculum documentation. It was found that SVMS graduates feel they have a good level of reasoning ability, but they still experience a deficit in their reasoning capabilities when starting their first job. Overarching themes arising from the data suggest that a lack of responsibility for clinical decisions during the program and the embedded nature of the clinical reasoning skill within the curriculum could be restricting development. In addition, SVMS students would benefit from clinical reasoning training where factors influencing "real life" decisions (e.g., finances) are explored in more depth. Integrating these factors into the curriculum could lead to improved decision-making ability among SVMS graduates and better prepare students for the stressful transition to practice. These findings are likely to have implications for other veterinary curricula.

  2. Critical care providers refer to information tools less during communication tasks after a critical care clinical information system introduction.

    Science.gov (United States)

    Ballermann, Mark; Shaw, Nicola T; Mayes, Damon C; Gibney, R T Noel

    2011-01-01

    Electronic documentation methods may assist critical care providers with information management tasks in Intensive Care Units (ICUs). We conducted a quasi-experimental observational study to investigate patterns of information tool use by ICU physicians, nurses, and respiratory therapists during verbal communication tasks. Critical care providers used tools less at 3 months after the CCIS introduction. At 12 months, care providers referred to paper and permanent records, especially during shift changes. The results suggest potential areas of improvement for clinical information systems in assisting critical care providers in ensuring informational continuity around their patients.

  3. When is there sufficient information from the Site Investigations?

    International Nuclear Information System (INIS)

    Andersson, Johan; Munier, Raymond; Stroem, Anders; Soederbaeck, Bjoern; Almen, Karl-Erik; Olsson, Lars

    2004-04-01

    SKB has started site investigations for a deep repository for spent nuclear fuel at two different sites in Sweden. The investigations should provide necessary information for a licence application aimed at starting underground exploration. The investigations and analyses of them are supposed to provide the broad knowledge base that is required to achieve the overall goals of the site investigation phase. The knowledge will be utilized to evaluate the suitability of investigated sites for the deep repository and must be comprehensive enough to: Show whether the selected site satisfies requirements on safety and technical aspects. Serve as a basis for adaptation of the deep repository to the characteristics of the site with an acceptable impact on society and the environment. Permit comparisons with other investigated sites. Furthermore, the investigations are discontinued when the reliability of the site description has reached such a level that the body of data for safety assessment and design is sufficient, or until the body of data shows that the rock does not satisfy the requirements. These objectives are valid, but do not provide sufficient and concrete guidance. For this reason SKB has conducted this project which should acquire concrete guidance on how to judge when the surface based Site Investigation Phase does not need to continue. After a general assessment of the problem, the following specific objectives of the current work were identified: Demonstrate concretely how the assessed uncertainties in a Site Description based on a specific level of investigations, together with expected feedback from Safety Assessment and Engineering, can be used to decide whether the site investigations are sufficient - or need to continue. This demonstration will be based on a practical application of relevant aspects of decision analysis tools. Highlight and make concrete the type of feedback to be expected from Safety Assessment and Engineering and show how this feedback

  4. Designing healthcare information technology to catalyse change in clinical care

    Directory of Open Access Journals (Sweden)

    William Lester

    2008-05-01

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

  5. CliniProteus: A flexible clinical trials information management system

    Science.gov (United States)

    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

  6. Prosody and informativity: A cross-linguistic investigation

    Science.gov (United States)

    Ouyang, Iris Chuoying

    the speaker and the interlocutor: speakers prosodically emphasize contextually probable corrections and the corrections in response to contextually improbable misstatements. Experiment 4 demonstrates the multi-functionality of prosody by investigating its discourse-level functions in Mandarin Chinese, a tone language where a word's prosodic patterns is crucial to its meaning. The results show that, although prosody serves fundamental, lexical-level functions in Mandarin Chinese, it nevertheless provides cues to information structure as well. Similar to what has been found with English, corrective information is prosodically more prominent than non-corrective information, and new information is prosodically more prominent than given information. Taken together, these experiments demonstrate the complex relationship between prosody and the different types of information it encodes in a given language. To better understand prosody, it is important to integrate insights from different traditions of research and to investigate across languages. In addition, the findings of this research suggest that speakers' assumptions about what their interlocutors know -- as well as speakers' ability to update these expectations -- play a key role in shaping the prosody of utterances. I hypothesize that prosodic prominence may reflect the gap between what speakers had expected their interlocutors to say and what their interlocutors have actually said.

  7. Young Investigator Program: Modular Paradigm for Scalable Quantum Information

    Science.gov (United States)

    2016-03-04

    actuator When both direct driving and a quantum controller are available, one can take advantage of both to achieve faster driving of the qubit. In...pointing to advantages to be found in particular geometries for larger quantum information architectures. • We investigated the effect of dephasing and...Montangero, T. Calarco, F. Nori, and M. B. Plenio, “Scal- able quantum computation via local control of only two qubits,” Phys. Rev. A, vol. 81, no. 4, p

  8. Changes in information behavior in clinical teams after introduction of a clinical librarian service

    Science.gov (United States)

    Urquhart, Christine; Turner, Janet; Durbin, Jane; Ryan, Jean

    2007-01-01

    Objectives: The eighteen-month evaluation of a clinical librarian project (October 2003–March 2005) conducted in North Wales, United Kingdom (UK) assessed the benefits of clinical librarian support to clinical teams, the impact of mediated searching services, and the effectiveness of information skills training, including journal club support. Methods: The evaluation assessed changes in teams' information-seeking behavior and their willingness to delegate searching to a clinical librarian. Baseline (n = 69 responses, 73% response rate) and final questionnaire (n = 57, 77% response rate) surveys were complemented by telephone and face-to-face interviews (n = 33) among 3 sites served. Those attending information skills training sessions (n = 130) completed evaluations at the session and were surveyed 1 month after training (n = 24 questionnaire responses, n = 12 interviews). Results: Health professionals in clinical teams reported that they were more willing to undertake their own searching, but also more willing to delegate some literature searching, than at the start of the project. The extent of change depended on the team and the type of information required. Information skills training was particularly effective when organized around journal clubs. Conclusions: Collaboration with a clinical librarian increased clinician willingness to seek information. Clinical librarian services should leverage structured training opportunities such as journal clubs. PMID:17252062

  9. Detecting clinically relevant new information in clinical notes across specialties and settings.

    Science.gov (United States)

    Zhang, Rui; Pakhomov, Serguei V S; Arsoniadis, Elliot G; Lee, Janet T; Wang, Yan; Melton, Genevieve B

    2017-07-05

    Automated methods for identifying clinically relevant new versus redundant information in electronic health record (EHR) clinical notes is useful for clinicians and researchers involved in patient care and clinical research, respectively. We evaluated methods to automatically identify clinically relevant new information in clinical notes, and compared the quantity of redundant information across specialties and clinical settings. Statistical language models augmented with semantic similarity measures were evaluated as a means to detect and quantify clinically relevant new and redundant information over longitudinal clinical notes for a given patient. A corpus of 591 progress notes over 40 inpatient admissions was annotated for new information longitudinally by physicians to generate a reference standard. Note redundancy between various specialties was evaluated on 71,021 outpatient notes and 64,695 inpatient notes from 500 solid organ transplant patients (April 2015 through August 2015). Our best method achieved at best performance of 0.87 recall, 0.62 precision, and 0.72 F-measure. Addition of semantic similarity metrics compared to baseline improved recall but otherwise resulted in similar performance. While outpatient and inpatient notes had relatively similar levels of high redundancy (61% and 68%, respectively), redundancy differed by author specialty with mean redundancy of 75%, 66%, 57%, and 55% observed in pediatric, internal medicine, psychiatry and surgical notes, respectively. Automated techniques with statistical language models for detecting redundant versus clinically relevant new information in clinical notes do not improve with the addition of semantic similarity measures. While levels of redundancy seem relatively similar in the inpatient and ambulatory settings in the Fairview Health Services, clinical note redundancy appears to vary significantly with different medical specialties.

  10. A qualitative investigation of the nature of "informal supervision" among therapists in training.

    Science.gov (United States)

    Coren, Sidney; Farber, Barry A

    2017-11-29

    This study investigated how, when, why, and with whom therapists in training utilize "informal supervision"-that is, engage individuals who are not their formally assigned supervisors in significant conversations about their clinical work. Participants were 16 doctoral trainees in clinical and counseling psychology programs. Semi-structured interviews were conducted and analyzed using the Consensual Qualitative Research (CQR) method. Seven domains emerged from the analysis, indicating that, in general, participants believe that informal and formal supervision offer many of the same benefits, including validation, support, and reassurance; freedom and safety to discuss doubts, anxieties, strong personal reactions to patients, clinical mistakes and challenges; and alternative approaches to clinical interventions. However, several differences also emerged between these modes of learning-for example, formal supervision is seen as more focused on didactics per se ("what to do"), whereas informal supervision is seen as providing more of a "holding environment." Overall, the findings of this study suggest that informal supervision is an important and valuable adjunctive practice by which clinical trainees augment their professional competencies. Recommendations are proposed for clinical practice and training, including the need to further specify the ethical boundaries of this unique and essentially unregulated type of supervision.

  11. Informal Leadership in the Clinical Setting: Occupational Therapist Perspectives

    Directory of Open Access Journals (Sweden)

    Clark Patrick Heard

    2018-04-01

    Full Text Available Background: Leadership is vital to clinical, organizational, and professional success. This has compelled a high volume of research primarily related to formal leadership concepts. However, as organizations flatten, eliminate departmental structures, or decentralize leadership structures the relevance of informal leaders has markedly enhanced. Methods: Using a qualitative phenomenological methodology consistent with interpretative phenomenological analysis, this study examines the impact of informal leadership in the clinical setting for occupational therapists. Data was collected through the completion of semi-structured interviews with 10 peer-identified informal occupational therapy leaders in Ontario, Canada. Collected data was transcribed verbatim and coded for themes by multiple coders. Several methods were employed to support trustworthiness. Results: The results identify that informal leaders are collaborative, accessible, and considered the “go to” staff. They demonstrate professional competence knowledge, experience, and accountability and are inspirational and creative. Practically, informal leaders organically shape the practice environment while building strength and capacity among their peers. Conclusion: Recommendations for supporting informal leaders include acknowledgement of the role and its centrality, enabling informal leaders time to undertake the role, and supporting consideration of informal leadership concepts at the curriculum and professional level.

  12. Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level.

    Science.gov (United States)

    Kim, Eun Jin; Kim, Su Hyun

    2015-06-01

    This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy. © The Author(s) 2015.

  13. Clinical and Para Clinical Information Needs of Infertility Electronic Health Records in Iran: A Delphi Study.

    Science.gov (United States)

    Farzandipour, Mehrdad; Jeddi, Fateme Rangraz; Gilasi, Hamid Reza; Shirzadi, Diana

    2017-09-01

    infertility is referred to the person's inability to conceive pregnancy after one year of intercourse without using protection. This study paves the ground for creating a complete, united, and coherent source of patients' medical information. this is an applied research of descriptive-cross sectional type which has been carried out through qualitative - quantitative methods. The sample of the present study was 50 specialists in the field of infertility which has been chosen based on purposive sampling method. Designing the questionnaire was done based on library studies and Gathering experts' views was done based on Delphi technique. 261 items from clinical and Para clinical information of infertile patients' electronic health records were subjected to an opinion poll by experts. During this process 223 items were accepted and 38 items have been rejected after two sessions of surveys by infertility experts. Para clinical information section consisted of 57 items that all of them have been accepted by the experts. Also, clinical information section consisted of 242 items from which 204 items were accepted and 38 items were rejected by the experts. existence of a structured electronic record system of infertile patients' information leads to the integration of patients' information, improvement of health care services and a decrease in treatment costs: all working to increase information safety. Furthermore, only essential and relevant information would be provided for the specialists and it will facilitate and direct the future infertility related studies due to the coherence, unity and relevance of the information.

  14. Informed consent for clinical trials: a review | Lema | East African ...

    African Journals Online (AJOL)

    Data sources: Published original research findings and reviews in the English literature, together with anecdotal information from our current professional experiences with clinical trials. Design: Review of peer-reviewed articles. Data extraction: Online searches were done and requests for reprints from corresponding ...

  15. The regulation of informed consent to participation in clinical ...

    African Journals Online (AJOL)

    participation in clinical research by mentally ill persons – the discussion on informed consent .... usually lay persons without scientific and medical knowledge. It is .... is not defined by the Mental Health Care Act; nor is it stated anywhere in the ...

  16. The value of pathogen information in treating clinical mastitis

    NARCIS (Netherlands)

    Cha, Elva; Smith, Rebecca L.; Kristensen, Anders R.; Hertl, Julia A.; Schukken, Ynte H.; Tauer, Loren W.; Welcome, Frank L.; Gröhn, Yrjö T.

    2016-01-01

    The objective of this study was to determine the economic value of obtaining timely and more accurate clinical mastitis (CM) test results for optimal treatment of cows. Typically CM is first identified when the farmer observes recognisable outward signs. Further information of whether the

  17. The value of pathogen information in treating clinical mastitis

    NARCIS (Netherlands)

    Cha, Elva; Smith, Rebecca L.; Kristensen, Anders R.; Hertl, Julia A.; Schukken, Ynte H.; Tauer, Loren W.; Welcome, Frank L.; Gröhn, Yrjö T.

    2016-01-01

    The objective of this study was to determine the economic value of obtaining timely and more accurate clinical mastitis (CM) test results for optimal treatment of cows. Typically CM is first identified when the farmer observes recognisable outward signs. Further information of whether the pathogen

  18. Clinical investigation on RBE estimation for heavy particle radiotherapy

    International Nuclear Information System (INIS)

    Tsuji, Hiroshi; Kamada, Tadashi; Yanagi, Takeshi; Mizoe, Junetsu; Tsujii, Hirohiko

    2004-01-01

    Analysis of the clinical updated data of the prostate cancer patients treated with carbon-ions was performed for the purpose of investigating the clinical relative biological effectiveness (RBE) values of carbon ion beams. Most of the patients received the carbon ion radiotherapy (C-ion RT) with the dose of 66.0 GyE/20 fractions. Probabilities of the late urethral morbidity and biochemical tumor control with this dose fractionation were calculated using the actual updated clinical data. The linear energy transfer (LET) values and physical carbon ion doses of urethra were obtained from treatment planning data. RBE values were calculated from the ratio of average carbon physical doses and photon doses which cause the same grade of urethra reaction with the same probabilities. Obtained RBE values were compared with the values that are being used in actual carbon ion radiotherapy in National Institute of Radiological Sciences (NIRS). In addition, relative RBE of carbon ion beams for biochemical tumor control was calculated using the data from the literature. As a result, the RBE values being used for the treatment were thought to be proper enough for both the urethra reaction and tumor control. (author)

  19. Physician capability to electronically exchange clinical information, 2011.

    Science.gov (United States)

    Patel, Vaishali; Swain, Matthew J; King, Jennifer; Furukawa, Michael F

    2013-10-01

    To provide national estimates of physician capability to electronically share clinical information with other providers and to describe variation in exchange capability across states and electronic health record (EHR) vendors using the 2011 National Ambulatory Medical Care Survey Electronic Medical Record Supplement. Survey of a nationally representative sample of nonfederal office-based physicians who provide direct patient care. The survey was administered by mail with telephone follow-up and had a 61% weighted response rate. The overall sample consisted of 4326 respondents. We calculated estimates of electronic exchange capability at the national and state levels, and applied multivariate analyses to examine the association between the capability to exchange different types of clinical information and physician and practice characteristics. In 2011, 55% of physicians had computerized capability to send prescriptions electronically; 67% had the capability to view lab results electronically; 42% were able to incorporate lab results into their EHR; 35% were able to send lab orders electronically; and, 31% exchanged patient clinical summaries with other providers. The strongest predictor of exchange capability is adoption of an EHR. However, substantial variation exists across geography and EHR vendors in exchange capability, especially electronic exchange of clinical summaries. In 2011, a majority of office-based physicians could exchange lab and medication data, and approximately one-third could exchange clinical summaries with patients or other providers. EHRs serve as a key mechanism by which physicians can exchange clinical data, though physicians' capability to exchange varies by vendor and by state.

  20. Information systems as a quality management tool in clinical laboratories

    Science.gov (United States)

    Schmitz, Vanessa; Rosecler Bez el Boukhari, Marta

    2007-11-01

    This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system.

  1. Information systems as a quality management tool in clinical laboratories

    International Nuclear Information System (INIS)

    Schmitz, Vanessa; Boukhari, Marta Rosecler Bez el

    2007-01-01

    This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system

  2. When is there sufficient information from the Site Investigations?

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan [JA Streamflow AB, Aelvsjoe (Sweden); Munier, Raymond; Stroem, Anders; Soederbaeck, Bjoern [Swedish Nuclear Fuel and Waste Management Co., Stockholm (Sweden); Almen, Karl-Erik [KEA Geo-konsult (Sweden); Olsson, Lars [Geostatistik AB, Tumba (Sweden)

    2004-04-01

    SKB has started site investigations for a deep repository for spent nuclear fuel at two different sites in Sweden. The investigations should provide necessary information for a licence application aimed at starting underground exploration. The investigations and analyses of them are supposed to provide the broad knowledge base that is required to achieve the overall goals of the site investigation phase. The knowledge will be utilized to evaluate the suitability of investigated sites for the deep repository and must be comprehensive enough to: Show whether the selected site satisfies requirements on safety and technical aspects. Serve as a basis for adaptation of the deep repository to the characteristics of the site with an acceptable impact on society and the environment. Permit comparisons with other investigated sites. Furthermore, the investigations are discontinued when the reliability of the site description has reached such a level that the body of data for safety assessment and design is sufficient, or until the body of data shows that the rock does not satisfy the requirements. These objectives are valid, but do not provide sufficient and concrete guidance. For this reason SKB has conducted this project which should acquire concrete guidance on how to judge when the surface based Site Investigation Phase does not need to continue. After a general assessment of the problem, the following specific objectives of the current work were identified: Demonstrate concretely how the assessed uncertainties in a Site Description based on a specific level of investigations, together with expected feedback from Safety Assessment and Engineering, can be used to decide whether the site investigations are sufficient - or need to continue. This demonstration will be based on a practical application of relevant aspects of decision analysis tools. Highlight and make concrete the type of feedback to be expected from Safety Assessment and Engineering and show how this feedback

  3. A Curriculum for Teaching Information Technology Investigative Techniques for Auditors

    Directory of Open Access Journals (Sweden)

    Grover S. Kearns

    2006-12-01

    Full Text Available Recent prosecutions of highly publicized white-collar crimes combined with public outrage have resulted in heightened regulation of financial reporting and greater emphasis on systems of internal control. Because both white-collar and cybercrimes are usually perpetrated through computers, internal and external auditors’ knowledge of information technology (IT is now more vital than ever. However, preserving digital evidence and investigative techniques, which can be essential to fraud examinations, are not skills frequently taught in accounting programs and instruction in the use of computer assisted auditing tools and techniques – applications that might uncover fraudulent activity – is limited. Only a few university-level accounting classes provide instruction in IT investigative techniques. This paper explains why such a course would be beneficial to the program, the college, and the student. Additionally, it presents a proposed curriculum and suggests useful resources for the instructor and student.

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

    Science.gov (United States)

    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. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  5. Spontaneously Reported Symptoms by Informants Are Associated with Clinical Severity in Dementia Help-Seekers.

    Science.gov (United States)

    Xu, Jia-Qi; Choy, Jacky C P; Tang, Jennifer Y M; Liu, Tian-Yin; Luo, Hao; Lou, Vivian W Q; Lum, Terry Y S; Wong, Gloria H Y

    2017-09-01

    To investigate the predictive value of symptoms of dementia that the person or an informant noticed spontaneously in determining the clinical severity of dementia. Cross-sectional. Community-based open-referral dementia assessment service in Hong Kong between 2005 and 2013. Help-seekers for dementia assessment service and their informants (N = 965 dyads). Participants underwent a clinical dementia interview based on the Clinical Dementia Rating. Spontaneous complaints that the person and the informant made that had prompted their help-seeking of groups with interview results suggestive of no impairment, mild cognitive impairment, and dementia were compared. Logistic regression was used to evaluate the predictive value of spontaneous complaints for clinical severity. Independent raters blinded to clinical results coded spontaneously reported symptoms into theoretical themes: memory, executive function, language, time and place orientation, neuropsychiatric, mood, and avolition. Memory problems were the most frequently reported complaints for participants (87.7%) and their informants (95.5%), followed by self-reported language (33.0%) and informant-reported orientation (33.0%) difficulties. Informant-reported but not self-reported symptoms predicted clinical severity. Compared with the persons themselves, informants reported more pervasive symptoms corresponding to clinical severity. Persons with dementia self-reported fewer types of symptoms than their healthy or mildly impaired counterparts. Spontaneously reported language and orientation symptoms by the informant distinguished persons with mild or worse dementia (P < .001, Nagelkerke coefficient of determination = 29.7%, percentage correct 85.6%). The type and pervasiveness of symptoms spontaneously that informants reported predicted clinical severity. This may provide a quick reference for triage. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  6. Human-Assisted Machine Information Exploitation: a crowdsourced investigation of information-based problem solving

    Science.gov (United States)

    Kase, Sue E.; Vanni, Michelle; Caylor, Justine; Hoye, Jeff

    2017-05-01

    The Human-Assisted Machine Information Exploitation (HAMIE) investigation utilizes large-scale online data collection for developing models of information-based problem solving (IBPS) behavior in a simulated time-critical operational environment. These types of environments are characteristic of intelligence workflow processes conducted during human-geo-political unrest situations when the ability to make the best decision at the right time ensures strategic overmatch. The project takes a systems approach to Human Information Interaction (HII) by harnessing the expertise of crowds to model the interaction of the information consumer and the information required to solve a problem at different levels of system restrictiveness and decisional guidance. The design variables derived from Decision Support Systems (DSS) research represent the experimental conditions in this online single-player against-the-clock game where the player, acting in the role of an intelligence analyst, is tasked with a Commander's Critical Information Requirement (CCIR) in an information overload scenario. The player performs a sequence of three information processing tasks (annotation, relation identification, and link diagram formation) with the assistance of `HAMIE the robot' who offers varying levels of information understanding dependent on question complexity. We provide preliminary results from a pilot study conducted with Amazon Mechanical Turk (AMT) participants on the Volunteer Science scientific research platform.

  7. Information needs for the rapid response team electronic clinical tool.

    Science.gov (United States)

    Barwise, Amelia; Caples, Sean; Jensen, Jeffrey; Pickering, Brian; Herasevich, Vitaly

    2017-10-02

    Information overload in healthcare is dangerous. It can lead to critical errors and delays. During Rapid Response Team (RRT) activations providers must make decisions quickly to rescue patients from physiological deterioration. In order to understand the clinical data required and how best to present that information in electronic systems we aimed to better assess the data needs of providers on the RRT when they respond to an event. A web based survey to evaluate clinical data requirements was created and distributed to all RRT providers at our institution. Participants were asked to rate the importance of each data item in guiding clinical decisions during a RRT event response. There were 96 surveys completed (24.5% response rate) with fairly even distribution throughout all clinical roles on the RRT. Physiological data including heart rate, respiratory rate, and blood pressure were ranked by more than 80% of responders as being critical information. Resuscitation status was also considered critically useful by more than 85% of providers. There is a limited dataset that is considered important during an RRT. The data is widely available in EMR. The findings from this study could be used to improve user-centered EMR interfaces.

  8. Tools in a clinical information system supporting clinical trials at a Swiss University Hospital.

    Science.gov (United States)

    Weisskopf, Michael; Bucklar, Guido; Blaser, Jürg

    2014-12-01

    Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient-trial-assignment-tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of

  9. [Informed consent process in clinical trials: Insights of researchers, patients and general practitioners].

    Science.gov (United States)

    Giménez, Nuria; Pedrazas, David; Redondo, Susana; Quintana, Salvador

    2016-10-01

    Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. GPs, researchers and patients involved in clinical trials. Included, 504 GPs, 108 researchers, and 71 patients. Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  10. Sesame seed allergy: Clinical manifestations and laboratory investigations

    Directory of Open Access Journals (Sweden)

    Fazlollahi MR.

    2007-10-01

    Full Text Available Background: Plant-origin foods are among the most important sources of food allergic reactions. An increase in the incidence of sesame seed allergy among children and adults has been reported in recent years. The aim of this preliminary study was to investigate the prevalence, importance and clinical manifestations of sesame allergy among Iranian patients.Methods: In a cross-sectional survey, 250 patients with suspected IgE-mediated food allergies completed a questionnaire and underwent skin prick tests with sesame extract as well as cross-reacting foods (walnut, soya and peanut. Total IgE and sesame-specific IgE levels were measured. Patients with positive skin test reactions and/or IgE specific for sesame without clinical symptoms were considered sensitive to sesame. The patients who also had clinical symptoms with sesame consumption were diagnosed as allergic to sesame.Results: Of the 250 patients enrolled in this study, 129 were male and 121 female, with a mean age of 11.7 years. The most common food allergens were cow's milk, egg, curry, tomato and sesame. Sesame sensitivity was found in 35 patients (14.1%. Only five patients (2% had sesame allergy. Sesame-sensitive patients had a significantly higher frequency of positive prick test to cross-reacting foods when compared to non-sensitized patients (p=0.00. The type of symptom was independent of gender and age of the patients, but urticaria and dermatitis-eczema were significantly more frequent in sensitized patients (p=0.008.Conclusions: This is the first study addressing the prevalence of sesame seed allergy in Iranian population. We found sesame to be a common and important cause of food allergy. The panel of foods recommended for use in diagnostic allergy tests should be adjusted.

  11. [Clinical investigation of the positioning accuracy of acute pulpitis pain].

    Science.gov (United States)

    Wang, Jin; Sun, Wei; Ji, Aiping

    2013-10-01

    This study aims to investigate the positioning accuracy of acute pulpitis pain and its possible factors. The clinical symptoms and physical signs of 3 432 cases of acute pulpitis were recorded and analyzed by using questionnaire forms, which included age, gender, tooth position, infection origin, pain history, time of acute attack, duration and nature of pain, pain frequency, referred pain areas, percussion examination, temperature pulp test, pulp bleeding, and positioning accuracy. Univariate analysis and multivariate stepwise regression analysis were used for data processing. Pain location was accurately identified by 39.1% of the patients with acute pulpitis. Referred pain could reduce the positioning accuracy of pain (P 0.05). Some cases of acute pulpitis pain can be located accurately. Referred pain and periodontium infection origin are related to the positioning accuracy of acute pulpitis pain. The exact cause of this correlation needs further study.

  12. Clinical Investigation of Radiation Retinopathy Fundus and Fluorescein Angiographic Features

    Institute of Scientific and Technical Information of China (English)

    LiMei; QiuGT

    1999-01-01

    Purpose:To investigate the fundus and fluorescein angiographic features in the patients with radiation retinopathy.Clinical Materials:Color fundus photography and/or fluorescein angiography from 13 patients with nasopharyngeal carcinomas received external beam radiation were retrospectively analyzed.Reslts:In this study,26 damaged eyes of 13 patients eveloped some degree of radiation retinopathy.The earliest and most common finding was macular microvascular changes (microaneurysms and/or telangiectasia),which was observed in 100%(26/26)of the eyes.Intraretinal hemorrhages,macular capillary nonperfusion,and macular edema were noted in 84%,50%,and 42% of the eyes,respectively.Conclusions:Radiation retinopathy is common after external beam radiation of nasopharyngeal carcinomas.The prominent changes include maular microvascular changes,intraretinal hemorrhages and macular capillary nonperfusion.

  13. [The role of gonadal peptides in clinical investigation].

    Science.gov (United States)

    Lahlou, N; Bouvattier, C; Linglart, A; Rodrigue, D; Teinturier, C

    2009-01-01

    Inhibins, activins, and anti-Mullerian hormone (AMH) are gonadal dimeric peptides produced in ovaries and testes by homologous cells, granulosa cells and Sertoli cells, respectively. The production of inhibins is driven by FSH, that of AMH may indirectly depends on FSH, while it is down regulated, at least in the male, by testosterone. In the past decade, measurements of serum inhibin and AMH have provided useful tools for clinical investigation in gonadal disorders: pseudohermaphroditism, androgen insensitivity, anorchidism, gonadal dysgenesis, disorders of pubertal developpement. Inhibins, activins, and AMH are also reliable markers of gonadal tumors. They are extensively used as indexes of fertility: in the male the production of inhibin B reflects the spermatogenetic activity, in women both inhibin B and AMH levels are correlated with the number of preantral and early antral follicles and reflect the ovarian reserve of follicles available for recruitment.

  14. Clinical investigation of 14C-urea breath test

    International Nuclear Information System (INIS)

    Yu Yongli; Zhu Ruisen; Ji Hong; Luo Quanyong

    2000-01-01

    To investigate clinical value of 14 C-urea breath test ( 14 C-UBT) for the diagnosis of Helicobacter pylori(Hp), 70 patients were both performed gastroscopy (taking gastric mucosae biopsy for rapid urease test and histology) and 14 C-UBT (some patients by Hp-IgG or DNAHp test also) within two days. The positive cases of both rapid urease test and histology was defined as 'gold standard' of Hp-positive, whereas the negative cases of both rapid urease test and histology as 'gold standard' of Hp-negative. The sensitivity of 14 C-UBT was 93.2%, the specificity 73.1%, and the diagnostic accuracy 85.7%. The difference (comparing with 'gold standard') was not marked (x 2 = 0.9 0.05(1) 2 = 3.84, P>0.05). But the diagnostic accuracy of 14 C-UBT (85.7%) and Hp-IgG (50%) had a marked difference (x 2 13.80>x 0.01(1) 2 = 6.64, P 14 C-UBT was easy to operate, reliable and suitable for clinical application

  15. Basic and clinical investigation of T3 immunoassay kit

    International Nuclear Information System (INIS)

    Konishi, Junji; Nakajima, Akiko; Morita, Rikushi; Endo, Keigo; Ikekubo, Katsuji

    1976-01-01

    T 3 immunoassay kit was investigated basically and clinically. A good result was obtained at the prescribed incubation temperature and for 16 hours of incubation time. Moreover, it was thought to be possible that incubation time could be shortened to 1 - 4 hours at 37 0 C. Specificity of antibody was good. Recovery of added T 3 was 100+-5 (S.D.) % on an average and parallel of dilution curve of high T 3 serum was also good. Variation coefficient of accuracy of this kit was 1.5 - 2.1 % and that of reproducibility was 1.3 - 6.6 %. Mild hemolysis did not affect measurement value. Serum T 3 level in normals, untreated patients with Basedow's disease and patients with primary hypothyroidism was 142+-21 ng/100 ml, 452+-156 ng/100 ml and 67+-17 ng/100 ml, respectively. Serum T 3 level in patients with Hashimoto's disease was distributed to a wide extent, but that of patients with goiter and simple goiter ranged within normal range. On the other side, serum T 3 level of normal pregnant woman was high and that of patients with anorexia nervosa showed low level. From the above mentioned results, it was concluded that this kit was simple in method and good in sensitivity, specificity and reproducibility and it was also useful for clinical applications. (M. Tsunoda)

  16. Clinical information system based on the medical smart card.

    Science.gov (United States)

    Danon, Y L; Saiag, E

    2000-07-01

    Over the last 5 years Israel has implemented a nationwide health insurance plan covering the entire population of the country. We have developed a clinical information system based on electronic-chip health care medical smart cards. Health care cards are used in several European countries and chip smart cards have been successful in many sectors. Our project involves the community use of the MSC, thereby enabling health care professionals to skillfully employ card systems in the health care sector. This system can easily arrange electronic medical charts in clinics, facilitating the confidential sharing of personal health databases among health professionals. To develop an MSC applicable for daily use in the community and hospital system. The MSC project, currently underway in Israel and the USA, will aid in determining the costs, benefits and feasibility of the MSC. Successful implementation of the MSC in chosen clinics will promote a nationwide willingness to adopt this promising technology.

  17. Federally qualified health center dental clinics: financial information.

    Science.gov (United States)

    Bailit, Howard L; Devitto, Judy; Myne-Joslin, Ronnie; Beazoglou, Tryfon; McGowan, Taegan

    2013-01-01

    Federally Qualified Health Center (FQHC) dental clinics are a major component of the dental safety net system, providing care to 3.75 million patients annually. This study describes the financial and clinical operations of a sample of FQHCs. In cooperation with the National Network for Oral Health Access, FQHC dental clinics that could provide 12 months of electronic dental record information were asked to participate in the study. Based on data from 28 dental clinics (14 FQHCs), 50 percent of patients were under 21 years of age. The primary payers were Medicaid (72.4 percent) and sliding-scale/self-pay patients (17.5 percent). Sites averaged 3.1 operatories, 0.66 dental hygienists, and 1.9 other staff per dentist. Annually, each FTE dentist and hygienist provided 2,801 and 2,073 patient visits, respectively. Eighty percent of services were diagnostic, preventive, and restorative. Patient care accounted for 82 percent of revenues, and personnel (64.2 percent) and central administration (13.4 percent) accounted for most expenses. Based on a small convenience sample of FQHC dental clinics, this study presents descriptive data on their clinical and financial operations. Compared with data from the UDS (Uniform Data System) report, study FQHCs were larger in terms of space, staff, and patients served. However, there was substantial variation among clinics for almost all measures. As the number and size of FQHC dental clinics increase, the Health Resources and Services Administration needs to provide them access to comparative data that they can use to benchmark their operations. © 2013 American Association of Public Health Dentistry.

  18. The value of pathogen information in treating clinical mastitis.

    Science.gov (United States)

    Cha, Elva; Smith, Rebecca L; Kristensen, Anders R; Hertl, Julia A; Schukken, Ynte H; Tauer, Loren W; Welcome, Frank L; Gröhn, Yrjö T

    2016-11-01

    The objective of this study was to determine the economic value of obtaining timely and more accurate clinical mastitis (CM) test results for optimal treatment of cows. Typically CM is first identified when the farmer observes recognisable outward signs. Further information of whether the pathogen causing CM is Gram-positive, Gram-negative or other (including no growth) can be determined by using on-farm culture methods. The most detailed level of information for mastitis diagnostics is obtainable by sending milk samples for culture to an external laboratory. Knowing the exact pathogen permits the treatment method to be specifically targeted to the causation pathogen, resulting in less discarded milk. The disadvantages are the additional waiting time to receive test results, which delays treating cows, and the cost of the culture test. Net returns per year (NR) for various levels of information were estimated using a dynamic programming model. The Value of Information (VOI) was then calculated as the difference in NR using a specific level of information as compared to more detailed information on the CM causative agent. The highest VOI was observed where the farmer assumed the pathogen causing CM was the one with the highest incidence in the herd and no pathogen specific CM information was obtained. The VOI of pathogen specific information, compared with non-optimal treatment of Staphylococcus aureus where recurrence and spread occurred due to lack of treatment efficacy, was $20.43 when the same incorrect treatment was applied to recurrent cases, and $30.52 when recurrent cases were assumed to be the next highest incidence pathogen and treated accordingly. This indicates that negative consequences associated with choosing the wrong CM treatment can make additional information cost-effective if pathogen identification is assessed at the generic information level and if the pathogen can spread to other cows if not treated appropriately.

  19. Combining Clinical Information and Patient Reported Outcome Measures in Orthopaedic Surgery and Sports Medicine

    NARCIS (Netherlands)

    Kampen, D.A. van

    2013-01-01

    In this thesis we investigated the use of clinical information and Patient Reported Outcome Measures (PROMs) for patient evaluation in orthopaedic surgery and sports medicine. In the first part, we showed that the Dutch version of the Simple Shoulder Test (SST) is a valid and reliable

  20. Information Content in Radio Waves: Student Investigations in Radio Science

    Science.gov (United States)

    Jacobs, K.; Scaduto, T.

    2013-12-01

    We describe an inquiry-based instructional unit on information content in radio waves, created in the summer of 2013 as part of a MIT Haystack Observatory (Westford, MA) NSF Research Experiences for Teachers (RET) program. This topic is current and highly relevant, addressing science and technical aspects from radio astronomy, geodesy, and atmospheric research areas as well as Next Generation Science Standards (NGSS). Projects and activities range from simple classroom demonstrations and group investigations, to long term research projects incorporating data acquisition from both student-built instrumentation as well as online databases. Each of the core lessons is applied to one of the primary research centers at Haystack through an inquiry project that builds on previously developed units through the MIT Haystack RET program. In radio astronomy, students investigate the application of a simple and inexpensive software defined radio chip (RTL-SDR) for use in systems implementing a small and very small radio telescope (SRT and VSRT). Both of these systems allow students to explore fundamental principles of radio waves and interferometry as applied to radio astronomy. In ionospheric research, students track solar storms from the initial coronal mass ejection (using Solar Dynamics Observatory images) to the resulting variability in total electron density concentrations using data from the community standard Madrigal distributed database system maintained by MIT Haystack. Finally, students get to explore very long-baseline interferometry as it is used in geodetic studies by measuring crustal plate displacements over time. Alignment to NextGen standards is provided for each lesson and activity with emphasis on HS-PS4 'Waves and Their Applications in Technologies for Information Transfer'.

  1. Atomoxetine for hoarding disorder: A pre-clinical and clinical investigation.

    Science.gov (United States)

    Grassi, Giacomo; Micheli, Laura; Di Cesare Mannelli, Lorenzo; Compagno, Elisa; Righi, Lorenzo; Ghelardini, Carla; Pallanti, Stefano

    2016-12-01

    Despite several studies suggested that inattention and impulsivity-compulsivity could represent two core dimensions of hoarding disorder (HD), only a small case series study investigated the effectiveness of attention-deficit-hyperactivity-disorder (ADHD) medications in HD. The aim of the present study was to target attentional and inhibitory control networks in HD patients through the ADHD medication atomoxetine, moving from a preclinical investigation on an animal model of compulsive-like behavior (marble burying test) to a clinical investigation on both medicated and unmedicated patients with a primary diagnosis of HD without ADHD. Our preclinical investigation showed that acute administration of atomoxetine significantly reduced the compulsive-like behaviours of mice in the marble burying test without affecting neither locomotor activity and coordination nor exploration behaviours. When compared, atomoxetine and fluoxetine showed similar effects on the marble burying test. However, fluoxetine impaired both locomotor and exploratory activity. In our clinical investigation 12 patients were enrolled and 11 patients completed an open trial with atomoxetine at flexible dose (40-80 mg) for 12 weeks. At the endpoint the mean UCLA Hoarding Severity Scale score decreased by 41.3% for the whole group (p = 0003). Six patients were classified as full responders (mean symptom reduction of 57.2%) and three patients as partial responders (mean symptom reduction of 27.3%). Inattentive and impulsivity symptoms showed a significant mean score reduction of 18.5% from baseline to the endpoint (F (1,9) = 20.9, p = 0.0013). Hoarding symptoms improvement was correlated to reduction of patients' disability and increased in their global functioning. These preclinical and clinical data suggest that atomoxetine may be effective for HD and therefore should be considered for future controlled trials. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Dosimetry investigation of MOSFET for clinical IMRT dose verification.

    Science.gov (United States)

    Deshpande, Sudesh; Kumar, Rajesh; Ghadi, Yogesh; Neharu, R M; Kannan, V

    2013-06-01

    In IMRT, patient-specific dose verification is followed regularly at each centre. Simple and efficient dosimetry techniques play a very important role in routine clinical dosimetry QA. The MOSFET dosimeter offers several advantages over the conventional dosimeters such as its small detector size, immediate readout, immediate reuse, multiple point dose measurements. To use the MOSFET as routine clinical dosimetry system for pre-treatment dose verification in IMRT, a comprehensive set of experiments has been conducted, to investigate its linearity, reproducibility, dose rate effect and angular dependence for 6 MV x-ray beam. The MOSFETs shows a linear response with linearity coefficient of 0.992 for a dose range of 35 cGy to 427 cGy. The reproducibility of the MOSFET was measured by irradiating the MOSFET for ten consecutive irradiations in the dose range of 35 cGy to 427 cGy. The measured reproducibility of MOSFET was found to be within 4% up to 70 cGy and within 1.4% above 70 cGy. The dose rate effect on the MOSFET was investigated in the dose rate range 100 MU/min to 600 MU/min. The response of the MOSFET varies from -1.7% to 2.1%. The angular responses of the MOSFETs were measured at 10 degrees intervals from 90 to 270 degrees in an anticlockwise direction and normalized at gantry angle zero and it was found to be in the range of 0.98 ± 0.014 to 1.01 ± 0.014. The MOSFETs were calibrated in a phantom which was later used for IMRT verification. The measured calibration coefficients were found to be 1 mV/cGy and 2.995 mV/cGy in standard and high sensitivity mode respectively. The MOSFETs were used for pre-treatment dose verification in IMRT. Nine dosimeters were used for each patient to measure the dose in different plane. The average variation between calculated and measured dose at any location was within 3%. Dose verification using MOSFET and IMRT phantom was found to quick and efficient and well suited for a busy radiotherapy

  3. Clinical dosimetry in photon radiotherapy. A Monte Carlo based investigation

    International Nuclear Information System (INIS)

    Wulff, Joerg

    2010-01-01

    Practical clinical dosimetry is a fundamental step within the radiation therapy process and aims at quantifying the absorbed radiation dose within a 1-2% uncertainty. To achieve this level of accuracy, corrections are needed for calibrated and air-filled ionization chambers, which are used for dose measurement. The procedures of correction are based on cavity theory of Spencer-Attix and are defined in current dosimetry protocols. Energy dependent corrections for deviations from calibration beams account for changed ionization chamber response in the treatment beam. The corrections applied are usually based on semi-analytical models or measurements and are generally hard to determine due to their magnitude of only a few percents or even less. Furthermore the corrections are defined for fixed geometrical reference-conditions and do not apply to non-reference conditions in modern radiotherapy applications. The stochastic Monte Carlo method for the simulation of radiation transport is becoming a valuable tool in the field of Medical Physics. As a suitable tool for calculation of these corrections with high accuracy the simulations enable the investigation of ionization chambers under various conditions. The aim of this work is the consistent investigation of ionization chamber dosimetry in photon radiation therapy with the use of Monte Carlo methods. Nowadays Monte Carlo systems exist, which enable the accurate calculation of ionization chamber response in principle. Still, their bare use for studies of this type is limited due to the long calculation times needed for a meaningful result with a small statistical uncertainty, inherent to every result of a Monte Carlo simulation. Besides heavy use of computer hardware, techniques methods of variance reduction to reduce the needed calculation time can be applied. Methods for increasing the efficiency in the results of simulation were developed and incorporated in a modern and established Monte Carlo simulation environment

  4. Text de-identification for privacy protection: a study of its impact on clinical text information content.

    Science.gov (United States)

    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

  5. An integrated clinical and genomic information system for cancer precision medicine.

    Science.gov (United States)

    Jang, Yeongjun; Choi, Taekjin; Kim, Jongho; Park, Jisub; Seo, Jihae; Kim, Sangok; Kwon, Yeajee; Lee, Seungjae; Lee, Sanghyuk

    2018-04-20

    Increasing affordability of next-generation sequencing (NGS) has created an opportunity for realizing genomically-informed personalized cancer therapy as a path to precision oncology. However, the complex nature of genomic information presents a huge challenge for clinicians in interpreting the patient's genomic alterations and selecting the optimum approved or investigational therapy. An elaborate and practical information system is urgently needed to support clinical decision as well as to test clinical hypotheses quickly. Here, we present an integrated clinical and genomic information system (CGIS) based on NGS data analyses. Major components include modules for handling clinical data, NGS data processing, variant annotation and prioritization, drug-target-pathway analysis, and population cohort explorer. We built a comprehensive knowledgebase of genes, variants, drugs by collecting annotated information from public and in-house resources. Structured reports for molecular pathology are generated using standardized terminology in order to help clinicians interpret genomic variants and utilize them for targeted cancer therapy. We also implemented many features useful for testing hypotheses to develop prognostic markers from mutation and gene expression data. Our CGIS software is an attempt to provide useful information for both clinicians and scientists who want to explore genomic information for precision oncology.

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

    Directory of Open Access Journals (Sweden)

    In Young Choi

    2013-12-01

    Full Text Available 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.

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

    Directory of Open Access Journals (Sweden)

    Patricia A. Abbott

    2012-01-01

    Full Text Available 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.

  8. Investigation Clinical Competence and Its Relationship with Professional Ethics and Spiritual Health in Nurses

    Directory of Open Access Journals (Sweden)

    Elahe Ramezanzade Tabriz

    2017-03-01

    Full Text Available Abstract Background and Objectives: Study of clinical competence in nursing helps determine the quality of health care delivered to patients. Given the priority of observance of principles over caretaking and necessity of spirituality existence at the core of health care provision, this study was conducted to investigate clinical competence and its relationship with professional ethics and spiritual health in nurses. Methods: In this cross-sectional, descriptive, and correlational study, 281 nurses were enrolled by consensus sampling. Sampling was conducted from February, 2016 till June, 2016. The data were gathered by a demographics questionnaire, a self-assessment scale of clinical competence, a nursing ethics questionnaire, and a spiritual health questionnaire, and analyzed by descriptive statistics and t-test, Pearson's correlation coefficient, ANOVA, and linear regression analysis in SPSS 21. Results: The total scores for self-assessment scale of nurses' clinical competence, professional ethics, and spiritual health were moderate. In the light of the results of Spearman's correlation coefficient, there was a significant and positive correlation between clinical competence and spiritual health. Moreover, a significant positive correlation was observed between professional ethics and spiritual health but there was no correlation between professional ethics and clinical competence. Conclusion: Managers' and personnel's Knowledge about the level of nurses clinical competence, professional ethics, and spiritual health in teaching health care centers provides valuable information to develop in-service and efficacious education programs and ultimately to improve the quality of nursing services.

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

    Science.gov (United States)

    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. © The Author(s) 2015.

  10. Good clinical practice regulatory inspections: Lessons for Indian investigator sites

    Directory of Open Access Journals (Sweden)

    R Marwah

    2010-01-01

    Full Text Available Regulatory inspections are important to evaluate the integrity of the data submitted to health authorities (HAs, protect patient safety, and assess adequacy of site/sponsor quality systems to achieve the same. Inspections generally occur after submission of data for marketing approval of an investigational drug. In recent years, there has been a significant increase in number of inspections by different HAs, including in India. The assessors/inspectors generally do a thorough review of site data before inspections. All aspects of ICH-GCP, site infrastructure, and quality control systems are assessed during the inspection. Findings are discussed during the close out meeting and a detailed inspection report issued afterward, which has to be responded to within 15-30 days with effective Corrective and Preventive Action Plan (CAPA. Protocol noncompliance, inadequate/inaccurate records, inadequate drug accountability, informed consent issues, and adverse event reporting were some of the most common findings observed during recent Food and Drug Administration (FDA inspections. Drug development is being increasingly globalized and an increased number of patients enrolled in studies submitted as part of applications come from all over the world including India. Because of the steep increase in research activity in the country, inexperienced sites, and more stakeholders, increased efforts will be required to ensure continuous quality and compliance. HAs have also made clear that enforcement will be increased and be swift, aggressive, and effective.

  11. Grounded theory for radiotherapy practitioners: Informing clinical practice

    International Nuclear Information System (INIS)

    Walsh, N.A.

    2010-01-01

    Radiotherapy practitioners may be best placed to undertake qualitative research within the context of cancer, due to specialist knowledge of radiation treatment and sensitivity to radiotherapy patient's needs. The grounded theory approach to data collection and analysis is a unique method of identifying a theory directly based on data collected within a clinical context. Research for radiotherapy practitioners is integral to role expansion within the government's directive for evidence-based practice. Due to the paucity of information on qualitative research undertaken by radiotherapy radiographers, this article aims to assess the potential impact of qualitative research on radiotherapy patient and service outcomes.

  12. A Framework for Adaptive Information Security Systems : A Holistic Investigation

    OpenAIRE

    Mwakalinga, Jeffy

    2011-01-01

    This research proposes a framework for adaptive information security systems that considers both the technical and social aspects of information systems security. Initial development of information systems security focused on computer technology and communication protocols. Researchers and designers did not consider culture, traditions, ethics, and other social issues of the people using the systems when designing and developing information security systems. They also seemed to ignore environ...

  13. Using information management to implement a clinical resource management program.

    Science.gov (United States)

    Rosenstein, A H

    1997-12-01

    This article provides a consultant's account of a 250-bed community hospital's experience in implementing the Clinical Resource Management (CRM) program, a four-stage process of using information to identify opportunities for improvement, developing an effective resource management team, implementing process improvement activities, and measuring the impact on outcomes of care. CASE STUDY EXAMPLE--CONGESTIVE HEART FAILURE: The chair of the departments of internal medicine and family practice selected congestive heart failure for in-depth study. A task force focused on treatment and patient disposition in the emergency room (ER), where most of the nonelective admissions originated. A set of standardized ER orders was developed that emphasized rapid and effective diuresis through the initiation of a progressive diuretic dosing schedule directly linked to patient response. Factors critical to the success of the CRM program included allocating adequate time to promote and sell the value and importance of the program, as well as securing the support of both information systems and physicians. The main barriers to success involved limitations in the information system infrastructure and delays attributable to committee review. Short-term results from the CRM program were encouraging, with average lengths of stay reduced by 0.5 days and average costs of care reduced by 12% for the ten diagnoses studied with no adverse results. Nonstudy diagnoses showed no notable improvement. Recognizing the growing importance of information management not only for clinical decision support but for accommodating all the necessary internal and external reporting requirements will require a significant commitment and investment in technology and personnel resources.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Identifying developmental features in students' clinical reasoning to inform teaching.

    Science.gov (United States)

    Pinnock, Ralph; Anakin, Megan; Lawrence, Julie; Chignell, Helen; Wilkinson, Tim

    2018-04-27

    There is increasing evidence that students at different levels of training may benefit from different methods of learning clinical reasoning. Two of the common methods of teaching are the "whole - case" format and the "serial cue" approach. There is little empirical evidence to guide teachers as to which method to use and when to introduce them. We observed 23 students from different stages of training to examine how they were taking a history and how they were thinking whilst doing this. Each student interviewed a simulated patient who presented with a straightforward and a complex presentation. We inferred how students were reasoning from how they took a history and how they described their thinking while doing this. Early in their training students can only take a generic history. Only later in training are they able to take a focused history, remember the information they have gathered, use it to seek further specific information, compare and contrast possibilities and analyze their data as they are collecting it. Early in their training students are unable to analyze data during history taking. When they have started developing illness scripts, they are able to benefit from the "serial cue" approach of teaching clinical reasoning.

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

    Science.gov (United States)

    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.

  18. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Science.gov (United States)

    2013-02-26

    ... marketing applications, (2) what is meant by ``due diligence'' in obtaining financial disclosures from...: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

  19. Hospital clinicians' information behaviour and attitudes towards the 'Clinical Informationist': an Irish survey.

    LENUS (Irish Health Repository)

    Flynn, Maura G

    2012-02-01

    BACKGROUND: Hospital clinicians are increasingly expected to practice evidence-based medicine (EBM) in order to minimize medical errors and ensure quality patient care, but experience obstacles to information-seeking. The introduction of a Clinical Informationist (CI) is explored as a possible solution. AIMS: This paper investigates the self-perceived information needs, behaviour and skill levels of clinicians in two Irish public hospitals. It also explores clinicians\\' perceptions and attitudes to the introduction of a CI into their clinical teams. METHODS: A questionnaire survey approach was utilised for this study, with 22 clinicians in two hospitals. Data analysis was conducted using descriptive statistics. RESULTS: Analysis showed that clinicians experience diverse information needs for patient care, and that barriers such as time constraints and insufficient access to resources hinder their information-seeking. Findings also showed that clinicians struggle to fit information-seeking into their working day, regularly seeking to answer patient-related queries outside of working hours. Attitudes towards the concept of a CI were predominantly positive. CONCLUSION: This paper highlights the factors that characterise and limit hospital clinicians\\' information-seeking, and suggests the CI as a potentially useful addition to the clinical team, to help them to resolve their information needs for patient care.

  20. Clinical Investigations and Management of Refractive Changes in ...

    African Journals Online (AJOL)

    AJRH Managing Editor

    Pregnancy: A Case Report ... condition therefore requires clinical observation and monitoring until the resolution of the serous detachment is ... bilateral involvement in 40% cases of CSCR. .... edema, acute hypertensive retinopathy, retinal.

  1. Proteogenomic Investigation of Strain Variation in Clinical Mycobacterium tuberculosis Isolates

    KAUST Repository

    Heunis, Tiaan; Dippenaar, Anzaan; Warren, Robin M.; van Helden, Paul D.; van der Merwe, Ruben G.; Gey van Pittius, Nicolaas C.; Pain, Arnab; Sampson, Samantha L.; Tabb, David L.

    2017-01-01

    Mycobacterium tuberculosis consists of a large number of different strains that display unique virulence characteristics. Whole-genome sequencing has revealed substantial genetic diversity among clinical M. tuberculosis isolates, and elucidating the phenotypic variation encoded by this genetic diversity will be of utmost importance to fully understand M. tuberculosis biology and pathogenicity. In this study we integrated whole-genome sequencing and mass spectrometry (GeLC-MS/MS) to reveal strain-specific characteristics in the proteomes of two clinical M. tuberculosis Latin American-Mediterranean isolates. Using this approach we identified 59 peptides containing single amino acid variants, which covered ~9% of all total coding nonsynonymous single nucleotide variants detected by whole-genome sequencing. Furthermore, we identified 29 distinct peptides that mapped to a hypothetical protein not present in the M. tuberculosis H37Rv reference proteome. Here we provide evidence for the expression of this protein in the clinical M. tuberculosis SAWC3651 isolate. The strain-specific databases enabled confirmation of genomic differences (i.e. large genomic regions of difference and nonsynonymous single nucleotide variants) in these two clinical M. tuberculosis isolates and allowed strain differentiation at the proteome level. Our results contribute to the growing field of clinical microbial proteogenomics and can improve our understanding of phenotypic variation in clinical M. tuberculosis isolates.

  2. Proteogenomic Investigation of Strain Variation in Clinical Mycobacterium tuberculosis Isolates

    KAUST Repository

    Heunis, Tiaan

    2017-08-18

    Mycobacterium tuberculosis consists of a large number of different strains that display unique virulence characteristics. Whole-genome sequencing has revealed substantial genetic diversity among clinical M. tuberculosis isolates, and elucidating the phenotypic variation encoded by this genetic diversity will be of utmost importance to fully understand M. tuberculosis biology and pathogenicity. In this study we integrated whole-genome sequencing and mass spectrometry (GeLC-MS/MS) to reveal strain-specific characteristics in the proteomes of two clinical M. tuberculosis Latin American-Mediterranean isolates. Using this approach we identified 59 peptides containing single amino acid variants, which covered ~9% of all total coding nonsynonymous single nucleotide variants detected by whole-genome sequencing. Furthermore, we identified 29 distinct peptides that mapped to a hypothetical protein not present in the M. tuberculosis H37Rv reference proteome. Here we provide evidence for the expression of this protein in the clinical M. tuberculosis SAWC3651 isolate. The strain-specific databases enabled confirmation of genomic differences (i.e. large genomic regions of difference and nonsynonymous single nucleotide variants) in these two clinical M. tuberculosis isolates and allowed strain differentiation at the proteome level. Our results contribute to the growing field of clinical microbial proteogenomics and can improve our understanding of phenotypic variation in clinical M. tuberculosis isolates.

  3. Proteogenomic Investigation of Strain Variation in Clinical Mycobacterium tuberculosis Isolates.

    Science.gov (United States)

    Heunis, Tiaan; Dippenaar, Anzaan; Warren, Robin M; van Helden, Paul D; van der Merwe, Ruben G; Gey van Pittius, Nicolaas C; Pain, Arnab; Sampson, Samantha L; Tabb, David L

    2017-10-06

    Mycobacterium tuberculosis consists of a large number of different strains that display unique virulence characteristics. Whole-genome sequencing has revealed substantial genetic diversity among clinical M. tuberculosis isolates, and elucidating the phenotypic variation encoded by this genetic diversity will be of the utmost importance to fully understand M. tuberculosis biology and pathogenicity. In this study, we integrated whole-genome sequencing and mass spectrometry (GeLC-MS/MS) to reveal strain-specific characteristics in the proteomes of two clinical M. tuberculosis Latin American-Mediterranean isolates. Using this approach, we identified 59 peptides containing single amino acid variants, which covered ∼9% of all coding nonsynonymous single nucleotide variants detected by whole-genome sequencing. Furthermore, we identified 29 distinct peptides that mapped to a hypothetical protein not present in the M. tuberculosis H37Rv reference proteome. Here, we provide evidence for the expression of this protein in the clinical M. tuberculosis SAWC3651 isolate. The strain-specific databases enabled confirmation of genomic differences (i.e., large genomic regions of difference and nonsynonymous single nucleotide variants) in these two clinical M. tuberculosis isolates and allowed strain differentiation at the proteome level. Our results contribute to the growing field of clinical microbial proteogenomics and can improve our understanding of phenotypic variation in clinical M. tuberculosis isolates.

  4. Information technology for clinical, translational and comparative effectiveness research. Findings from the section clinical research informatics.

    Science.gov (United States)

    Daniel, C; Choquet, R

    2013-01-01

    To summarize advances of excellent current research in the new emerging field of Clinical Research Informatics. Synopsis of four key articles selected for the IMIA Yearbook 2013. The selection was performed by querying PubMed and Web of Science with predefined keywords. From the original set of 590 papers, a first subset of 461 articles which was in the scope of Clinical Research Informatics was refined into a second subset of 79 relevant articles from which 15 articles were retained for peer-review. The four selected articles exemplify current research efforts conducted in the areas of data representation and management in clinical trials, secondary use of EHR data for clinical research, information technology platforms for translational and comparative effectiveness research and implementation of privacy control. The selected articles not only illustrate how innovative information technology supports classically organized randomized controlled trials but also demonstrate that the long promised benefits of electronic health care data for research are becoming a reality through concrete platforms and projects.

  5. Quality of information about success rates provided on assisted reproductive technology clinic websites in Australia and New Zealand.

    Science.gov (United States)

    Hammarberg, Karin; Prentice, Tess; Purcell, Isabelle; Johnson, Louise

    2018-06-01

    Many factors influence the chance of having a baby with assisted reproductive technologies (ART). A 2016 Australian Competition and Consumer Commission (ACCC) investigation concluded that ART clinics needed to improve the quality of information they provide about chance of ART success. To evaluate changes in the quality of information about success rates provided on the websites of ART clinics in Australia and New Zealand before and after the ACCC investigation. Desktop audits of websites of ART clinics in Australia and New Zealand were conducted in 2016 and 2017 and available information about success rates was scored using a matrix with eight variables and a possible range of scores of 0-9. Of the 54 clinic websites identified in 2016, 32 had unique information and were eligible to be audited. Of these, 29 were also eligible to be audited in 2017. While there was a slight improvement in the mean score from 2016 to 2017 (4.93-5.28), this was not statistically significantly different. Of the 29 clinics, 14 had the same score on both occasions, 10 had a higher and five a lower information quality score in 2017. To allow people who consider ART to make informed decisions about treatment they need comprehensive and accurate information about what treatment entails and what the likely outcomes are. As measured by a scoring matrix, most ART clinics had not improved the quality of the information about success rates following the ACCC investigation. © 2017 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  6. What Clinical Information Is Valuable to Doctors Using Mobile Electronic Medical Records and When?

    Science.gov (United States)

    Kim, Junetae; Lee, Yura; Lim, Sanghee; Kim, Jeong Hoon; Lee, Byungtae; Lee, Jae-Ho

    2017-10-18

    There has been a lack of understanding on what types of specific clinical information are most valuable for doctors to access through mobile-based electronic medical records (m-EMRs) and when they access such information. Furthermore, it has not been clearly discussed why the value of such information is high. The goal of this study was to investigate the types of clinical information that are most valuable to doctors to access through an m-EMR and when such information is accessed. Since 2010, an m-EMR has been used in a tertiary hospital in Seoul, South Korea. The usage logs of the m-EMR by doctors were gathered from March to December 2015. Descriptive analyses were conducted to explore the overall usage patterns of the m-EMR. To assess the value of the clinical information provided, the usage patterns of both the m-EMR and a hospital information system (HIS) were compared on an hourly basis. The peak usage times of the m-EMR were defined as continuous intervals having normalized usage values that are greater than 0.5. The usage logs were processed as an indicator representing specific clinical information using factor analysis. Random intercept logistic regression was used to explore the type of clinical information that is frequently accessed during the peak usage times. A total of 524,929 usage logs from 653 doctors (229 professors, 161 fellows, and 263 residents; mean age: 37.55 years; males: 415 [63.6%]) were analyzed. The highest average number of m-EMR usage logs (897) was by medical residents, whereas the lowest (292) was by surgical residents. The usage amount for three menus, namely inpatient list (47,096), lab results (38,508), and investigation list (25,336), accounted for 60.1% of the peak time usage. The HIS was used most frequently during regular hours (9:00 AM to 5:00 PM). The peak usage time of the m-EMR was early in the morning (6:00 AM to 10:00 AM), and the use of the m-EMR from early evening (5:00 PM) to midnight was higher than during regular

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

    Science.gov (United States)

    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

  8. Adoption of health information technologies by physicians for clinical practice

    DEFF Research Database (Denmark)

    Villalba-Mora, Elena; Casas, Isabel; Lupiañez-Villanueva, Francisco

    2015-01-01

    OBJECTIVES: We investigated the level of adoption of Health Information Technologies (HIT) services, and the factors that influence this, amongst specialised and primary care physicians; in Andalusia, Spain. METHODS: We analysed the physicians' responses to an online survey. First, we performed...... Technologies: Electronic Health Records (EHR), ePrescription and patient management and telemedicine services. Results from an ordered logit model showed that the frequency of use of HIT is associated with the physicians' perceived usefulness. Lack of financing appeared as a common barrier to the adoption...

  9. Aspectos éticos en investigaciones no clínicas en el campo de la salud: Algunas consideraciones acerca del consentimiento informado en personas declaradas incapaces Ethical aspects in non - clinical investigations in health: Some considerations about the informed consent in incapable people

    Directory of Open Access Journals (Sweden)

    Pamela Garbus

    2009-12-01

    Full Text Available Este trabajo se enmarca en el proyecto de investigación UBACyT P040 cuya directora es Alicia Stolkiner. El consentimiento informado es un aspecto dentro de la investigación social cuya utilización se ha convertido en una condición ineludible para sostener la viabilidad de un estudio dentro de aspectos éticos aceptables. El objetivo de este trabajo es analizar la especificidad que adquiere el consentimiento informado en investigación cuando se trata de realizar estudios con sujetos que han atravesado un juicio de insania y como resultado del mismo han sido declarados incapaces. Como metodología para este trabajo, se realizará un estudio documental de instrumentos normativos y legales (nacionales e internacionales que regulan los aspectos éticos que deben ser considerados en investigaciones no clínicas en salud, y aquellos que legislan los derechos de las personas con problemáticas psiquiátricas en la Ciudad Autónoma de Buenos Aires y en la Provincia de Buenos Aires.This paper is framed in the proyect of investigation UBACyT P040 whose director is Alicia Stolkiner. Informed consent is an aspect of social research that has become in recent years a prerequisite for sustaining the viability of a study within acceptable ethical aspects. The aim of this paper is to analyze the specificity of informed consent in research with people who has undergone a trial of insanity and as a result of it has been declared incapable. The methodology for this work is a documental study and the analysis of legal instruments (domestic and international that legislate ethical aspects that must be considered in clinical research in health, and those that legislate the rights of people with psychiatric problems in Buenos Aires City and the Province of Buenos Aires.

  10. An investigation into the adoption of Health Information Technology ...

    African Journals Online (AJOL)

    pc

    2018-03-05

    Mar 5, 2018 ... Business School Dublin City University, Whitehall, Dublin, Ireland ... information technology in public hospitals in Saudi Arabia. The goal was to analyze ... core systems in Saudi Arabia's healthcare for both private and public ...

  11. Automated Extraction of Substance Use Information from Clinical Texts.

    Science.gov (United States)

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

    2015-01-01

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

  12. Using language models to identify relevant new information in inpatient clinical notes.

    Science.gov (United States)

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

    2014-01-01

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

  13. 77 FR 25353 - Disqualification of a Clinical Investigator

    Science.gov (United States)

    2012-04-30

    .... * * * * * Sec. 312.70, relating to whether an investigator is eligible to receive test articles under part 312... ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also... marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon...

  14. Electrochemical impedance spectroscopy investigation on the clinical lifetime of ProTaper rotary file system.

    Science.gov (United States)

    Penta, Virgil; Pirvu, Cristian; Demetrescu, Ioana

    2014-01-01

    The main objective of the current paper is to show that electrochemical impedance spectroscopy (EIS) could be a method for evaluating and predicting of ProTaper rotary file system clinical lifespan. This particular aspect of everyday use of the endodontic files is of great importance in each dental practice and has profound clinical implications. The method used for quantification resides in the electrochemical impedance spectroscopy theory and has in its main focus the characteristics of the surface titanium oxide layer. This electrochemical technique has been adapted successfully to identify the quality of the Ni-Ti files oxide layer. The modification of this protective layer induces changes in corrosion behavior of the alloy modifying the impedance value of the file. In order to assess the method, 14 ProTaper sets utilized on different patients in a dental clinic have been submitted for testing using EIS. The information obtained in regard to the surface oxide layer has offered an indication of use and proves that the said layer evolves with each clinical application. The novelty of this research is related to an electrochemical technique successfully adapted for Ni-Ti file investigation and correlation with surface and clinical aspects.

  15. Clinical Simulation and Workflow by use of two Clinical Information Systems, the Electronic Health Record and Digital Dictation

    DEFF Research Database (Denmark)

    Schou Jensen, Iben; Koldby, Sven

    2013-01-01

    digital dictation and the EHR (electronic health record) were simulated in realistic and controlled clinical environments. Useful information dealing with workflow and patient safety were obtained. The clinical simulation demonstrated that the EHR locks during use of the integration of digital dictation......Clinical information systems do not always support clinician workflows. An increasing number of unintended clinical inci-dents might be related to implementation of clinical infor-mation systems and to a new registration praxis of unin-tended clinical incidents. Evidence of performing clinical...... simulations before implementation of new clinical information systems provides the basis for use of this method. The intention has been to evaluate patient safety issues, functionality, workflow, and usefulness of a new solution before implementation in the hospitals. Use of a solution which integrates...

  16. Department of Clinical Investigation Annual Research Progress Report, FY 1992

    Science.gov (United States)

    1992-09-30

    parameters in a group of residents over the course of their first year Graduate Medical Education training to follow changes in diet and exercise habits... hypocaloric state. This study would analyze the serum from these nine men collected before and after their training to correlate declines in body...ideal body weight, and % usual body weight. A clinical assessment (history and physical exam) will be done and a diet history taken. Patients will be

  17. Clinical Investigation Program Report, RCS MED-300 (R1).

    Science.gov (United States)

    1986-10-31

    handpieces . Technical Approach: The study will be conducted in vitro using the palatal roots of human maxillary molar teeth which previously extracted due...109 1985 Histoplasmosis Seroconversion Study. (T) 110 1986 A Comparative Study of Fetal Movement Perceptions in the Third Trimester of Multiparous and...Hartwell G, Portell FR: Clinical management of middle mesial root canals in mandibular molars : Two case reports. Submitted to J Am Dent Assn. DeFiore

  18. Clinical investigation of set-shifting subtypes in anorexia nervosa.

    Science.gov (United States)

    Abbate-Daga, Giovanni; Buzzichelli, Sara; Marzola, Enrica; Amianto, Federico; Fassino, Secondo

    2014-11-30

    While evidence continues to accumulate on the relevance of cognitive inflexibility in anorexia nervosa (AN), its clinical correlates remain unclear. We aimed at examining the relationship between set-shifting and clinical variables (i.e., eating psychopathology, depression, and personality) in AN. Ninety-four individuals affected by AN and 59 healthy controls (HC) were recruited. All participants were assessed using: Eating Disorders Inventory-2 (EDI-2), Temperament and Character Inventory (TCI), Beck Depression Inventory (BDI), and Wisconsin Card Sorting Test (WCST). The AN group scored worse than HCs on set-shifting. According to their neuropsychological performances, AN patients were split into two groups corresponding to poor (N=30) and intact (N=64) set-shifting subtypes. Interoceptive awareness, impulse regulation, and maturity fears on the EDI-2 and depression on the BDI differed across all groups (HC, intact, and poor set-shifting subtype). Self-directedness on the TCI differed significantly among all groups. Cooperativeness and reward dependence differed instead only between HC and AN poor set-shifting subtype. After controlling for depression, only interoceptive awareness remained significant with reward dependence showing a trend towards statistical significance. These findings suggest that multiple clinical variables may be correlated with set-shifting performances in AN. The factors contributing to impaired cognitive inflexibility could be more complex than heretofore generally considered. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  19. Investigation into the supply of information and measurement of ...

    African Journals Online (AJOL)

    a mathematically based computer software programme that produces an estimate of market value based on analysis of location, market conditions, and real-estate characteristics from information collected, whereas the Collateral Risk Management Consortium. (2003: 3) indicated that an AVM can be defined as the generic.

  20. An Investigation of Contingency Factors Influencing Intellectual Capital Information

    OpenAIRE

    Mohammad Soheily; Shahnaznayebzadeh; Ramin Abghari

    2014-01-01

    The purpose of this study was to determine the contingency factors influencing the companies' intellectual capital information operating in Yazd industrial city. The study model was formed using intellectual capital as dependent variable and environmental uncertainty, technology advancement and business strategy as independent variables. For purpose of the present study, the applied and correlational methods were used. Data collection was conducted using questionnaires and survey methods. The...

  1. Clinical Investigation Program Report Control Symbol MED 300.

    Science.gov (United States)

    1983-10-01

    delayed initially in Triton fed rats. The sustained increased levels of gastrin in Triton fed rats is due to the pro- longed gastric distension due to...Study Objective: To determine whether increasing the amount of information about muscle tension given to patients with muscular control problems will...pain, and tension as well as evaluate the effectiveness of muscular relaxation training as a treatment for these problems. The relative effectiveness of

  2. Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

    Science.gov (United States)

    Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

    2017-10-01

    Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study

  3. A clinical nutritional information system with personalized nutrition assessment.

    Science.gov (United States)

    Kuo, Su-E; Lai, Hui-San; Hsu, Jen-Ming; Yu, Yao-Chang; Zheng, Dong-Zhe; Hou, Ting-Wei

    2018-03-01

    Traditional nutrition evaluations not only require the use of numerous tables and lists to provide sufficient recommendations for patients' diets but are also very time-consuming due to cross-referencing and calculations. To personalize patient assessments, this study implemented a Clinical Nutritional Information System (CNIS) to help hospital dietitians perform their daily work more effectively in terms of time management and paper work. The CNIS mainly targets in-patients who require cancer-nutrition counselling. The development of the CNIS occurred in three phases. Phase 1 included system design and implementation based on the Nutrition Care Process and Model (NCPM) and the Patient Nutrition Care Process. Phase 2 involved a survey to characterize the efficiency, quality and accuracy of the CNIS. In Phase 3, a second survey was conducted to determine how well dietitians had adapted to the system and the extent of improvement in efficiency after the CNIS had been available online for three years. The work time requirements decreased by approximately 58% with the assistance of the CNIS. Of the dietitians who used the CNIS, 95% reported satisfaction, with 91.66% indicating that the CNIS was really helpful in their work. However, some shortcomings were also evident according to the results. Dietitians favoured the standardization of nutritional intervention and monitoring. The CNIS meets the needs of dietitians by increasing the quality of nutritional interventions by providing accurate calculations and cross-referencing for information regarding patients' conditions, with the benefit of decreasing the processing time, such as handwritten documentation. In addition, the CNIS also helps dietitians statistically analyse each patient's personal nutritional needs to achieve nutritional improvement. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Forensic Evidence and Criminal Investigations: The Impact of Ballistics Information on the Investigation of Violent Crime in Nine Cities.

    Science.gov (United States)

    King, William R; Campbell, Bradley A; Matusiak, Matthew C; Katz, Charles M

    2017-07-01

    We explore the impact of information from ballistics imaging hit reports on the investigation into violent crimes. Ballistics imaging hits link two crimes involving the same firearm by forensically matching tool marks on the fired bullets or cartridge cases. Interview data collected from detectives who received a hit report were used to explore the relationship between the presence of a hit report and outcomes in 65 gun-related violent crime investigations in nine U.S. police agencies. Findings indicate hit reports rarely contribute to identification, arrest, charging, or sentencing of suspects, because of delays in producing hit reports. On average, hit reports were completed 181.4 days after the focal crime. This delay forces investigations to proceed without the benefit of information from ballistics analysis. Additionally, hit reports rarely contained detailed information that was immediately useful to investigators. Instead, hit reports required additional research by the investigator to unlock useful information. © 2017 American Academy of Forensic Sciences.

  5. Preliminary clinical pharmacological investigations of tylosin and tiamulin in chickens.

    Science.gov (United States)

    Ziv, G

    1980-10-15

    The minimal inhibitory concentrations (MIC) of tiamulin and tylosin for mycoplasma, Gram-positive, and Gram-negative micro-organisms isolated from chickens were determinated by the agar dilution method. Median MIC values for tiamulin against Mycoplasma gallisepticum (0.05 microgram/ml) and Mycoplasma synoviae (0.10 microgram/ml) were 2 to 4 times lower than the corresponding values for tylosin. Tiamulin was also slightly more effective in vitro in inhibiting Escherichia coli, Pasteurella multocida, and beta-haemolytic streptococci than was tylosin. Groups of chicken were offered tiamulin medicated drinking water at rates of 125 and 250 mg/litre for 48 hours. Average serum tiamulin concentrations were 0.38 and 0.78 microgram/ml, respectively. When tylosin tartrate was added to the drinking water at 500 and 700 mg/litre, average serum drug levels were 0.12 and 0.17 microgram/ml, respectively. Tiamulin was 45% bound in chicken serum, as against 30% serum protein binding for tylosin. Correlations were made between free (non protein bound) serum drug levels and the MIC values of the two drugs. Such comparisons suggest that when tiamulin is given in the drinking water at rates of 125 to 250 mg/litre, better antimycoplasmal activity is to be expected in vivo than by giving tylosin tartrate in the drinking water at 500 to 700 mg/litre. Based on these data, no clinical efficacy of these dose rates can be expected in flocks infected by gram-negative micro-organisms such as E. coli or P. multocida. The tylosin tartrate rate of 500 to 700 mg/litre, may be clinical ineffective the treatment of Staphylococcus aureus infections.

  6. Clinical Investigation Program RCS-MED-300 (R1)

    Science.gov (United States)

    1988-09-30

    deprivation noted in the history or physical. Subjects agree to participate in the study. The independent variable is touch which if present is administered...INVESTIGATORS: MAJ Lynn Whittington , MC KEY WORDS: Intubation, pediatric training Study Objective: This training is designed to teach physicians and other health...with a high stress job are medical interns. Interns are sleep deprived , eat poorly, and have a high degree of emotional stress due to the novelty of

  7. An investigation of clinical studies suggests those with multiple objectives should have at least 90% power for each endpoint.

    NARCIS (Netherlands)

    Borm, G.F.; Houben, R.; Welsing, P.M.J.; Zielhuis, G.A.

    2006-01-01

    BACKGROUND AND OBJECTIVES: Many clinical studies have more than one objective, either formally or informally, but this is not usually taken into account in the determination of the sample size. We investigated the overall power of a study, that is, the probability that all the objectives will be

  8. Effect of clinical information in brain CT scan interpretation : a blinded double crossover study

    International Nuclear Information System (INIS)

    Zhianpour, M.; Janghorbani, M.

    2004-01-01

    Errors and variations in interpretation can happen in clinical imaging. Few studies have examined the biased effect of clinical information on reporting of brain CT scans. In a blinded double crossover design, we studied whether three radiologists were biased by clinical information when making CT scan diagnosis of the brain. Three consultant radiologists in three rounds with at least a one month interval assessed 100 consecutive cases of brain CT scan. In the first round, clinical information was not available and 100 films without clinical information were given to radiologists. In the second round, the same 100 films were given and true clinical information was available. In the third round, the same 100 films were given and false clinical information was allocated. In 180 cases (60%) the evaluation resulted in the same diagnosis on all three occasions (95% confidence interval (CI): 54.5, 65.5), whereas 120(40%; 95% CI:34.5, 45.5) sets were evaluated differently. 48 cases (16%; 95% CI:11.9,20.1) had discordant evaluation with true and 33 (11%; 95% CI:7.5, 14.5) with false clinical information. Discordance without and with true and false clinical information was 39 (13%; 95% CI:9.2, 16.8). Correct clinical information improves the brain CT report, while the report became less accurate false clinical information was allocated. These results indicate that radiologists are biased by clinical information when reporting brian CT scans

  9. Spatial information as a forensic tool to investigate crime

    CSIR Research Space (South Africa)

    Schmitz, Peter MU

    2012-10-01

    Full Text Available is that area of the geographic profile that shows the highest probability in which the criminal?s anchor point can be found. ? CSIR 2012 Slide 17 Geographic profiling ? Wemmerpan Serial Killer ? The Wemmerpan serial killer in Johannesburg, South Africa... involved with the Wemmerpan serial killer case by mapping all the locations for court purposes and to demonstrate the use of GIS in investigations. As part of this demonstration the CSIR invited Dr Kim Rossmo to South Africa in 1999 with the aim to see...

  10. Clinical investigations of receptive and expressive musical functions after stroke

    Directory of Open Access Journals (Sweden)

    Ken eRosslau

    2015-06-01

    Full Text Available There is a long tradition of investigating various disorders of musical abilities after stroke. These impairments, associated with acquired amusia, can be highly selective, affecting only music perception (i.e., receptive abilities/functions or expression (music production abilities, and some patients report that these may dramatically influence their emotional state. The aim of this study was to systematically test both the melodic and rhythmic domains of music perception and expression in left- and right-sided stroke patients compared to healthy subjects. Music perception was assessed using rhythmic and melodic discrimination tasks, while tests of expressive function involved the vocal or instrumental reproduction of rhythms and melodies. Our approach revealed deficits in receptive and expressive functions in stroke patients, mediated by musical expertise. Those patients who had experienced a short period of musical training in childhood and adolescence performed better in the receptive and expressive subtests compared to those without any previous musical training. While discrimination of specific musical patterns was unimpaired after a right-sided stroke, patients with a left-sided stroke had worse results for fine melodic and rhythmic analysis. In terms of expressive testing, the most consistent results were obtained from a test that required patients to reproduce sung melodies. This implies that the means of investigating production abilities can impact the identification of deficits.

  11. Clinical investigations of receptive and expressive musical functions after stroke.

    Science.gov (United States)

    Rosslau, Ken; Steinwede, Daniel; Schröder, C; Herholz, Sibylle C; Lappe, Claudia; Dobel, Christian; Altenmüller, Eckart

    2015-01-01

    There is a long tradition of investigating various disorders of musical abilities after stroke. These impairments, associated with acquired amusia, can be highly selective, affecting only music perception (i.e., receptive abilities/functions) or expression (music production abilities), and some patients report that these may dramatically influence their emotional state. The aim of this study was to systematically test both the melodic and rhythmic domains of music perception and expression in left- and right-sided stroke patients compared to healthy subjects. Music perception was assessed using rhythmic and melodic discrimination tasks, while tests of expressive function involved the vocal or instrumental reproduction of rhythms and melodies. Our approach revealed deficits in receptive and expressive functions in stroke patients, mediated by musical expertise. Those patients who had experienced a short period of musical training in childhood and adolescence performed better in the receptive and expressive subtests compared to those without any previous musical training. While discrimination of specific musical patterns was unimpaired after a left-sided stroke, patients with a right-sided stroke had worse results for fine melodic and rhythmic analysis. In terms of expressive testing, the most consistent results were obtained from a test that required patients to reproduce sung melodies. This implies that the means of investigating production abilities can impact the identification of deficits.

  12. Informed consent for inclusion into clinical trials: a serious subject to note in the developing world.

    Science.gov (United States)

    Izadi, Morteza; Fazel, Mozhgan; Nasiri-Vanashi, Taha; Saadat, Seyed Hasan; Taheri, Saeed

    2012-05-01

    Informed consent is a critical issue especially in conducting clinical trials that expose human life to medical or surgical interventions. It necessitates a long and complex process through which the participant is presented with all potential favorable and non-favorable consequences upon getting enrolled in the study. The process of taking informed consent is well-understood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to participate or not. This may not be the case in the developing world.The information given to patients before the trial might not be properly developed and presented, an issue that can result in serious threat to the decision-making process. On the other hand, investigators should remember that enrolling people into a trial with no potential benefit for themselves cannot be considered ethical. In the current debate, we aim to address the issue of how respectfully and ethically clinical research trials can be done on human subjects and what we can do to enhance the practice in an ethical context. Development of a system through which we could warrant all rights of study participants in all cases around the world seems far from view. However, if we are in doubt about the ethics of a clinical trial, we can ask ourselves: "what would we do, if we were in the same position our patients are in now?"

  13. Information security knowledge sharing in organizations : Investigating the effect of behavioral information security governance and national culture

    OpenAIRE

    Rocha Flores, Waldo; Antonsen, Egil; Ekstedt, Mathias

    2014-01-01

    This paper presents an empirical investigation on what behavioral information security governance factors drives the establishment of information security knowledge sharing in organizations. Data was collected from organizations located in different geographic regions of the world, and the amount of data collected from two countries – namely, USA and Sweden – allowed us to investigate if the effect of behavioral information security governance factors on the establishment of security knowledg...

  14. Annual Progress Report FY 93 (Walter Reed Army Medical Center, Department of Clinical Investigation). Clinical Investigation Program. Volume 2

    Science.gov (United States)

    1993-01-01

    129 REPORT DATE: 03/04/93 WORK UNIT a 1332-91 DETAIL SUMMARY SHEET TITLE: Thermogenic Agent Promotion of Weight Loss in Obese Soldiers KEYWORDS...thermogenic, promotion, obese PRINCIPAL INVESTIGATOR: Solomon, Barbara DNSc DEPARTMENT: Department of Medicine STATUS: Completed SERVICE: Endocrine...are: possible variance between adult and chilhood forms of HD, patterns of previous infectious disease exposure, socioeconomic patterns, familial

  15. How information systems should support the information needs of general dentists in clinical settings: suggestions from a qualitative study

    Directory of Open Access Journals (Sweden)

    Wali Teena

    2010-02-01

    Full Text Available Abstract Background A major challenge in designing useful clinical information systems in dentistry is to incorporate clinical evidence based on dentists' information needs and then integrate the system seamlessly into the complex clinical workflow. However, little is known about the actual information needs of dentists during treatment sessions. The purpose of this study is to identify general dentists' information needs and the information sources they use to meet those needs in clinical settings so as to inform the design of dental information systems. Methods A semi-structured interview was conducted with a convenience sample of 18 general dentists in the Pittsburgh area during clinical hours. One hundred and five patient cases were reported by these dentists. Interview transcripts were coded and analyzed using thematic analysis with a constant comparative method to identify categories and themes regarding information needs and information source use patterns. Results Two top-level categories of information needs were identified: foreground and background information needs. To meet these needs, dentists used four types of information sources: clinical information/tasks, administrative tasks, patient education and professional development. Major themes of dentists' unmet information needs include: (1 timely access to information on various subjects; (2 better visual representations of dental problems; (3 access to patient-specific evidence-based information; and (4 accurate, complete and consistent documentation of patient records. Resource use patterns include: (1 dentists' information needs matched information source use; (2 little use of electronic sources took place during treatment; (3 source use depended on the nature and complexity of the dental problems; and (4 dentists routinely practiced cross-referencing to verify patient information. Conclusions Dentists have various information needs at the point of care. Among them, the needs

  16. Using Patient-Reported Information to Improve Clinical Practice.

    Science.gov (United States)

    Schlesinger, Mark; Grob, Rachel; Shaller, Dale

    2015-12-01

    To assess what is known about the relationship between patient experience measures and incentives designed to improve care, and to identify how public policy and medical practices can promote patient-valued outcomes in health systems with strong financial incentives. Existing literature (gray and peer-reviewed) on measuring patient experience and patient-reported outcomes, identified from Medline and Cochrane databases; evaluations of pay-for-performance programs in the United States, Europe, and the Commonwealth countries. We analyzed (1) studies of pay-for-performance, to identify those including metrics for patient experience, and (2) studies of patient experience and of patient-reported outcomes to identify evidence of influence on clinical practice, whether through public reporting or private reporting to clinicians. First, we identify four forms of "patient-reported information" (PRI), each with distinctive roles shaping clinical practice: (1) patient-reported outcomes measuring self-assessed physical and mental well-being, (2) surveys of patient experience with clinicians and staff, (3) narrative accounts describing encounters with clinicians in patients' own words, and (4) complaints/grievances signaling patients' distress when treatment or outcomes fall short of expectations. Because these forms vary in crucial ways, each must be distinctively measured, deployed, and linked with financial incentives. Second, although the literature linking incentives to patients experience is limited, implementing pay-for-performance systems appears to threaten certain patient-valued aspects of health care. But incentives can be made compatible with the outcomes patients value if: (a) a sufficient portion of incentives is tied to patient-reported outcomes and experiences, (b) incentivized forms of PRI are complemented by other forms of patient feedback, and (c) health care organizations assist clinicians to interpret and respond to PRI. Finally, we identify roles for the

  17. A self-scaling, distributed information architecture for public health, research, and clinical care.

    Science.gov (United States)

    McMurry, Andrew J; Gilbert, Clint A; Reis, Ben Y; Chueh, Henry C; Kohane, Isaac S; Mandl, Kenneth D

    2007-01-01

    This study sought to define a scalable architecture to support the National Health Information Network (NHIN). This architecture must concurrently support a wide range of public health, research, and clinical care activities. The architecture fulfils five desiderata: (1) adopt a distributed approach to data storage to protect privacy, (2) enable strong institutional autonomy to engender participation, (3) provide oversight and transparency to ensure patient trust, (4) allow variable levels of access according to investigator needs and institutional policies, (5) define a self-scaling architecture that encourages voluntary regional collaborations that coalesce to form a nationwide network. Our model has been validated by a large-scale, multi-institution study involving seven medical centers for cancer research. It is the basis of one of four open architectures developed under funding from the Office of the National Coordinator of Health Information Technology, fulfilling the biosurveillance use case defined by the American Health Information Community. The model supports broad applicability for regional and national clinical information exchanges. This model shows the feasibility of an architecture wherein the requirements of care providers, investigators, and public health authorities are served by a distributed model that grants autonomy, protects privacy, and promotes participation.

  18. Patient engagement: an investigation at a primary care clinic

    Science.gov (United States)

    Gill, Preetinder Singh

    2013-01-01

    Background Engaged employees are an asset to any organization. They are instrumental in ensuring good commercial outcomes through continuous innovation and incremental improvement. A health care facility is similar to a regular work setting in many ways. A health care provider and a patient have roles akin to a team leader and a team member/stakeholder, respectively. Hence it can be argued that the concept of employee engagement can be applied to patients in health care settings in order to improve health outcomes. Methods Patient engagement data were collected using a survey instrument from a primary care clinic in the northern Indian state of Punjab. Canonical correlation equations were formulated to identify combinations which were strongly related to each other. In addition, the cause-effect relationship between patient engagement and patient-perceived health outcomes was described using structural equation modeling. Results Canonical correlation analysis showed that the first set of canonical variables had a fairly strong relationship, ie, a magnitude > 0.80 at the 95% confidence interval, for five dimensions of patient engagement. Structural equation modeling analysis yielded a β ≥ 0.10 and a Student’s t statistic ≥ 2.96 for these five dimensions. The threshold Student’s t statistic was 1.99. Hence it was found the β values were significant at the 95% confidence interval for all census regions. Conclusion A scaled reliable survey instrument was developed to measured patient engagement. Better patient engagement is associated with better patient-perceived health outcomes. This study provides preliminary evidence that patient engagement has a causal relationship with patient-perceived health outcomes. PMID:23515133

  19. A method for investigating relative timing information on phylogenetic trees.

    Science.gov (United States)

    Ford, Daniel; Matsen, Frederick A; Stadler, Tanja

    2009-04-01

    In this paper, we present a new way to describe the timing of branching events in phylogenetic trees. Our description is in terms of the relative timing of diversification events between sister clades; as such it is complementary to existing methods using lineages-through-time plots which consider diversification in aggregate. The method can be applied to look for evidence of diversification happening in lineage-specific "bursts", or the opposite, where diversification between 2 clades happens in an unusually regular fashion. In order to be able to distinguish interesting events from stochasticity, we discuss 2 classes of neutral models on trees with relative timing information and develop a statistical framework for testing these models. These model classes include both the coalescent with ancestral population size variation and global rate speciation-extinction models. We end the paper with 2 example applications: first, we show that the evolution of the hepatitis C virus deviates from the coalescent with arbitrary population size. Second, we analyze a large tree of ants, demonstrating that a period of elevated diversification rates does not appear to have occurred in a bursting manner.

  20. Adapting Cognitive Task Analysis to Investigate Clinical Decision Making and Medication Safety Incidents.

    Science.gov (United States)

    Russ, Alissa L; Militello, Laura G; Glassman, Peter A; Arthur, Karen J; Zillich, Alan J; Weiner, Michael

    2017-05-03

    Cognitive task analysis (CTA) can yield valuable insights into healthcare professionals' cognition and inform system design to promote safe, quality care. Our objective was to adapt CTA-the critical decision method, specifically-to investigate patient safety incidents, overcome barriers to implementing this method, and facilitate more widespread use of cognitive task analysis in healthcare. We adapted CTA to facilitate recruitment of healthcare professionals and developed a data collection tool to capture incidents as they occurred. We also leveraged the electronic health record (EHR) to expand data capture and used EHR-stimulated recall to aid reconstruction of safety incidents. We investigated 3 categories of medication-related incidents: adverse drug reactions, drug-drug interactions, and drug-disease interactions. Healthcare professionals submitted incidents, and a subset of incidents was selected for CTA. We analyzed several outcomes to characterize incident capture and completed CTA interviews. We captured 101 incidents. Eighty incidents (79%) met eligibility criteria. We completed 60 CTA interviews, 20 for each incident category. Capturing incidents before interviews allowed us to shorten the interview duration and reduced reliance on healthcare professionals' recall. Incorporating the EHR into CTA enriched data collection. The adapted CTA technique was successful in capturing specific categories of safety incidents. Our approach may be especially useful for investigating safety incidents that healthcare professionals "fix and forget." Our innovations to CTA are expected to expand the application of this method in healthcare and inform a wide range of studies on clinical decision making and patient safety.

  1. Readability and comprehensibility of informed consent forms for clinical trials

    Directory of Open Access Journals (Sweden)

    Anvita Pandiya

    2010-01-01

    A shortened Informed Consent Form, with information that a reasonable person would want to understand along with specific information that the person wants in particular would be a good option to improve understanding or comprehensibility. Additional informational meetings with a qualified person like a counselor could help in comprehension. Questionnaires designed to test comprehension of patient, peer review, patient writing the salient features could help evaluate the comprehensibility of the Informed Consent Form.

  2. Information Extraction for Clinical Data Mining: A Mammography Case Study.

    Science.gov (United States)

    Nassif, Houssam; Woods, Ryan; Burnside, Elizabeth; Ayvaci, Mehmet; Shavlik, Jude; Page, David

    2009-01-01

    Breast cancer is the leading cause of cancer mortality in women between the ages of 15 and 54. During mammography screening, radiologists use a strict lexicon (BI-RADS) to describe and report their findings. Mammography records are then stored in a well-defined database format (NMD). Lately, researchers have applied data mining and machine learning techniques to these databases. They successfully built breast cancer classifiers that can help in early detection of malignancy. However, the validity of these models depends on the quality of the underlying databases. Unfortunately, most databases suffer from inconsistencies, missing data, inter-observer variability and inappropriate term usage. In addition, many databases are not compliant with the NMD format and/or solely consist of text reports. BI-RADS feature extraction from free text and consistency checks between recorded predictive variables and text reports are crucial to addressing this problem. We describe a general scheme for concept information retrieval from free text given a lexicon, and present a BI-RADS features extraction algorithm for clinical data mining. It consists of a syntax analyzer, a concept finder and a negation detector. The syntax analyzer preprocesses the input into individual sentences. The concept finder uses a semantic grammar based on the BI-RADS lexicon and the experts' input. It parses sentences detecting BI-RADS concepts. Once a concept is located, a lexical scanner checks for negation. Our method can handle multiple latent concepts within the text, filtering out ultrasound concepts. On our dataset, our algorithm achieves 97.7% precision, 95.5% recall and an F 1 -score of 0.97. It outperforms manual feature extraction at the 5% statistical significance level.

  3. The Virtuous Circles of Clinical Information Systems: a Modern Utopia.

    Science.gov (United States)

    Degoulet, P

    2016-11-10

    Clinical information systems (CIS) are developed with the aim of improving both the efficiency and the quality of care. This position paper is based on the hypothesis that such vision is partly a utopian view of the emerging eSociety. Examples are drawn from 15 years of experience with the fully integrated Georges Pompidou University Hospital (HEGP) CIS and temporal data series extracted from the data warehouses of Assistance Publique - Hôpitaux de Paris (AP-HP) acute care hospitals which share the same administrative organization as HEGP. Three main virtuous circles are considered: user satisfaction vs. system use, system use vs. cost efficiency, and system use vs quality of care. In structural equation models (SEM), the positive bidirectional relationship between user satisfaction and use was only observed in the early HEGP CIS deployment phase (first four years) but disappeared in late post-adoption (≥8 years). From 2009 to 2013, financial efficiency of 20 AP-HP hospitals evaluated with stochastic frontier analysis (SFA) models diminished by 0.5% per year. The lower decrease of efficiency observed between the three hospitals equipped with a more mature CIS and the 17 other hospitals was of the same order of magnitude than the difference observed between pediatric and non-pediatric hospitals. Outcome quality benefits that would bring evidence to the system use vs. quality loop are unlikely to be obtained in a near future since they require integration with population-based outcome measures including mortality, morbidity, and quality of life that may not be easily available. Barriers to making the transformation of the utopian part of the CIS virtuous circles happen should be overcome to actually benefit the emerging eSociety.

  4. Clinical investigation on application of water swallowing to MR esophagography

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, Jinping, E-mail: zjpmri@163.com [Department of Radiology, Tongling People' s Hospital, Bijiashan Road 468, Tongling 244000, Anhui (China); Hu, Weijian; Zang, Lin [Department of Cardiothoracic Surgery, Tongling People' s Hospital, Bijiashan Road 468, Tongling 244000, Anhui (China); Yao, Yibin; Tang, Yongxiang; Qian, Zhen; Gao, Ping; Wu, Xiaoyan; Li, Shijian [Department of Radiology, Tongling People' s Hospital, Bijiashan Road 468, Tongling 244000, Anhui (China); Xie, Zhenlan; Yuan, Xiaoqing [Department of Pathology, Tongling People' s Hospital, Bijiashan Road 468, Tongling 244000, Anhui (China)

    2012-09-15

    Objective: To verify the clinical outcomes of applying water swallowing to MR esophagography. Methods: Thirty patients confirmed postoperatively or histopathologically with thoracic esophageal carcinoma by endoscopic biopsy and 10 healthy volunteers with normal esophagus underwent respectively conventional magnetic resonance imaging (MRI) detection and water swallowing MR esophagography. Of those patients, 4 underwent second examination after radiotherapy. Assessment on imaging effects of MR esophagography was performed. Assessment on definition on MR esophagography of the tumor in both upper and lower ends, specific localization, tumor size finally measured, coincidence with the gross pathologic types and tumor staging were respectively performed by comparison with conventional MRI. Additionally, we evaluated the outcomes of radiotherapy by comparing the previous MR esophagography with the second one with interventional technique. Results: Of the total 44 images of MR esophagography, 97.7% (43/44) were in high resolution by sagittal view and 81.8% (36/44) by cross-section. 93.3% (56/60) of the MR esophagography were clearly defined with the neoplastic lesion ends in the 30 patients with thoracic esophageal carcinoma, compared with 11.7% (7/60) by conventional MRI. The results were totally different in statistics (P < 0.005). Preoperative conventional MRI detection of the 22 cases in 25 undergone radical resection suggested vague diameter of the primary tumor and impossibly identified it at middle-lower thoracic esophagus in 5, and even failed to confirm gross pathologic types in 19 cases. Yet, MR esophagography with water swallowing represented accurate tumor length (graded as excellent) in 88% (22/25), localization in 100% (25/25), exact gross pathologic types in 88% (22/25), and accuracy for tumor staging in 80.8% (21/26) compared to 92.3% (24/26) by conventional MRI. Therapeutic effects achieved in 4 patients with radiotherapy. Conclusions: MR esophagography

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

    Science.gov (United States)

    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 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.

  6. Investigation of clinical pharmacokinetic variability of an opioid antagonist through physiologically based absorption modeling.

    Science.gov (United States)

    Ding, Xuan; He, Minxia; Kulkarni, Rajesh; Patel, Nita; Zhang, Xiaoyu

    2013-08-01

    Identifying the source of inter- and/or intrasubject variability in pharmacokinetics (PK) provides fundamental information in understanding the pharmacokinetics-pharmacodynamics relationship of a drug and project its efficacy and safety in clinical populations. This identification process can be challenging given that a large number of potential causes could lead to PK variability. Here we present an integrated approach of physiologically based absorption modeling to investigate the root cause of unexpectedly high PK variability of a Phase I clinical trial drug. LY2196044 exhibited high intersubject variability in the absorption phase of plasma concentration-time profiles in humans. This could not be explained by in vitro measurements of drug properties and excellent bioavailability with low variability observed in preclinical species. GastroPlus™ modeling suggested that the compound's optimal solubility and permeability characteristics would enable rapid and complete absorption in preclinical species and in humans. However, simulations of human plasma concentration-time profiles indicated that despite sufficient solubility and rapid dissolution of LY2196044 in humans, permeability and/or transit in the gastrointestinal (GI) tract may have been negatively affected. It was concluded that clinical PK variability was potentially due to the drug's antagonism on opioid receptors that affected its transit and absorption in the GI tract. Copyright © 2013 Wiley Periodicals, Inc.

  7. Methods to reduce medication errors in a clinical trial of an investigational parenteral medication

    Directory of Open Access Journals (Sweden)

    Gillian L. Fell

    2016-12-01

    Full Text Available There are few evidence-based guidelines to inform optimal design of complex clinical trials, such as those assessing the safety and efficacy of intravenous drugs administered daily with infusion times over many hours per day and treatment durations that may span years. This study is a retrospective review of inpatient administration deviation reports for an investigational drug that is administered daily with infusion times of 8–24 h, and variable treatment durations for each patient. We report study design modifications made in 2007–2008 aimed at minimizing deviations from an investigational drug infusion protocol approved by an institutional review board and the United States Food and Drug Administration. Modifications were specifically aimed at minimizing errors of infusion rate, incorrect dose, incorrect patient, or wrong drug administered. We found that the rate of these types of administration errors of the study drug was significantly decreased following adoption of the specific study design changes. This report provides guidance in the design of clinical trials testing the safety and efficacy of study drugs administered via intravenous infusion in an inpatient setting so as to minimize drug administration protocol deviations and optimize patient safety.

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

    Science.gov (United States)

    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…

  9. Clinical trials information in drug development and regulation : existing systems and standards

    NARCIS (Netherlands)

    Valkenhoef, Gert van; Tervonen, Tommi; Brock, Bert de; Hillege, Hans

    2012-01-01

    Clinical trials provide pivotal evidence on drug efficacy and safety. The evidence, information from clinical trials, is currently used by regulatory decision makers in marketing authorization decisions, but only in an implicit manner. For clinical trials information to be used in a transparent and

  10. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Science.gov (United States)

    2011-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

  11. Investigations with FDG-PET Scanning in Prostate Cancer Show Limited Value for Clinical Practice

    Energy Technology Data Exchange (ETDEWEB)

    Salminen, Eeva [Univ. of Turku (Finland). Department of Oncology and Radiotherapy; Hogg, Annette; Binns, David; Hicks, Rodney [The Peter MacCallum Cancer Institute, East Melbourne, Vic (Australia). Dept. of Diagnostic Imaging; Frydenberg, Mark [Monash Medical Centre, Clayton, Vic (Australia)

    2002-09-01

    The aim of this study was to investigate FDG-PET (fluorodeoxyglucose positron emission tomography) imaging in the management of prostate cancer. Twenty-two patients were studied during different disease phases of prostate cancer, for staging or restaging to clarify specific clinical questions. FDG-PET was performed encompassing the thorax, abdomen and pelvis using the Penn PET 300H scanner. Scanning was begun 60 min after {sup 18}F fluorodeoxyglucose marker. Patients were catheterized and administered diuretics to minimize urinary activity. Information obtained with FDG-PET was concordant with findings from other investigations in 7/22 (32%) patients, discordant in 15/22 (68%) patients and equivalent in one patient (4%). PET indicated progressive disease in five patients with prostate-specific antigen (PSA) <4 ng/L. The impact on management of the patients was high in 46% of cases, low in 41% and for 14% there was no impact on management. The accuracy of FDG-PET was 72% (95% CI 50-89) as confirmed by invasive diagnostics/follow-up. FDG-PET can provide useful information and improve the clinician's decision on further management procedures in selected patients with low PSA and bone or lymph node changes. A negative PET scan in prostate cancer should be interpreted with caution.

  12. Clinical trials using a radiopharmaceutical investigational drug: What legal environment and what authorizations required?

    International Nuclear Information System (INIS)

    El-Deeb, G.; Nguon, B.; Tibi, A.; Rizzo-Padoin, N.

    2009-01-01

    Recent revision of the legal environment for clinical research in France provided an opportunity to review what a hospital needs to carry out clinical trials using a radiopharmaceutical investigational drug. Legal measures concerning radiopharmaceutical investigational drugs are indeed more complex than those of classical clinical trials because of the additional legal provisions governing the use of ionizing radiation. Thus, requirements by the concerned staff (sponsor, pharmacist, person in charge of the nuclear activity) are described here. (authors) [fr

  13. An Investigation of Factors Influencing Nurses' Clinical Decision-Making Skills.

    Science.gov (United States)

    Wu, Min; Yang, Jinqiu; Liu, Lingying; Ye, Benlan

    2016-08-01

    This study aims to investigate the influencing factors on nurses' clinical decision-making (CDM) skills. A cross-sectional nonexperimental research design was conducted in the medical, surgical, and emergency departments of two university hospitals, between May and June 2014. We used a quantile regression method to identify the influencing factors across different quantiles of the CDM skills distribution and compared the results with the corresponding ordinary least squares (OLS) estimates. Our findings revealed that nurses were best at the skills of managing oneself. Educational level, experience, and the total structural empowerment had significant positive impacts on nurses' CDM skills, while the nurse-patient relationship, patient care and interaction, formal empowerment, and information empowerment were negatively correlated with nurses' CDM skills. These variables explained no more than 30% of the variance in nurses' CDM skills and mainly explained the lower quantiles of nurses' CDM skills distribution. © The Author(s) 2016.

  14. Physician to investigator: clinical practice to clinical research--ethical, operational, and financial considerations.

    Science.gov (United States)

    Pierre, Christine

    2008-01-01

    Physicians who participate in clinical research studies gain benefits for themselves, their practice, and their patients. Historically, private practice physicians have chosen to defer to their counterparts in academic medicine when it comes to contributing to scientific advancement through clinical studies. A growing number of private practice physicians are now taking a serious second look and deciding that there are unique benefits for both the practice and the patient. Physicians who decide to participate in clinical research should give serious consideration to the time and resources that are required to meet both federal regulations and industry standards. In addition, ethical and scientific principles for assuring the protection of human research subjects must be a paramount commitment.

  15. Towards a multi-agent system for regulated information exchange in crime investigations

    NARCIS (Netherlands)

    Dijkstra, Pieter; Prakken, H.; Vey Mestdagh, C.N.J. de

    2005-01-01

    This paper outlines a multi-agent architecture for regulated information exchange of crime investigation data between police forces. Interactions between police officers about information exchange are analysed as negotiation dialogues with embedded persuasion dialogues. An architecture is then

  16. Clinical Information Systems as the Backbone of a Complex Information Logistics Process: Findings from the Clinical Information Systems Perspective for 2016.

    Science.gov (United States)

    Hackl, W O; Ganslandt, T

    2017-08-01

    Objective: To summarize recent research and to propose a selection of best papers published in 2016 in the field of Clinical Information Systems (CIS). Method: The query used to retrieve the articles for the CIS section of the 2016 edition of the IMIA Yearbook of Medical Informatics was reused. It again aimed at identifying relevant publications in the field of CIS from PubMed and Web of Science and comprised search terms from the Medical Subject Headings (MeSH) catalog as well as additional free text search terms. The retrieved articles were categorized in a multi-pass review carried out by the two section editors. The final selection of candidate papers was then peer-reviewed by Yearbook editors and external reviewers. Based on the review results, the best papers were then chosen at the selection meeting with the IMIA Yearbook editorial board. Text mining, term co-occurrence mapping, and topic modelling techniques were used to get an overview on the content of the retrieved articles. Results: The query was carried out in mid-January 2017, yielding a consolidated result set of 2,190 articles published in 921 different journals. Out of them, 14 papers were nominated as candidate best papers and three of them were finally selected as the best papers of the CIS field. The content analysis of the articles revealed the broad spectrum of topics covered by CIS research. Conclusions: The CIS field is multi-dimensional and complex. It is hard to draw a well-defined outline between CIS and other domains or other sections of the IMIA Yearbook. The trends observed in the previous years are progressing. Clinical information systems are more than just sociotechnical systems for data collection, processing, exchange, presentation, and archiving. They are the backbone of a complex, trans-institutional information logistics process. Georg Thieme Verlag KG Stuttgart.

  17. An investigation on physicians' acceptance of hospital information systems: a case study.

    Science.gov (United States)

    Chen, Rai-Fu; Hsiao, Ju-Ling

    2012-12-01

    Information technology is used to support a wide range of highly specified healthcare tasks and services. There is, therefore, a need to understand the factors affecting the acceptance of this technology by healthcare professionals. Physicians are key providers of healthcare services and are among the principal users of hospital information systems. Their acceptance of hospital information systems is hence of great significance when evaluating the success of those systems. The survey methodology was employed to targeted physicians in the selected case hospital for investigating factors affecting physicians' acceptance of hospital information systems. A total of 202 questionnaires were sent out, with 124 completed copies returned, indicating a valid response rate of 61.4%. We used structural equation modeling to analyze the data. The results indicated that top management support (γ=0.431, psystem quality (γ=0.369, pinformation systems. Physicians' perceptions of the usefulness (β=0.132, pinformation systems had a significant impact on the acceptance of the systems, accounting for 81.4% of total explained variance. Through the understanding of the identified critical factors affecting physicians' HIS acceptance, the planners and managers should ensure that hospital information systems to be introduced into a hospital are useful and ease to use. Effort should be focuses on providing sufficient top management support, selecting qualified project team members, and delivering higher system quality in addressing physicians' clinical needs. Thus, our research results can help planners and managers understand key considerations affecting HIS development and use, and may be used as a reference for system design, development and implementation. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

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

    Science.gov (United States)

    ... of Personal Stories Peers Celebrating Art Peers Celebrating Music Be Vocal Support Locator DBSA In-Person Support ... contribution made by a clinical trial is to science first and to the patient second. back to ...

  19. Understanding managerial behaviour during initial steps of a clinical information system adoption.

    Science.gov (United States)

    Rodríguez, Charo; Pozzebon, Marlei

    2011-06-17

    While the study of the information technology (IT) implementation process and its outcomes has received considerable attention, the examination of pre-adoption and pre-implementation stages of configurable IT uptake appear largely under-investigated. This paper explores managerial behaviour during the periods prior the effective implementation of a clinical information system (CIS) by two Canadian university multi-hospital centers. Adopting a structurationist theoretical stance and a case study research design, the processes by which CIS managers' patterns of discourse contribute to the configuration of the new technology in their respective organizational contexts were longitudinally examined over 33 months. Although managers seemed to be aware of the risks and organizational impact of the adoption of a new clinical information system, their decisions and actions over the periods examined appeared rather to be driven by financial constraints and power struggles between different groups involved in the process. Furthermore, they largely emphasized technological aspects of the implementation, with organizational dimensions being put aside. In view of these results, the notion of 'rhetorical ambivalence' is proposed. Results are further discussed in relation to the significance of initial decisions and actions for the subsequent implementation phases of the technology being configured. Theoretical and empirically grounded, the paper contributes to the underdeveloped body of literature on information system pre-implementation processes by revealing the crucial role played by managers during the initial phases of a CIS adoption.

  20. RESEARCH Voluntary informed consent and good clinical practice ...

    African Journals Online (AJOL)

    of South Africa (1996) and applicable legislation, it is apparent that voluntary informed ... Seoul, 2008);4 Ethics in Health Research: Principles, Structures and. Processes (Department of Health 2004 – 'ethical guidelines' for the purpose of this ... workers have a legal duty to obtain a patient's informed consent for any medical ...

  1. Pre-Clinical and Clinical Investigation of the Impact of Obesity on Ovarian Cancer Pathogenesis

    Science.gov (United States)

    2015-12-01

    clinical cancer drug discovery , including 10 years as a Research Assistant Professor in the Department of Surgery at Duke University Medical Center...cancer therapy. Nature chemical biology . 2015;11(1):9-15. Epub 2014/12/18. doi: 10.1038/nchembio.1712. PubMed PMID: 25517383; PubMed Central PMCID...Assistant Professor of Nutrition, a member of the Nutrition Obesity Research Center, Center for Gastrointestinal Biology and Disease, McCallister Heart

  2. Comparative clinical and haematological investigations in lactating cows with subclinical and clinical ketosis

    Directory of Open Access Journals (Sweden)

    Vania Marutsova

    2015-10-01

    Full Text Available Ketosis of lactating cows is among the most common metabolic diseases in modern dairy farms. The economic importance of the disease is caused by the reduced milk yield and body weight loss, poor feed conversion, lower conception rates, culling and increased mortality of affected animals. In the present study, a total of 47 high-yielding dairy cows up to 45 days in milk (DIM are included. All animals were submitted to physical examination wich included checking the rectal body temperature, heart rate, respiratory and rumen contraction rates, and inspection of visible mucous coats. The body condition was scored, and blood β-hydroxybutyrate (BHBA concentrations were assayed. The cows were divided into 3 groups: first group (control (n=24 with blood β-hydroxybutyrate level 2.6 mmol/l (clinical ketosis. Whole blood samples were obtained and analyzed for Red Blood Cell (RBC, 1012/l, Hemoglobin (HGB, g/l, Hematocrit (HCT, %, Mean Corpuscular Volume (MCV, fl, Mean Corpuscular Hemoglobin (MCH, pg, Mean Corpuscular Hemoglobin Concentration (MCHC, g/l, White Blood Cell (WBC, 109/l, Lymphocytes (LYM, 109/l, Monocytes (MON, 109/l, Granulocytes (GRA, 109/l, Red Blood Distribution Width (RDW, %, Red Blood Cell Distribution Width Absolute (RDWa, fl, Platelets (PLT, 109/l and Mean Platelet Volume (MPV, fl. In this study, deviations in the clinical parameters in the control group and in those with subclinical ketosis were not identified. The cows from the third group (clinical ketosis exhibited hypotonia, anorexia and body weight loss vs. control group. Hematological analysis showed leukocytosis and lymphocytosis in cows with subclinical ketosis vs. control group. In cows with clinical ketosis WBC counts decreased (leukopenia, while hemoglobin content and hematocrit values are higher vs. control group. Blood BHBA values are higher in both groups of ketotic cows vs. the control group. The other analyzed parameters (RBC, MCH, MCHC, MCV, RDW, RDWa, MON, GRA, PLT

  3. Social vs. Clinical Perspectives on the Use of Information: Implications for School-based Information Systems. Systemic Evaluation Project.

    Science.gov (United States)

    Sirotnik, Kenneth A.; And Others

    This paper presents a study of the contrast of social and clinical perspectives on the selection and use of information by school staff, including: (1) an outline of the context and activities of the study; (2) a definition and discussion of the basic distinction between social and clinical perspectives; (3) an examination of case material…

  4. 77 FR 38634 - Request for Information: Collection and Use of Patient Work Information in the Clinical Setting...

    Science.gov (United States)

    2012-06-28

    ... (specialty) health care: At your clinical facility, how is the patient's work information collected... the Clinical Setting: Electronic Health Records AGENCY: The National Institute for Occupational Safety... Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of...

  5. Transparency and public accessibility of clinical trial information in Croatia: how it affects patient participation in clinical trials.

    Science.gov (United States)

    Šolić, Ivana; Stipčić, Ana; Pavličević, Ivančica; Marušić, Ana

    2017-06-15

    Despite increased visibility of clinical trials through international trial registries, patients often remain uninformed of their existence, especially if they do not have access to adequate information about clinical research, including the language of the information. The aim of this study was to describe the context for transparency of clinical trials in Croatia in relation to countries in Central and Eastern Europe, and to assess how informed Croatian patients are about clinical trials and their accessibility. We assessed the transparency of clinical trials from the data available in the public domain. We also conducted an anonymous survey on a convenience sample of 257 patients visiting two family medicine offices or an oncology department in south Croatia, and members of national patients' associations. Despite legal provisions for transparency of clinical trials in Croatia, they are still not sufficiently visible in the public domain. Among countries from Central and Eastern Europe, Croatia has the fewest number of registered trials in the EU Clinical Trials Registry. 66% of the patients in the survey were aware of the existence of clinical trials but only 15% were informed about possibilities of participating in a trial. Although 58% of the respondents were willing to try new treatments, only 6% actually participated in a clinical trial. Only 2% of the respondents were aware of publicly available trial registries. Our study demonstrates that there is low transparency of clinical trials in Croatia, and that Croatian patients are not fully aware of clinical trials and the possibilities of participating in them, despite reported availability of Internet resources and good communication with their physicians. There is a need for active policy measures to increase the awareness of and access to clinical trials to patients in Croatia, particularly in their own language.

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

    Science.gov (United States)

    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

  7. Information and communication in the context of a clinical trial

    DEFF Research Database (Denmark)

    Hietanen, P; Aro, A R; Holli, K

    2000-01-01

    The aim of this study was to determine the communicative needs of the patients in the context of being invited to participate in a clinical trial. A questionnaire was sent to 299 patients with breast cancer randomised in a trial of adjuvant therapy. It was returned by 261 (87%) of them. Ninety...

  8. Informed consent in clinical trials: Perceptions and experiences of a ...

    African Journals Online (AJOL)

    It is recommended that more recognition be given to the important role of trial counsellors in clinical trials, and that they be given more formal training, support and ... Daar word aanbeveel dat meer erkenning gegee word aan die rol van proefvoorligters in kliniese proewe, dat hulle meer formele opleiding ondergaan, dat ...

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

    Science.gov (United States)

    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)

  10. Investigation Into Informational Compatibility Of Building Information Modelling And Building Performance Analysis Software Solutions

    OpenAIRE

    Hyun, S.; Marjanovic-Halburd, L.; Raslan, R.

    2015-01-01

    There are significant opportunities for Building Information Modelling (BIM) to address issues related to sustainable and energy efficient building design. While the potential benefits associated with the integration of BIM and BPA (Building Performance Analysis) have been recognised, its specifications and formats remain in their early infancy and often fail to live up to the promise of seamless interoperability at various stages of design process. This paper conducts a case study to investi...

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

    Science.gov (United States)

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

    2017-05-01

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

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

    Science.gov (United States)

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

    2011-01-01

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

  13. [Methods of investigation in clinical cardiology. VIII. Socioeconomic evaluation of clinical cardiology practice].

    Science.gov (United States)

    Lázaro de Mercado, P

    1997-06-01

    Health services are systems whose mission is to improve the health status of both individuals and society in general. In recent decades, these systems have faced challenges such as their increasing complexity, limited resources, rapid innovation and diffusion of medical technologies, pressures on demand from society and professionals, and the lack of knowledge of the effects of these factors on costs and society's health. In addition, health care expenditures have grown twice as fast as wealth in industrialized countries during the last 25 years. These problems have prompted cost containment as a key issue in health policy and, at the same time, have promoted the development of socioeconomic evaluation as a scientific activity in the frame of health services research. Socioeconomic evaluation tries to determine if the sacrifice made by society, which devotes part of its limited resources to health care, maximizes the outcomes for population. This article describes basic concepts and methods of economic appraisal in health services which are illustrated with examples of clinical practice in cardiology. Common methods of evaluation are described; the relation between the clinical outcome of a procedure and its associated costs is emphasized in explaining the types of efficiency analysis (cost-efficacy, cost-effectiveness, cost-utility, and cost-benefit); and finally a guide for socioeconomic evaluation is provided.

  14. Applicable or non-applicable: investigations of clinical heterogeneity in systematic reviews

    Directory of Open Access Journals (Sweden)

    Laura E. Chess

    2016-02-01

    Full Text Available Abstract Background Clinical heterogeneity can be defined as differences in participant characteristics, types or timing of outcome measurements and intervention characteristics. Clinical heterogeneity in systematic reviews has the possibility to significantly affect statistical heterogeneity leading to inaccurate conclusions and misled decision making. The aim of this study is to identify to what extent investigators are assessing clinical heterogeneity in both Cochrane and non-Cochrane systematic reviews. Methods The most recent 100 systematic reviews from the top five journals in medicine—JAMA, Archives of Internal Medicine, British Medical Journal, The Lancet, and PLOS Medicine—and the 100 most recently published and/or updated systematic reviews from Cochrane were collected. Various defined items of clinical heterogeneity were extracted from the included reviews. Investigators used chi-squared tests, logarithmic modeling and linear regressions to determine if the presence of such items served as a predictor for clinical heterogeneity when comparing Cochrane to non-Cochrane reviews. Extracted variables include number of studies, number of participants, presence of quantitative synthesis, exploration of clinical heterogeneity, heterogeneous characteristics explored, basis and methods used for investigating clinical heterogeneity, plotting/visual aids, author contact, inferences from clinical heterogeneity investigation, reporting assessment, and the presence of a priori or post-hoc analysis. Results A total of 317 systematic reviews were considered, of which 199 were in the final analysis. A total of 81 % of Cochrane reviews and 90 % of non-Cochrane reviews explored characteristics that are considered aspects of clinical heterogeneity and also described the methods they planned to use to investigate the influence of those characteristics. Only 1 % of non-Cochrane reviews and 8 % of Cochrane reviews explored the clinical

  15. Efficiency achievements from a user-developed real-time modifiable clinical information system.

    Science.gov (United States)

    Bishop, Roderick O; Patrick, Jon; Besiso, Ali

    2015-02-01

    This investigation was initiated after the introduction of a new information system into the Nepean Hospital Emergency Department. A retrospective study determined that the problems introduced by the new system led to reduced efficiency of the clinical staff, demonstrated by deterioration in the emergency department's (ED's) performance. This article is an investigation of methods to improve the design and implementation of clinical information systems for an ED by using a process of clinical team-led design and a technology built on a radically new philosophy denoted as emergent clinical information systems. The specific objectives were to construct a system, the Nepean Emergency Department Information Management System (NEDIMS), using a combination of new design methods; determine whether it provided any reduction in time and click burden on the user in comparison to an enterprise proprietary system, Cerner FirstNet; and design and evaluate a model of the effect that any reduction had on patient throughput in the department. The methodology for conducting a direct comparison between the 2 systems used the 6 activity centers in the ED of clerking, triage, nursing assessments, fast track, acute care, and nurse unit manager. A quantitative study involved the 2 systems being measured for their efficiency on 17 tasks taken from the activity centers. A total of 332 task instances were measured for duration and number of mouse clicks in live usage on Cerner FirstNet and in reproduction of the same Cerner FirstNet work on NEDIMS as an off-line system. The results showed that NEDIMS is at least 41% more efficient than Cerner FirstNet (95% confidence interval 21.6% to 59.8%). In some cases, the NEDIMS tasks were remodeled to demonstrate the value of feedback to create improvements and the speed and economy of design revision in the emergent clinical information systems approach. The cost of the effort in remodeling the designs showed that the time spent on remodeling is

  16. Investigators' viewpoint of clinical trials in India: Past, present and future

    Directory of Open Access Journals (Sweden)

    Mohandas K Mallath

    2017-01-01

    Full Text Available India's success in producing food and milk for its population (Green Revolution and White Revolution happened because of scientific research and field trials. Likewise improving the health of Indians needs clinical research and clinical trials. A Large proportion of the sick Indians are poor, illiterate with no access to good health care. They are highly vulnerable to inducement and exploitation in clinical trials. The past two decades saw the rise and fall of clinical trials in India. The rise happened when our regulators created a favorable environment, and Indian investigators were invited to participate in global clinical trials. The gap between the demand and supply resulted in inadequate protection of the trial participants. Reports of abuses of the vulnerable trial participants followed by public interest litigations led to strengthening of regulations by the regulators. The stringent new regulations made the conduct of clinical trials more laborious and increased the cost of clinical trials in India. There was a loss of interest in sponsored clinical trials resulting in the fall in global clinical trials in India. Following repeated appeals by the investigators, the Indian regulators have recently relaxed some of the stringent regulations, while continuing to ensure the adequate patient protection. Clinical trials that are relevant to our population and conducted by well-trained investigators and monitored by trained and registered Ethics Committees will increase in the future. We must remain vigilant, avoid previous mistakes, and strive hard to protect the trial participants in the future trials.

  17. Clinical Investigation of the Dopaminergic System with PET and FLUORINE-18-FLUORO-L-DOPA.

    Science.gov (United States)

    Oakes, Terrence Rayford

    1995-01-01

    Positron Emission Tomography (PET) is a tool that provides quantitative physiological information. It is valuable both in a clinical environment, where information is sought for an individual, and in a research environment, to answer more fundamental questions about physiology and disease states. PET is particularly attractive compared to other nuclear medicine imaging techniques in cases where the anatomical regions of interest are small or when true metabolic rate constants are required. One example with both of these requirements is the investigation of Parkinson's Disease, which is characterized as a presynaptic motor function deficit affecting the striatum. As dopaminergic neurons die, the ability of the striatum to affect motor function decreases. The extent of functional neuronal damage in the small sub-structures may be ascertained by measuring the ability of the caudate and putamen to trap and store dopamine, a neurotransmitter. PET is able to utilize a tracer of dopamine activity, ^ {18}F- scL-DOPA, to quantitate the viability of the striatum. This thesis work deals with implementing and optimizing the many different elements that compose a PET study of the dopaminergic system, including: radioisotope production; conversion of aqueous ^{18}F ^-into [^ {18}F]-F2; synthesis of ^{18}F- scL -DOPA; details of the PET scan itself; measurements to estimate the radiation dosimetry; accurate measurement of a plasma input function; and the quantitation of dopaminergic activity in normal human subjects as well as in Parkinson's Disease patients.

  18. A Preliminary Investigation into the Information Sharing Behavior of Social Media Users after a Natural Disaster

    Science.gov (United States)

    Maruyama, Yukiko

    2016-01-01

    The paper provides the results of a preliminary investigation into the information sharing behavior of social media users after a natural disaster. The results indicate that users shared information that they thought victims would find useful. On the other hand, they reported that they usually do not or never share information considered useful to…

  19. Systems for the management of information in a university context: an investigation of user need. Information systems, Universities, Information strategy

    Directory of Open Access Journals (Sweden)

    Marcella R.

    2004-01-01

    Full Text Available The accessibility, reliability, consistency, and relevance of data underpinning information systems are crucial to its use and effectiveness in a university setting. This article reports on the findings of a research project carried out at a new university, which highlighted the role information plays in the success of the operation and in allowing the institution to evolve and meet the challenges posed by the government, students and other stakeholders. Data were gathered from the academic and administrative staff of the university through interviews with senior managers, and a Web-based questionnaire completed by 863 respondents (a 47.9% response rate. The project aimed to explore data and information activities supporting management and strategic decision making in a new university. Project results indicate that there are real deficiencies in the realization of the case institution's information strategy and that these deficiencies must be addressed in developments focusing on improving strategic effectiveness in the future. Particular issues identified included the lack of clarity in responsibility regarding information and concerns about the validity of much of the internally created and maintained data.

  20. [Ethics in clinical routine care: example of prognosis information].

    Science.gov (United States)

    Elger, Bernice S

    2002-09-15

    The article discusses from an ethical point of view the question whether a physician should tell the patient the whole truth about a poor prognosis. From a legal viewpoint, the therapeutic privilege gives physicians in most countries the right to limit information, if they are concerned that this information will severely harm the patient. An overview about empirical studies, especially surveys of physicians and patients, shows that most patients always wish to know their prognosis, while physicians would less often tell the whole truth. Physicians explain their attitudes by referring to the ethical principles of nonmaleficience and beneficience. These principles are apparently in conflict with the principles of veracity and respect of patient autonomy. However, it can be shown that this conflict does not persist when empirical data about consequences of truthful information are considered: telling the truth seems not to have negative, but rather positive consequences on the overall well-being of the patient. After having summarized the empirical studies that have examined the consequences of truthful information about severe and incurable diseases, the article argues for always telling patients the truth if they want to know it. Many conflicts in medical ethics are between prima facie principles. In cases where the principles of beneficience and nonmaleficience are used in the argumentation, some of the conflicts can be eliminated when the ethical judgment is made on a thorough empirical basis, as shown by the example of truth-telling about prognosis.

  1. 59th Medical Wing Clinical Research Division Clinical Investigations Program Posters (Count: 2)

    Science.gov (United States)

    2017-05-08

    Investigations Program Posters (Count: 2) presented at/published to Graduate School Faculty Development and Research Symposium, Gateway Club, JBSA...copy of your abstract, paper. poster and other supporting documentation. 5. Save and forward, via email, the processing form and all supporting...you a final letter of approval or disapproval. g, Once your manuscript, poster or presentation has been approved for a one-lime public release, you may

  2. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Science.gov (United States)

    2013-11-07

    .... 66, rm. 2110, Silver Spring, MD 20993-0002, 301- 796-5750. For devices regulated by CBER: Stephen... the best clinical and statistical practices for investigational medical device studies. A medical...

  3. Clinical investigation of CT-guided ozone-blowing and fumigation ...

    African Journals Online (AJOL)

    Clinical investigation of CT-guided ozone-blowing and fumigation therapy for the chronic ... African Journal of Biotechnology ... In control group, seven patients were completely cured in 45 days after being treated by traditional surgery.

  4. Ethics in clinical research: need for assessing comprehension of informed consent form?

    Science.gov (United States)

    Shafiq, Nusrat; Malhotra, Samir

    2011-03-01

    Comprehension of informed consent form has not achieved the attention it deserves. We made a 24-item questionnaire to assess clinical research participants' comprehension of informed consent form (Contemp Clin Trials 2009;30:427-30). Due to repeated requests by clinical researchers in our country and abroad, we are publishing the questionnaire in this article. Copyright © 2010 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2009-04-01

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

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

    Science.gov (United States)

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

    2010-07-01

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

  7. Clinical epidemiology of premenstrual disorder: informing optimized patient outcomes

    Directory of Open Access Journals (Sweden)

    Robinson LLL

    2015-09-01

    Full Text Available Lynne LL Robinson,1 Khaled MK Ismail1,21Department of Obstetrics and Gynaecology, Birmingham Women’s Hospital, Birmingham, UK; 2Birmingham Centre for Women’s and Children’s Health, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UKAbstract: Premenstrual disorders encompass a spectrum that ranges from mild cyclical psychological and somatic symptoms to the rarer but much-more-severe premenstrual dysphoric disorder. This condition is serious and the etiology is unclear, but possible causes include genetic factors, hormonal fluctuations, and neurotransmitter dysfunctions. Differentiation from other affective disorders can be difficult but is key to providing appropriate management. This comprehensive review will discuss the most-recent classification of premenstrual disorders, etiology, diagnosis, and potential current management strategies.Keywords: premenstrual dysphoric disorder, progesterone, oestrogen, oophrectomy, GNRH analogues

  8. Tendinopathy: Evidence-Informed Physical Therapy Clinical Reasoning.

    Science.gov (United States)

    Vicenzino, Bill

    2015-11-01

    Patients presenting with pain at the tendon, which is associated with physical tasks and activities that specifically load that tendon, are at the center of this special issue. The current terminology for a symptomatic tendon presentation is tendinopathy, as this does not denote an underlying pathology, but rather signals that all is not well in the tendon. Tendinopathy is a prevalent and substantial problem, as it interferes with a person's capacity to lead a physically active and healthy life, which has a considerable flow-on effect on society in general. This issue deals with the contemporary physical therapy management of tendinopathy by providing a mix of evidence review and clinical expert opinion on commonly presenting tendinopathies of the lower and upper limbs. J Orthop Sports Phys Ther 2015;45(11):816-818. doi:10.2519/jospt.2015.0110.

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

    Science.gov (United States)

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

    2012-01-01

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

  10. A clinical scoring system to prioritise investigation for tuberculosis among adults attending HIV clinics in South Africa.

    Directory of Open Access Journals (Sweden)

    Yasmeen Hanifa

    Full Text Available The World Health Organization (WHO recommendation for regular tuberculosis (TB screening of HIV-positive individuals with Xpert MTB/RIF as the first diagnostic test has major resource implications.To develop a diagnostic prediction model for TB, for symptomatic adults attending for routine HIV care, to prioritise TB investigation.Cohort study exploring a TB testing algorithm.HIV clinics, South Africa.Representative sample of adult HIV clinic attendees; data from participants reporting ≥1 symptom on the WHO screening tool were split 50:50 to derive, then internally validate, a prediction model.TB, defined as "confirmed" if Xpert MTB/RIF, line probe assay or M. tuberculosis culture were positive; and "clinical" if TB treatment started without microbiological confirmation, within six months of enrolment.Overall, 79/2602 (3.0% participants on ART fulfilled TB case definitions, compared to 65/906 (7.2% pre-ART. Among 1133/3508 (32.3% participants screening positive on the WHO tool, 1048 met inclusion criteria for this analysis: 52/515 (10.1% in the derivation and 58/533 (10.9% in the validation dataset had TB. Our final model comprised ART status (on ART > 3 months vs. pre-ART or ART 1 symptom. We converted this to a clinical score, using clinically-relevant CD4 and BMI categories. A cut-off score of ≥3 identified those with TB with sensitivity and specificity of 91.8% and 34.3% respectively. If investigation was prioritised for individuals with score of ≥3, 68% (717/1048 symptomatic individuals would be tested, among whom the prevalence of TB would be 14.1% (101/717; 32% (331/1048 of tests would be avoided, but 3% (9/331 with TB would be missed amongst those not tested.Our clinical score may help prioritise TB investigation among symptomatic individuals.

  11. Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

    Science.gov (United States)

    Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

    2016-12-15

    Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by

  12. [THE RESULTS OF CLINICAL AND PSYCHOPATHOLOGICAL AND PSYCHOLOGICAL DIAGNOSTIC INVESTIGATIONS EMPLOYEES OF FINANCIAL INSTITUTIONS WHICH WERE IDENTIFIED NEUROTIC DISORDERS].

    Science.gov (United States)

    Solovyova, M

    2014-12-01

    The article presents the results of the clinical and psychopathological and psychological diagnostic, investigations mental health employees of financial institutions, description and analysis of clinical forms identified disorders.

  13. Diagnostic investigation of patients with chronic polyneuropathy: evaluation of a clinical guideline

    NARCIS (Netherlands)

    Rosenberg, N. R.; Portegies, P.; de Visser, M.; Vermeulen, M.

    2001-01-01

    OBJECTIVE: (1) To evaluate a clinical guideline for the diagnostic investigation of patients presenting with signs and symptoms (present for longer than 6 weeks) suggesting a chronic polyneuropathy. (2) To investigate the contribution of electrophysiological studies to a focused search for aetiology

  14. Micro-costing the provision of emotional support and information in UK eye clinics

    OpenAIRE

    Gillespie-Gallery, Hanna; Subramanian, Ahalya; Conway, Miriam L

    2013-01-01

    Background Sight loss has wide ranging implications for an individual in terms of education, employment, mobility and mental health. Therefore there is a need for information and support to be provided in eye clinics at the point of diagnosis of sight threatening conditions, but these aspects of care are often missing from clinics. To meet these needs, some clinics employ an Eye Clinic Liaison Officer (ECLO) but the position has yet to be widely implemented. The aims of this study were: (1) T...

  15. The value of informal care: A further investigation of the feasibility of contingent valuation in informal caregivers

    NARCIS (Netherlands)

    Meijer, C.A.M.; Brouwer, W.B.F.; Koopmanschap, M.A.; van den Berg, B.; Exel, N.J.A.

    2010-01-01

    Including informal care in economic evaluations is increasingly advocated but problematic. We investigated three well-known concerns regarding contingent valuation (CV): (1) the item non-response of CV values, (2) the sensitivity of CV values to the individual circumstances of caring, and (3) the

  16. Strategies to exclude subjects who conceal and fabricate information when enrolling in clinical trials

    Directory of Open Access Journals (Sweden)

    Eric G. Devine

    2017-03-01

    Full Text Available Clinical trials within the US face an increasing challenge with the recruitment of quality candidates. One readily available group of subjects that have high rates of participation in clinical research are subjects who enroll in multiple trials for the purpose of generating income through study payments. Aside from issues of safety and generalizability, evidence suggests that these subjects employ methods of deception to qualify for the strict entrance criteria of some studies, including concealing information and fabricating information. Including these subjects in research poses a significant risk to the integrity of data quality and study designs. Strategies to limit enrollment of subjects whose motivation is generating income have not been systematically addressed in the literature. The present paper is intended to provide investigators with a range of strategies for developing and implementing a study protocol with protections to minimize the enrollment of subjects whose primary motivation for enrolling is to generate income. This multifaceted approach includes recommendations for advertising strategies, payment strategies, telephone screening strategies, and baseline screening strategies. The approach also includes recommendations for attending to inconsistent study data and subject motivation. Implementing these strategies may be more or less important depending upon the vulnerability of the study design to subject deception. Although these strategies may help researchers exclude subjects with a higher rate of deceptive practices, widespread adoption of subject registries would go a long way to decrease the chances of subjects enrolling in multiple studies or more than once in the same study.

  17. Strategies to exclude subjects who conceal and fabricate information when enrolling in clinical trials.

    Science.gov (United States)

    Devine, Eric G; Peebles, Kristina R; Martini, Valeria

    2017-03-01

    Clinical trials within the US face an increasing challenge with the recruitment of quality candidates. One readily available group of subjects that have high rates of participation in clinical research are subjects who enroll in multiple trials for the purpose of generating income through study payments. Aside from issues of safety and generalizability, evidence suggests that these subjects employ methods of deception to qualify for the strict entrance criteria of some studies, including concealing information and fabricating information. Including these subjects in research poses a significant risk to the integrity of data quality and study designs. Strategies to limit enrollment of subjects whose motivation is generating income have not been systematically addressed in the literature. The present paper is intended to provide investigators with a range of strategies for developing and implementing a study protocol with protections to minimize the enrollment of subjects whose primary motivation for enrolling is to generate income. This multifaceted approach includes recommendations for advertising strategies, payment strategies, telephone screening strategies, and baseline screening strategies. The approach also includes recommendations for attending to inconsistent study data and subject motivation. Implementing these strategies may be more or less important depending upon the vulnerability of the study design to subject deception. Although these strategies may help researchers exclude subjects with a higher rate of deceptive practices, widespread adoption of subject registries would go a long way to decrease the chances of subjects enrolling in multiple studies or more than once in the same study.

  18. [Informed consent right of the appraised individuals in forensic clinical examination].

    Science.gov (United States)

    Li, Ju-Ping; Han, Wei; Gu, Shan-Zhi; Chen, Teng

    2015-02-01

    Informed consent right is not just for basic ethical consideration, but is important for protecting patient's right by law, which is expressed through informed consent contract. The appraised individuals of forensic clinical examination have the similar legal status as the patients in medical system. However, the law does not require informed consent right for the appraised individuals. I recommend giving certain informed consent right to the appraised individuals in the forensic clinical examination. Under the contracted relationship with the institution, the appraised individuals could participate in the examination process, know the necessary information, and make a selected consent on the examination results, which can assure the justice and fairness of judicial examination procedure.

  19. Clinical decision support for whole genome sequence information leveraging a service-oriented architecture: a prototype.

    Science.gov (United States)

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

    2014-01-01

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

  20. Practitioner-Customizable Clinical Information Systems: A Case Study to Ground Further Research and Development Opportunities

    Directory of Open Access Journals (Sweden)

    Cecily Morrison

    2010-01-01

    Full Text Available The uptake of electronic records and information technology support in intensive care medicine has been slower than many people predicted. One of the engineering challenges to overcome has been the subtle, but important, variation in clinical practice in different units. A relatively recent innovation that addresses this challenge is practitioner-customizable clinical information systems, allowing clinicians wide scope in adjusting their systems to suit their clinical practice. However, these systems present a significant design challenge, not only of added technical complexity, but in providing tools that support clinicians in doing many of the tasks of a software engineer. This paper reviews the use of a commercially available clinical information system that is intended to be practitioner-customizable, and considers the further design and development of tools to support healthcare practitioners doing end-user customization on their own clinical information systems.

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

    Science.gov (United States)

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

    2013-12-01

    Temporal information extraction from clinical narratives is of critical importance to many clinical applications. We participated in the EVENT/TIMEX3 track of the 2012 i2b2 clinical temporal relations challenge, and presented our temporal information extraction system, MedTime. MedTime comprises a cascade of rule-based and machine-learning pattern recognition procedures. It achieved a micro-averaged f-measure of 0.88 in both the recognitions of clinical events and temporal expressions. We proposed and evaluated three time normalization strategies to normalize relative time expressions in clinical texts. The accuracy was 0.68 in normalizing temporal expressions of dates, times, durations, and frequencies. This study demonstrates and evaluates the integration of rule-based and machine-learning-based approaches for high performance temporal information extraction from clinical narratives. Copyright © 2013 Elsevier Inc. All rights reserved.

  2. Investigation into information flow during the accident at Three Mile Island

    International Nuclear Information System (INIS)

    1981-01-01

    This report was prepared in response to a request from NRC Chairman Ahearne that directed the Office of Inspection and Enforcement to resume its investigation of information flow during the accident at Three Mile Island (TMI) that occurred on March 28, 1979. This investigation was resumed on March 21, 1980. The transfer of information among individuals, agencies, and personnel from Metropolitan Edison was analyzed to ascertain what knowledge was held by various individuals of the specific events, parameters, and systems during the accident at TMI. Maximum use was made of existing records, and additional interviews were conducted to clarify areas that had not been pursued during earlier investigations. Although the passage of time between the accident and post-accident interviews hampered precise recollections of events and circumstances, the investigation revealed that information was not intentionally withheld during the accident and that the system for effective transfer of information was inadequate during the accident

  3. An investigation of the search behaviour associated with Ingwersen’s three types of information needs

    DEFF Research Database (Denmark)

    Borlund, Pia; Dreier, Sabine

    2014-01-01

    We report a naturalistic interactive information retrieval (IIR) study of 18 ordinary users in the age of 20–25 who carry out everyday-life information seeking (ELIS) on the Internet with respect to the three types of information needs identified by Ingwersen (1986): the verificative information...... need (VIN), the conscious topical information need (CIN), and the muddled topical information need (MIN). The searches took place in the private homes of the users in order to ensure as realistic searching as possible. Ingwersen (1996) associates a given search behaviour to each of the three types...... of information needs, which are analytically deduced, but not yet empirically tested. Thus the objective of the study is to investigate whether empirical data does, or does not, conform to the predictions derived from the three types of information needs. The main conclusion is that the analytically deduced...

  4. Evaluation of the clinical process in a critical care information system using the Lean method: a case study

    Directory of Open Access Journals (Sweden)

    Yusof Maryati Mohd

    2012-12-01

    Full Text Available Abstract Background There are numerous applications for Health Information Systems (HIS that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS, known as IntelliVue Clinical Information Portfolio (ICIP, and recommends solutions to the problems that were identified during the study. Methods We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. Results We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. Conclusions The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy.

  5. Investigation of the Usability of Computerized Critical Care Information Systems in Germany.

    Science.gov (United States)

    von Dincklage, Falk; Suchodolski, Klaudiusz; Lichtner, Gregor; Friesdorf, Wolfgang; Podtschaske, Beatrice; Ragaller, Maximilian

    2017-01-01

    The term "usability" describes how effectively, efficiently, and with what level of user satisfaction an information system can be used to accomplish specific goals. Computerized critical care information systems (CCISs) with high usability increase quality of care and staff satisfaction, while reducing medication errors. Conversely, systems lacking usability can interrupt clinical workflow, facilitate errors, and increase charting time. The aim of this study was to investigate and compare usability across CCIS currently used in Germany. In this study, German intensive care unit (ICU) nurses and physicians completed a specialized, previously validated, web-based questionnaire. The questionnaire assessed CCIS usability based on three rating models: an overall rating of the systems, a model rating technical usability, and a model rating task-specific usability. We analyzed results from 535 survey participants and compared eight different CCIS commonly used in Germany. Our results showed that usability strongly differs across the compared systems. The system ICUData had the best overall rating and technical usability, followed by the platforms ICM and MetaVision. The same three systems performed best in the rating of task-specific usability without significant differences between each other. Across all systems, overall ratings were more dependent on ease-of-use aspects than on aspects of utility/functionality, and the general scope of the functions offered was rated better than how well the functions are realized. Our results suggest that manufacturers should shift some of their effort away from the development of new features and focus more on improving the ease-of-use and quality of existing features.

  6. The value of an information leaflet for patients having nuclear medicine investigations

    International Nuclear Information System (INIS)

    Ahmed, Susan Mohamed; Mohammed, Nada Yousif; Elhasseen, Amna Elnour

    2001-01-01

    This research aimed at design an information leaflet about nuclear medicine investigations usually done at the radiation and isotopes centre of Khartoum (RICK). The objectives are: to confirm lack of knowledge among patients attending hospital, to find out kind of information required and to improve service quality

  7. Weight of the evidence of genetic investigations of ancestry informative markers

    DEFF Research Database (Denmark)

    Tvedebrink, Torben; Eriksen, Poul Svante; Mogensen, Helle Smidt

    2018-01-01

    Ancestry-informative markers (AIMs) are markers that give information about the ancestry of individuals. They are used in forensic genetics for predicting the geographic origin of the investigated individual in crime and identification cases. In the exploration of the genogeographic origin...

  8. Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series.

    Science.gov (United States)

    Adam, Gaelen P; Springs, Stacey; Trikalinos, Thomas; Williams, John W; Eaton, Jennifer L; Von Isenburg, Megan; Gierisch, Jennifer M; Wilson, Lisa M; Robinson, Karen A; Viswanathan, Meera; Middleton, Jennifer Cook; Forman-Hoffman, Valerie L; Berliner, Elise; Kaplan, Robert M

    2018-04-16

    We investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews. We considered five reviews that included 495 studies total. Each review team conducted a search of ClinicalTrials.gov up to the date of the review's last literature search, screened the records using the review's eligibility criteria, extracted information, and assessed risk of bias and applicability. Each team then evaluated the impact of the evidence found in ClinicalTrials.gov on the conclusions in the review. Across the five reviews, the number of studies that had both a registry record and a publication varied widely, from none in one review to 43% of all studies identified in another. Among the studies with both a record and publication, there was also wide variability in the match between published outcomes and those listed in ClinicalTrials.gov. Of the 173 total ClinicalTrials.gov records identified across the five projects, between 11 and 43% did not have an associated publication. In the 14% of records that contained results, the new data provided in the ClinicalTrials.gov records did not change the results or conclusions of the reviews. Finally, a large number of published studies were not registered in ClinicalTrials.gov, but many of these were published before ClinicalTrials.gov's inception date of 2000. Improved prospective registration of trials and consistent reporting of results in ClinicalTrials.gov would help make ClinicalTrials.gov records more useful in finding unpublished information and identifying potential biases. In addition, consistent indexing in databases, such as MEDLINE, would allow for better matching of records and publications, leading to increased utility of these searches for systematic review projects.

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

    Science.gov (United States)

    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.

  10. [Development of an ophthalmological clinical information system for inpatient eye clinics].

    Science.gov (United States)

    Kortüm, K U; Müller, M; Babenko, A; Kampik, A; Kreutzer, T C

    2015-12-01

    In times of increased digitalization in healthcare, departments of ophthalmology are faced with the challenge of introducing electronic clinical health records (EHR); however, specialized software for ophthalmology is not available with most major EHR sytems. The aim of this project was to create specific ophthalmological user interfaces for large inpatient eye care providers within a hospitalwide EHR. Additionally the integration of ophthalmic imaging systems, scheduling and surgical documentation should be achieved. The existing EHR i.s.h.med (Siemens, Germany) was modified using advanced business application programming (ABAP) language to create specific ophthalmological user interfaces for reproduction and moreover optimization of the clinical workflow. A user interface for documentation of ambulatory patients with eight tabs was designed. From June 2013 to October 2014 a total of 61,551 patient contact details were documented. For surgical documentation a separate user interface was set up. Digital clinical orders for documentation of registration and scheduling of operations user interfaces were also set up. A direct integration of ophthalmic imaging modalities could be established. An ophthalmologist-orientated EHR for outpatient and surgical documentation for inpatient clinics was created and successfully implemented. By incorporation of imaging procedures the foundation of future smart/big data analyses was created.

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

    Science.gov (United States)

    Hahn, Daniel; Wanjala, Pepela; Marx, Michael

    2013-08-29

    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. 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. 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. 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.

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

    Directory of Open Access Journals (Sweden)

    Daniel Hahn

    2013-08-01

    Full Text Available 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.

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

    Science.gov (United States)

    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. PMID:23993022

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

    Science.gov (United States)

    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.

  15. A short version of the revised 'experience of close relationships questionnaire': investigating non-clinical and clinical samples.

    Science.gov (United States)

    Wongpakaran, Tinakon; Wongpakaran, Nahathai

    2012-01-01

    This study seeks to investigate the psychometric properties of the short version of the revised 'Experience of Close Relationships' questionnaire, comparing non-clinical and clinical samples. In total 702 subjects participated in this study, of whom 531 were non-clinical participants and 171 were psychiatric patients. They completed the short version of the revised 'Experience of Close Relationships' questionnaire (ECR-R-18), the Perceived Stress Scale-10(PSS-10), the Rosenberg Self-Esteem Scale (RSES) and the UCLA Loneliness scale. A retest of the ECR-R-18 was then performed at four-week intervals. Then, confirmatory factor analyses were performed to test the validity of the new scale. The ECR-R-18 showed a fair to good internal consistency (α 0.77 to 0.87) for both samples, and the test-retest reliability was found to be satisfactory (ICC = 0.75). The anxiety sub-scale demonstrated concurrent validity with PSS-10 and RSES, while the avoidance sub-scale showed concurrent validity with the UCLA Loneliness Scale. Confirmatory factor analysis using method factors yielded two factors with an acceptable model fit for both groups. An invariance test revealed that the ECR-R-18 when used on the clinical group differed from when used with the non-clinical group. The ECR-R-18 questionnaire revealed an overall better level of fit than the original 36 item questionnaire, indicating its suitability for use with a broader group of samples, including clinical samples. The reliability of the ECR-R- 18 might be increased if a modified scoring system is used and if our suggestions with regard to future studies are followed up.

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

    Science.gov (United States)

    Goossen, William T F

    2014-07-01

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

  17. Care for a break? An investigation of informal caregivers' attitudes toward respite care using Q-methodology

    NARCIS (Netherlands)

    Exel, J.; de Graaf, G.; Brouwer, W.

    2007-01-01

    Objective: To investigate informal caregivers' attitudes toward respite care. Method: Interviews with informal caregivers during open-house support groups (three) for informal caregivers, conducted late 2004 at Informal Care Support Centres in the city of Rotterdam, The Netherlands. A

  18. Integrating Building Information Modeling and Augmented Reality to Improve Investigation of Historical Buildings

    Directory of Open Access Journals (Sweden)

    Francesco Chionna

    2015-12-01

    Full Text Available This paper describes an experimental system to support investigation of historical buildings using Building Information Modeling (BIM and Augmented Reality (AR. The system requires the use of an off-line software to build the BIM representation and defines a method to integrate diagnostic data into BIM. The system offers access to such information during site investigation using AR glasses supported by marker and marker-less technologies. The main innovation is the possibility to contextualize through AR not only existing BIM properties but also results from non-invasive tools. User evaluations show how the use of the system may enhance the perception of engineers during the investigation process.

  19. System of automated processing of radionuclide investigations (SAPRI-01) in clinical practice

    International Nuclear Information System (INIS)

    Sivachenko, T.P.; Mechev, D.S.; Krupka, I.N.

    1988-01-01

    The author described the results of clinical testing of a system SAPRI-01 designed for automated collection, storage and processing of data on radionuclide investigations. He gave examples of automated processing of RCG and the results of positive scintigraphy of tumors of different sites using 67 Ga-citrate and 99m Tc pertechnetate in statistical and dynamic investigations. Short-comings and ways for updating 4 the system during its serial production were pointed out. The introduction of the system into clinical practice on a wide scale was shown to hold promise

  20. Parent-Adolescent Cross-Informant Agreement in Clinically Referred Samples

    DEFF Research Database (Denmark)

    Rescorla, Leslie A; Ewing, Grace; Ivanova, Masha Y

    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...

  1. EM-GE-5 Regulation. Standard for the first-rate application clinical practices in the execution of the clinical investigations for medical teams' evaluation

    International Nuclear Information System (INIS)

    2015-01-01

    This guide has the following objectives: a) To guide methodologically the implementation of Good Clinical Practice for the execution of clinical research with medical devices that need to be evaluated, in addition to the Regulation E R-6. Requirements for the Conduct of Clinical Trials for Medical Devices , b) Provide the fundamental aspects to be taken into count for quality control to clinical investigations.

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

    Science.gov (United States)

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

    2014-01-10

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

  3. Is the Internet a Suitable Patient Resource for Information on Common Radiological Investigations?: Radiology-Related Information on the Internet.

    Science.gov (United States)

    Bowden, Dermot J; Yap, Lee-Chien; Sheppard, Declan G

    2017-07-01

    This study aimed to assess the quality of Internet information about common radiological investigations. Four search engines (Google, Bing, Yahoo, and Duckduckgo) were searched using the terms "X-ray," "cat scan," "MRI," "ultrasound," and "pet scan." The first 10 webpage results returned for each search term were recorded, and their quality and readability were analyzed by two independent reviewers (DJB and LCY), with discrepancies resolved by consensus. Analysis of information quality was conducted using validated instruments for the assessment of health-care information (DISCERN score is a multi-domain tool for assessment of health-care information quality by health-care professionals and laypeople (max 80 points)) and readability (Flesch-Kincaid and SMOG or Simple Measure of Gobbledygook scores). The search result pages were further classified into categories as follows: commercial, academic (educational/institutional), and news/magazine. Several organizations offer website accreditation for health-care information, and accreditation is recognized by the presence of a hallmark or logo on the website. The presence of any valid accreditation marks on each website was recorded. Mean scores between groups were compared for significance using the Student t test. A total of 200 webpages returned (108 unique website addresses). The average DISCERN score was search engines. No significant difference was seen in readability between modalities or between search engines. Websites carrying validated accreditation marks were associated with higher average DISCERN scores: X-ray (39.36 vs 25.35), computed tomography (45.45 vs 31.33), and ultrasound (40.91 vs 27.62) (P information on the Internet is poor. High-quality online resources should be identified so that patients may avoid the use of poor-quality information derived from general search engine queries. Copyright © 2017 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

  4. 75 FR 1790 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB...

    Science.gov (United States)

    2010-01-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0605... clinical investigators and sponsors better understand their responsibilities related to continuing review...-463-6332 or 301-796-3400); or the Office of Communication, Outreach and Development (HFM-40), Center...

  5. Naa Technique for Clinical Investigation of Mice Immunized with BOTHROP Venom

    Science.gov (United States)

    Zamboni, C. B.; Aguiar, R. O.; Kovacs, L.; Suzuki, M.; Sant'Anna, O. A.

    2009-06-01

    In the present study Neutron Activation Analysis (NAA) technique was used to determine sodium concentration in whole blood of mice immunized with Bothrops venom. With this value it was possible to perform clinical investigation in this animal model using whole blood.

  6. Using Hermeneutic Phenomenology to Investigate How Experienced Practitioners Learn to Communicate Clinical Reasoning

    Science.gov (United States)

    Ajjawi, Rola; Higgs, Joy

    2007-01-01

    This paper is primarily targeted at doctoral students and other researchers considering using hermeneutic phenomenology as a research strategy. We present interpretive paradigm research designed to investigate how experienced practitioners learn to communicate their clinical reasoning in professional practice. Twelve experienced physiotherapy…

  7. 21 CFR 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand...

    Science.gov (United States)

    2010-04-01

    ... that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health... opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children... clinical investigation presents a reasonable opportunity to further the understanding, prevention, or...

  8. 77 FR 11555 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional...

    Science.gov (United States)

    2012-02-27

    ..., Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the Agencies... criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of... review to assure the protection of the rights and welfare of subjects in clinical investigations. The...

  9. 76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

    Science.gov (United States)

    2011-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0457] Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated... other electrical continence devices; protective garment for incontinence; surgical mesh; electrosurgical...

  10. Peer Review of Clinical Information Models: A Web 2.0 Crowdsourced Approach.

    Science.gov (United States)

    Leslie, Heather; Ljosland Bakke, Silje

    2017-01-01

    Over the past 8 years the openEHR Clinical Model program has been developing a Web 2.0 approach and tooling to support the development, review and governance of atomic clincial information models, known as archetypes. This paper describes the background and review process, and provides a practical example where cross standards organisation collaboration resulted in jointly agreed clinical content which was subsequently represented in different implementation formalisms that were effectively semantically aligned. The discussion and conclusions highlight some of the socio-technical benefits and challenges facing organisations who seek to govern automic clinical information models in a global and collaborative online community.

  11. 78 FR 27243 - Proposed Collection; 60-Day Comment Request: Interactive Informed Consent for Pediatric Clinical...

    Science.gov (United States)

    2013-05-09

    ... consent or the interactive computer-based program, will be assessed by face-to-face interview. In addition... Comment Request: Interactive Informed Consent for Pediatric Clinical Trials SUMMARY: In compliance with... other technological collection techniques or other forms of information technology. To Submit Comments...

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

    Science.gov (United States)

    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…

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

    Science.gov (United States)

    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…

  14. Investigating factors determining the use of the clinical care module by nurses through the UTAUT model

    CSIR Research Space (South Africa)

    Zhou, M

    2016-04-01

    Full Text Available conditions, and treatment plans. A clinical decision based on information that has been efficiently managed and processed lends itself to quality care outcomes.’ The Ministry of Health and Child Care (MoHCC) and the hospital health authorities have managed... : The Eighth International Conference on eHealth, Telemedicine, and Social Medicine (with DIGITAL HEALTHY LIVING 2016 / MATH 2016) Electronic Health (E-Health) projects rolled out do not offer the clinical services module to aid clinicians during decision...

  15. Are Clinical Trial Experiences Utilized?: A Differentiated Model of Medical Sites’ Information Transfer Ability

    DEFF Research Database (Denmark)

    Smed, Marie; Schultz, Carsten; Getz, Kenneth A.

    2015-01-01

    The collaboration with medical professionals in pharmaceutical clinical trials facilitates opportunities to gain valuable market information concerning product functionality issues, as well as issues related to market implementation and adoption. However, previous research on trial management lacks......’ information transfer ability, their methods of communicating, are included. The model is studied on a unique dataset of 395 medical site representatives by applying Rasch scale modeling to differentiate the stickiness of the heterogenic information issues. The results reveal that economic measures...... a differentiated perspective on the potential for information transfer from site to producer. An exploration of the variation in stickiness of information, and therefore the complexity of information transfer in clinical trials, is the main aim of this study. To further enrich the model of the dispersed sites...

  16. Genomic investigation of Staphylococcus aureus isolates from bulk tank milk and dairy cows with clinical mastitis.

    Science.gov (United States)

    Ronco, Troels; Klaas, Ilka C; Stegger, Marc; Svennesen, Line; Astrup, Lærke B; Farre, Michael; Pedersen, Karl

    2018-02-01

    Staphylococcus aureus is one of the most common pathogens that cause mastitis in dairy cows. Various subtypes, virulence genes and mobile genetic elements have been associated with isolates from bulk tank milk and clinical mastitis. So far, no Danish cattle associated S. aureus isolates have been whole-genome sequenced and further analyzed. Thus, the main objective was to investigate the population structure and genomic content of isolates from bulk tank milk and clinical mastitis, using whole-genome sequencing. This may reveal the origin of strains that cause clinical mastitis. S. aureus isolates from bulk tank milk (n = 94) and clinical mastitis (n = 63) were collected from 91 and 24 different farms, respectively and whole-genome sequenced. The genomic content was analyzed and a phylogenetic tree based on single nucleotide polymorphisms was constructed. In general, the isolates from both bulk tank milk and clinical mastitis were of similar genetic background. This suggests that dairy cows are natural carriers of the S. aureus subtypes that cause clinical mastitis if the right conditions are present and that a broad range of subtypes cause mastitis. A phylogenetic cluster that mostly consisted of ST151 isolates carried three mobile genetic elements that were primarily found in this group. The prevalence of resistance genes was generally low. However, the first ST398 methicillin resistant S. aureus isolate from a Danish dairy cow with clinical mastitis was detected. Copyright © 2018 Elsevier B.V. All rights reserved.

  17. The relationship between senior management team culture and clinical governance: Empirical investigation and managerial implications.

    Science.gov (United States)

    Prenestini, Anna; Calciolari, Stefano; Lega, Federico; Grilli, Roberto

    2015-01-01

    Health care organizations are pressured to improve the cost-effectiveness of service delivery. Clinical governance is an important trigger to improve care quality and safety and rank high in the reform agenda of health systems. The senior management team culture plays a major role in establishing clinical governance practices, because it strongly influences the values, attitudes, and behaviors of the members of an organization. The aim of this study was to investigate the relationship between senior management team culture and clinical governance in the public health care organizations of three Italian regions. The assessment of senior management culture was conducted using the Competing Values Framework and a corresponding instrument adapted for the Italian context. Clinical governance was assessed using an ad hoc instrument focused on the senior management team's perception and attitude toward clinical governance. The survey achieved a 54% response rate. The results of four different models demonstrate that organizations characterized by different dominant cultures are associated with significant differences in attitudes toward clinical governance. In particular, on average, dominant cultures with a prevailing external focus are associated with a more positive attitude toward clinical governance. The selection and appointments of top managers should consider the style of leadership that is most apt to facilitate the growth of rational and developmental cultures. Furthermore, the training of top managers and leading doctors should reinforce leadership aptitude and approaches that are consistent with the desired organizational cultures.

  18. Natural language processing systems for capturing and standardizing unstructured clinical information: A systematic review.

    Science.gov (United States)

    Kreimeyer, Kory; Foster, Matthew; Pandey, Abhishek; Arya, Nina; Halford, Gwendolyn; Jones, Sandra F; Forshee, Richard; Walderhaug, Mark; Botsis, Taxiarchis

    2017-09-01

    We followed a systematic approach based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses to identify existing clinical natural language processing (NLP) systems that generate structured information from unstructured free text. Seven literature databases were searched with a query combining the concepts of natural language processing and structured data capture. Two reviewers screened all records for relevance during two screening phases, and information about clinical NLP systems was collected from the final set of papers. A total of 7149 records (after removing duplicates) were retrieved and screened, and 86 were determined to fit the review criteria. These papers contained information about 71 different clinical NLP systems, which were then analyzed. The NLP systems address a wide variety of important clinical and research tasks. Certain tasks are well addressed by the existing systems, while others remain as open challenges that only a small number of systems attempt, such as extraction of temporal information or normalization of concepts to standard terminologies. This review has identified many NLP systems capable of processing clinical free text and generating structured output, and the information collected and evaluated here will be important for prioritizing development of new approaches for clinical NLP. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

    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:

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

    Science.gov (United States)

    Uciteli, Alexandr; Groß, Silvia; Kireyev, Sergej; Herre, Heinrich

    2011-08-09

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

  1. An investigation of nurse educator's perceptions and experiences of undertaking clinical practice.

    Science.gov (United States)

    Williams, Angela; Taylor, Cathy

    2008-11-01

    Educational policy (DOH, 1999. Making a difference: strengthening the nursing, midwifery and health visiting contribution to health and healthcare. Department of Health, London; UKCC, 1999. Fitness for Practice. United Kingdom Central Council for Nursing, Midwifery and Health Visiting, London; Nursing and Midwifery Council, 2006. Standards to support learning and assessment in practice. Nursing and Midwifery Council, London) and current nursing literature (Griscti, O., Jacono, B., Jacono, J., 2005. The nurse educator's clinical role. Journal of Advanced Nursing 50 (1), 84-92; Owen, S., Ferguson, K., Baguley, I., 2005. The clinical activity of mental health nurse lecturers. Journal of Psychiatric and Mental Health Nursing 12, 310-316), place increasing emphasis on nurse educators undertaking clinical practice to facilitate their clinical confidence and competence. This study investigated nurse educators' perceptions and experiences of undertaking clinical practice. A qualitative design and descriptive, exploratory approach were used. A purposive sample of 11 nurse educators in one nursing department, took part in two focus group interviews, one with 5 and the other with 6 respondents, to identify and discuss their perceptions and experiences of undertaking clinical practice. A process of thematic content analysis revealed three broad themes relating to the meaning and importance of clinical practice, perceived benefits and barriers which are examined and discussed. The paper concludes that despite policy recommendations, barriers highlighted in this study such as insufficient time, heavy workload and a lack of valuing of the clinical role have been raised over the past few decades. The effect of undertaking clinical practice, particularly on the quality of teaching is argued to be valuable armoury in the battle to secure sufficient resources to support engagement in clinical practice. Financial and organisational commitment; valuing of clinical practice and research

  2. Satisfaction Survey on Information Technology-Based Glucose Monitoring System Targeting Diabetes Mellitus in Private Local Clinics in Korea

    Directory of Open Access Journals (Sweden)

    Hun-Sung Kim

    2017-06-01

    Full Text Available BackgroundPrivate local clinics in Korea have little experience with information technology (IT-based glucose monitoring (ITGM. Our aim is to examine user satisfaction and the possibility of using ITGM service practically.MethodsPatients sent their blood glucose levels to physicians in local clinics. The physicians reviewed the blood glucose values online and provided personal consultations through text messaging or phone calls. Thereafter, a satisfaction survey on the ITGM service, the modified Morisky scale, and patient assessment of chronic illness care were administered.ResultsOne hundred and seventy patients from seven private local clinics used the ITGM. Overall satisfaction, including that about the ITGM service, the device, and its usefulness, was rated higher than “mostly satisfied” (score 4.2±0.8 out of 5.0 and even higher among the elderly. Satisfaction was positively associated with age, especially in those older than 60 years. The main reason for intent for future use of the service was the time/place flexibility. Highly motivated patients tended to answer positively regarding information satisfaction (P=0.0377.ConclusionOur study is the first to investigate ITGM satisfaction in private local clinics. The feasibility of users utilizing ITGM should be clarified, and future clinical research on the service's clinical effects and cost-benefit analysis is needed.

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

    Science.gov (United States)

    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.

  4. Rational clinical evaluation of suspected acute coronary syndromes: The value of more information.

    Science.gov (United States)

    Hancock, David G; Chuang, Ming-Yu Anthony; Bystrom, Rebecca; Halabi, Amera; Jones, Rachel; Horsfall, Matthew; Cullen, Louise; Parsonage, William A; Chew, Derek P

    2017-12-01

    Many meta-analyses have provided synthesised likelihood ratio data to aid clinical decision-making. However, much less has been published on how to safely combine clinical information in practice. We aimed to explore the benefits and risks of pooling clinical information during the ED assessment of suspected acute coronary syndrome. Clinical information on 1776 patients was collected within a randomised trial conducted across five South Australian EDs between July 2011 and March 2013. Bayes theorem was used to calculate patient-specific post-test probabilities using age- and gender-specific pre-test probabilities and likelihood ratios corresponding to the presence or absence of 18 clinical factors. Model performance was assessed as the presence of adverse cardiac outcomes among patients theoretically discharged at a post-test probability less than 1%. Bayes theorem-based models containing high-sensitivity troponin T (hs-troponin) outperformed models excluding hs-troponin, as well as models utilising TIMI and GRACE scores. In models containing hs-troponin, a plateau in improving discharge safety was observed after the inclusion of four clinical factors. Models with fewer clinical factors better approximated the true event rate, tended to be safer and resulted in a smaller standard deviation in post-test probability estimates. We showed that there is a definable point where additional information becomes uninformative and may actually lead to less certainty. This evidence supports the concept that clinical decision-making in the assessment of suspected acute coronary syndrome should be focused on obtaining the least amount of information that provides the highest benefit for informing the decisions of admission or discharge. © 2017 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  5. An Investigation into Information Needs and Information Seeking Behavior of Elementary and Middle School Teachers Teaching Indigenous Courses

    Directory of Open Access Journals (Sweden)

    Shan-Ju L. Chang

    2006-12-01

    Full Text Available The purpose of this research is to systematically study the information need, seeking, and use behavior of middle school teachers of Taiwan historical resources, and to explore the implications of the findings for digital library system design. This research employs multiple methods, first by qualitative approach followed by quantitative approach. The study investigated elementary and high school teachers, and compared the findingswith those of the scholar user group, using literature analysis, deep interview, and questionnaire survey as the methods for data collection, and content analysis, case study, and statistic analysis for data analysis. The results lead to (1 a better understanding of information seeking and use behavior of primary and middle school teachers of Taiwan historical archives; (2 deeper knowledge and empirical data for developing theory on human information behavior of Taiwan local people; (3 identification of important teaching and learning resources on Taiwan and the salient characteristics of those resources; (4 development of information organization guideline for localized digital library and museum systems. [Article content in Chinese

  6. Numerical Investigations into the Value of Information in Lifecycle Analysis of Structural Systems

    DEFF Research Database (Denmark)

    Konakli, Katerina; Sudret, Bruno; Faber, Michael Havbro

    2015-01-01

    of decisions related to maintenance of structural systems. In this context, experiments may refer to inspections or structural health monitoring. The value-of-information concept comprises a powerful tool for determining whether the experimental cost is justified by the expected gained benefit during...... investigations demonstrate how the decision problem is influenced by the assumed probabilistic models, including the type of probability distribution and the degree of uncertainty reflected in the coefficient of variation, the degradation law, the quantity and quality of information, and the probabilistic...... dependencies between the components of a system. Furthermore, challenges and potentials in value-of-information analysis for structural systems are discussed....

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

    Directory of Open Access Journals (Sweden)

    Brandon M. Welch

    2014-04-01

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

  8. A proposed clinical decision support architecture capable of supporting whole genome sequence information.

    Science.gov (United States)

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

    2014-04-04

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

  9. An investigation on task-technology fit of mobile nursing information systems for nursing performance.

    Science.gov (United States)

    Hsiao, Ju-Ling; Chen, Rai-Fu

    2012-05-01

    This study investigates factors affecting the fit between nursing tasks and mobile nursing information systems and the relationships between the task-technology fit of mobile nursing information systems and nurse performance from the perspective of task-technology fit. Survey research recruited nursing staffs as subjects from selected case hospital. A total of 310 questionnaires were sent out, and 219 copies were obtained, indicating a valid response rate of 70.6%. Collected data were analyzed using the structural equation modeling technique. Our study found that dependence tasks have positive effects on information acquisition (γ=0.234, Pinformation identification (γ=0.478, Pinformation acquisition (γ=0.213, Pintroduction of mobile nursing information systems in assisting nursing practices can help facilitate both independent and dependent nursing tasks. Our study discovered that the supporting functions of mobile nursing information systems have positive effects on information integration and interpretation (γ=0.365, Pinformation acquisition (γ=0.253, Pinformation systems have positive effects on information acquisition (γ=0.318, Pinformation integration and interpretation (γ=0.143, Pinformation identification (β=.055, Pinformation acquisition (β=.176, Pinformation integration and interpretation (β=.706, Pinformation systems have positive effects on nursing performance, indicating 83.2% of totally explained variance. As shown, the use of mobile nursing information systems could provide nursing staffs with real-time and accurate information to increase efficiency and effectiveness in patient-care duties, further improving nursing performance.

  10. Improvements in Clinical Trials Information Will Improve the Reproductive Health and Fertility of Cancer Patients.

    Science.gov (United States)

    Dauti, Angela; Gerstl, Brigitte; Chong, Serena; Chisholm, Orin; Anazodo, Antoinette

    2017-06-01

    There are a number of barriers that result in cancer patients not being referred for oncofertility care, which include knowledge about reproductive risks of antineoplastic agents. Without this information, clinicians do not always make recommendations for oncofertility care. The objective of this study was to describe the level of reproductive information and recommendations that clinicians have available in clinical trial protocols regarding oncofertility management and follow-up, and the information that patients may receive in clinical trials patient information sheets or consent forms. A literature review of the 71 antineoplastic drugs included in the 68 clinical trial protocols showed that 68% of the antineoplastic drugs had gonadotoxic animal data, 32% had gonadotoxic human data, 83% had teratogenic animal data, and 32% had teratogenic human data. When the clinical trial protocols were reviewed, only 22% of the protocols reported the teratogenic risks and 32% of the protocols reported the gonadotoxic risk. Only 56% of phase 3 protocols had gonadotoxic information and 13% of phase 3 protocols had teratogenic information. Nine percent of the protocols provided fertility preservation recommendations and 4% provided reproductive information in the follow-up and survivorship period. Twenty-six percent had a section in the clinical trials protocol, which identified oncofertility information easily. When gonadotoxic and teratogenic effects of treatment were known, they were not consistently included in the clinical trial protocols and the lack of data for new drugs was not reported. Very few protocols gave recommendations for oncofertility management and follow-up following the completion of cancer treatment. The research team proposes a number of recommendations that should be required for clinicians and pharmaceutical companies developing new trials.

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

    Science.gov (United States)

    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.

  12. Investigations on an environmental technology transfer information network; Kankyo gijutsu iten joho network chosa

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-03-01

    With developing countries (APEC countries) as the main objects, investigations were carried out to issue environmental technology transfer information that Japan has accumulated, and advance exchanges of technical information with persons related inside and outside Japan. As a result of the investigations, it was found that the environmental technology information that serves more effectively for the developing countries is the technical information that has been developed by repeating improvements, has provided actual results in work sites, and is actually used, rather than the state-of-art technologies. Based on this result, business entities having factories and operation centers located in Mie Prefecture and the city of Yokkaichi were asked to provide data for the actually used environmental technologies. Out of 51 items provided by 17 companies, nine items were selected to be used as prototype database materials for an information network. The objects of information sources will be expanded to a nationwide scale in the future to improve the contents of the database. Problems of handling information copyrights and technical know-hows were presented in the course of data collection, urging the necessity of due considerations on the matter. Necessity was indicated on maintenance and management of data base as well as its quantitative expansion. 1 ref., 4 figs.

  13. Quantitative metrics for evaluating the phased roll-out of clinical information systems.

    Science.gov (United States)

    Wong, David; Wu, Nicolas; Watkinson, Peter

    2017-09-01

    We introduce a novel quantitative approach for evaluating the order of roll-out during phased introduction of clinical information systems. Such roll-outs are associated with unavoidable risk due to patients transferring between clinical areas using both the old and new systems. We proposed a simple graphical model of patient flow through a hospital. Using a simple instance of the model, we showed how a roll-out order can be generated by minimising the flow of patients from the new system to the old system. The model was applied to admission and discharge data acquired from 37,080 patient journeys at the Churchill Hospital, Oxford between April 2013 and April 2014. The resulting order was evaluated empirically and produced acceptable orders. The development of data-driven approaches to clinical Information system roll-out provides insights that may not necessarily be ascertained through clinical judgment alone. Such methods could make a significant contribution to the smooth running of an organisation during the roll-out of a potentially disruptive technology. Unlike previous approaches, which are based on clinical opinion, the approach described here quantitatively assesses the appropriateness of competing roll-out strategies. The data-driven approach was shown to produce strategies that matched clinical intuition and provides a flexible framework that may be used to plan and monitor Clinical Information System roll-out. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

  14. Metropolises in the Twittersphere: An Informetric Investigation of Informational Flows and Networks

    Directory of Open Access Journals (Sweden)

    Thorsten Förster

    2015-09-01

    Full Text Available Information flows on social media platforms are able to show trends and user interests as well as connections between users. In this paper, we present a method how to analyze city related networks on the social media platform Twitter based on the user content. Forty million tweets have been downloaded via Twitter’s REST API (application programming interface and Twitter’s Streaming API. The investigation focuses on two aspects: firstly, trend detection has been done to analyze 31 informational world cities, according the user activity, popularity of shared websites and topics defined by hashtags. Secondly, a hint of how connected informational cities are to each other is given by creating a clustered network based on the number of connections between different city pairs. Tokyo, New York City, London and Paris clearly lead the ranking of the most active cities if compared by the total number of tweets. The investigation shows that Twitter is very frequently used to share content from other services like Instagram or YouTube. The most popular topics in tweets reveal great differences between the cities. In conclusion, the investigation shows that social media services like Twitter also can be a mirror of the society they are used in and bring to light information flows of connected cities in a global network. The presented method can be applied in further research to analyze information flows regarding specific topics and/or geographical locations.

  15. Improving Service Delivery: Investigating the Role of Information Sharing, Job Characteristics, and Employee Satisfaction

    Science.gov (United States)

    Bontis, Nick; Richards, David; Serenko, Alexander

    2011-01-01

    Purpose: The purpose of this study is to propose and test a model designed to investigate the impact of job characteristics, employee satisfaction, and information sharing on two key indicators of quality service delivery, such as worker perceptions of their efficiency and customer focus. Design/methodology/approach: During the project, 9,060…

  16. 36 CFR 1256.58 - Information related to law enforcement investigations.

    Science.gov (United States)

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Information related to law enforcement investigations. 1256.58 Section 1256.58 Parks, Forests, and Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION PUBLIC AVAILABILITY AND USE ACCESS TO RECORDS AND DONATED HISTORICAL MATERIALS General Restrictions § 1256.58...

  17. In search of informed discretion: an experimental investigation of fairness and trust reciprocity

    NARCIS (Netherlands)

    Maas, V.; van Rinsum, M.; Towry, K.

    2012-01-01

    This paper investigates managerial discretion in compensation decisions in a team setting, in which a measure of the team's aggregate performance is readily available from the accounting system. Specifically, we examine the willingness of managers to obtain additional, costly information that would

  18. The Digital Literacy Debate: An Investigation of Digital Propensity and Information and Communication Technology

    Science.gov (United States)

    Nasah, Angelique; DaCosta, Boaventura; Kinsell, Carolyn; Seok, Soonhwa

    2010-01-01

    Research suggests students' use of information and communication technology (ICT) may be more a matter of digital literacy and access rather than a generational trait. We sought to identify ICT preferences of post-secondary students (N = 580) through a Digital Propensity Index (DPI), investigating communication methods, Internet practices and the…

  19. Investigating Chinese Migrants’ Information-Seeking Patterns in Canada: Media Selection and Language Preference

    Directory of Open Access Journals (Sweden)

    Yuping Mao

    2015-12-01

    Full Text Available Taking a quantitative approach, this research surveyed Chinese migrants in Canada regarding channels they rely on to seek various information. This research also investigates how Chinese migrants’ preferences of channels correlate with their intercultural sensitivity level. Chinese migrants prefer Chinese newspapers and websites for government/policy information and life information rather than English newspapers and websites. However, they use English newspapers and websites more frequently for job and career development information. Overall, English television and radio are more frequently used by Chinese migrants than Chinese television and radio broadcasts. The intercultural sensitivity levels of Chinese migrants have a positive correlation with their frequencies of using English information resources, including government websites, English newspapers, English non-government websites, government officers, personal non-Chinese social networks, and English television and radio. Findings of this research suggest that Chinese ethnic media play an important role in Chinese migrants’ information-seeking behaviours and patterns in Canada. On one hand, government and other organizations can reach the Chinese migrant community through information diffusion in Chinese ethnic media. On the other hand, Chinese migrants should make an active effort to improve their English proficiency and intercultural communication sensitivity to better integrate themselves into the Canadian society. A more balanced approach of seeking information from English and Chinese media sources could be more beneficial for Chinese migrants.

  20. Clinical social networking--a new revolution in provider communication and delivery of clinical information across providers of care?

    Science.gov (United States)

    Kolowitz, Brian J; Lauro, Gonzalo Romero; Venturella, James; Georgiev, Veliyan; Barone, Michael; Deible, Christopher; Shrestha, Rasu

    2014-04-01

    The adoption of social media technologies appears to enhance clinical outcomes through improved communications as reported by Bacigalupe (Fam Syst Heal 29(1):1-14, 2011). The ability of providers to more effectively, directly, and rapidly communicate among themselves as well as with patients should strengthen collaboration and treatment as reported by Bacigalupe (Fam Syst Heal 29(1):1-14, 2011). This paper is a case study in one organization's development of an internally designed and developed social technology solution termed "Unite." The Unite system combines social technologies' features including push notifications, messaging, community groups, and user lists with clinical workflow and applications to construct dynamic provider networks, simplify communications, and facilitate clinical workflow optimization. Modeling Unite as a social technology may ease adoption barriers. Developing a social network that is integrated with healthcare information systems in the clinical space opens the doors to capturing and studying the way in which providers communicate. The Unite system appears to have the potential to breaking down existing communication paradigms. With Unite, a rich set of usage data tied to clinical events may unravel alternative networks that can be leveraged to advance patient care.

  1. Impact of Information Technology, Clinical Resource Constraints, and Patient-Centered Practice Characteristics on Quality of Care

    Directory of Open Access Journals (Sweden)

    JongDeuk Baek

    2015-02-01

    Full Text Available Objective: Factors in the practice environment, such as health information technology (IT infrastructure, availability of other clinical resources, and financial incentives, may influence whether practices are able to successfully implement the patient-centered medical home (PCMH model and realize its benefits. This study investigates the impacts of those PCMH-related elements on primary care physicians’ perception of quality of care. Methods: A multiple logistic regression model was estimated using the 2004 to 2005 CTS Physician Survey, a national sample of salaried primary care physicians (n = 1733. Results: The patient-centered practice environment and availability of clinical resources increased physicians’ perceived quality of care. Although IT use for clinical information access did enhance physicians’ ability to provide high quality of care, a similar positive impact of IT use was not found for e-prescribing or the exchange of clinical patient information. Lack of resources was negatively associated with physician perception of quality of care. Conclusion: Since health IT is an important foundation of PCMH, patient-centered practices are more likely to have health IT in place to support care delivery. However, despite its potential to enhance delivery of primary care, simply making health IT available does not necessarily translate into physicians’ perceptions that it enhances the quality of care they provide. It is critical for health-care managers and policy makers to ensure that primary care physicians fully recognize and embrace the use of new technology to improve both the quality of care provided and the patient outcomes.

  2. High-end clinical domain information systems for effective healthcare delivery.

    Science.gov (United States)

    Mangalampalli, Ashish; Rama, Chakravarthy; Muthiyalian, Raja; Jain, Ajeet K

    2007-01-01

    The Electronic Health Record (EHR) provides doctors with a quick, reliable, secure, real-time and user-friendly source of all relevant patient data. The latest information system technologies, such as Clinical Data Warehouses (CDW), Clinical Decision-Support (CDS) systems and data-mining techniques (Online Analytical Processing (OLAP) and Online Transactional Processing (OLTP)), are used to maintain and utilise patient data intelligently, based on the users' requirements. Moreover, clinical trial reports for new drug approvals are now being submitted electronically for faster and easier processing. Also, information systems are used in educating patients about the latest developments in medical science through the internet and specially configured kiosks in hospitals and clinics.

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

    Science.gov (United States)

    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.

  4. Anatomical-clinical investigations of variations of the human coronary arteries

    OpenAIRE

    Aida Hasanović; Faruk Dilberović; Fehim Ovčina

    2003-01-01

    Variations of the human coronary arteries have always attracted the attention of many researchers. A review of the literature shows that variations can cause ischemic heart disease or sudden cardiac death. The aim of the investigations was to examine the existence and clinical significance of variations of the human coronary arteries. Special attention has been focused on myocardial bridging of the coronary arteries and coronary arteriovenous fistula. Our investigations were carried out on th...

  5. Department of Clinical Investigation: Annual Research Progress Report for Fiscal Year 1992. Volume 2

    Science.gov (United States)

    1993-01-01

    A-5-90 Production of Mouse Positive and Negative Control Slides for 295 Use in Rabies FRA Test. (0) A-7-90 Clinical Investigation on the...Dose Intensification of Methotrexate and 519 6- Mercaptopurine for ALL in Childhood. (0) POG 9006 ALinC 15: Up-Front 6-MP/MTX vs. Up-Front Alternating 520...for the mouse bioassay as a means for detecting Clostridium botulinum toxin in cultures, food products , serum and fecal specimens. Technical Approach

  6. Investigation of the Impact of Extracting and Exchanging Health Information by Using Internet and Social Networks.

    Science.gov (United States)

    Pistolis, John; Zimeras, Stelios; Chardalias, Kostas; Roupa, Zoe; Fildisis, George; Diomidous, Marianna

    2016-06-01

    Social networks (1) have been embedded in our daily life for a long time. They constitute a powerful tool used nowadays for both searching and exchanging information on different issues by using Internet searching engines (Google, Bing, etc.) and Social Networks (Facebook, Twitter etc.). In this paper, are presented the results of a research based on the frequency and the type of the usage of the Internet and the Social Networks by the general public and the health professionals. The objectives of the research were focused on the investigation of the frequency of seeking and meticulously searching for health information in the social media by both individuals and health practitioners. The exchanging of information is a procedure that involves the issues of reliability and quality of information. In this research, by using advanced statistical techniques an effort is made to investigate the participant's profile in using social networks for searching and exchanging information on health issues. Based on the answers 93 % of the people, use the Internet to find information on health-subjects. Considering principal component analysis, the most important health subjects were nutrition (0.719 %), respiratory issues (0.79 %), cardiological issues (0.777%), psychological issues (0.667%) and total (73.8%). The research results, based on different statistical techniques revealed that the 61.2% of the males and 56.4% of the females intended to use the social networks for searching medical information. Based on the principal components analysis, the most important sources that the participants mentioned, were the use of the Internet and social networks for exchanging information on health issues. These sources proved to be of paramount importance to the participants of the study. The same holds for nursing, medical and administrative staff in hospitals.

  7. An Investigation on the Current Situation of Management Information Systems Discipline in Turkey

    Directory of Open Access Journals (Sweden)

    Serdar YARLIKAŞ

    2015-09-01

    Full Text Available The purpose of this research is to investigate the development of management information systems field by evaluating the theses conducted at universities in Turkey in the departments of management information systems and science of management information systems. First, this study aims to determine the distribution of the theses in terms of years, subjects and the research methods used. Another purpose of this study was to determine which of the related disciplines of management information systems are used most in the theses. In addition, as a result of the study, the compatibility degree between the theses written and the courses taught in the graduate programs of management information systems were determined. In this research, content analysis method is used. Through this method, each of the theses was evaluated with a 10-question ‘thesis evaluation question set' constructed towards the purpose of the study. Through this evaluation, the current situation of the field was determined. It was observed that the number of doctoral theses associated with the field was less. Using the combination of qualitative and quantitative techniques most in the theses denoted that the interdisciplinary approaches were adopted in the theses associated with management information systems. It was observed that the literature analysis and survey techniques were the most studied research methods in the theses. Besides, statistical techniques were used highly in the theses. As a result of this study, it was concluded that out of the associated disciplines of management information systems, management science, computer science and statistics disciplines were more associated with the investigated theses. When the study results were evaluated as a whole, it was seen that significant progress was made in the discipline of management information systems compared to the early 2000s.

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

    Science.gov (United States)

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

    2009-10-08

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

  9. Clinical Information Systems Integration in New York City's First Mobile Stroke Unit.

    Science.gov (United States)

    Kummer, Benjamin R; Lerario, Michael P; Navi, Babak B; Ganzman, Adam C; Ribaudo, Daniel; Mir, Saad A; Pishanidar, Sammy; Lekic, Tim; Williams, Olajide; Kamel, Hooman; Marshall, Randolph S; Hripcsak, George; Elkind, Mitchell S V; Fink, Matthew E

    2018-01-01

    Mobile stroke units (MSUs) reduce time to thrombolytic therapy in acute ischemic stroke. These units are widely used, but the clinical information systems underlying MSU operations are understudied. The first MSU on the East Coast of the United States was established at New York Presbyterian Hospital (NYP) in October 2016. We describe our program's 7-month pilot, focusing on the integration of our hospital's clinical information systems into our MSU to support patient care and research efforts. NYP's MSU was staffed by two paramedics, one radiology technologist, and a vascular neurologist. The unit was equipped with four laptop computers and networking infrastructure enabling all staff to access the hospital intranet and clinical applications during operating hours. A telephone-based registration procedure registered patients from the field into our admit/discharge/transfer system, which interfaced with the institutional electronic health record (EHR). We developed and implemented a computerized physician order entry set in our EHR with prefilled values to permit quick ordering of medications, imaging, and laboratory testing. We also developed and implemented a structured clinician note to facilitate care documentation and clinical data extraction. Our MSU began operating on October 3, 2016. As of April 27, 2017, the MSU transported 49 patients, of whom 16 received tissue plasminogen activator (t-PA). Zero technical problems impacting patient care were reported around registration, order entry, or intranet access. Two onboard network failures occurred, resulting in computed tomography scanner malfunctions, although no patients became ineligible for time-sensitive treatment as a result. Thirteen (26.5%) clinical notes contained at least one incomplete time field. The main technical challenges encountered during the integration of our hospital's clinical information systems into our MSU were onboard network failures and incomplete clinical documentation. Future

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

    Directory of Open Access Journals (Sweden)

    Brinner Kristin M

    2009-10-01

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

  11. Micro-costing the provision of emotional support and information in UK eye clinics.

    Science.gov (United States)

    Gillespie-Gallery, Hanna; Subramanian, Ahalya; Conway, Miriam L

    2013-11-19

    Sight loss has wide ranging implications for an individual in terms of education, employment, mobility and mental health. Therefore there is a need for information and support to be provided in eye clinics at the point of diagnosis of sight threatening conditions, but these aspects of care are often missing from clinics. To meet these needs, some clinics employ an Eye Clinic Liaison Officer (ECLO) but the position has yet to be widely implemented. The aims of this study were:(1) To evaluate the forms of advice and emotional support in eye clinics provided by ECLOs.(2) To determine the cost of the ECLO service per patient. Micro-costing was carried out using interviews, a survey and administrative data. The survey was completed by 18 of the 49 accredited ECLOs in the UK (37%) and provided information on the activities performed by ECLOs, numbers of patients seen per day, training costs incurred and the salary of the ECLOs. ECLOs provided information about the services in eye clinics and the community, referral to social services, emotional support to patients and also other advice. The cost of an ECLO per patient per contact was £17.94 based on an average annual ECLO salary of £23,349.60 per year, reviewing on average 9.1 patients per day, in a 42 week year. This study provides the first costing of support services in hospital eye clinics, providing a range of estimates to suit the circumstances of different clinics. The information can be used by local decision makers to estimate the cost of implementing an ECLO service.

  12. SANDS: an architecture for clinical decision support in a National Health Information Network.

    Science.gov (United States)

    Wright, Adam; Sittig, Dean F

    2007-10-11

    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.

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

    Science.gov (United States)

    Gupta, Nitin; Varghese, Suresh; Virkar, Hemant

    2011-01-01

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

  14. [ISO 9001certification of a quality management system in a clinical investigation center].

    Science.gov (United States)

    Chesnais, Jimmy; Fougerou-Leurent, Claire; Laforest, Claire; Renault, Alain; Bellissant, Eric; Laviolle, Bruno

    2018-05-03

    Beyond the application of legal requirements, clinical trials must have a permanent approach of quality control. The clinical investigation centers (CICs) are academic structures of clinical research certified by the French National institute of health and medical research (Inserm) and whose functioning relies on recommendations of good practice. It is important to accompany this standardization of practices by the implementation of a quality management system. This article presents the process that enabled the CIC of Rennes to become certified ISO 9001 by French standards association (Afnor) certification in May, 2016. The application of the fundamental principles of the standard ISO 9001 in the domain of clinical research is approached. The problem of the perimeter for the certification and the related process mapping are exposed. The activities of methodology, management and analysis of clinical studies were chosen for the initial certification of the CIC of Rennes. The perspectives for the extension of the perimeter of certification are also approached at the end of article. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  15. Competing infant feeding information in mothers' networks: advice that supports v. undermines clinical recommendations.

    Science.gov (United States)

    Ashida, Sato; Lynn, Freda B; Williams, Natalie A; Schafer, Ellen J

    2016-05-01

    To identify the social contextual factors, specifically the presence of information that supports v. undermines clinical recommendations, associated with infant feeding behaviours among mothers in low-income areas. Cross-sectional survey evaluating social support networks and social relationships involved in providing care to the infant along with feeding beliefs and practices. Out-patient paediatric and government-funded (Women, Infants, and Children) clinics in an urban, low-income area of the south-eastern USA. Eighty-one low-income mothers of infants between 0 and 12 months old. Most mothers reported receiving both supportive and undermining advice. The presence of breast-feeding advice that supports clinical recommendations was associated with two infant feeding practices that are considered beneficial to infant health: ever breast-feeding (OR=6·7; 95% CI 1·2, 38·1) and not adding cereal in the infant's bottle (OR=15·9; 95% CI 1·1, 227·4). Advice that undermines clinical recommendations to breast-feed and advice about solid foods were not associated with these behaviours. Efforts to facilitate optimal infant feeding practices may focus on increasing information supportive of clinical recommendations while concentrating less on reducing the presence of undermining information within mothers' networks. Cultural norms around breast-feeding may be stronger than the cultural norms around the introduction of solid foods in mothers' social environments; thus, additional efforts to increase information regarding introduction of solid foods earlier in mothers' infant care career may be beneficial.

  16. MedEx: a medication information extraction system for clinical narratives

    Science.gov (United States)

    Stenner, Shane P; Doan, Son; Johnson, Kevin B; Waitman, Lemuel R; Denny, Joshua C

    2010-01-01

    Medication information is one of the most important types of clinical data in electronic medical records. It is critical for healthcare safety and quality, as well as for clinical research that uses electronic medical record data. However, medication data are often recorded in clinical notes as free-text. As such, they are not accessible to other computerized applications that rely on coded data. We describe a new natural language processing system (MedEx), which extracts medication information from clinical notes. MedEx was initially developed using discharge summaries. An evaluation using a data set of 50 discharge summaries showed it performed well on identifying not only drug names (F-measure 93.2%), but also signature information, such as strength, route, and frequency, with F-measures of 94.5%, 93.9%, and 96.0% respectively. We then applied MedEx unchanged to outpatient clinic visit notes. It performed similarly with F-measures over 90% on a set of 25 clinic visit notes. PMID:20064797

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

    Science.gov (United States)

    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.

  18. Ethical aspect of the clinical research. Informed consent in the clinical research for heavy ion radiotherapy of cancer

    International Nuclear Information System (INIS)

    Murata, Hajime

    2003-01-01

    The research center for heavy ion therapy of cancer was decided to be built in 1984 as a part of the national 10-year anticancer campaign, and construction of Heavy Ion Medical Accelerator in Chiba (HIMAC) was completed at the National Institute of Radiological Sciences in 1993. The HIMAC is the first heavy ion accelerator for only medical use in the world, and the clinical research of cancer radiotherapy was begun in 1994 using carbon ion generated by HIMAC. The purposes of the clinical research are to evaluate the safety and usefulness of carbon ion for cancer treatment, and to establish carbon ion therapy as a new and valuable tool for cancer therapy. Therefore, to obtain exact data in ethical aspect as well as scientific aspect of the clinical research, many special committees have been organized like as the committees of protocol planning for each organ, clinical study groups for each organ, evaluating committee of clinical data, and the ethical committee. Each clinical research is performed according to the research protocol of each organ, in which study purpose, rationale, patient condition, end-point of the study, adverse reaction are described. The document of informed consent (IC) contains study purpose, patient condition, method, predicted effect and demerit, protection of privacy, etc.. IC to each patient is done precisely by the doctor, and the freely-given IC of the patient is obtained. After the IC was completed, judgement of propriety for carbon ion therapy is done by the ethical committee for IC of each patient. Since 1994 carbon ion therapy has been performed over 1300 patients with cancer in various organs, and its safety and usefulness for cancer treatment has been clarified gradually. The carbon ion therapy is thought to be a new and promising tool for cancer treatment near future. (authors)

  19. What versus where: Investigating how autobiographical memory retrieval differs when accessed with thematic versus spatial information.

    Science.gov (United States)

    Sheldon, Signy; Chu, Sonja

    2017-09-01

    Autobiographical memory research has investigated how cueing distinct aspects of a past event can trigger different recollective experiences. This research has stimulated theories about how autobiographical knowledge is accessed and organized. Here, we test the idea that thematic information organizes multiple autobiographical events whereas spatial information organizes individual past episodes by investigating how retrieval guided by these two forms of information differs. We used a novel autobiographical fluency task in which participants accessed multiple memory exemplars to event theme and spatial (location) cues followed by a narrative description task in which they described the memories generated to these cues. Participants recalled significantly more memory exemplars to event theme than to spatial cues; however, spatial cues prompted faster access to past memories. Results from the narrative description task revealed that memories retrieved via event theme cues compared to spatial cues had a higher number of overall details, but those recalled to the spatial cues were recollected with a greater concentration on episodic details than those retrieved via event theme cues. These results provide evidence that thematic information organizes and integrates multiple memories whereas spatial information prompts the retrieval of specific episodic content from a past event.

  20. Investigation of display issues relevant to the presentation of aircraft fault information

    Science.gov (United States)

    Allen, Donald M.

    1989-01-01

    This research, performed as a part of NASA Langley's Faultfinder project, investigated display implementation issues related to the introduction of real time fault diagnostic systems into next generation commercial aircraft. Three major issues were investigated: visual display styles for presenting fault related information to the crew, the form the output from the expert system should take, and methods for filtering fault related information for presentation to the crew. Twenty-four flight familiar male volunteers participated as subjects. Five subjects were NASA test pilots, six were Commercial Airline Pilots, seven were Air Force Lear Jet pilots, and six were NASA personnel familiar with flight (non-pilots). Subjects were presented with aircraft subsystem information on a CRT screen. They were required to identify the subsystems presented in a display and to remember the state (normal or abnormal) of subsystem parameter information contained in the display. The results of the study indicated that in the simpler experimental test cases (i.e., those involving single subsystem failures and composite hypothesis displays) subjects' performance did not differ across the different display formats. However, for the more complex cases (i.e., those involving multiple subsystem faults and multiple hypotheses displays), subjects' performance was superior in the text- and picture-based display formats compared to the symbol-based format. In addition, the findings suggest that a layered approached to information display is appropriate.

  1. Investigating the Information Needs of University Students in Foundational Foreign Language Courses

    Directory of Open Access Journals (Sweden)

    Glenna Westwood

    2012-06-01

    Full Text Available This investigation seeks to address two issues: first, to discover if there is evidence that university students in foundational language courses need information resources to support their language learning and second, if such evidence exists, what the specific information resource needs might be and how important those resources are to students’ language learning. After engaging in a year of foreign language study, the author used the evidence gathered to develop and conduct a survey of the user needs of language students at the Self Access Centre (CAADI of the University of Guanajuato, Mexico. Results of the survey supported the personal learning experiences of the author. Over 80% of students surveyed reported using the information resources in the CAADI at least once a week with general grammar books, course text books and films being reported as the most important resources. This investigation provides a starting point for research in to the collection development practices of academic libraries supporting the learning of foreign languages. By examining the information needs of one population, evidence has been provided that these students do indeed need information resources to support their language learning. The study suggests specific resource types that could be important for these users.

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

    Science.gov (United States)

    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.

  3. System requirements for a computerised patient record information system at a busy primary health care clinic

    Directory of Open Access Journals (Sweden)

    PJ Blignaut

    2001-09-01

    Full Text Available A prototyping approach was used to determine the essential system requirements of a computerised patient record information system for a typical township primary health care clinic. A pilot clinic was identified and the existing manual system and business processes in this clinic was studied intensively before the first prototype was implemented. Interviews with users, incidental observations and analysis of actual data entered were used as primary techniques to refine the prototype system iteratively until a system with an acceptable data set and adequate functionalities were in place. Several non-functional and user-related requirements were also discovered during the prototyping period.

  4. Reconciling disparate information in continuity of care documents: Piloting a system to consolidate structured clinical documents.

    Science.gov (United States)

    Hosseini, Masoud; Jones, Josette; Faiola, Anthony; Vreeman, Daniel J; Wu, Huanmei; Dixon, Brian E

    2017-10-01

    Due to the nature of information generation in health care, clinical documents contain duplicate and sometimes conflicting information. Recent implementation of Health Information Exchange (HIE) mechanisms in which clinical summary documents are exchanged among disparate health care organizations can proliferate duplicate and conflicting information. To reduce information overload, a system to automatically consolidate information across multiple clinical summary documents was developed for an HIE network. The system receives any number of Continuity of Care Documents (CCDs) and outputs a single, consolidated record. To test the system, a randomly sampled corpus of 522 CCDs representing 50 unique patients was extracted from a large HIE network. The automated methods were compared to manual consolidation of information for three key sections of the CCD: problems, allergies, and medications. Manual consolidation of 11,631 entries was completed in approximately 150h. The same data were automatically consolidated in 3.3min. The system successfully consolidated 99.1% of problems, 87.0% of allergies, and 91.7% of medications. Almost all of the inaccuracies were caused by issues involving the use of standardized terminologies within the documents to represent individual information entries. This study represents a novel, tested tool for de-duplication and consolidation of CDA documents, which is a major step toward improving information access and the interoperability among information systems. While more work is necessary, automated systems like the one evaluated in this study will be necessary to meet the informatics needs of providers and health systems in the future. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Investigating the management information needs of academic Heads of Department: a Critical Success Factors approach

    Directory of Open Access Journals (Sweden)

    Francis Green

    1996-01-01

    Full Text Available This paper describes a research project in the Department of Information Studies at the University of Sheffield. With funding from the British Library Research and Development Department a critical success factors-based investigation of the management information needs of academic Heads of Department in an number of English universities was undertaken in 1994/1995, following publication of the results of a pilot study byPellow and Wilson (1993. Senior academic staff, university administrators and librarians in sixteen universities were interviewed between December, 1994 and March, 1995. Collation of data and analysis of results have been completed

  6. Demonstration of SLUMIS: a clinical database and management information system for a multi organ transplant program.

    OpenAIRE

    Kurtz, M.; Bennett, T.; Garvin, P.; Manuel, F.; Williams, M.; Langreder, S.

    1991-01-01

    Because of the rapid evolution of the heart, heart/lung, liver, kidney and kidney/pancreas transplant programs at our institution, and because of a lack of an existing comprehensive database, we were required to develop a computerized management information system capable of supporting both clinical and research requirements of a multifaceted transplant program. SLUMIS (ST. LOUIS UNIVERSITY MULTI-ORGAN INFORMATION SYSTEM) was developed for the following reasons: 1) to comply with the reportin...

  7. Doctors, Patients, and Nudging in the Clinical Context--Four Views on Nudging and Informed Consent.

    Science.gov (United States)

    Ploug, Thomas; Holm, Søren

    2015-01-01

    In an analysis of recent work on nudging we distinguish three positions on the relationship between nudging founded in libertarian paternalism and the protection of personal autonomy through informed consent. We argue that all three positions fail to provide adequate protection of personal autonomy in the clinical context. Acknowledging that nudging may be beneficial, we suggest a fourth position according to which nudging and informed consent are valuable in different domains of interaction.

  8. Lexical analysis in schizophrenia: how emotion and social word use informs our understanding of clinical presentation.

    Science.gov (United States)

    Minor, Kyle S; Bonfils, Kelsey A; Luther, Lauren; Firmin, Ruth L; Kukla, Marina; MacLain, Victoria R; Buck, Benjamin; Lysaker, Paul H; Salyers, Michelle P

    2015-05-01

    The words people use convey important information about internal states, feelings, and views of the world around them. Lexical analysis is a fast, reliable method of assessing word use that has shown promise for linking speech content, particularly in emotion and social categories, with psychopathological symptoms. However, few studies have utilized lexical analysis instruments to assess speech in schizophrenia. In this exploratory study, we investigated whether positive emotion, negative emotion, and social word use was associated with schizophrenia symptoms, metacognition, and general functioning in a schizophrenia cohort. Forty-six participants generated speech during a semi-structured interview, and word use categories were assessed using a validated lexical analysis measure. Trained research staff completed symptom, metacognition, and functioning ratings using semi-structured interviews. Word use categories significantly predicted all variables of interest, accounting for 28% of the variance in symptoms and 16% of the variance in metacognition and general functioning. Anger words, a subcategory of negative emotion, significantly predicted greater symptoms and lower functioning. Social words significantly predicted greater metacognition. These findings indicate that lexical analysis instruments have the potential to play a vital role in psychosocial assessments of schizophrenia. Future research should replicate these findings and examine the relationship between word use and additional clinical variables across the schizophrenia-spectrum. Copyright © 2015 Elsevier Ltd. All rights reserved.

  9. The Shared Health Research Information Network (SHRINE): a prototype federated query tool for clinical data repositories.

    Science.gov (United States)

    Weber, Griffin M; Murphy, Shawn N; McMurry, Andrew J; Macfadden, Douglas; Nigrin, Daniel J; Churchill, Susanne; Kohane, Isaac S

    2009-01-01

    The authors developed a prototype Shared Health Research Information Network (SHRINE) to identify the technical, regulatory, and political challenges of creating a federated query tool for clinical data repositories. Separate Institutional Review Boards (IRBs) at Harvard's three largest affiliated health centers approved use of their data, and the Harvard Medical School IRB approved building a Query Aggregator Interface that can simultaneously send queries to each hospital and display aggregate counts of the number of matching patients. Our experience creating three local repositories using the open source Informatics for Integrating Biology and the Bedside (i2b2) platform can be used as a road map for other institutions. The authors are actively working with the IRBs and regulatory groups to develop procedures that will ultimately allow investigators to obtain identified patient data and biomaterials through SHRINE. This will guide us in creating a future technical architecture that is scalable to a national level, compliant with ethical guidelines, and protective of the interests of the participating hospitals.

  10. A survey of evidence users about the information need of acupuncture clinical evidence.

    Science.gov (United States)

    Shi, Xiue; Wang, Xiaoqin; Liu, Yali; Li, Xiuxia; Wei, Dang; Zhao, Xu; Gu, Jing; Yang, Kehu

    2016-11-10

    The PRISMA statement was rarely used in the field of acupuncture, possibly because of knowledge gaps and the lack of items tailored for characteristics of acupuncture. And with an increasing number of systematic reviews in acupuncture, it is necessary to develop an extension of PRISMA for acupuncture. And this study was the first step of our project, of which the aim was to investigate the need for information of clinical evidence on acupuncture from the perspectives of evidence users. We designed a questionnaire based on a pilot survey and a literature review of acupuncture systematic review or meta-analysis(SR/MA). Participants from five cities (Lanzhou, Chengdu, Shanghai, Nanjing and Beijing) representing the different regions of China, including clinicians, researchers and postgraduates in their second year of Master studies or higher level, were surveyed. A total of 269 questionnaires were collected in 18 hospitals, medical universities and research agencies, and 251 (93 %) with complete data were used for analysis. The average age of respondents was 33 years (SD 8.959, range 25-58) with male 43 % and female 57 %. Most respondents had less than 5 years of working experience on acupuncture, and read only one to five articles per month. Electronic databases, search engines and academic conferences were the most common sources for obtaining information. Fifty-six percent of the respondents expressed low satisfaction of the completeness of information from the literature. The eight items proposed for acupuncture SR/MAs received all high scores, and five of the items scored higher than eight on a scale zero to ten. The differences for the scores of most items between postgraduates and non-postgraduates were not statistically significant. The majority of the respondents were not very satisfied with the information provided in acupuncture SRs. Most of the items proposed in this questionnaire received high scores, and opinions from postgraduates and non

  11. Procedures of recruiting, obtaining informed consent, and compensating research participants in Qatar: findings from a qualitative investigation.

    Science.gov (United States)

    Killawi, Amal; Khidir, Amal; Elnashar, Maha; Abdelrahim, Huda; Hammoud, Maya; Elliott, Heather; Thurston, Michelle; Asad, Humna; Al-Khal, Abdul Latif; Fetters, Michael D

    2014-02-04

    Very few researchers have reported on procedures of recruiting, obtaining informed consent, and compensating participants in health research in the Arabian Gulf Region. Empirical research can inform the debate about whether to adjust these procedures for culturally diverse settings. Our objective was to delineate procedures related to recruiting, obtaining informed consent, and compensating health research participants in the extremely high-density multicultural setting of Qatar. During a multistage mixed methods project, field observations and qualitative interviews were conducted in a general medicine clinic of a major medical center in Qatar. Participants were chosen based on gender, age, literacy, and preferred language, i.e., Arabic, English, Hindi and Urdu. Qualitative analysis identified themes about recruitment, informed consent, compensation, and other research procedures. A total of 153 individuals were approached and 84 enrolled; the latter showed a diverse age range (18 to 75 years); varied language representation: Arabic (n = 24), English (n = 20), Hindi (n = 20), and Urdu (n = 20); and balanced gender distribution: women (n = 43) and men (n = 41). Primary reasons for 30 declinations included concern about interview length and recording. The study achieved a 74% participation rate. Qualitative analytics revealed key themes about hesitation to participate, decisions about participation with family members as well as discussions with them as "incidental research participants", the informed consent process, privacy and gender rules of the interview environment, reactions to member checking and compensation, and motivation for participating. Vulnerability emerged as a recurring issue throughout the process among a minority of participants. This study from Qatar is the first to provide empirical data on recruitment, informed consent, compensation and other research procedures in a general adult population in the Middle East and Arabian Gulf. This

  12. Developing a Workflow Composite Score to Measure Clinical Information Logistics. A Top-down Approach.

    Science.gov (United States)

    Liebe, J D; Hübner, U; Straede, M C; Thye, J

    2015-01-01

    Availability and usage of individual IT applications have been studied intensively in the past years. Recently, IT support of clinical processes is attaining increasing attention. The underlying construct that describes the IT support of clinical workflows is clinical information logistics. This construct needs to be better understood, operationalised and measured. It is therefore the aim of this study to propose and develop a workflow composite score (WCS) for measuring clinical information logistics and to examine its quality based on reliability and validity analyses. We largely followed the procedural model of MacKenzie and colleagues (2011) for defining and conceptualising the construct domain, for developing the measurement instrument, assessing the content validity, pretesting the instrument, specifying the model, capturing the data and computing the WCS and testing the reliability and validity. Clinical information logistics was decomposed into the descriptors data and information, function, integration and distribution, which embraced the framework validated by an analysis of the international literature. This framework was refined selecting representative clinical processes. We chose ward rounds, pre- and post-surgery processes and discharge as sample processes that served as concrete instances for the measurements. They are sufficiently complex, represent core clinical processes and involve different professions, departments and settings. The score was computed on the basis of data from 183 hospitals of different size, ownership, location and teaching status. Testing the reliability and validity yielded encouraging results: the reliability was high with r(split-half) = 0.89, the WCS discriminated between groups; the WCS correlated significantly and moderately with two EHR models and the WCS received good evaluation results by a sample of chief information officers (n = 67). These findings suggest the further utilisation of the WCS. As the WCS does not

  13. The information needs and behaviour of clinical researchers: a user-needs analysis.

    Science.gov (United States)

    Korjonen-Close, Helena

    2005-06-01

    As part of the strategy to set up a new information service, including a physical Resource Centre, the analysis of information needs of clinical research professionals involved with clinical research and development in the UK and Europe was required. It also aimed to identify differences in requirements between the various roles of professionals and establish what information resources are currently used. A user-needs survey online of the members of The Institute. Group discussions with specialist subcommittees of members. Two hundred and ninety members responded to the online survey of 20 questions. This makes it a response rate of 7.9%. Members expressed a lack of information in their particular professional area, and lack the skills to retrieve and appraise information. The results of the survey are discussed in more detail, giving indications of what the information service should collect, what types of materials should be provided to members and what services should be on offer. These were developed from the results of the needs analysis and submitted to management for approval. Issues of concern, such as financial constraint and staff constraints are also discussed. There is an opportunity to build a unique collection of clinical research material, which will promote The Institute not only to members, but also to the wider health sector. Members stated that the most physical medical libraries don't provide what they need, but the main finding through the survey and discussions is that it's pointless to set up 'yet another medical library'.

  14. Clinical information has low sensitivity for postmortem diagnosis of heart valve disease.

    Science.gov (United States)

    Coffey, Sean; Harper, Andrew R; Cairns, Benjamin J; Roberts, Ian Sd; Prendergast, Bernard D

    2017-07-01

    Accuracy of routinely collected information concerning cause of death is essential for public health and health systems planning. Since clinical examination has relatively low sensitivity for detection of valvular heart disease (VHD), mortality data based on clinical information alone might routinely underestimate the number of deaths due to VHD. We compared autopsy findings against premortem clinical information for 8198 consecutive adult postmortems (mean age 69.1 years, 61.3% men), performed in a single UK tertiary referral centre with on-site cardiac surgical facilities over a 10-year period (2004-2013) during which 21% of the adult population underwent postmortem examination. Following postmortem, VHD was the principal cause of death in 165 individuals (2.0%), a principal or contributory cause ('any cause') of death in 326 (4.0%) and an incidental (ie, non-causal) finding in a further 346 (4.2%). Clinical documentation of VHD before death was highly specific but relatively insensitive for postmortem identification of VHD as the principal (specificity 96.8%; 95% CI 96.4% to 97.2%; sensitivity 69.7%, 95% CI 62.1% to 76.6%) or any (specificity 98.1%; 95% CI 97.8% to 98.4%; sensitivity 68.4%, 95% CI 63.1% to 73.4%) cause of death. VHD (principally aortic stenosis, endocarditis and rheumatic heart disease) was newly noted at postmortem and listed as a cause of death in 142 individuals (1.7%). Clinical information recorded premortem is highly specific but relatively insensitive for the cause of death established at autopsy. Population-based mortality statistics that depend on premortem clinical information are likely to routinely underestimate the mortality burden of VHD. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. Investigating the Experiences of Childhood Cancer Patients and Parents Participating in Optional Nontherapeutic Clinical Research Studies in the UK.

    Science.gov (United States)

    Errington, Julie; Malik, Ghada; Evans, Julie; Baston, Jenny; Parry, Annie; Price, Lisa; Johnstone, Hina; Peters, Selena; Oram, Victoria; Howe, Karen; Whiteley, Emma; Tunnacliffe, Jane; Veal, Gareth J

    2016-07-01

    While the majority of childhood cancer clinical trials are treatment related, additional optional research investigations may be carried out that do not directly impact on treatment. It is essential that these studies are conducted ethically and that the experiences of families participating in these studies are as positive as possible. A questionnaire study was carried out to investigate the key factors that influence why families choose to participate in optional nontherapeutic research studies, the level of understanding of the trials involved, and the experiences of participation. A total of 100 participants from six UK centers were studied; 77 parents, 10 patients >16 years, and 13 patients aged 8-15 years. Ninety-seven percent of parents and 90% of patients felt that information provided prior to study consent was of the right length, with 52% of parents and 65% of patients fully understanding the information provided. Seventy-four percent of parents participated in research studies in order to "do something important", while 74% of patients participated "to help medical staff". Encouragingly, <5% of participants felt that their clinical care would be negatively affected if they did not participate. Positive aspects of participation included a perception of increased attention from medical staff. Negative aspects included spending longer periods in hospital and the requirement for additional blood samples. Ninety-six percent of parents and 87% of patients would participate in future studies. The study provides an insight into the views of childhood cancer patients and their parents participating in nontherapeutic clinical research studies. Overwhelmingly, the findings suggest that participation is seen as a positive experience. © 2016 The Authors. Pediatric Blood & Cancer, published by Wiley Periodicals, Inc.

  16. An Exploratory Study Investigating the Non-Clinical Benefits of Evidence-Based Veterinary Medicine

    Directory of Open Access Journals (Sweden)

    Elizabeth Jackson

    2017-05-01

    Full Text Available Objective: As little prior research exists about the non-clinical benefits of evidence-based veterinary medicine (EBVM, this exploratory study was conducted to identify non-clinical benefits of EBVM to veterinary practices, as well as highlighting the barriers to further implementation, and ways to overcome them.Background: A PICO-based literature review (Hauser and Jackson, 2016 was conducted to establish current knowledge about the non-clinical benefits of EBVM. It found that while there are some papers suggesting a link between the practice of EBVM and better non-clinical benefits such as client satisfaction and client retention, a single study, focusing on the non-clinical benefits of EBVM, had yet to be conducted.Evidentiary value: This exploratory study provides a solid basis for the further development of a confirmatory study of the themes identified in the interviews. The impact on practice from our findings is significant as it details the key areas where the use of EBVM can yield commercial benefits from the perspective of a group of EBVM experts via interview. It is entirely possible that international veterinary environments which mirror that of the UK will find this research beneficial.Methods: Due to the paucity of data about the non-clinical benefits of EBVM, an exploratory, qualitative approach was taken to this research in order to build a platform for further confirmatory, quantitative investigation (Zikmund, 2003. In February and March 2016 interviews with 16 RCVS Knowledge Group chairs[1] were conducted. The interview guide contained broad, open-ended questions to explore existing tacit knowledge about the non-commercial benefits of EBVM. The interviews were audio recorded and transcribed verbatim and subsequently analysed using NVivo 11 software.Results: This qualitative enquiry showed that the key areas where the use of EBVM can yield non-clinical benefits are through increased client satisfaction and retention, improved

  17. Clinical neurophysiology and quantitative sensory testing in the investigation of orofacial pain and sensory function.

    Science.gov (United States)

    Jääskeläinen, Satu K

    2004-01-01

    Chronic orofacial pain represents a diagnostic and treatment challenge for the clinician. Some conditions, such as atypical facial pain, still lack proper diagnostic criteria, and their etiology is not known. The recent development of neurophysiological methods and quantitative sensory testing for the examination of the trigeminal somatosensory system offers several tools for diagnostic and etiological investigation of orofacial pain. This review presents some of these techniques and the results of their application in studies on orofacial pain and sensory dysfunction. Clinical neurophysiological investigation has greater diagnostic accuracy and sensitivity than clinical examination in the detection of the neurogenic abnormalities of either peripheral or central origin that may underlie symptoms of orofacial pain and sensory dysfunction. Neurophysiological testing may also reveal trigeminal pathology when magnetic resonance imaging has failed to detect it, so these methods should be considered complementary to each other in the investigation of orofacial pain patients. The blink reflex, corneal reflex, jaw jerk, sensory neurography of the inferior alveolar nerve, and the recording of trigeminal somatosensory-evoked potentials with near-nerve stimulation have all proved to be sensitive and reliable in the detection of dysfunction of the myelinated sensory fibers of the trigeminal nerve or its central connections within the brainstem. With appropriately small thermodes, thermal quantitative sensory testing is useful for the detection of trigeminal small-fiber dysfunction (Adelta and C). In neuropathic conditions, it is most sensitive to lesions causing axonal injury. By combining different techniques for investigation of the trigeminal system, an accurate topographical diagnosis and profile of sensory fiber pathology can be determined. Neurophysiological and quantitative sensory tests have already highlighted some similarities among various orofacial pain conditions

  18. Investigating dynamical information transfer in the brain following a TMS pulse: Insights from structural architecture.

    Science.gov (United States)

    Amico, Enrico; Van Mierlo, Pieter; Marinazzo, Daniele; Laureys, Steven

    2015-01-01

    Transcranial magnetic stimulation (TMS) has been used for more than 20 years to investigate connectivity and plasticity in the human cortex. By combining TMS with high-density electroencephalography (hd-EEG), one can stimulate any cortical area and measure the effects produced by this perturbation in the rest of the cerebral cortex. The purpose of this paper is to investigate changes of information flow in the brain after TMS from a functional and structural perspective, using multimodal modeling of source reconstructed TMS/hd-EEG recordings and DTI tractography. We prove how brain dynamics induced by TMS is constrained and driven by its structure, at different spatial and temporal scales, especially when considering cross-frequency interactions. These results shed light on the function-structure organization of the brain network at the global level, and on the huge variety of information contained in it.

  19. An Investigation of Factors Affecting Utilization of Information Technology (IT by Agricultural Students

    Directory of Open Access Journals (Sweden)

    Masoud Rezaei

    2012-03-01

    Full Text Available The present study was carried out with the aim of investigating factors affecting utilization of information technology by students of agriculture. A survey approach was used in this study and a questionnaire was developed to gather the data. The study population was postgraduate students (MS and PhD of economic and agricultural development faculty in Tehran University who were selected by applying random sampling technique. Sample size for students was 61 persons. Data was analyzed by using SPSS/WIN software. The results of the research indicated that there was a positive significant relationship between using of information technology by students and their age, average, prior experience, information technology skills, innovativeness, perceived ease of use, attitude and self-efficacy. The relationship between computer anxiety and using of IT was negative. Stepwise Regression Analysis showed that innovativeness and attitude predict 53.2 percent of variations of IT use by students.

  20. Simulation Based Investigation of the Impact of Information Sharing on the Offshore Wind Farm Installation Process

    Directory of Open Access Journals (Sweden)

    Moritz Quandt

    2017-01-01

    Full Text Available In the recent decades, the introduction of a sustainable and green energy infrastructure, and, by this, the reduction of emissions caused by fossil energy generation, has been focused on by industry-oriented nations worldwide. Among the technologies of renewable energy generation, wind energy has the highest deployment rate, due to the high wind resource availability and the high technology maturity reached mainly by the onshore installation of wind turbines. However, the planning and the installation of offshore wind farms are a challenging task, because of harsh weather conditions and limited resource availability. Due to the current practice of decentralised information acquisition by the supply chain partners, we investigate the impact of sharing information on the installation process of offshore wind farms by means of a simulation model. Therefore, relevant information items will be identified in order to improve the installation process.

  1. An Investigation of the Academic Information Finding and Re-finding Behavior on the Web

    Directory of Open Access Journals (Sweden)

    Hsiao-Tieh Pu

    2014-12-01

    Full Text Available Academic researchers often need and re-use relevant information found after a period of time. This preliminary study used various methods, including experiments, interviews, search log analysis, sequential analysis, and observation to investigate characteristics of academic information finding and re-finding behavior. Overall, the participants in this study entered short queries either in finding or re-finding phases. Comparatively speaking, the participants entered greater number of queries, modified more queries, browsed more web pages, and stayed longer on web pages in the finding phase. On the other hand, in the re-finding phase, they utilized personal information management tools to re-find instead of finding again using search engine, such as checking browsing history; moreover, they tend to input less number of queries and stayed shorter on web pages. In short, the participants interacted more with the retrieval system during the finding phase, while they increased the use of personal information management tools in the re-finding phase. As to the contextual clues used in re-finding phase, the participants used less clues from the target itself, instead, they used indirect clues more often, especially location-related information. Based on the results of sequential analysis, the transition states in the re-finding phase was found to be more complex than those in the finding phase. Web information finding and re-finding behavior is an important and novel area of research. The preliminary results would benefit research on Web information re-finding behavior, and provide useful suggestions for developing personal academic information management systems. [Article content in Chinese

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

    Directory of Open Access Journals (Sweden)

    Hersh WR

    2014-07-01

    Full Text Available William R Hersh,1 Paul N Gorman,1 Frances E Biagioli,2 Vishnu Mohan,1 Jeffrey A Gold,3 George C Mejicano4 1Department of Medical Informatics and Clinical Epidemiology, 2Department of Family Medicine, 3Department of Medicine, 4School of Medicine, Oregon Health & Science University, Portland, OR, USA Abstract: Physicians in the 21st century will increasingly interact in diverse ways with information systems, requiring competence in many aspects of clinical informatics. In recent years, many medical school curricula have added content in information retrieval (search and basic use of the electronic health record. However, this omits the growing number of other ways that physicians are interacting with information that includes activities such as clinical decision support, quality measurement and improvement, personal health records, telemedicine, and personalized medicine. We describe a process whereby six faculty members representing different perspectives came together to define competencies in clinical informatics for a curriculum transformation process occurring at Oregon Health & Science University. From the broad competencies, we also developed specific learning objectives and milestones, an implementation schedule, and mapping to general competency domains. We present our work to encourage debate and refinement as well as facilitate evaluation in this area. Keywords: curriculum transformation, clinical decision support, patient safety, health care quality, patient engagement

  3. An empirical investigation of incompleteness in a large clinical sample of obsessive compulsive disorder.

    Science.gov (United States)

    Sibrava, Nicholas J; Boisseau, Christina L; Eisen, Jane L; Mancebo, Maria C; Rasmussen, Steven A

    2016-08-01

    Obsessive Compulsive Disorder (OCD) is a disorder with heterogeneous clinical presentations. To advance our understanding of this heterogeneity we investigated the prevalence and clinical features associated with incompleteness (INC), a putative underlying core feature of OCD. We predicted INC would be prominent in individuals with OCD and associated with greater severity and impairment. We examined the impact of INC in 307 adults with primary OCD. Participants with clinically significant INC (22.8% of the sample) had significantly greater OCD severity, greater rates of comorbidity, poorer ratings of functioning, lower quality of life, and higher rates of unemployment and disability. Participants with clinically significant INC were also more likely to be diagnosed with OCPD and to endorse symmetry/exactness obsessions and ordering/arranging compulsions than those who reported low INC. Our findings provide evidence that INC is associated with greater severity, comorbidity, and impairment, highlighting the need for improved assessment and treatment of INC in OCD. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. [Clinical investigation of basophil activation test as a complementary test for house dust mite allergen].

    Science.gov (United States)

    Ren, H L; Li, J D; Miao, Y H; Xu, T

    2018-03-01

    Objective: To investigate the clinical application of glass micro fiber basophil activation test (BAT) used as a complementary test for house dust mite allergen. Method: Forty patients with clinical diagnosed allergic rhinitis was test by three methods for house dust mite allergen, skin prick test(SPT),Immuno CAP sIgE, and BAT in vitro. The sensitivity and specificity of glass micro fiber were accessed, and the consistency between BAT, SPT, and Immuno sIgE was analyzed. As in vivo provocation was not performed, gold standard is regarded as the combination of medical history and positive reports of SPT and/or ImmunoCAP sIgE test. Result: Twentythree patients are diagnosed as house dust mite allergic rhinitis by gold standard. The sensitivity and specificity of glass micro fiber BAT were 60.9% and 88.2%, the sensitivity of SPT and sIgE was 87.0% and sIgE 73.9%. The correlation rates between BAT with SPT is 0.67( P house dust mite allergic rhinitis, BAT have a good consistency with SPT and sIgE, while as it has only moderate consistency with "gold standard", further studies are needed to prove its clinical significance. Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.

  5. [What role for paraclinical investigations within clinical trials conducted in psychiatric patients?

    Science.gov (United States)

    Kaladjian, A; Adida, M; Simon, N; Belzeaux, R; Blin, O; Fakra, E; Azorin, J-M

    2016-12-01

    As in the usual care of patients, paraclinical investigations have today only a very modest role in clinical trials in psychiatry, mainly to complete the pre-therapeutical assessments prior to inclusion of subjects or to monitor treatment tolerance. Yet, the accumulation of data in neurosciences suggests the next emergence of biomarkers, whose interest is that they are closely associated to the biological disturbances underlying psychiatric illnesses, and that they are accessible by means of technological tools such as imaging devices. These tools allow to explore the effects on brain of psychotropic medications, such as antidepressants, antipsychotics, or mood stabilizers, in relation to their therapeutic action. The obtained results allow to consider the use of such biomarkers in clinical trials in addition to more conventional approaches. In particular, they could be used as targets to measure brain response to treatment in association with clinical response, to predict a therapeutic response from the neurofunctional characteristics of patients, or to establish the safety profile of drugs on the nervous system. The use of such biomarkers in clinical trials would help to better define the explored populations and their characteristics, as well as the variables to assess, and to better measure the impact of the treatments and their potential harmful effects on the nervous system. © L’Encéphale, Paris, 2016.

  6. Use of Clinical Health Information Technology in Nursing Homes: Nursing Home Characteristics and Quality Measures

    Science.gov (United States)

    Spinelli-Moraski, Carla

    2014-01-01

    This study compares quality measures among nursing homes that have adopted different levels of clinical health information technology (HIT) and examines the perceived barriers and benefits of the adoption of electronic health records as reported by Nursing Home Administrators and Directors of Nursing. A cross-sectional survey distributed online to…

  7. Informed consent in clinical trials using stem cells: Sugges tions and ...

    African Journals Online (AJOL)

    2015-08-01

    Aug 1, 2015 ... research. The correlated results showed the need for continuous training and education of elucidators in order to make sure that they acquire and maintain ... in the recommendations show that improving IC related to stem cell research is a .... of this clinical trial. • Contact information and consultation service.

  8. Informing family members about a hereditary predisposition to cancer: attitudes and practices among clinical geneticists

    NARCIS (Netherlands)

    Stol, Y.; Menko, F.H.; Westerman, M.J.; Janssens, M.J.P.A.

    2010-01-01

    If a hereditary predisposition to colorectal cancer or breast cancer is diagnosed, most guidelines state that clinical geneticists should request index patients to inform their at-risk relatives about the existence of this condition in their family, thus enabling them to consider presymptomatic

  9. Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference?

    Directory of Open Access Journals (Sweden)

    Gitanjali B

    2003-01-01

    Full Text Available CONTEXT: Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread. AIMS: To determine the percentage of patients who agree to participate in a trial after receiving either complete or partial information regarding a trial and to find out whether there were gender or educational status-related differences. To assess reasons for consenting or refusing and their depth of understanding of informed consent. SETTINGS AND DESIGN: A simulated clinical trial in two tertiary health care facilities on in-patients. METHODS AND MATERIAL: An informed consent form for a mock clinical trial of a drug was prepared. The detailed / partial procedure was explained to a purposive sample of selected in-patients and their consent was asked for. Patients were asked to free list the reasons for giving or withholding consent. Their depth of understanding was assessed using a questionnaire. Chi-square test was used for statistical analyses. RESULTS: The percentages of those consenting after full disclosure 29/102 (30% and after partial disclosure 15/50 (30% were the same. There was a significant (p=0.043 gender difference with a lesser percentage of females (30% consenting to participation in a trial. Educational status did not alter this percentage. Most patients withheld consent because they did not want to give blood or take a new drug. Understanding of informed consent was poor in those who consented. CONCLUSIONS: The fact that only one-third of subjects are likely to give consent to participate in a trial needs to be considered while planning clinical trials with a large sample size. Gender but not educational status influences the number of subjects consenting for a study. Poor understanding of the elements of informed consent in patients necessitates evolving better methods of implementing consent procedures in India.

  10. Investigation research of core-basic information associated with the coupling analysis. Outline report

    International Nuclear Information System (INIS)

    Kataoka, Shinichi; Matsunaga, Kenichi; Ishihara, Yoshinao; Kawahara, Kenichi; Neyama, Atsushi; Nakagawa, Koichi; Iwata, Hiroshi; Mori, Koji

    2001-03-01

    The newest literature information in the foreign countries was researched, and this research showed the basic concept of the coupling analysis code to realize coupling analysis in near field of the geological disposal system. The outline of this research is shown in the following. (1) The combination of M (Mechanical) and C (Chemistry) is placed on the weak relations, because coupling analysis of the United States Yucca Mountain limits a site and the specifications of engineered barrier. (2) One of the purposes of this research is information collecting about coupling analysis code NUFT-C adopted in the United States Yucca Mountain. Therefore, we carried out an information exchange with the United States Lawrence Livermore National Laboratory. We could collect the development purpose of analysis code, key function, and information such as a test case analysis. (3) The investigation of the analysis code concerned with the newest information of coupling analysis which contains the geochemistry process and 2 phase system was done based on the public information for the purpose of building some concept of the coupling analysis code, the extraction of the development issues. It could be understood about the future development strategy and the precaution in addition to a phenomenon to deal with, the current status of the coupling analysis technique as a result of the investigation. (4) It was cleared about the mission of the coupling analysis code and the requirement items (function, quality) by this research. Then, some development options were presented. (5) It was studied about the procedure of developing it to satisfy the above requirement toward the conditions that a site isn't selected, the short development. The tool (Diffpack) which could cope with the speed-up of the calculation time and visualization flexibly was effective, and it was summarized about the test case by using this tool, the key function of this tool as that result. (author)

  11. Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

    Science.gov (United States)

    Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

    2017-02-01

    This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

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

    Science.gov (United States)

    Safari, Leila; Patrick, Jon D

    2013-01-01

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

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

    Science.gov (United States)

    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'.

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

    Directory of Open Access Journals (Sweden)

    Elena Villamañán

    2016-05-01

    Full Text Available 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

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

    Science.gov (United States)

    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.

  16. Using thermographic cameras to investigate eye temperature and clinical severity in depression

    Science.gov (United States)

    Maller, Jerome J.; George, Shefin Sam; Viswanathan, Rekha Puzhavakkathumadom; Fitzgerald, Paul B.; Junor, Paul

    2016-02-01

    Previous studies suggest that altered corneal temperature may be a feature of schizophrenia, but the association between major depressive disorder (MDD) and corneal temperature has yet to be assessed. The aim of this study is to investigate whether eye temperature is different among MDD patients than among healthy individuals. We used a thermographic camera to measure and compare the temperature profile across the corneas of 16 patients with MDD and 16 age- and sex-matched healthy subjects. We found that the average corneal temperature between the two groups did not differ statistically, although clinical severity correlated positively with right corneal temperature. Corneal temperature may be an indicator of clinical severity in psychiatric disorders, including depression.

  17. Clinical investigation of large perfusion defect cases with 201Tl exercise myocardial scintigraphy

    International Nuclear Information System (INIS)

    Morota, Motoi; Kobayashi, Yasuhiko

    1999-01-01

    We investigated retrospectively the clinical significance of large perfusion defect on 201 Thallium myocardial scintigraphy from the records of 833 patients during the past 3 years from 1991 to 1994. The patients were divided into 3 groups according to the extent of perfusion defect; cases with normal perfusion (n=561), with small perfusion defect (n=211) and with large perfusion defect (n=61). We found that the proportions of cases with large perfusion defect was significantly larger than that of cases with small perfusion defect in myocardial disease (MD; hypertrophic cardiomyopathy, dilated cardiomyopathy, and post myocarditis combined) (P 201 Thallium myocardial scintigraphy and that complication of diabetes mellitus and clinical symptoms may be useful in differentiating IHD from MD. (author)

  18. Investigating the connections between health lean management and clinical risk management.

    Science.gov (United States)

    Crema, Maria; Verbano, Chiara

    2015-01-01

    The purpose of this paper is to investigate connections and overlaps between health lean management (HLM) and clinical risk management (CRM) understanding whether and how these two approaches can be combined together to pursue efficiency and patient safety improvements simultaneously. A systematic literature review has been carried out. Searching in academic databases, papers that focus not only on HLM, but also on clinical errors and risk reduction, were included. The general characteristics of the selected papers were analysed and a content analysis was conducted. In most of the papers, pursing objectives of HLM and CRM and adopting tools and practices of both approaches, results of quality and, particularly, of safety improvements were obtained. A two-way arrow between HLM and CRM emerged but so far, none of the studies has been focused on the relationship between HLM and CRM. Results highlight an emerging research stream, with many useful theoretical and practical implications and opportunities for further research.

  19. Research Capacity at Traditional Chinese Medicine (TCM) Centers in China: A Survey of Clinical Investigators.

    Science.gov (United States)

    Feng, Shuo; Han, Mei; Lai, Lily; Wang, Si-Cheng; Liu, Jian-Ping

    2017-01-01

    Background. The development of an evidence-based approach to traditional Chinese medicine (TCM), which depends on the generation of good quality evidence, requires an adequate workforce. However, the research capacity of TCM investigators is not known. Study Design. This cross-sectional study was conducted to describe the research capacity of TCM clinical investigators in China. Participants. A total of 584 participants from TCM hospitals and research centers were included. They were asked about the academic and research characteristics, needs for research capacity building, and barriers to clinical research. Results. The majority (80.82%) were qualified to at least a Master's degree, whilst a smaller proportion (40.24%) held a senior professional title. We found that academic outputs were low with the majority (62.16%) authoring less than five publications in total. The most pressing needs for building research capacity identified were training in research methodology (97.43%) and identification of research questions (86.81%), whilst the highest ranking barriers to conducting research were limited motivation, funding (40.72%), and time (37.15%). Conclusion. The methodology training, along with investment in the research workforce, needs to be urgently addressed to improve investigators' research capacity and the development of an evidence-based approach of TCM.

  20. Towards democracy in spatial planning through spatial information built by communities: The investigation of spatial information built by citizens from participatory mapping to volunteered geographic information in Indonesia

    Science.gov (United States)

    Yudono, Adipandang

    2017-06-01

    Recently, crowd-sourced information is used to produce and improve collective knowledge and community capacity building. Triggered by broadening and expanding access to the Internet and cellular telephones, the utilisation of crowd-sourcing for policy advocacy, e-government and e-participation has increased globally [1]. Crowd-sourced information can conceivably support government’s or general social initiatives to inform, counsel, and cooperate, by engaging subjects and empowering decentralisation and democratization [2]. Crowd-sourcing has turned into a major technique for interactive mapping initiatives by urban or rural community because of its capability to incorporate a wide range of data. Continuously accumulated spatial data can be sorted, layered, and envisioned in ways that even beginners can comprehend with ease. Interactive spatial visualization has the possibility to be a useful democratic planning tool to empower citizens participating in spatial data provision and sharing in government programmes. Since the global emergence of World Wide Web (WWW) technology, the interaction between information providers and users has increased. Local communities are able to produce and share spatial data to produce web interfaces with territorial information in mapping application programming interfaces (APIs) public, such as Google maps, OSM and Wikimapia [3][4][5]. In terms of the democratic spatial planning action, Volunteered Geographic Information (VGI) is considered an effective voluntary method of helping people feel comfortable with the technology and other co-participants in order to shape coalitions of local knowledge. This paper has aim to investigate ‘How is spatial data created by citizens used in Indonesia?’ by discussing the characteristics of spatial data usage by citizens to support spatial policy formulation, starting with the history of participatory mapping to current VGI development in Indonesia.

  1. Sustaining the Clinical and Translational Research Workforce: Training and Empowering the Next Generation of Investigators.

    Science.gov (United States)

    Yin, Helen L; Gabrilove, Janice; Jackson, Rebecca; Sweeney, Carol; Fair, Alecia M; Toto, Robert

    2015-07-01

    There is mounting concern that clinician-scientists are a vanishing species and that the pipeline for clinical and translational research (CTR) investigators is in jeopardy. For the majority of current junior CTR investigators, the career path involves first obtaining a National Institutes of Health (NIH)-funded K-type career development award, particularly K08 and K23, and subsequently an NIH R01. This transition, popularly referred to as K2R, is a major hurdle with a low success rate and gaps in funding. In this Perspective, the authors identify factors that facilitate K2R transition and important aspects of increasing and sustaining the pipeline of CTR investigators. They also highlight significant differences in success rates of women and those underrepresented in biomedical research. Early career exposure to research methodology, protected time, multidisciplinary mentoring, and institutional "culture shift" are important for fostering and rewarding team science. Mentoring is the single most important contributor to K2R success, and emerging evidence suggests that formal mentor training and team mentoring are effective. Leadership training can empower junior investigators to thrive as independent CTR investigators. Future research should focus on delineating the difference between essential and supplemental factors to achieve this transition, and mentoring methods that foster success, including those that promote K2R transition of women and those underrepresented in biomedical research. The Clinical and Translational Science Awards National Consortium is well positioned to test existing models aimed at shortening the time frame, increasing the rate of K2R transition, and identifying strategies that improve success.

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

    Science.gov (United States)

    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.

  3. Clinical, information and business process modeling to promote development of safe and flexible software.

    Science.gov (United States)

    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.

  4. Truth telling and informed consent: is "primum docere" the new motto of clinical practice?

    Science.gov (United States)

    Byk, Christian

    2007-09-01

    Autonomy has become in many countries a key concept in the patient-physician relationship, leaving the old paternalistic medical attitude out of the realm of common good clinical practice. Consequently, the validity of the informed consent procedure which is related to any medical intervention, should imply that the information given is true. Raising the question as such obliges us to consider the truth not for itself but in regard to the validity of the consent to a medical intervention. Although a clinical approach reveals that loyalty should guide the patient-physician relationship, there are still some situations in which informed consent and truth telling may be controversial: in some circumstances, the physician should or may not tell the truth, in others he can simply forget to tell.

  5. Clinical investigations of the therapeutic potential of ayahuasca: rationale and regulatory challenges.

    Science.gov (United States)

    McKenna, Dennis J

    2004-05-01

    Ayahuasca is a hallucinogenic beverage that is prominent in the ethnomedicine and shamanism of indigenous Amazonian tribes. Its unique pharmacology depends on the oral activity of the hallucinogen, N,N-dimethyltryptamine (DMT), which results from inhibition of monoamine oxidase (MAO) by beta-carboline alkaloids. MAO is the enzyme that normally degrades DMT in the liver and gut. Ayahuasca has long been integrated into mestizo folk medicine in the northwest Amazon. In Brazil, it is used as a sacrament by several syncretic churches. Some of these organizations have incorporated in the United States. The recreational and religious use of ayahuasca in the United States, as well as "ayahuasca tourism" in the Amazon, is increasing. The current legal status of ayahuasca or its source plants in the United States is unclear, although DMT is a Schedule I controlled substance. One ayahuasca church has received favorable rulings in 2 federal courts in response to its petition to the Department of Justice for the right to use ayahuasca under the Religious Freedom Restoration Act. A biomedical study of one of the churches, the Uñiao do Vegetal (UDV), indicated that ayahuasca may have therapeutic applications for the treatment of alcoholism, substance abuse, and possibly other disorders. Clinical studies conducted in Spain have demonstrated that ayahuasca can be used safely in normal healthy adults, but have done little to clarify its potential therapeutic uses. Because of ayahuasca's ill-defined legal status and variable botanical and chemical composition, clinical investigations in the United States, ideally under an approved Investigational New Drug (IND) protocol, are complicated by both regulatory and methodological issues. This article provides an overview of ayahuasca and discusses some of the challenges that must be overcome before it can be clinically investigated in the United States.

  6. Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process.

    Science.gov (United States)

    Mexas, Fernanda; Efron, Anne; Luiz, Ronir Raggio; Cailleaux-Cezar, Michelle; Chaisson, Richard E; Conde, Marcus B

    2014-02-01

    for assessing the level of understanding of trial-related information during the informed consent (IC) process in developing countries are lacking. To assess the understanding and retention of trial-related information presented in the IC process by administering an informed consent assessment instrument (ICAI) to participants in a clinical trial for a new tuberculosis (TB) regimen being conducted in Rio de Janeiro (Brazil). Methods The format of the ICAI was based on the language and structure of the United States National Cancer Institute's IC comprehension checklist. The ICAI was designed to assess points of the RioMAR study IC process that addressed the principles of research ethics requested by Brazilian Regulatory Authority: autonomy, beneficence, non-maleficence, and justice. Briefly, (1) Is the respondent participating in a clinical trial? (2) Are two different treatments being evaluated? (3) Is the treatment arm chosen by chance? (4) Is an HIV test required? (5) Are liver function tests required? (6) Can participants leave the study at any time? (7) Are the risks and benefits of taking part in the study clear? (8) May pregnant women participate in the study? (9) Can one of the study drugs reduce the effectiveness of contraceptives? (10) Are patients paid to participate in the study? The ICAI was applied at two time points: immediately after enrollment in the clinical trial and 2 months later. A total of 61 patients who enrolled in the RioMAR study participated in this study. The percentage of correct answers to all questions was 82% at the time of the first ICAI; 31 participants (51%) did not recall that an HIV test was required (question 4) and 43 (70%) did not know that they could leave the study (question 6). Other individual questions were answered correctly by at least 76% of participants. There was no association between incorrect answers and age, gender, monthly family income, neighborhood, or level of education (p > 0.07). When the responses to the

  7. Duplex investigations in children: Are clinical signs in children with venous disorders relevant?

    Science.gov (United States)

    Birgitte Maessen-Visch, M; Smeets, L; van Vleuten, C

    2015-12-01

    Ultra sound colored duplex sonography is the preferred method in diagnosing chronic venous disease. Data in children on incidence, indications, and results are lacking. From the total of 9180 duplex investigations performed in our hospital from 2009 to 2012, data on indication and results of the investigation as well as patient characteristics were evaluated retrospectively for the proportion of pediatric patients. Duplex investigations were performed 49 times in 38 children (6-18 years), with an average of 1.3 times (1-6 times) per child. Forty percent showed abnormalities: 17 times deep venous thrombosis was suspected; deep venous thrombosis was objectified in 18%. In the 21 investigations performed for varicosis-related complaints, varicose veins or venous malformations were objectified in 57%. Edema was never a symptom of chronic venous disease. Duplex investigation is not often performed in children. In children with established deep venous thrombosis, a family history with deep venous thrombosis is common. In general, edema was not seen in children with varicose veins and, therefore, does not seem a reliable clinical sign at young age. © The Author(s) 2014.

  8. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

    Science.gov (United States)

    2008-07-15

    The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

  9. A descriptive survey investigating pre-registration student nurses' perceptions of clinical skill development in clinical placements.

    Science.gov (United States)

    Stayt, Louise C; Merriman, Clair

    2013-04-01

    Clinical skill development is essential to nurse education. Clinical skills are frequently taught in higher education institutions using clinical simulation. It is unclear if clinical skills are subsequently consolidated and developed in clinical placements. The aim of this survey was to evaluate pre-registration student nurses perceptions of the frequency of opportunities to practise, the level of supervision and assessment of, clinical skills in their clinical placements. This was a cross-sectional survey design using an online, self-report questionnaire including a Likert-type scale and open ended comments. Four hundred and twenty one students, from all year groups, from a university in the south of England on a wide variety of clinical placements participated. Participants evaluated the frequency of opportunity to practise, level of supervision and assessment of and feedback on performance of specific clinical skills. Clinical skills evaluated were measurement of vital signs, aseptic non-touch technique, assisting with eating and drinking, and assisting with comfort and hygiene. Data were analysed utilising Statistical Package for the Social Sciences Version 19. The frequency of opportunities to practise skills in clinical placement was variable with some participants reporting that they never had opportunity to practise essential skills. Similarly the level of supervision and assessment was also inconsistent suggesting that participants frequently practised clinical skills unsupervised without being assessed as competent. Inconsistencies in clinical skill development may lead to graduates who are not work ready and as a result, insufficient clinical competence potentially leads to unsafe practice and poor patient care. This calls for stronger partnerships between educators and clinical areas and the prioritisation of mentor preparation and education as well as organisational support in terms of mentor workload planning. Copyright © 2012 Elsevier Ltd. All

  10. YouTube Videos as a Source of Information About Clinical Trials: Observational Study.

    Science.gov (United States)

    Hillyer, Grace Clarke; MacLean, Sarah A; Beauchemin, Melissa; Basch, Corey H; Schmitt, Karen M; Segall, Leslie; Kelsen, Moshe; Brogan, Frances L; Schwartz, Gary K

    2018-06-26

    Clinical trials are essential to the advancement of cancer treatment but fewer than 5% of adult cancer patients enroll in a trial. A commonly cited barrier to participation is the lack of understanding about clinical trials. Since the internet is a popular source of health-related information and YouTube is the second most visited website in the world, we examined the content of the top 115 YouTube videos about clinical trials to evaluate clinical trial information available through this medium. YouTube videos posted prior to March 2017 were searched using selected keywords. A snowballing technique was used to identify videos wherein sequential screening of the autofill search results for each set of keywords was conducted. Video characteristics (eg, number of views and video length) were recorded. The content was broadly grouped as related to purpose, phases, design, safety and ethics, and participant considerations. Stepwise multivariable logistic regression analysis was conducted to assess associations between video type (cancer vs noncancer) and video characteristics and content. In total, 115 videos were reviewed. Of these, 46/115 (40.0%) were cancer clinical trials videos and 69/115 (60.0%) were noncancer/general clinical trial videos. Most videos were created by health care organizations/cancer centers (34/115, 29.6%), were oriented toward patients (67/115, 58.3%) and the general public (68/115, 59.1%), and were informational (79/115, 68.7%); altruism was a common theme (31/115, 27.0%). Compared with noncancer videos, cancer clinical trials videos more frequently used an affective communication style and mentioned the benefits of participation. Cancer clinical trial videos were also much more likely to raise the issue of costs associated with participation (odds ratio [OR] 5.93, 95% CI 1.15-29.46) and advise patients to communicate with their physician about cancer clinical trials (OR 4.94, 95% CI 1.39-17.56). Collectively, YouTube clinical trial videos

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

    Science.gov (United States)

    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.

  12. Clinical and ECG investigations in subjects with acute carbon monoxide poisoning

    Energy Technology Data Exchange (ETDEWEB)

    Capellini, A; Tomasini, M; Limonta, A

    1974-01-01

    Research carried out on more than 100 workers hospitalized for acute CO poisoning at the Milan Clinica del Lavoro and some 50 subjects undergoing treatment at the Milan polyclinic. The purpose of the research was to investigate the incidence and frequency of myocardial and coronary impairment in cases of acute CO poisoning. The authors concluded from their clinical and ECG findings that myocardial and coronary impairment in subjects suffering from acute CO poisoning was rarely serious or irreversible unless there was preexistent coronary disease. (CIS Abstr. Vol. 2)

  13. Department of Clinical Investigation Annual Research Progress Report, Fiscal Year 1993. Volume 2

    Science.gov (United States)

    1993-10-01

    A-5-90 Production of Mouse Positive and Negative Control Slides for 382 Use in Rabies FRA Test. (0) A-7-90 Clinical Investigation on the...Possible 402 Diagnostic and Therapeutic Manuever as Tested in a Mouse Model Utilizing PET Scanning. (0) A-93-04 Production of Monoclonal Antibodies to...xlv Project Page Number POG 9005 ALinC 15: Dose Intensification of Methotrexate and 583 6- Mercaptopurine for ALL in Childhood. (0) P00 9006 ALinC 15

  14. Hysterosalpingographic picture encountered during the investigation of female infertility clinic has Lemba of Saint Raphael

    International Nuclear Information System (INIS)

    Kitenge, N.; Nzeza, N.; Mbanzulu, P.; Ndaye, B.

    2010-01-01

    A cross-sectional study was conducted at the St Raphael Lemba Clinic on a sample of 115 patients suspected of infertility during the period from june 1 1997 in 1 march 2003 (6 years). The technique of hysterosalpingography has allowed the identification of female infertility presents images that can diagnose one or more causes utero-tubal. Men also carry a significant responsibility in the genesis of the sterility of the couple: thus, they must also undergo exploration. Hormonal factors also have an important contribution in the investigation of infertility in women and must be taken in addition to hysterosalpingography

  15. An investigation of children's levels of inquiry in an informal science setting

    Science.gov (United States)

    Clark-Thomas, Beth Anne

    Elementary school students' understanding of both science content and processes are enhanced by the higher level thinking associated with inquiry-based science investigations. Informal science setting personnel, elementary school teachers, and curriculum specialists charged with designing inquiry-based investigations would be well served by an understanding of the varying influence of certain present factors upon the students' willingness and ability to delve into such higher level inquiries. This study examined young children's use of inquiry-based materials and factors which may influence the level of inquiry they engaged in during informal science activities. An informal science setting was selected as the context for the examination of student inquiry behaviors because of the rich inquiry-based environment present at the site and the benefits previously noted in the research regarding the impact of informal science settings upon the construction of knowledge in science. The study revealed several patterns of behavior among children when they are engaged in inquiry-based activities at informal science exhibits. These repeated behaviors varied in the children's apparent purposeful use of the materials at the exhibits. These levels of inquiry behavior were taxonomically defined as high/medium/low within this study utilizing a researcher-developed tool. Furthermore, in this study adult interventions, questions, or prompting were found to impact the level of inquiry engaged in by the children. This study revealed that higher levels of inquiry were preceded by task directed and physical feature prompts. Moreover, the levels of inquiry behaviors were haltered, even lowered, when preceded by a prompt that focused on a science content or concept question. Results of this study have implications for the enhancement of inquiry-based science activities in elementary schools as well as in informal science settings. These findings have significance for all science educators

  16. Providing an information prescription in veterinary medical clinics: a pilot study.

    Science.gov (United States)

    Kogan, Lori R; Schoenfeld-Tacher, Regina; Gould, Lauren; Viera, Ann R; Hellyer, Peter W

    2014-01-01

    The study assesses the impact on client behavior and attitudes toward receiving an information prescription as part of a veterinary office visit. A random sample of veterinary clinics from a Western US metropolitan area was asked to distribute an information prescription in addition to their customary veterinary services. All clients, regardless of the reason for their visit, were presented with an information prescription: a handout that included the uniform resource locator (URL) to a general veterinary medicine website and several tips to help their clients make more informed choices about where to seek pet health information online. Nearly 40% of clients who reported that they remembered receiving the information prescription accessed the website at least once. Of the clients who reported accessing the suggested website, 86.3% reported finding it "very helpful" or "somewhat helpful." Nearly all the clients (87.9%) reported feeling the information on the site helped them make better decisions for their pets. Most clients reported that it helped them talk to their veterinarians (89.9%) and added to the information they received during their veterinary visits (83.5%). Clients appreciate and utilize veterinary prescriptions, suggesting that this is a tool that both veterinarians and librarians can use to improve animal health and client relations. The value placed on reliable Internet information by veterinary clients suggests several opportunities for librarians to become more proactive in partnering with veterinarians to facilitate the education of pet owners.

  17. Developing the Role of a Health Information Professional in a Clinical Research Setting

    Directory of Open Access Journals (Sweden)

    Helen M. Seeley

    2010-06-01

    Full Text Available Objective ‐ This paper examines the role of a health information professional in a large multidisciplinary project to improve services for head injury.Methods ‐ An action research approach was taken, with the information professional acting as co‐ordinator. Change management processes were guided by theory and evidence. The health information professional was responsible for an ongoing literature review on knowledge management (clinical and political issues, data collection and analysis (from patient records, collating and comparing data (to help develop standards, and devising appropriate dissemination strategies.Results ‐ Important elements of the health information management role proved to be 1 co‐ordination; 2 setting up mechanisms for collaborative learning through information sharing; and 3 using the theoretical frameworks (identified from the literature review to help guide implementation. The role that emerged here has some similarities to the informationist role that stresses domain knowledge, continuous learning and working in context (embedding. This project also emphasised the importance of co‐ordination, and the ability to work across traditional library information analysis (research literature discovery and appraisal and information analysis of patient data sets (the information management role.Conclusion ‐ Experience with this project indicates that health information professionals will need to be prepared to work with patient record data and synthesis of that data, design systems to co‐ordinate patient data collection, as well as critically appraise external evidence.

  18. Care episode retrieval: distributional semantic models for information retrieval in the clinical domain.

    Science.gov (United States)

    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.

  19. Development of patient centric virtual organizations (PCVOs) in clinical environment for patient information management.

    Science.gov (United States)

    Mohyuddin; Gray, W A; Bailey, Hazel; Jones, Wendy; Morrey, David

    2007-01-01

    A novel Virtual Organization framework which incorporates wireless technology support is presented in the research work. The Virtual Organization is designed for a clinical environment to provide better patient information management and enhanced collaborative working of multidisciplinary care teams. The analysis studies the current clinical practices and looks at the general patient information resource structure currently in use for patient care. Based on this problem analysis and current requirements of the multi-disciplinary care team members, we propose a generic and sustainable Patient Centric Virtual Organization (PCVO) framework to complement the functionality of the existing infrastructure by incorporating wireless technologies support for improved patient information provision at the point of care. The preliminary results of the study identify and classify the specific point of care tasks suited to appropriate information resources needed by the care team members. This paper concentrates on the patient information management aspects brought in by incorporating wireless technologies at the point of care using patient information resources in a decentralized and distributed computing environment. This applied research is carried out in the secondary and tertiary care sector in the cancer domain. For the analysis and results of the pilot project, we have used a case study of a local NHS Cancer Hospital.

  20. Informed Consent in Clinical Trials Using Stem Cells: Suggestions and Points of Attention from Informed Consent Training Workshops in Japan

    Directory of Open Access Journals (Sweden)

    M Kusunose

    2015-09-01

    Full Text Available Informed consent (IC is an essential requirement of ethical research involving human participants, and usually is achieved by providing prospective research participants (PRPs with a document that explains the study and its procedures. However, results of a series of IC workshops held in Tokyo during 2014 indicate that consent forms alone are not enough to achieve full IC in regenerative medicine research due to the necessity of long-term patient-safety observations to meet the ethical challenges of such research. Adequate training of the people who are responsible for obtaining IC (elucidators is also necessary to ensure full IC. Elucidators must be able to provide PRPs with sufficient information to assure adequate comprehension of the study and its potential aftereffects; judge PRPs’ voluntariness and eligibility; and establish/maintain partnerships with PRPs. The workshops used role-playing simulations to demonstrate how to effectively obtain fuller IC to members of several Japanese research groups preparing for clinical stem cell trials. Workshop results were correlated with the results of a 2013 workshop on what information is patients want when considering participation in iPSC research. The correlated results showed the need for continuous training and education of elucidators in order to have them acquire and maintain IC competency. 

  1. Clinical psychology service users' experiences of confidentiality and informed consent: a qualitative analysis.

    Science.gov (United States)

    Martindale, S J; Chambers, E; Thompson, A R

    2009-12-01

    To explore and describe the experience of clinical psychology service users in relation to the processes associated with confidentiality and the generation of informed consent in individual therapy. A qualitative interview-based study employing interpretative phenomenological analysis was conducted with service users. User researchers were active collaborators in the study. A focus group of four users was convened to explore issues related to confidentiality and consent, which then informed the development of the semi-structured interview schedule. Twelve users of community mental health clinical psychology services were interviewed by user researchers. A user researcher and a clinical psychologist undertook joint analysis of the data. A second clinical psychologist facilitated reflexivity and wider consideration of validity issues. Four main themes were identified from the data: being referred; the participant's feelings, mental health difficulties, and their impact; relationships with workers and carers; and autonomy. The meaningfulness of processes of discussing confidentiality, and generating informed consent, can be improved by psychologists placing a greater emphasis on choice, control, autonomy, individual preferences, and actively involving the user in dialogue on repeated occasions.

  2. Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design.

    Science.gov (United States)

    Lipsman, Nir; Giacobbe, Peter; Bernstein, Mark; Lozano, Andres M

    2012-02-01

    Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of conventional therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population.

  3. Effect modification, interaction and mediation: an overview of theoretical insights for clinical investigators

    Directory of Open Access Journals (Sweden)

    Corraini P

    2017-06-01

    Full Text Available Priscila Corraini,1 Morten Olsen,1 Lars Pedersen,1 Olaf M Dekkers,1,2 Jan P Vandenbroucke1–3 1Department of Clinical Epidemiology, Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark; 2Leiden University Medical Center, Leiden, the Netherlands; 3Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK Abstract: We revisited the three interrelated epidemiological concepts of effect modification, interaction and mediation for clinical investigators and examined their applicability when using research databases. The standard methods that are available to assess interaction, effect modification and mediation are explained and exemplified. For each concept, we first give a simple “best-case” example from a randomized controlled trial, followed by a structurally similar example from an observational study using research databases. Our explanation of the examples is based on recent theoretical developments and insights in the context of large health care databases. Terminology is sometimes ambiguous for what constitutes effect modification and interaction. The strong assumptions underlying the assessment of interaction, and particularly mediation, require clinicians and epidemiologists to take extra care when conducting observational studies in the context of health care databases. These strong assumptions may limit the applicability of interaction and mediation assessments, at least until the biases and limitations of these assessments when using large research databases are clarified. Keywords: methods, epidemiology, effect modifiers, stratified analyses, health care administrative claims

  4. Investigating consumers' and informal carers' views and preferences for consumer directed care: A discrete choice experiment.

    Science.gov (United States)

    Kaambwa, Billingsley; Lancsar, Emily; McCaffrey, Nicola; Chen, Gang; Gill, Liz; Cameron, Ian D; Crotty, Maria; Ratcliffe, Julie

    2015-09-01

    Consumer directed care (CDC) is currently being embraced internationally as a means to promote autonomy and choice for consumers (people aged 65 and over) receiving community aged care services (CACSs). CDC involves giving CACS clients (consumers and informal carers of consumers) control over how CACSs are administered. However, CDC models have largely developed in the absence of evidence on clients' views and preferences. We explored CACS clients' preferences for a variety of CDC attributes and identified factors that may influence these preferences and potentially inform improved design of future CDC models. Study participants were clients of CACSs delivered by five Australian providers. Using a discrete choice experiment (DCE) approach undertaken in a group setting between June and December 2013, we investigated the relative importance to CACS consumers and informal (family) carers of gradations relating to six salient features of CDC (choice of service provider(s), budget management, saving unused/unspent funds, choice of support/care worker(s), support-worker flexibility and level of contact with service coordinator). The DCE data were analysed using conditional, mixed and generalised logit regression models, accounting for preference and scale heterogeneity. Mean ages for 117 study participants were 80 years (87 consumers) and 74 years (30 informal carers). All participants preferred a CDC approach that allowed them to: save unused funds from a CACS package for future use; have support workers that were flexible in terms of changing activities within their CACS care plan and; choose the support workers that provide their day-to-day CACSs. The CDC attributes found to be important to both consumers and informal carers receiving CACSs will inform the design of future CDC models of service delivery. The DCE approach used in this study has the potential for wide applicability and facilitates the assessment of preferences for elements of potential future aged care

  5. Clinical information modeling processes for semantic interoperability of electronic health records: systematic review and inductive analysis.

    Science.gov (United States)

    Moreno-Conde, Alberto; Moner, David; Cruz, Wellington Dimas da; Santos, Marcelo R; Maldonado, José Alberto; Robles, Montserrat; Kalra, Dipak

    2015-07-01

    This systematic review aims to identify and compare the existing processes and methodologies that have been published in the literature for defining clinical information models (CIMs) that support the semantic interoperability of electronic health record (EHR) systems. Following the preferred reporting items for systematic reviews and meta-analyses systematic review methodology, the authors reviewed published papers between 2000 and 2013 that covered that semantic interoperability of EHRs, found by searching the PubMed, IEEE Xplore, and ScienceDirect databases. Additionally, after selection of a final group of articles, an inductive content analysis was done to summarize the steps and methodologies followed in order to build CIMs described in those articles. Three hundred and seventy-eight articles were screened and thirty six were selected for full review. The articles selected for full review were analyzed to extract relevant information for the analysis and characterized according to the steps the authors had followed for clinical information modeling. Most of the reviewed papers lack a detailed description of the modeling methodologies used to create CIMs. A representative example is the lack of description related to the definition of terminology bindings and the publication of the generated models. However, this systematic review confirms that most clinical information modeling activities follow very similar steps for the definition of CIMs. Having a robust and shared methodology could improve their correctness, reliability, and quality. Independently of implementation technologies and standards, it is possible to find common patterns in methods for developing CIMs, suggesting the viability of defining a unified good practice methodology to be used by any clinical information modeler. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  6. Readability of informed consent forms in clinical trials conducted in a skin research center

    Science.gov (United States)

    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

  7. Research Capacity at Traditional Chinese Medicine (TCM Centers in China: A Survey of Clinical Investigators

    Directory of Open Access Journals (Sweden)

    Shuo Feng

    2017-01-01

    Full Text Available Background. The development of an evidence-based approach to traditional Chinese medicine (TCM, which depends on the generation of good quality evidence, requires an adequate workforce. However, the research capacity of TCM investigators is not known. Study Design. This cross-sectional study was conducted to describe the research capacity of TCM clinical investigators in China. Participants. A total of 584 participants from TCM hospitals and research centers were included. They were asked about the academic and research characteristics, needs for research capacity building, and barriers to clinical research. Results. The majority (80.82% were qualified to at least a Master’s degree, whilst a smaller proportion (40.24% held a senior professional title. We found that academic outputs were low with the majority (62.16% authoring less than five publications in total. The most pressing needs for building research capacity identified were training in research methodology (97.43% and identification of research questions (86.81%, whilst the highest ranking barriers to conducting research were limited motivation, funding (40.72%, and time (37.15%. Conclusion. The methodology training, along with investment in the research workforce, needs to be urgently addressed to improve investigators’ research capacity and the development of an evidence-based approach of TCM.

  8. Electron probe microanalysis for clinical investigations: Microdrop and soft tissue analysis

    International Nuclear Information System (INIS)

    Ingram, M.J.; Ingram, F.D.

    1984-01-01

    The most important advantage offered by electron probe microanalysis (EPA) for clinical investigations is the ability to analyze smaller volumes of tissue than is possible with conventional techniques. The sample can be a biological soft tissue specimen, which involves subcellular localization, or a picoliter fluid droplet. In either case, the analysis can be nondestructive and permit multiple analyses for a number of elements in a given sample. The most highly developed electron microprobe analytical technique is fluid drop analysis, popularly referred to as microdrop analysis. This method provides the investigator with an analytic capability that has an accuracy of measurement often 1% or better on 20 to 30 picoliter fluid droplets. Electron microprobe techniques have been used for studies of animal hard tissue and for studies that involve insoluble inclusions. However, the development of techniques for studies of labile constituents in animal soft tissue has been much slower. It has been necessary not only to develop appropriate methods of tissue preparation, but also to establish sound techniques for tissue collection. Although there are adequate methods for collection of most types of tissue from laboratory animals, many of these methods are not suitable for human subjects. In order to provide the reader with a better understanding of the capabilities and potential for the application of electron microprobe methodology to problems in clinical medicine, the authors discuss some of their experiences with liquid droplet analysis and quantitative electrolyte distribution measurements in animal soft tissue

  9. [Etiological, clinical and neuroradiological investigation of deaf children with additional neuropsychiatric disabilities].

    Science.gov (United States)

    Chilosi, A M; Scusa, M F; Comparini, A; Genovese, E; Forli, F; Berrettini, S; Cipriani, P

    2012-04-01

    Sensorineural hearing loss (SNHL) is complicated by additional disabilities in about 30% of cases, but the epidemiology of associated disorders, in terms of type, frequency and aetiology is still not clearly defined. Additional disabilities in a deaf child have important consequences in assessing and choosing a therapeutic treatment, in particular when considering cochlear implantation (CI) or hearing aids (HA). The aim of this paper was to evaluate frequency, type and severity of additional neurodevelopmental disabilities in children with profound bilateral sensorineural hearing loss and to investigate the relationship between disability and the etiology of deafness. Eighty children with profound bilateral sensorineural hearing loss (mean age 5.4 years) were investigated by means of a diagnostic protocol including clinical, neurodevelopmental, and audiological procedures together with genetic and neurometabolic tests and neuroradiological investigation by brain MRI. Fifty-five percent of the sample exhibited one or more disabilities in addition to deafness, with cognitive, behavioural-emotional and motor disorders being the most frequent. The risk of additional disabilities varied according to aetiology, with a higher incidence in hereditary syndromic deafness, in cases due to pre-perinatal pathology (in comparison to unknown and hereditary non syndromic forms) and in the presence of major brain abnormalities at MRI. Our results suggest that the aetiology of deafness may be a significant risk indicator for the presence of neuropsychiatric disorders. A multidimensional evaluation, including aetiological, neurodevelopmental and MRI investigation is needed for formulating prognosis and for planning therapeutic intervention, especially in those children candidated to cochlear implant.

  10. Investigation of paramedics' compliance with clinical practice guidelines for the management of chest pain.

    LENUS (Irish Health Repository)

    Figgis, Ken

    2012-01-31

    BACKGROUND: Acute coronary syndromes remain a leading cause of preventable early deaths. However, previous studies have indicated that paramedics\\' compliance with chest pain protocols is suboptimal and that many patients do not receive the benefits of appropriate prehospital treatment. AIMS: To evaluate paramedics\\' level of compliance with national clinical practice guidelines and to investigate why, in certain circumstances, they may deviate from the clinical guidelines. SETTING: The Health Service Executive Mid-Western Regional Ambulance Service which serves a mixed urban and rural population across three counties in the west of Ireland. METHOD: A retrospective review of completed ambulance Patient Care Report Forms was conducted for all adult patients with non-traumatic chest pain treated between 1 December 2007 and 31 March 2008. During the same study period, paramedics were asked to complete a prospective questionnaire survey investigating the rationale behind their treatment decisions, their estimation of patient risk and their attitudes towards the clinical practice guidelines and training. RESULTS: 382 completed Patient Care Report Forms were identified for patients with chest pain, of whom 84.8% received ECG monitoring, 75.9% were given oxygen, 44.8% were treated with sublingual glyceryl trinitrate (GTN) and 50.8% were treated with aspirin. Only 20.4% of patients had a prehospital 12-lead ECG recorded. 58 completed questionnaires were returned (response rate 15%); 64% of respondents said they had received insufficient training to identify ECG abnormalities. CONCLUSIONS: Prehospital treatment with oxygen, aspirin, sublingual GTN and ECG monitoring remains underused by paramedics, even though only a small number of patients had documented contraindications to their use. The small number of patients who received a prehospital 12-lead ECG is a cause of particular concern and suggests that incomplete patient assessment may contribute to undertreatment

  11. Understanding Career Success and Its Contributing Factors for Clinical and Translational Investigators

    Science.gov (United States)

    Robinson, Georgeanna F.W.B.; Schwartz, Lisa S.; DiMeglio, Linda A.; Ahluwalia, Jasjit S.; Gabrilove, Janice L.

    2015-01-01

    Purpose To understand the factors that facilitate career success for career development awardees in clinical and translational science and to reconceptualize understanding of career success for this population. Method In 2013–2014, the authors conducted semi-structured interviews with former NIH KL2 or K12 scholars from nine Clinical and Translational Science Award-funded institutions. Participants either had or had not secured independent funding at least two years after the end of their last K award. Questions covered the factors that facilitate or hinder junior investigators’ transition to independent funding. Interviews were recorded and transcribed and the transcripts analyzed thematically. Results Forty individuals participated, with equal representation by men and women and by independently and not independently funded investigators. Personal factors that facilitated success included: networks, persistence and resilience, initiative, autonomy, and personal and professional balance. Organizational factors included: appropriate mentorship, protected research time, and institutional resources and support. Even independently funded participants described challenges regarding career direction. Five participants without independent funding modeled a broad spectrum of successful career paths, having assumed leadership positions not reliant on grant funding. Alternative definitions of career success included: improving public health, enjoying work, seeing mentees succeed, and receiving external acknowledgement of successes. Conclusions Awareness of the factors that facilitate or hinder career success can help junior faculty, mentors, and institutional leaders support career development in clinical and translational science. New definitions of career success are needed, as are career paths for faculty who want to engage in research in roles other than principal investigator. PMID:26509600

  12. Investigating science communication in the information age implications for public engagement and popular media

    CERN Document Server

    Whitelegg, Elizabeth; Scanlon, Eileen; Smidt, Sam; Thomas, Jeff

    2008-01-01

    How are recent policy changes affecting how scientists engage with the public? How are new technologies influencing how scientists disseminate their work and knowledge? How are new media platforms changing the way the public interact with scientific information? Investigating Science Communication in the Information Age is a collection of newly-commissioned chapters by leading science communication scholars. It addresses current theoretical, practical and policy developments in science communication, including recent calls for greater openness and transparency; and engagement and dialogue on the part of professional scientists with members of the public. It provides a timely and wide-ranging review of contemporary issues in science communication, focusing on two broad themes. The first theme critically reviews the recent dialogic turn and ascendant branding of 'public engagement with science' It addresses contemporary theoretical and conceptual issues facing science communication researchers, and draws on a r...

  13. Investigation of relationship between mental workload and information flow rate of accident diagnosis tasks in NPPs

    International Nuclear Information System (INIS)

    Ha, Chang Hoon

    2005-02-01

    The objective of this study is to investigate experimentally the relationship between an operator's mental workload and the information flow rate of accident diagnosis tasks and further to propose the information flow rate as an analytic method for measuring the mental workload. There are two types of mental workload in the advanced MCR of NPPs: the information processing workload, which is the processing that the human operator must actually perform in order to complete the diagnosis task, and emotional stress workload experienced by the operator. In this study, the focus is on the former. Three kinds of methods are used to measure the operator's workload: information flow rate, subjective methods, and physiological measures. Information flows for eight accident diagnosis tasks are modeled qualitatively using a stage model and are quantified using Conant's model. The eight accident cases are considered here are: Loss Of Coolant Accident (LOCA), Steam Generator Tube Rupture (SGTR), Steam Line Break (SLB), Feedwater Line Break (FLB), Pressurizer (PZR) spray and heater failure, Reactor Coolant Pump (RCP) trip, Main Steam Isolation Valve (MSIV) failure, and PZR spray failure. The information flow rate is obtained for each diagnosis task by imposing time limit restrictions for the tasks. Subjective methods require the operators to respond to questionnaires to rate their level of mental effort. NASA-TLX and MCH scale are selected as subjective methods. NASA-TLX is a subjective method used in the various fields including the aviation, automobile, and nuclear industries. It has a multi-dimensional rating technique and provides an overall workload score based on a weighted average on six subscales using pair-wise comparison tests. MCH, on the other hand, is one-dimensional and uses a 10- point rating technique. As with NASA-TLX, the higher the score is, the higher the subjective workload is. For the physiological measurements, an eye tracking system analyzes eye movements

  14. Investigation of relationship between mental workload and information flow rate of accident diagnosis tasks in NPPs

    Energy Technology Data Exchange (ETDEWEB)

    Ha, Chang Hoon

    2005-02-15

    The objective of this study is to investigate experimentally the relationship between an operator's mental workload and the information flow rate of accident diagnosis tasks and further to propose the information flow rate as an analytic method for measuring the mental workload. There are two types of mental workload in the advanced MCR of NPPs: the information processing workload, which is the processing that the human operator must actually perform in order to complete the diagnosis task, and emotional stress workload experienced by the operator. In this study, the focus is on the former. Three kinds of methods are used to measure the operator's workload: information flow rate, subjective methods, and physiological measures. Information flows for eight accident diagnosis tasks are modeled qualitatively using a stage model and are quantified using Conant's model. The eight accident cases are considered here are: Loss Of Coolant Accident (LOCA), Steam Generator Tube Rupture (SGTR), Steam Line Break (SLB), Feedwater Line Break (FLB), Pressurizer (PZR) spray and heater failure, Reactor Coolant Pump (RCP) trip, Main Steam Isolation Valve (MSIV) failure, and PZR spray failure. The information flow rate is obtained for each diagnosis task by imposing time limit restrictions for the tasks. Subjective methods require the operators to respond to questionnaires to rate their level of mental effort. NASA-TLX and MCH scale are selected as subjective methods. NASA-TLX is a subjective method used in the various fields including the aviation, automobile, and nuclear industries. It has a multi-dimensional rating technique and provides an overall workload score based on a weighted average on six subscales using pair-wise comparison tests. MCH, on the other hand, is one-dimensional and uses a 10- point rating technique. As with NASA-TLX, the higher the score is, the higher the subjective workload is. For the physiological measurements, an eye tracking system analyzes

  15. [Clinical and genetic investigation of families with Waardenburg syndrome type 2].

    Science.gov (United States)

    Chen, H S; Liao, X B; Liu, Y L; He, C F; Zhang, H; Jiang, L; Feng, Y; Mei, L Y

    2016-12-01

    Objective: To investigate the clinical chacteration and molecular pathology of Waardenburg syndrome type 2 in seven families, and provide genetic diagnosis and hereditary counseling for family members. Method: Clinical data of seven families with WS2(14 patients)were collected. Peripheral blood samples of the probands and related family members were collected and genomic DNA was extracted. The coding sequences of microphthalmia associated transcription factor (MITF), sex-determining region Y-box 10(SOX10), snail family zinc finger 2 (SNAI2) and endothelin receptor type B(EDNRB)were analyzed by polymerase chain reaction and DNA sequencing. Then the raw data was analyzed. Result: The most common manifestations of WS2 are sensorineural hearing loss(10/14,71.4%), freckle(7/14, 50.0%),heterochromia iridis(6/14, 42.9%) and premature greying(5/14,35.7%). All the deafness phenotype is congenital, bilateral profound sensorineural hearing loss. Freckles phenotype is different from cutaneous pigment abnormalities of WS in Westerners. The heterozygous mutation, c.328C>T in exon 3 of the MITF gene was detected in the proband and all patients of pedigree 2. However, no pathological mutation of the relevant genes (SOX10,SNAI2 and EDNRB) was detected in other pedigrees. Conclusion: There are obvious variations in clinical features of WS, while freckles may be a special subtype of cutaneous pigment disturbances. The MITF gene mutation, R110X,is therefore considered the disease causing mutation in pedigree WS02.However, there are novel disease causing genes or copy number variations in Waardenburg syndrome type 2, which require further research. Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.

  16. Evaluating the Quality of Website Information of Private-Practice Clinics Offering Cell Therapies in Japan.

    Science.gov (United States)

    Kashihara, Hidenori; Nakayama, Takeo; Hatta, Taichi; Takahashi, Naomi; Fujita, Misao

    2016-05-24

    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. To evaluate the quality of website information of private-practice clinics offering cell therapies in Japan. 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. 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% (60/77) of treatments were mentioned with "benefits," whereas 77% (59

  17. The feasibility of using electronic clinical outcome assessments in people with schizophrenia and their informal caregivers

    Directory of Open Access Journals (Sweden)

    Tolley C

    2015-03-01

    Full Text Available Chloe Tolley,1 Diana Rofail,2 Adam Gater,1 Justine K Lalonde31Adelphi Values Ltd, Bollington, UK; 2Roche Products Ltd, Welwyn Garden City, UK; 3Roche S.A.S, Paris, France Abstract: Many clinical outcome assessments (COAs were originally developed for completion via pen and paper. However, in recent years there have been movements toward electronic capture of such data in an effort to reduce missing data, provide time-stamped records, minimize administrative burden, and avoid secondary data entry errors. Although established in many patient populations, the implications of using electronic COAs in schizophrenia are unknown. In accordance with International Society for Pharmacoeconomics and Outcomes Research (ISPOR Task Force recommendations, in-depth cognitive debriefing and usability interviews were conducted with people with schizophrenia (n=12, their informal (unpaid caregivers (n=12, and research support staff (n=6 to assess the suitability of administration of various electronic COA measures using an electronic tablet device. Minimal issues were encountered by participants when completing or administering the COAs in electronic format, with many finding it easier to complete instruments in this mode than by pen and paper. The majority of issues reported were specific to the device functionality rather than the electronic mode of administration. Findings support data collection via electronic tablet in people with schizophrenia and their caregivers. The appropriateness of other forms of electronic data capture (eg, smartphones, interactive voice response systems, etc is a topic for future investigation. Keywords: ePRO, eCOA, mode of administration, electronic data capture, usability 

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

    OpenAIRE

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

    2010-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators ...

  19. The Incremental Information Content of the Cash Flow Statement: An Australian Empirical Investigation

    OpenAIRE

    Hadri Kusuma

    2014-01-01

    The general objective of the present study is to investigate and assess the incremental information content of cash flow disclosures as required by the AASB 1026 ¡°Statement of Cash Flows¡±. This test addresses the issue of whether a change in cash flow components has the same relationship with security prices as that in earnings. Several previous studies indicate both income and cash flow statements may be mutually exclusive or mutually inclusive statements. The data to test three hypotheses...

  20. An Investigation of Information Technology-Enabled Remote Management and Remote Work Issues

    Directory of Open Access Journals (Sweden)

    D. Sandy Staples

    1997-05-01

    Full Text Available A two phase research study was done to investigate remote work and remote management issues. In Phase 1, focus groups were carried out with remote managers and remote employees to identify key issues. The most common key issues dealt with communications, information technology, leadership and coaching, teamwork, building trust, and performance management. In the second phase, a questionnaire was used to test hypotheses developed from phase 1. The findings supported that higher trust leads to higher job satisfaction and lower job stress, and that more communication between the manager and the remote employee develops higher levels of employee organizational commitment.

  1. Protocols for the Investigation of Information Processing in Human Assessment of Fundamental Movement Skills.

    Science.gov (United States)

    Ward, Brodie J; Thornton, Ashleigh; Lay, Brendan; Rosenberg, Michael

    2017-01-01

    Fundamental movement skill (FMS) assessment remains an important tool in classifying individuals' level of FMS proficiency. The collection of FMS performances for assessment and monitoring has remained unchanged over the last few decades, but new motion capture technologies offer opportunities to automate this process. To achieve this, a greater understanding of the human process of movement skill assessment is required. The authors present the rationale and protocols of a project in which they aim to investigate the visual search patterns and information extraction employed by human assessors during FMS assessment, as well as the implementation of the Kinect system for FMS capture.

  2. Can formal language planning link to grassroots cultural initiatives? An informal investigation

    Directory of Open Access Journals (Sweden)

    Wright, Laurence

    2002-12-01

    Full Text Available Formal language planning is inevitably a top-down, highly technical process. Success for such planning would seem to depend on engaging productively with existing or readily developed social motivation within the society. This article reports on an informal investigation into how ordinary language practitioners and cultural workers in South Africa view the possibilities of contributing to the country's emerging language dispensation, what they regard as their most useful possible contributions, and what they expect from the language planners and 'government' in support of South Africa's Language Policy and Plan.

  3. Investigation of Factors Affecting Body Temperature Changes During Routine Clinical Head Magnetic Resonance Imaging

    Science.gov (United States)

    Kim, Myeong Seong

    2016-01-01

    Background Pulsed radiofrequency (RF) magnetic fields, required to produce magnetic resonance imaging (MRI) signals from tissue during the MRI procedure have been shown to heat tissues. Objectives To investigate the relationship between body temperature rise and the RF power deposited during routine clinical MRI procedures, and to determine the correlation between this effect and the body’s physiological response. Patients and Methods We investigated 69 patients from the Korean national cancer center to identify the main factors that contribute to an increase in body temperature (external factors and the body’s response) during a clinical brain MRI. A routine protocol sequence of MRI scans (1.5 T and 3.0 T) was performed. The patient’s tympanic temperature was recorded before and immediately after the MRI procedure and compared with changes in variables related to the body’s physiological response to heat. Results Our investigation of the physiological response to RF heating indicated a link between increasing age and body temperature. A higher increase in body temperature was observed in older patients after a 3.0-T MRI (r = 0.07, P = 0.29 for 1.5-T MRI; r = 0.45, P = 0.002 for 3.0-T MRI). The relationship between age and body heat was related to the heart rate (HR) and changes in HR during the MRI procedure; a higher RF power combined with a reduction in HR resulted in an increase in body temperature. Conclusion A higher magnetic field strength and a decrease in the HR resulted in an increase in body temperature during the MRI procedure. PMID:27895872

  4. The regulation of informed consent to participation in clinical research by mentally ill persons: An overview

    Directory of Open Access Journals (Sweden)

    A Nienaber

    2010-12-01

    Full Text Available The article examines the legal requirements relating to the informed consent of mentally ill persons to participation in clinical research in South Africa. First, the juridical basis of informed consent in South African law is outlined; and second, the requirements for lawful consent developed in South African common law and case law are presented. Finally, the article deliberates upon the requirements for the participation of mentally ill persons in research as laid down by the Mental Health Care Act and its regulations, the National Health Act and its (draft regulations, and the South African Constitution.

  5. A Novel Electronic Device for Measuring Urine Flow Rate: A Clinical Investigation

    Directory of Open Access Journals (Sweden)

    Aliza Goldman

    2017-09-01

    Full Text Available Objective: Currently, most vital signs in the intensive care unit (ICU are electronically monitored. However, clinical practice for urine output (UO measurement, an important vital sign, usually requires manual recording of data that is subject to human errors. In this study, we assessed the ability of a novel electronic UO monitoring device to measure real-time hourly UO versus current clinical practice. Design: Patients were connected to the RenalSense Clarity RMS Sensor Kit with a sensor integrated within a standard sterile urinary catheter drainage tube to monitor urine flow in real time. The Clarity RMS Sensor Kit was modified to incorporate a standard urinometer (Unomedical for the nursing staff to record UO as per their standard practice. The drainage bag was placed in a container on a scientific scale (Precisa BJ to be used as the gold standard. Interventions: Nursing records for hourly UO were collected and compared with the electronically recorded UO. Sensor measurements and nursing staff manual records of UO were compared with the scale data. Setting: The study setting was the ICU of Hadassah Hospital, Jerusalem. Patients: Data from 23 patients with a urinary catheter were observed in this study. Measurements and main results: A total of 1046 hours of UO were recorded from 23 subjects. Compared with the scale data, the measurements of hourly urine flow measured with the RenalSense system were closer, had a better correlation, and narrower limits of agreement to gravimetrically determined values than the measurements obtained by the nurses. In addition, continuous monitoring of UO provided graphical display of response to repeated diuretic administration. Conclusions: An electronic device for recording UO has been shown to provide more reliable information of UO records and patient fluid status than current practice. Future applications of this device will provide valuable information to help set protocol goals such as decisions for

  6. A Systematic Approach to Find a Professional Audiology Clinic: Patient-Based Information

    Science.gov (United States)

    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

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

    Science.gov (United States)

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

    2015-01-01

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

  8. Online drug databases: a new method to assess and compare inclusion of clinically relevant information.

    Science.gov (United States)

    Silva, Cristina; Fresco, Paula; Monteiro, Joaquim; Rama, Ana Cristina Ribeiro

    2013-08-01

    Evidence-Based Practice requires health care decisions to be based on the best available evidence. The model "Information Mastery" proposes that clinicians should use sources of information that have previously evaluated relevance and validity, provided at the point of care. Drug databases (DB) allow easy and fast access to information and have the benefit of more frequent content updates. Relevant information, in the context of drug therapy, is that which supports safe and effective use of medicines. Accordingly, the European Guideline on the Summary of Product Characteristics (EG-SmPC) was used as a standard to evaluate the inclusion of relevant information contents in DB. To develop and test a method to evaluate relevancy of DB contents, by assessing the inclusion of information items deemed relevant for effective and safe drug use. Hierarchical organisation and selection of the principles defined in the EGSmPC; definition of criteria to assess inclusion of selected information items; creation of a categorisation and quantification system that allows score calculation; calculation of relative differences (RD) of scores for comparison with an "ideal" database, defined as the one that achieves the best quantification possible for each of the information items; pilot test on a sample of 9 drug databases, using 10 drugs frequently associated in literature with morbidity-mortality and also being widely consumed in Portugal. Main outcome measure Calculate individual and global scores for clinically relevant information items of drug monographs in databases, using the categorisation and quantification system created. A--Method development: selection of sections, subsections, relevant information items and corresponding requisites; system to categorise and quantify their inclusion; score and RD calculation procedure. B--Pilot test: calculated scores for the 9 databases; globally, all databases evaluated significantly differed from the "ideal" database; some DB performed

  9. Investigation of blended learning video resources to teach health students clinical skills: An integrative review.

    Science.gov (United States)

    Coyne, Elisabeth; Rands, Hazel; Frommolt, Valda; Kain, Victoria; Plugge, Melanie; Mitchell, Marion

    2018-04-01

    The aim of this review is to inform future educational strategies by synthesising research related to blended learning resources using simulation videos to teach clinical skills for health students. An integrative review methodology was used to allow for the combination of diverse research methods to better understand the research topic. This review was guided by the framework described by Whittemore and Knafl (2005), DATA SOURCES: Systematic search of the following databases was conducted in consultation with a librarian using the following databases: SCOPUS, MEDLINE, COCHRANE, PsycINFO databases. Keywords and MeSH terms: clinical skills, nursing, health, student, blended learning, video, simulation and teaching. Data extracted from the studies included author, year, aims, design, sample, skill taught, outcome measures and findings. After screening the articles, extracting project data and completing summary tables, critical appraisal of the projects was completed using the Mixed Methods Appraisal Tool (MMAT). Ten articles met all the inclusion criteria and were included in this review. The MMAT scores varied from 50% to 100%. Thematic analysis was undertaken and we identified the following three themes: linking theory to practice, autonomy of learning and challenges of developing a blended learning model. Blended learning allowed for different student learning styles, repeated viewing, and enabled links between theory and practice. The video presentation needed to be realistic and culturally appropriate and this required both time and resources to create. A blended learning model, which incorporates video-assisted online resources, may be a useful tool to teach clinical skills to students of health including nursing. Blended learning not only increases students' knowledge and skills, but is often preferred by students due to its flexibility. Copyright © 2018 Elsevier Ltd. All rights reserved.

  10. ASSESSING REFERRALS AND IMPROVING INFORMATION AVAILABILITY FOR CONSULTATIONS IN AN ACADEMIC ENDOCRINOLOGY CLINIC.

    Science.gov (United States)

    Hendrickson, Chase D; Saini, Saumya; Pothuloori, Avin; Mecchella, John N

    2017-02-01

    Outpatient specialty consultations rely on the timeliness and completeness of referral information to facilitate a valuable patient-specialist interaction. This project aimed to increase essential diagnostic information availability at the initial consultation for patients referred for common endocrine conditions frequently lacking such data-diabetes mellitus, thyroid nodule, thyrotoxicosis, and hypercalcemia. At an endocrinology clinic at an academic medical center in rural New England, providers see several thousand new patients annually, the majority of whom are referred by providers external to the clinic's healthcare system. Through consensus, endocrinology clinic providers agreed on the two or three data elements essential for a meaningful initial consultation for each. A quality improvement team employed a planned series of interventions based on previously published methods and an innovative approach: dissemination of a referral guideline, an assessment of referral adequacy in the endocrinology clinic workflow, coupled with focused requests for missing items, and a pre-visit lab appointment. Between April 2015 and March 2016, 762 referrals were reviewed. At baseline for the four conditions, referrals contained all essential elements only 27.5% (22 of 80) of the time. Over a 7-month period, the team implemented the interventions, with subsequent referrals containing all essential elements increasing to 75.5% (P<.0001), largely attributable to the pre-visit lab appointment. Incoming referrals that lack essential information are a significant problem in specialty care and may adversely affect patient experience, provider satisfaction, and clinic efficiency. Improvement may require innovative approaches, such as the potentially transferable and generalizable ones employed here. DHMC = Dartmouth-Hitchcock Medical Center EHR = electronic health record PDSA = Plan-Do-Study-Act.

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

    Science.gov (United States)

    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.

  12. The discrepancy between patients and informants on clinician-rated measures in major depressive disorder: implications for clinical trials and clinical practice.

    Science.gov (United States)

    Peselow, Eric D; Karamians, Reneh; Lord, Marie; Tobia, Gabriel; IsHak, Waguih William

    2014-03-01

    Clinician-rated measures are used in clinical trials and measurement-based clinical care settings to assess baseline symptoms and treatment outcomes of major depressive disorder (MDD), with a widely held dictum that they are sufficient in assessing the patient's clinical status. In this study, we examined clinician-rated measures of depressive and global symptom severity, obtained by interviewing patients as well as informants in an attempt to examine the potential difference or similarity between these two sources of information. The sample consisted of 89 treatment seeking, DSM-IV diagnosed MDD outpatients treated between 1995 and 2004. The clinician-rated measures used included the Montgomery Åsberg Depression Rating Scale (MADRS), and the Clinical Global Impression Scale (CGI) for Severity. The scores of the clinician-rated measures collected from patients' interviews were compared with those collected from informants' interviews. Clinician-rated scores, collected by interviewing patients, were significantly higher and indicative of greater symptom severity when compared with those collected by interviewing informants. This was true for both the MADRS before (Ppractical in MDD clinical trials or everyday clinical care. The discrepancies observed between the clinician-rated scores obtained from patients and informants emphasize the importance of incorporating collateral information during the assessment and rating of depressive symptom severity in both clinical trials as well as in clinical practice.

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

    Science.gov (United States)

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

    2017-12-01

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

  14. MendeLIMS: a web-based laboratory information management system for clinical genome sequencing.

    Science.gov (United States)

    Grimes, Susan M; Ji, Hanlee P

    2014-08-27

    Large clinical genomics studies using next generation DNA sequencing require the ability to select and track samples from a large population of patients through many experimental steps. With the number of clinical genome sequencing studies increasing, it is critical to maintain adequate laboratory information management systems to manage the thousands of patient samples that are subject to this type of genetic analysis. To meet the needs of clinical population studies using genome sequencing, we developed a web-based laboratory information management system (LIMS) with a flexible configuration that is adaptable to continuously evolving experimental protocols of next generation DNA sequencing technologies. Our system is referred to as MendeLIMS, is easily implemented with open source tools and is also highly configurable and extensible. MendeLIMS has been invaluable in the management of our clinical genome sequencing studies. We maintain a publicly available demonstration version of the application for evaluation purposes at http://mendelims.stanford.edu. MendeLIMS is programmed in Ruby on Rails (RoR) and accesses data stored in SQL-compliant relational databases. Software is freely available for non-commercial use at http://dna-discovery.stanford.edu/software/mendelims/.

  15. Resolution improvement of brain PET images using prior information from MRI: clinical application on refractory epilepsy

    International Nuclear Information System (INIS)

    Silva-Rodríguez, Jesus; Tsoumpas, Charalampos; Aguiar, Pablo; Cortes, Julia; Urdaneta, Jesus Lopez

    2015-01-01

    An important counterpart of clinical Positron Emission Tomography (PET) for early diagnosis of neurological diseases is its low resolution. This is particularly important when evaluating diseases related to small hypometabolisms such as epilepsy. The last years, new hybrid systems combining PET with Magnetic Resonance (MR) has been increasingly used for several different clinical applications. One of the advantages of MR is the production of high spatial resolution images and a potential application of PET-MR imaging is the improvement of PET resolution using MR information. A potential advantage of resolution recovery of PET images is the enhancement of contrast delivering at the same time better detectability of small lesions or hypometabolic areas and more accurate quantification over these areas. Recently, Shidahara et al (2009) proposed a new method using wavelet transforms in order to produce PET images with higher resolution. We optimised Shidahara’s method (SFS-RR) to take into account possible shortcomings on the particular clinical datasets, and applied it to a group of patients diagnosed with refractory epilepsy. FDG-PET and MRI images were acquired sequentially and then co-registered using software tools. A complete evaluation of the PET/MR images was performed before and after the correction, including different parameters related with PET quantification, such as atlas-based metabolism asymmetry coefficients and Statistical Parametric Mapping results comparing to a database of 87 healthy subjects. Furthermore, an experienced physician analyzed the results of non-corrected and corrected images in order to evaluate improvements of detectability on a visual inspection. Clinical outcome was used as a gold standard. SFS-RR demonstrated to have a positive impact on clinical diagnosis of small hypometabolisms. New lesions were detected providing additional clinically relevant information on the visual inspection. SPM sensitivity for the detection of small

  16. The impact of clinical leadership on health information technology adoption: systematic review.

    Science.gov (United States)

    Ingebrigtsen, Tor; Georgiou, Andrew; Clay-Williams, Robyn; Magrabi, Farah; Hordern, Antonia; Prgomet, Mirela; Li, Julie; Westbrook, Johanna; Braithwaite, Jeffrey

    2014-06-01

    To conduct a systematic review to examine evidence of associations between clinical leadership and successful information technology (IT) adoption in healthcare organisations. We searched Medline, Embase, Cinahl, and Business Source Premier for articles published between January 2000 to May 2013 with keywords and subject terms related to: (1) the setting--healthcare provider organisations; (2) the technology--health information technology; (3) the process--adoption; and (4) the intervention--leadership. We identified 3121 unique citations, of which 32 met our criteria and were included in the review. Data extracted from the included studies were assessed in light of two frameworks: Bassellier et al.'s IT competence framework; and Avgar et al.'s health IT adoption framework. The results demonstrate important associations between the attributes of clinical leaders and IT adoption. Clinical leaders who have technical informatics skills and prior experience with IT project management are likely to develop a vision that comprises a long-term commitment to the use of IT. Leaders who possess such a vision believe in the value of IT, are motivated to adopt it, and can maintain confidence and stability through the adversities that IT adoptions often entail. This leads to proactive leadership behaviours and partnerships with IT professionals that are associated with successful organisational and clinical outcomes. This review provides evidence that clinical leaders can positively contribute to successful IT adoption in healthcare organisations. Clinical leaders who aim for improvements in the processes and quality of care should cultivate the necessary IT competencies, establish mutual partnerships with IT professionals, and execute proactive IT behaviours to achieve successful IT adoption. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  17. Resolution improvement of brain PET images using prior information from MRI: clinical application on refractory epilepsy

    Energy Technology Data Exchange (ETDEWEB)

    Silva-Rodríguez, Jesus [Instituto de Investigaciones Sanitarias (IDIS), Santiago de Compostela (Spain); Tsoumpas, Charalampos [University of Leeds, Leeds (United Kingdom); Aguiar, Pablo; Cortes, Julia [Nuclear Medicine Department, University Hospital (CHUS), Santiago de Compostela (Spain); Urdaneta, Jesus Lopez [Instituto de Investigaciones Sanitarias (IDIS), Santiago de Compostela (Spain)

    2015-05-18

    An important counterpart of clinical Positron Emission Tomography (PET) for early diagnosis of neurological diseases is its low resolution. This is particularly important when evaluating diseases related to small hypometabolisms such as epilepsy. The last years, new hybrid systems combining PET with Magnetic Resonance (MR) has been increasingly used for several different clinical applications. One of the advantages of MR is the production of high spatial resolution images and a potential application of PET-MR imaging is the improvement of PET resolution using MR information. A potential advantage of resolution recovery of PET images is the enhancement of contrast delivering at the same time better detectability of small lesions or hypometabolic areas and more accurate quantification over these areas. Recently, Shidahara et al (2009) proposed a new method using wavelet transforms in order to produce PET images with higher resolution. We optimised Shidahara’s method (SFS-RR) to take into account possible shortcomings on the particular clinical datasets, and applied it to a group of patients diagnosed with refractory epilepsy. FDG-PET and MRI images were acquired sequentially and then co-registered using software tools. A complete evaluation of the PET/MR images was performed before and after the correction, including different parameters related with PET quantification, such as atlas-based metabolism asymmetry coefficients and Statistical Parametric Mapping results comparing to a database of 87 healthy subjects. Furthermore, an experienced physician analyzed the results of non-corrected and corrected images in order to evaluate improvements of detectability on a visual inspection. Clinical outcome was used as a gold standard. SFS-RR demonstrated to have a positive impact on clinical diagnosis of small hypometabolisms. New lesions were detected providing additional clinically relevant information on the visual inspection. SPM sensitivity for the detection of small

  18. Systematic review of research investigating psychotherapy and information and communication technologies

    Directory of Open Access Journals (Sweden)

    Sílvia Cristina Marceliano Hallberg

    2015-09-01

    Full Text Available Introduction:Information and communication technologies (ICTs are devices, services and knowledge that reproduce, process and distribute information. Psychotherapy has been influenced by these technologies, and there is a tendency for their role to expand.Objective: To describe the current panorama of the scientific literature on psychotherapy and ICTs.Method: This is a systematic and descriptive review. Searches were run on the electronic databases Biblioteca Virtual em Saude (BVS, PsycINFO, Scopus, PePSIC, ScienceDirect and Index Psi, using the Boolean operator AND and the descriptors psychotherapy, computers, Internet, cell phones and social networks.Results: A considerable volume of empirical research was found, published recently in many different parts of the world, especially in the United States. There is very little Brazilian research on the subject. The majority of the studies identified assess the efficacy or describe the development of techniques and psychotherapies, via ICTs, for prevention, diagnosis or treatment of mental and behavioral disorders. The psychopathology most investigated in this area is depression and it was not possible to draw conclusions on a possible trend for research into the subject to increase. The technology most investigated was the Internet and cognitive-behavioral therapy was the most common theoretical approach in these studies.Conclusions:Systematic reviews of published studies can detect gaps in the research agenda within a specific field of knowledge.

  19. Systematic review of research investigating psychotherapy and information and communication technologies.

    Science.gov (United States)

    Hallberg, Sílvia Cristina Marceliano; Lisboa, Carolina Saraiva de Macedo; de Souza, Déborah Brandão; Mester, Ariela; Braga, Andréia Zambon; Strey, Artur Marques; da Silva, Camila Sartori

    2015-01-01

    Information and communication technologies (ICTs) are devices, services and knowledge that reproduce, process and distribute information. Psychotherapy has been influenced by these technologies, and there is a tendency for their role to expand. To describe the current panorama of the scientific literature on psychotherapy and ICTs. This is a systematic and descriptive review. Searches were run on the electronic databases Biblioteca Virtual em Saude (BVS), PsycINFO, Scopus, PePSIC, ScienceDirect and Index Psi, using the Boolean operator AND and the descriptors psychotherapy, computers, Internet, cell phones and social networks. A considerable volume of empirical research was found, published recently in many different parts of the world, especially in the United States. There is very little Brazilian research on the subject. The majority of the studies identified assess the efficacy or describe the development of techniques and psychotherapies, via ICTs, for prevention, diagnosis or treatment of mental and behavioral disorders. The psychopathology most investigated in this area is depression and it was not possible to draw conclusions on a possible trend for research into the subject to increase. The technology most investigated was the Internet and cognitive-behavioral therapy was the most common theoretical approach in these studies. Systematic reviews of published studies can detect gaps in the research agenda within a specific field of knowledge.

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

    Directory of Open Access Journals (Sweden)

    Satish Chandrasekhar Nair

    2015-01-01

    Full Text Available 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 signifi cantly 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 signifi cantly 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, signifi cantly 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    Shao, W; Kupelian, P; Wang, J; Low, D; Ruan, D [UCLA School of Medicine, Los Angeles, CA (United States)

    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.

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

    International Nuclear Information System (INIS)

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

    2014-01-01

    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

  3. Investigation of the Effects of a Nursing Information System by Using the Technology Acceptance Model.

    Science.gov (United States)

    Hsu, Hung-Hsiou; Wu, Ya-Hui

    2017-06-01

    The purposes of this study are to investigate the effectiveness of implementing a nursing information system and to discuss several issues affecting its successful deployment from the perspectives of nurses, the major users of the system. The methodology was based on the theory of the technology acceptance model. This study adopted a cross-sectional study method to survey and collect data. In total, 167 questionnaires were distributed to subjects. Approximately 94.6%, or 158 valid questionnaires, were collected. The data were analyzed using SPSS and PLS software.The data analysis indicated that the factors that most significantly influenced the willingness of nurses to use the nursing information system were their degrees of satisfaction with the system and their perceptions of its usefulness. A nursing information system that can provide functions that are useful and convenient and that facilitate the avoidance of tedious repetitive writing and improve the quality of provided care can encourage nurse satisfaction with the system and thus stimulate their interest in using it for their work. The ease of use of the system can also affect the willingness of nurses to use it.

  4. College Students' Health Information Activities on Facebook: Investigating the Impacts of Health Topic Sensitivity, Information Sources, and Demographics.

    Science.gov (United States)

    Syn, Sue Yeon; Kim, Sung Un

    2016-07-01

    College students tend to lack access to health information. Because social networking sites (SNSs) are popularly adopted by college students, SNSs are considered to be good media channels for college students to obtain health-related information. This study examines the factors that influence college students' health information-seeking and -sharing activities on Facebook. An online survey was distributed to college students between the ages of 18 and 29 to determine intentions pertaining to health information activities according to the factors identified for the study. The factors included both contextual factors (such as health topic sensitivity and health information sources) as well as user factors (such as demographics). Our findings showed that college students are willing to read and post health-related information on Facebook when the health topic is not sensitive. In addition, there are clear differences in preferences between professional sources and personal sources as health information sources. It was found that most user factors, except gender, have no influence on health information activities. The impacts of SNS contexts, awareness of information sources, types of interlocutors, and privacy concerns are further discussed.

  5. General Practitioners' and patients' perceptions towards stratified care: a theory informed investigation.

    Science.gov (United States)

    Saunders, Benjamin; Bartlam, Bernadette; Foster, Nadine E; Hill, Jonathan C; Cooper, Vince; Protheroe, Joanne

    2016-08-31

    general practice when intervening to support GPs to make changes to their clinical behaviour. Findings will inform further stages of the research programme; specifically, the intervention format and content of support packages for GPs participating in a future randomised controlled trial (RCT). This study also contributes to the theoretical debate on how best to encourage clinical behaviour change in general practice, and the possible role of the TDF in that process.

  6. Idiopathic Canalicular Inflammatory Disease: New Disease Description of Clinical Patterns, Investigations, Management, and Outcomes.

    Science.gov (United States)

    Ali, Mohammad Javed

    2018-01-25

    The objective of this perspective is to present a separate disease description of "idiopathic canalicular inflammatory disease" and outline the diagnostic criteria and early experiences with its investigations and management. Retrospective case series of 44 canaliculi of 22 eyes of 11 patients presenting at a tertiary care Dacryology service over a period of 2 years with typical clinical patterns of inflammatory canaliculitis and its outcomes were studied. All the patients underwent microbiological work-up with culture and sensitivity, dacryoendoscopy imaging, serial Fourier domain ocular coherence tomography, and collagen vascular profiles. Stages in the evolution of the disease were studied. All patients were treated initially with topical steroids followed by punctal dilatation and placement of mini-monoka stents. Five patients in addition had a small biopsy from the inflamed portion of the vertical canaliculus. Stents were extubated at 6 weeks. Forty-four canaliculi were diagnosed to have idiopathic canalicular inflammatory disease during the study period. There was a female preponderance (81.8%, 9/11) and the mean age at presentation was 57 years. All patients presented with unilateral epiphora without any discharge, pain, or swelling. Collagen vascular profiles and screening for autoimmune diseases were negative. Clinical picture ranged from stages 1 to 5, consisting of edema, progressive centripetal vascularization, pouting of vascularized mucosa, membrane formation, and progressive scarring. The presentation begins in 1 eye and usually involves the other eye at a mean of 6 months. Ocular coherence tomography and dacryoendoscopy were of adjunctive value in the diagnosis. Histopathological examination was suggestive of a chronic inflammation. All patients had relentless progression to end-stage disease, although delayed significantly by steroids and monoka intubation. Idiopathic canalicular inflammatory disease has a distinct and typical clinical behavior and

  7. Investigation of Clinical Characteristics and Etiological Factors in Children with Molar Incisor Hypomineralization

    Directory of Open Access Journals (Sweden)

    Maria Rita Giuca

    2018-01-01

    Full Text Available Aim. The purpose of the present study was to evaluate the clinical defects and etiological factors potentially involved in the onset of MIH in a pediatric sample. Methods. 120 children, selected from the university dental clinic, were included: 60 children (25 boys and 35 girls; average age: 9.8 ± 1.8 years with MIH formed the test group and 60 children (27 boys and 33 girls; average age: 10.1 ± 2 years without MIH constituted the control group. Distribution and severity of MIH defects were evaluated, and a questionnaire was used to investigate the etiological variables; chi-square, univariate, and multivariate statistical tests were performed (significance level set at p<0.05. Results. A total of 186 molars and 98 incisors exhibited MIH defects: 55 molars and 75 incisors showed mild defects, 91 molars and 20 incisors had moderate lesions, and 40 molars and 3 incisors showed severe lesions. Univariate and multivariate statistical analysis showed a significant association (p<0.05 between MIH and ear, nose, and throat (ENT disorders and the antibiotics used during pregnancy (0.019. Conclusions. Moderate defects were more frequent in the molars, while mild lesions were more frequent in the incisors. Antibiotics used during pregnancy and ENT may be directly involved in the etiology of MIH in children.

  8. Investigation of Clinical Characteristics and Etiological Factors in Children with Molar Incisor Hypomineralization

    Science.gov (United States)

    Giuca, Maria Rita; Cappè, Maria; Carli, Elisabetta; Lardani, Lisa

    2018-01-01

    Aim The purpose of the present study was to evaluate the clinical defects and etiological factors potentially involved in the onset of MIH in a pediatric sample. Methods 120 children, selected from the university dental clinic, were included: 60 children (25 boys and 35 girls; average age: 9.8 ± 1.8 years) with MIH formed the test group and 60 children (27 boys and 33 girls; average age: 10.1 ± 2 years) without MIH constituted the control group. Distribution and severity of MIH defects were evaluated, and a questionnaire was used to investigate the etiological variables; chi-square, univariate, and multivariate statistical tests were performed (significance level set at p MIH defects: 55 molars and 75 incisors showed mild defects, 91 molars and 20 incisors had moderate lesions, and 40 molars and 3 incisors showed severe lesions. Univariate and multivariate statistical analysis showed a significant association (p MIH and ear, nose, and throat (ENT) disorders and the antibiotics used during pregnancy (0.019). Conclusions Moderate defects were more frequent in the molars, while mild lesions were more frequent in the incisors. Antibiotics used during pregnancy and ENT may be directly involved in the etiology of MIH in children. PMID:29861729

  9. Phase II drugs under clinical investigation for the treatment of chronic constipation.

    Science.gov (United States)

    Mozaffari, Shilan; Didari, Tina; Nikfar, Shekoufeh; Abdollahi, Mohammad

    2014-11-01

    Chronic constipation (CC) is a common gastrointestinal (GI) motility disorder that significantly impairs the quality of life in affected subjects. As almost half of the patients suffering from CC are not satisfied with currently available medicines, there is a need to develop new molecules with better effectiveness and tolerability. The authors include all experimental and clinical trials (up to Phase II) about new investigational drugs for the treatment of CC. The article identifies nine new agents: mitemcinal, TD-8954, YKP10811, itopride, RM-131, KWA-0711, elobixibat, velusetrag, and naronapride. All nine agents have shown prokinetic effects in different stages of the development. The mechanisms of new developing drugs include: the activation of 5-hydroxytryptamine type-4 (5-HT4), ghrelin and motilin receptors, antagonizing dopamine type-2 (D2) receptors, inhibition of ileal bile acid reabsorption and acetylcholine esterase, as well as water absorption from the GI tract. At this current point in time, new generations of 5-HT4 receptor agonists (velusetrag, noranopride and YKP10811) are hoped to progress, further in the future, due to better efficiency and safety. However, it is not possible to make a concise conclusion at this current time due to a lack of evidence. Further clinical trials with a longer duration and a larger sample size are warranted.

  10. Driving Organizational Change From the Bedside: The AACN Clinical Scene Investigator Academy.

    Science.gov (United States)

    Lacey, Susan R; Goodyear-Bruch, Caryl; Olney, Adrienne; Hanson, Dave; Altman, Marian S; Varn-Davis, Natasha S; Brinker, Debbie; Lavandero, Ramón; Cox, Karen S

    2017-08-01

    Staff nurses are pivotal in leading change related to quality improvement efforts, although many lack skills to steer change from the bedside. The American Association of Critical-Care Nurses (AACN) staff nurse leadership program, Clinical Scene Investigator (CSI) Academy, teaches and empowers staff nurses in leadership skills and change concepts to translate evidence into practice affecting patient outcomes. To describe the curriculum of the AACN CSI Academy that provides staff nurses with the leadership skills required to create unit-based change projects that positively impact patient/family outcomes. The curriculum of the Academy included leadership topics, communication, change concepts, quality improvement methods, project management, and data management and analysis. Each team of participants collected project data to show improvements in patient care. The program evaluation used many data sources to assess the program effectiveness, relating to the professional growth of the participant nurses. The participants assessed project patient outcomes, sustainability, and spread. The first cohort of CSI participants included 164 direct care nurses from 42 hospitals in 6 cities. They rated the Academy highly in the program evaluation, and they reported that the Academy contributed to their professional development. The individual hospital quality improvement projects resulted in positive patient and estimated fiscal outcomes that were generally sustained 1 year after the program. With the skills, tools, and support obtained from participation in the CSI Academy, staff nurses can make substantial contributions to their organizations in clinical and possibly fiscal outcomes. ©2017 American Association of Critical-Care Nurses.

  11. Formalize clinical processes into electronic health information systems: Modelling a screening service for diabetic retinopathy.

    Science.gov (United States)

    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. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. Ethical communication in clinical trials. Issues faced by data managers in obtaining informed consent.

    Science.gov (United States)

    Loh, Winnie Y; Butow, Phyllis N; Brown, Richard F; Boyle, Frances

    2002-12-01

    Informed consent has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. However, it is known that problems with informed consent exist from the perspective of both patients and physicians. This has led to the suggestion that a third party, such as a research nurse or data manager, should be responsible for obtaining informed consent. The objective of this study was to explore the views of data managers concerning the nature, challenges, and rewards of their role and the similarities and differences between their role and that of physicians in obtaining informed consent. Four focus groups in three large teaching hospitals were conducted. Twenty-one data managers who were involved in cancer or pain clinical trials participated. The focus groups were audiotaped, transcribed, and subjected to content analysis to identify themes. Data managers identified three primary roles complementary to that of physicians: information provision, quality assurance of the informed consent process, and ongoing support during the trial. Despite expressed concern that medical and drug company interests may lead to subtle coercion of the patient, participants did not support the notion that they may be solely responsible for the consent process. Participants described a range of ethical dilemmas they confronted, including patients asking them for medical details they could not provide and situations in which they felt that informed consent was compromised in some way, for example, dealing with situations in which the patient appeared to be entering the trial for the wrong reasons due to misunderstanding, need, or passivity. Effective functioning of the multidisciplinary team assisted data managers in performing their role. A range of training needs were identified, particularly communication skills training and trial start-up briefing. The issues raised by these data managers have important implications for the successful conduct of

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

    Science.gov (United States)

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

    2018-07-01

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

  14. Public transparency Web sites for radiology practices: prevalence of price, clinical quality, and service quality information.

    Science.gov (United States)

    Rosenkrantz, Andrew B; Doshi, Ankur M

    2016-01-01

    To assess information regarding radiology practices on public transparency Web sites. Eight Web sites comparing radiology centers' price and quality were identified. Web site content was assessed. Six of eight Web sites reported examination prices. Other reported information included hours of operation (4/8), patient satisfaction (2/8), American College of Radiology (ACR) accreditation (3/8), on-site radiologists (2/8), as well as parking, accessibility, waiting area amenities, same/next-day reports, mammography follow-up rates, examination appropriateness, radiation dose, fellowship-trained radiologists, and advanced technologies (1/8 each). Transparency Web sites had a preponderance of price (and to a lesser extent service quality) information, risking fostering price-based competition at the expense of clinical quality. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Digital information and communication networks and scientific research substance: An investigation of meteorology

    Science.gov (United States)

    Shen, Yi

    This study investigated research meteorologists' current usage and evaluation of information and communication technologies (ICT) in performing research tasks and the current relationship between meteorologists' ICT use and content characteristics of their research outputs. It surveyed research meteorologists working in three NOAA funded research institutes based at universities. Follow-up interviews with two selective samples of the survey participants were conducted to provide additional evidence to survey results and make suggestions for future measurement development work. Multiple regression analysis was performed to test the hypothesized relationships between meteorologists' ICT use and two substantive characteristics of their research---data integration and intra-/interdisciplinarity. Descriptive statistics were calculated to discern inferences of the scientists' current state of use and their degree of satisfaction with ICT tools. Follow-up interviews were transcribed and analyzed qualitatively with open coding and axial coding. The study findings contradicted the two assumptions of ICT effects on meteorological research by showing that the greater frequency of networked ICT use is not significantly associated with either greater data integration in research analysis, or greater intra- or interdisciplinary research. The major ICT barrier is the lack of a data and information infrastructure and support system for integrated, standardized, specialized, and easily accessible data and information from distributed servers. Suggestions were provided on the improvements of technical, social, political, and educational settings to promote large-scale date integration and intra-/interdisciplinary research. By moving further from theoretical assumptions to practical examinations, the research findings provide empirical evidence of Bowker's theories on the social shaping and social impact of infrastructure in sciences and affirmed some of Bowker's arguments regarding

  16. Investigating patient narratives posted on Internet and their informativeness level for pharmacovigilance purpose: The example of comments about statins.

    Science.gov (United States)

    Kheloufi, Farid; Default, Anne; Blin, Olivier; Micallef, Joelle

    2017-09-01

    Health-related networks like patient health forums may be considered as potential sources of information to early detect pharmacovigilance issues or complete data on drug safety. However, the clinical and pharmacological relevancy of such a source has not been clearly explored. We aimed to describe the characteristics and the informativeness level of Internet narratives posted by patients and mentioning adverse drug reactions (ADRs) related to statins. A retrospective cross-sectional study was conducted on an Internet website dedicated to share experience on medicines. One day of December 2012, postings about simvastatin, rosuvastatin and atorvastatin publicly available on the website were collected. Their informativeness according to 16 key elements of information (including drug start and stop date, duration of treatment, time to onset and duration of the ADR, outcome, medical history, concomitant medication) was assessed. General information about reported ADRs was also investigated. Among the 96 postings related to statins, 72 (40 women, 32 men; mean age: 59 [40-78]) mentioned at least one ADR accounting for a total of 176 ADRs. Musculoskeletal and connective tissue disorders (42.6%) and nervous system disorders (15.3%) were the main represented ADRs. Only 2 patients mentioned ADRs that could be considered as serious but 24 patients mentioned they stopped or switched their treatment toward another lipid modifying agent because of the ADR. Mean number of available key elements of information per narrative was 6/16. Time to onset and duration of the ADR were respectively available in only 31% and 3% of the narratives. Medical history and concomitant medication were respectively lacking in 87% and 86% of the narratives. Outcome was found only in 39% of the narratives. Patient narratives posted on Internet include mainly non-serious expected ADR. However, their informativeness level is very incomplete and makes difficult their assessment and use for

  17. Implementing Trauma-Informed Partner Violence Assessment in Family Planning Clinics.

    Science.gov (United States)

    Decker, Michele R; Flessa, Sarah; Pillai, Ruchita V; Dick, Rebecca N; Quam, Jamie; Cheng, Diana; McDonald-Mosley, Raegan; Alexander, Kamila A; Holliday, Charvonne N; Miller, Elizabeth

    2017-09-01

    Intimate partner violence (IPV) and reproductive coercion (RC) are associated with poor reproductive health. Little is known about how family planning clinics implement brief IPV/RC assessment interventions in practice. We describe the uptake and impact of a brief, trauma-informed, universal IPV/RC assessment and education intervention. Intervention implementation was evaluated via a mixed methods study among women ages 18 and up receiving care at one of two family planning clinics in greater Baltimore, MD. This mixed methods study entailed a quasi-experimental, single group pretest-posttest study with family planning clinic patients (baseline and exit survey n = 132; 3-month retention n = 68; retention rate = 52%), coupled with qualitative interviews with providers and patients (total n = 35). Two thirds (65%) of women reported receiving at least one element of the intervention on their exit survey immediately following the clinic-visit. Patients reported that clinic-based IPV assessment is helpful, irrespective of IPV history. Relative to those who reported neither, participants who received either intervention element reported greater perceived caring from providers, confidence in provider response to abusive relationships, and knowledge of IPV-related resources at follow-up. Providers and patients alike described the educational card as a valuable tool. Participants described trade-offs of paper versus in-person, electronic medical record-facilitated screening, and patient reluctance to disclose current situations of abuse. In real-world family planning clinic settings, a brief assessment and support intervention was successful in communicating provider caring and increasing knowledge of violence-related resources, endpoints previously deemed valuable by IPV survivors. Results emphasize the merit of universal education in IPV/RC clinical interventions over seeking IPV disclosure.

  18. Investigate the relation between the media literacy and information literacy of students of communication science and information science and knowledge

    Directory of Open Access Journals (Sweden)

    Elham Esmaeil Pounaki

    2017-03-01

    Full Text Available The new millennium is called Information Age, in which information and communication technologies have been developed. The transfer from industrial society to information society has changed the form and level of education and information from those of the past times. In the past, literacy meant the ability of reading and writing, but today the meaning of literacy has been changed through the time and such a type of literacy is not enough to meet people’s needs in the industrial society of the 21st century. Today’s life requires media and information literacy especially for the students, whose duty is to research and who have a significant role in the development of their country from any perspective. This research aims to study the relation between the media literacy and information literacy of the students of the fields of communication science and information science and knowledge. This is an applied research in terms of its objective and uses a survey-correlation method. The statistical population of this research consists of the postgraduate students studying in the fields of study of information science and knowledge and communication science at Tehran University and Allameh Tabatabai University. The data required for this research were collected by a researcher-made questionnaire. The reliability of the questionnaire has been evaluated by Cronbach’s Alpha, which was equal to 0.936. The data were analyzed using descriptive and inferential statistic methods. The results showed that the level of media literacy and information literacy of students is desirable. There is a significant relationship between the economic status of students and their media literacy. However, the social status of students was directly related to their "ability to communicate" variable of media literacy. Also the Pearson correlation test showed a significant relationship between the variables of media literacy and information literacy.

  19. Investigational Clinical Trial of a Prototype Optoelectronic Computer-Aided Navigation Device for Dental Implant Surgery.

    Science.gov (United States)

    Jokstad, Asbjørn; Winnett, Brenton; Fava, Joseph; Powell, David; Somogyi-Ganss, Eszter

    New digital technologies enable real-time computer-aided (CA) three-dimensional (3D) guidance during dental implant surgery. The aim of this investigational clinical trial was to demonstrate the safety and effectiveness of a prototype optoelectronic CA-navigation device in comparison with the conventional approach for planning and effecting dental implant surgery. Study participants with up to four missing teeth were recruited from the pool of patients referred to the University of Toronto Graduate Prosthodontics clinic. The first 10 participants were allocated to either a conventional or a prototype device study arm in a randomized trial. The next 10 participants received implants using the prototype device. All study participants were restored with fixed dental prostheses after 3 (mandible) or 6 (maxilla) months healing, and monitored over 12 months. The primary outcome was the incidence of any surgical, biologic, or prosthetic adverse events or device-related complications. Secondary outcomes were the incidence of positioning of implants not considered suitable for straightforward prosthetic restoration (yes/no); the perception of the ease of use of the prototype device by the two oral surgeons, recorded by use of a Likert-type questionnaire; and the clinical performance of the implant and superstructure after 1 year in function. Positioning of the implants was appraised on periapical radiographs and clinical photographs by four independent blinded examiners. Peri-implant bone loss was measured on periapical radiographs by a blinded examiner. No adverse events occurred related to placing any implants. Four device-related complications led to a switch from using the prototype device to the conventional method. All implants placed by use of the prototype device were in a position considered suitable for straightforward prosthetic restoration (n = 21). The qualitative evaluation by the surgeons was generally positive, although ergonomic challenges were identified

  20. Investigating Clinically and Scientifically Useful Cut Points on the Compulsive Sexual Behavior Inventory.

    Science.gov (United States)

    Miner, Michael H; Raymond, Nancy; Coleman, Eli; Swinburne Romine, Rebecca

    2017-05-01

    clinical screening tool and the other, more conservative measurement that is useful for etiologic and epidemiologic research. Miner MH, Raymond N, Coleman E, Swinburne Romine R. Investigating Clinically and Scientifically Useful Cut Points on the Compulsive Sexual Behavior Inventory. J Sex Med 2017;14:715-720. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  1. Health information exchanges--Unfulfilled promise as a data source for clinical research.

    Science.gov (United States)

    Parker, Carol; Weiner, Michael; Reeves, Mathew

    2016-03-01

    To determine the use of health information exchange organizations (HIEs) to support and conduct clinical research. This scoping review included US-based studies published between January 2003 and March 2014 that used data from an HIE to address at least one of three categories of research: clinical or epidemiological research, financial evaluation, or utilization of health services. Eligibility was not restricted to research on HIEs. Studies with research questions outside of the evaluation of HIEs themselves were sought. Eighteen articles met final study inclusion criteria from an initial list of 847 hits. Fifteen studies addressed a clinical or epidemiological research question, 6 addressed a financial consideration, and 8 addressed a utilization issue. Considerable overlap was found among the research categories: 13 articles addressed more than one category. Of the eighteen included studies, only two used HIE data to answer a research objective that was NOT specific to HIE use. Research designs were varied and ranged from observational studies, such as cohort and cross-sectional studies, to randomized trials. The 18 articles represent the involvement of a small number of HIEs; 7 of the studies were from a single HIE. This review demonstrates that HIE-provided information is available and used to answer clinical or epidemiological, financial, or utilization-based research questions; however, the majority of the studies using HIE data are done with the primary goal of evaluating the use and impact of HIEs on health care delivery and outcomes. As HIEs mature and become integrated parts of the health care industry, the authors anticipate that fewer studies will be published that describe or validate the role of HIEs, and more will use HIEs as multi-institutional data sources for conducting clinical research and improving health services and clinical outcomes. Articles identified in this review indicate the limited extent that HIE data are being used for clinical

  2. Investigating the Challenges and Opportunities in Home Care to Facilitate Effective Information Technology Adoption.

    Science.gov (United States)

    Koru, Güneş; Alhuwail, Dari; Topaz, Maxim; Norcio, Anthony F; Mills, Mary Etta

    2016-01-01

    As home care utilization increases, information technology (IT) becomes a critical tool for providing quality home care. However, most home health agencies (HHAs) in the United States are in a position to adopt and leverage IT solutions in budget-constrained settings, where it is crucial to address important and pressing challenges and opportunities for achieving effectiveness in IT adoption. (1) Explore HHAs' challenges and opportunities related to delivering home care as well as performing administrative functions and conducting business, (2) learn about current IT implementation levels and activities in home care, and (3) make recommendations to facilitate efforts and initiatives designed for adopting IT in home care effectively. Semistructured interviews were conducted to elicit rich contextual information from the participants recruited from 13 local HHAs in one of the states in the United States. Established systems analysis techniques were used to ask questions during the interviews. Framework, a qualitative research method, was used to analyze the qualitative data obtained from the interviews. Coordinating clinical and administrative workflows was an important challenge. Inadequate access to patients' medical history and difficulties with medication reconciliation detracted from the quality of care. Hiring, training, scheduling, and retaining qualified personnel constituted another important challenge. Training and educating patients, caregivers, and families hold important opportunities for improving the quality of care. All except one HHA adopted electronic health records (EHR) but many continued to struggle considerably in their day-to-day functions. Health information exchange (HIE) seems to be the most needed technology. Telehealth solutions were perceived to be promising but their added value and financial viability in the long run were questioned. The recommendations for effective IT adoption include keeping a quality improvement focus, keeping a

  3. To compare PubMed Clinical Queries and UpToDate in teaching information mastery to clinical residents: a crossover randomized controlled trial.

    Science.gov (United States)

    Sayyah Ensan, Ladan; Faghankhani, Masoomeh; Javanbakht, Anna; Ahmadi, Seyed-Foad; Baradaran, Hamid Reza

    2011-01-01

    To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. Based on intention-to-treat analysis, participants retrieved the answer of 67 (76%) questions using UpToDate and 38 (43%) questions using PubMed Clinical Queries (PPubMed Clinical Queries (PPubMed Clinical Queries users (PPubmed Clinical Queries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient.

  4. Interface, information, interaction: a narrative review of design and functional requirements for clinical decision support.

    Science.gov (United States)

    Miller, Kristen; Mosby, Danielle; Capan, Muge; Kowalski, Rebecca; Ratwani, Raj; Noaiseh, Yaman; Kraft, Rachel; Schwartz, Sanford; Weintraub, William S; Arnold, Ryan

    2018-05-01

    Provider acceptance and associated patient outcomes are widely discussed in the evaluation of clinical decision support systems (CDSSs), but critical design criteria for tools have generally been overlooked. The objective of this work is to inform electronic health record alert optimization and clinical practice workflow by identifying, compiling, and reporting design recommendations for CDSS to support the efficient, effective, and timely delivery of high-quality care. A narrative review was conducted from 2000 to 2016 in PubMed and The Journal of Human Factors and Ergonomics Society to identify papers that discussed/recommended design features of CDSSs that are associated with the success of these systems. Fourteen papers were included as meeting the criteria and were found to have a total of 42 unique recommendations; 11 were classified as interface features, 10 as information features, and 21 as interaction features. Features are defined and described, providing actionable guidance that can be applied to CDSS development and policy. To our knowledge, no reviews have been completed that discuss/recommend design features of CDSS at this scale, and thus we found that this was important for the body of literature. The recommendations identified in this narrative review will help to optimize design, organization, management, presentation, and utilization of information through presentation, content, and function. The designation of 3 categories (interface, information, and interaction) should be further evaluated to determine the critical importance of the categories. Future work will determine how to prioritize them with limited resources for designers and developers in order to maximize the clinical utility of CDSS. This review will expand the field of knowledge and provide a novel organization structure to identify key recommendations for CDSS.

  5. Informal learning processes in support of clinical service delivery in a service-oriented community pharmacy.

    Science.gov (United States)

    Patterson, Brandon J; Bakken, Brianne K; Doucette, William R; Urmie, Julie M; McDonough, Randal P

    The evolving health care system necessitates pharmacy organizations' adjustments by delivering new services and establishing inter-organizational relationships. One approach supporting pharmacy organizations in making changes may be informal learning by technicians, pharmacists, and pharmacy owners. Informal learning is characterized by a four-step cycle including intent to learn, action, feedback, and reflection. This framework helps explain individual and organizational factors that influence learning processes within an organization as well as the individual and organizational outcomes of those learning processes. A case study of an Iowa independent community pharmacy with years of experience in offering patient care services was made. Nine semi-structured interviews with pharmacy personnel revealed initial evidence in support of the informal learning model in practice. Future research could investigate more fully the informal learning model in delivery of patient care services in community pharmacies. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Clinical investigation of TROP-2 as an independent biomarker and potential therapeutic target in colon cancer.

    Science.gov (United States)

    Zhao, Peng; Yu, Hai-Zheng; Cai, Jian-Hui

    2015-09-01

    Colon cancer is associated with a severe demographic and economic burden worldwide. The pathogenesis of colon cancer is highly complex and involves sequential genetic and epigenetic mechanisms. Despite extensive investigation, the pathogenesis of colon cancer remains to be elucidated. As the third most common type of cancer worldwide, the treatment options for colon cancer are currently limited. Human trophoblast cell‑surface marker (TROP‑2), is a cell‑surface transmembrane glycoprotein overexpressed by several types of epithelial carcinoma. In addition, TROP‑2 has been demonstrated to be associated with tumorigenesis and invasiveness in solid types of tumor. The aim of the present study was to investigate the protein expression of TROP‑2 in colon cancer tissues, and further explore the association between the expression of TROP‑2 and clinicopathological features of patients with colon cancer. The expression and localization of the TROP‑2 protein was examined using western blot analysis and immunofluorescence staining. Finally, the expression of TROP‑2 expression was correlated to conventional clinicopathological features of colon cancer using a χ2 test. The results revealed that TROP‑2 protein was expressed at high levels in the colon cancer tissues, which was associated with the development and pathological process of colon cancer. Therefore, TROP‑2 may be used as a biomarker to determine the clinical prognosis, and as a potential therapeutic target in colon cancer.

  7. Methodology optimization and diversification for the investigation of virulence potential in Haemophilus influenzae clinical strains.

    Science.gov (United States)

    Giucă, Mihaela Cristina; Străuţ, Monica; Surdeanu, Maria; Nica, Maria; Ungureanu, Vasilica; Mihăescu, Grigore

    2011-01-01

    Ten Haemophilus influenzae strains were isolated from patients aged between 1.6 - 24 years, with various diagnoses (acute meningitis, acute upper respiratory infection, otitis media and acute sinusitis). Identification was based on phenotypic and molecular characteristics; antibiotic susceptibility testing was performed by diffusion method according to CLSI standards 2011 for seven antibiotics. The results of molecular testing showed that all the studied strains produced an amplicon of 1000 bp with ompP2 primers indicating that all strains were H. influenzae. For six strains, the PCR amplicon obtained with bexA specific primers, proving that the strains were capsulated. The results of phenotypic testing showed that four strains were ampicillin nonsusceptible and (beta-lactamase-positive. The virulence potential of H. influenzae clinical strains was investigated by phenotypic methods, including the assessment of the soluble virulence factors on specific media containing the biochemical substratum for the investigated enzymatic factor, as well as the adherence and invasion capacity to HeLa cells monolayer using Cravioto modified method. The studied strains exhibited mainly a diffuse adherence pattern and different adherence indexes. Interestingly, two strains isolated from the same pacient (blood and CSF) showed a different degree of invasiveness, the strain isolated from blood being 20 times more invasive than the one isolated from CSF.

  8. Accelerating Plasma Mirrors to Investigate the Black Hole Information Loss Paradox.

    Science.gov (United States)

    Chen, Pisin; Mourou, Gerard

    2017-01-27

    The question of whether Hawking evaporation violates unitarity, and therefore results in the loss of information, has remained unresolved since Hawking's seminal discovery. To date, the investigations have remained mostly theoretical since it is almost impossible to settle this paradox through direct astrophysical black hole observations. Here, we point out that relativistic plasma mirrors can be accelerated drastically and stopped abruptly by impinging intense x-ray pulses on solid plasma targets with a density gradient. This is analogous to the late time evolution of black hole Hawking evaporation. A conception of such an experiment is proposed and a self-consistent set of physical parameters is presented. Critical issues, such as how the black hole unitarity may be preserved, can be addressed through the entanglement between the analog Hawking radiation photons and their partner modes.

  9. Investigations of portable cadmium telluride (CdTe(Cl)) detectors for clinical studies with radioactive indicators

    International Nuclear Information System (INIS)

    Bojsen, J.

    1985-01-01

    The combination of small, portable γ-radiation-sensitive Cadmium Telluride (CdTE(Cl)) crystal detectors and portable solid state data storage memories makes it feasible to extend the measuring period in a number of clinical investigations based on the use of various radioisotopes and external detection. Blood sampling can be avoided in some cases. Continuous ambulatory monitoring of relevant physiological parameters is practicable, e.g. kidney function (GFR), left ventricular ejection fraction, subcutaneous blood flow, muscle blood flow and insulin absorption in diabetic patients. In the present methodological study the applicability of the 133-Xe washout technique to subcutaneous (s.c.) adipose tissue blood flow (SBF) has been investigated and adapted to the use of CdTe(Cl) detectors attached to the skin surface for the measurement of local 133-Xe-disappearance rate constants (k). Physical characterization of CdTe(Cl) detectors as γ-sensitive devices has been performed, and adequate counting sensitivities were found without detector energy-resolution properties. The CdTe(Cl) detectors are therefore suitable for single indicator studies. The measuring geometry of CdTe(Cl) detectors was studied and compared with that of stationary Sodium Iodide (NaI(Tl)) detectors in both phantom and in vivo investigations. The spatial properties of CdTe(Cl) detectors could to some extent be adjusted by pulse height discrimination and lead collimation. When long-term measurements were complicated by for instance physical activity of the patients, the small CdTe(Cl) detectors in general showed equal or better performance than the heavy and voluminous NaI(Tl) detectors. The free movement of the ambulatory patient and the avoidance of cable connections to stationary data-collecting systems gave improved possibilities for measurements of the relevant parameters. From this point of view, portable CdTe(Cl) detectors must be considered an important advance for radioactivity studies in

  10. Supporting Clinical Cognition: A Human-Centered Approach to a Novel ICU Information Visualization Dashboard.

    Science.gov (United States)

    Faiola, Anthony; Srinivas, Preethi; Duke, Jon

    2015-01-01

    Advances in intensive care unit bedside displays/interfaces and electronic medical record (EMR) technology have not adequately addressed the topic of visual clarity of patient data/information to further reduce cognitive load during clinical decision-making. We responded to these challenges with a human-centered approach to designing and testing a decision-support tool: MIVA 2.0 (Medical Information Visualization Assistant, v.2). Envisioned as an EMR visualization dashboard to support rapid analysis of real-time clinical data-trends, our primary goal originated from a clinical requirement to reduce cognitive overload. In the study, a convenience sample of 12 participants were recruited, in which quantitative and qualitative measures were used to compare MIVA 2.0 with ICU paper medical-charts, using time-on-task, post-test questionnaires, and interviews. Findings demonstrated a significant difference in speed and accuracy with the use of MIVA 2.0. Qualitative outcomes concurred, with participants acknowledging the potential impact of MIVA 2.0 for reducing cognitive load and enabling more accurate and quicker decision-making.

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    Lesther ePapa

    2015-11-01

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

  13. Confidence and Information Access in Clinical Decision-Making: An Examination of the Cognitive Processes that affect the Information-seeking Behavior of Physicians.

    Science.gov (United States)

    Uy, Raymonde Charles; Sarmiento, Raymond Francis; Gavino, Alex; Fontelo, Paul

    2014-01-01

    Clinical decision-making involves the interplay between cognitive processes and physicians' perceptions of confidence in the context of their information-seeking behavior. The objectives of the study are: to examine how these concepts interact, to determine whether physician confidence, defined in relation to information need, affects clinical decision-making, and if information access improves decision accuracy. We analyzed previously collected data about resident physicians' perceptions of information need from a study comparing abstracts and full-text articles in clinical decision accuracy. We found that there is a significant relation between confidence and accuracy (φ=0.164, p<0.01). We also found various differences in the alignment of confidence and accuracy, demonstrating the concepts of underconfidence and overconfidence across years of clinical experience. Access to online literature also has a significant effect on accuracy (p<0.001). These results highlight possible CDSS strategies to reduce medical errors.

  14. Frequency, clinical correlates and rating of behavioural changes in primary brain tumour patients: A preliminary investigation.

    Directory of Open Access Journals (Sweden)

    Grahame K Simpson

    2015-04-01

    Full Text Available PurposeFew studies have addressed the specific behavioural changes associated with primary brain tumour (PBT. This paper will report on the frequency and demographic/clinical correlates of such behaviours, and the reliability of rating such behaviours amongst people with PBT, family informants and clinicians. The association of behavioural changes and patient functional status will also be discussed.MethodsA total of 57 patients with 37 family informants were recruited from two large Australian metropolitan hospitals. Each completed three neuro-behavioural self-report measures. Patients also completed a depression symptom measure. Functional status was defined by clinician-rated Karnofsky Performance Status.ResultsPatients were on average 52 years old, a median of four months (range 1-82 post-diagnosis, with high grade (39%, low grade (22% or benign tumours (39%. Patients reported frequency rates of 7-40% across various behavioural domains including anger, inappropriate behaviour, apathy, inertia and executive impairment. The presence of epileptic seizures was associated with significantly higher levels of behavioural changes. Notably, behaviour did not correlate with tumour grade or treatment modality. There was moderate agreement between patients and relatives on the presence or absence of behavioural changes, and substantial agreement between relative and clinician ratings. Depressed patients did not generally report more changes than non-depressed patients. Increases in the relative and clinician-rated behaviour scores were significantly correlated with decreasing functional status in the patient.ConclusionsBehavioural changes were a common sequela of both benign and malignant PBT. Larger scale studies are required to confirm these results. The results suggest the importance of including behaviour in brain cancer psychosocial assessments and the need to develop interventions to treat these patients and reduce the burden of care on families.

  15. Effects of video-game play on information processing: a meta-analytic investigation.

    Science.gov (United States)

    Powers, Kasey L; Brooks, Patricia J; Aldrich, Naomi J; Palladino, Melissa A; Alfieri, Louis

    2013-12-01

    Do video games enhance cognitive functioning? We conducted two meta-analyses based on different research designs to investigate how video games impact information-processing skills (auditory processing, executive functions, motor skills, spatial imagery, and visual processing). Quasi-experimental studies (72 studies, 318 comparisons) compare habitual gamers with controls; true experiments (46 studies, 251 comparisons) use commercial video games in training. Using random-effects models, video games led to improved information processing in both the quasi-experimental studies, d = 0.61, 95% CI [0.50, 0.73], and the true experiments, d = 0.48, 95% CI [0.35, 0.60]. Whereas the quasi-experimental studies yielded small to large effect sizes across domains, the true experiments yielded negligible effects for executive functions, which contrasted with the small to medium effect sizes in other domains. The quasi-experimental studies appeared more susceptible to bias than were the true experiments, with larger effects being reported in higher-tier than in lower-tier journals, and larger effects reported by the most active research groups in comparison with other labs. The results are further discussed with respect to other moderators and limitations in the extant literature.

  16. INVESTIGATION OF THE MODEL FOR DYNAMICS OF DESTRUCTIVE INFORMATION AND PSYCHOLOGICAL INFLUENCE ON MASS CONSCIOUSNESS

    Directory of Open Access Journals (Sweden)

    V. A. Minaev

    2016-12-01

    Full Text Available The article examines a mathematical model of destructive information-psychological influence (IPI dynamics on mass consciousness. It is shown that a model taking into account three main processes - informational influence on mass consciousness of interpersonal communication, mass media, effect of influence forgetting - has solution in the form of a generalized logistic curve. Given a statistical distribution over time of society individuals, who share ideas of IPI, which qualitatively confirms a formal decision model, presented in the form of nonlinear differential equations describing of innovation diffusion. Investigated special cases of the model, which in all cases confirmed existence of asymptotic stationary solutions. To use the model in practice to analyze and predict characteristics of IPI on society, and, ultimately, to control this effect, estimation of its parameters based on statistical data. Accented that the development of the model is essential in modern conditions complicate the problem of ensuring cyber security of the state, society and every individual member of society, including considering the development of social networks.

  17. Characteristic Investigation of Unfolded Neutron Spectra with Different Priori Information and Gamma Radiation Interference

    International Nuclear Information System (INIS)

    Kim, Bong Hwan

    2006-01-01

    Neutron field spectrometry using multi spheres such as Bonner Spheres (BS) has been almost essential in radiation protection dosimetry for a long time at workplace in spite of poor energy resolution because it is not asking the fine energy resolution but requiring easy operation and measurement performance over a wide range of energy interested. KAERI has developed and used extended BS system based on a LiI(Eu) scintillator as the representative neutron spectrometry system for workplace monitoring as well as for the quantification of neutron calibration fields such as those recommended by ISO 8529. Major topics in using BS are how close the unfolded spectra is the real one and to minimize the interference of gamma radiation in neutron/gamma mixed fields in case of active instrument such as a BS with a LiI(Eu) scintillator. The former is related with choosing a priori information when unfolding the measured data and the latter is depend on how to discriminate it in intense gamma radiation fields. Influence of a priori information in unfolding and effect of counting loss due to pile-up of signals for the KAERI BS system were investigated analyzing the spectral measurement results of Scattered Neutron Calibration Fields (SNCF)

  18. Combining Empirical Relationships with Data Based Mechanistic Modeling to Inform Solute Tracer Investigations across Stream Orders

    Science.gov (United States)

    Herrington, C.; Gonzalez-Pinzon, R.; Covino, T. P.; Mortensen, J.

    2015-12-01

    Solute transport studies in streams and rivers often begin with the introduction of conservative and reactive tracers into the water column. Information on the transport of these substances is then captured within tracer breakthrough curves (BTCs) and used to estimate, for instance, travel times and dissolved nutrient and carbon dynamics. Traditionally, these investigations have been limited to systems with small discharges (turbidity (e.g., nitrate signals with SUNA instruments or fluorescence measures) and/or high total dissolved solids (e.g., making prohibitively expensive the use of salt tracers such as NaCl) in larger systems. Additionally, a successful time-of-travel study is valuable for only a single discharge and river stage. We have developed a method to predict tracer BTCs to inform sampling frequencies at small and large stream orders using empirical relationships developed from multiple tracer injections spanning several orders of magnitude in discharge and reach length. This method was successfully tested in 1st to 8th order systems along the Middle Rio Grande River Basin in New Mexico, USA.

  19. Investigating nurse practitioners in the private sector: a theoretically informed research protocol.

    Science.gov (United States)

    Adams, Margaret; Gardner, Glenn; Yates, Patsy

    2017-06-01

    To report a study protocol and the theoretical framework normalisation process theory that informs this protocol for a case study investigation of private sector nurse practitioners. Most research evaluating nurse practitioner service is focused on public, mainly acute care environments where nurse practitioner service is well established with strong structures for governance and sustainability. Conversely, there is lack of clarity in governance for emerging models in the private sector. In a climate of healthcare reform, nurse practitioner service is extending beyond the familiar public health sector. Further research is required to inform knowledge of the practice, operational framework and governance of new nurse practitioner models. The proposed research will use a multiple exploratory case study design to examine private sector nurse practitioner service. Data collection includes interviews, surveys and audits. A sequential mixed method approach to analysis of each case will be conducted. Findings from within-case analysis will lead to a meta-synthesis across all four cases to gain a holistic understanding of the cases under study, private sector nurse practitioner service. Normalisation process theory will be used to guide the research process, specifically coding and analysis of data using theory constructs and the relevant components associated with those constructs. This article provides a blueprint for the research and describes a theoretical framework, normalisation process theory in terms of its flexibility as an analytical framework. Consistent with the goals of best research practice, this study protocol will inform the research community in the field of primary health care about emerging research in this field. Publishing a study protocol ensures researcher fidelity to the analysis plan and supports research collaboration across teams. © 2016 John Wiley & Sons Ltd.

  20. Clinical utility of self-disclosure for adults who stutter: Apologetic versus informative statements.

    Science.gov (United States)

    Byrd, Courtney T; Croft, Robyn; Gkalitsiou, Zoi; Hampton, Elizabeth

    2017-12-01

    The purpose of the present study was to explore the clinical utility of self-disclosure, particularly, whether disclosing in an informative manner would result in more positive observer ratings of the speaker who stutters than either disclosing in an apologetic manner or choosing not to self-disclose at all. Observers (N=338) were randomly assigned to view one of six possible videos (i.e., adult male informative self-disclosure, adult male apologetic self-disclosure, adult male no self-disclosure, adult female informative self-disclosure, adult female apologetic self-disclosure, adult female no self-disclosure). Observers completed a survey assessing their perceptions of the speaker they viewed immediately after watching the video. Results suggest that self-disclosing in an informative manner leads to significantly more positive observer ratings than choosing not to self-disclose. In contrast, use of an apologetic statement, for the most part, does not yield significantly more positive ratings than choosing not to self-disclose. Clinicians should recommend their clients self-disclose in an informative manner to facilitate more positive observer perceptions. Copyright © 2017. Published by Elsevier Inc.

  1. Informing Hospital Change Processes through Visualization and Simulation: A Case Study at a Children's Emergency Clinic.

    Science.gov (United States)

    Persson, Johanna; Dalholm, Elisabeth Hornyánszky; Johansson, Gerd

    2014-01-01

    To demonstrate the use of visualization and simulation tools in order to involve stakeholders and inform the process in hospital change processes, illustrated by an empirical study from a children's emergency clinic. Reorganization and redevelopment of a hospital is a complex activity that involves many stakeholders and demands. Visualization and simulation tools have proven useful for involving practitioners and eliciting relevant knowledge. More knowledge is desired about how these tools can be implemented in practice for hospital planning processes. A participatory planning process including practitioners and researchers was executed over a 3-year period to evaluate a combination of visualization and simulation tools to involve stakeholders in the planning process and to elicit knowledge about needs and requirements. The initial clinic proposal from the architect was discarded as a result of the empirical study. Much general knowledge about the needs of the organization was extracted by means of the adopted tools. Some of the tools proved to be more accessible than others for the practitioners participating in the study. The combination of tools added value to the process by presenting information in alternative ways and eliciting questions from different angles. Visualization and simulation tools inform a planning process (or other types of change processes) by providing the means to see beyond present demands and current work structures. Long-term involvement in combination with accessible tools is central for creating a participatory setting where the practitioners' knowledge guides the process. © 2014 Vendome Group, LLC.

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

    Science.gov (United States)

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

    2018-01-01

    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.

  3. [Clinical outcomes of parenterally administered shuxuetong--analysis of hospital information system data].

    Science.gov (United States)

    Zhi, Ying-Jie; Zhang, Hui; Xie, Yan-Ming; Yang, Wei; Yang, Hu; Zhuang, Yan

    2013-09-01

    Hospital information system data of cerebral infaction patients who received parenterally administered Shuxuetong was analyzed. This provided frequency data regarding patients' conditions and related information in order to provide a clinical reference guide. In this study, HIS data from 18 hospitals was analyzed. Patients receiving parenterally administered Shuxuetong for the treatment of cerebral infarction were included. Information on age, gender, costsand route of administration were collated. The average age of patients was 66 years old. Days of hospitalization ranged from 15 to 28 days. The majority of patients were classified as having phlegm and blood stasis syndrome, which is inaccordance with the indications for this drug. The most commonly used drugs used in combination with parenterally administered Shuxuetong were: aspirin, insulin and heparin. Patients with cerebral infarction crowd using parenterally administered Shuxuetong were a mostly elderly population, with an average age of 66. Although generally use was in accordance with indications, dosage, and route of administration, there were however some discrepancies. Therefore, doctors need to pay close attention to guidelines and closely observe patients when using parenterally administered Shuxuetong and to consider both the clinical benefits and risks.

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

    Science.gov (United States)

    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. Copyright © 2011 Elsevier Inc. All rights reserved.

  5. The importance of clinical information in patients with gastroenteropancreatic neuroendocrine tumor.

    Science.gov (United States)

    Kudo, Atsushi; Akashi, Takumi; Kumagai, Jiro; Ban, Daisuke; Inokuchi, Mikito; Kojima, Kazuyuki; Kawano, Tatsuyuki; Tanaka, Shinji; Arii, Shigeki

    2012-01-01

    The WHO 2010 grading system for gastroenteropancreatic neuroendocrine tumors(GEP-NETs) is used to evaluate the malignant potential without clinicopathological information. This study was conducted to examine whether the new index is superior to the previous WHO 2004 classification, e.g.for well-differentiated endocrine carcinoma (WEC),involving clinical information. Between 2000 and 2011, 77 patients with sporadic GEP-NETs were treated at our institution and statistically estimated risk factors for overall survival (OS) were evaluated. Cox proportional hazards regression analyses were performed to estimate risk factors for OS. Overall 1-, 3- and 5-year survival rates were 92.8%, 78.4% and 76.0%, respectively. Median OS was 551 days in WEC-patients (odds ratio (OR)for OS=13.1, 95% confidence interval (CI)=2.90-59.5;p=0.001). The median OS was 813 days in G3-patients as compared with 1885 days in G1/G2-patients(OR for OS= 2.64, p=0.002). Multivariate analyses according to baseline characteristics revealed WEC as independent risk factor (OR=9.06, p=0.01). WEC was the only predictor of prognosis with an area under the receiver operating characteristic curves of 0.78(p=0.001). Clinical information was the best predictor for the prognosis of NETs.

  6. Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

    DEFF Research Database (Denmark)

    Gluud, Christian; Kubiak, Christine; Whitfield, Kate

    2012-01-01

    In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.......In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe....

  7. Clinical investigation of flat panel CT following middle ear reconstruction: a study of 107 patients

    Energy Technology Data Exchange (ETDEWEB)

    Zaoui, K. [University Hospital Heidelberg, Ruprecht Karls University, Department of Otorhinolaryngology, Head and Neck Surgery, Heidelberg (Germany); Kromeier, J. [St. Josefs Hospital, RkK, Department of Radiology, Freiburg (Germany); Neudert, M.; Beleites, T.; Zahnert, T. [University Hospital Dresden, Technical University, Department of Otorhinolaryngology, Head and Neck Surgery, Dresden (Germany); Laszig, R.; Offergeld, C. [University Hospital Freiburg, Albert Ludwigs University, Department of Otorhinolaryngology, Head and Neck Surgery, Freiburg (Germany)

    2014-03-15

    After middle ear reconstruction using partial or total ossicular replacement prostheses (PORP/TORP), an air-bone gap (ABG) may persist because of prosthesis displacement or malposition. So far, CT of the temporal bone has played the main role in the diagnosis of reasons for postoperative insufficient ABG improvement. Recent experimental and clinical studies have evaluated flat panel CT (fpCT) as an alternative imaging technique that provides images with high isovolumetric resolution, fewer metal-induced artefacts and lower irradiation doses. One hundred and seven consecutive patients with chronic otitis media with or without cholesteatoma underwent reconstruction by PORP (n = 52) or TORP (n = 55). All subjects underwent preoperative and postoperative audiometric testing and postoperative fpCT. Statistical evaluation of all 107 patients as well as the sole sub-assembly groups (PORP or TORP) showed a highly significant correlation between hearing improvement and fpCT-determined prosthesis position. FpCT enables detailed postoperative information on patients with middle ear reconstruction. FpCT is a new imaging technique that provides immediate feedback on surgical results after reconstructive middle ear surgery. Specific parameters evaluated by fpCT may serve as a predictive tool for estimated postoperative hearing improvement. Therefore this imaging technique is suitable for postoperative quality control in reconstructive middle ear surgery. (orig.)

  8. Implementation of an anonymisation tool for clinical trials using a clinical trial processor integrated with an existing trial patient data information system

    NARCIS (Netherlands)

    Aryanto, Kadek Y. E.; Broekema, Andre; Oudkerk, Matthijs; van Ooijen, Peter M. A.

    To present an adapted Clinical Trial Processor (CTP) test set-up for receiving, anonymising and saving Digital Imaging and Communications in Medicine (DICOM) data using external input from the original database of an existing clinical study information system to guide the anonymisation process. Two

  9. The personal usage of online information services: theory and empirical investigation

    NARCIS (Netherlands)

    Heijden, van der H.

    2002-01-01

    In this paper we develop a conceptual framework around the attitudes and intentions towards using online information service, and we theorise about thedifferences in relationships between regular information systems and online information services, Specifically we hypothesize (1) that affect

  10. Qualitative study of patient consent for health information exchange in an HIV clinic.

    Science.gov (United States)

    Ramos, S Raquel; Bakken, Suzanne

    2014-01-01

    Health information exchange (HIE) is the secure, electronic transfer and/or accessibility of clinical data among healthcare providers. In the United States (US), the consent process for participation varies state to state. New York State (NYS) mandates written patient consent. The purpose of this study was to examine workflow and perceptions related to obtaining HIE consent in an HIV clinic. We used contextual inquiry to observe the HIE consent-related workflow of four registration clerks for a total of 4 hours on two weekdays and subsequently created a flow chart and sequence model diagram. Clerks were also interviewed and the resulting narrative data were coded into themes. Observational and interview data suggested that patient privacy/confidentiality/trust, high volume workflow, and multiple competing demands affect the patient HIE consent process. Additional qualitative data needs to be gathered from the perspectives of patients and clinicians about the HIE consent process.

  11. How Qualitative Research Informs Clinical and Policy Decision Making in Transplantation: A Review.

    Science.gov (United States)

    Tong, Allison; Morton, Rachael L; Webster, Angela C

    2016-09-01

    Patient-centered care is no longer just a buzzword. It is now widely touted as a cornerstone in delivering quality care across all fields of medicine. However, patient-centered strategies and interventions necessitate evidence about patients' decision-making processes, values, priorities, and needs. Qualitative research is particularly well suited to understanding the experience and perspective of patients, donors, clinicians, and policy makers on a wide range of transplantation-related topics including organ donation and allocation, adherence to prescribed therapy, pretransplant and posttransplant care, implementation of clinical guidelines, and doctor-patient communication. In transplantation, evidence derived from qualitative research has been integrated into strategies for shared decision-making, patient educational resources, process evaluations of trials, clinical guidelines, and policies. The aim of this article is to outline key concepts and methods used in qualitative research, guide the appraisal of qualitative studies, and assist clinicians to understand how qualitative research may inform their practice and policy.

  12. What's New in the Medicine Cabinet?: A Panoramic Review of Clinically Relevant Information for the Busy Dermatologist.

    Science.gov (United States)

    Del Rosso, James Q; Zeichner, Joshua

    2014-01-01

    This article is the first in a periodic series of therapeutic topics with short reviews gleaned from major dermatology meetings, especially Scientific Poster Sessions, and is designed to provide information that may assist the readers in adapting information from the literature to their clinical practice. The topics covered in this issue are discussions of the clinical relevance of newer information about acne pathophysiology, acne in adult women, and topical corticosteroid spray formulations for chronic plaque psoriasis.

  13. Elucidation of salvage laryngectomy pathologic and clinical variables to guide further treatment intensification investigation.

    Science.gov (United States)

    Scharpf, Joseph; Ward, Matthew; Adelstein, David; Koyfman, Shlomo; Li, Mingsi

    2018-04-01

    There are limited treatment options beyond surgical salvage for patients who fail nonoperative treatment for laryngeal squamous cell carcinoma. In this study, we examine the failure patterns after surgical salvage and the potential pathologic and clinical prognostic variables that might guide further postoperative intensification investigation. Retrospective analysis at a tertiary academic referral center. From an institutional review board-approved institutional head and neck cancer registry, a consecutive series of 147 patients who underwent salvage laryngectomy for squamous cell cancer recurrence or persistence after radiotherapy with or without chemotherapy between May 1995 and May 2016 were identified. Variables potentially associated with oncologic outcome after surgical salvage were then collected and retrospectively evaluated. The projected 2-year locoregional failure rate was 21.8% (95% confidence interval [CI], 14.6%-29.0%]), and the overall survival 65% (95% CI, 57.5%-74.3%) for the entire cohort after salvage laryngectomy. On multivariable analysis, sarcomatoid/spindle cell pathology (hazard ratio [HR], 3.147; 95% CI, 1.181-8.386; P = 0.022), lymphovascular space invasion (LVSI) (positive vs. negative; HR, 2.31; 95% CI, 1.21-4.42; P = 0.011), and advanced initial American Joint Committee on Cancer 7th Edition grouped stage (stages III-IVB vs. stages I-II; HR, 1.64; 95% CI, 1.04-2.6; P = 0.035) were found to be independently associated with inferior disease-free survival. No other clinical or pathologic variables predicted failure. Salvage laryngectomy after nonoperative treatment failure results in successful locoregional control rates and survival in the majority of patients failing initial therapy. This should temper enthusiasm for routine treatment intensification with postoperative re-irradiation and/or other systemic treatments for the vast majority of patients. Sarcomatoid pathology, LVSI, and an advanced initial stage are associated with inferior

  14. DEVELOPMENT OF CLINICAL SCENARIO’S INFORMATION MODEL IN THE MEDICAL SIMULATION CENTER

    Directory of Open Access Journals (Sweden)

    I. V. Tolmachyov

    2014-01-01

    Full Text Available There is the big issue in medical education which is students don’t have enough skills. Often even with theoretical knowledge graduate medical students need to improve their skills by working with patients. Obviously it can be a risk for patients and takes quite long time. This situation could be changed with applying simulation technologies in medical education. Medical education with virtual simulators allows reducing the time of skills development and improving the quality of training. The aims of this work are developing informational model and creating clinical scenarios of emergency states in the Medical Simulation Center.Objectives:– to analyze the process of scenario conducting;– to create clinical scenarios of emergency states (anaphylactic shock, hypovolemic shock, obstructive shock with specialist’s help.The scenarios consist of sections such as main aim, skills, required mannequins, preparation of the mannequins, preparation of medical equipment and instruments for the scenario, preparation of special materials, scenario description, guide for operator, information for trainees.By analyzing the process of scenario conducting the key participants were defined who are operator, assistant, trainer, trainees. Also the main scenario stages were defined. Based on the stages diagram of variants of scenario conducting was designed.As an example there are fragments of scenario “Obstructive shock – a pulmonary embolism” in this article. Learn skills are cognitive, technical, social ones.Results. This paper presents an analysis of the clinical scenario conducting. Information model was developed which based on object-oriented decomposition. The model is the diagram of variants of scenario conducting. Scenario’s structure for emergency states was formulated. The scenarios are anaphylactic shock, hypovolemic shock, obstructive shock (pulmonary embolism, tension pneumothorax, pulmonary edema, hypertensive crisis, respiratory

  15. Differences in Investigator-Initiated Trials between Japan and Other Countries: Analyses of Clinical Trials Sponsored by Academia and Government in the ClinicalTrials.gov Registry and in the Three Japanese Registries.

    Directory of Open Access Journals (Sweden)

    Tatsuya Ito

    Full Text Available Following the amendment of the Pharmaceutical Affairs Law in Japan in 2003 researchers were permitted to begin investigator-initiated trials (IITs. In subsequent years, however, the number of IITs remained low. In other countries in Asia as well as in Europe, North America, and South Africa, the number of IITs has increased over the past decade. The differences in the characteristics of IITs between Japan and other countries are unknown. Some studies have analyzed the characteristics of all clinical trials according to registry databases, but there has been less research focusing on IITs.The purpose of this study is to analyze the characteristics of IITs in the ClinicalTrials.gov registry and in the three Japanese registries, to identify differences in IITs between Japan and other countries.Using Thomson Reuters Pharma™, trials sponsored by academia and government as IITs in 2010 and registered in ClinicalTrials.gov were identified. IITs from 2004 to 2012 in Japan were identified in the three Japanese registries: the University Hospital Medical Information Network Clinical Trials Registry, the Japan Pharmaceutical Information Center Clinical Trials Information, and the Japan Medical Association Center for Clinical Trials, Clinical Trials Registry. Characterization was made of the trial purposes, phases, participants, masking, arms, design, controls, and other data.New and revised IITs registered in ClinicalTrials.gov during 2010 averaged about 40% of all sponsor-identified trials. IITs were nearly all early-phase studies with small numbers of participants. A total of 56 Japanese IITs were found over a period of 8 years, and these were also almost nearly all early-phase studies with small numbers of participants.There appear to be no great differences between Japan and other countries in terms of characteristics of IITs. These results should prompt a new review of the IIT environment in Japan.

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

    Science.gov (United States)

    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.

  17. [The analytical reliability of clinical laboratory information and role of the standards in its support].

    Science.gov (United States)

    Men'shikov, V V

    2012-12-01

    The article deals with the factors impacting the reliability of clinical laboratory information. The differences of qualities of laboratory analysis tools produced by various manufacturers are discussed. These characteristics are the causes of discrepancy of the results of laboratory analyses of the same analite. The role of the reference system in supporting the comparability of laboratory analysis results is demonstrated. The project of national standard is presented to regulate the requirements to standards and calibrators for analysis of qualitative and non-metrical characteristics of components of biomaterials.

  18. Association of Informal Clinical Integration of Physicians With Cardiac Surgery Payments.

    Science.gov (United States)

    Funk, Russell J; Owen-Smith, Jason; Kaufman, Samuel A; Nallamothu, Brahmajee K; Hollingsworth, John M

    2018-05-01

    To reduce inefficiency and waste associated with care fragmentation, many current programs target greater clinical integration among physicians. However, these programs have led to only modest Medicare spending reductions. Most programs focus on formal integration, which often bears little resemblance to actual physician interaction patterns. To examine how physician interaction patterns vary between health systems and to assess whether variation in informal integration is associated with care delivery payments. National Medicare data from January 1, 2008, through December 31, 2011, identified 253 545 Medicare beneficiaries (aged ≥66 years) from 1186 health systems where Medicare beneficiaries underwent coronary artery bypass grafting (CABG) procedures. Interactions were mapped between all physicians who treated these patients-including primary care physicians and surgical and medical specialists-within a health system during their surgical episode. The level of informal integration was measured in these networks of interacting physicians. Multivariate regression models were fitted to evaluate associations between payments for each surgical episode made on a beneficiary's behalf and the level of informal integration in the health system where the patient was treated. The informal integration level of a health system. Price-standardized total surgical episode and component payments. The total 253 545 study participants included 175 520 men (69.2%; mean [SD] age, 74.51 [5.75] years) and 78 024 women (34.3%; 75.67 [5.91] years). One beneficiary of the 253 545 participants did not have sex information. The low level of informal clinical integration included 84 598 patients (33.4%; mean [SD] age, 75.00 [5.93] years); medium level, 84 442 (33.30%; 74.94 [5.87] years); and high level, 84 505 (33.34%; 74.66 [5.72] years) (P integration levels varied across health systems. After adjusting for patient, health-system, and community factors, higher levels

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

    Science.gov (United States)

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

    2011-12-01

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

  20. Discrepancy between information reported by the victims of sexual assaults and clinical forensic findings

    DEFF Research Database (Denmark)

    Scherer, Susanne; Hansen, Steen Holger; Lynnerup, Niels

    2014-01-01

    INTRODUCTION: From the clinical forensic examination reports made at the Department of Forensic Medicine, the University of Copenhagen, in 2007 concerning rape, attempted rape and sexual assault (RAS), information about the assault, including both violence and the perpetrator's line of sexual...... action was extracted, analysed and compared to the observed lesions (LE). MATERIAL AND METHODS: A total of 184 girls and women were included in this retrospective study. RESULTS: 75.5% of the victims were under 30 years of age. Observed LE: 79% had observed LE. 41% had body LE only, 19% genito-anal LE...... by slight, blunt force. Information on line of sexual action was present in 148 cases. A total of 123 victims reported penetration: 94% vaginal, 16% anal and 20% oral. Three were exposed to anal penetration only. Eleven perpetrators used a condom. 50% of the cases with vaginal and/or anal penetration had...

  1. Wearable Therapy - Detecting Information from Wearables and Mobiles that are Relevant to Clinical and Self-directed Therapy.

    Science.gov (United States)

    Arnrich, Bert; Ersoy, Cem; Mayora, Oscar; Dey, Anind; Berthouze, Nadia; Kunze, Kai

    2017-01-09

    This accompanying editorial provides a brief introduction into the focus theme "Wearable Therapy". The focus theme "Wearable Therapy" aims to present contributions which target wearable and mobile technologies to support clinical and self-directed therapy. A call for papers was announced to all participants of the "9th International Conference on Pervasive Computing Technologies for Healthcare" and was published in November 2015. A peer review process was conducted to select the papers for the focus theme. Six papers were selected to be included in this focus theme. The paper topics cover a broad range including an approach to build a health informatics research program, a comprehensive literature review of self-quantification for health self-management, methods for affective state detection of informal care givers, social-aware handling of falls, smart shoes for supporting self-directed therapy of alcohol addicts, and reference information model for pervasive health systems. More empirical evidence is needed that confirms sustainable effects of employing wearable and mobile technology for clinical and self-directed therapy. Inconsistencies between different conceptual approaches need to be revealed in order to enable more systematic investigations and comparisons.

  2. On-site management of investigational products and drug delivery systems in conformity with Good Clinical Practices (GCPs).

    Science.gov (United States)

    Méthot, Julie; Brisson, Diane; Gaudet, Daniel

    2012-04-01

    Investigators and research teams participating in clinical trials have to deal with complex investigational products, study designs, and research environments. The emergence of new drug delivery systems and investigational products combining more than one drug and the development of biodrugs such as monoclonal antibodies, peptides, siRNA, and gene therapy to treat orphan or common diseases constitute a new challenge for investigators and clinical sites. We describe the requirements and challenges of drug management in conformity with Good Clinical Practices (GCPs) for investigators and sites participating in clinical trials. Review At all sites participating in clinical trials, standard operating procedures (SOPs) covering the critical path of drug and drug delivery systems management are required. All steps should be auditable, including reception, validation, storage, access, preparation, distribution, techniques of administration, use, return, and destruction of research products. Biodrugs require traceability and specific SOPs on the management of potential immune reactions. Investigational products must be stored under standard auditable conditions. The traceability of storage conditions (including temperature) requires these conditions to be monitored on a continuous basis. A dedicated space with restricted access limited to authorized qualified personnel facilitates the monitoring. The development of standardized, auditable settings and the application of dedicated, site-specific SOPs for the management of investigational products and drug delivery systems contribute to guarantee the compliance to GCP requirements.

  3. Non-inflammatory destructive periodontal disease: a clinical, microbiological, immunological and genetic investigation

    Directory of Open Access Journals (Sweden)

    Carlos Eduardo Repeke

    2012-02-01

    Full Text Available Periodontitis comprises a group of multifactorial diseases in which periodontopathogens accumulate in dental plaque and trigger host chronic inflammatory and immune responses against periodontal structures, which are determinant to the disease outcome. Although unusual cases of non-inflammatory destructive periodontal disease (NIDPD are described, their pathogenesis remains unknown. A unique NIDPD case was investigated by clinical, microbiological, immunological and genetic tools. The patient, a non-smoking dental surgeon with excessive oral hygiene practice, presented a generalized bone resorption and tooth mobility, but not gingival inflammation or occlusion problems. No hematological, immunological or endocrine alterations were found. No periodontopathogens (A. actinomycetemcomitans, P. gingivalis, F. nucleatum and T. denticola or viruses (HCMV, EBV-1 and HSV-1 were detected, along with levels of IL-1β and TNF-a in GCF compatible with healthy tissues. Conversely ALP, ACP and RANKL GCF levels were similar to diseased periodontal sites. Genetic investigation demonstrated that the patient carried some SNPs, as well HLA-DR4 (*0404 and HLA-B27 alleles, considered risk factors for bone loss. Then, a less vigorous and diminished frequency of toothbrushing was recommended to the patient, resulting in the arrest of alveolar bone loss, associated with the return of ALP, ACP and RANKL in GCF to normality levels. In conclusion, the unusual case presented here is compatible with the previous description of NIDPD, and the results that a possible combination of excessive force and frequency of mechanical stimulation with a potentially bone loss prone genotype could result in the alveolar bone loss seen in NIDPD.

  4. [Establishing a clinical information system for surgical ophthalmology and orthopedics specialties with reference to GSG '93].

    Science.gov (United States)

    Dick, B; Basad, E

    1996-04-01

    As a result of new health care guidelines (Gesundheitsstrukturgesetz) and the federal hospital and nursing ordinance, there has been a large increase in the documentation required for diagnoses (ICD-9) and service ("Operationenschlüssel nach section 301 SGB V" = ICPM), all of which is done in the form of a numeric code. The method of coding diagnoses is supposed to make possible data entry and statistical evaluation of plausibility controls, as well as conspicuous and random testing of economic feasibility. Our data processing system is designed to assist in the planning and organization of clinical activities, while at the same time making documentation in accordance with health care guidelines easier and providing scientific documentation and evaluation. The application MedAccess was developed by clinicians on the basis of a relational client-server database. The application has been in use since June 1992 and has been further developed during operation according to the requirements and wishes of clinic and administrative staff. In cooperation with the Institute for Medical Information Technology, a computer interface with the patient check-in system was created, making possible the importing of patient data. The application is continuously updated according to the current needs of the clinic and administration. The primary functions of MedAccess include managing patient data, planning of in-patient admissions, surgical planning, organization, documentation (surgery book, reports with follow-up treatment records), administration of the tissue bank, clinic communications, clinic work processing, and management of the staff duty roster. Clinical data are entered into a computer and processed on site, and the user is assisted by practical applications which do not require special knowledge of data processing or encoding systems. The data is entered only once, but can be further used for other purposes, such as evaluations or selective transfer, for example, to

  5. Genetics of Post-Traumatic Stress Disorder: Informing Clinical Conceptualizations and Promoting Future Research

    Science.gov (United States)

    Nugent, Nicole R.; Amstadter, Ananda B.; Koenen, Karestan C.

    2009-01-01

    The purpose of this article is to provide an overview of genetic research involving post-traumatic stress disorder (PTSD). First, we summarize evidence for genetic influences on PTSD from family investigations. Second, we discuss the distinct contributions to our understanding of the genetics of PTSD permitted by twin studies. Finally, we summarize findings from molecular genetic studies, which have the potential to inform our understanding of underlying biological mechanisms for the development of PTSD. PMID:18412098

  6. BRIDG: a domain information model for translational and clinical protocol-driven research.

    Science.gov (United States)

    Becnel, Lauren B; Hastak, Smita; Ver Hoef, Wendy; Milius, Robert P; Slack, MaryAnn; Wold, Diane; Glickman, Michael L; Brodsky, Boris; Jaffe, Charles; Kush, Rebecca; Helton, Edward

    2017-09-01

    It is critical to integrate and analyze data from biological, translational, and clinical studies with data from health systems; however, electronic artifacts are stored in thousands of disparate systems that are often unable to readily exchange data. To facilitate meaningful data exchange, a model that presents a common understanding of biomedical research concepts and their relationships with health care semantics is required. The Biomedical Research Integrated Domain Group (BRIDG) domain information model fulfills this need. Software systems created from BRIDG have shared meaning "baked in," enabling interoperability among disparate systems. For nearly 10 years, the Clinical Data Standards Interchange Consortium, the National Cancer Institute, the US Food and Drug Administration, and Health Level 7 International have been key stakeholders in developing BRIDG. BRIDG is an open-source Unified Modeling Language-class model developed through use cases and harmonization with other models. With its 4+ releases, BRIDG includes clinical and now translational research concepts in its Common, Protocol Representation, Study Conduct, Adverse Events, Regulatory, Statistical Analysis, Experiment, Biospecimen, and Molecular Biology subdomains. The model is a Clinical Data Standards Interchange Consortium, Health Level 7 International, and International Standards Organization standard that has been utilized in national and international standards-based software development projects. It will continue to mature and evolve in the areas of clinical imaging, pathology, ontology, and vocabulary support. BRIDG 4.1.1 and prior releases are freely available at https://bridgmodel.nci.nih.gov . © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  7. Clinical and genetic investigation of families with type II Waardenburg syndrome.

    Science.gov (United States)

    Chen, Yong; Yang, Fuwei; Zheng, Hexin; Zhou, Jianda; Zhu, Ganghua; Hu, Peng; Wu, Weijing

    2016-03-01

    The present study aimed to investigate the molecular pathology of Waardenburg syndrome type II in three families, in order to provide genetic diagnosis and hereditary counseling for family members. Relevant clinical examinations were conducted on the probands of the three pedigrees. Peripheral blood samples of the probands and related family members were collected and genomic DNA was extracted. The coding sequences of paired box 3 (PAX3), microphthalmia‑associated transcription factor (MITF), sex‑determining region Y‑box 10 (SOX10) and snail family zinc finger 2 (SNAI2) were analyzed by polymerase chain reaction and DNA sequencing. The heterozygous mutation, c.649_651delAGA in exon 7 of the MITF gene was detected in the proband and all patients of pedigree 1; however, no pathological mutation of the relevant genes (MITF, SNAI2, SOX10 or PAX3) was detected in pedigrees 2 and 3. The heterozygous mutation c.649_651delAGA in exon 7 of the MITF gene is therefore considered the disease‑causing mutation in pedigree 1. However, there are novel disease‑causing genes in Waardenburg syndrome type II, which require further research.

  8. Ischaemic memory imaging using metabolic radiopharmaceuticals: overview of clinical settings and ongoing investigations

    Energy Technology Data Exchange (ETDEWEB)

    Yoshinaga, Keiichiro [Hokkaido University Graduate School of Medicine, Department of Molecular Imaging, Sapporo (Japan); Naya, Masanao [Hokkaido University Graduate School of Medicine, Department of Cardiology, Sapporo (Japan); Shiga, Tohru; Suzuki, Eriko; Tamaki, Nagara [Hokkaido University Graduate School of Medicine, Department of Nuclear Medicine, Sapporo (Japan)

    2014-02-15

    ''Ischaemic memory'' is defined as a prolonged functional and/or biochemical alteration remaining after a particular episode of severe myocardial ischaemia. The biochemical alteration has been reported as metabolic stunning. Metabolic imaging has been used to detect the footprint left by previous ischaemic episodes evident due to delayed recovery of myocardial metabolism (persistent dominant glucose utilization with suppression of fatty acid oxidation). β-Methyl-p-[{sup 123}I]iodophenylpentadecanoic acid (BMIPP) is a single-photon emission computed tomography (SPECT) radiotracer widely used for metabolic imaging in clinical settings in Japan. In patients with suspected coronary artery disease but no previous myocardial infarction, BMIPP has shown acceptable diagnostic accuracy. In particular, BMIPP plays an important role in the identification of prior ischaemic insult in patients arriving at emergency departments with acute chest pain syndrome. Recent data also show the usefulness of {sup 123}I-BMIPP SPECT for predicting cardiovascular events in patients undergoing haemodialysis. Similarly, SPECT or PET imaging with {sup 18}F-FDG injected during peak exercise or after exercise under fasting conditions shows an increase in FDG uptake in postischaemic areas. This article will overview the roles of ischaemic memory imaging both under established indications and in ongoing investigations. (orig.)

  9. Variability of intraductal papillomas of the mammary gland: Clinical, roentgenologic and morphologic investigations

    International Nuclear Information System (INIS)

    Rummel, W.

    1974-01-01

    The radiodiagnostical method of choice is the galactographic technique. However, a specific X-ray image of the papilloma does not exist. The galactographic technique has to be adapted to the surgical and histologic one. Only by combining these three techniques good results can be achieved. It is not possible to draw conclusions from the colour of the pathologic discharge about the type and character of the pathologic process. Contrary to the findings documented in the literature, we were able to diagnose with our technique not only small tumours, but also tumours situated in the periphery of the lactiferous duct. Because of our investigations it is no longer possible to maintain and keep the strict division of the proliferative changes occurring at the lactiferous duct walls. In this study, the most significant morphologic results are described in detail. In all patients with pathologic discharge of the mammary gland, the so-called papillo-carcinoma was found only in one case. As clinical consequence it has therefore to be demanded that in all women with the symptom of pathologic mamillary discharge first of all the origin of this discharge has to be localised by means of galactography. Only the individual morphologic picture of a proliferative change of the lactiferous duct provides some prognostic value. The prerequisites for such an individual assessment are differentiated roentgenologic, surgical and histological techniques. (orig./MG) [de

  10. Clinical investigation of 131I therapy combined with low-dose lithium carbonate for Graves disease

    International Nuclear Information System (INIS)

    Xu Haiqing; Wu Bian

    2006-01-01

    Objective: To investigate the clinical curative effects of 131 I therapy combined with low-dose lithium carbonate for Graves disease. Methods: Patients with Graves disease took lithium carbonate (250 mg, once per day) orally for 5 weeks. Then they were treated with 131 I (doses=3.15 MBq(80 uCi)/g, based on 60%-70% of the thyroid size). We kept track from 6 to 24 months (averaging 14 months) and classified the results into three: cured, improved or no effect. Results: After a single cycle of 131 I therapy combined with low-dose lithium carbonate, 106 patients with Graves disease were cured, 28 were improved and 8 saw no effects, respectively 74.6%, 19.7% and 5.6% among the 142 patients. We then treated 23 of them with another 131 I therapy (without lithium carbonate). 10 of such were cured (43.5%), 8 were improved (34.8%) and the other 5 saw no effects. Among all patients, hypothyroidism was observed from 25(17.6%), 6 months after the first 131 I therapy. Conclusions: Notable curative results were observed from 131 I therapy combined with low-dose lithium carbonate for Graves disease. Moreover, the dosage of 131 I was therefore decreased, which also lowered the toxicity response. (authors)

  11. Investigation of Exon 1 in FXN Gene in Patients with Clinical Symptomatic of Friedreich Ataxia

    Directory of Open Access Journals (Sweden)

    Naseroleslami M

    2013-01-01

    Full Text Available Background and Objectives: Friedreich’s ataxia (FRDA is an autosomal recessive disorder that is typically associated with dysarthria, muscle weakness, spasticity in the lower limbs, scoliosis, bladder dysfunction, absent lower limb reflexes, and loss of position and vibration sense. Approximately two-thirds of these patients suffer from cardiomyopathy and more than 30% have diabetes mellitus. Individuals with FRDA have identifiable mutations in the FXN gene. The most common type of mutation which is observed on both alleles in more than 98% of patients is an expansion of a GAA triplet-repeat in intron of FXN gene. Approximately 2% of individuals with FRDA are compound heterozygotes, who have a GAA expansion in the disease-causing range in one FXN allele and an inactivating FXN mutation in another allele. Aim of the present study was to investigate exon 1 in FRDA gene in patients with clinical symptoms of Friedreich’s Ataxia that have not GAA triplet-repeat expansion in intron 1 of FXN gene.Methods: In this study, exon 1 in 5 patients suspected of FRDA analyzed using PCR and sequencing. Results: An A to G transition at nucleotide number 815284, in exon 1 was observed in all patients. Conclusion: The results of this study showed that disease-causing homozygous mutations could be because of consanguinity marriage in Iran. Therefore, sequencing of all exons of the gene is necessary.

  12. Clinical distinctions between selective mutism and social phobia: an investigation of childhood psychopathology.

    Science.gov (United States)

    Yeganeh, Robin; Beidel, Deborah C; Turner, Samuel M; Pina, Armando A; Silverman, Wendy K

    2003-09-01

    To investigate the hypothesis that children with selective mutism are more socially anxious than children with social anxiety disorder but who are not selectively mute. Twenty-three children with comorbid selective mutism and social phobia and 23 age-matched controls with social phobia alone and their parents participated in a comprehensive assessment of social anxiety and related aspects of psychopathology. The results do not uniformly support previous suggestions that children with selective mutism refuse speech because they are "frozen with fear." Although clinician and observer ratings for children with selective mutism revealed higher ratings of social distress than for children with social phobia alone, self-report data do not support this conclusion. Furthermore, although there were no group differences on measures of trait anxiety, general fears, or scores on the Child Behavior Checklist broadband Internalizing or Externalizing scales, children with selective mutism scored higher than children with social phobia alone on the Child Behavior Checklist Delinquency subscale, suggesting the presence of a broader clinical syndrome. It remains unclear whether children with selective mutism have extreme levels of social anxiety. Potential areas that might shed further light on this interesting disorder are discussed.

  13. Ischaemic memory imaging using metabolic radiopharmaceuticals: overview of clinical settings and ongoing investigations

    International Nuclear Information System (INIS)

    Yoshinaga, Keiichiro; Naya, Masanao; Shiga, Tohru; Suzuki, Eriko; Tamaki, Nagara

    2014-01-01

    ''Ischaemic memory'' is defined as a prolonged functional and/or biochemical alteration remaining after a particular episode of severe myocardial ischaemia. The biochemical alteration has been reported as metabolic stunning. Metabolic imaging has been used to detect the footprint left by previous ischaemic episodes evident due to delayed recovery of myocardial metabolism (persistent dominant glucose utilization with suppression of fatty acid oxidation). β-Methyl-p-[ 123 I]iodophenylpentadecanoic acid (BMIPP) is a single-photon emission computed tomography (SPECT) radiotracer widely used for metabolic imaging in clinical settings in Japan. In patients with suspected coronary artery disease but no previous myocardial infarction, BMIPP has shown acceptable diagnostic accuracy. In particular, BMIPP plays an important role in the identification of prior isch