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Sample records for reported clinical effects

  1. Clinical and patient reported outcomes of bleaching effectiveness.

    Science.gov (United States)

    Klaric Sever, Eva; Budimir, Zrinka; Cerovac, Matea; Stambuk, Mario; Par, Matej; Negovetic Vranic, Dubravka; Tarle, Zrinka

    2018-01-01

    The objective of this study is to evaluate clinical and patient reported outcomes of different bleaching products. Thirty participants were randomly divided into three bleaching groups (n = 10). Bleaching was performed with high concentrations of hydrogen peroxide (HP) - Boost (40%) and Dash (30%), and with prefabricated splints Bite&White (6% HP). Tooth colour was measured before, immediately after, and 1 and 6 months after the bleaching by using classical shade guide and spectrophotometer. Tooth hypersensitivity was self-rated by patients on the Wong-Baker's face scale. Patient satisfaction was evaluated on a 7-point Likert-type scales that measured perceived performance and importance of different characteristics of bleaching treatment. All products were effective in teeth colour change (ΔE > 3.3), which was significantly higher for Boost (p = .016) and Dash (p = .024) than Bite&White treatment. Perception of hypersensitivity was the highest in Boost group, followed by Dash and Bite&White treatment. Most of the patients were satisfied with final tooth colour, length and comfort during treatment, but were dissatisfied with the stability of bleached tooth colour. Materials with the higher concentrations of bleaching agent demonstrated greater bleaching effectiveness than at-home bleaching product, but also a greater hypersensitivity. Lengthening the treatment process, but achieving a more stable tooth colour may improve the perceived value of a bleaching service.

  2. Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal

    Directory of Open Access Journals (Sweden)

    Kent David M

    2010-08-01

    Full Text Available Abstract Mounting evidence suggests that there is frequently considerable variation in the risk of the outcome of interest in clinical trial populations. These differences in risk will often cause clinically important heterogeneity in treatment effects (HTE across the trial population, such that the balance between treatment risks and benefits may differ substantially between large identifiable patient subgroups; the "average" benefit observed in the summary result may even be non-representative of the treatment effect for a typical patient in the trial. Conventional subgroup analyses, which examine whether specific patient characteristics modify the effects of treatment, are usually unable to detect even large variations in treatment benefit (and harm across risk groups because they do not account for the fact that patients have multiple characteristics simultaneously that affect the likelihood of treatment benefit. Based upon recent evidence on optimal statistical approaches to assessing HTE, we propose a framework that prioritizes the analysis and reporting of multivariate risk-based HTE and suggests that other subgroup analyses should be explicitly labeled either as primary subgroup analyses (well-motivated by prior evidence and intended to produce clinically actionable results or secondary (exploratory subgroup analyses (performed to inform future research. A standardized and transparent approach to HTE assessment and reporting could substantially improve clinical trial utility and interpretability.

  3. Health Clinic Cost Reports

    Data.gov (United States)

    U.S. Department of Health & Human Services — Healthcare Cost Report Information System (HCRIS) Dataset - Independent Rural Health Clinic and Freestanding Federally Qualified Health Center (HCLINIC).This data...

  4. Clinical events in coronary patients who report low distress: adverse effect of repressive coping.

    Science.gov (United States)

    Denollet, Johan; Martens, Elisabeth J; Nyklícek, Ivan; Conraads, Viviane M; de Gelder, Beatrice

    2008-05-01

    Coronary artery disease (CAD) patients who report low distress are considered to be at low psychological risk for clinical events. However, patients with a repressive coping style may fail to detect and report signals of emotional distress. The authors hypothesized that repressive CAD patients are at risk for clinical events, despite low self-rated distress. This was a prospective 5- to 10-year follow-up study, with a mean follow-up of 6.6 years. At baseline, 731 CAD patients filled out Trait-Anxiety (distress), Marlowe-Crowne (defensiveness), and Type D scales; 159 patients were classified as "repressive," 360 as "nonrepressive," and 212 as "Type D." The primary endpoint was a composite of total mortality or myocardial infarction (MI); the secondary endpoint was cardiac mortality/MI. No patients were lost to follow-up; 91 patients had a clinical event (including 35 cardiac death and 32 MI). Repressive patients reported low levels of anxiety, anger and depression at baseline, but were at increased risk for death/MI (21/159 = 13%) compared with nonrepressive patients (22/360 = 6%), p = .009. Poor systolic function, poor exercise tolerance, 3-vessel disease, index MI and Type-D personality--but not depression, anxiety or anger--also independently predicted clinical events. After controlling for these variables, repressive patients still had a twofold increased risk of death/MI, OR = 2.17, 95% CI = 1.10-4.08, p = .025). These findings were replicated for cardiac mortality/MI. CAD patients who use a repressive coping style are at increased risk for clinical events, despite their claims of low emotional distress. This phenomenon may cause an underestimation of the effect of stress on the heart. (PsycINFO Database Record (c) 2008 APA, all rights reserved).

  5. Cost-effectiveness analysis alongside clinical trials II-An ISPOR Good Research Practices Task Force report.

    Science.gov (United States)

    Ramsey, Scott D; Willke, Richard J; Glick, Henry; Reed, Shelby D; Augustovski, Federico; Jonsson, Bengt; Briggs, Andrew; Sullivan, Sean D

    2015-03-01

    Clinical trials evaluating medicines, medical devices, and procedures now commonly assess the economic value of these interventions. The growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. As decision makers increasingly demand evidence of economic value for health care interventions, conducting high-quality economic analyses alongside clinical studies is desirable because they broaden the scope of information available on a particular intervention, and can efficiently provide timely information with high internal and, when designed and analyzed properly, reasonable external validity. In 2005, ISPOR published the Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force report. ISPOR initiated an update of the report in 2014 to include the methodological developments over the last 9 years. This report provides updated recommendations reflecting advances in several areas related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members note that trials should be designed to evaluate effectiveness (rather than efficacy) when possible, should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. An incremental analysis should be conducted with an intention-to-treat approach, complemented by relevant subgroup analyses. Uncertainty should be characterized. Articles should adhere to established standards for reporting results of cost-effectiveness analyses. Economic studies alongside trials are complementary to other evaluations (e.g., modeling studies) as information for decision

  6. Effect of response format for clinical vignettes on reporting quality of physician practice

    Directory of Open Access Journals (Sweden)

    Durieux Pierre

    2009-07-01

    Full Text Available Abstract Background Clinical vignettes have been used widely to compare quality of clinical care and to assess variation in practice, but the effect of different response formats has not been extensively evaluated. Our objective was to compare three clinical vignette-based survey response formats – open-ended questionnaire (A, closed-ended (multiple-choice questionnaire with deceptive response items mixed with correct items (B, and closed-ended questionnaire with only correct items (C – in rheumatologists' pre-treatment assessment for tumor-necrosis-factor (TNF blocker therapy. Methods Study design: Prospective randomized study. Setting: Rheumatologists attending the 2004 French Society of Rheumatology meeting. Physicians were given a vignette describing the history of a fictitious woman with active rheumatoid arthritis, who was a candidate for therapy with TNF blocking agents, and then were randomized to receive questionnaire A, B, or C, each containing the same four questions but with different response formats, that asked about their pretreatment assessment. Measurements: Long (recommended items and short (mandatory items checklists were developed for pretreatment assessment for TNF-blocker therapy, and scores were expressed on the basis of responses to questionnaires A, B, and C as the percentage of respondents correctly choosing explicit items on these checklists. Statistical analysis: Comparison of the selected items using pairwise Chi-square tests with Bonferonni correction for variables with statistically significant differences. Results Data for all surveys distributed (114 As, 118 Bs, and 118 Cs were complete and available for analysis. The percentage of questionnaire A, B, and C respondents for whom data was correctly complete for the short checklist was 50.4%, 84.0% and 95.0%, respectively, and was 0%, 5.0% and 5.9%, respectively, for the long version. As an example, 65.8%, 85.7% and 95.8% of the respondents of A, B, and C

  7. Are self-report scales as effective as clinician rating scales in measuring treatment response in routine clinical practice?

    Science.gov (United States)

    Zimmerman, Mark; Walsh, Emily; Friedman, Michael; Boerescu, Daniela A; Attiullah, Naureen

    2018-01-01

    Recent treatment guidelines have suggested that outcome should be measured in routine clinical practice. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we compared three self-report scales of depressive symptoms and the two most widely used clinician administered scales in treatment studies in their sensitivity to change and evaluation of treatment response in depressed patients treated in routine practice. At baseline and 4-month follow-up 153 depressed outpatients with DSM-IV MDD completed the Clinically Useful Depression Outcome Scale (CUDOS), Quick Inventory of Depressive Symptomatology-Self-report version (QIDS-SR), and Patient Health Questionnaire (PHQ-9). The patients were rated on the 17-item Hamilton Depression Rating Scale (HAMD) and the Montgomery-Asberg Depression Rating Scale (MADRS). On each scale treatment response was defined as a 50% or greater reduction in scores from baseline. While there were some differences in the percentage of patients considered to be responders on the different scales, a large effect size was found for each scale, with little variability amongst the scales. The level of agreement between the three self-report scales and the clinician rating scales was approximately the same LIMITATIONS: The present study was conducted in a single clinical practice in which the majority of the patients were white, female, and had health insurance. When measuring outcome in clinical practice the magnitude of change in depressive symptoms is as great on self-report scales as on clinician rating scales. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. Self- and rater-assessed effectiveness of "thinking-aloud" and "regular" morning report to intensify young physicians' clinical skills.

    Science.gov (United States)

    Hsu, Hui-Chi; Lee, Fa-Yauh; Yang, Ying-Ying; Tsao, Yen-Po; Lee, Wen-Shin; Chuang, Chiao-Lin; Chang, Ching-Chih; Huang, Chia-Chang; Huang, Chin-Chou; Ho, Shung-Tai

    2015-09-01

    This study compared the effects of the "thinking aloud" (TA) morning report (MR), which is characterized by sequential and interactive case discussion by all participants, with "regular" MR for clinical skill training of young physicians. Between February 2011 and February 2014, young physicians [including postgraduate year-1 (PGY1) residents, interns, and clerks) from our hospital were sequentially enrolled and followed for 3 months. The self- and rater-assessed educational values of two MR models for building up clinical skills of young physicians were compared. The junior (intern and clerk) attendees had higher self-assessed educational values scores and reported post-training application frequency of skills trained by TA MR compared with the senior (PGY1 resident) attendees. Higher average and percentage of increased overall rater-assessed OSCE scores were noted among the regular MR senior attendees and TA MR junior attendees than in their corresponding control groups (regular MR junior attendees and TA MR senior attendees). Interestingly, regular MRs provided additional beneficial effects for establishing the "professionalism, consulting skills and organization efficiency" aspects of clinical skills of senior/junior attendees. Moreover, senior and junior attendees benefited the most by participating in seven sessions of regular MR and TA MR each month, respectively. TA MR effectively trains junior attendees in basic clinical skills, whereas regular MR enhances senior attendees' "work reports, professionalism, organizational efficiency, skills in dealing with controversial and professional issues." Undoubtedly, all elements of the two MR models should be integrated together to ensure patient safety and good discipline among young physicians. Copyright © 2015. Published by Elsevier Taiwan.

  9. Myelography with iohexol (Omnipaque); a clinical report with special reference to the adverse effects

    International Nuclear Information System (INIS)

    Skalpe, I.O.; Nakstad, P.

    1988-01-01

    One thousand myelographies (370 cervical, 77 thoracic and 553 lumbar examinations) with iohexol (Omnipaque) were performed in 922 patients. No convulsions were seen. Transient hallucinations were reported in one patient. Headache occurred in 38%. The highest frequency of headache (52%) was reported following cervical myelography with lumbar puncture technique, placing the patient horizontally after the examination. The lowest frequency (20%) occurred following cervical myelography with the C1-C2 puncture technique, placing the patient in bed with the head end elevated 20 degrees. Lumbar myelography was performed on an out-patient basis in 243 patients. The frequency of headache was slightly higher (49%) in this group than in the other lumbar myelography patients (34-44%), but no serious complications were seen. (orig.)

  10. Clinical effect of etidronate on alveolar pyorrhoea associated with chronic marginal periodontitis: report of four cases.

    Science.gov (United States)

    Takaishi, Y; Miki, T; Nishizawa, Y; Morii, H

    2001-01-01

    Etidronate 200 mg daily was administered to four female patients with periodontitis and resultant alveolar pyorrhoea for periods of 2 weeks, followed by off-periods of 10 weeks or more, for 2-3 years. The macroscopic appearance of gingival mobility of the teeth, depth of periodontal pockets, and X-ray findings of alveolar bones improved markedly during this time. The effects were first observed after 6-12 months of treatment. These findings indicate that bisphosphonates may be effective in the treatment of periodontitis and resultant alveolar pyorrhoea. The effect may be mediated by the inhibitory action on bone resorption and the anti-inflammatory action of etidronate. Concomitant conventional dental management is also required.

  11. NASPGHAN Capsule Endoscopy Clinical Report.

    Science.gov (United States)

    Friedlander, Joel A; Liu, Quin Y; Sahn, Benjamin; Kooros, Koorosh; Walsh, Catharine M; Kramer, Robert E; Lightdale, Jenifer R; Khlevner, Julie; McOmber, Mark; Kurowski, Jacob; Giefer, Matthew J; Pall, Harpreet; Troendle, David M; Utterson, Elizabeth C; Brill, Herbert; Zacur, George M; Lirio, Richard A; Lerner, Diana G; Reynolds, Carrie; Gibbons, Troy E; Wilsey, Michael; Liacouras, Chris A; Fishman, Douglas S

    2017-03-01

    Wireless capsule endoscopy (CE) was introduced in 2000 as a less invasive method to visualize the distal small bowel in adults. Because this technology has advanced it has been adapted for use in pediatric gastroenterology. Several studies have described its clinical use, utility, and various training methods but pediatric literature regarding CE is limited. This clinical report developed by the Endoscopic and Procedures Committee of the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition outlines the current literature, and describes the recommended current role, use, training, and future areas of research for CE in pediatrics.

  12. Clinical Effectiveness of Prospectively Reported Sonographic Twinkling Artifact for the Diagnosis of Renal Calculus in Patients Without Known Urolithiasis.

    Science.gov (United States)

    Masch, William R; Cohan, Richard H; Ellis, James H; Dillman, Jonathan R; Rubin, Jonathan M; Davenport, Matthew S

    2016-02-01

    The purpose of this study was to determine the clinical effectiveness of prospectively reported sonographic twinkling artifact for the diagnosis of renal calculus in patients without known urolithiasis. All ultrasound reports finalized in one health system from June 15, 2011, to June 14, 2014, that contained the words "twinkle" or "twinkling" in reference to suspected renal calculus were identified. Patients with known urolithiasis or lack of a suitable reference standard (unenhanced abdominal CT with ≤ 2.5-mm slice thickness performed ≤ 30 days after ultrasound) were excluded. The sensitivity, specificity, and positive likelihood ratio of sonographic twinkling artifact for the diagnosis of renal calculus were calculated by renal unit and stratified by two additional diagnostic features for calcification (echogenic focus, posterior acoustic shadowing). Eighty-five patients formed the study population. Isolated sonographic twinkling artifact had sensitivity of 0.78 (82/105), specificity of 0.40 (26/65), and a positive likelihood ratio of 1.30 for the diagnosis of renal calculus. Specificity and positive likelihood ratio improved and sensitivity declined when the following additional diagnostic features were present: sonographic twinkling artifact and echogenic focus (sensitivity, 0.61 [64/105]; specificity, 0.65 [42/65]; positive likelihood ratio, 1.72); sonographic twinkling artifact and posterior acoustic shadowing (sensitivity, 0.31 [33/105]; specificity, 0.95 [62/65]; positive likelihood ratio, 6.81); all three features (sensitivity, 0.31 [33/105]; specificity, 0.95 [62/65]; positive likelihood ratio, 6.81). Isolated sonographic twinkling artifact has a high false-positive rate (60%) for the diagnosis of renal calculus in patients without known urolithiasis.

  13. Temporomandibular joint dysfunction syndrome. A clinical report.

    Science.gov (United States)

    Passero, P L; Wyman, B S; Bell, J W; Hirschey, S A; Schlosser, W S

    1985-08-01

    We have presented two clinical case reports of patients with TMJ dysfunction syndrome as an example of coordinated treatments between dentists and physical therapists. The clinical profiles of these patients with craniocervical pain were compiled from comprehensive physical therapy and dental-orthopedic evaluations. The significance of the relationship between the rest position of the mandible and forward head posture has been shown by the changes observed after correction of the postural deviations and vertical resting dimensions by dental treatments and physical therapy. Additional research is necessary to determine long-term effects of this combined approach in TMJ dysfunction syndrome.

  14. Self- and rater-assessed effectiveness of “thinking-aloud” and “regular” morning report to intensify young physicians' clinical skills

    Directory of Open Access Journals (Sweden)

    Hui-Chi Hsu

    2015-09-01

    Conclusion: TA MR effectively trains junior attendees in basic clinical skills, whereas regular MR enhances senior attendees' “work reports, professionalism, organizational efficiency, skills in dealing with controversial and professional issues.” Undoubtedly, all elements of the two MR models should be integrated together to ensure patient safety and good discipline among young physicians.

  15. The effects of anger and sadness on clinical pain reports and experimentally-induced pain thresholds in women with and without fibromyalgia.

    NARCIS (Netherlands)

    Middendorp, H. van; Lumley, M.A.; Jacobs, J.W.G.; Bijlsma, J.W.J.; Geenen, R.

    2010-01-01

    OBJECTIVE: Negative emotions are commonly experienced in fibromyalgia and may affect pain. This study examined the effects of anger and sadness on clinical pain reports and on pain threshold and tolerance in response to electrical stimulation in women with and without fibromyalgia. METHODS: In an

  16. How are growth hormone and insulin-like growth factor-1 reported as markers for drug effectiveness in clinical acromegaly research? A comprehensive methodologic review

    NARCIS (Netherlands)

    Van Esdonk, Michiel J.; Van Zutphen, Eline J. M.; Roelfsema, Ferdinand; Pereira, Alberto M.; Van Der Graaf, Piet H.; Biermasz, Nienke R.; Stevens, Jasper; Burggraaf, Jacobus

    2018-01-01

    Objective. In rare disease research, most randomized prospective clinical trials can only use limited number of patients and are comprised of highly heterogeneous populations. Therefore, it is crucial to report the results in such a manner that it allows for comparison of treatment effectiveness and

  17. No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals.

    Science.gov (United States)

    Gabler, Nicole B; Duan, Naihua; Raneses, Eli; Suttner, Leah; Ciarametaro, Michael; Cooney, Elizabeth; Dubois, Robert W; Halpern, Scott D; Kravitz, Richard L

    2016-07-16

    When subgroup analyses are not correctly analyzed and reported, incorrect conclusions may be drawn, and inappropriate treatments provided. Despite the increased recognition of the importance of subgroup analysis, little information exists regarding the prevalence, appropriateness, and study characteristics that influence subgroup analysis. The objective of this study is to determine (1) if the use of subgroup analyses and multivariable risk indices has increased, (2) whether statistical methodology has improved over time, and (3) which study characteristics predict subgroup analysis. We randomly selected randomized controlled trials (RCTs) from five high-impact general medical journals during three time periods. Data from these articles were abstracted in duplicate using standard forms and a standard protocol. Subgroup analysis was defined as reporting any subgroup effect. Appropriate methods for subgroup analysis included a formal test for heterogeneity or interaction across treatment-by-covariate groups. We used logistic regression to determine the variables significantly associated with any subgroup analysis or, among RCTs reporting subgroup analyses, using appropriate methodology. The final sample of 416 articles reported 437 RCTs, of which 270 (62 %) reported subgroup analysis. Among these, 185 (69 %) used appropriate methods to conduct such analyses. Subgroup analysis was reported in 62, 55, and 67 % of the articles from 2007, 2010, and 2013, respectively. The percentage using appropriate methods decreased over the three time points from 77 % in 2007 to 63 % in 2013 (p < 0.05). Significant predictors of reporting subgroup analysis included industry funding (OR 1.94 (95 % CI 1.17, 3.21)), sample size (OR 1.98 per quintile (1.64, 2.40), and a significant primary outcome (OR 0.55 (0.33, 0.92)). The use of appropriate methods to conduct subgroup analysis decreased by year (OR 0.88 (0.76, 1.00)) and was less common with industry funding (OR 0.35 (0.18, 0

  18. Genetic risk of major depressive disorder: the moderating and mediating effects of neuroticism and psychological resilience on clinical and self-reported depression.

    Science.gov (United States)

    Navrady, L B; Adams, M J; Chan, S W Y; Ritchie, S J; McIntosh, A M

    2017-11-29

    Polygenic risk scores (PRS) for depression correlate with depression status and chronicity, and provide causal anchors to identify depressive mechanisms. Neuroticism is phenotypically and genetically positively associated with depression, whereas psychological resilience demonstrates negative phenotypic associations. Whether increased neuroticism and reduced resilience are downstream mediators of genetic risk for depression, and whether they contribute independently to risk remains unknown. Moderating and mediating relationships between depression PRS, neuroticism, resilience and both clinical and self-reported depression were examined in a large, population-based cohort, Generation Scotland: Scottish Family Health Study (N = 4166), using linear regression and structural equation modelling. Neuroticism and resilience were measured by the Eysenck Personality Scale Short Form Revised and the Brief Resilience Scale, respectively. PRS for depression was associated with increased likelihood of self-reported and clinical depression. No interaction was found between PRS and neuroticism, or between PRS and resilience. Neuroticism was associated with increased likelihood of self-reported and clinical depression, whereas resilience was associated with reduced risk. Structural equation modelling suggested the association between PRS and self-reported and clinical depression was mediated by neuroticism (43-57%), while resilience mediated the association in the opposite direction (37-40%). For both self-reported and clinical diagnoses, the genetic risk for depression was independently mediated by neuroticism and resilience. Findings suggest polygenic risk for depression increases vulnerability for self-reported and clinical depression through independent effects on increased neuroticism and reduced psychological resilience. In addition, two partially independent mechanisms - neuroticism and resilience - may form part of the pathway of vulnerability to depression.

  19. Lack of Effect of Sodium Benzoate at Reported Clinical Therapeutic Concentration on d-Alanine Metabolism in Dogs.

    Science.gov (United States)

    Popiolek, Michael; Tierney, Brendan; Steyn, Stefanus J; DeVivo, Michael

    2018-06-19

    Cognitive decline and psychosis have been hypothesized to be mediated by N-methyl-d-aspartate receptor (NMDAR) hypofunction. Consistent with this hypothesis, chronic treatment with d-alanine, a coagonist at the glycine site of the NMDAR, leads to an improvement of positive and cognitive symptoms in schizophrenic patients. d-alanine is oxidized by d-amino acid oxidase (DAAO); thus, an inhibitor of DAAO would be expected to enhance d-alanine levels and likewise lead to desirable clinical outcomes. Sodium benzoate, on the basis of d-amino acid inhibition, was observed to display beneficial clinical effects in schizophrenic and Alzheimer's patients. However, in the clinical pilot studies using sodium benzoate, d-amino acids were not quantified to verify that sodium benzoate's efficacy was mediated through DAAO inhibition. In this study, d-alanine content was monitored in cerebral spinal fluid (CSF) of dogs treated with daily injections of d-alanine (30 mg/kg) alone and in combination with sodium benzoate (30 mg/kg) for seven consecutive days. We reasoned that the cerebral spinal fluid d-alanine quantity is reflective of the brain d-alanine levels and it would increase as a consequence of DAAO inhibition with sodium benzoate. We found that d-alanine treatment lead to maximal concentration of 7.51 μM CSF d-alanine level; however, coadministration of sodium benzoate and d-alanine did not change CSF d-alanine level beyond that of d-alanine treatment alone. As a consequence, we conclude that clinical efficacy associated with chronic administration of sodium benzoate in schizophrenic and Alzheimer's patients is likely not mediated through inhibition of DAAO.

  20. Effective choices for diagnostic imaging in clinical practice. Excerpts from a report of a WHO Scientific Group on Clinical Diagnostic Imaging

    International Nuclear Information System (INIS)

    1992-01-01

    There are so many different methods of diagnostic imaging that medical practitioners may need guidance to choose the best through the maze of options for each clinical problem. Advice may be required for more than just the first choice, because the first imaging procedure does not always give the desired answer and, depending on the results, further imaging may have to undertaken. The alternative is to submit the patient to a barrage of imaging and hope that one type, at least provides the diagnosis. This is a quite unacceptable way to practice medicine because of the cost and the risk of radiation damage from unnecessary examinations. The choice of the most effective imaging is often difficult and frequently controversial. The sequence to be followed vries with many factors: the equipment available, the skills of the practitioner, the expected quality of the results, the quality of interpretation, and conclusion which can be drawn

  1. PROPAFENONE, A NEW EFFECTIVE ANTIARRHYTHMIC DRUG. REPORT OF 2 YEARS CLINICAL EXPERIMENT WITH PROPAFENONE (WITH BRIEF REVIEW OF ARTICLES

    Directory of Open Access Journals (Sweden)

    IRAJ NAZERY

    1986-05-01

    Full Text Available Propafenone HCI (p, is a relatively new Class IC antiarrhythmic agent. It has been reported to be superior to conventional antiarrhythmics in the control of supraventricular, ventricular and WPW associated tachyarrhythmias. It has been also shown to be well tolerated. In our study protocol, which extends over 2~ years period , we used (p in 87 patients for management of various types of cardiac arrhythmias (most of whom were resistant to conventmonal antiarrhythmics . Intravenously administered, (P was effective in 85% of patients with paroxysmal reentrant supraventricular tachycardia (PRSVT, 75% of those with paroxysmal atrial fibrillation (PAF , 50% and 42% of those with refractory premature ventricular contractions (PVC and ventricular tachycardia (V. Tach, respectively. Orally administered, (P was effective in 73% of those with resistant PVCs and nonsustained ventricular tachycardia (NSV Tach, and 75% of those with resistant sustained ventricular tachycardia (RSVT •

  2. Developing Effective Clinical Trainers

    Directory of Open Access Journals (Sweden)

    Kevin Khamarko

    2012-05-01

    Full Text Available Continuing education and training provides a means to improve performance among health care professionals (HCP. Research shows, however, that continuing professional education activities have inconsistent effects on HCP competence, performance, and patient health outcomes. Furthermore, the trainer’s role as a facilitator of knowledge translation (KT has been understudied. To understand how clinical trainers support their trainees in translating what they learned into practice, we conducted 16 in-depth interviews with expert trainers. These interviews yielded a variety of KT-enhancing strategies, including tailoring training activities to their trainees’ needs. In addition, participants recommended trainers familiarize themselves with their trainees’ work environments, be able to identify their knowledge deficits, and devote time to provide trainees with post-training support. Creating an effective training, one that leads to transfer, requires active planning, communication, and command of the training topic by skilled trainers.

  3. Effects of clinical breakpoint changes in CLSI guidelines 2010/2011 and EUCAST guidelines 2011 on antibiotic susceptibility test reporting of Gram-negative bacilli.

    Science.gov (United States)

    Hombach, Michael; Bloemberg, Guido V; Böttger, Erik C

    2012-03-01

    The aim of this study was to analyse the effects of clinical breakpoint changes in CLSI 2010 and 2011 guidelines and EUCAST 2011 guidelines on antibiotic susceptibility testing (AST) reports. In total, 3713 non-duplicate clinical isolates of Enterobacteriaceae, Pseudomonas aeruginosa, Stenotrophomonas maltophilia and Acinetobacter baumannii were analysed. Inhibition zone diameters were determined for β-lactams, carbapenems, fluoroquinolones, aminoglycosides and trimethoprim/sulfamethoxazole. CLSI 2009-11 and EUCAST 2011 clinical breakpoints were applied. Changes in resistance as defined per the guidelines affected individual species and drug classes differently. The cefepime resistance rate in Escherichia coli and Enterobacter cloacae increased from 2.1% and 1.3% to 8.2% and 6.9%, respectively, applying CLSI 2009-11 versus EUCAST 2011 guidelines. Ertapenem resistance rates in E. cloacae increased from 2.6% with CLSI 2009 to 7.2% for CLSI 2010 and 2011, and to 10.1% when applying EUCAST 2011. Cefepime and meropenem resistance rates in P. aeruginosa increased from 12.2% and 20.6% to 19.8% and 27.7%, respectively, comparing CLSI 2009-11 with EUCAST 2011. Tobramycin and gentamicin resistance rates in A. baumannii increased from 15.9% and 25.4% to 34.9% and 44.4% applying CLSI 2009-11 versus EUCAST 2011. Higher resistance rates reported due to breakpoint changes in CLSI and EUCAST guidelines will result in increasing numbers of Gram-negative bacilli reported as multidrug resistant. AST reports classifying amoxicillin/clavulanic acid, cefepime or carbapenem resistance will lead clinicians to use alternative agents. Upon implementation of the EUCAST guidelines, laboratories should be aware of the implications of modified drug susceptibility testing reports on antibiotic prescription policies.

  4. Clinical report writing: Process and perspective

    Science.gov (United States)

    Ewald, H. R.

    1981-01-01

    Clinical report writing in psychology and psychiatry is addressed. Audience/use analysis and the basic procedures of information gathering, diagnosis, and prognosis are described. Two interlinking processes are involved: the process of creation and the process of communication. Techniques for good report writing are presented.

  5. Best clinical trials reported in 2010.

    Science.gov (United States)

    Garner, John B; Grayburn, Paul A; Yancy, Clyde W

    2011-07-01

    Each year, a number of clinical trials emerge with data sufficient to change clinical practice. Determining which findings will result in practice change and which will provide only incremental benefit can be a dilemma for clinicians. The authors review selected clinical trials reported in 2010 in journals, at society meetings, and at conferences, focusing on those studies that have the potential to change clinical practice. This review offers 3 separate means of analysis: an abbreviated text summary, organized by subject area; a comprehensive table of relevant clinical trials that provides a schematic review of the hypotheses, interventions, methods, primary end points, results, and implications; and a complete bibliography for further reading as warranted. It is hoped that this compilation of relevant clinical trials and their important findings released in 2010 will be of benefit in the everyday practice of cardiovascular medicine. Copyright © 2011 Elsevier Inc. All rights reserved.

  6. Unsupervised grammar induction of clinical report sublanguage.

    Science.gov (United States)

    Kate, Rohit J

    2012-10-05

    Clinical reports are written using a subset of natural language while employing many domain-specific terms; such a language is also known as a sublanguage for a scientific or a technical domain. Different genres of clinical reports use different sublaguages, and in addition, different medical facilities use different medical language conventions. This makes supervised training of a parser for clinical sentences very difficult as it would require expensive annotation effort to adapt to every type of clinical text. In this paper, we present an unsupervised method which automatically induces a grammar and a parser for the sublanguage of a given genre of clinical reports from a corpus with no annotations. In order to capture sentence structures specific to clinical domains, the grammar is induced in terms of semantic classes of clinical terms in addition to part-of-speech tags. Our method induces grammar by minimizing the combined encoding cost of the grammar and the corresponding sentence derivations. The probabilities for the productions of the induced grammar are then learned from the unannotated corpus using an instance of the expectation-maximization algorithm. Our experiments show that the induced grammar is able to parse novel sentences. Using a dataset of discharge summary sentences with no annotations, our method obtains 60.5% F-measure for parse-bracketing on sentences of maximum length 10. By varying a parameter, the method can induce a range of grammars, from very specific to very general, and obtains the best performance in between the two extremes.

  7. [Other Possible Clinical Applications of Drugs with 5HT2A effect in Liaison Psychiatry: Cases Report].

    Science.gov (United States)

    Corredor, Catalina Ayala; Castillo, Carolina Solís

    2012-03-01

    In liaison psychiatry it is possible to get an integral view of patient's treatment and needs, paying special attention to pharmacological interactions and contraindications. Some particular cases motivated the description, report and review about other possible applications of 5HT2A and 5HT3 antagonist, particularly Mirtazapine and Olanzapine, in hyperalgesia syndrome, tinnitus and Progressive Multifocal Leukoencephalopathy by JC virus. Cases report. We describe 3 cases of patients in which Mirtazapine and Olanzapine were necessary not only to control psychiatric symptoms (affective / behavioral symptoms and insomnia) but to act as adjuvant therapy in axis III diseases. The use of any drug in psychiatry must take in to account the context of the patient, the presence of comorbidity, contraindications and pharmacological interactions so as to grant a positive outcome also promoting the multidisciplinary work between specialists. Copyright © 2012 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

  8. Clinical use of metal post- case report

    OpenAIRE

    Denkova, Natasa; Zlatanovska, Katerina; Kovacevska, Ivona; Nedelkova, Marija; Denkov, Nikola

    2016-01-01

    Background: Some teeth are severely mutilated because of caries or trauma. In case of an evident horizontal loss of clinical crown, most of the teeth could be unable to retain the final restoration without some additional support. Among other means, after endodontic treatment the use of endodontic posts can now be avoided in many cases. Aim:The aim of this case report was to show our management on teeth with evident loss of clinical crown from caries without set a prosthetic rehabilitation...

  9. Clinical effects of posterior pedicle screw fixation on spinal deformity in growing period: a report of 360 cases

    Directory of Open Access Journals (Sweden)

    Zheng-lei WANG

    2011-08-01

    Full Text Available Objective To observe the effect of a new kind of pedicle screw frame system with sliding terminus and locked middle segment on spinal deformity in growing period.Methods Three hundred and sixty patients in growing period were involved in the present study,and among them 82 were suffering from congenital scoliosis,218 idiopathic scoliosis and 60 kyphosis.All the patients were treated with the pedicle screw frame system with sliding terminus and locked middle segment.The treatment effects and postoperative complications were observed,and the Cobb angle before and after the operation was compared.Results The Cobb angle of 300 scoliosis patients was corrected from 53°±3° to 8°±2°,and the Cobb angle of 60 kyphosis patients was corrected from 60°±2° to 25°±3°,and the corrective effect was satisfactory.The correction rate of patients with Cobb angle ≤50° was 80%.Two hundred and ten patients were followed-up for 1 to 6 years,and the longitudinal growth of spine was 1.5-4.0cm.No severe complication,such as screw fracture,rod fracture or nerve injury,occurred.Conclusion The pedicle screw frame system with sliding terminus had a favorable three-dimensional correction effect,and the spine growth would not be restricted,and there was no stiffness,vertebral rotation,or distortion of shaft after operation.

  10. A Retrospective Study of Clinical Effects of Powdered Caffeine Exposures Reported to Three US Poison Control Centers.

    Science.gov (United States)

    Beauchamp, Gillian A; Johnson, Amberly R; Crouch, Barbara I; Valento, Matthew; Horowitz, B Zane; Hendrickson, Robert G

    2016-09-01

    Anhydrous caffeine, often sold on the Internet as a powdered caffeine product, is sold as "pure caffeine" to be used as an additive to beverages and has also been used as an ingredient in energy supplement products. This is a retrospective multiple-poison center chart review of calls regarding powdered caffeine to poison centers covering Oregon, Alaska, Guam, Washington, and Utah between January 1, 2013 and June 30, 2015. There were 40 calls to three poison centers over 30 months for powdered caffeine exposure. The majority of patients were over age 19 (52.5 %; 21/40) and male (70 %; 28/40). Sixty percent (24/40) of the patients were symptomatic but only 10 % (4/40) required admission; 52.5 % (21/40) of the patient calls were for inadvertent overdose of powdered caffeine; one patient overdosed in a self-harm attempt. Powdered caffeine calls to three poison centers during a 30-month study period were rare, and severe caffeine toxicity due to exposure was found in few patients. The majority of symptoms were reported after an inadvertent powdered caffeine overdose. An analysis of calls to three poison centers for powdered caffeine found that exposures were uncommon, but did result in toxicity, and highlighted that the lack of clear dosing instructions on product packaging may place patients at risk of inadvertent overdose.

  11. Summary reports for key Hoodia clinical studies

    CSIR Research Space (South Africa)

    Maharaj, VJ

    2011-12-01

    Full Text Available The CSIR has acquired the reports to 14 clinical studies in which Hoodia has been assesses, using crude extracts and concentrated active ingredients formulated in a number of different ways. In many of the studies Hoodia was found to be generally...

  12. Refining the structure and content of clinical genomic reports.

    Science.gov (United States)

    Dorschner, Michael O; Amendola, Laura M; Shirts, Brian H; Kiedrowski, Lesli; Salama, Joseph; Gordon, Adam S; Fullerton, Stephanie M; Tarczy-Hornoch, Peter; Byers, Peter H; Jarvik, Gail P

    2014-03-01

    To effectively articulate the results of exome and genome sequencing we refined the structure and content of molecular test reports. To communicate results of a randomized control trial aimed at the evaluation of exome sequencing for clinical medicine, we developed a structured narrative report. With feedback from genetics and non-genetics professionals, we developed separate indication-specific and incidental findings reports. Standard test report elements were supplemented with research study-specific language, which highlighted the limitations of exome sequencing and provided detailed, structured results, and interpretations. The report format we developed to communicate research results can easily be transformed for clinical use by removal of research-specific statements and disclaimers. The development of clinical reports for exome sequencing has shown that accurate and open communication between the clinician and laboratory is ideally an ongoing process to address the increasing complexity of molecular genetic testing. © 2014 Wiley Periodicals, Inc.

  13. Unsupervised grammar induction of clinical report sublanguage

    Directory of Open Access Journals (Sweden)

    Kate Rohit J

    2012-10-01

    Full Text Available Abstract Background Clinical reports are written using a subset of natural language while employing many domain-specific terms; such a language is also known as a sublanguage for a scientific or a technical domain. Different genres of clinical reports use different sublaguages, and in addition, different medical facilities use different medical language conventions. This makes supervised training of a parser for clinical sentences very difficult as it would require expensive annotation effort to adapt to every type of clinical text. Methods In this paper, we present an unsupervised method which automatically induces a grammar and a parser for the sublanguage of a given genre of clinical reports from a corpus with no annotations. In order to capture sentence structures specific to clinical domains, the grammar is induced in terms of semantic classes of clinical terms in addition to part-of-speech tags. Our method induces grammar by minimizing the combined encoding cost of the grammar and the corresponding sentence derivations. The probabilities for the productions of the induced grammar are then learned from the unannotated corpus using an instance of the expectation-maximization algorithm. Results Our experiments show that the induced grammar is able to parse novel sentences. Using a dataset of discharge summary sentences with no annotations, our method obtains 60.5% F-measure for parse-bracketing on sentences of maximum length 10. By varying a parameter, the method can induce a range of grammars, from very specific to very general, and obtains the best performance in between the two extremes.

  14. Women with breast cancer report substantially more disease- and treatment-related side or late effects than registered by clinical oncologists: a cross-sectional study of a standard follow-up program in an oncological department

    DEFF Research Database (Denmark)

    Ellegaard, Mai Britt Bjørklund; Grau, Cai; Zachariae, Robert

    2017-01-01

    effects were hot flushes (35%), fatigue (32%), and sleep disturbance (31%). CONCLUSION: None of the scheduled or additional visits resulted in detection of recurrent disease. Furthermore, the majority of patients reported side or late effects. Statistically significant more women reported side or late...... effects than registered by the clinical oncologists. This suggests the need for rethinking of the follow-up programs with more emphasis upon side or late effects of the treatment....

  15. Women with breast cancer report substantially more disease- and treatment-related side or late effects than registered by clinical oncologists: a cross-sectional study of a standard follow-up program in an oncological department.

    Science.gov (United States)

    Ellegaard, Mai-Britt Bjørklund; Grau, Cai; Zachariae, Robert; Jensen, Anders Bonde

    2017-08-01

    Follow-up after breast cancer treatment is standard due to the risk of development of new primary cancers and recurrent disease. The aim of the present study was to evaluate a standard follow-up program in an oncological department by assessing: (1) Symptoms or signs of new primary cancer or recurrent disease, (2) Disease- and treatment-related physical and psychosocial side or late effects, and (3) relevant actions by oncology staff. In a cross-sectional study, 194 women who came for follow-up visit after treatment for primary surgery were included. The clinical oncologists registered symptoms and signs of recurrent disease or new primary cancer. Side or late effects were both assessed by patient and the clinical oncologists. Loco-regional or distant signs of recurrent disease were suspected in eight (5%) patients. Further examinations revealed no disease recurrence. Most patients (93%) reported some degree of side or late effects. Statistically significant more side or late effects were reported by the women (average: 6.9) than registered by the clinical oncologists (average: 2.4), p effects were hot flushes (35%), fatigue (32%), and sleep disturbance (31%). None of the scheduled or additional visits resulted in detection of recurrent disease. Furthermore, the majority of patients reported side or late effects. Statistically significant more women reported side or late effects than registered by the clinical oncologists. This suggests the need for rethinking of the follow-up programs with more emphasis upon side or late effects of the treatment.

  16. Updated clinical guidelines experience major reporting limitations

    Directory of Open Access Journals (Sweden)

    Robin W.M. Vernooij

    2017-10-01

    Full Text Available Abstract Background The Checklist for the Reporting of Updated Guidelines (CheckUp was recently developed. However, so far, no systematic assessment of the reporting of updated clinical guidelines (CGs exists. We aimed to examine (1 the completeness of reporting the updating process in CGs and (2 the inter-observer reliability of CheckUp. Methods We conducted a systematic assessment of the reporting of the updating process in a sample of updated CGs using CheckUp. We performed a systematic search to identify updated CGs published in 2015, developed by a professional society, reporting a systematic review of the evidence, and containing at least one recommendation. Three reviewers independently assessed the CGs with CheckUp (16 items. We calculated the median score per item, per domain, and overall, converting scores to a 10-point scale. Multiple linear regression analyses were used to identify differences according to country, type of organisation, scope, and health topic of updated CGs. We calculated the intraclass coefficient (ICC and 95% confidence interval (95% CI for domains and overall score. Results We included in total 60 updated CGs. The median domain score on a 10-point scale for presentation was 5.8 (range 1.7 to 10, for editorial independence 8.3 (range 3.3 to 10, and for methodology 5.7 (range 0 to 10. The median overall score on a 10-point scale was 6.3 (range 3.1 to 10. Presentation and justification items at recommendation level (respectively reported by 27 and 38% of the CGs and the methods used for the external review and implementing changes in practice were particularly poorly reported (both reported by 38% of the CGs. CGs developed by a European or international institution obtained a statistically significant higher overall score compared to North American or Asian institutions (p = 0.014. Finally, the agreement among the reviewers on the overall score was excellent (ICC 0.88, 95% CI 0.75 to 0.95. Conclusions The

  17. Clinical effectiveness of garlic (Allium sativum).

    Science.gov (United States)

    Pittler, Max H; Ernst, Edzard

    2007-11-01

    The objective of this review is to update and assess the clinical evidence based on rigorous trials of the effectiveness of garlic (A. sativum). Systematic searches were carried out in Medline, Embase, Amed, the Cochrane Database of Systematic Reviews, Natural Standard, and the Natural Medicines Comprehensive Database (search date December 2006). Our own files, the bibliographies of relevant papers and the contents pages of all issues of the review journal FACT were searched for further studies. No language restrictions were imposed. To be included, trials were required to state that they were randomized and double blind. Systematic reviews and meta-analyses of garlic were included if based on the results of randomized, double-blind trials. The literature searches identified six relevant systematic reviews and meta-analysis and double-blind randomized trials (RCT) that were published subsequently. These relate to cancer, common cold, hypercholesterolemia, hypertension, peripheral arterial disease and pre-eclampsia. The evidence based on rigorous clinical trials of garlic is not convincing. For hypercholesterolemia, the reported effects are small and may therefore not be of clinical relevance. For reducing blood pressure, few studies are available and the reported effects are too small to be clinically meaningful. For all other conditions not enough data are available for clinical recommendations.

  18. Childhood bruxism: a clinical review and case report.

    Science.gov (United States)

    Gupta, B; Marya, C M; Anegundi, R

    2010-01-01

    The present case report refers to a patient who reported to the department with the complaint of teeth grinding (Bruxism). A brief review of the literature is reported concerning the aetiology, clinical diagnosis and the therapeutic approach of the disease.

  19. Cost Reporting at a Navy Branch Clinic

    Science.gov (United States)

    1993-03-01

    John Wiley & Sons, 1991. 15 Horngren , Charles, Cost Accounting -=A Managerial Emphasis, 5th Edition, Prentice Hall, Inc., Englewood Cliffs, N.J., 1982...traditionally reported under a partial cost reporting system. By applying basic principles of managerial accounting , a full cost reporting system is...traditionally reported under a partial cost reporting system. By applying basic principles of managerial accounting , a proposed full cost reporting

  20. Antiphospholipid Syndrome Clinical Research Task Force Report

    NARCIS (Netherlands)

    Erkan, D.; Derksen, R.; Levy, R.; Machin, S.; Ortel, T.; Pierangeli, S.; Roubey, R.; Lockshin, M.

    The Antiphospholipid Syndrome (APS) Clinical Research Task Force (CRTF) was one of six Task Forces developed by the 13(th) International Congress on Antiphospholipid Antibodies (aPL) organization committee with the purpose of: a) evaluating the limitations of APS clinical research and developing

  1. Community Mental Health Clinic Cost Reports

    Data.gov (United States)

    U.S. Department of Health & Human Services — Healthcare Cost Report Information System (HCRIS) Dataset - Community Mental Health Center (CMHC). This data was reported on form CMS-2088-92. The data in this...

  2. Ethics of safety reporting of a clinical trial

    Directory of Open Access Journals (Sweden)

    Amrita Sil

    2017-01-01

    Full Text Available Clinical trial related injury and serious adverse events (SAE are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensating the participant in case of any SAE. The Ethics Committee and regulatory body of the country are to uphold the ethical principles of beneficence, justice, non-maleficence in such cases. Any unwanted and noxious effect of a drug when used in recommended doses is an adverse drug reaction (ADR whereas if causal association is not yet established it is termed adverse event (AE. An AE or ADR that is associated with death, in-patient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, a congenital anomaly, or is otherwise life threatening is termed as an SAE. The principal investigator reports the event to the licensing authority (DCGI, sponsor and Chairperson of the Ethics Committee (EC within 24 hours of occurrence of the SAE. This report is furthered by a detailed report by both the investigator and the EC and given to the DCGI who then gives a final decision on the amount of compensation to be given by the sponsor or the sponsor's representative to the grieving party.

  3. Case report: Suspected clinical-radiological discord

    Directory of Open Access Journals (Sweden)

    Martin Tombe

    2013-02-01

    Full Text Available 17-year male student presented with vague constitutional symptoms and jaundice. His clinical chest findings initially suggested a discord with radiological findings. It turned out that the patient had a rare congenital disorder in addition to a seemingly common condition that brought him to the hospital. The purpose of this case presentation is to share some challenges of a clinical-radiological discord in a teaching hospital in Zimbabwe. It shows a flow of teamwork from House Officers to the Consultants as well as radiological back up.

  4. Clinical Investigation Program Annual Progress Report.

    Science.gov (United States)

    1984-09-30

    Clark, J.R.: Cecal Volvulus : Report of 10 Cases and a Review of the Literature. Presented: Gary Wratten Surgical Symposium/Workshop, Walter Reed Army...1984. (C). DEPARTMENT OF SURGERY General Surgery Service Allen, J.J. and Clark, J.R.: Cecal Volvulus : Report of 10 Cases *and a Review of the

  5. Modeling the longitudinal latent effect of pregabalin on self-reported changes in sleep disturbances in outpatients with generalized anxiety disorder managed in routine clinical practice

    Directory of Open Access Journals (Sweden)

    Ruiz MA

    2015-08-01

    Full Text Available Miguel A Ruiz,1 Enrique Álvarez,2 Jose L Carrasco,3 José M Olivares,4 María Pérez,5 Javier Rejas6 1Department of Methodology, School of Psychology, Universidad Autónoma de Madrid, Madrid, 2Department of Psychiatry, Hospital de la Santa Creu i San Pau, Barcelona, 3Department of Psychiatry, Hospital Clínico San Carlos, Madrid, 4Department of Psychiatry, Hospital Meixoeiro, Complejo Hospitalario Universitario, Vigo, 5Medical Department, Pfizer, S.L.U., Alcobendas, Madrid, 6Health Economics and Outcomes Research Department, Pfizer, S.L.U., Alcobendas, Madrid, Spain Background: Anxiety disorders are among the most common psychiatric illnesses, with generalized anxiety disorder (GAD being one of the most common. Sleep disturbances are highly prevalent in GAD patients. While treatment with pregabalin has been found to be associated with significant improvement in GAD-related sleep disturbance across many controlled clinical trials, mediational analysis has suggested that a substantial portion of this effect could be the result of a direct effect of pregabalin. Thus, the objective of this study was to model the longitudinal latent effect of pregabalin or usual care (UC therapies on changes in sleep in outpatients with GAD under routine clinical practice. Methods: Male and female GAD outpatients, aged 18 years or above, from a 6-month prospective noninterventional trial were analyzed. Direct and indirect effects of either pregabalin or UC changes in anxiety symptoms (assessed with Hamilton Anxiety Scale and sleep disturbances (assessed with Medical Outcomes Study-Sleep Scale [MOS-S] were estimated by a conditional latent curve model applying structural equation modeling. Results: A total of 1,546 pregabalin-naïve patients were analyzed, 984 receiving pregabalin and 562 UC. Both symptoms of anxiety and sleep disturbances were significantly improved in both groups, with higher mean (95% confidence interval score reductions in subjects receiving

  6. The importance of clinical case reports in research

    Directory of Open Access Journals (Sweden)

    Ricardo Pineda-Leguízamo

    2018-04-01

    Full Text Available Clinical case reports correspond to articles that have the lowest level of evidence within different research trials. However, not only are they common and significant in the medical field, but they have often been the basis the generation of research. The purpose of their publication can be scientific or educational. In general terms, the discovery of new diseases, the presentation of rare diseases, unusual forms of common diseases, the complications of a common treatment, or the effect (beneficial or adverse of a treatment, among other things, are narrated in these documents. Clinical case reports continue to be one of the most important sources of knowledge. The advent of a standardized guideline for the creation of this type of reports allows homogenizing the form and content of the cases intended to be described in the near future and, furthermore, will enable authors to have a reference when preparing this type of publications. Case reports are valuable resources of new and unusual information that can encourage and serve to conduct future research studies with a higher level of evidence.

  7. Aggressive malignant abdominal mesothelioma: Clinical report

    International Nuclear Information System (INIS)

    Al-Hassan, Ahmad M.; Al-Saigh, Abdulrehman A.

    2004-01-01

    A 32-year-old Filipino female, working as an x-ray technician, presented to the Emergency Room (ER) with acute abdominal pain for one day. The pain was mainly on the left side and left hypochondrium. She had recurring abdominal pain before but not significant to worry her. She also complained of abdominal distension, which she noticed one week ago. Abdominal examination revealed fullness in the left hypochondrium with marked tenderness but negative rebound. Abdominal ultrasound (US) showed a huge mass mainly in the left hypochondrium. The origin of the mass cannot be identified by US. A computerized tomography scan showed a mass in the left side of the abdomen crossing the midline with a necrotic centre. The hospital course of the patient runs smoothly, and she was discharged after 7-days and referred to an Oncology Center. Abdominal mesothelioma is a neoplasm arising from the mesothelial surface lining the abdominal cavity. It is less frequent than that of the pleura. It is a rapidly growing and fatal malignancy with a median survival of less than 1-year. The relation between pleural malignant mesothelioma and asbestos is well recognized since it was described in 19602 but implication of asbestos exposure in the etiology of the peritoneal type is less obvious. This patient history is giving no obvious exposure to asbestos but as she is working in the Radiology Department as an x-ray technician she is well exposed to x-ray, but the effect of radioactivity on induction of mesothelioma is still disputed.4 There are several reports linking malignant mesothelioma to radioactivity due to radiation therapy.The fibrous mesothelioma (sarcomatous), as in this case, which is difficult to diagnose microscopically, looks like a fibroma, unless helped by tissue culture. The treatment options of malignant mesothelioma include surgery, intraperitoneal chemotherapy and whole abdominal radiation or multimodality therapy, which were suggested that might prolong the survival in

  8. Clinical exome sequencing reports: current informatics practice and future opportunities.

    Science.gov (United States)

    Swaminathan, Rajeswari; Huang, Yungui; Astbury, Caroline; Fitzgerald-Butt, Sara; Miller, Katherine; Cole, Justin; Bartlett, Christopher; Lin, Simon

    2017-11-01

    The increased adoption of clinical whole exome sequencing (WES) has improved the diagnostic yield for patients with complex genetic conditions. However, the informatics practice for handling information contained in whole exome reports is still in its infancy, as evidenced by the lack of a common vocabulary within clinical sequencing reports generated across genetic laboratories. Genetic testing results are mostly transmitted using portable document format, which can make secondary analysis and data extraction challenging. This paper reviews a sample of clinical exome reports generated by Clinical Laboratory Improvement Amendments-certified genetic testing laboratories at tertiary-care facilities to assess and identify common data elements. Like structured radiology reports, which enable faster information retrieval and reuse, structuring genetic information within clinical WES reports would help facilitate integration of genetic information into electronic health records and enable retrospective research on the clinical utility of WES. We identify elements listed as mandatory according to practice guidelines but are currently missing from some of the clinical reports, which might help to organize the data when stored within structured databases. We also highlight elements, such as patient consent, that, although they do not appear within any of the current reports, may help in interpreting some of the information within the reports. Integrating genetic and clinical information would assist the adoption of personalized medicine for improved patient care and outcomes. © 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.

  9. Reporting of clinical trials: a review of research funders' guidelines

    Directory of Open Access Journals (Sweden)

    Williamson Paula R

    2008-11-01

    Full Text Available Abstract Background Randomised controlled trials (RCTs represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias. Methods National and international organisations and UK based charities listed on the Association for Medical Research Charities website were contacted in 2007; they were considered eligible for this review if they funded RCTs. Guidelines were obtained and assessed in relation to what was written about trial registration, protocol adherence and trial publication. It was also noted whether any monitoring against these guidelines was undertaken. This information was necessary to discover how much guidance researchers are given on the publication of results, in order to prevent study publication bias and outcome reporting bias. Results Seventeen organisations and 56 charities were eligible of 140 surveyed for this review, although there was no response from 12. Trial registration, protocol adherence, trial publication and monitoring against the guidelines were often explicitly discussed or implicitly referred too. However, only eleven of these organisations or charities mentioned the publication of negative as well as positive outcomes and just three of the organisations specifically stated that the statistical analysis plan should be strictly adhered to and all changes should be reported. Conclusion Our review indicates that there is a need to provide more detailed guidance for those conducting and reporting clinical trials to help prevent the selective reporting of results. Statements found in the guidelines generally refer to publication bias rather than outcome reporting bias

  10. Clinical Investigation Program Annual Progress Report

    Science.gov (United States)

    1989-10-01

    Meeting, Washington DC, September 1989 Parsons MK: Acute Shift of Right Ventricular Distensibility After Balloon Pulmonary Vavuloplasty. American Heart...selected range of motion using both concentric and eccentric muscular contractions. PROGRESS: No. of Subjects Enrolled - To Date: 8 Reporting Period: 8 1

  11. [Fournier syndrome: report of a clinical case].

    Science.gov (United States)

    La Torre, F; Otti, M; Ruggeri, E; Taglienti, D; Bonanno, L; Bianchini, G P; Veneroso, S; Tintisona, O; Monti, M

    2001-01-01

    The case of a Fournier's syndrome in a 58 years old patient is reported from the Authors that describe the ethiopathogenetic and therapeutic aspects. They analyse the importance of an early surgical treatment associated with antibiotic therapy and later a riparation of the lesions with a myocutaneous skin flap of TLF.

  12. Mandible osteoradionecrosis: a clinical case report

    International Nuclear Information System (INIS)

    Biazolla, E.R.; Biazolla, T.C.M.; Oliveira Marinho, M.A.

    1991-01-01

    This is a case report of the mandible osteoradionecrosis with its evolution and treatment, until the patient's cure. It's briefly discussed the treatment used, stressing the dentistry conscientiousness about the careless upon the manipulation of the patients submitted to radiotherapy. (author)

  13. First report of oligodendroglioma in a sheep : clinical communication

    Directory of Open Access Journals (Sweden)

    A. Derakhshanfar

    2010-05-01

    Full Text Available Oligodendrogliomas occur most commonly in the dog, but have also been reported in cattle, horses and cats. A 1-year-old sheep with neurological disturbances, including blindness, ataxia, circling and incoordination was referred to the veterinary clinic of Shahid Bahonar University of Kerman. Following euthanasia and necropsy, a soft, relatively well-demarcated mass was observed in the white and grey matter of the right cerebral hemisphere, close to the sylvian fissure in the right cerebral hemisphere. Microscopic examination revealed a sheet of densely packed tumour cells with hyperchromatic nuclei, lightly staining cytoplasm and characteristic perinuclear halo effect which is consistent with a diagnosis of oligodendroglioma. This is the 1st report of oligodendroglioma in sheep.

  14. Prevalence of estimated GFR reporting among US clinical laboratories.

    Science.gov (United States)

    Accetta, Nancy A; Gladstone, Elisa H; DiSogra, Charles; Wright, Elizabeth C; Briggs, Michael; Narva, Andrew S

    2008-10-01

    Routine laboratory reporting of estimated glomerular filtration rate (eGFR) may help clinicians detect kidney disease. The current national prevalence of eGFR reporting in clinical laboratories is unknown; thus, the extent of the situation of laboratories not routinely reporting eGFR with serum creatinine results is not quantified. Observational analysis. National Kidney Disease Education Program survey of clinical laboratories conducted in 2006 to 2007 by mail, web, and telephone follow-up. A national random sample, 6,350 clinical laboratories, drawn from the Federal Clinical Laboratory Improvement Amendments database and stratified by 6 major laboratory types/groupings. Laboratory reports serum creatinine results. Reporting eGFR values with serum creatinine results. Percentage of laboratories reporting eGFR along with reporting serum creatinine values, reporting protocol, eGFR formula used, and style of reporting cutoff values. Of laboratories reporting serum creatinine values, 38.4% report eGFR (physician offices, 25.8%; hospitals, 43.6%; independents, 38.9%; community clinics, 47.2%; health fair/insurance/public health, 45.5%; and others, 43.2%). Physician office laboratories have a reporting prevalence lower than other laboratory types (P laboratories reporting eGFR, 66.7% do so routinely with all adult serum creatinine determinations; 71.6% use the 4-variable Modification of Diet in Renal Disease Study equation; and 45.3% use the ">60 mL/min/1.73 m(2)" reporting convention. Independent laboratories are least likely to routinely report eGFR (50.6%; P laboratories across all strata are more likely to report eGFR (P laboratories, federal database did not have names of laboratory directors/managers (intended respondents), assumed accuracy of federal database for sample purposes. Routine eGFR reporting with serum creatinine values is not yet universal, and laboratories vary in their reporting practices.

  15. Catastrophic antiphospholipid syndrome and pregnancy. Clinical report.

    Science.gov (United States)

    Khizroeva, J; Bitsadze, V; Makatsariya, A

    2018-01-08

    We have observed the development of a catastrophic antiphospholipid syndrome (CAPS) in a pregnant woman hospitalized at 28 weeks of gestation with a severe preeclampsia. On the same day, an eclampsia attack developed, and an emergency surgical delivery was performed. On the third day, multiorgan failure developed. Examination showed a persistent circulation of lupus anticoagulant, high level of antibodies to cardiolipin, b2-glycoprotein I, and prothrombin. The usual diagnosis of the severe preeclampsia masked a catastrophic antiphospholipid syndrome, exacerbated by the coincident presence of several types of antiphospholipid antibodies. The first pregnancy resulted in a premature birth at 25 weeks, possibly also due to the circulation of antiphospholipid antibodies. The trigger of the catastrophic form development was the pregnancy itself, surgical intervention, and hyperhomocysteinemia. CAPS is the most severe form of antiphospholipid syndrome, manifested in multiple microthrombosis of microcirculation of vital organs and in the development of multiorgan failure against the background of the high level of antiphospholipid antibodies. CAPS is characterized by renal, cerebral, gastrointestinal, adrenal, ovarian, skin, and other forms of microthrombosis. Thrombosis recurrence is typical. Thrombotic microvasculopathy lies at the heart of multiorgan failure and manifests clinically in central nervous system lesions, adrenal insufficiency, and ARDS development. CAPS is a life-threatening condition, therefore, requires an urgent treatment. Optimal treatment of CAPS is not developed. CAPS represent a general medical multidisciplinary problem.

  16. Developments in clinical trials: a Pharma Matters report.

    Science.gov (United States)

    Arjona, A; Nuskey, B; Rabasseda, X; Arias, E

    2014-08-01

    As the pharmaceutical industry strives to meet the ever-increasing complexity of drug development, new technology in clinical trials has become a beacon of hope. With big data comes the promise of accelerated patient recruitment, real-time monitoring of clinical trials, bioinformatics empowerment of quicker phase progression, and the overwhelming benefits of precision medicine for select trials. Risk-based monitoring stands to benefit as well. With a strengthening focus on centralized data by the FDA and industry's transformative initiative, TransCelerate, a new era in trial risk mitigation has begun. The traditional method of intensive on-site monitoring is becoming a thing of the past as statistical, real-time analysis of site and trial-wide data provides the means to monitor with greater efficiency and effectiveness from afar. However, when it comes to big data, there are challenges that lie ahead. Patient privacy, commercial investment protection, technology woes and data variability are all limitations to be met with considerable thought. At the Annual Meeting of the American Academy of Dermatology this year, clinical trials on psoriasis, atopic dermatitis and other skin diseases were discussed in detail. This review of clinical research reports on novel therapies for psoriasis and atopic dermatitis reveals the impact of these diseases and the drug candidates that have been successful in phase II and III studies. Data-focused highlights of novel dermatological trials, as well as real-life big data approaches and an insight on the new methodology of risk-based monitoring, are all discussed in this edition of Developments in Clinical Trials. Copyright 2014 Prous Science, S.A.U. or its licensors. All rights reserved.

  17. Report of the Task Force on Clinical Research in Dentistry.

    Science.gov (United States)

    Journal of Dental Education, 1994

    1994-01-01

    A report on clinical dental research reviews current conditions and makes recommendations for increased funding, improved peer review for research proposals, establishment of a well-defined training track for clinical researchers, and better institutional integration of and support for research and teaching. Projected need for researchers is also…

  18. First reports of clinical pharmacokinetics in Nigeria | Michael ...

    African Journals Online (AJOL)

    It is the basis of therapeutic drug monitoring with the ultimate goal of keeping drugs safe. This branch of pharmacology has become the most relevant to the sub-specialty of clinical pharmacology. First reports of Clinical Pharmacokinetics in Nigeria can be credited to two gifted Nigerians, Prof Ayodele O. Iyun and Prof Lateef ...

  19. Teamwork and Clinical Error Reporting among Nurses in Korean Hospitals

    OpenAIRE

    Jee-In Hwang, PhD; Jeonghoon Ahn, PhD

    2015-01-01

    Purpose: To examine levels of teamwork and its relationships with clinical error reporting among Korean hospital nurses. Methods: The study employed a cross-sectional survey design. We distributed a questionnaire to 674 nurses in two teaching hospitals in Korea. The questionnaire included items on teamwork and the reporting of clinical errors. We measured teamwork using the Teamwork Perceptions Questionnaire, which has five subscales including team structure, leadership, situation monitori...

  20. Methylene blue for clinical anaphylaxis treatment: a case report

    Directory of Open Access Journals (Sweden)

    Janine Moreira Rodrigues

    Full Text Available CONTEXT AND OBJECTIVE: Nitric oxide has a pathophysiological role in modulating systemic changes associated with anaphylaxis. Nitric oxide synthase inhibitors may exacerbate bronchospasm in anaphylaxis and worsen clinical conditions, with limited roles in anaphylactic shock treatment. The aim here was to report an anaphylaxis case (not anaphylactic shock, reversed by methylene blue (MB, a guanylyl cyclase inhibitor. CASE REPORT: A 23-year-old female suddenly presented urticaria and pruritus, initially on her face and arms, then over her whole body. Oral antihistamine was administered initially, but without improvement in symptoms and signs until intravenous methylprednisolone 500 mg. Recurrence occurred after two hours, plus vomiting. Associated upper respiratory distress, pulmonary sibilance, laryngeal stridor and facial angioedema (including erythema and lip edema marked the evolution. At sites with severe pruritus, petechial lesions were observed. The clinical situation worsened, with dyspnea, tachypnea, peroral cyanosis, laryngeal edema with severe expiratory dyspnea and deepening unconsciousness. Conventional treatment was ineffective. Intubation and ventilatory support were then considered, because of severe hypoventilation. But, before doing that, based on our previous experience, 1.5 mg/kg (120 mg bolus of 4% MB was infused, followed by one hour of continuous infusion of another 120 mg diluted in dextrose 5% in water. Following the initial intravenous MB dose, the clinical situation reversed completely in less than 20 minutes, thereby avoiding tracheal intubation. CONCLUSION: Although the nitric oxide hypothesis for MB effectiveness discussed here remains unproven, our intention was to share our accumulated cohort experience, which strongly suggests MB is a lifesaving treatment for anaphylactic shock and/or anaphylaxis and other vasoplegic conditions.

  1. Atypical presentation of HELLP syndrome: clinical case report

    Directory of Open Access Journals (Sweden)

    Juan Manuel Tobar Parra

    2017-12-01

    Full Text Available Objective: To describe a case of HELLP syndrome with atypical presentation form. Background: HELLP syndrome is a complication of preeclampsia, characterized by: haemolysis, elevation of liver enzymes and thrombocytopenia; Can present atypical, without hypertension or proteinuria, 10-20% of the cases. Case report: 38 year old female patient, with a pregnancy of 38.5 weeks of gestation, treated at the Hospital Universitario San José de Popayán (Colombia. Atypical HELLP syndrome is diagnosed in a pregnant woman with thrombocytopenia, impaired liver enzymes, but no evidence of proteinuria or hypertension. Gestation is terminated by cesarean section and magnesium sulfate is given for 24 hours, with adequate post-surgical evolution, clinical improvement of the symptomatology presented, normalization of liver enzymes and platelet elevation. Conclusion: Knowledge of this syndrome, although of rare occurrence, allows a fast action, an effective diagnosis and treatment, to avoid morbidity and greater maternal fetal mortality.

  2. Observation of radiation effects on skin clinical roentgenologists

    International Nuclear Information System (INIS)

    Chen Weizhong; Liu Yunling

    1987-01-01

    The clinical observation of the effects of chronic irradiation on skin in 158 cases of clinical roentgenologists was reported. The results revealed that the incidence of morphological changes of microcirculaton in finger nail fold was as high as 47.6% for roentgenologists in contract to 5.2% for healthy adults. Other positive signs for skin injury were found in about 10.8-46.2% of roentgenologists. Two cases with typical chronic dermatitis were reported in this paper as well. These resuls attracted our attention to the radiation protection for clinical roentgenologists

  3. Basics of case report form designing in clinical research

    Directory of Open Access Journals (Sweden)

    Shantala Bellary

    2014-01-01

    Full Text Available Case report form (CRF is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

  4. Basics of case report form designing in clinical research.

    Science.gov (United States)

    Bellary, Shantala; Krishnankutty, Binny; Latha, M S

    2014-10-01

    Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

  5. [Writing and publication of a clinical case report].

    Science.gov (United States)

    Târcoveanu, E; Roca, M; Mihăescu, T

    2011-01-01

    A case report represents a collection of detailed information about an individual patient, written with the purpose to disseminate clinical outcomes, not previously reported. Case reports provide a rich resource for teaching and research in medicine. Despite the limitation of case reports, these are useful to generate new hypothesis for future large scale clinical trials. A clinical case report should be well structured and convey a clear message. Elements of a case report are similar to all forms of medical scientific articles: title, structured abstract, introduction, case report, discussion, conclusion and references. A well written case report with literature support and a detailed description of management of the case has the greatest chances to be published. "Uniform Requirements for Manuscripts to Biomedical Journals" form the basis for most journal instructions regarding content and formatting and should be consulted when journal's instructions don't answer to author's questions. In this paper we present a case report check sheet to use as a form of self-evaluation, prior to submitting the articles.

  6. Human reporter genes: potential use in clinical studies

    Energy Technology Data Exchange (ETDEWEB)

    Serganova, Inna [Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Ponomarev, Vladimir [Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Blasberg, Ronald [Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States)], E-mail: blasberg@neuro1.mskcc.org

    2007-10-15

    The clinical application of positron-emission-tomography-based reporter gene imaging will expand over the next several years. The translation of reporter gene imaging technology into clinical applications is the focus of this review, with emphasis on the development and use of human reporter genes. Human reporter genes will play an increasingly more important role in this development, and it is likely that one or more reporter systems (human gene and complimentary radiopharmaceutical) will take leading roles. Three classes of human reporter genes are discussed and compared: receptors, transporters and enzymes. Examples of highly expressed cell membrane receptors include specific membrane somatostatin receptors (hSSTrs). The transporter group includes the sodium iodide symporter (hNIS) and the norepinephrine transporter (hNET). The endogenous enzyme classification includes human mitochondrial thymidine kinase 2 (hTK2). In addition, we also discuss the nonhuman dopamine 2 receptor and two viral reporter genes, the wild-type herpes simplex virus 1 thymidine kinase (HSV1-tk) gene and the HSV1-tk mutant (HSV1-sr39tk). Initial applications of reporter gene imaging in patients will be developed within two different clinical disciplines: (a) gene therapy and (b) adoptive cell-based therapies. These studies will benefit from the availability of efficient human reporter systems that can provide critical monitoring information for adenoviral-based, retroviral-based and lenteviral-based gene therapies, oncolytic bacterial and viral therapies, and adoptive cell-based therapies. Translational applications of noninvasive in vivo reporter gene imaging are likely to include: (a) quantitative monitoring of gene therapy vectors for targeting and transduction efficacy in clinical protocols by imaging the location, extent and duration of transgene expression; (b) monitoring of cell trafficking, targeting, replication and activation in adoptive T-cell and stem/progenitor cell therapies

  7. Human reporter genes: potential use in clinical studies

    International Nuclear Information System (INIS)

    Serganova, Inna; Ponomarev, Vladimir; Blasberg, Ronald

    2007-01-01

    The clinical application of positron-emission-tomography-based reporter gene imaging will expand over the next several years. The translation of reporter gene imaging technology into clinical applications is the focus of this review, with emphasis on the development and use of human reporter genes. Human reporter genes will play an increasingly more important role in this development, and it is likely that one or more reporter systems (human gene and complimentary radiopharmaceutical) will take leading roles. Three classes of human reporter genes are discussed and compared: receptors, transporters and enzymes. Examples of highly expressed cell membrane receptors include specific membrane somatostatin receptors (hSSTrs). The transporter group includes the sodium iodide symporter (hNIS) and the norepinephrine transporter (hNET). The endogenous enzyme classification includes human mitochondrial thymidine kinase 2 (hTK2). In addition, we also discuss the nonhuman dopamine 2 receptor and two viral reporter genes, the wild-type herpes simplex virus 1 thymidine kinase (HSV1-tk) gene and the HSV1-tk mutant (HSV1-sr39tk). Initial applications of reporter gene imaging in patients will be developed within two different clinical disciplines: (a) gene therapy and (b) adoptive cell-based therapies. These studies will benefit from the availability of efficient human reporter systems that can provide critical monitoring information for adenoviral-based, retroviral-based and lenteviral-based gene therapies, oncolytic bacterial and viral therapies, and adoptive cell-based therapies. Translational applications of noninvasive in vivo reporter gene imaging are likely to include: (a) quantitative monitoring of gene therapy vectors for targeting and transduction efficacy in clinical protocols by imaging the location, extent and duration of transgene expression; (b) monitoring of cell trafficking, targeting, replication and activation in adoptive T-cell and stem/progenitor cell therapies

  8. Reporting and evaluation of HIV-related clinical endpoints in two multicenter international clinical trials

    DEFF Research Database (Denmark)

    Lifson, A; Rhame, F; Bellosa, W

    2006-01-01

    adjudication between reviewers before diagnostic certainty was assigned. CONCLUSION: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation......PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression...... and death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure...

  9. Teamwork and clinical error reporting among nurses in Korean hospitals.

    Science.gov (United States)

    Hwang, Jee-In; Ahn, Jeonghoon

    2015-03-01

    To examine levels of teamwork and its relationships with clinical error reporting among Korean hospital nurses. The study employed a cross-sectional survey design. We distributed a questionnaire to 674 nurses in two teaching hospitals in Korea. The questionnaire included items on teamwork and the reporting of clinical errors. We measured teamwork using the Teamwork Perceptions Questionnaire, which has five subscales including team structure, leadership, situation monitoring, mutual support, and communication. Using logistic regression analysis, we determined the relationships between teamwork and error reporting. The response rate was 85.5%. The mean score of teamwork was 3.5 out of 5. At the subscale level, mutual support was rated highest, while leadership was rated lowest. Of the participating nurses, 522 responded that they had experienced at least one clinical error in the last 6 months. Among those, only 53.0% responded that they always or usually reported clinical errors to their managers and/or the patient safety department. Teamwork was significantly associated with better error reporting. Specifically, nurses with a higher team communication score were more likely to report clinical errors to their managers and the patient safety department (odds ratio = 1.82, 95% confidence intervals [1.05, 3.14]). Teamwork was rated as moderate and was positively associated with nurses' error reporting performance. Hospital executives and nurse managers should make substantial efforts to enhance teamwork, which will contribute to encouraging the reporting of errors and improving patient safety. Copyright © 2015. Published by Elsevier B.V.

  10. Effective use of technology in clinical supervision

    Directory of Open Access Journals (Sweden)

    Priya Martin

    2017-06-01

    Full Text Available Clinical supervision is integral to continuing professional development of health professionals. With advances in technology, clinical supervision too can be undertaken using mediums such as videoconference, email and teleconference. This mode of clinical supervision is termed as telesupervision. While telesupervision could be useful in any context, its value is amplified for health professionals working in rural and remote areas where access to supervisors within the local work environment is often diminished. While telesupervision offers innovative means to undertake clinical supervision, there remain gaps in the literature in terms of its parameters of use in clinical practice. This article outlines ten evidence-informed, practical tips stemming from a review of the literature that will enable health care stakeholders to use technology effectively and efficiently while undertaking clinical supervision. By highlighting the “how to” aspect, telesupervision can be delivered in the right way, to the right health professional, at the right time.

  11. Analysis of the Radiology Reports from Radiology Clinics

    International Nuclear Information System (INIS)

    Kim, Eun Jin; Kwack, Kyu Sung; Cho, Jae Hyun; Jang, Eun Ho

    2009-01-01

    The purpose of this study was to investigate the form and content of the radiology reports from radiology clinics in Korea. One hundred and sixty six radiology reports from 49 radiology clinics were collected, and these reports were referred to the academic tertiary medical center from March 2008 to February 2009. These included reports for CT (n = 18), MRI (n = 146) and examinations not specified (n = 2). Each report was evaluated for the presence of required contents (demographics, technical information, findings, conclusion, the name, license number and signature of the radiologist and the referring facility). These requirements were based on the guideline of the American College of Radiology and the previous research. The name of the patient, the gender, the body part, the type of examination, the time of examination and the conclusion, the name of the radiologist and the name of facility were well recorded in over 90% of the radiology reports. However, the identification number of the patient, the referring facility, the referring physician, the use of contrast material, the clinical information, the time of dictation, the signature of the radiologist and the license number of the radiologist were poorly recorded (less than 50%). The optimal format of a radiology report should be established for reliable and valid communication with clinicians

  12. The STAR Data Reporting Guidelines for Clinical High Altitude Research.

    Science.gov (United States)

    Brodmann Maeder, Monika; Brugger, Hermann; Pun, Matiram; Strapazzon, Giacomo; Dal Cappello, Tomas; Maggiorini, Marco; Hackett, Peter; Bärtsch, Peter; Swenson, Erik R; Zafren, Ken

    2018-03-01

    Brodmann Maeder, Monika, Hermann Brugger, Matiram Pun, Giacomo Strapazzon, Tomas Dal Cappello, Marco Maggiorini, Peter Hackett, Peter Baärtsch, Erik R. Swenson, Ken Zafren (STAR Core Group), and the STAR Delphi Expert Group. The STARdata reporting guidelines for clinical high altitude research. High AltMedBiol. 19:7-14, 2018. The goal of the STAR (STrengthening Altitude Research) initiative was to produce a uniform set of key elements for research and reporting in clinical high-altitude (HA) medicine. The STAR initiative was inspired by research on treatment of cardiac arrest, in which the establishment of the Utstein Style, a uniform data reporting protocol, substantially contributed to improving data reporting and subsequently the quality of scientific evidence. The STAR core group used the Delphi method, in which a group of experts reaches a consensus over multiple rounds using a formal method. We selected experts in the field of clinical HA medicine based on their scientific credentials and identified an initial set of parameters for evaluation by the experts. Of 51 experts in HA research who were identified initially, 21 experts completed both rounds. The experts identified 42 key parameters in 5 categories (setting, individual factors, acute mountain sickness and HA cerebral edema, HA pulmonary edema, and treatment) that were considered essential for research and reporting in clinical HA research. An additional 47 supplemental parameters were identified that should be reported depending on the nature of the research. The STAR initiative, using the Delphi method, identified a set of key parameters essential for research and reporting in clinical HA medicine.

  13. The CARE guidelines: consensus-based clinical case report guideline development.

    Science.gov (United States)

    Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

    2014-01-01

    A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate, and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. Copyright © 2014 Reproduced with permission of Global Advances in Health and Medicine. Published by Elsevier Inc. All rights reserved.

  14. Importance of placebo effect in cough clinical trials.

    Science.gov (United States)

    Eccles, Ron

    2010-01-01

    Cough is a unique symptom because, unlike sneeze and other symptoms, it can be under voluntary control and this complicates clinical trials on cough medicines. All over-the-counter cough medicines (OTC) are very effective treatments because of their placebo effect. The placebo effect is enhanced by expectancy related to advertising, brand, packaging, and formulation. This placebo effect creates a problem for the conduct of clinical trials on OTC cough medicines that attempt to demonstrate the efficacy of a pharmacological agent above that of any placebo effect. Up to 85% of the efficacy of some cough medicines can be attributed to a placebo effect. The placebo effect apparent in clinical trials consists of several components: natural recovery, regression of cough response toward mean, demulcent effect, effect of sweetness, voluntary control, and effects related to expectancy and meaning of the treatment. The placebo effect has been studied most in the pain model, and placebo analgesia is reported to depend on the activation of endogenous opioid systems in the brain; this model may be applicable to cough. A balanced placebo design may help to control for the placebo effect, but this trial design may not be acceptable due to deception of patients. The placebo effect in clinical trials may be controlled by use of a crossover design, where feasible, and the changes in the magnitude of the placebo effect in this study design are discussed.

  15. Electronic clinical safety reporting system: a benefits evaluation.

    Science.gov (United States)

    Elliott, Pamela; Martin, Desmond; Neville, Doreen

    2014-06-11

    Eastern Health, a large health care organization in Newfoundland and Labrador (NL), started a staged implementation of an electronic occurrence reporting system (used interchangeably with "clinical safety reporting system") in 2008, completing Phase One in 2009. The electronic clinical safety reporting system (CSRS) was designed to replace a paper-based system. The CSRS involves reporting on occurrences such as falls, safety/security issues, medication errors, treatment and procedural mishaps, medical equipment malfunctions, and close calls. The electronic system was purchased from a vendor in the United Kingdom that had implemented the system in the United Kingdom and other places, such as British Columbia. The main objective of the new system was to improve the reporting process with the goal of improving clinical safety. The project was funded jointly by Eastern Health and Canada Health Infoway. The objectives of the evaluation were to: (1) assess the CSRS on achieving its stated objectives (particularly, the benefits realized and lessons learned), and (2) identify contributions, if any, that can be made to the emerging field of electronic clinical safety reporting. The evaluation involved mixed methods, including extensive stakeholder participation, pre/post comparative study design, and triangulation of data where possible. The data were collected from several sources, such as project documentation, occurrence reporting records, stakeholder workshops, surveys, focus groups, and key informant interviews. The findings provided evidence that frontline staff and managers support the CSRS, identifying both benefits and areas for improvement. Many benefits were realized, such as increases in the number of occurrences reported, in occurrences reported within 48 hours, in occurrences reported by staff other than registered nurses, in close calls reported, and improved timelines for notification. There was also user satisfaction with the tool regarding ease of use

  16. Errors in self-reports of health services use: impact on alzheimer disease clinical trial designs.

    Science.gov (United States)

    Callahan, Christopher M; Tu, Wanzhu; Stump, Timothy E; Clark, Daniel O; Unroe, Kathleen T; Hendrie, Hugh C

    2015-01-01

    Most Alzheimer disease clinical trials that compare the use of health services rely on reports of caregivers. The goal of this study was to assess the accuracy of self-reports among older adults with Alzheimer disease and their caregiver proxy respondents. This issue is particularly relevant to Alzheimer disease clinical trials because inaccuracy can lead both to loss of power and increased bias in study outcomes. We compared respondent accuracy in reporting any use and in reporting the frequency of use with actual utilization data as documented in a comprehensive database. We next simulated the impact of underreporting and overreporting on sample size estimates and treatment effect bias for clinical trials comparing utilization between experimental groups. Respondents self-reports have a poor level of accuracy with κ-values often below 0.5. Respondents tend to underreport use even for rare events such as hospitalizations and nursing home stays. In analyses simulating underreporting and overreporting of varying magnitude, we found that errors in self-reports can increase the required sample size by 15% to 30%. In addition, bias in the reported treatment effect ranged from 3% to 18% due to both underreporting and overreporting errors. Use of self-report data in clinical trials of Alzheimer disease treatments may inflate sample size needs. Even when adequate power is achieved by increasing sample size, reporting errors can result in a biased estimate of the true effect size of the intervention.

  17. Pyometra in a Great Dane: A Clinical Case Report

    Directory of Open Access Journals (Sweden)

    Malik Abu Rafee

    2015-04-01

    Full Text Available A 4-year-old Great Dane was admitted with continuous sanguino-purulent vaginal discharge, distended abdomen, and cachexia. The dog was clinically diagnosed with pyometra and successfully cured by ovario-hysterectomy. This is the first case report of pyometra seen in as Great Dane in Bareilly, India.

  18. Random effects models in clinical research

    NARCIS (Netherlands)

    Cleophas, T. J.; Zwinderman, A. H.

    2008-01-01

    BACKGROUND: In clinical trials a fixed effects research model assumes that the patients selected for a specific treatment have the same true quantitative effect and that the differences observed are residual error. If, however, we have reasons to believe that certain patients respond differently

  19. Yoga & Cancer Interventions: A Review of the Clinical Significance of Patient Reported Outcomes for Cancer Survivors

    Directory of Open Access Journals (Sweden)

    S. Nicole Culos-Reed

    2012-01-01

    Full Text Available Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004–2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies.

  20. Changes in clinical and hotel expenditures following publication of the nursing home compare report card.

    Science.gov (United States)

    Mukamel, Dana B; Spector, William D; Zinn, Jacqueline; Weimer, David L; Ahn, Richard

    2010-10-01

    Nursing Home Compare first published clinical quality measures at the end of 2002. It is a quality report card that for the first time offers consumers easily accessible information about the clinical quality of nursing homes. It led to changes in consumers' demand, increasing the relative importance of clinical versus hotel aspects of quality in their search and choice of a nursing home. To examine the hypothesis that nursing homes responding to these changes in demand shifted the balance of resources from hotel to clinical activities. The study included 10,022 free-standing nursing homes nationwide during 2001 to 2006. RESEARCH DESIGN AND DATA: A retrospective multivariate statistical analysis of trends in the ratio of clinical to hotel expenditures, using Medicare cost reports, Minimum Data Set and Online Survey, Certification and Reporting data, controlling for changes in residents' acuity and facility fixed effects. Inference is based on robust standard errors. The ratio of clinical to hotel expenditures averaged 1.78. It increased significantly (P hotel expenditures following publication of the report card suggests that nursing homes responded as expected to the changes in the elasticity of demand with respect to clinical quality brought about by the public reporting of clinical quality measures. The response was stronger among nursing homes facing stronger incentives.

  1. Adverse event reporting in cancer clinical trial publications.

    Science.gov (United States)

    Sivendran, Shanthi; Latif, Asma; McBride, Russell B; Stensland, Kristian D; Wisnivesky, Juan; Haines, Lindsay; Oh, William K; Galsky, Matthew D

    2014-01-10

    Reporting adverse events is a critical element of a clinical trial publication. In 2003, the Consolidated Standards of Reporting Trials (CONSORT) group generated recommendations regarding the appropriate reporting of adverse events. The degree to which these recommendations are followed in oncology publications has not been comprehensively evaluated. A review of citations from PubMed, Medline, and Embase published between Jan 1, 2009 and December 31, 2011, identified eligible randomized, controlled phase III trials in metastatic solid malignancies. Publications were assessed for 14 adverse event-reporting elements derived from the CONSORT harms extension statement; a completeness score (range, 0 to 14) was calculated by adding the number of elements reported. Linear regression analysis identified which publication characteristics associated with reporting completeness. A total of 175 publications, with data for 96,125 patients, were included in the analysis. The median completeness score was eight (range, three to 12). Most publications (96%) reported only adverse events occurring above a threshold rate or severity, 37% did not specify the criteria used to select which adverse events were reported, and 88% grouped together adverse events of varying severity. Regression analysis revealed that trials without a stated funding source and with an earlier year of publication had significantly lower completeness scores. Reporting of adverse events in oncology publications of randomized trials is suboptimal and characterized by substantial selectivity and heterogeneity. The development of oncology-specific standards for adverse event reporting should be established to ensure consistency and provide critical information required for medical decision-making.

  2. Review of the Reported Measures of Clinical Validity and Clinical Utility as Arguments for the Implementation of Pharmacogenetic Testing: A Case Study of Statin-Induced Muscle Toxicity

    Directory of Open Access Journals (Sweden)

    Marleen E. Jansen

    2017-08-01

    Full Text Available Advances from pharmacogenetics (PGx have not been implemented into health care to the expected extent. One gap that will be addressed in this study is a lack of reporting on clinical validity and clinical utility of PGx-tests. A systematic review of current reporting in scientific literature was conducted on publications addressing PGx in the context of statins and muscle toxicity. Eighty-nine publications were included and information was selected on reported measures of effect, arguments, and accompanying conclusions. Most authors report associations to quantify the relationship between a genetic variation an outcome, such as adverse drug responses. Conclusions on the implementation of a PGx-test are generally based on these associations, without explicit mention of other measures relevant to evaluate the test's clinical validity and clinical utility. To gain insight in the clinical impact and select useful tests, additional outcomes are needed to estimate the clinical validity and utility, such as cost-effectiveness.

  3. Eating epilepsy: clinical and neuro image aspects - case report

    International Nuclear Information System (INIS)

    Buchpiguel, Carlos A.; Yacubian, Elza Marcia T.; Fiore, Lia Arno; Jorge, Carmen Lisa; Yamaga, Liliam I.; Watanabe, Tomoco; Bacheschi, Luis A.; Scaff, Milberto; Magalhaes, Alvaro E.A.

    1994-01-01

    Eating epilepsy is an uncommon form of reflex epilepsy. The authors present a case report of a patient with clinical diagnosis of eating epilepsy who was submitted to clinical tests, neuroimaging studies (MRI and SPECT) and surface EEG. Multiple intercritical EEGs showed sharp discharges in the posterior left temporal area. The MRI did not show any abnormality. The intercritical brain SPECT showed clear hypoperfusion in the posterior left temporal area; so confirming the epileptogenic focus in producing the partial complex seizures triggered by eating. (author)

  4. Pattern of breast diseases: preliminary report of breast clinic

    International Nuclear Information System (INIS)

    Siddiqui, K.; Rasool, I.

    2001-01-01

    Objective: To find out the pattern of breast disease in this part of the county and create public awareness about breast diseases especially cancer. Design: Ac cross sectional and cohort study. Place and Duration of Study: The study was conducted at Department of Surgery, Jinnah Hospital /Allama Iqbal Medical College, Lahore from March 1999 to July 2000. Subjects and Methods: All the female patients reported were included in this study. They were diagnosed by history, physical examination and rel event investigations like ultrasonography, mammography, FNAS and biopsy. Appropriate medical and surgical management was carried out. The breast cancer was treated according to TNA staging system by multidisciplinary approach. Method of breast self examination (BSE) was taught with the help of charts and brochures. Results: The age ranged from 10 years to 75 years. Maximum number of patients (30%) was seen between 20-29 years of age while 15 (1%) cases did not suffer from any disease. Among 1485 patients the common conditions were non cyclical mastalgia in 362 (24.37%), fibroadenoma in 289 (19.46%), fibrocystic disease in 276(17.98%) breast abscess in 149 (10%) and breast cancer (6.19%). Other diseases were puberty mastitis 49(3.2%), galactocele 40(2.69%), accessory breast 45(3%) and nipple discharge 28(1.88%). Among the palpable lumps, breast caner accounted for 11.75%. The commonest age of presentation of breast cancer was 5th decade (31%) followed by 4th decade (26%). Majority of cancer patients (45%) presented in stage III. All the women with beast abscesses were lactating. Non cyclical mastalgia was commonly seen in 4th decade (30.66%) while 44.63% patients of fibroadenoma reported in the 2nd decade. Fibrocystic disease was reported between 3rd and 4th decade (62.17%). Conclusion: Commonest being conditions were non cyclical mastalgia followed by fibroadenoma while breast cancer contributed a significant percentage of palpable lumps. Due to effective public awareness

  5. Using Local Grammar for Entity Extraction from Clinical Reports

    Directory of Open Access Journals (Sweden)

    Aicha Ghoulam

    2015-06-01

    Full Text Available Information Extraction (IE is a natural language processing (NLP task whose aim is to analyze texts written in natural language to extract structured and useful information such as named entities and semantic relations linking these entities. Information extraction is an important task for many applications such as bio-medical literature mining, customer care, community websites, and personal information management. The increasing information available in patient clinical reports is difficult to access. As it is often in an unstructured text form, doctors need tools to enable them access to this information and the ability to search it. Hence, a system for extracting this information in a structured form can benefits healthcare professionals. The work presented in this paper uses a local grammar approach to extract medical named entities from French patient clinical reports. Experimental results show that the proposed approach achieved an F-Measure of 90. 06%.

  6. Providing effective supervision in clinical neuropsychology.

    Science.gov (United States)

    Stucky, Kirk J; Bush, Shane; Donders, Jacobus

    2010-01-01

    A specialty like clinical neuropsychology is shaped by its selection of trainees, educational standards, expected competencies, and the structure of its training programs. The development of individual competency in this specialty is dependent to a considerable degree on the provision of competent supervision to its trainees. In clinical neuropsychology, as in other areas of professional health-service psychology, supervision is the most frequently used method for teaching a variety of skills, including assessment, report writing, differential diagnosis, and treatment. Although much has been written about the provision of quality supervision in clinical and counseling psychology, very little published guidance is available regarding the teaching and provision of supervision in clinical neuropsychology. The primary focus of this article is to provide a framework and guidance for the development of suggested competency standards for training of neuropsychological supervisors, particularly at the residency level. In this paper we outline important components of supervision for neuropsychology trainees and suggest ways in which clinicians can prepare for supervisory roles. Similar to Falender and Shafranske (2004), we propose a competency-based approach to supervision that advocates for a science-informed, formalized, and objective process that clearly delineates the competencies required for good supervisory practice. As much as possible, supervisory competencies are related to foundational and functional competencies in professional psychology, as well as recent legislative initiatives mandating training in supervision. It is our hope that this article will foster further discussion regarding this complex topic, and eventually enhance training in clinical neuropsychology.

  7. 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

  8. Figures in clinical trial reports: current practice & scope for improvement.

    Science.gov (United States)

    Pocock, Stuart J; Travison, Thomas G; Wruck, Lisa M

    2007-11-19

    Most clinical trial publications include figures, but there is little guidance on what results should be displayed as figures and how. To evaluate the current use of figures in Trial reports, and to make constructive suggestions for future practice. We surveyed all 77 reports of randomised controlled trials in five general medical journals during November 2006 to January 2007. The numbers and types of figures were determined, and then each Figure was assessed for its style, content, clarity and suitability. As a consequence, guidelines are developed for presenting figures, both in general and for each specific common type of Figure. Most trial reports contained one to three figures, mean 2.3 per article. The four main types were flow diagram, Kaplan Meier plot, Forest plot (for subgroup analyses) and repeated measures over time: these accounted for 92% of all figures published. For each type of figure there is a considerable diversity of practice in both style and content which we illustrate with selected examples of both good and bad practice. Some pointers on what to do, and what to avoid, are derived from our critical evaluation of these articles' use of figures. There is considerable scope for authors to improve their use of figures in clinical trial reports, as regards which figures to choose, their style of presentation and labelling, and their specific content. Particular improvements are needed for the four main types of figures commonly used.

  9. Figures in clinical trial reports: current practice & scope for improvement

    Directory of Open Access Journals (Sweden)

    Travison Thomas G

    2007-11-01

    Full Text Available Abstract Background Most clinical trial publications include figures, but there is little guidance on what results should be displayed as figures and how. Purpose To evaluate the current use of figures in Trial reports, and to make constructive suggestions for future practice. Methods We surveyed all 77 reports of randomised controlled trials in five general medical journals during November 2006 to January 2007. The numbers and types of figures were determined, and then each Figure was assessed for its style, content, clarity and suitability. As a consequence, guidelines are developed for presenting figures, both in general and for each specific common type of Figure. Results Most trial reports contained one to three figures, mean 2.3 per article. The four main types were flow diagram, Kaplan Meier plot, Forest plot (for subgroup analyses and repeated measures over time: these accounted for 92% of all figures published. For each type of figure there is a considerable diversity of practice in both style and content which we illustrate with selected examples of both good and bad practice. Some pointers on what to do, and what to avoid, are derived from our critical evaluation of these articles' use of figures. Conclusion There is considerable scope for authors to improve their use of figures in clinical trial reports, as regards which figures to choose, their style of presentation and labelling, and their specific content. Particular improvements are needed for the four main types of figures commonly used.

  10. Multiparametric prostate MRI: technical conduct, standardized report and clinical use.

    Science.gov (United States)

    Manfredi, Matteo; Mele, Fabrizio; Garrou, Diletta; Walz, Jochen; Fütterer, Jurgen J; Russo, Filippo; Vassallo, Lorenzo; Villers, Arnauld; Emberton, Mark; Valerio, Massimo

    2018-02-01

    Multiparametric prostate MRI (mp-MRI) is an emerging imaging modality for diagnosis, characterization, staging, and treatment planning of prostate cancer (PCa). The technique, results reporting, and its role in clinical practice have been the subject of significant development over the last decade. Although mp-MRI is not yet routinely used in the diagnostic pathway, almost all urological guidelines have emphasized the potential role of mp-MRI in several aspects of PCa management. Moreover, new MRI sequences and scanning techniques are currently under evaluation to improve the diagnostic accuracy of mp-MRI. This review presents an overview of mp-MRI, summarizing the technical applications, the standardized reporting systems used, and their current roles in various stages of PCa management. Finally, this critical review also reports the main limitations and future perspectives of the technique.

  11. Dual cusped protostylid: Case report and clinical significance

    Directory of Open Access Journals (Sweden)

    Preeti Bhattacharya

    2016-01-01

    Full Text Available Protostylids are superstructures on maxillary or mandibular molars, which have rarely been reported in literature, and the significance of their presence has also been underestimated. The dental practitioners may easily misdiagnose a tooth, with such conical tubercles as malformed tooth. Interestingly, this is neither a malformation nor an anomaly but rather an important morphological trait of an individual. Once in a while, one may come across such a distinct morphological trait without being able to diagnose. To the authors' best knowledge, only one similar case has been reported previously, and the second such case internationally. Bearing all such facts in mind, the authors attempt to educate the readers towards the existence of such a trait so that it can be identified and studied in larger numbers. Hence, it is the authors' endeavor to report an unusual case of dual cusped maxillary protostylid along with its clinical significance.

  12. Clinical effectiveness and cost effect analysis of quadrivalent HPV vaccine

    OpenAIRE

    Lekić, Nataša

    2008-01-01

    1 ABSTRACT Quadrivalent Human Papillomavirus Vaccine- Evaluation of clinical effectiveness and national vaccine programs Author: Nataša Lekić Research Advisor: PharmDr. Lenka Práznovcová, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University in Prague. SUMMARY QUADRIVALENT HPV VACCINE- EVALUATION OF CLINICAL EFFECTIVENESS AND NATIONAL VACCINE PROGRAMS Background: Human papillomavirus types 6, 11,16 and 18 cause majority of genital warts an...

  13. 75 FR 4827 - Submission for OMB Review; Comment Request Clinical Trials Reporting Program (CTRP) Database (NCI)

    Science.gov (United States)

    2010-01-29

    ... subsequent comment concerning corruption in clinical trials conducted by large pharmaceutical companies. The... Collection: Title: Clinical Trials Reporting Program (CTRP) Database. Type of Information Collection Request... institutions. Type of Respondents: Clinical research administrators on behalf of clinical investigators. The...

  14. Six-year susceptibility trends and effect of revised Clinical Laboratory Standards Institute breakpoints on ciprofloxacin susceptibility reporting in typhoidal Salmonellae in a tertiary care paediatric hospital in Northern India

    Directory of Open Access Journals (Sweden)

    R Saksena

    2016-01-01

    Full Text Available The antimicrobial trends over 6 years were studied, and the effect of revised Clinical Laboratory Standards Institute (CLSI breakpoints (2012 for ciprofloxacin susceptibility reporting in typhoidal Salmonellae was determined. A total of 874 (95.4% isolates were nalidixic acid-resistant (NAR. Using the CLSI 2011 guidelines (M100-S21, 585 (66.9% isolates were ciprofloxacin susceptible. The susceptibility reduced to 11 (1.25% isolates when interpreted using 2012 guidelines (M100-S22. Among the forty nalidixic acid susceptible (NAS Salmonellae, susceptibility to ciprofloxacin decreased from 37 isolates (M100-S21 to 12 isolates (M100-S22. The 25 cases which appeared resistant with newer guidelines had a minimum inhibitory concentration (MIC range between 0.125 and 0.5 μg/ml. MIC50 for the third generation cephalosporins varied between 0.125 and 0.5 μg/ml over 6 years whereas MIC90 varied with a broader range of 0.19–1 μg/ml. The gap between NAR and ciprofloxacin-resistant strains identified using 2011 guidelines has been reduced; however, it remains to be seen whether additional NAS, ciprofloxacin-resistant isolates are truly resistant to ciprofloxacin by other mechanisms of resistance.

  15. 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

  16. Case reports and clinical guidelines for managing radix entomolaris

    Directory of Open Access Journals (Sweden)

    Bejoy J Thomas

    2016-01-01

    Full Text Available Knowledge about the external and internal anatomy of the tooth is essential for successful dental practice. Anomalies in the tooth are often encountered which poses difficulties in dental treatments. As like any other tooth, mandibular first molars are also prone for anatomic malformations. One such anatomic variation is the presence of extra root distolingually. This distolingual root is called radix entomolaris (RE. The presence of an additional root can lead to difficulties during endodontic therapy. This article is a report of two cases describing the management of the first mandibular molars with an RE and clinical guidelines for its management.

  17. Report of the results of the International Clinical Cytometry Society and American Society for Clinical Pathology workload survey of clinical flow cytometry laboratories.

    Science.gov (United States)

    Wolniak, Kristy; Goolsby, Charles; Choi, Sarah; Ali, Asma; Serdy, Nina; Stetler-Stevenson, Maryalice

    2017-11-01

    Thorough review of current workload, staffing, and testing practices in clinical laboratories allows for optimization of laboratory efficiency and quality. This information is largely missing with regard to clinical flow cytometry laboratories. The purpose of this survey is to provide comprehensive, current, and accurate data on testing practices and laboratory staffing in clinical laboratories performing flow cytometric studies. Survey data was collected from flow cytometry laboratories through the ASCP website. Data was collected on the workload during a 1-year time period of full-time and part-time technical and professional (M.D./D.O./Ph.D. or equivalent) flow cytometry employees. Workload was examined as number of specimens and tubes per full time equivalent (FTE) technical and professional staff. Test complexity, test result interpretation, and reporting practices were also evaluated. There were 205 respondent laboratories affiliated predominantly with academic and health system institutions. Overall, 1,132 FTE employees were reported with 29% professional FTE employees and 71% technical. Fifty-one percent of the testing performed was considered high complexity and 49% was low complexity. The average number of tubes per FTE technologist was 1,194 per year and the average number of specimens per FTE professional was 1,659 per year. The flow cytometry reports were predominantly written by pathologists (57%) and were typically written as a separate report (58%). This survey evaluates the overall status of the current practice of clinical flow cytometry and provides a comprehensive dataset as a framework to help laboratory departments, directors, and managers make appropriate, cost-effective staffing decisions. © 2016 International Clinical Cytometry Society. © 2016 International Clinical Cytometry Society.

  18. Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A Systematic Review.

    Science.gov (United States)

    de Jong, Marin J; Huibregtse, Roxanne; Masclee, Ad A M; Jonkers, Daisy M A E; Pierik, Marie J

    2018-05-01

    Mucosal inflammation must be carefully monitored to improve the long-term outcomes of patients with inflammatory bowel diseases (IBD). Patient-reported outcome measures (PROMs) are used increasingly to monitor disease activity in clinical practice and as endpoints in clinical trials. We performed a systematic review to provide an overview of the available PROMs on IBD activity and to evaluate their diagnostic value. A systematic search of the PubMed, Medline, Cochrane library, and Embase databases using defined keywords, identified 973 articles. These were screened by 2 independent reviewers, and 37 articles on development or validation of PROMs to assess IBD activity were identified for further analysis. Based on the recommendations of the Food and Drug Administration (FDA), the following measurement properties were evaluated: content, construct, and criterion validity; reliability; and responsiveness to change. In addition, data on ease of use in clinical practice were collected. Seventeen articles presenting 20 different PROMs were included the final analysis, although none met all the FDA-recommended criteria. Only 2 PROMs (patient-reported Harvey Bradshaw Index and Simple Clinical Colitis Activity Index scores) reported patient involvement during its development. Only 6 PROMs (patient-reported global assessment, patient assessment of disease activity, mobile health index for Crohn's disease, mobile health index for ulcerative colitis, patient-reported outcome derived from the Mayo score, and the 6-point Mayo score) were validated as markers of IBD activity, using findings from endoscopy as the reference standard; these PROMs identified patients with mucosal inflammation with area under the curve values of 0.63-0.82. The mobile health index for CD and UC scores had the best measurement properties for use in clinical practice and in clinical trials. In a systematic review, we identified more than 20 PROMS that have been developed and tested for their ability to

  19. Patients Reporting Ritual Abuse in Childhood: A Clinical Syndrome. Report of 37 Cases.

    Science.gov (United States)

    Young, Walter C.; And Others

    1991-01-01

    Thirty-seven adult dissociative disorder patients who reported ritual abuse in childhood by satanic cults are described. A clinical syndrome is presented that includes dissociative states with satanic overtones, posttraumatic stress disorder, survivor guilt, unusual fears, and substance abuse. Questions concerning reliability, credibility, and…

  20. Ultrasonographic and clinical features of fetal cholelithiasis. Three case reports

    International Nuclear Information System (INIS)

    Agnifili, Alessio; Gola, Piersante; Marino, Maria; Verzaro, Roberto; Carducci, Giuseppe; Mancini, Ermanno; Rizzo, Franz Maria; Carducci, Augusto; Biasini, Giancarlo

    1997-01-01

    Fetal cholelithiasis was first diagnosed in 1983 and since then there have been only few reports about the presence of gallstones in the fetus. Maternal conditions, fetal or obstetrical predisposing risk factors have been proposed to have a causative role, by the pathogenesis of fetal gallstones remains unknown. Clinical sequelae of fetal gallstones are poorly understood as well as the role of fetal cholelithiasis in predisposing the adult to gallstones. They report on 3 patients whose cholelithiasis was diagnosed by obstetrical ultrasonography. Repeated ultrasound scans were performed in each patient until resolution of the US images. The goal of US was to correctly identify the number, size and US features of the material within the gallbladder. The presence of distal shadowing or comet-tail artifact was assess. Multiple, small echogenic foci without distal shadowing were recognized in the fetal gallbladder in their patients. In the third case echogenic foci disappeared during pregnancy. In all the cases, US showed no biliary tract abnormality, and neither the mothers nor the patients had clinical or laboratory findings consistent with liver or biliary diseases. The authors discuss a diagnostic protocol to detect and follow-up gallstones in the perinatal period by ultrasonography. In their experience, fetal cholelithiasis confirmed to be a self-limiting disease without complications and did not require any form of therapy. However a close follow-up is indicated in these patients until spontaneous resolution is demonstrated by US

  1. Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals

    Directory of Open Access Journals (Sweden)

    E.D. Moreira Jr.

    2001-11-01

    Full Text Available Results of subgroup analysis (SA reported in randomized clinical trials (RCT cannot be adequately interpreted without information about the methods used in the study design and the data analysis. Our aim was to show how often inaccurate or incomplete reports occur. First, we selected eight methodological aspects of SA on the basis of their importance to a reader in determining the confidence that should be placed in the author's conclusions regarding such analysis. Then, we reviewed the current practice of reporting these methodological aspects of SA in clinical trials in four leading journals, i.e., the New England Journal of Medicine, the Journal of the American Medical Association, the Lancet, and the American Journal of Public Health. Eight consecutive reports from each journal published after July 1, 1998 were included. Of the 32 trials surveyed, 17 (53% had at least one SA. Overall, the proportion of RCT reporting a particular methodological aspect ranged from 23 to 94%. Information on whether the SA preceded/followed the analysis was reported in only 7 (41% of the studies. Of the total possible number of items to be reported, NEJM, JAMA, Lancet and AJPH clearly mentioned 59, 67, 58 and 72%, respectively. We conclude that current reporting of SA in RCT is incomplete and inaccurate. The results of such SA may have harmful effects on treatment recommendations if accepted without judicious scrutiny. We recommend that editors improve the reporting of SA in RCT by giving authors a list of the important items to be reported.

  2. Treatnebt if Addiction - Clinical and Judicial Perspectives: Two Case Reports

    Directory of Open Access Journals (Sweden)

    Sofia Fonseca

    2013-12-01

    Full Text Available The sporadic or chronic use of drugs and alcohol is directly related to conduct disorders and to the triggering of psychopathological states of sub-acute or chronic course. The excessive consumption of alcohol and excessive traffic/consumption of illicit drugs by individuals without mental illness or disability are actions of free will; they are therefore criminally responsible for their behaviour, even if they commit a crime during the state of intoxication, which the individual chose voluntarily to experience. In clinical practice, it is widely accepted that the treatment of these disorders is only effective when the patient accepts it voluntarily and that involuntary commitment (compulsive treatment is only carried out when the psychopathological state associated justifies the presuppositions of Article 12 of the Mental Health Law. However, if the compulsive treatment is of a penal character, mandated by a judge, the individual is obligated to accept treatment, independent of whether or not he suffers from mental illness. The authors present two case studies, one of drug addiction, the other of alcoholism, and discuss the clinical and judicial perspectives on the treatment of these clinical entities.

  3. The triphasics: insights for effective clinical use.

    Science.gov (United States)

    Youngkin, E Q; Miller, L G

    1987-02-01

    Three triphasic oral contraceptive preparations are currently being widely used in the United States. These are Ortho-Novum 7/7/7 (Ortho Pharmaceutical), Tri-Norinyl (Syntex) and Triphasil (Wyeth). The hormone manipulation in these formulations more closely mimics the normal menstrual cycle and decreases the total amount of hormone delivered. These drugs were formulated to decrease menstrual irregularities and nuisance side effects and increase menstrual control, while maintaining efficacy and safety. This article describes these products, their mechanisms of action, efficacy and selected areas of concern for clinical practice in relation to side effects, safety and menstrual control. Findings and suggestions related to the therapeutic administration, patient use, counseling and management of these newer oral contraceptives will assist the nurse practitioner in providing optimum care to the consumer.

  4. Clinical evaluation based on cost-effectiveness

    International Nuclear Information System (INIS)

    Inoue, Takehiro; Inoue, Toshihiko

    1998-01-01

    We carried out two Phase III clinical trials using high dose rate (HDR) remote afterloading brachytherapy unit. We evaluated the clinical results based not only on the medical but also the economical standpoint. The first trial is the Phase III trial for cervical cancer treated with HDR or medium dose rate (MDR) intracavitary radiotherapy. The second one is the Phase III trial for tongue cancer treated with HDR or low dose rate (LDR) interstitial radiation. For cervical cancer, the survival rate of patients treated with HDR brachytherapy is the some as for LDR brachytherapy. The average total cost of treatment for the HDR group was 1.47 million yen, while that for the MDR group was 1.58 million yen. The average total admission days was 63. For tongue cancer, the local control rate of the HDR group is almost the same as that of the LDR groups. The average total cost for the HDR group was 780 thousand yen, and that for the LDR group was 830 thousand yen. The average total admission days was 34. According to the cost-effectiveness, HDR brachytherapy for cervical cancer has the same result as MDR, and HDR brachytherapy for tongue cancer has the same result as LDR. However, HDR can be treated without admission for patients who live near the hospital. HDR can be applied for these patients with less expense. We must be aware of not only the medical results but also the cost-effectiveness. (author)

  5. FAMILIAL AMYLOID POLYNEUROPATHY——CLINICAL REPORT OF A FAMILY

    Institute of Scientific and Technical Information of China (English)

    李延峰; 郭玉璞; 池田修一; 方定华

    1996-01-01

    This paper reports a familial amyloid polyneumpathy (FAP) family in China. This family being investigated had 69 members of five generations. From the third generation, there have been 16 patients. The age of onset was about 3 to 5 decades. The initial symptoms were autonomic nerve symptcans, such as impotence, dyspepaia and diarrhoea, associated with the sensory loss of lower extremities. As the disease progressed. the upper extremities and motor ability were also involved. The duration of disease course wasabout 8-10 years, most patients died of infection and cacbexia. Sural biopsy in 3 patients had showed positive Congo red staining. From the clinical view, this FAP family is similar to FAP I found in Japan. Thetrue classification, however, should be confirmed by further genetic analysis.

  6. Effects of reiki in clinical practice: a systematic review of randomised clinical trials.

    Science.gov (United States)

    Lee, M S; Pittler, M H; Ernst, E

    2008-06-01

    The aim of this systematic review is to summarise and critically evaluate the evidence for the effectiveness of reiki. We searched the literature using 23 databases from their respective inceptions through to November 2007 (search again 23 January 2008) without language restrictions. Methodological quality was assessed using the Jadad score. The searches identified 205 potentially relevant studies. Nine randomised clinical trials (RCTs) met our inclusion criteria. Two RCTs suggested beneficial effects of reiki compared with sham control on depression, while one RCT did not report intergroup differences. For pain and anxiety, one RCT showed intergroup differences compared with sham control. For stress and hopelessness a further RCT reported effects of reiki and distant reiki compared with distant sham control. For functional recovery after ischaemic stroke there were no intergroup differences compared with sham. There was also no difference for anxiety between groups of pregnant women undergoing amniocentesis. For diabetic neuropathy there were no effects of reiki on pain. A further RCT failed to show the effects of reiki for anxiety and depression in women undergoing breast biopsy compared with conventional care. In total, the trial data for any one condition are scarce and independent replications are not available for each condition. Most trials suffered from methodological flaws such as small sample size, inadequate study design and poor reporting. In conclusion, the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore the value of reiki remains unproven.

  7. Streptococcal necrotizing myositis: a case report and clinical review.

    Science.gov (United States)

    Hourmozdi, Justin J; Hawley, Dean A; Hadi, Christiane M; Tahir, Bilal; Seupaul, Rawle A

    2014-03-01

    Streptococcal necrotizing myositis, also known as gangrenous myositis, is a very rare and severe soft tissue infection that predominately involves skeletal muscle and, eventually, superficial fascia and surrounding tissues. The presentation is often nonspecific until the rapidly progressing clinical course becomes apparent. A high morbidity and mortality rate has been reported in the small number of cases since 1900. Despite several attempts to better define the different entities causing necrotizing myositis, no single definitive causal relationship has been defined. A review of the literature is presented here to help clinicians distinguish those with necrotizing myositis from those with nonnecrotizing myositis when the clinician is at all confronted with the suspicion for such an infection. The case presented is that of a 48-year-old woman who had streptococcal necrotizing myositis. She died roughly 72 h after admission. After the patient's death, the clinical team sought consent for autopsy. Hospital staff made contact with family, and information was obtained from the family that the onset of the patient's symptoms was allegedly temporally related to her acquisition of a new tattoo on the right back, where the tattoo process allegedly included injection of cremated ashes of a pet dog. A high level of suspicion for necrotizing myositis must be maintained for a patient with unexplained severe muscle pain and soft tissue swelling accompanied by systemic inflammatory response syndrome. Copyright © 2014 Elsevier Inc. All rights reserved.

  8. Clinical signs, diagnosis, and case reports of Vaccinia virus infections

    Directory of Open Access Journals (Sweden)

    Daniela Carla Medeiros Silva

    Full Text Available Vaccinia virus is responsible for a zoonosis that usually affects cattle and human beings in Brazil. The initial clinical signs of the infection are focal red skin areas, fever, and general symptoms similar to those of a cold. Then, pustules and ulcerated lesions surrounded by edema and erythema follow, as well as local lymphadenopathy that can last for weeks. Cure and healing of the lesions occur over several weeks, leaving a typical scar in the skin of people and animals affected. The infection definitive diagnosis is made through morphological characterization of the virus by use of electron microscopy, followed by PCR for specific viral genes. Since 1963, circulating orthopoxviruses in infectious outbreaks in several regions of Brazil have been reported. Later, the etiological agent of those infections was characterized as samples of Vaccinia virus. In addition, the widespread use of those viruses in research laboratories and mass vaccination of militaries have contributed to increase the cases of those infections worldwide. Thus, several epidemiological and clinical studies are required, as well as studies of viral immunology, public health, and economic impact, because little is known about those Vaccinia virus outbreaks in Brazil.

  9. Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

    Science.gov (United States)

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-01-01

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

  10. Improved clinical documentation leads to superior reportable outcomes: An accurate representation of patient's clinical status.

    Science.gov (United States)

    Elkbuli, Adel; Godelman, Steven; Miller, Ashley; Boneva, Dessy; Bernal, Eileen; Hai, Shaikh; McKenney, Mark

    2018-05-01

    Clinical documentation can be an underappreciated. Trauma Centers (TCs) are now routinely evaluated for quality performance. TCs with poor documentation may not accurately reflect actual injury burden or comorbidities and can impact accuracy of mortality measures. Markers exist to adjust crude death rates for injury severity: observed over expected deaths (O/E) adjust for injury; Case Mix Index (CMI) reflects disease burden, and Severity of Illness (SOI) measures organ dysfunction. We aim to evaluate the impact of implementing a Clinical Documentation Improvement Program (CDIP) on reported outcomes. Review of 2-years of prospectively collected data for trauma patients, during the implementation of CDIP. A two-group prospective observational study design was used to evaluate the pre-implementation and the post-implementation phase of improved clinical documentation. T-test and Chi-Squared were used with significance defined as p deaths out of 1419 (3.45%), while post-implementation period, had 38 deaths out of 1454 (2.61%), (non-significant). There was however, a significant difference between O/E ratios. In the pre-phase, the O/E was 1.36 and 0.70 in the post-phase (p < 0.001). The two groups also differed on CMI with a pre-group mean of 2.48 and a post-group of 2.87 (p < 0.001), indicating higher injury burden in the post-group. SOI started at 2.12 and significantly increased to 2.91, signifying more organ system dysfunction (p < 0.018). Improved clinical documentation results in improved accuracy of measures of mortality, injury severity, and comorbidities and a more accurate reflection in O/E mortality ratios, CMI, and SOI. Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  11. Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

    Science.gov (United States)

    Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B

    2017-01-01

    A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of

  12. Quality assessment of reports on clinical trials in the Journal of Hepatology

    DEFF Research Database (Denmark)

    Gluud, C; Nikolova, D

    1998-01-01

    Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make...... a qualitative assessment of the reporting....

  13. A time series analysis of the effects of financial incentives and mandatory clinical applications as interventions to improve spontaneous adverse drug reaction reporting by hospital medical staff in China.

    Science.gov (United States)

    Chang, Feng; Xi, Yue; Zhao, Jie; Zhang, Xiaojian; Lu, Yun

    2017-12-01

    Spontaneous reporting of adverse drug reactions (ADRs) in hospitals is often under-reported, which may lead to problems in patient management. This study was aimed to assess the effectiveness of a financial intervention based on a fine and a bonus for improving spontaneous reporting of ADRs by physicians in a hospital setting. This study was conducted at the First Affiliated Hospital of Zhengzhou University (China). Starting in 2009, a bonus of 20 RMB (Chinese currency) was given for each spontaneous ADR report, and a fine of 50 RMB was given for any withheld ADR report. A time series analysis using autoregressive integrated moving average models was performed to assess the changes in the total number of spontaneous ADR reports between the preintervention period (2006-2008) and during the first (2009-2011) and second (2012-2014) intervention periods. The median number of reported ADRs per year increased from 29 (range 27-72) in the preintervention period to 277 (range 199-284) in the first intervention period and to 666 in the second (range 644-691). The monthly number of reported ADRs was stable during the 3 periods: 3.56 ± 3.60/month (95% confidence interval (CI), 2.42-4.75) during the preintervention period, 21 ± 13/month (95% CI, 16.97-25.80) in the first intervention period, and 56 ± 20/month (95% CI, 48.81-62.17) in the second intervention period. A financial incentive and ADR management regulations had a significant effect on the increase of reported ADRs. © 2017 John Wiley & Sons, Ltd.

  14. Confidence intervals for effect sizes: compliance and clinical significance in the Journal of Consulting and clinical Psychology.

    Science.gov (United States)

    Odgaard, Eric C; Fowler, Robert L

    2010-06-01

    In 2005, the Journal of Consulting and Clinical Psychology (JCCP) became the first American Psychological Association (APA) journal to require statistical measures of clinical significance, plus effect sizes (ESs) and associated confidence intervals (CIs), for primary outcomes (La Greca, 2005). As this represents the single largest editorial effort to improve statistical reporting practices in any APA journal in at least a decade, in this article we investigate the efficacy of that change. All intervention studies published in JCCP in 2003, 2004, 2007, and 2008 were reviewed. Each article was coded for method of clinical significance, type of ES, and type of associated CI, broken down by statistical test (F, t, chi-square, r/R(2), and multivariate modeling). By 2008, clinical significance compliance was 75% (up from 31%), with 94% of studies reporting some measure of ES (reporting improved for individual statistical tests ranging from eta(2) = .05 to .17, with reasonable CIs). Reporting of CIs for ESs also improved, although only to 40%. Also, the vast majority of reported CIs used approximations, which become progressively less accurate for smaller sample sizes and larger ESs (cf. Algina & Kessleman, 2003). Changes are near asymptote for ESs and clinical significance, but CIs lag behind. As CIs for ESs are required for primary outcomes, we show how to compute CIs for the vast majority of ESs reported in JCCP, with an example of how to use CIs for ESs as a method to assess clinical significance.

  15. Clinical Prediction Models for Cardiovascular Disease: Tufts Predictive Analytics and Comparative Effectiveness Clinical Prediction Model Database.

    Science.gov (United States)

    Wessler, Benjamin S; Lai Yh, Lana; Kramer, Whitney; Cangelosi, Michael; Raman, Gowri; Lutz, Jennifer S; Kent, David M

    2015-07-01

    Clinical prediction models (CPMs) estimate the probability of clinical outcomes and hold the potential to improve decision making and individualize care. For patients with cardiovascular disease, there are numerous CPMs available although the extent of this literature is not well described. We conducted a systematic review for articles containing CPMs for cardiovascular disease published between January 1990 and May 2012. Cardiovascular disease includes coronary heart disease, heart failure, arrhythmias, stroke, venous thromboembolism, and peripheral vascular disease. We created a novel database and characterized CPMs based on the stage of development, population under study, performance, covariates, and predicted outcomes. There are 796 models included in this database. The number of CPMs published each year is increasing steadily over time. Seven hundred seventeen (90%) are de novo CPMs, 21 (3%) are CPM recalibrations, and 58 (7%) are CPM adaptations. This database contains CPMs for 31 index conditions, including 215 CPMs for patients with coronary artery disease, 168 CPMs for population samples, and 79 models for patients with heart failure. There are 77 distinct index/outcome pairings. Of the de novo models in this database, 450 (63%) report a c-statistic and 259 (36%) report some information on calibration. There is an abundance of CPMs available for a wide assortment of cardiovascular disease conditions, with substantial redundancy in the literature. The comparative performance of these models, the consistency of effects and risk estimates across models and the actual and potential clinical impact of this body of literature is poorly understood. © 2015 American Heart Association, Inc.

  16. Clinical analysis of polycythemia after kidney transplantation: 65 cases report

    Directory of Open Access Journals (Sweden)

    Chao ZHANG

    2014-01-01

    Full Text Available Objective To analyze the clinical characteristics, risk factors, treatment and turnover of the polycythemia after kidney transplantation. Methods The clinical data of 329 renal transplantation recipients who had undergone kidney transplantation in the Transplant Center of 309 Hospital of PLA from Jan. 2008 to Jan. 2012, were retrospectively analyzed. Posttransplant erythrocytosis (PTE was found in 65 recipients (PTE group, and no PTE was found in 264 recipients (control group. The pre- and post-operative parameters, the therapeutic effect of different treatments, and outcomes were compared between PTE group and control group. Results Patients in PTE group were younger, and the ratio of males was higher compared with that of control group (P0.05. PTE incidence was higher in recipients (24.3%, n=185 who had accepted cyclosporine than those recipients (13.9%, n=144 who had accepted tacrolimus, and the difference was statistically significant (P0.05, but the relapse rate and the embolism rate due to concurrent thrombus were lower in conservative treatment group than in venesection group with statistical significance (P<0.05. Conclusion PTE is more common in male recipients with good graft function. Smoking, high nutritional status, concomitant hypertension and diabetes are the risk factors for PTE. Administration of tacrolimus may reduce the PTE incidence. Compared with venesection treatment, conservative treatment may be more effective in treating PTE with lower relapse rate and embolism rate due to concurrent thrombus. DOI: 10.11855/j.issn.0577-7402.2013.12.10

  17. Clinical effects of Bofutsushosan to obese patients

    International Nuclear Information System (INIS)

    Shintani, Takahiro; Tahara, Eiichi; Moriyama, Kenzou; Nakao, Kikuyo; Takaya, Yutaka; Amatsu, Akinori; Izutani, Satoru; Tsukioka, Yasuyuki; Sowa, Tomoko

    2007-01-01

    Performed was a clinical open trial to examine the anti-obesity effect of Bofutsushosan, a Japanese OTC, oriental herbal medicine (ROHTO Pharma. Co., Ltd.) used for constipation release. Subjects were 40-65 years old, 20 females with the body mass index 25-35, who t.i.d. ingested 3 tablets of the medicine, which corresponding to 3.0 g of dried extract of the Bofutsusho material per day, for 6 months (Sep. 2006-Feb. 2007). Before, 3 and 6 months after the beginning of the study, CT imaging was done to measure the fat areas on umbilical cross section for efficacy evaluation, with Siemens SOMATOM Sensation 16. Total, subcutaneous and inter-visceral fat areas were found to be significantly reduced by medication as well as improvement in other body-measure, hematological and biochemical parameters related with obesity and metabolism. No significant adverse effects were found. The medicine can be useful for improvement of the so-called metabolic syndrome not only for obesity and constipation. (R.T.)

  18. Children's self reported discomforts as participants in clinical research.

    NARCIS (Netherlands)

    Staphorst, M.S.; Hunfeld, J.A.M.; van de Vathorst, S.; Passchier, J.; van Goudoever, J.B.

    2015-01-01

    Introduction: There is little empirical evidence on children's subjective experiences of discomfort during clinical research procedures. Therefore, Institutional Review Boards have limited empirical information to guide their decision-making on discomforts for children in clinical research. To get

  19. Children's self reported discomforts as participants in clinical research

    NARCIS (Netherlands)

    Staphorst, Mira S.; Hunfeld, Joke A. M.; van de Vathorst, Suzanne; Passchier, Jan; van Goudoever, Johannes B.

    2015-01-01

    There is little empirical evidence on children's subjective experiences of discomfort during clinical research procedures. Therefore, Institutional Review Boards have limited empirical information to guide their decision-making on discomforts for children in clinical research. To get more insight

  20. Clinical outcomes of the inclusion of the therapeutic drug monitoring report in the electronic clinical record

    Directory of Open Access Journals (Sweden)

    Marina Sáez Belló

    2016-12-01

    Full Text Available Objectives: To assess the inclusion of the Therapeutic Drug Monitoring Report (TDMR in the Electronic Clinical Record (ECR. Method: An observational ambispective cohort study with a duration of 149 days: PRE (retrospective, 49 days with the TDMR printed in paper, and POST (prospective, 100 days with the TDMR included in the ECR. Exclusion criteria: Patients not hospitalized, applications for Therapeutic Drug Monitoring by Critical Care and Neonatal Units, as well as monitoring with an objective other than dose adjustment. Variables: Number of TDMRs prepared, number of patients admitted with TDMR, time of delay for treatment adjustment, defined as the number of adjustments made to the treatment within over or under 24 hours from the time of TDMR preparation, and medication errors (MEs associated with said delay, as well as the degree of acceptance of the TDMR. Results: 690 TDMRs were conducted in 391 patients, 339 in PRE (n = 206 and 351 in POST (n = 185. The number of treatment modifications made in under 24 hours increased from 73.9% in PRE to 87.3% in POST [RR = 1.2 (CI95% = 0.97-1.43. We identified 35 patients with ME, 9.7% of them in PRE and 8.1% in POST (RR = 0.84 (CI95% = 0.44-1.58]. The degree of acceptance of the pharmacist recommendation increased from 53.3% in PRE to 68.3% in POST [RR = 1.3 (CI95% = 1.02- 1.62]. Conclusions: The inclusion of the Therapeutic Drug Monitoring Report (TDMR in the Electronic Clinical Record increases the degree of acceptance of recommendations, and may reduce the delay in treatment modifications, reducing MEs and improving the process quality in terms of efficacy and safety

  1. Effectiveness of manual therapies: the UK evidence report

    OpenAIRE

    Bronfort, Gert; Haas, Mitch; Evans, Roni; Leininger, Brent; Triano, Jay

    2010-01-01

    Abstract Background The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions. Methods The conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs), widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet incl...

  2. Orthokeratinized Odontogenic Cyst: A Report of Three Clinical Cases

    Directory of Open Access Journals (Sweden)

    María del Carmen González Galván

    2013-01-01

    Full Text Available The orthokeratinized odontogenic cyst (OOC is a rare developmental odontogenic cyst that has been considered as a variant of the keratocystic odontogenic tumour (KCOT until Wright (1981 defined it as a different entity. Surgery is the usual treatment, and recurrence or association with Gorlin-Goltz syndrome has rarely been described. In this report, we presented three cases of this pathology, and we review the principal clinical, histological, radiological, and therapeutic aspects. Case 1. A 73-year-old female presents with a slight swelling on the right mandible, associated with an unilocular well-defined radiolucent lesion. Case 2. A 27-year-old female presents with a painful mandibular swelling associated with an unilocular radiolucent lesion posterior to the 4.8. Case 3. A 61-year-old male was casually detected presents with an unilocular radiolucent lesion distal to the 4.8. Conclusion. The OOC is a specific odontogenic clinicopathological entity that should be differentiated from the KCOT as it presents a completely different biological behaviour.

  3. [Nursing methodology applicated in patients with pressure ulcers. Clinical report].

    Science.gov (United States)

    Galvez Romero, Carmen

    2014-05-01

    The application of functional patterns lets us to make a systematic and premeditated nursing assessment, with which we obtain a lot of relevant patient data in an organized way, making easier to analize them. In our case, we use Marjory Gordon's functional health patterns and NANDA (North American Nursing Diagnosis Association), NOC (Nursing Outcomes Classification), NIC (Nursing Intervention Classification) taxonomy. The overall objective of this paper is to present the experience of implementation and development of nursing methodology in the care of patients with pressure ulcers. In this article it's reported a case of a 52-year-old female who presented necrosis of phalanxes in upper and lower limbs and suffered amputations of them after being hospitalized in an Intensive Care Unit. She was discharged with pressure ulcers on both heels. GENERAL ASSESSMENT: It was implemented the nursing theory known as "Gordon's functional health patterns" and the affected patterns were identified. The Second Pattern (Nutritional-Metabolic) was considered as reference, since this was the pattern which altered the rest. EVOLUTION OF THE PATIENT: The patient had a favourable evolution, improving all the altered patterns. The infections symptoms disappeared and the pressure ulcers of both heels healed completely. The application of nursing methodology to care patients with pressure ulcers using clinical practice guidelines, standardized procedures and rating scales of assessment improves the evaluation of results and the performance of nurses.

  4. Closed-eye orbital prosthesis: a clinical report.

    Science.gov (United States)

    Hatamleh, Muhanad M; Watson, Jason; Srinivasan, Dilip

    2015-03-01

    One of the most challenging prostheses to fabricate is an acceptable orbital prosthesis. Successful reconstruction of the complex missing tissues, the globe, muscle, skin, and bony elements requires time and high levels of practical skill. A good match to the contralateral nondefect side will help mask the underlying defect and give the patient confidence to return to normal, routine life. The contralateral eye opening will commonly dictate the eye opening of such a prosthesis, but because of the expressive nature of the eye and its high levels of mobility, this can be difficult to achieve. This clinical report presents a patient who had an extended orbital exenteration and right maxillectomy to remove a maxillary squamous cell carcinoma. An alternative approach to constructing an orbital prosthesis was undertaken with the eye closed. Compared to the normal method of fabrication, this process was less complex and quicker, made the prosthesis less "staring," camouflaged the defect, and reduced the detection of the prosthesis because of movements in the remaining eye. The patient engaged in his routine daily life, which reinforced his self-esteem, confidence, and reintegration into the community. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  5. Multidisciplinary Clinical Management of Paraneoplastic Pemphigus – A Case Report

    Directory of Open Access Journals (Sweden)

    Sadaksharam Jayachandran

    2017-10-01

    Full Text Available Paraneoplastic pemphigus is a rare immunobullous disorder commonly associated with lymphoproliferative neoplasms and less commonly in carcinomas with a poor prognosis. The neoplasms produce autoantibodies that react with members of plakin family to produce a suprabasilar split and varied clinical presentations in the skin and mucous membrane. Oral erosions are the first manifestation most resistant to treatment and persist even after the underlying tumour has been resected or treated. We report here a rare case of paraneoplastic pemphigus with an underlying squamous cell carcinoma of the oesophagus that constitutes only 8% of the neoplasms associated with this condition. It was successfully managed by a multidisciplinary approach involving the Departments of Dermatology, Surgical Oncology and Oral Medicine. The oral erosions were resistant to treatment however, a patient-tailored treatment was advocated using professionally administered debridement with hydrogen peroxide diluted with hypotonic saline, high potency topical steroids, analgesic oral rinses and topical anaesthetics with systemically administered immunomodulators. Hence, management of such cases exhibiting systemic and oral manifestations require a multidisciplinary team approach to improve the quality of life of the patients.

  6. Clinical educators' self-reported personal and professional ...

    African Journals Online (AJOL)

    The target group was inter-professional clinical educators that are involved in student education on the clinical platform. Although the course participants were professionals and specialists in their own fields, the majority of clinical educators have very little or no knowledge of adult education. The Supervision Course aims to ...

  7. Consistency between Self-Reported and Recorded Values for Clinical Measures

    OpenAIRE

    III, Joseph Thomas; Paulet, Mindy; Rajpura, Jigar R.

    2016-01-01

    Objectives. This study evaluated consistency between self-reported values for clinical measures and recorded clinical measures. Methods. Self-reported values were collected for the clinical measures: systolic blood pressure, diastolic blood pressure, glucose level, height, weight, and cholesterol from health risk assessments completed by enrollees in a privately insured cohort. Body mass index (BMI) was computed from reported height and weight. Practitioner recorded values for the clinical me...

  8. Environment-effect reporting. Chapter 6

    International Nuclear Information System (INIS)

    Hermens, P.A.H.

    1989-01-01

    Environment-effect reporting is a tool in the resolution of one or more government bodies about activities which may have important disadvantageous impacts upon the environment. This chapter gives a treatment of environment-effect reporting as a process consisting of the preparation, draw-up, judgement and use of an environment-effect report (MER), followed by an evaluation. The contentsof an environment-effect report are indicated. The role of environment-effect reporting in relation with other procedures is discussed. Some experience with the application of environment-effect reporting is presented and a number of experiences in the application are discussed. (H.W.). 5 refs.; 3 figs.; 3 tabs

  9. How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

    Science.gov (United States)

    Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

    2017-09-18

    Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive

  10. Traumatic Maculopathy 6 Months after Injury: A Clinical Case Report

    Directory of Open Access Journals (Sweden)

    Sílvia Mendes

    2014-03-01

    Full Text Available Purpose: This study aims to report a case of traumatic maculopathy in a 12-year-old male following blunt trauma in his left eye (LE who presented 6 months after injury. Methods: Retrospective and descriptive case report based on data from clinical records, patient observation and analysis of diagnostic tests. Results: A previously healthy, 12-year-old male presented for a routine visit with complaints of a 2-month history of decreased visual acuity in his LE. Six months before the initial visit, he suffered blunt trauma to the LE during a struggle and had no medical observation. At the visit, best-corrected visual acuity (BCVA in the LE was counting fingers and in the right eye, it was 20/20. Fundus examination of the LE showed a central macular lesion of 1 disc diameter with fibrosis, increased retinal thickness and intraretinal hemorrhage. Optical coherence tomography showed disruption of the inner/outer segment (IS/OS photoreceptor junction, increased reflectivity, cell infiltration of the retinal wall and retinal pigment epithelium detachment. Retinal thickness was 289 μm at the site of the lesion. A fluorescein angiogram revealed early impregnation and late diffusion. High-dose steroid pulse therapy (intravenous methylprednisolone 500 mg for 3 days and oral prednisolone 30 mg, tapering for 10 days was done. LE BCVA increased to 20/200, and retinal thickness decreased by 71 μm 1 week after treatment. Off-label intravitreal triamcinolone (IVTA; 0.05 ml/2 mg was administered 2 weeks after oral treatment in an attempt to achieve additional improvement. Three weeks after IVTA, LE BCVA improved to 20/150 and retinal thickness decreased by 10 μm. Three months after the initial visit, LE BCVA was 20/125 and retinal thickness 208 μm. Conclusion: We present a case of commotio retinae caused by an ocular blunt trauma 6 months before, with loss of BCVA. BCVA improved after oral steroids and IVTA. Nevertheless, fibrosis and disruption of the IS

  11. Effect of operator and institutional volume on clinical outcomes after percutaneous coronary interventions performed in Canada and the United States: a brief report from the Enhanced Suppression of the Platelet glycoprotein IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) study.

    Science.gov (United States)

    Madan, Mina; Nikhil, Janarthan; Hellkamp, Anne S; Pieper, Karen S; Labinaz, Marino; Cohen, E A; Buller, Christopher E; Cantor, Warren J; Seidelin, Peter; Ducas, John; Carere, Ronald G; Natarajan, Madhu K; O'Shea, J Conor; Tcheng, James E

    2009-08-01

    The Enhanced Suppression of the Platelet glycoprotein IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial compared the use of eptifibatide with placebo in 2064 coronary intervention patients. It was previously reported that Canadian patients had reduced rates of 30-day and one-year death, myocardial infarction (MI) or target vessel revascularization (TVR) compared with patients in the United States (US). To examine whether operator or institutional volume differences explain the regional variation in clinical outcome. Each site received an operator and institutional volume survey. Fifty-seven sites (62%) returned complete data on 1338 patients. In this smaller cohort, Canadian patients had reduced rates of 30-day and one-year death, MI or TVR compared with US patients (6.3% versus 10.3% and 14.9% versus 20.1%, respectively; PESPRIT study, institutional volume was associated with a modest reduction in risk of death, MI or TVR over short- and long-term follow-up periods. The Canadian and US investigators and institutions selected in ESPRIT had similar annual procedural volumes. Therefore, volume variables did not explain the differential risk of clinical events observed for patients enrolled in the two countries.

  12. The Consumer Reports Effectiveness Score: What Did Consumers Report?

    Science.gov (United States)

    Nielsen, Stevan Lars; Smart, David W.; Isakson, Richard L.; Worthen, Vaughn E.; Gregersen, Ann T.; Lambert, Michael J.

    2004-01-01

    From readers' ratings of satisfaction, problem resolution, and perceived emotional change during treatment, Consumer Reports magazine (CR, 1995) concluded both that psychotherapy is effective and that longer, more intensive therapy is more effective. The authors compared prospectively gathered 45-Item Outcome Questionnaire scores (OQ-45; M. J.…

  13. Combining radiotherapy and ipilimumab induces clinically relevant radiation-induced abscopal effects in metastatic melanoma patients: A systematic review

    Directory of Open Access Journals (Sweden)

    Rodolfo Chicas-Sett

    2018-02-01

    Conclusion: Early clinical outcomes reports suggest that the combination of ipilimumab and RT may improve survival in metastatic melanoma patients. The abscopal responses become a clinically relevant effect of such combination and should be studied in controlled randomized trials.

  14. Clinical diagnosis and treatment of necrotizing ulcerative gingivitis in the orthodontic patient. A case report.

    Directory of Open Access Journals (Sweden)

    Jesús Rodríguez-Pulido

    2016-04-01

    Full Text Available Introduction: About 0.1% of the population suffers from necrotizing ulcerative gingivitis, a disease of rapid progression and acute manifestation, which may progress to necrotizing ulcerative periodontitis and eventually to bone sequestration and loss of gingival tissue. Case report: A 21-year-old female patient undergoing orthodontic treatment for six months, diagnosed with necrotizing ulcerative gingivitis due to acute pain in the gingival tissue, spontaneous bleeding, halitosis and abundant plaque. The treatment was conservative and effective, obtaining total remission of the lesion after seven days and three months of postoperative follow-up. Conclusion: Today there are no epidemiological or clinical reports that support the relationship of necrotizing ulcerative gingivitis and orthodontic treatment. Prevention is critical to the success of the treatment, which is why the dentist should recognize the clinical features of necrotizing ulcerative gingivitis to raise awareness of its risks in the orthodontic patient.

  15. Preclinical and Clinical Effects of Mistletoe against Breast Cancer

    Directory of Open Access Journals (Sweden)

    Mohsen Marvibaigi

    2014-01-01

    Full Text Available Breast cancer is among the most frequent types of cancer in women worldwide. Current conventional treatment options are accompanied by side effects. Mistletoe is amongst the important herbal medicines traditionally used as complementary remedies. An increasing number of studies have reported anticancer activity of mistletoe extracts on breast cancer cells and animal models. Some recent evidence suggests that cytotoxic activity of mistletoe may be mediated through different mechanisms. These findings provide a good base for clinical trials. Various studies on mistletoe therapy for breast cancer patients revealed similar findings concerning possible benefits on survival time, health-related quality of life (HRQoL, remission rate, and alleviating adverse reactions to conventional therapy. This review provides an overview of the recent findings on preclinical experiments and clinical trials of mistletoe for its cytotoxic and antitumor activity and its effect on HRQoL in breast cancer patients. Moreover, studies investigating molecular and cellular mechanisms underlying antitumor activity of mistletoe are discussed in this paper. The analyzed trials provided evidence that there might be a combination of pharmacological and motivational aspects mediated by the mistletoe extract application which may contribute to the clinical benefit and positive outcome such as improved HRQoL and self-regulation in breast cancer patients.

  16. 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

  17. 'Cloud computing' and clinical trials: report from an ECRIN workshop.

    Science.gov (United States)

    Ohmann, Christian; Canham, Steve; Danielyan, Edgar; Robertshaw, Steve; Legré, Yannick; Clivio, Luca; Demotes, Jacques

    2015-07-29

    Growing use of cloud computing in clinical trials prompted the European Clinical Research Infrastructures Network, a European non-profit organisation established to support multinational clinical research, to organise a one-day workshop on the topic to clarify potential benefits and risks. The issues that arose in that workshop are summarised and include the following: the nature of cloud computing and the cloud computing industry; the risks in using cloud computing services now; the lack of explicit guidance on this subject, both generally and with reference to clinical trials; and some possible ways of reducing risks. There was particular interest in developing and using a European 'community cloud' specifically for academic clinical trial data. It was recognised that the day-long workshop was only the start of an ongoing process. Future discussion needs to include clarification of trial-specific regulatory requirements for cloud computing and involve representatives from the relevant regulatory bodies.

  18. Capital Allocation Effects of Financial Reporting Regulation

    NARCIS (Netherlands)

    Koenigsgruber, R.

    2012-01-01

    This paper analyses the effects of stricter financial reporting enforcement on capital allocation and reporting quality in a game-theoretic model and derives conclusions about optimal enforcement strictness. Analysis of the model shows that reporting quality strictly increases with tighter

  19. [Clinical effect of bipolar radiofrequency thermotherapy on allergic rhinitis].

    Science.gov (United States)

    Oyake, Daisuke; Ochi, Kentaro; Takatsu, Mitsuharu; Shintani, Toshiharu; Umehara, Tsuyoshi; Koizuka, Izumi

    2004-07-01

    The clinical effect of bipolar radiofrequency thermotherapy on allergic rhinitis was evaluated. A bipolar radiofrequency system (CelonLab ENT) was used to treat 16 patients suffering from allergic rhinitis between February 2003 and August 2003. The thermotherapy was performed under local anesthesia at the otolaryngology outpatient clinic of St. Marianna University Toyoko Hospital. Data were collected by questionnaire and rhinomanometry preoperatively and 2 months postoperatively. The mean visual analogue scale (VAS) score for intraoperative pain was 31 mm (range, 0-100), and nearly all the patients felt no or a subtle pain during the thermotherapy. Postoperative pain was also well tolerated, with nearly all the patients not requiring analgesic drugs. Postoperative bleeding was minor, and none of the patients required additional treatment for bleeding. Nearly all the patients reported an improvement in their nasal patency, rhinorrhea, headaches, and sleeping. Statistically significant improvements were observed for all the measured VAS scores: nasal patency, rhinorrhea, headache, and olfactory function. Nasal resistance, as measured by anterior rhinomanometry, significantly improved after treatment. The effect of decongestion was also measured using anterior rhinomanometry. The ratio of nasal resistance before and after decongestion was significantly higher after thermotherapy, suggesting that nasal decongestion had a smaller effect on nasal patency after treatment. The current results suggest that the CelonLab ENT device is an effective and safe treatment for allergic rhinitis.

  20. The effect of reporting speed on plain film reporting errors

    International Nuclear Information System (INIS)

    Edwards, A.J.; Ricketts, C.; Dubbins, P.A.; Roobottom, C.A.; Wells, I.P.

    2003-01-01

    AIM: To determine whether reporting plain films at faster rates lead to a deterioration in accuracy. METHODS: Fourteen consultant radiologists were asked to report a total of 90 radiographs in three sets of 30. They reported the first set at the rate they would report normally and the subsequent two sets in two thirds and one half of the original time. The 90 radiographs were the same for each radiologist, however, the order was randomly generated for each. RESULTS: There was no significant difference in overall accuracy for each of the three film sets (p=0.74). Additionally no significant difference in the total number of false-negatives for each film set was detected (p=0.14). However, there was a significant decrease in the number of false-positive reports when the radiologists were asked to report at higher speeds (p=0.003). CONCLUSIONS: When reporting accident and emergency radiographs increasing reporting speed has no overall effect upon accuracy, however, it does lead to less false-positive reports

  1. Teamwork and Clinical Error Reporting among Nurses in Korean Hospitals

    Directory of Open Access Journals (Sweden)

    Jee-In Hwang, PhD

    2015-03-01

    Conclusions: Teamwork was rated as moderate and was positively associated with nurses' error reporting performance. Hospital executives and nurse managers should make substantial efforts to enhance teamwork, which will contribute to encouraging the reporting of errors and improving patient safety.

  2. The clinical testing of male gonad shields. Technical report

    International Nuclear Information System (INIS)

    Church, W.W.; Burnett, B.M.

    1975-11-01

    Two types of male gonad shields, designed for use with support garments, were tested in a number of hospitals and clinics throughout the United States. The clinical evaluation consisted of: (1) measuring dose reduction with thermoluminescent dosimeters; and (2) determining acceptability of the shields for routine use in x-ray facilities, through the use of survey forms completed by patients, technologists, and facilities. The shields proved to provide a basis for a very satisfactory male gonad shield program

  3. The clinical testing of male gonad shields. Technical report

    Energy Technology Data Exchange (ETDEWEB)

    Church, W.W.; Burnett, B.M.

    1975-11-01

    Two types of male gonad shields, designed for use with support garments, were tested in a number of hospitals and clinics throughout the United States. The clinical evaluation consisted of: (1) measuring dose reduction with thermoluminescent dosimeters; and (2) determining acceptability of the shields for routine use in x-ray facilities, through the use of survey forms completed by patients, technologists, and facilities. The shields proved to provide a basis for a very satisfactory male gonad shield program. (GRA)

  4. Effect of voice recognition on radiologist reporting time

    International Nuclear Information System (INIS)

    Bhan, S.N.; Coblentz, C.L.; Norman, G.R.; Ali, S.H.

    2008-01-01

    To study the effect that voice recognition (VR) has on radiologist reporting efficiency in a clinical setting and to identify variables associated with faster reporting time. Five radiologists were observed during the routine reporting of 402 plain radiograph studies using either VR (n 217) or conventional dictation (CD) (n = 185). Two radiologists were observed reporting 66 computed tomography (CT) studies using either VR (n - 39) or CD (n - 27). The time spent per reporting cycle, defined as the radiologist's time spent on a study from report finalization to the subsequent report finalization, was compared. As well, characteristics about the radiologist and their reporting style were collected and correlated against reporting time. For plain radiographs, radiologists took 134% (P = 0.048) more time to produce reports using VR, but there was significant variability between radiologists. Significant association with faster reporting times using VR included: English as a first language (r-0.24), use of a template (r -0.34), use of a headset microphone (r -0.46), and increased experience with VR (r -0.43). Experience as a staff radiologist and having previous study for comparison did not correlate with reporting time. For CT, there was no significant difference in reporting time identified between VR and CD (P 0.61). Overall, VR slightly decreases the reporting efficiency of radiologists. However, efficiency may be improved if English is a first language, a headset microphone, and macros and templates are use. (author)

  5. Combining bimodal presentation schemes and buzz groups improves clinical reasoning and learning at morning report.

    Science.gov (United States)

    Balslev, Thomas; Rasmussen, Astrid Bruun; Skajaa, Torjus; Nielsen, Jens Peter; Muijtjens, Arno; De Grave, Willem; Van Merriënboer, Jeroen

    2014-12-11

    Abstract Morning reports offer opportunities for intensive work-based learning. In this controlled study, we measured learning processes and outcomes with the report of paediatric emergency room patients. Twelve specialists and 12 residents were randomised into four groups and discussed the same two paediatric cases. The groups differed in their presentation modality (verbal only vs. verbal + text) and the use of buzz groups (with vs. without). The verbal interactions were analysed for clinical reasoning processes. Perceptions of learning and judgment of learning were reported in a questionnaire. Diagnostic accuracy was assessed by a 20-item multiple-choice test. Combined bimodal presentation and buzz groups increased the odds ratio of clinical reasoning to occur in the discussion of cases by a factor of 1.90 (p = 0.013), indicating superior reasoning for buzz groups working with bimodal materials. For specialists, a positive effect of bimodal presentation was found on perceptions of learning (p presentation on diagnostic accuracy was noted in the specialists (p presentation and buzz group discussion of emergency cases improves clinicians' clinical reasoning and learning.

  6. The clinical case report: a review of its merits and limitations.

    Science.gov (United States)

    Nissen, Trygve; Wynn, Rolf

    2014-04-23

    The clinical case report has a long-standing tradition in the medical literature. While its scientific significance has become smaller as more advanced research methods have gained ground, case reports are still presented in many medical journals. Some scholars point to its limited value for medical progress, while others assert that the genre is undervalued. We aimed to present the various points of view regarding the merits and limitations of the case report genre. We searched Google Scholar, PubMed and select textbooks on epidemiology and medical research for articles and book-chapters discussing the merits and limitations of clinical case reports and case series. The major merits of case reporting were these: Detecting novelties, generating hypotheses, pharmacovigilance, high applicability when other research designs are not possible to carry out, allowing emphasis on the narrative aspect (in-depth understanding), and educational value. The major limitations were: Lack of ability to generalize, no possibility to establish cause-effect relationship, danger of over-interpretation, publication bias, retrospective design, and distraction of reader when focusing on the unusual. Despite having lost its central role in medical literature in the 20th century, the genre still appears popular. It is a valuable part of the various research methods, especially since it complements other approaches. Furthermore, it also contributes in areas of medicine that are not specifically research-related, e.g. as an educational tool. Revision of the case report genre has been attempted in order to integrate the biomedical model with the narrative approach, but without significant success. The future prospects of the case report could possibly be in new applications of the genre, i.e. exclusive case report databases available online, and open access for clinicians and researchers.

  7. Varenicline in Autism: Theory and Case Report of Clinical and Biochemical Changes.

    Science.gov (United States)

    Mostafavi, Mojdeh; Hardy, Paul; Arnold, L Eugene

    2016-11-01

    To explore the potential benefits of varenicline (CHANTIX ® ), a highly specific partial agonist of neuronal α4β2 nicotinic acetylcholine receptors (nAChR), for autistic symptoms, and present resulting biochemical changes in light of dopamine-related genotype. The clinical and biochemical changes exhibited by a 19-year-old severely autistic man following the use of low-dose varenicline in an ABA experiment of nature, and his genotype, were extracted from chart review. Clinical outcome was measured by the Ohio Autism Clinical Impression Scale and 12 relevant urine and saliva metabolites were measured by Neuroscience Laboratory. With varenicline, this patient improved clinically and autonomic biochemical indicators in saliva and urine normalized, including dopamine, 3,4-dihydroxyphenylacetic acid (DOPAC), epinephrine, norepinephrine, taurine, and histamine levels. In addition, with varenicline, the dopamine D1 receptor (DRD1) antibody titer as well as the percent of baseline calmodulin-dependent protein kinase II (CaM KII) activity dropped significantly. When varenicline stopped, he deteriorated; when it was resumed, he again improved. Doses of 0.5, 1, and 2 mg daily were tried before settling on a dose of 1.5 mg daily. He has remained on varenicline for over a year with no noticeable side effects. This report is, to the best of our knowledge, only the second to demonstrate positive effects of varenicline in autism, the first to show it in a severe case, and the first to show normalization of biochemical parameters related to genotype. As with the previous report, these encouraging results warrant further controlled research before clinical recommendations can be made.

  8. Management of cannabis-induced periodontitis via resective surgical therapy: A clinical report.

    Science.gov (United States)

    Momen-Heravi, Fatemeh; Kang, Philip

    2017-03-01

    There is a lack of clinical research on the potential effect of cannabis use on the periodontium as well as its effect on treatment outcomes. The aim of this case report is to illustrate the clinical presentation of periodontal disease in a young woman who was a chronic cannabis user, as well as successful treatment involving motivating the patient to quit cannabis use and undergo nonsurgical and surgical therapy. A 23-year-old woman sought care at the dental clinic for periodontal treatment. During a review of her medical history, the patient reported using cannabis frequently during a 3-year period, which coincided with the occurrence of gingival inflammation. She used cannabis in the form of cigarettes that were placed at the mandibular anterior region of her mouth for prolonged periods. Localized prominent papillary and marginal gingival enlargement of the anterior mandible were present. The mandibular anterior teeth showed localized severe chronic periodontitis. The clinicians informed the patient about the potentially detrimental consequences of continued cannabis use; she was encouraged to quit, which she did. The clinicians performed nonsurgical therapy (scaling and root planing) and osseous surgery. The treatment outcome was evaluated over 6 months; improved radiographic and clinical results were observed throughout the follow-up period. Substantial availability and usage of cannabis, specifically among young adults, requires dentists to be vigilant about clinical indications of cannabis use and to provide appropriate treatments. Behavioral modification, nonsurgical therapy, and surgical therapy offer the potential for successful management of cannabis-related periodontitis. Copyright © 2017 American Dental Association. Published by Elsevier Inc. All rights reserved.

  9. CT diagnosis and clinical of leukoaraosis (with 145 cases report)

    International Nuclear Information System (INIS)

    Yang Minzheng

    2005-01-01

    Objective: To investigate pathogenesis of leukoaraosis, the correlation between CT presentation and clinical symptom and to provide useful evidence for clinical diagnosis and treatment. Methods: CT presentation and clinical symptoms in the Leukoaraosis of 145 cases were retrospectively analyzed. Results: Leukoaraosis manifested symmetrical hypo-dense lesion adjacent to frontal horn and/or occipital horn of bilateral ventricles; symmetrical hypo-dense peri-ventricle patches; or diffuse hypo-dense white matter. Lacunar infarction or hemorrhage of basal ganglion and/or thalamus may also be revealed. Conclusion: Leukoaraosis often involves the white matter adjacent to the frontal horn and occipital horn of bilateral ventricles. And entire peri-ventricle white matter may be affected in severe cases. The pathology of the disease is related to demyelination of brain white matter, resulting in the characteristic vascularity in white matter, which may alter under hypertension. (authors)

  10. On heterogeneity of treatment effects and clinical freedom.

    Science.gov (United States)

    Sacristán, J A; Avendaño-Solá, C

    2015-01-01

    Three decades ago, John R Hampton announced the death of clinical freedom. Since then, evidence-based medicine has been the predominant paradigm in clinical research. By applying a population-based approach, the randomised controlled trial has become the cornerstone for demonstrating the overall effect of a treatment and for developing guidelines. The new patient-centred medicine movement is rediscovering the important implications of heterogeneity of treatment effects for clinical practice and that a better understanding of such variability can contribute to improve health outcomes for individual patients through practicing a science-based clinical freedom. © 2015 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

  11. Transient epileptic amnesia: clinical report of a cohort of patients.

    Science.gov (United States)

    Lapenta, Leonardo; Brunetti, Valerio; Losurdo, Anna; Testani, Elisa; Giannantoni, Nadia Mariagrazia; Quaranta, Davide; Di Lazzaro, Vincenzo; Della Marca, Giacomo

    2014-07-01

    Transient epileptic amnesia is a seizure disorder, usually with onset in the middle-elderly and good response to low dosages of antiepileptic drugs. We describe the clinical, electroencephalography (EEG), and neuroimaging features of 11 patients with a temporal lobe epilepsy characterized by amnesic seizures as the sole or the main symptom. We outline the relevance of a detailed clinical history to recognize amnesic seizures and to avoid the more frequent misdiagnoses. Moreover, the response to monotherapy was usually good, although the epileptic disorder was symptomatic of acquired lesions in the majority of patients.

  12. A Clinical Report of Psychosis Associated with Hyperthyroidism.

    OpenAIRE

    Asagami, Yoshifumi

    1996-01-01

    A case of hyperthyroidism associated with psychosis of a 49-year-old housewife was reported. A pararell relationship between the hyperthyroidism and the associated psychotic symptoms was observed. The psychotic symptoms was improved by treatment of hyperthyroidism and by administration of psychotonica. It might be noted that the patient in the present report has a predisposition to psychosis.

  13. A direct bonded fixed partial dental prosthesis: A clinical report

    OpenAIRE

    Tanoue, Naomi; Tanaka, Takuo

    2015-01-01

    A direct bonded fixed partial dental prosthesis, with a composite resin denture tooth as a pontic, a tri-n-butylborane initiated adhesive resin, and screw posts for reinforcement, was still functioning after an observation period of 20 years. The prosthesis was found to be reliable for long-term clinical use when chemically and mechanically reinforced.

  14. 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

  15. Interconnecting smartphone, image analysis server, and case report forms in clinical trials for automatic skin lesion tracking in clinical trials

    Science.gov (United States)

    Haak, Daniel; Doma, Aliaa; Gombert, Alexander; Deserno, Thomas M.

    2016-03-01

    Today, subject's medical data in controlled clinical trials is captured digitally in electronic case report forms (eCRFs). However, eCRFs only insufficiently support integration of subject's image data, although medical imaging is looming large in studies today. For bed-side image integration, we present a mobile application (App) that utilizes the smartphone-integrated camera. To ensure high image quality with this inexpensive consumer hardware, color reference cards are placed in the camera's field of view next to the lesion. The cards are used for automatic calibration of geometry, color, and contrast. In addition, a personalized code is read from the cards that allows subject identification. For data integration, the App is connected to an communication and image analysis server that also holds the code-study-subject relation. In a second system interconnection, web services are used to connect the smartphone with OpenClinica, an open-source, Food and Drug Administration (FDA)-approved electronic data capture (EDC) system in clinical trials. Once the photographs have been securely stored on the server, they are released automatically from the mobile device. The workflow of the system is demonstrated by an ongoing clinical trial, in which photographic documentation is frequently performed to measure the effect of wound incision management systems. All 205 images, which have been collected in the study so far, have been correctly identified and successfully integrated into the corresponding subject's eCRF. Using this system, manual steps for the study personnel are reduced, and, therefore, errors, latency and costs decreased. Our approach also increases data security and privacy.

  16. Proton Radiotherapy for Parameningeal Rhabdomyosarcoma: Clinical Outcomes and Late Effects

    Energy Technology Data Exchange (ETDEWEB)

    Childs, Stephanie K. [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Kozak, Kevin R. [Department of Radiation Oncology, University of Wisconsin Cancer Center Johnson Creek, Madison, WI (United States); Friedmann, Alison M. [Department of Pediatric Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Yeap, Beow Y. [Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Adams, Judith; MacDonald, Shannon M.; Liebsch, Norbert J.; Tarbell, Nancy J. [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Yock, Torunn I., E-mail: tyock@partners.org [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States)

    2012-02-01

    Purpose: To report the clinical outcome and late side effect profile of proton radiotherapy in the treatment of children with parameningeal rhabdomyosarcoma (PM-RMS). Methods and Materials: Seventeen consecutive children with PM-RMS were treated with proton radiotherapy at Massachusetts General Hospital between 1996 and 2005. We reviewed the medical records of all patients and asked referring physicians to report specific side effects of interest. Results: Median patient age at diagnosis was 3.4 years (range, 0.4-17.6). Embryonal (n = 11), alveolar (n = 4), and undifferentiated (n = 2) histologies were represented. Ten patients (59%) had intracranial extension. Median prescribed dose was 50.4 cobalt gray equivalents (GyRBE) (range, 50.4-56.0 GyRBE) delivered in 1.8-2.0-GyRBE daily fractions. Median follow-up was 5.0 years for survivors. The 5-year failure-free survival estimate was 59% (95% confidence interval, 33-79%), and overall survival estimate was 64% (95% confidence interval, 37-82%). Among the 7 patients who failed, sites of first recurrence were local only (n = 2), regional only (n = 2), distant only (n = 2), and local and distant (n = 1). Late effects related to proton radiotherapy in the 10 recurrence-free patients (median follow-up, 5 years) include failure to maintain height velocity (n = 3), endocrinopathies (n = 2), mild facial hypoplasia (n = 7), failure of permanent tooth eruption (n = 3), dental caries (n = 5), and chronic nasal/sinus congestion (n = 2). Conclusions: Proton radiotherapy for patients with PM-RMS yields tumor control and survival comparable to that in historical controls with similar poor prognostic factors. Furthermore, rates of late effects from proton radiotherapy compare favorably to published reports of photon-treated cohorts.

  17. Design and Effectiveness of a Required Pre-Clinical Simulation-based Curriculum for Fundamental Clinical Skills and Procedures

    Directory of Open Access Journals (Sweden)

    Daryl P. Lofaso

    2011-12-01

    Full Text Available For more than 20 years, medical literature has increasingly documented the need for students to learn, practice and demonstrate competence in basic clinical knowledge and skills. In 2001, the Louisiana State University Health Science Centers (LSUHSC School of Medicine – New Orleans replaced its traditional Introduction in to Clinical Medicine (ICM course with the Science and Practice of Medicine (SPM course. The main component within the SPM course is the Clinical Skills Lab (CSL. The CSL teaches 30 plus skills to all pre-clinical medical students (Years 1 and 2. Since 2002, an annual longitudinal evaluation questionnaire was distributed to all medical students targeting the skills taught in the CSL. Students were asked to rate their self- confidence (Dreyfus and Likert-type and estimate the number of times each clinical skill was performed (clinically/non-clinically. Of the 30 plus skills taught, 8 were selected for further evaluation. An analysis was performed on the eight skills selected to determine the effectiveness of the CSL. All students that participated in the CSL reported a significant improvement in self-confidence and in number performed in the clinically/non-clinically setting when compared to students that did not experience the CSL. For example, without CSL training, the percentage of students reported at the end of their second year self-perceived expertise as “novice” ranged from 21.4% (CPR to 84.7% (GU catheterization. Students who completed the two-years CSL, only 7.8% rated their self-perceived expertise at the end of the second year as “novice” and 18.8% for GU catheterization. The CSL design is not to replace real clinical patient experiences. It's to provide early exposure, medial knowledge, professionalism and opportunity to practice skills in a patient free environment.

  18. Sexual revictimization in a clinical sample of women reporting childhood sexual abuse

    DEFF Research Database (Denmark)

    Lau, Marianne; Kristensen, Ellids

    2010-01-01

    BACKGROUND: Child and adolescent sexual abuse (CSA) increases the risk for adult sexual assault (ASA), and psychological vulnerability as well as aspects of CSA and upbringing might influence the risk. AIMS: The aims of this study were to investigate whether women who reported both CSA and ASA: 1......: The results showed an increased psychological vulnerability among women with ASA, but whether the results are cause or effect of sexual revictimization or can be generalized to other clinical samples are not clear. Interventions targeting the increased risk of ASA should be developed, implemented and tested...

  19. Clinical Research Careers: Reports from a NHLBI Pediatric Heart Network Clinical Research Skills Development Conference

    Science.gov (United States)

    Lai, Wyman W.; Richmond, Marc; Li, Jennifer S.; Saul, J. Philip; Mital, Seema; Colan, Steven D.; Newburger, Jane W.; Sleeper, Lynn A.; McCrindle, Brain W.; Minich, L. LuAnn; Goldmuntz, Elizabeth; Marino, Bradley S.; Williams, Ismee A.; Pearson, Gail D.; Evans, Frank; Scott, Jane D.; Cohen, Meryl S.

    2013-01-01

    Background Wyman W. Lai, MD, MPH, and Victoria L. Vetter, MD, MPH. The Pediatric Heart Network (PHN), funded under the U.S. National Institutes of Health-National Heart, Lung, and Blood Institute (NIH–NHLBI), includes two Clinical Research Skills Development (CRSD) Cores, which were awarded to The Children's Hospital of Philadelphia and to the Morgan Stanley Children's Hospital of New York–Presbyterian. To provide information on how to develop a clinical research career to a larger number of potential young investigators in pediatric cardiology, the directors of these two CRSD Cores jointly organized a one-day seminar for fellows and junior faculty from all of the PHN Core sites. The participants included faculty members from the PHN and the NHLBI. The day-long seminar was held on April 29, 2009, at the NHLBI site, immediately preceding the PHN Steering Committee meeting in Bethesda, MD. Methods The goals of the seminar were 1) to provide fellows and early investigators with basic skills in clinical research 2) to provide a forum for discussion of important research career choices 3) to introduce attendees to each other and to established clinical researchers in pediatric cardiology, and 4) to publish a commentary on the future of clinical research in pediatric cardiology. Results The following chapters are compilations of the talks given at the 2009 PHN Clinical Research Skills Development Seminar, published to share the information provided with a broader audience of those interested in learning how to develop a clinical research career in pediatric cardiology. The discussions of types of clinical research, research skills, career development strategies, funding, and career management are applicable to research careers in other areas of clinical medicine as well. Conclusions The aim of this compilation is to stimulate those who might be interested in the research career options available to investigators. PMID:21167335

  20. Reporting clinical outcomes of breast reconstruction: a systematic review.

    Science.gov (United States)

    Potter, S; Brigic, A; Whiting, P F; Cawthorn, S J; Avery, K N L; Donovan, J L; Blazeby, J M

    2011-01-05

    Breast reconstruction after mastectomy for cancer requires accurate evaluation to inform evidence-based participatory decision making, but the standards of outcome reporting after breast reconstruction have not previously been considered. We used extensive searches to identify articles reporting surgical outcomes of breast reconstruction. We extracted data using published criteria for complication reporting modified to reflect reconstructive practice. Study designs included randomized controlled trials, cohort studies, and case series. The Cochrane Risk of Bias tool was used to critically appraise all study designs. Other criteria used to assess the studies were selection and funding bias, statistical power calculations, and institutional review board approval. Wilcoxon signed rank tests were used to compare the breadth and frequency of study outcomes, and χ² tests were used to compare the number of studies in each group reporting each of the published criteria. All statistical tests were two-sided. Surgical complications following breast reconstruction in 42,146 women were evaluated in 134 studies. These included 11 (8.2%) randomized trials, 74 (55.2%) cohort studies, and 49 (36.6%) case series. Fifty-three percent of studies demonstrated a disparity between methods and results in the numbers of complications reported. Complications were defined by 87 (64.9%) studies and graded by 78 (58.2%). Details such as the duration of follow-up and risk factors for adverse outcomes were omitted from 47 (35.1%) and 58 (43.3%) studies, respectively. Overall, the studies defined fewer than 20% of the complications they reported, and the definitions were largely inconsistent. The results of this systematic review suggest that outcome reporting in breast reconstruction is inconsistent and lacks methodological rigor. The development of a standardized core outcome set is recommended to improve outcome reporting in breast reconstruction.

  1. Clinical effect of Fuzheng quyu therapy in patients undergoing ...

    African Journals Online (AJOL)

    Clinical effect of Fuzheng quyu therapy in patients undergoing radiotherapy after cervical carcinoma surgery. ... The clinical effects and the incidence of adverse events were compared between the groups. Results: The plasma prothrombin time and activated partial thromboplastin time improved after treatment in the study ...

  2. Clinical Management of Acute Interstitial Pneumonia: A Case Report

    Directory of Open Access Journals (Sweden)

    Yang Xia

    2012-01-01

    Full Text Available We describe a 51-year-old woman who was admitted to hospital because of cough and expectoration accompanied with general fatigue and progressive dyspnea. Chest HRCT scan showed areas of ground glass attenuation, consolidation, and traction bronchiectasis in bilateral bases of lungs. BAL fluid test and transbronchial lung biopsy failed to offer insightful evidence for diagnosis. She was clinically diagnosed with acute interstitial pneumonia (AIP. Treatment with mechanical ventilation and intravenous application of methylprednisolone (80 mg/day showed poor clinical response and thus was followed by steroid pulse therapy (500 mg/day, 3 days. However, she died of respiratory dysfunction eventually. Autopsy showed diffuse alveolar damage associated with hyaline membrane formation, pulmonary interstitial, immature collagen edema, and focal type II pneumocyte hyperplasia.

  3. Babesiosis in equines in Pakistan: a clinical report

    Directory of Open Access Journals (Sweden)

    Asif Rashid

    2009-09-01

    Full Text Available Equine babesiosis is a tick-borne haematological disease of equidae that can affect acutely, subacutely and chronically. The disease is manifested by intermittent fever, anaemia, icterus and haemoglobinuria. The authors describe the clinical, haematological and therapeutic aspects of babesiosis in equines at two units in Kotley and at two units in Jehlum of the Remount Veterinary and Farms Corps (RVFC. Animals on these units showed the signs of illness. On clinical examination, intermittent temperature, increased respiratory rate, anaemia, lacrimation, conjunctivitis and pale mucous membranes were observed. Haematological examination revealed a decrease in red blood cell count and haemoglobin concentration, accompanied by an increase in total white blood cell count. Cases of babesiosis in horses were successfully treated with imidocarb dipropionate at a dose rate of 4 mg/kg body weight, administered intramuscularly four times at 72 h intervals, together with supportive therapy.

  4. Whipple's disease. Report of five cases with different clinical features

    OpenAIRE

    FERRARI,Maria de Lourdes de Abreu; VILELA,Eduardo Garcia; FARIA,Luciana Costa; COUTO,Claudia Alves; SALGADO,Célio Jefferson; LEITE,Virgínia Rios; BRASILEIRO FILHO,Geraldo; BAMBIRRA,Eduardo Alves; MENDES,Claudia Maria de Castro; CARVALHO,Silas de Castro; OLIVEIRA,Celso Affonso de; CUNHA,Aloísio Sales da

    2001-01-01

    Whipple's disease (WD) is a rare systemic disease of infectious etiology which involves the small intestine but can virtually affect any organ. We present here five cases (four males and one female) ranging in age from 20 to 59 years. All patients had intestinal involvement associated or not with clinical manifestations linked to this organ. Vegetation in the tricuspid valve was observed in one patient, suggesting endocarditis caused by Tropheryma whippelii, with disappearance of the echocard...

  5. 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

  6. Corona mortis: an anatomical variation with clinical relevance. Case report.

    Directory of Open Access Journals (Sweden)

    Guillermo Adrián Rivera-Cardona

    2010-12-01

    Full Text Available The obturator artery is one of the parietal branches arising from the internal iliac artery, the anatomical variation from which this artery originates is called “The corona mortis”, generally from the external iliac artery or the inferior epigastric artery. This finding was observed bilaterally in a male cadaver during a pelvis dissection. Clinical consideration of the anatomical variation in the obturator artery, during surgical procedures, is of great importance due to the risk of pelvic hemorrhage.

  7. Whipple's disease. Report of five cases with different clinical features.

    Science.gov (United States)

    Ferrari, M de L; Vilela, E G; Faria, L C; Couto, C A; Salgado, C J; Leite, V R; Brasileiro Filho, G; Bambirra, E A; Mendes, C M; Carvalho, S de C; de Oliveira, C A; da Cunha, A S

    2001-01-01

    Whipple's disease (WD) is a rare systemic disease of infectious etiology which involves the small intestine but can virtually affect any organ. We present here five cases (four males and one female) ranging in age from 20 to 59 years. All patients had intestinal involvement associated or not with clinical manifestations linked to this organ. Vegetation in the tricuspid valve was observed in one patient, suggesting endocarditis caused by Tropheryma whippelii, with disappearance of the echocardiographic alterations after treatment. In one of the male patients the initial clinical manifestation was serologically negative spondylitis, with no diarrhea occurring at any time during follow-up. Ocular involvement associated with intestinal malabsorption and significant weight loss were observed in one case. In the other two cases, diarrhea was the major clinical manifestation. All patients were diagnosed by histological examination of the jejunal mucosa and, when indicated, of extraintestinal tissues by light and electron microscopy. After antibiotic treatment, full remission of symptoms occurred in all cases. A control examination of the intestinal mucosa performed after twelve months of treatment with sulfamethoxazole-trimethoprim revealed the disappearance of T. whippelii in four patients. The remaining patient was lost to follow-up.

  8. Whipple's disease. Report of five cases with different clinical features

    Directory of Open Access Journals (Sweden)

    FERRARI Maria de Lourdes de Abreu

    2001-01-01

    Full Text Available Whipple's disease (WD is a rare systemic disease of infectious etiology which involves the small intestine but can virtually affect any organ. We present here five cases (four males and one female ranging in age from 20 to 59 years. All patients had intestinal involvement associated or not with clinical manifestations linked to this organ. Vegetation in the tricuspid valve was observed in one patient, suggesting endocarditis caused by Tropheryma whippelii, with disappearance of the echocardiographic alterations after treatment. In one of the male patients the initial clinical manifestation was serologically negative spondylitis, with no diarrhea occurring at any time during follow-up. Ocular involvement associated with intestinal malabsorption and significant weight loss were observed in one case. In the other two cases, diarrhea was the major clinical manifestation. All patients were diagnosed by histological examination of the jejunal mucosa and, when indicated, of extraintestinal tissues by light and electron microscopy. After antibiotic treatment, full remission of symptoms occurred in all cases. A control examination of the intestinal mucosa performed after twelve months of treatment with sulfamethoxazole-trimethoprim revealed the disappearance of T. whippelii in four patients. The remaining patient was lost to follow-up.

  9. Clinical applications of selected binaural effects.

    Science.gov (United States)

    Noffsinger, D

    1982-01-01

    Examination was made of the behaviors exhibited on selected binaural tasks by 556 persons with diagnosed peripheral hearing loss or central nervous system damage. The tasks used included loudness balancing (LB), intracranial midline imaging (MI), masking level differences (MLD), and binaural beats (BB). The methods used were chosen for their clinical utility. Loudness balancing and midline imaging were of the most diagnostic value when hearing loss was present. Masking level differences were best at detecting pathology which did not produce hearing loss. None of the techniques were sensitive to cortical damage.

  10. Clinical assessment and patient-reported outcome measures in low-back pain - a survey among primary health care physiotherapists.

    Science.gov (United States)

    Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva

    2018-05-09

    We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of rehabilitation in low-back pain, yellow flags, and other

  11. Is Internet Pornography Causing Sexual Dysfunctions? A Review with Clinical Reports

    Science.gov (United States)

    Park, Brian Y.; Wilson, Gary; Berger, Jonathan; Christman, Matthew; Reina, Bryn; Bishop, Frank; Klam, Warren P.; Doan, Andrew P.

    2016-01-01

    Traditional factors that once explained men’s sexual difficulties appear insufficient to account for the sharp rise in erectile dysfunction, delayed ejaculation, decreased sexual satisfaction, and diminished libido during partnered sex in men under 40. This review (1) considers data from multiple domains, e.g., clinical, biological (addiction/urology), psychological (sexual conditioning), sociological; and (2) presents a series of clinical reports, all with the aim of proposing a possible direction for future research of this phenomenon. Alterations to the brain's motivational system are explored as a possible etiology underlying pornography-related sexual dysfunctions. This review also considers evidence that Internet pornography’s unique properties (limitless novelty, potential for easy escalation to more extreme material, video format, etc.) may be potent enough to condition sexual arousal to aspects of Internet pornography use that do not readily transition to real-life partners, such that sex with desired partners may not register as meeting expectations and arousal declines. Clinical reports suggest that terminating Internet pornography use is sometimes sufficient to reverse negative effects, underscoring the need for extensive investigation using methodologies that have subjects remove the variable of Internet pornography use. In the interim, a simple diagnostic protocol for assessing patients with porn-induced sexual dysfunction is put forth. PMID:27527226

  12. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports

    DEFF Research Database (Denmark)

    Maund, Emma; Guski, Louise Schow; Gøtzsche, Peter C.

    2017-01-01

    BACKGROUND: The European Medicines Agency makes clinical study reports publicly available and publishes reasons for not approving applications for marketing authorization. Duloxetine has been approved in Europe for the treatment of stress urinary incontinence in women. The reported adverse effects...... of duloxetine include mental health problems and suicidality. We obtained clinical study reports from the European Medicines Agency concerning use of this drug for stress urinary incontinence. METHODS: We performed a meta-analysis of 4 randomized placebo-controlled trials of duloxetine (involving a total...... of 1913 patients) submitted to the European Medicines Agency for marketing approval for the indication of stress urinary incontinence in women. We used data from the clinical study reports (totalling 6870 pages and including individual patient data) to assess benefits (including frequency of incontinence...

  13. The clinical consequences of the oxygen effect

    International Nuclear Information System (INIS)

    Dische, S.

    1989-01-01

    This paper presents experiments performed under conditions which in the laboratory showed the oxygen effect to be at its greatest, i.e., the use of a single large radiation dose. Knowledge derived from cell kinetic studies is introduced and explored. The author offers conclusions concerning the oxygen effect and its uses

  14. Case report: clinical and postmortem findings in four cows with rib fracture

    OpenAIRE

    Braun, Ueli; Warislohner, Sonja; Hetzel, Udo; Nuss, Karl

    2017-01-01

    BACKGROUND: Published reports of rib fractures in adult cattle are limited to the occurrence of chronic rib swellings caused by calluses, which are unremarkable from a clinical standpoint, whereas studies identifying clinical signs of rib fractures were not found in a literature search. This report describes the clinical and postmortem findings in four cows with rib fractures. CASE PRESENTATION: The 13th rib was fractured in three cows and the 11th rib in the remaining cow; three fractures...

  15. Acute unintentional intoxication with paraffin in a 25-year old patient - clinical case report.

    Science.gov (United States)

    Chibishev, Andon; Simonovska, Natasa

    2014-08-01

    "Fire-breathing" or "fire-eating" is a special kind of street art where the acts are always stunning, spectacular and amazing. People exhibiting this kind of show are professionals, not rare amateurs, who use different kind of fuels, usually hydrocarbons, in order to produce a pillar of fire. Intoxications caused by ingestion or inhalation of liquid paraffin, used as a fuel while performing, are numerous and various. We present a clinical case report of a 25-year old, previously healthy, amateur "fire-breather". During October, 2010 this young men arrived at the Emergency Unit of the University Clinic for toxicology and Urgent Internal Medicine in a severe clinical condition, after his unsuccessful attempt to perform real "fire-breathing". He had fever, strong headaches, mild abdominal and chest pain and he also had difficulties breathing and persistent dry cough. The patient was extremely dyspneic with peripheral cyanosis and shortness of breath. "Fire-breathers" must be viewed as a population at risk of paraffin-induced pneumonia, which has low mortality rate, but still is related with numerous and various chronic complications. Our patient was first in a life threatening, extremely serious clinical condition which was urgently treated with appropriate vigorous and effective therapy. This therapeutic protocol led to successful full recovery of these young men, who luckily didn't exhibit any chronic complications. Copyright © 2014 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

  16. Epidermolysis bullosa acquisita: clinical manifestations, microscopic findings, and surgical periodontal therapy. A case report.

    Science.gov (United States)

    Hakki, S S; Celenligil-Nazliel, H; Karaduman, A; Usubütün, A; Ertoy, D; Ayhan, A; Ruacan, S

    2001-04-01

    Epidermolysis bullosa acquisita (EBA) is an uncommon, acquired, chronic subepidermal bullous disease. This report describes a case of EBA with gingival involvement. A 43-year-old woman with EBA was referred to our clinic for periodontal therapy because of gingival tenderness and bleeding. She has been on cyclosporin A therapy for the last 2 years. Clinical findings were analyzed. Anterior gingivectomy operations were performed in 2 stages. The samples obtained during the surgery were examined using histopathologic, immunohistologic, and electronmicroscopic methods. Long-term effects of the surgical periodontal treatment on gingiva were evaluated both clinically and microscopically. The dentition displayed minimal enamel hypoplasia. Decayed, missing, and filled surfaces score was found to be elevated. Periodontal examination showed generalized diffuse gingival inflammation and gingival enlargement localized mainly to the anterior region. Nikolsky's sign was positive. However, wound healing was uneventful after the operations. Microscopic findings were similar to those obtained from the skin. Twenty-one months after the operations, Nikolsky's sign was negative and no remarkable gingival inflammation was noted. Microscopic examination revealed that the blisters were fewer in number and smaller in size. These results indicate that gingival tissues may also be involved in EBA. Uneventful wound healing after periodontal surgery in this case suggests that periodontal surgery can be performed in patients with EBA. Moreover, both our clinical and histopathologic findings imply that gingivectomy proves useful in maintaining gingival integrity in these patients. Our data may also suggest that the patients with EBA are highly likely to develop dental caries.

  17. [The clinical application of zirconium-dioxide-ceramics. Case report].

    Science.gov (United States)

    Somfai, Dóra; Zsigmond, Ágnes; Károlyházy, Katalin; Kispély, Barbara; Hermann, Péter

    2015-12-01

    Due to its outstanding physical, mechanical and esthetic properties, zirconium-dioxide is one of the most popular non-metal denture, capable of surpassing PFM in most cases. The recent advances of CAD/CAM technology makes it a good alternitve. Here we show the usefulness of zirconium-dioxide in everyday dental practice through three case reports.

  18. Fabrication of temporary speech bulb prosthesis: A clinical report

    OpenAIRE

    Kasim Mohamed, K.; Anand Kumar, V.; Devi, N.; Padmanaban, T. V.

    2010-01-01

    Maxillofacial prosthesis is an art and science which not only replaces the lost structure sometimes it restores the functions also. Pharyngeal obturator is a prosthesis which closes the palatal and pharyngeal defects and improving the speech and other function. The following case report discusses palatopharyngeal insufficiency, impression procedures, fabrication of prosthesis and improvements in speech.

  19. SeqReporter: automating next-generation sequencing result interpretation and reporting workflow in a clinical laboratory.

    Science.gov (United States)

    Roy, Somak; Durso, Mary Beth; Wald, Abigail; Nikiforov, Yuri E; Nikiforova, Marina N

    2014-01-01

    A wide repertoire of bioinformatics applications exist for next-generation sequencing data analysis; however, certain requirements of the clinical molecular laboratory limit their use: i) comprehensive report generation, ii) compatibility with existing laboratory information systems and computer operating system, iii) knowledgebase development, iv) quality management, and v) data security. SeqReporter is a web-based application developed using ASP.NET framework version 4.0. The client-side was designed using HTML5, CSS3, and Javascript. The server-side processing (VB.NET) relied on interaction with a customized SQL server 2008 R2 database. Overall, 104 cases (1062 variant calls) were analyzed by SeqReporter. Each variant call was classified into one of five report levels: i) known clinical significance, ii) uncertain clinical significance, iii) pending pathologists' review, iv) synonymous and deep intronic, and v) platform and panel-specific sequence errors. SeqReporter correctly annotated and classified 99.9% (859 of 860) of sequence variants, including 68.7% synonymous single-nucleotide variants, 28.3% nonsynonymous single-nucleotide variants, 1.7% insertions, and 1.3% deletions. One variant of potential clinical significance was re-classified after pathologist review. Laboratory information system-compatible clinical reports were generated automatically. SeqReporter also facilitated quality management activities. SeqReporter is an example of a customized and well-designed informatics solution to optimize and automate the downstream analysis of clinical next-generation sequencing data. We propose it as a model that may envisage the development of a comprehensive clinical informatics solution. Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

  20. [The conservative treatment of placenta accreta. A clinical case report].

    Science.gov (United States)

    Artuso, A; Rocchi, B; Garbo, S; Baudino, G; Repetti, F

    1993-09-01

    The following description is a clinical case of placenta accreta and its conservative treatment. According to some authors, abnormal adhesion of the placenta depends on the alteration of the equilibrium between the trophoblastic tissue invasion and the reaction of the decidua. Consequently we have various degrees of penetration of the myometrium by chorionic villi into areas of deficit, sparse or absent decidua. Whatever the pathogenetic mechanism, the final clinical picture is slight to deep penetration of the trophoblastic tissue into the uterine wall. That causes absence of the normal plane of cleavage between placenta and maternal decidua, no spontaneous placental detachment during the third stage of labour and no possible manual removal. The patient, primigravida, was admitted at the 36th Week of gestation with PROM and physiologically delivered a neonate weighing 1820 g, after she spontaneously began labour. The newborn was admitted in the neonatal-pathology ward because it was premature although the Apgar score at 1-5 minutes after birth was 5-9. Placental ejection was awaited for 1 hour, then manual exploration of the uterine cavity was undertaken. The normal plane of cleavage between placental tissue and decidua was absent and therefore manual extraction of the placenta was impossible. Surgery was stopped and, after informed consensus was obtained from the patient, a conservative treatment was tried. After cutting the umbilical cord as short as possible and checking for vaginal bleeding, the patient was moved to obstetrics ward.(ABSTRACT TRUNCATED AT 250 WORDS)

  1. Prevalence and reporting of recruitment, randomisation and treatment errors in clinical trials: A systematic review.

    Science.gov (United States)

    Yelland, Lisa N; Kahan, Brennan C; Dent, Elsa; Lee, Katherine J; Voysey, Merryn; Forbes, Andrew B; Cook, Jonathan A

    2018-06-01

    Background/aims In clinical trials, it is not unusual for errors to occur during the process of recruiting, randomising and providing treatment to participants. For example, an ineligible participant may inadvertently be randomised, a participant may be randomised in the incorrect stratum, a participant may be randomised multiple times when only a single randomisation is permitted or the incorrect treatment may inadvertently be issued to a participant at randomisation. Such errors have the potential to introduce bias into treatment effect estimates and affect the validity of the trial, yet there is little motivation for researchers to report these errors and it is unclear how often they occur. The aim of this study is to assess the prevalence of recruitment, randomisation and treatment errors and review current approaches for reporting these errors in trials published in leading medical journals. Methods We conducted a systematic review of individually randomised, phase III, randomised controlled trials published in New England Journal of Medicine, Lancet, Journal of the American Medical Association, Annals of Internal Medicine and British Medical Journal from January to March 2015. The number and type of recruitment, randomisation and treatment errors that were reported and how they were handled were recorded. The corresponding authors were contacted for a random sample of trials included in the review and asked to provide details on unreported errors that occurred during their trial. Results We identified 241 potentially eligible articles, of which 82 met the inclusion criteria and were included in the review. These trials involved a median of 24 centres and 650 participants, and 87% involved two treatment arms. Recruitment, randomisation or treatment errors were reported in 32 in 82 trials (39%) that had a median of eight errors. The most commonly reported error was ineligible participants inadvertently being randomised. No mention of recruitment, randomisation

  2. Effect of immersive workplace experience on undergraduate nurses' mental health clinical confidence.

    Science.gov (United States)

    Patterson, Christopher; Moxham, Lorna; Taylor, Ellie K; Perlman, Dana; Brighton, Renee; Sumskis, Susan; Heffernan, Tim; Lee-Bates, Benjamin

    2017-12-01

    Preregistration education needs to ensure that student nurses are properly trained with the required skills and knowledge, and have the confidence to work with people who have a mental illness. With increased attention on non-traditional mental health clinical placements, further research is required to determine the effects of non-traditional mental health clinical placements on mental health clinical confidence. The aim of the present study was to investigate the impact of a non-traditional mental health clinical placement on mental health nursing clinical confidence compared to nursing students undergoing traditional clinical placements. Using the Mental Health Nursing Clinical Confidence Scale, the study investigated the relative effects of two placement programmes on the mental health clinical confidence of 79 nursing students. The two placement programmes included a non-traditional clinical placement of Recovery Camp and a comparison group that attended traditional clinical placements. Overall, the results indicated that, for both groups, mental health placement had a significant effect on improving mean mental health clinical confidence, both immediately upon conclusion of placement and at the 3-month follow up. Students who attended Recovery Camp reported a significant positive difference, compared to the comparison group, for ratings related to communicating effectively with clients with a mental illness, having a basic knowledge of antipsychotic medications and their side-effects, and providing client education regarding the effects and side-effects of medications. The findings suggest that a unique clinical placement, such as Recovery Camp, can improve and maintain facets of mental health clinical confidence for students of nursing. © 2017 Australian College of Mental Health Nurses Inc.

  3. Clinical Case Reporting in the Peer-Reviewed Physical Therapy Literature: Time to Move Toward Functioning.

    Science.gov (United States)

    Davenport, Todd E

    2015-12-01

    Physical therapists increasingly are contributing clinical case reports to the health literature, which form the basis for higher quality evidence that has been incorporated into clinical practice guidelines. Yet, few resources exist to assist physical therapists with the basic mechanics and quality standards of producing a clinical case report. This situation is further complicated by the absence of uniform standards for quality in case reporting. The importance of including a concise yet comprehensive description of patient functioning in all physical therapy case reports suggest the potential appropriateness of basing quality guidelines on the World Health Organization's International Classification of Functioning Disability and Health (ICF) model. The purpose of this paper is to assist physical therapists in creating high-quality clinical case reports for the peer-reviewed literature using the ICF model as a guiding framework. Along these lines, current recommendations related to the basic mechanics of writing a successful clinical case report are reviewed, as well and a proposal for uniform clinical case reporting requirements is introduced with the aim to improve the quality and feasibility of clinical case reporting in physical therapy that are informed by the ICF model. Copyright © 2013 John Wiley & Sons, Ltd.

  4. The feasibility, perceived satisfaction, and value of using synchronous webinars to educate clinical research professionals on reporting adverse events in clinical trials: a report from the Children's Oncology Group.

    Science.gov (United States)

    Borgerson, Dawn; Dino, Jennifer

    2012-01-01

    Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.

  5. End-word dysfluencies in young children: a clinical report.

    Science.gov (United States)

    MacMillan, Verity; Kokolakis, Artemi; Sheedy, Stacey; Packman, Ann

    2014-01-01

    We report on 12 children with end-word dysfluencies (EWDs). Our aim was to document this little-reported type of dysfluency and to develop a possible explanation for them and how they relate to developmental stuttering. Audio recordings were made for 9 of the 12 children in the study. The EWDs were identified by consensus of two specialist speech pathologists and confirmed on acoustic displays. A segment of participant 1's speech was transcribed, including phonetic transcription of EWDs. The EWDs typically consisted of repetitions of the nucleus and/or the coda. However, there were also some EWDs that consisted of fixed postures on the nucleus (when in final position) or coda. We also report on the infrequent occurrence of broken words. Ten of the 12 children also stuttered, with 9 of them coming from four families, each with a history of stuttering. This study indicates that EWDs may be more prevalent than previously thought, but they may go largely unnoticed due to their perceptually fleeting nature. The hypothesis was developed that EWDs be regarded as another type of developmental dysfluency, along with stuttering and cluttering. Ideas for further research are suggested. © 2014 S. Karger AG, Basel.

  6. Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.

    Science.gov (United States)

    Fleischmann, Robert; Decker, Anne-Marie; Kraft, Antje; Mai, Knut; Schmidt, Sein

    2017-12-01

    Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity. This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics. All randomized patients were included in the study (eCRF group n = 13, pCRF group n = 14). eCRF, as compared to pCRF, data collection was associated with significant time savings  across all conditions (8.29 ± 5.15 min vs. 10.54 ± 6.98 min, p = .047). This effect was not defined by participant type, i.e. patients or study nurses (F (1,112)  = .15, p = .699), CRF length (F (2,112)  = .49, p = .609) or patient age (Beta = .09, p = .534). Additional 5.16 ± 2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was

  7. Clinical applications of a high quantum utilization scanner. Final report

    International Nuclear Information System (INIS)

    Crandall, P.H.; Cassen, B.

    1973-04-01

    The clinical usefulness of a tomographic imaging process employing a fast rectilinear scanner consisted of a spherical-cap nest of seven individual detectors (3'' x 1 / 2 '' activated sodium iodide) collimated to a common focal point at 10 cm. Hydraulic drives permitted a fast rectilinear scan to be made and, when raised or lowered, at different planes. Patients with well-defined brain lesions were studied using /sup 99m/Tc-pertechnetate or 203 Hg-chlormerodrin as tracers by measuring three dimensions of their lesions and anatomical location at the time of operation. Brain maps were used to identify this location at operation and also the location of images traced from film density displays of a conventional radioisotopic scan, the tomographic scan, and cerebral angiograms. (U.S.)

  8. Orthodontic Camouflage: A Treatment Option – A Clinical Case Report

    Science.gov (United States)

    Mazzini, William Ubilla; Torres, Fátima Mazzini

    2017-01-01

    Orthodontic camouflage provides an alternative treatment for angle III malocclusion since patients with limited economic resources cannot opt for orthognathic surgery, it being clear that correction will be achieved at the dental level and not at the bone complex. Objective: To determine an alternative treatment for patients who do not have the possibility of having orthognathic surgery. Clinical case: A 13-year-old female patient, dolico facial biotype with slightly concave profile, with Class III Skeletal by mandibular prognathism, anterior crossbite, anterior diastema, and large mandibular body, molar class, and canine III. Alexander technique brackets were placed; premolar extraction was not planned. Once the case was completed, the correction of the anterior crossbite was achieved, thanks to the use of the spaces that existed at the beginning of the treatment and also that a correct distalization of canines and retraction of the lower anterior segment were performed. PMID:29326524

  9. Report of a clinical case of headphone mixoma

    International Nuclear Information System (INIS)

    Manzur J, Fernando; Patino N, Gustavo A; Sierra C, Luis E

    2000-01-01

    We describe the case of a patient who presented syncope and repetitive palpitations that had been previously studied by the neurology section with a simple CT scan and a MRI, showing multiples embolic lesions, for that reason she was referred to the service of cardiology. With clinical triad of palpitations, syncope and embolic lesions, an M mode a two-dimensional and a color Doppler Trans-thoracic echocardiography was performed, showing the presence of a mass in the left atrium attached to the posterior wall. The patient underwent a cardio pulmonary bypass surgery and the mass was removed with no complication during the postoperative period. In the histological study the mass appeared to be a typical mixoma. This case has a great interest not only because the presentation of this tumor is unusual, but also because the use of the m mode and two-dimensional echocardiography has a high sensibility in the detection of the tumor

  10. Thyrotropin-producing adenoma. Report of two clinical cases

    Directory of Open Access Journals (Sweden)

    Ani R. Karapetyan

    2017-03-01

    Full Text Available Diagnosis of hyperthyroidism does not present serious difficulties currently. Distribution of imaging techniques increasing the detection of pituitary adenomas every year. Thyrotropin-producing adenoma is a rare cause of hyperthyroidism. Early detection will alert its errors in treatment strategy, unjustified surgery on the thyroid gland, and will improve the quality of patients life. The article presents two clinical cases of thyroid-stimulating hormone (TSH-secreting pituitary adenomas in patients with different disease duration, and thus the presence of hyperthyroidism complications. Both patients were operated in the Federal Center of Neurosurgery Novosibirsk by transnasal transsphenoidal approach. The resistant euthyroidism was reached postoperatively, but in patients with long-term history of the disease, large size of adenoma in the postoperative period developed secondary adrenal insufficiency and her quality of life is significantly lower, taking into account comorbidities. The period of follow-up consists 3 years and one year respectively.

  11. Clinical and Electrophysiological Report of a Unilateral Retinitis Pigmentosa Case

    Directory of Open Access Journals (Sweden)

    Sedaghat MR

    2014-04-01

    Full Text Available Introduction: To describe clinical and electrophysiological features of a patient with unilateral Retinitis Pigmentosa (RP. Case: A 29-year-old female with a long history of progressive visual disturbance in the right eye has undergone multiple eye examinations during the past eight years. There was nothing noticeable in her past medical and ocular history. Comprehensive eye examinations were done in the first visit. All data was suggestive of right eye RP. Posterior segment fundal examination findings were: a pallor waxy disc, vessel attenuation, and extended pigmentary degeneration of the mid-peripheral retina. The left eye examination was normal. Comparing the automated 60 degree and 30 degree visual fields of both eyes obviously showed significant defects in the right eye visual field but normal in the left eye.  All of the probable infectious agents, which can cause similar ocular manifestations, were ruled out by serological tests. The standard photopic and scotopic electroretinographies were significantly reduced in amplitude in the right eye; however, they were normal in the left eye. Also, the standard Electro-Oculography (EOG results were the same as the Electro-Retinography (ERG ones in both eyes. Eye examinations were normal in other family members. Over an eight-year follow-up period, progressive deteriorating vision has gradually become more noticeable in the right eye. The left eye has been completely normal since.  This data was compatible with the Francois and Verriesr unilateral RP diagnostic criteria. Conclusion: Clinical signs and symptoms, a minimum of a five-year follow-up period, and confirmatory ERG and EOG are very helpful to diagnose andaffirm the case of unilateral RP.

  12. 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

  13. [Development of Autogenic Training Clinical Effectiveness Scale (ATCES)].

    Science.gov (United States)

    Ikezuki, Makoto; Miyauchi, Yuko; Yamaguchi, Hajime; Koshikawa, Fusako

    2002-02-01

    The purpose of the present study was to develop a scale measuring clinical effectiveness of autogenic training. In Study 1, 167 undergraduates completed a survey of items concerning physical and mental states, which were thought to vary in the course of autogenic training. With item and factor analyses, 20 items were selected, and the resulting scale (ATCES) had high discrimination and clear factor structure. In Study 2, reliability and concurrent and clinical validity of the scale were examined with three groups of respondents: 85 mentally healthy, 31 control, 13 clinical persons. The scale showed a high test-retest correlation (r = .83) and alpha coefficient (alpha = .86). ATCES had a Pearson correlation coefficient of r = .56 with General Health Questionnaire (GHQ-12), and r = .73 with trait anxiety (STAI-T). And ATCES successfully discriminated the mentally healthy and clinical groups in terms of clinical effectiveness. These results demonstrated high reliability and sufficient concurrent and clinical validity of the new scale.

  14. Effects of Clinical Mastitis on Reproductive Performance in Holstein Cows

    Directory of Open Access Journals (Sweden)

    A. Gunay

    2008-01-01

    Full Text Available The objective of this study was to determine the effects of clinical mastitis on reproductive performance in 135 early lactation cows. The animals were divided into two groups according to the occurrence of mastitis as follows: group I (n = 45, clinical mastitis prior to the first artificial insemination breeding; group II (n = 45, clinical mastitis after artificial insemination and being diagnosed pregnant. Forty-five cows without any mastitis served as control group. Calving to first service intervals were significantly longer (P P P < 0.05 in cows with clinical mastitis after first service (3.4 ± 0.9 than in cows with clinical mastitis before first service (2.1 ± 0.9 and in cows with no clinical mastitis (1.8 ± 0.8. This study indicated that clinical mastitis during early lactation in Holstein cows had a negative impact on their reproductive performance.

  15. Effects of dry period length on clinical mastitis and other major clinical health disorders

    DEFF Research Database (Denmark)

    Enevoldsen, Carsten; Sørensen, J.T.

    1992-01-01

    Four, 7-, and 10-wk dry periods were randomly assigned to 366 dairy cows in eight herds. A multiple polytomous logistic regression analysis was conducted with the objective to reveal possible important effects of the dry period on the risk of contracting major clinical health disorders. Several...... complex statistical interactions were revealed. Complications around and after drying off occurred least frequently at 7-wk dry periods. There was little evidence of an effect of the dry period on the risk of clinical mastitis and other severe clinical disorders around and after calving. With short...... like milk yield at drying off and previous mastitis are much more important predisposing factors....

  16. Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice.

    Science.gov (United States)

    Refolo, P; Minacori, R; Mele, V; Sacchini, D; Spagnolo, A G

    2012-10-01

    Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.

  17. Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review.

    Science.gov (United States)

    Motte, Anne-France; Diallo, Stéphanie; van den Brink, Hélène; Châteauvieux, Constance; Serrano, Carole; Naud, Carole; Steelandt, Julie; Alsac, Jean-Marc; Aubry, Pierre; Cour, Florence; Pellerin, Olivier; Pineau, Judith; Prognon, Patrice; Borget, Isabelle; Bonan, Brigitte; Martelli, Nicolas

    2017-11-01

    The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items. A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Effects of Clinical Mastitis on Reproductive Performance in Holstein Cows

    OpenAIRE

    A. Gunay; U. Gunay

    2008-01-01

    The objective of this study was to determine the effects of clinical mastitis on reproductive performance in 135 early lactation cows. The animals were divided into two groups according to the occurrence of mastitis as follows: group I (n = 45), clinical mastitis prior to the first artificial insemination breeding; group II (n = 45), clinical mastitis after artificial insemination and being diagnosed pregnant. Forty-five cows without any mastitis served as control group. Calving to first serv...

  19. Advancing medicine one research note at a time: the educational value in clinical case reports.

    Science.gov (United States)

    Cabán-Martinez, Alberto J; Beltrán, Wilfredo F García

    2012-07-06

    A case report--a brief written note that describes unique aspects of a clinical case--provides a significant function in medicine given its rapid, succinct, and educational contributions to scientific literature and clinical practice. Despite the growth of, and emphasis on, randomized clinical trials and evidenced-based medicine, case reports continue to provide novel and exceptional knowledge in medical education. The journal BMC Research Notes introduces a new "case reports" section to provide the busy clinician with a forum in which to document any authentic clinical case that provide educational value to current clinical practice. The aim is for this article type to be reviewed, wherever possible, by specialized Associate Editors for the journal, in order to provide rapid but thorough decision making. New ideas often garnered by and documented in case reports will support the advancement of medical science--one research note at a time.

  20. [Ankle arthroscopy in clinical application: a preliminary report].

    Science.gov (United States)

    Xu, J S

    1989-01-01

    The results of arthroscopy or arthroscopic synovectomy on 31 ankle joints in 24 cases were reported. All the patients were followed for 2 to 10 months with an average of 6 months. The results were as follows of the 26 rheumatoid arthritis: excellent in 5 ankles (19.2%), good in 8 (30.8%), fair in 7 (26.9%), and poor in 6 (23.6%), of the three traumatic arthritis: good in one and fair in two; of the remaining 2: good in 1 tuberculous synovitis and fair in 1 chronic pyogenic arthritis. The operative procedure, indications and value of ankle arthroscopy together with its advantages were discussed in detail.

  1. Clinical Management of Glanzmann's Thrombasthenia: A Case Report.

    Directory of Open Access Journals (Sweden)

    Indu Varkey

    2014-04-01

    Full Text Available Glanzmann's thrombasthenia (GT is a rare, genetically inherited platelet disorder in which the platelet glycoprotein IIb/IIIa (GP IIb/IIIa complex is either deficient or, dysfunctional. The incidence is about 1 in 1,000,000. This case report deals with a 4 year-old girl diagnosed with GT presenting with dental caries and periapical lesions in the primary mandibular first molars. To provide the best care, an interdisciplinary approach was followed by a team consisting of pediatric dentists, pediatricians and anesthesiologists. Complete oral rehabilitation was planned under general anesthesia which included extractions, multiple esthetic restorations and space maintainers with the utmost care to prevent unwarranted bleeding.

  2. Dental Management of Ectodermal Dysplasia: Two Clinical Case Reports

    Directory of Open Access Journals (Sweden)

    Somayeh Hekmatfar

    2012-06-01

    Full Text Available Ectodermal dysplasia is a hereditary disorder associated with abnormal development of embryonic ectodermally-derived organs including teeth, nails, hair and sweat glands. Hypodontia of the primary and permanent dentition is the most common oral finding. Therefore, affected patients need dental prosthetic treatments during their developmental years. This report presents two cases of children affected by ectodermal dysplasia with anodontia. Oral rehabilitation was accomplished with removable acrylic prostheses. Treatment had major impacts on self-esteem, masticatory function, speech and facial esthetic.

  3. [The effects of Omega-3 fatty acids in clinical medicine].

    Science.gov (United States)

    Reiner, Martin F; Stivala, Simona; Camici, Giovanni G; Beer, Jürg H

    2014-03-12

    Effects of Omega-3 fatty acids (n-3 FA) in particular on the development of cardiovascular disease (CVD) are of major interest. Many experimental studies reported their anti-inflammatory, anti-thrombotic and anti-atherosclerotic properties and suggested favourable effects on the prevention of CVD. While the majority of former studies showed a benefit of n-3 FA acid intake, recent clinical trials using n-3 supplements on top of established medication and prudent nutrition did not confirm these findings. The conflicting data may be due to several factors such as the selection of study population with different sizes or characteristics as well as choosing different doses or types of n-3 FA. The most recent meta-analyses observed clear benefits of fish consumption, but not of n-3 capsules intake. Furthermore, a nutrition rich in plant-derived n-3 FA alpha-linolenic acid has been found to have beneficial effects on the development of cardio- and cerebrovascular diseases.

  4. Hypnosis is More Effective than Clinical Interviews.

    Science.gov (United States)

    Almeida-Marques, Francisco Xavier De; Sánchez-Blanco, José; Cano-García, Francisco Javier

    2018-01-01

    To determine whether hypnosis is more effective than conventional interviewing to find traumatic life events in patients with fibromyalgia, we carried out a within-subject experimental design with complete intragroup counterbalancing. Thirty-two women under care in a public primary care center gave 2 identical interviews, with an interval of 3 months, in which the occurrence of traumatic life events was explored, once in a state of wakefulness and once in a state of hypnosis. The state of consciousness was evaluated using 3 measures: bispectral index, skin conductance level, and pain intensity. In the hypnotic state, the patients expressed 9.8 times more traumatic life events than in the waking state, a statistically significant difference with a large effect size.

  5. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry.

    Science.gov (United States)

    Perlis, Roy H; Perlis, Clifford S; Wu, Yelena; Hwang, Cindy; Joseph, Megan; Nierenberg, Andrew A

    2005-10-01

    Financial conflict of interest has been reported to be prevalent in clinical trials in general medicine and associated with a greater likelihood of reporting results favorable to the intervention being studied. The extent and implications of industry sponsorship and financial conflict of interest in psychiatric clinical trials have not been investigated, to the authors' knowledge. The authors examined funding source and author financial conflict of interest in all clinical trials published in the American Journal of Psychiatry, the Archives of General Psychiatry, the Journal of Clinical Psychopharmacology, and the Journal of Clinical Psychiatry between 2001 and 2003. Among 397 clinical trials identified, 239 (60%) reported receiving funding from a pharmaceutical company or other interested party, and 187 studies (47%) included at least one author with a reported financial conflict of interest. Among the 162 randomized, double-blind, placebo-controlled studies examined, those that reported conflict of interest were 4.9 times more likely to report positive results; this association was significant only among the subset of pharmaceutical industry-funded studies. Author conflict of interest appears to be prevalent among psychiatric clinical trials and to be associated with a greater likelihood of reporting a drug to be superior to placebo.

  6. Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology.

    Science.gov (United States)

    Rorie, David A; Flynn, Robert W V; Grieve, Kerr; Doney, Alexander; Mackenzie, Isla; MacDonald, Thomas M; Rogers, Amy

    2017-09-01

    Researchers in clinical and pharmacoepidemiology fields have adopted information technology (IT) and electronic data capture, but these remain underused despite the benefits. This review discusses electronic case report forms and electronic data capture, specifically within pharmacoepidemiology and clinical research. The review used PubMed and the Institute of Electrical and Electronic Engineers library. Search terms used were agreed by the authors and documented. PubMed is medical and health based, whereas Institute of Electrical and Electronic Engineers is technology based. The review focuses on electronic case report forms and electronic data capture, but briefly considers other relevant topics; consent, ethics and security. There were 1126 papers found using the search terms. Manual filtering and reviewing of abstracts further condensed this number to 136 relevant manuscripts. The papers were further categorized: 17 contained study data; 40 observational data; 27 anecdotal data; 47 covering methodology or design of systems; one case study; one literature review; two feasibility studies; and one cost analysis. Electronic case report forms, electronic data capture and IT in general are viewed with enthusiasm and are seen as a cost-effective means of improving research efficiency, educating participants and improving trial recruitment, provided concerns about how data will be protected from misuse can be addressed. Clear operational guidelines and best practises are key for healthcare providers, and researchers adopting IT, and further work is needed on improving integration of new technologies with current systems. A robust method of evaluation for technical innovation is required. © 2017 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

  7. Training clinicians in how to use patient-reported outcome measures in routine clinical practice.

    Science.gov (United States)

    Santana, Maria J; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina

    2015-07-01

    Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor symptoms, evaluate treatment outcomes and support shared decision-making. A key issue limiting successful implementation is clinicians' lack of knowledge on how to effectively utilize PROs data in their clinical encounters. Using a change management theoretical framework, this paper describes the development and implementation of three programs for training clinicians to effectively use PRO data in routine practice. The training programs are in three diverse clinical areas (adult oncology, lung transplant and paediatrics), in three countries with different healthcare systems, thus providing a rare opportunity to pull out common approaches whilst recognizing specific settings. For each program, we describe the clinical and organizational setting, the program planning and development, the content of the training session with supporting material, subsequent monitoring of PROs use and evidence of adoption. The common successful components and practical steps are identified, leading to discussion and future recommendations. The results of the three training programs are described as the implementation. In the oncology program, PRO data have been developed and are currently evaluated; in the lung transplant program, PRO data are used in daily practice and the integration with electronic patient records is under development; and in the paediatric program, PRO data are fully implemented with around 7,600 consultations since the start of the implementation. Adult learning programs teaching clinicians

  8. Hypercalcemia in children: three cases report with unusual clinical presentations

    Directory of Open Access Journals (Sweden)

    Bruna Barros Garbim

    Full Text Available Abstract Hypercalcemia is a rare condition in childhood; the most common causes are primary hyperparathyroidism, malignancy, prolonged immobilisation, thyrotoxicosis, thiazide diuretic, supplements containing calcium, milk-alkali syndrome, vitamin D intoxication, infections and idiopathic. We present three cases of severe hypercalcemia of unusual causes in children. The first patient had high fever, poor general condition, weight loss and myalgia. Extensive preliminary investigation did not define the etiology, but a review of medical history revealed prolonged contact with pet bird and a positive serology for Chlamydia confirmed the diagnosis of psittacosis. The second patient had generalized lymphadenopathy and hepatosplenomegaly with fever a month ago. Paracoccidioides brasiliensis was identified in myelogram; the patient showed partial improvement with the use of co-trimoxazole, with subsequent emergence of multiple osteolytic lesions. A smear of gastric lavage was positive for Mycobacterium tuberculosis and the patient was treated with rifampicin, isoniazid, ethambutol and pyrazinamide, with improvement of clinical condition. The third patient was treated by hypercalciuria and idiopathic hypomagnesiuria with daily use of cholecalciferol; the patient had a two quilograms of weight loss in the past two months. No cause of hypercalcemia could be detected in laboratory workout. The capsules of cholecalciferol were analyzed and presented an amount of 832,000 IU of vitamin D per capsule. Acute hypercalcemia in childhood may be due to exogenous vitamin D intoxication, as well as infectious causes. The possible causal relationship between psittacosis and occurrence of hypercalcemia alert to the need for detailed investigation of the epidemiological antecedents.

  9. A clinical report on three cases of subacute radiation sickness

    International Nuclear Information System (INIS)

    Huang Shimin; Ye genyao; Liang Demin

    1989-01-01

    On April 20, 1985 a 137 Cs gamma-ray source of about 10 curies was taken into a family's bedroom. The son and both his parents were exposed to a nearly continuous irradiation for 150 days with estimated accumulated dose of 8-15 Gy. The father was complicated by skin radiation burn. The essential clinical findings on admission were general malaise, bleeding and pancytopenia (Hb 50g/l; WBC 0.4-0.7 x 10 9 /l; platelets 10 x 10 9 /l). The bone marrow was hypocellular with low colony yield in CFU-GM culture. The immunological examinations were essentially normal except for low E-RFC and lymphocyte transformation in all cases, and low IgA was seen only in the mother. Abnormalities were found in nail-bed microcirculation and thromboelastogram. Aspermia was detected twice in the son. The principal therapeutic measures were complete rest and adequated nutrition. The ward and nursing services were strictly controlled to avoid contamination. The son was transferred to LAFR for 2 weeks when the WBC was as low as 0.4 x 10 9 /l. Combined large doses of stanozolol and anisodamine were prescribed for all cases, while the son and his father received fetal liver transfusions in addition. All of them recovered well, especially the son

  10. A national clinical quality program for Veterans Affairs catheterization laboratories (from the Veterans Affairs clinical assessment, reporting, and tracking program).

    Science.gov (United States)

    Maddox, Thomas M; Plomondon, Mary E; Petrich, Megan; Tsai, Thomas T; Gethoffer, Hans; Noonan, Gregory; Gillespie, Brian; Box, Tamara; Fihn, Stephen D; Jesse, Robert L; Rumsfeld, John S

    2014-12-01

    A "learning health care system", as outlined in a recent Institute of Medicine report, harnesses real-time clinical data to continuously measure and improve clinical care. However, most current efforts to understand and improve the quality of care rely on retrospective chart abstractions complied long after the provision of clinical care. To align more closely with the goals of a learning health care system, we present the novel design and initial results of the Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) program-a national clinical quality program for VA cardiac catheterization laboratories that harnesses real-time clinical data to support clinical care and quality-monitoring efforts. Integrated within the VA electronic health record, the CART program uses a specialized software platform to collect real-time patient and procedural data for all VA patients undergoing coronary procedures in VA catheterization laboratories. The program began in 2005 and currently contains data on 434,967 catheterization laboratory procedures, including 272,097 coronary angiograms and 86,481 percutaneous coronary interventions, performed by 801 clinicians on 246,967 patients. We present the initial data from the CART program and describe 3 quality-monitoring programs that use its unique characteristics-procedural and complications feedback to individual labs, coronary device surveillance, and major adverse event peer review. The VA CART program is a novel approach to electronic health record design that supports clinical care, quality, and safety in VA catheterization laboratories. Its approach holds promise in achieving the goals of a learning health care system. Published by Elsevier Inc.

  11. Recommendations for improving the quality of reporting clinical electrochemotherapy studies based on qualitative systematic review

    DEFF Research Database (Denmark)

    Campana, LG; Clover, AJ; Valpione, S

    2016-01-01

    Electrochemotherapy is becoming a well-established treatment for malignancies of skin and non-skin origin and its use is widening across Europe. The technique was developed and optimized from solid experimental and clinical evidence. A consensus document is now warranted to formalize reporting re...... studies and to provide the recommendations for reporting clinical trials on electrochemotherapy....... results, which should strengthen evidence-based practice recommendations. This consensus should be derived from high quality clinical data collection, clinical expertise and summarizing patient feedback. The first step, which is addressed in this paper, aims to critically analyze the quality of published...

  12. Characteristics of effective clinical guidelines for general practice.

    NARCIS (Netherlands)

    Burgers, J.S.; Grol, R.P.T.M.; Zaat, J.O.M.; Spies, T.H.; Bij, A.K. van der; Mokkink, H.G.A.

    2003-01-01

    BACKGROUND: The use of clinical guidelines in general practice is often limited. Research on barriers to guideline adherence usually focuses on attitudinal factors. Factors linked to the guideline itself are much less studied. AIM: To identify characteristics of effective clinical guidelines for

  13. Clinical survey on adverse reaction of contrast media, final report

    International Nuclear Information System (INIS)

    Katayama, Hitoshi; Ishida, Osamu; Osawa, Tadashi

    1988-01-01

    This report is a final analysis of adverse reactions to iodinated contrast media examined in 33,440 patients from 11 hospitals during the period from October 1983 through June 1986. Adverse reactions, such as nausea, exanthema and vomiting, to contrast media occurred in 2,523 patients (7.5 %), with the higher number occuring in patients aged 40 - 60, irrespective of sex. There were no significant alternations in vital signs. Patients positive for pretesting and having a history of allergy had higher incidences of adverse reactions (48 % and 52 %, respectively). A history of allergy is the most potential predictor for adverse reactions to contrast media. There was no definitive correlation between prior medication of contrast media and the occurrence of their adverse reactions. The relationship between the occurrence of adverse reactions and both kinds and dosage of contrast media was unknown. (Namekawa, K.)

  14. Review of the Clinical Effect of Orlistat

    Science.gov (United States)

    Qi, Xiguang

    2018-01-01

    Obesity has been a main risk for the development of diabetes mellitus, cardiovascular diseases and many other chronic problems worldwide. Lifestyle modification is the best way to lose weight but very hard to implement, thus pharmacotherapy is regarded as a good add-on to dietary and lifestyle therapies. This review provides an overview of the olistat, a drug for obesity approved by FDA, about its mechanism of action, efficacy for obesity and some other diseases including cardiovascular disease, type 2 diabetes and some cancers, as well as its safety and adverse effects.

  15. The Role of Technical Advances in the Adoption and Integration of Patient-Reported Outcomes in Clinical Care

    Science.gov (United States)

    Jensen, Roxanne E.; Rothrock, Nan E.; DeWitt, Esi Morgan; Spiegel, Brennan; Tucker, Carole A.; Crane, Heidi M.; Forrest, Christopher B.; Patrick, Donald L.; Fredericksen, Rob; Shulman, Lisa M.; Cella, David; Crane, Paul K.

    2016-01-01

    Background Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (e.g., touch screen tablets, Internet accessibility, and electronic health records (EHRs)), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. Objectives To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Methods Five practical case studies across diverse healthcare settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, pre-visit screening, effective evaluation, and EHR integration. Conclusions These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems. PMID:25588135

  16. Effectiveness of clinical supervision of physiotherapists: a survey.

    Science.gov (United States)

    Snowdon, David A; Millard, Geraldine; Taylor, Nicholas F

    2015-04-01

    Limited literature exists on the practice of clinical supervision (CS) of professional physiotherapists despite current Australian safety and quality health standards stating that CS is to be provided to all physiotherapists. The aim of the present study was to evaluate the effectiveness of CS of physiotherapists working in an Australian public health service. CS was measured using the allied health-specific 26-item modified Manchester Clinical Supervision Scale (MCSS-26). Subscales of the MCSS-26 were summed for three domain scores (normative, restorative and formative) and a total score was calculated, which was compared with the reported threshold score of 73 for effective supervision. Sixty registered physiotherapists (response rate 92%), working for a large metropolitan public health service, with six different site locations, completed the survey. The mean (± s.d.) total MCSS-26 score was 71.0 ± 14.3 (95% confidence interval (CI) 67.4-74.6). Hospital site was the only variable that had a significant effect on total MCSS-26 score (P=0.005); there was no effect for supervisor or supervisee experience, or hospital setting (acute vs subacute). Physiotherapists scored a significantly lower mean percentage MCSS-26 score on the normative domain compared with the restorative domain (mean difference 7.8%; 95% CI 2.9-12.7; P=0.002) and the formative domain (mean difference 9.6%; 95% CI 6.3-13.0; P<0.001). Of the two subscales that form the normative domain, 'finding time' had a significantly lower mean percentage MCSS-26 score than 'importance/value of CS' (mean difference 35.4%; 95% CI 31.3-39.4; P<0.001). Within this publicly funded physiotherapy department there was uncertainty about the effectiveness of CS, with more than half the physiotherapists rating their supervision as less than effective, suggesting there is opportunity for improvement in the practice of physiotherapy CS. Physiotherapists scored lowest in the normative domain, indicating that they found it

  17. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

    2014-01-01

    OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events...... identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. SETTING: 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency...... for marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...

  18. Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

    Science.gov (United States)

    Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

    2017-12-01

    Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

  19. 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.

  20. Clinical Investigation Service Annual Research Progress Report Fiscal Year 1980,

    Science.gov (United States)

    1980-10-01

    piror to stimulation will be 3tudied. The amount of DNA synthesis will be measured by incorporation of tritiated thymidine (3HT). The time of optimum...required for optimal DNA synthesis by nitrogen- stimulated T-lymphocytes. Most human beings are far from being saturated with PLP, and, therefore, their...splenectomy, immediate and remote, including fulminating infections, and (e) effective- ness of penicillin prophylaxis in the prevention of post

  1. Clinical effect of intravenous thrombolysis combined with nicorandil ...

    African Journals Online (AJOL)

    Tropical Journal of Pharmaceutical Research June 2016; 15 (6): 1335-1339. ISSN: 1596-5996 ... Original Research Article. Clinical effect of ... pain and arrhythmia; but the most representative .... people who are given placebo, confirming the.

  2. Cannabis - its clinical effects | Solomons | South African Medical ...

    African Journals Online (AJOL)

    The range of clinical, intoxicating, psychological and psychiatric effects of cannabis ('dagga') are reviewed. Controversial subjects, such as the entities of toxic cannabis psychosis and the cannabis amotivational syndrome, are discussed. S Afr Med J 1989; 76: 102-104.

  3. The accuracy of clinical malaria case reporting at primary health care facilities in Honiara, Solomon Islands

    Directory of Open Access Journals (Sweden)

    Kunimitsu Ayano

    2009-04-01

    Full Text Available Abstract Background The accuracy of malaria case reporting is challenging due to restricted human and material resources in many countries. The reporting often depends on the clinical diagnosis because of the scarcity of microscopic examinations. Particularly, clinical malaria case reporting by primary health care facilities (local clinics, which constitutes the baseline data of surveillance, has never previously been sufficiently evaluated. In order to improve the malaria reporting system to the level required to eventually eliminate this disease, this study estimates the gaps between the records of clinics and government statistics regarding the incidence of clinical malaria, and then also examines some factors that might explain the data discrepancy, including such variables as clinic staffing and record keeping. Methods All medical records for outpatients in 2007, handwritten by nurses, were collected from local clinics in Honiara, the capital of the Solomon Islands. The all-monthly clinical malaria cases were then recalculated. The corresponding monthly data in official statistics were provided by the government. Next, in order to estimate any data discrepancy, the ratio of the cases recorded at clinics to the cases reported to the government was determined on the monthly basis. Finally, the associations between the monthly discrepancy and other variables were evaluated by a multiple regression analysis. Results The mean data discrepancy between the records of clinics and government statistics was 21.2% (n = 96. Significant associations were observed between the discrepancy and the average number of patients (coefficient: 0.05, 95%CI: 0.31, 0.07, illegible handwriting (coefficient: 0.09, 95%CI: 0.04, 0.15, the use of tally sheets (coefficient:-0.38, 95%CI: -0.54, -0.22, and the clinic level (coefficient:-0.48, 95%CI:-0.89,-0.06. Conclusion The findings of this study demonstrate the huge data discrepancy between the records of clinics and

  4. Quality Improvement in Pediatric Endoscopy: A Clinical Report From the NASPGHAN Endoscopy Committee.

    Science.gov (United States)

    Kramer, Robert E; Walsh, Catharine M; Lerner, Diana G; Fishman, Douglas S

    2017-07-01

    The current era of healthcare reform emphasizes the provision of effective, safe, equitable, high-quality, and cost-effective care. Within the realm of gastrointestinal endoscopy in adults, renewed efforts are in place to accurately define and measure quality indicators across the spectrum of endoscopic care. In pediatrics, however, this movement has been less-defined and lacks much of the evidence-base that supports these initiatives in adult care. A need, therefore, exists to help define quality metrics tailored to pediatric practice and provide a toolbox for the development of robust quality improvement (QI) programs within pediatric endoscopy units. Use of uniform standards of quality reporting across centers will ensure that data can be compared and compiled on an international level to help guide QI initiatives and inform patients and their caregivers of the true risks and benefits of endoscopy. This report is intended to provide pediatric gastroenterologists with a framework for the development and implementation of endoscopy QI programs within their own centers, based on available evidence and expert opinion from the members of the NASPGHAN Endoscopy Committee. This clinical report will require expansion as further research pertaining to endoscopic quality in pediatrics is published.

  5. The Workforce Task Force report: clinical implications for neurology.

    Science.gov (United States)

    Freeman, William D; Vatz, Kenneth A; Griggs, Robert C; Pedley, Timothy

    2013-07-30

    The American Academy of Neurology Workforce Task Force (WFTF) report predicts a future shortfall of neurologists in the United States. The WFTF data also suggest that for most states, the current demand for neurologist services already exceeds the supply, and by 2025 the demand for neurologists will be even higher. This future demand is fueled by the aging of the US population, the higher health care utilization rates of neurologic services, and by a greater number of patients gaining access to the health care system due to the Patient Protection and Affordable Care Act. Uncertainties in health care delivery and patient access exist due to looming concerns about further Medicare reimbursement cuts. This uncertainty is set against a backdrop of Congressional volatility on a variety of issues, including the repeal of the sustainable growth rate for physician reimbursement. The impact of these US health care changes on the neurology workforce, future increasing demands, reimbursement, and alternative health care delivery models including accountable care organizations, nonphysician providers such as nurse practitioners and physician assistants, and teleneurology for both stroke and general neurology are discussed. The data lead to the conclusion that neurologists will need to play an even larger role in caring for the aging US population by 2025. We propose solutions to increase the availability of neurologic services in the future and provide other ways of meeting the anticipated increased demand for neurologic care.

  6. Elders with implant overdentures: a 22-year clinical report.

    Science.gov (United States)

    Alsabeeha, Nabeel H M

    2012-09-01

    To report on the long-term survival and prosthodontic maintenance of two edentulous adults with mandibular overdentures supported by hydroxyapatite (HA)-coated implants. Mandibular implant overdentures are a successful treatment option with positive impact on the quality of life of elderly edentulous adults. Long-term survival of the implants requires continued rigorous prosthodontic maintenance. Two elderly edentulous adults with mandibular overdentures supported by 2 HA-coated implants were presented for prosthodontic rehabilitation after 22 years of placement. The implants were osseo-integrated and surviving at presentation based on accepted criteria. The mandibular implant overdentures suffered recurrent loss of retention and stability. Prosthodontic treatment involving the replacement of defective attachment systems and construction of new sets of mandibular implant overdentures opposing complete maxillary dentures is presented. The long-term survival of mandibular 2-implant overdentures requires continued prosthodontic maintenance. A conservative approach in the rehabilitation of two older edentulous adults with mandibular 2-implant overdentures was described including proper selection of attachment systems. © 2012 The Gerodontology Society and John Wiley & Sons A/S.

  7. Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain - a single-arm clinical trial investigating the effects of thrust spinal manipulation.

    Science.gov (United States)

    Xia, Ting; Long, Cynthia R; Vining, Robert D; Gudavalli, Maruti R; DeVocht, James W; Kawchuk, Gregory N; Wilder, David G; Goertz, Christine M

    2017-06-09

    Spinal manipulation (SM) is used commonly for treating low back pain (LBP). Spinal stiffness is routinely assessed by clinicians performing SM. Flexion-relaxation ratio (FRR) was shown to distinguish between LBP and healthy populations. The primary objective of this study was to examine the association of these two physiological variables with patient-reported pain intensity and disability in adults with chronic LBP (>12 weeks) receiving SM. A single-arm trial provided 12 sessions of side-lying thrust SM in the lumbosacral region over 6 weeks. Inclusion criteria included 21-65 years old, Roland-Morris Disability Questionnaire (RMDQ) score ≥ 6 and numerical pain rating score ≥ 2. Spinal stiffness and FRR were assessed pre-treatment at baseline, after 2 weeks and after 6 weeks of treatment. Lumbar spine global stiffness (GS) were calculated from the force-displacement curves obtained using i) hand palpation, ii) a hand-held device, and iii) an automated indenter device. Lumbar FRR was assessed during trunk flexion-extension using surface electromyography. The primary outcomes were RMDQ and pain intensity measured by visual analog scale (VAS). Mixed-effects regression models were used to analyze the data. The mean age of the 82 participants was 45 years; 48% were female; and 84% reported LBP >1 year. The mean (standard deviation) baseline pain intensity and RMDQ were 46.1 (18.1) and 9.5 (4.3), respectively. The mean reduction (95% confidence interval) after 6 weeks in pain intensity and RMDQ were 20.1 mm (14.1 to 26.1) and 4.8 (3.7 to 5.8). There was a small change over time in the palpatory GS but not in the hand-held or automated GS, nor in FRR. The addition of each physiologic variable did not affect the model-estimated changes in VAS or RMDQ over time. There was no association seen between physiological variables and LBP intensity. Higher levels of hand-held GS at L3 and automated GS were significantly associated with higher levels of RMDQ (p

  8. Prediction methods environmental-effect reporting

    International Nuclear Information System (INIS)

    Jonker, R.J.; Koester, H.W.

    1987-12-01

    This report provides a survey of prediction methods which can be applied to the calculation of emissions in cuclear-reactor accidents, in the framework of environment-effect reports (dutch m.e.r.) or risk analyses. Also emissions during normal operation are important for m.e.r.. These can be derived from measured emissions of power plants being in operation. Data concerning the latter are reported. The report consists of an introduction into reactor technology, among which a description of some reactor types, the corresponding fuel cycle and dismantling scenarios - a discussion of risk-analyses for nuclear power plants and the physical processes which can play a role during accidents - a discussion of prediction methods to be employed and the expected developments in this area - some background information. (aughor). 145 refs.; 21 figs.; 20 tabs

  9. Herbal products in pregnancy: experimental studies and clinical reports.

    Science.gov (United States)

    Smeriglio, Antonella; Tomaino, Antonio; Trombetta, Domenico

    2014-08-01

    The aim of this work is to provide an update from an overview of the literature of the most frequently consumed herbal remedies during pregnancy, both alone and concomitantly with prescribed medications and particularly on their side effects to the mother and fetus. We have also analyzed some of the adverse interactions that may occur due to concomitant use of herbal and pharmaceutical products during pregnancy. Herbal remedies are not evaluated according to the same standards as pharmaceuticals, and in the USA some of it are not licensed but sold as food supplements. There is a lack of basic knowledge on the part of both clinicians and patients as to the indications for use and safety of herbal medicines used in pregnancy and lactation. If 'traditional use' is the only available information, the pregnant woman should be made aware of this to enable her to make an informed decision concerning potential use. Copyright © 2014 John Wiley & Sons, Ltd.

  10. Can the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) be used to accurately report clinic total reproductive potential (TRP)?

    Science.gov (United States)

    Stern, Judy E; Hickman, Timothy N; Kinzer, Donna; Penzias, Alan S; Ball, G David; Gibbons, William E

    2012-04-01

    To assess whether total reproductive potential (TRP), the chance of a live birth from each fresh cycle (fresh cycle plus frozen transfers), could be calculated from the national Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) database and whether information not available in SART CORS resulted in significant changes to the TRP calculation. Retrospective study using SART CORS and clinic data. Three assisted reproductive technology clinics. Women undergoing ART. None. Two- and three-year TRPs for 2005 and 2006 were calculated according to patient age at cycle start by linking fresh to frozen cycles up to first live birth. Clinic records were used to adjust for (remove) frozen cycles that used more than one fresh cycle as a source of embryos and for any embryos donated to other patients or research or shipped to another facility before a live birth. TRP was higher than fresh per-cycle rates for most ages at all clinics, although accuracy was compromised when there were fewer than 20 cycles per category. Two- and 3-year TRPs differed in only 2 of 24 calculations. Adjusted TRPs differed less than three percentage points from unadjusted TRPs when volume was sufficient. Clinic TRP can be calculated from SART CORS. Data suggest that calculations of clinic TRP from the national dataset would be meaningful. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  11. Prosthetic rehabilitation of a patient after partial maxillectomy: A clinical report

    Directory of Open Access Journals (Sweden)

    Shobha J Rodrigues

    2011-01-01

    Full Text Available Malignant melanoma of the oral cavity is very rare. This clinical report describes a method for prosthetic rehabilitation of a patient with malignant melanoma of the palate following partial maxillectomy with a closed hollow interim obturator.

  12. Prosthetic rehabilitation of a patient after partial maxillectomy: A clinical report

    OpenAIRE

    Rodrigues, Shobha J.; Saldanha, Sharon

    2011-01-01

    Malignant melanoma of the oral cavity is very rare. This clinical report describes a method for prosthetic rehabilitation of a patient with malignant melanoma of the palate following partial maxillectomy with a closed hollow interim obturator.

  13. Highly effective cystic fibrosis clinical research teams: critical success factors.

    Science.gov (United States)

    Retsch-Bogart, George Z; Van Dalfsen, Jill M; Marshall, Bruce C; George, Cynthia; Pilewski, Joseph M; Nelson, Eugene C; Goss, Christopher H; Ramsey, Bonnie W

    2014-08-01

    Bringing new therapies to patients with rare diseases depends in part on optimizing clinical trial conduct through efficient study start-up processes and rapid enrollment. Suboptimal execution of clinical trials in academic medical centers not only results in high cost to institutions and sponsors, but also delays the availability of new therapies. Addressing the factors that contribute to poor outcomes requires novel, systematic approaches tailored to the institution and disease under study. To use clinical trial performance metrics data analysis to select high-performing cystic fibrosis (CF) clinical research teams and then identify factors contributing to their success. Mixed-methods research, including semi-structured qualitative interviews of high-performing research teams. CF research teams at nine clinical centers from the CF Foundation Therapeutics Development Network. Survey of site characteristics, direct observation of team meetings and facilities, and semi-structured interviews with clinical research team members and institutional program managers and leaders in clinical research. Critical success factors noted at all nine high-performing centers were: 1) strong leadership, 2) established and effective communication within the research team and with the clinical care team, and 3) adequate staff. Other frequent characteristics included a mature culture of research, customer service orientation in interactions with study participants, shared efficient processes, continuous process improvement activities, and a businesslike approach to clinical research. Clinical research metrics allowed identification of high-performing clinical research teams. Site visits identified several critical factors leading to highly successful teams that may help other clinical research teams improve clinical trial performance.

  14. Clinical experience for radiolucent stones; A report of 27 cases

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hyung Jee; Lee, Gil Ho [Dankook University, Seoul (Korea, Republic of)

    1997-02-01

    The cause of radiolucent filling defects in the upper urinary tract are malignant tumor, radiolucent stones, blood clots, air bubbles, congenital deformities of renal parenchyme, and various specific and non-specific infection and their sequence. So the differential diagnosis between malignancy and radiolucent stones is very important, and the exact and fast diagnosis of radiolucent stones is useful in excluding the possibility of malignancy. 27 cases with radiolucent stones were evaluated retrospectively for exact diagnosis and appropriate treatment method. Intravenous urography was done in all cases, and retrograde pyelography, ultrasonography, computed tomography and/or ureterorenoscopy were performed for diagnosis, if needed. Size of stones were measured below 10mm by transverse length in 19 cases (70.4%) with a range of 3 to 30mm. The locations of stones were pelvicalyceal system in 8 cases (29.6%) and ureter in 19 cases (70.4%). Among the diagnostic methods, computed tomography was used most frequency. ESWL with retrograde pyelography was most frequent used method of treatment, also simple hydration to small stone was effective. (author).

  15. Clinical experience for radiolucent stones; A report of 27 cases

    International Nuclear Information System (INIS)

    Kim, Hyung Jee; Lee, Gil Ho

    1997-01-01

    The cause of radiolucent filling defects in the upper urinary tract are malignant tumor, radiolucent stones, blood clots, air bubbles, congenital deformities of renal parenchyme, and various specific and non-specific infection and their sequence. So the differential diagnosis between malignancy and radiolucent stones is very important, and the exact and fast diagnosis of radiolucent stones is useful in excluding the possibility of malignancy. 27 cases with radiolucent stones were evaluated retrospectively for exact diagnosis and appropriate treatment method. Intravenous urography was done in all cases, and retrograde pyelography, ultrasonography, computed tomography and/or ureterorenoscopy were performed for diagnosis, if needed. Size of stones were measured below 10mm by transverse length in 19 cases (70.4%) with a range of 3 to 30mm. The locations of stones were pelvicalyceal system in 8 cases (29.6%) and ureter in 19 cases (70.4%). Among the diagnostic methods, computed tomography was used most frequency. ESWL with retrograde pyelography was most frequent used method of treatment, also simple hydration to small stone was effective. (author)

  16. Public Reporting of Primary Care Clinic Quality: Accounting for Sociodemographic Factors in Risk Adjustment and Performance Comparison.

    Science.gov (United States)

    Wholey, Douglas R; Finch, Michael; Kreiger, Rob; Reeves, David

    2018-01-03

    Performance measurement and public reporting are increasingly being used to compare clinic performance. Intended consequences include quality improvement, value-based payment, and consumer choice. Unintended consequences include reducing access for riskier patients and inappropriately labeling some clinics as poor performers, resulting in tampering with stable care processes. Two analytic steps are used to maximize intended and minimize unintended consequences. First, risk adjustment is used to reduce the impact of factors outside providers' control. Second, performance categorization is used to compare clinic performance using risk-adjusted measures. This paper examines the effects of methodological choices, such as risk adjusting for sociodemographic factors in risk adjustment and accounting for patients clustering by clinics in performance categorization, on clinic performance comparison for diabetes care, vascular care, asthma, and colorectal cancer screening. The population includes all patients with commercial and public insurance served by clinics in Minnesota. Although risk adjusting for sociodemographic factors has a significant effect on quality, it does not explain much of the variation in quality. In contrast, taking into account the nesting of patients within clinics in performance categorization has a substantial effect on performance comparison.

  17. Core Data Necessary for Reporting Clinical Trials on Nutrition in Infancy

    NARCIS (Netherlands)

    Koletzko, Berthold; Fewtrell, Mary; Gibson, Robert; van Goudoever, Johannes B.; Hernell, Olle; Shamir, Raanan; Szajewska, Hania

    2015-01-01

    This paper presents an updated and revised summary of the 'core data set' that has been proposed to be recorded and reported in all clinical trials on infant nutrition by the recently formed Consensus Group on Outcome Measures Made in Paediatric Enteral Nutrition Clinical Trials (COMMENT). This core

  18. High School Students' Self-Reported Use of School Clinics and Nurses

    Science.gov (United States)

    Harper, Christopher R.; Liddon, Nicole; Dunville, Richard; Habel, Melissa A.

    2016-01-01

    Access to school health clinics and nurses has been linked with improved student achievement and health. Unfortunately, no studies have examined how many students report using school clinics or nurses and for which services. This study addressed this gap with data from a nationally representative sample of 15- to 25-year-olds. Respondents who…

  19. The 7q11.23 Microduplication Syndrome: A Clinical Report with Review of Literature

    OpenAIRE

    Abbas, Elham; Cox, Devin M.; Smith, Teri; Butler, Merlin G.

    2016-01-01

    We report a 14-year-old adolescent girl with selective mutism (SM) and a 7q11.23 microduplication detected by chromosomal microarray (CMA) analysis and reviewed the literature from 18 published clinical reports. Our patient had specific phobias, SM, extreme anxiety, obesity, cutis marmorata, and a round appearing face with a short neck and over folded ears. We reviewed the published clinical, cognitive, behavioral, and cytogenetic findings grouped by speech and language delay, growth and deve...

  20. Unusual clinical presentation of rare case of vaginal leiomyoma: a case report

    OpenAIRE

    Ishrat Zuber; Purnima K. Nadkarni; Aditi A. Nadkarni; Akshay Nadkarni

    2016-01-01

    Primary vaginal leiomyoma are rare and usually arise from anterior vaginal wall, approximately 330 cases of vaginal fibroid reported in world literature. Vaginal myoma usually presented as discharge per vaginum, abnormal bleeding, pain lower abdomen, dyspareunia etc. We report a case of primary vaginal leiomyoma arising from lateral vaginal wall which is presented clinically as pain in hip joint and radiating to ipsilateral leg which is unusual clinical presentation creating diagnostic dilemm...

  1. [Pathological nighttime fears in children: Clinical specificities and effective therapeutics].

    Science.gov (United States)

    Ducasse, D; Denis, H

    2015-09-01

    Pathological nighttime fears in children have been little studied. However, this disorder is commonly encountered in medical consultations and is discomforting and dysfunctional for both the child and the family. Most nighttime fears are part and parcel of normal development, and emanate from increasingly sophisticated cognitive development in the growing child. Thus, most children report a variety of coping strategies generally helpful in reducing their anxiety, which resolves spontaneously in the growing child. Nevertheless, in about 10% of children, nighttime fears are related to one or more anxiety disorders according to Diagnostic and Statistical Manual of Mental Disorders criteria. Then, it is estimated that severe nighttime fears and sleep problems occur in 20-30% of children. This problem is not transient and has to be treated. This study aims to review clinical features of nighttime fears and possible treatments for these patients and their families. This systematic review follows the preferred reporting items for systematic reviews and meta-analysis (PRISMA) statement guidelines. Two databases (Medline and Web of Science) were searched combining the search terms: nighttime fears AND children. English and French languages were imposed. There were no publication date or publication status limitations. Pathological nighttime fears are responsible for emotional (crying, panic, tantrums at bedtime, loss of confidence, self-disparaging negative statements, and feeling of social embarrassment) and behavioral (wandering alone in the house at night, calls for parental or sibling comfort, bed sharing with parents or siblings, light source at night, refusal to go to the toilet alone at night) disturbances. This leads to a poor quality of sleep interfering with school learning, and also affects social development and family functioning. A full assessment has to be made to eliminate organic causes, have a baseline functioning, and search for comorbid anxiety diseases

  2. Anti-N-Methyl-d-Aspartate receptor (NMDAR) encephalitis during pregnancy: Clinical analysis of reported cases.

    Science.gov (United States)

    Shi, Yan-Chao; Chen, Xiu-Ju; Zhang, Hong-Mei; Wang, Zhen; Du, Da-Yong

    2017-06-01

    To analyze the clinical features of 13 pregnant patients with anti-N-Methyl-d-Aspartate receptor (NMDAR) encephalitis. Retrospective review of thirteen reported cases was conducted for anti-NMDAR encephalitis patients during pregnancy. The clinical data were collected from papers published in PubMed prior to 16 February 2016. Statistical analysis of the data was performed, which encompasses the patients' age, past medical history, onset of symptoms, concomitant with ovarian teratomas, immunotherapy, outcomes of mothers and newborns. Thirteen cases were reported in 11 articles with a median age of 23 (interquartile range, 19-27) years old. There were eight cases in which the onset periods of gestation happened in the first trimester and five cases in the second trimester. Among 13 cases, five patients had a past medical history, one concomitant with autoimmune Graves' hyperthyroidism, one with bilateral ovarian teratomas removed history, one with anti-NMDAR encephalitis five years before pregnancy and two with psychiatric symptoms. Five patients were found with ovarian teratomas. Seven patients responded to first-line immunotherapy whereas all of two patients responded to second-line immunotherapy when the first-line immunotherapy failed. Following up all the 13 patients, most experienced a substantial recovery, except one had spasticity and dystonia in one hand, and one died of a superimposed infection. Three fetuses were miscarried or aborted in total. Most newborns were healthy, except two cases (2/10) with abnormal neurologic signs. Clinical analysis of the data indicates that most patients respond to first-line immunotherapy. A second-line immunotherapy is effective when first-line immunotherapy fails. It has also been found that most mothers and newborns can have good outcomes. Copyright © 2017. Published by Elsevier B.V.

  3. Malignant PEComa: a case report with emphasis on clinical and morphological criteria

    Directory of Open Access Journals (Sweden)

    Legnini Margherita

    2011-01-01

    Full Text Available Abstract Background Malignant perivascular epitheliod cell tumor (PEComa is a very rare entity composed of distinctive perivascular epitheliod cells with variable immunoreactivity for melanocytic and muscle markers. At present this neoplasm does not have a known normal cellular counterpart and the natural history is often unpredictable. Up to now, few cases of PEComa have been described and treatment modalities are still controversial, particularly in advanced conditions. Case presentation We handled the case of a 42-year-old man with unresectable PEComa of the abdomen. A 7 cm hepatic hypodense lesion between segment V and VIII of the liver and diffuse intraperitoneal nodules of 0,3-3,5 cm along the right subcapsular hepatic region, were documented by a CT scan. Radiological images showed abnormal lymph nodes of the right internal mammary chain and anterior mediastinum. The patient underwent an explorative laparotomy for uncontrolled intrabdominal hemorrhage without a well-defined preoperative tumor diagnosis. At surgery, multiple lobulated nodules containing hemorrhagic fluid on the liver surface, peritoneum and omentum were confirmed. The procedure had a palliative intent and consisted of hemostasis, hematomas evacuation and omentectomy. The diagnosis of PEComa was made after surgery on the basis of morphological and immunohystochemical criteria. Radiological and intra operative findings suggest that the mass has an hepatic origin with diffuse involvement of hepatic capsule and suspensory ligaments. The patient received medical support care with blood and plasma transfusions. In our experience, PEComa was clinically malignant, leading to a fatal outcome 25 days after hospital admission of patient. Conclusions Here we report and discuss the peculiar clinical, radiological and morphological presentation of unresectable PEComa. Although in the majority of the reported series, PEComas show a more better prognosis, our case presents with a

  4. Annual report of Radiation Effects Research Foundation

    International Nuclear Information System (INIS)

    1980-01-01

    The Radiation Effects Research Foundation was established in April, 1975, as a private nonprofit Japanese Foundation supported equally by the Government of Japan through the Ministry of Health and Welfare, and the Government of the United States through the National Academy of Sciences under contract with the Energy Research and Development Administration. First, the messages from the chairman and the vice-chairman are described. In the annual report, the review of ABCC-RERF studies of atomic bomb survivors, the summary of research activities, the research projects, the technical report abstracts, the research papers published in Japanese and foreign journals, and the oral presentation and lectures, all from April 1, 1978, to March 31, 1979, are reported. Also the report from the Secretariat and the appendixes are given. The surveys and researches carried out in Hiroshima and Nagasaki have offered very valuable informations to the atomic bomb survivors. Many fears were eliminated, medical interests were given to the serious effects of the exposure to atomic bombs, and many things concerning the cancer induced by radiation were elucidated. The knowledges obtained will save many human lives in future by utilizing them for setting up the health and safety standard in the case of handling ionizing radiation. The progress in researches such as life span study, adult health study, pathology study, genetics program, special cancer program and so on is reported. (Kako, I.)

  5. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study

    OpenAIRE

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

    2014-01-01

    Objective To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Design Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical codi...

  6. Report on Provider-Client Interaction From 68 Methadone Maintenance Clinics in China.

    Science.gov (United States)

    Li, Li; Comulada, W Scott; Lin, Chunqing; Lan, Chiao-Wen; Cao, Xiaobin; Wu, Zunyou

    2017-11-01

    Provider-client interaction is an integral of clinical practice and central to the delivery of high-quality medical care. This article examines factors related to the provider-client interaction in the context of methadone maintenance treatment (MMT). Data were collected from 68 MMT clinics in China. In total, 418 service providers participated in the survey. Linear mixed effects regression models were performed to identify factors associated with provider-client interaction. It was observed that negative attitude toward drug users was associated with lower level of provider-client interaction and less time spent with each client. Other factors associated with lower level of interaction included being female, being younger, being a nurse, and fewer years in medical field. Higher provider-client interaction was associated with provider reported job satisfaction. The findings of this study call for a need to address provider negative attitudes that can impact provider-client interaction and the effectiveness of MMT. Future intervention efforts targeting MMT providers should be tailored by gender, provider type, and medical experiences.

  7. Media Reporting of Practice-Changing Clinical Trials in Oncology: A North American Perspective.

    Science.gov (United States)

    Andrew, Peter; Vickers, Michael M; O'Connor, Stephen; Valdes, Mario; Tang, Patricia A

    2016-03-01

    Media reporting of clinical trials impacts patient-oncologist interactions. We sought to characterize the accuracy of media and Internet reporting of practice-changing clinical trials in oncology. The first media articles referencing 17 practice-changing clinical trials were collected from 4 media outlets: newspapers, cable news, cancer websites, and industry websites. Measured outcomes were media reporting score, social media score, and academic citation score. The media reporting score was a measure of completeness of information detailed in media articles as scored by a 15-point scoring instrument. The social media score represented the ubiquity of social media presence referencing 17 practice-changing clinical trials in cancer as determined by the American Society of Clinical Oncology in its annual report, entitled Clinical Cancer Advances 2012; social media score was calculated from Twitter, Facebook, and Google searches. The academic citation score comprised total citations from Google Scholar plus the Scopus database, which represented the academic impact per clinical cancer advance. From 170 media articles, 107 (63%) had sufficient data for analysis. Cohen's κ coefficient demonstrated reliability of the media reporting score instrument with a coefficient of determination of 94%. Per the media reporting score, information was most complete from industry, followed by cancer websites, newspapers, and cable news. The most commonly omitted items, in descending order, were study limitations, exclusion criteria, conflict of interest, and other. The social media score was weakly correlated with academic citation score. Media outlets appear to have set a low bar for coverage of many practice-changing advances in oncology, with reports of scientific breakthroughs often omitting basic study facts and cautions, which may mislead the public. The media should be encouraged to use a standardized reporting template and provide accessible references to original source

  8. Bystander effects and their implications for clinical radiotherapy

    International Nuclear Information System (INIS)

    Munro, Alastair J

    2009-01-01

    Radiation-induced bystander effects are defined as those biological effects expressed, after irradiation, by cells whose nuclei have not been directly irradiated. Radiation oncologists are only gradually beginning to appreciate the clinical relevance of radiation-induced bystander effects and associated phenomena: adaptive responses, genomic instability and abscopal effects. Incorporating bystander effects into the science underpinning clinical radiotherapy will involve moving beyond simple mechanistic models and towards a more systems-based approach. It is, given the protean nature of bystander effects, difficult to devise a coherent research strategy to investigate the clinical impact and relevance of bystander phenomena. Epidemiological approaches will be required, the traditional research models based on randomised controlled trials are unlikely to be adequate for the task. Any consideration of bystander effects challenges not only clinicians' preconceptions concerning the effects of radiation on tumours and normal tissues but also their ingenuity. This review covers, from a clinical perspective, the issues and problems associated with radiation-induced bystander effects.

  9. Perceptual derailment and confabulation in the Rorschach projective technique: a clinical report

    Directory of Open Access Journals (Sweden)

    Giovanni Genovese

    2015-12-01

    Full Text Available Perceptual derailment and confabulations often appear in a subtle way, being processes addressable to the field of inner world, conditioning the diagnostic process. The present clinical report aims to explore the role of Rorschach projective technique in eliciting processes otherwise unsearchable. Psycho-diagnostics data were compared to other psychometric tests such as the MMPI-2 (Minnesota Multiphasic Personality Inventory and the POMS (Profile of Mood States at time 0 and time 1 (after six months. Among these, the exploration of the projective process was crucial to understand the patient's mental functioning, as an elective instrument,  thanks to its ambiguous nature, which leads to effectively explore both the inner world and the cognitive processes.

  10. A Simplified Technique for Orientation of a Bone Anchored Auricular Prostheses: a Clinical Report

    Directory of Open Access Journals (Sweden)

    Hussein G. El Charkawi

    2012-08-01

    Full Text Available Background: A simple technique was presented in this clinical report for orientation of a bone anchored auricular prosthesis.Methods: The proposed technique includes drawing the intact ear on a transparent celluloid paper or radiographic film and flipping it to the opposite side and relating it to the fixed anatomical features on the face of patient.Results: The drawing, by this way provides a simple and easy way to duplicate and transfer the exact size and position of the intact ear to the defect side.Conclusions: This technique provides a simple, safe, inexpensive and time saving yet, an accurate and effective surgical template that orients the craniofacial implants to the confines of the definitive auricular prosthesis. It is indicated for restoration of single missing external ear either in aplasia, injuries and total resection.

  11. Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

    Science.gov (United States)

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

    2015-09-01

    An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

  12. Impact of a clinical guideline for prescribing antibiotics to inpatients reporting penicillin or cephalosporin allergy.

    Science.gov (United States)

    Blumenthal, Kimberly G; Shenoy, Erica S; Varughese, Christy A; Hurwitz, Shelley; Hooper, David C; Banerji, Aleena

    2015-10-01

    Self-reported penicillin allergy infrequently reflects an inability to tolerate penicillins. Inpatients reporting penicillin allergy receive alternative antibiotics that might be broader spectrum, more toxic, or less effective. To develop and assess a clinical guideline for the general inpatient provider that directs taking a history and prescribing antibiotics for patients with penicillin or cephalosporin allergy. A guideline was implemented to assist providers with assessing allergy history and prescribing antibiotics for patients with reported penicillin or cephalosporin allergy. The guideline used a standard 2-step graded challenge or test dose. A quasi-experimental study was performed to assess safety, feasibility, and impact on antibiotic use by comparing treatment 21 months before guideline implementation with 12 months after guideline implementation. Significantly more test doses to β-lactam antibiotics were performed monthly after vs before guideline implementation (median 14.5, interquartile range 13-16.25, vs 2, interquartile range 1-3.25, P  .5) between periods. Guideline-driven test doses decreased alternative antimicrobial therapy after the test dose, including vancomycin (68.3% vs 37.2%, P penicillin or cephalosporin allergy was associated with an almost 7-fold increase in the number of test doses to β-lactams without increased adverse drug reactions. Patients assessed with guideline-driven test doses were observed to have significantly decreased alternative antibiotic exposure. Copyright © 2015 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  13. Research and clinical aspects of the late effects of poliomyelitis

    Energy Technology Data Exchange (ETDEWEB)

    Halstead, L.S.; Wiechers, D.O.

    1986-01-01

    This book contains 32 selections. Some of the titles are: Late effects of Polio: Historical Perspectives; Sleep-Disordered Breathing as a Late Effect of Poliomyelitis; Clinical Subtypes, DNA Repair Efficiency, and Therapeutic Trials in the Post-Polio Syndromes; and Post-Polio Muscle Function.

  14. Clinical effect of Resina Draconis capsules on primary dysmenorrhoea

    African Journals Online (AJOL)

    Clinical effect of Resina Draconis capsules on primary dysmenorrhoea. Li Sun, Jia Wang. Abstract. Purpose: To examine the effectiveness of Resina Draconis capsules in the treatment of primary dysmenorrhoea. Methods: In total, 324 patients with primary dysmenorrhoea were randomly allocated to three groups based on ...

  15. Teaching Effectiveness: Preparing Occupational Therapy Students for Clinical Practice

    Directory of Open Access Journals (Sweden)

    Jane C. OBrien PhD, MS.MEdL, OTR/L

    2013-06-01

    Full Text Available Medical educators must examine the ability of teaching methodologies to prepare students for clinical practice. Two types of assessment methods commonly used in medical education include the Short Objective Structured Clinical Examination (OSCE and the Integrated Performance Procedural Instrument (IPPI. The use of these methods in occupational therapy (OT education is less understood. With the increasing number of students enrolled in programs, faculty face challenges to examine how clinical competence is established using data to determine teaching effectiveness. This study examines two educational methodologies used in OT curriculum: the long written case study (IPPI and short performance-based OSCE. The authors describe the effectiveness of each examination as it relates to student performance in clinical practice (as measured by the Fieldwork Performance Evaluation [FWPE]. The findings obtained from separate focus group sessions with faculty and students further provide insight into the advantages and disadvantages of the educational methodologies.

  16. Advancing medicine one research note at a time: the educational value in clinical case reports

    Directory of Open Access Journals (Sweden)

    Cabán-Martinez Alberto J

    2012-07-01

    Full Text Available Abstract A case report—a brief written note that describes unique aspects of a clinical case—provides a significant function in medicine given its rapid, succinct, and educational contributions to scientific literature and clinical practice. Despite the growth of, and emphasis on, randomized clinical trials and evidenced-based medicine, case reports continue to provide novel and exceptional knowledge in medical education. The journal BMC Research Notes introduces a new “case reports” section to provide the busy clinician with a forum in which to document any authentic clinical case that provide educational value to current clinical practice. The aim is for this article type to be reviewed, wherever possible, by specialized Associate Editors for the journal, in order to provide rapid but thorough decision making. New ideas often garnered by and documented in case reports will support the advancement of medical science — one research note at a time.

  17. Research and Clinical Center for Child Development Annual Report, 1994-1995, No. 18.

    Science.gov (United States)

    Wakai, Kunio, Ed.; Chen, Shing-Jen, Ed.

    This annual report discusses several topics related to the work of the Research and Clinical Center for Child Development. Seven topics are covered in the report. The articles are: (1) "Fathers' Participation in the Lives of Their 4-Month-Old Infants: The United States and Japan" (Marguerite Stevenson Barratt, Koichi Negayama and…

  18. Perceptions and Attitudes towards Medication Error Reporting in Primary Care Clinics: A Qualitative Study in Malaysia.

    Science.gov (United States)

    Samsiah, A; Othman, Noordin; Jamshed, Shazia; Hassali, Mohamed Azmi

    2016-01-01

    To explore and understand participants' perceptions and attitudes towards the reporting of medication errors (MEs). A qualitative study using in-depth interviews of 31 healthcare practitioners from nine publicly funded, primary care clinics in three states in peninsular Malaysia was conducted for this study. The participants included family medicine specialists, doctors, pharmacists, pharmacist assistants, nurses and assistant medical officers. The interviews were audiotaped and transcribed verbatim. Analysis of the data was guided by the framework approach. Six themes and 28 codes were identified. Despite the availability of a reporting system, most of the participants agreed that MEs were underreported. The nature of the error plays an important role in determining the reporting. The reporting system, organisational factors, provider factors, reporter's burden and benefit of reporting also were identified. Healthcare practitioners in primary care clinics understood the importance of reporting MEs to improve patient safety. Their perceptions and attitudes towards reporting of MEs were influenced by many factors which affect the decision-making process of whether or not to report. Although the process is complex, it primarily is determined by the severity of the outcome of the errors. The participants voluntarily report the errors if they are familiar with the reporting system, what error to report, when to report and what form to use.

  19. Clinical neuropharmacology of drugs of abuse: a comparison of drug-discrimination and subject-report measures.

    Science.gov (United States)

    Kelly, Thomas H; Stoops, William W; Perry, Andrea S; Prendergast, Mark A; Rush, Craig R

    2003-12-01

    Advances in molecular pharmacology and behavioral science have helped elucidate the structure and function of the central nervous system and its relationship to behavior and has sparked the development of pharmacological agents that have increasingly selective and potent effects with fewer adverse side effects. The sensitivity and predictive validity of the two most commonly used methodologies for assessing the neuropharmacological effects of centrally active drugs, subject report of drug effects and drug discrimination, were examined. The sensitivity of the measures was comparable across stimulant, sedative, and opioid drugs. Results with drug-discrimination methodologies were generally consistent with hypothesized neuropharmacological mechanisms across all drug classes, whereas subject reports conformed under more limited testing conditions. Firm conclusions regarding the relative utility of drug-discrimination and subject-report measures for clinical studies of neuropharmacological mechanisms are limited by the small number of studies in which the two methodologies have been tested using identical pharmacological pretreatment manipulations.

  20. [Effectiveness of cognitive-behavioral therapy in childhood anxiety disorders in a university psychiatric outpatient clinic].

    Science.gov (United States)

    Goletz, Hildegard; Yang, Young-Im; Suhr-Dachs, Lydia; Walter, Daniel; Döpfner, Manfred

    2013-07-01

    Only few studies have examined whether the efficacy of cognitive-behavioral therapy for childhood anxiety disorders as demonstrated in randomized controlled trials (RCTs) generalizes to clinical practice. This study examines the effectiveness of cognitive-behavioral therapy for juvenile anxiety disorders under routine care conditions in a university-based psychiatric outpatient clinic. 92 children and adolescents with parent-ratings regarding anxiety and comorbid symptoms and 61 children and adolescents with self-ratings regarding anxiety and comorbid symptoms were treated with cognitive-behavioral interventions. Pre/post mean comparisons, effect sizes, and the clinical significance of changes in symptoms were examined. The effect size for reduction of anxiety symptoms was .81 for children whose parents had completed the rating scale and .79 for children who had filled in a self-rating scale. Effect sizes for reduction of comorbid symptoms varied between .37 and .84 for parent ratings and between .21 and .62 for self-ratings. The percentage of children and adolescents who achieved clinically significant improvements in anxiety symptoms was 55.1 % according to the parent ratings and 65.7 % according to the children's self-ratings. More than 50 % of parents and children reported clinically significant improvements in comorbid symptoms. Significant reductions in both anxiety and comorbid symptoms were demonstrated over the course of cognitive-behavioral therapy of juvenile anxiety disorders in a university psychiatric outpatient clinic. The effect sizes for anxiety symptoms were found to be comparable to the effect sizes reported in RCTs. Similarly, clinically significant improvements were as frequent as the rates of remission of anxiety symptoms reported in RCTs.

  1. Evidence of the clinical effectiveness of cognitive pharmaceutical services for aged patients.

    Science.gov (United States)

    Sáez-Benito, Loreto; Fernandez-Llimos, Fernando; Feletto, Eleonora; Gastelurrutia, Miguel Angel; Martinez-Martinez, Fernando; Benrimoj, Shalom I

    2013-07-01

    cognitive pharmaceutical services (CPSs) encompass a variety of pharmacists' interventions to optimise pharmacotherapy. The clinical effectiveness of CPSs for aged patients remains controversial. to analyse and describe the evidence of the clinical effectiveness of CPSs in aged patients by means of performing a systematic review of systematic reviews. using the recommended methodology by Cochrane, a search was undertaken for systematic reviews of the clinical effectiveness of CPSs in MEDLINE, EMBASE, DOAJ, SCIELO and COCHRANE LIBRARY. Reviews were assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) instrument. Quality of the evidence in the reviews was ranked using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. a total of 14 systematic reviews and one meta-analysis were analysed. The overall quality of the reviews was moderate. High and moderate strength of evidence was found for the positive effect of certain CPSs on reducing the number and improving the appropriateness of medicines. There was conflicting evidence of the effect on adherence. There was limited evidence of high and moderate strength on clinical outcomes. No positive evidence was found on mortality, hospitalisations, functional capacity and cognitive function. No systematic reviews reported the effect on the level of control of health problems. certain types of CPSs reduce the number of medicines and improve the appropriateness of prescriptions. Longer follow-up periods and/or the use of surrogate clinical variables measuring the short-term impact are required to demonstrate the effect on clinical outcomes.

  2. Clinical report of a 17q12 microdeletion with additionally unreported clinical features.

    Science.gov (United States)

    Roberts, Jennifer L; Gandomi, Stephanie K; Parra, Melissa; Lu, Ira; Gau, Chia-Ling; Dasouki, Majed; Butler, Merlin G

    2014-01-01

    Copy number variations involving the 17q12 region have been associated with developmental and speech delay, autism, aggression, self-injury, biting and hitting, oppositional defiance, inappropriate language, and auditory hallucinations. We present a tall-appearing 17-year-old boy with marfanoid habitus, hypermobile joints, mild scoliosis, pectus deformity, widely spaced nipples, pes cavus, autism spectrum disorder, intellectual disability, and psychiatric manifestations including physical and verbal aggression, obsessive-compulsive behaviors, and oppositional defiance. An echocardiogram showed borderline increased aortic root size. An abdominal ultrasound revealed a small pancreas, mild splenomegaly with a 1.3 cm accessory splenule, and normal kidneys and liver. A testing panel for Marfan, aneurysm, and related disorders was negative. Subsequently, a 400 K array-based comparative genomic hybridization (aCGH) + SNP analysis was performed which identified a de novo suspected pathogenic deletion on chromosome 17q12 encompassing 28 genes. Despite the limited number of cases described in the literature with 17q12 rearrangements, our proband's phenotypic features both overlap and expand on previously reported cases. Since syndrome-specific DNA sequencing studies failed to provide an explanation for this patient's unusual habitus, we postulate that this case represents an expansion of the 17q12 microdeletion phenotype. Further analysis of the deleted interval is recommended for new genotype-phenotype correlations.

  3. Clinical Report of a 17q12 Microdeletion with Additionally Unreported Clinical Features

    Directory of Open Access Journals (Sweden)

    Jennifer L. Roberts

    2014-01-01

    Full Text Available Copy number variations involving the 17q12 region have been associated with developmental and speech delay, autism, aggression, self-injury, biting and hitting, oppositional defiance, inappropriate language, and auditory hallucinations. We present a tall-appearing 17-year-old boy with marfanoid habitus, hypermobile joints, mild scoliosis, pectus deformity, widely spaced nipples, pes cavus, autism spectrum disorder, intellectual disability, and psychiatric manifestations including physical and verbal aggression, obsessive-compulsive behaviors, and oppositional defiance. An echocardiogram showed borderline increased aortic root size. An abdominal ultrasound revealed a small pancreas, mild splenomegaly with a 1.3 cm accessory splenule, and normal kidneys and liver. A testing panel for Marfan, aneurysm, and related disorders was negative. Subsequently, a 400 K array-based comparative genomic hybridization (aCGH + SNP analysis was performed which identified a de novo suspected pathogenic deletion on chromosome 17q12 encompassing 28 genes. Despite the limited number of cases described in the literature with 17q12 rearrangements, our proband’s phenotypic features both overlap and expand on previously reported cases. Since syndrome-specific DNA sequencing studies failed to provide an explanation for this patient’s unusual habitus, we postulate that this case represents an expansion of the 17q12 microdeletion phenotype. Further analysis of the deleted interval is recommended for new genotype-phenotype correlations.

  4. Task force report on health effects assessment

    International Nuclear Information System (INIS)

    Anderson, C.; Hushon, J.

    1978-08-01

    From April to August, 1978 MITRE supported the Health Effects Assessment Task Force sponsored by the Office of the Assistant Secretary for the Environment at DOE. The findings of that Task Force are incorporated in this report and include a detailed definition of health effects assessment, a survey of the mandates for health effects assessments within DOE/EV, a review of current DOE-EV health effects assessment activities, an analysis of the constraints affecting the health effects assessment process and a discussion of the Task Force recommendations. Included as appendices are summaries of two workshops conducted by the Task Force to determine the state-of-the-art of health effects assessment and modeling and a review of risk assessment activities in other federal agencies. The primary recommendation of the panel was that an office be designated or created under the Office of the Assistant Secretary for the Environment to coordinate the Health Effects Risk Assessment effort covering up to 40 program and policy areas; a similar need was expressed for the environmental effects assessment area. 1 tab

  5. Clinical Cancer Advances 2018: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology.

    Science.gov (United States)

    Heymach, John; Krilov, Lada; Alberg, Anthony; Baxter, Nancy; Chang, Susan Marina; Corcoran, Ryan; Dale, William; DeMichele, Angela; Magid Diefenbach, Catherine S; Dreicer, Robert; Epstein, Andrew S; Gillison, Maura L; Graham, David L; Jones, Joshua; Ko, Andrew H; Lopez, Ana Maria; Maki, Robert G; Rodriguez-Galindo, Carlos; Schilsky, Richard L; Sznol, Mario; Westin, Shannon Neville; Burstein, Harold

    2018-04-01

    A MESSAGE FROM ASCO'S PRESIDENT I remember when ASCO first conceived of publishing an annual report on the most transformative research occurring in cancer care. Thirteen reports later, the progress we have chronicled is remarkable, and this year is no different. The research featured in ASCO's Clinical Cancer Advances 2018 report underscores the impressive gains in our understanding of cancer and in our ability to tailor treatments to tumors' genetic makeup. The ASCO 2018 Advance of the Year, adoptive cell immunotherapy, allows clinicians to genetically reprogram patients' own immune cells to find and attack cancer cells throughout the body. Chimeric antigen receptor (CAR) T-cell therapy-a type of adoptive cell immunotherapy-has led to remarkable results in young patients with acute lymphoblastic leukemia (ALL) and in adults with lymphoma and multiple myeloma. Researchers are also exploring this approach in other types of cancer. This advance would not be possible without robust federal investment in cancer research. The first clinical trial of CAR T-cell therapy in children with ALL was funded, in part, by grants from the National Cancer Institute (NCI), and researchers at the NCI Center for Cancer Research were the first to report on possible CAR T-cell therapy for multiple myeloma. These discoveries follow decades of prior research on immunology and cancer biology, much of which was supported by federal dollars. In fact, many advances that are highlighted in the 2018 Clinical Cancer Advances report were made possible thanks to our nation's support for biomedical research. Funding from the US National Institutes of Health and the NCI helps researchers pursue critical patient care questions and addresses vital, unmet needs that private industry has little incentive to take on. Federally supported cancer research generates the biomedical innovations that fuel the development and availability of new and improved treatments for patients. We need sustained federal

  6. Variability in the Reporting of Serum Urate and Flares in Gout Clinical Trials

    DEFF Research Database (Denmark)

    Stamp, Lisa K; Morillon, Melanie B; Taylor, William J

    2018-01-01

    OBJECTIVE: To describe the ways in which serum urate (SU) and gout flares are reported in clinical trials, and to propose minimum reporting requirements. METHODS: This analysis was done as part of a systematic review aiming to validate SU as a biomarker for gout. The ways in which SU and flares.......3%) of these reporting at more than just the final study visit. Two ways of reporting gout flares were identified: mean flare rate and percentage of participants with flares. There was variability in time periods over which flares rates were reported. CONCLUSION: There is inconsistent reporting of SU and flares in gout...... studies. Reporting the percentage of participants who achieve a target SU reflects international treatment guidelines. SU should also be reported as a continuous variable with a relevant central and dispersion estimate. Gout flares should be reported as both percentage of participants and mean flare rates...

  7. General practitioner's reported use of clinical guidelines for hypertension and ambulatory blood pressure.

    LENUS (Irish Health Repository)

    Flynn, E

    2012-03-01

    ABPM is an invaluable clinical tool, as it has been shown to improve blood pressure control in primary care. Many clinical guidelines for hypertension advocate ambulatory blood pressure monitoring. This study aims to quantify the use of clinical guidelines for hypertension and to explore the role of ABPM in Primary Care. A questionnaire survey was sent to GPs working in the West of Ireland. 88% (n=139) of GPs use clinical guidelines that recommend the use of ABPM. 82% (n=130) of GPs find use of clinic blood pressure monitoring insufficient for the diagnosis and monitoring of hypertension. Despite good access to ABPM, GPs report lack of remuneration, 72% (n=116), cost 68% (n=108), and lack of time, 51% (n=83) as the main limiting factors to use of ABPM. GPs recognise the clinical value of ABPM, but this study identifies definite barriers to the use of ABPM in Primary Care.

  8. Nursing Students’ Perceptions on Characteristics of an Effective Clinical Instructor

    Directory of Open Access Journals (Sweden)

    Joan E. Niederriter PhD, MSN, CMSRN, RN-BC

    2017-01-01

    Full Text Available Purpose To identify characteristics and teaching techniques of effective clinical instructors that can be utilized or implemented to improve the student nurse clinical experience. Background The clinical instructor is an integral part of a quality clinical experience. They help students transfer didactic information to the practice setting. The clinical nursing experience is a vital component in the developmental process of the nursing student. Research has been done on this subject, but gaps remain. The need for a more in-depth understanding of students’ perceptions of the characteristics and teaching techniques that best aid their comprehension and learning will help instructors to maximize student learning experiences in the practice setting. Method This qualitative research study utilized the phenomenological research method. Three open-ended questions were posed to 14 nursing students to identify the characteristics and teaching techniques they believed comprised an effective clinical instructor. Individual interviews were conducted and transcribed interviews were reviewed to identify common themes. Three faculty members provided member checking to prevent bias by reviewing the transcribed interviews for common themes. Findings Participants identified four main themes which include a trusting relationship, experience or knowledge, coach, and role model. The students found that they gained more knowledge, developed more critical thinking, and felt more confident with instructors who utilized characteristics and techniques from these four areas. Conclusion Clinical instructors play an important role in preparing the student nurse in becoming a competent nurse in the practice setting. This information can be used to provide a foundation in creating an educational opportunity to inform nurse educators in the ways to become a more effective clinical instructor.

  9. Optic nerve sheath meningioma treated with radiation conformal therapy. Clinical case report with long follow up

    International Nuclear Information System (INIS)

    Zomosa R, Gustavo; Cruz T, Sebastian; Miranda G, Gonzalo; Harbst S, Hans

    2016-01-01

    Optic nerve sheath meningiomas (ONSM) are rare tumors of the anterior visual pathway. Without treatment, tumor growth leads to progressive loss of visual acuity and blindness due to optic nerve compression. Case report: Patient, female, 42 years without other morbility , begins in 1992 with decreased visual acuity of the left eye, magnetic resonance imaging (MRI) showed enlargement of the left optic nerve sheath, suggestive of ONSM. On that occasion, orbit exploration failed, so it was decided to follow up with annual clinical and imaging controls. About ten years later, begins with progressive deterioration of visual acuity and visual field , with ptosis and ocular motor palsy of the left eye, confirmed with neuro-ophthalmological examinations. MRI shows tumor progression. A new surgical approach was discarded by the risk of visual worsening. A conformal radiotherapy was performed with a fractionated 54 Gy dose. Today, at age 65, after 24 years of follow up,13 post radiation therapy. clinical and radiological stability of ONSM is confirmed. Discussion: Conformal radiotherapy has been shown as an effective therapy, with fewer complications and better outcomes in the preservation of visual function in the long term follow up Radio-fluoro guided surgery in high grade gliomas

  10. Intensity-modulated radiotherapy for pituitary adenomas: The preliminary report of Cleveland Clinic experience

    International Nuclear Information System (INIS)

    Mackley, Heath B.; Reddy, Chandana A. M.S.; Lee, S.-Y.; Harnisch, Gayle A.; Mayberg, Marc R.; Hamrahian, Amir H.; Suh, John H.

    2007-01-01

    Purpose: Intensity-modulated radiotherapy (IMRT) is being increasingly used for the treatment of pituitary adenomas. However, there have been few published data on the short- and long-term outcomes of this treatment. This is the initial report of Cleveland Clinic's experience. Methods and Materials: Between February 1998 and December 2003, 34 patients with pituitary adenomas were treated with IMRT. A retrospective chart review was conducted for data analysis. Results: With a median follow-up of 42.5 months, the treatment has proven to be well tolerated, with performance status remaining stable in 90% of patients. Radiographic local control was 89%, and among patients with secretory tumors, 100% had a biochemical response. Only 1 patient required salvage surgery for progressive disease, giving a clinical progression free survival of 97%. The only patient who received more than 46 Gy experienced optic neuropathy 8 months after radiation. Smaller tumor volume significantly correlated with subjective improvements in nonvisual neurologic complaints (p = 0.03), and larger tumor volume significantly correlated with subjective worsening of visual symptoms (p = 0.05). New hormonal supplementation was required for 40% of patients. Younger patients were significantly more likely to require hormonal supplementation (p 0.03). Conclusions: Intensity-modulated radiation therapy is a safe and effective treatment for pituitary adenomas over the short term. Longer follow-up is necessary to determine if IMRT confers any advantage with respect to either tumor control or toxicity over conventional radiation modalities

  11. Psychosocial impact, perceived stress and learning effect in undergraduate dental students during transition from pre-clinical to clinical education.

    Science.gov (United States)

    Frese, C; Wolff, D; Saure, D; Staehle, H J; Schulte, A

    2018-04-10

    This study aimed to develop a suitable instrument for a comprehensive quantitative and qualitative assessment of perceived psychosocial impact, levels of stress and learning effect in undergraduate dental students during the transition from pre-clinical to clinical education. These findings might improve curricular structures and didactic organisation during this period. At the beginning of their first clinical year, undergraduate dental students were asked to complete an anonymous forty-item questionnaire. Two hundred and seventy-six undergraduate dental students were willing to participate and completed the questionnaire and participated during the years 2011-2016. The response rate was between 45% and 96%. Correlational analysis (Spearman-Rho) in the field of psychosocial impact showed the dental teacher to be the most important multiplier of students' feelings. If the students feel that their teacher acts cooperatively, positive items increase and negative items decrease significantly (P < .0001). Also, students who report high levels of stress are affected significantly in their psychosocial interaction (P < .0001). Wilcoxon test yielded highest levels of stress in endodontology during the first weeks (P < .0001). During the same period, the greatest learning increment was seen for diagnostics and caries excavation. In conclusion, teaching of undergraduate dental students during the transition period from pre-clinical to clinical education can be positively influenced by a supportive learning environment and by specific chronological modifications in the curriculum. Students should start their clinical training with diagnostics, preventive dentistry and initial periodontal treatment. Due to high levels of perceived stress, endodontology should be introduced later in the clinical curriculum. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. The effect of electronic monitoring feedback on medication adherence and clinical outcomes: A systematic review.

    Science.gov (United States)

    van Heuckelum, Milou; van den Ende, Cornelia H M; Houterman, Anne E J; Heemskerk, Charlotte P M; van Dulmen, Sandra; van den Bemt, Bart J F

    2017-01-01

    This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF.

  13. The patient-physician partnership in asthma: real-world observations associated with clinical and patient-reported outcomes.

    Science.gov (United States)

    Small, M; Vickers, A; Anderson, P; Kay, S

    2010-09-01

    It is hypothesized that a good partnership between asthma patients and their physicians has a direct and positive influence on the patients' clinical and patient-reported outcomes. Conversely, poor partnership has a detrimental effect on clinical and patient-reported outcomes. This paper uses data from a real-world observational study to define partnership through matched physician and patient data and correlate the quality of partnership with observed clinical and patient-reported outcomes. Data were drawn from Adelphi's Respiratory Disease Specific Programme, a cross-sectional study of consulting patients in five European countries undertaken between June and September 2009. A range of clinical and patient-reported outcomes were observed allowing analysis of the partnership between 2251 asthma patients and their physicians. Analysis demonstrates that the better the partnership between patient and physician, the more likely the patient is to have their asthma condition controlled (PPartnership is also associated with lower impact on lifestyle (Ppartnership is a contributory factor in the improvement of asthma treatment, and patient education may lead to improvement in a patient's ability to contribute to this. Device satisfaction is one of the markers of good partnership.

  14. Possible Oxcarbazepine Inductive Effects on Aripiprazole Metabolism: A Case Report.

    Science.gov (United States)

    McGrane, Ian R; Loveland, Joshua G; de Leon, Jose

    2017-01-01

    Oxcarbazepine is a cytochrome P450 (CYP) 3A4 inducer, which is structurally similar to carbamazepine. Although lacking Food and Drug Administration approval, oxcarbazepine is sometimes prescribed to treat aggressive behavior in youth with autism spectrum disorder (ASD). These youths may also be taking second-generation antipsychotics, some of which are substrates of the CYP3A4 metabolic pathway. The combination of these medications may result in decreased serum antipsychotic concentrations, potentially reducing effectiveness. A limited number of reports are available which discuss reduced atypical antipsychotic concentrations secondary to oxcarbazepine CYP3A4 induction. We report a young boy taking oxcarbazepine (1200 mg/d) who presented with an unexpectedly low serum aripiprazole concentration. Utilizing therapeutic drug monitoring, pharmacogenetic testing, and a tool to evaluate drug-drug interactions, we estimate that oxcarbazepine possibly reduced his serum aripiprazole concentration by 68%. Our report is important, as it is the first to describe a drug-drug interaction between oxcarbazepine and aripiprazole. This report should encourage the completion of in vitro and clinical studies and the publication of case reports describing the possible inductive effects of oxcarbazepine on atypical antipsychotics (including cariprazine, lurasidone, quetiapine, aripiprazole, brexpiprazole, iloperidone, and risperidone) mediated by induction of the CYP3A4 metabolic pathway.

  15. Hepatic veno-occlusive disease during chemotherapy for nephroblastoma: successful and safe treatment with defibrotide. Report of a clinical case.

    Science.gov (United States)

    Cecinati, Valerio; Giordano, Paola; De Leonardis, Francesco; Grassi, Massimo; Arcamone, Giampaolo; De Mattia, Domenico; Santoro, Nicola

    2009-01-01

    Here we report a case of administration of defibrotide in an 11 months old infant with hepatic veno-occlusive disease during chemotherapy for nephroblastoma. He presented with abdominal distension, a weight gain of 15%, ascites, hepatomegaly with right upper quadrant pain, thrombocytopenia and hypertransaminasemia. Despite therapy, his clinical conditions aggravated, and, therefore intravenous administration of defibrotide on a compassionate-use basis was started. The dosage was 15 mg/kg/day in 4 divided doses, which was increased gradually (in 3 days) to 40 mg/kg/day in 4 divided doses. Defibrotide proved safe and effective in resolving clinical symptoms and normalizing serological findings in the syndrome.

  16. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes

    Directory of Open Access Journals (Sweden)

    Mehrfam Khoshkhounejad

    2015-11-01

    Full Text Available Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA and BiodentineTM as coronal barriers and different irrigants, which led to different clinical outcomes.

  17. Placebo effect in clinical trial design for irritable bowel syndrome.

    Science.gov (United States)

    Shah, Eric; Pimentel, Mark

    2014-04-30

    Ongoing efforts to improve clinical trial design in irritable bowel syndrome have been hindered by high placebo response rates and ineffective outcome measures. We assessed established strategies to minimize placebo effect as well as the various ap-proaches to placebo effect which can affect trial design. These include genetic markers such as catechol-O-methyltransferase, opioidergic and dopaminergic neurobiologic theory, pre-cebo effect centered on expectancy theory, and side effect unblinding grounded on conditioning theory. We reviewed endpoints used in the study of IBS over the past decade including adequate relief and subjective global relief, emphasizing their weaknesses in fully evaluating the IBS condition, specifically their motility effects based on functional net value and relative benefit-harm based on dropouts due to adverse events. The focus of this review is to highlight ongoing efforts to improve clinical trial design which can lead to better outcomes in a real-world setting.

  18. Evolution of the clinical review station for enterprise-wide multimedia radiology reporting

    Science.gov (United States)

    Hanlon, William B.; Valtchinov, Vladimir I.; Davis, Scott D.; Lester, James; Khorasani, Ramin; Carrino, John A.; Benfield, Andrew

    2000-05-01

    Efforts to develop Picture Archiving and Communications Systems (PACS) for the last ten years have concentrated mainly on developing systems for primary interpretation of digital radiological images. Much less attention has been paid to the clinical aspects of the radiology process. Clinical radiology services are an important component of the overall care delivery process, providing information and consultation services to referring physicians, the customers of radiology, in a timely fashion to aid in care decisions. Information management systems (IMS) are playing an increasingly central role in the care delivery process. No suitable commercial PACS or IMS products were available that could effectively provide for the requirements of the clinicians. We endeavored to fill this void at our institution by developing a system to deliver images and text reports electronically on-demand to the referring physicians. This system has evolved substantially since initial deployment eight years ago. As new technologies become available they are evaluated and integrated as appropriate to improve system performance and manageability. Not surprisingly, the internet and World Wide Web (WWW) technology has had the greatest impact on system design in recent years. Additional features have been added over time to provide services for teleradiology, teaching, and research needs. We also discovered that these value-added services give us a competitive edge in attracting new business to our department. Commercial web-based products are now becoming available which do a satisfactory job of providing many of these clinical services. These products are evaluated for integration into our system as they mature. The result is a system that impacts positively on patient care.

  19. The impact of patient-reported outcome measures in clinical practice for pain: a systematic review.

    Science.gov (United States)

    Holmes, Michelle M; Lewith, George; Newell, David; Field, Jonathan; Bishop, Felicity L

    2017-02-01

    Patient-reported outcome measures (PROMs) have increasingly been incorporated into clinical practice. Research suggests that PROMs could be viewed as active components of complex interventions and may affect the process and outcome of care. This systematic review examines PROMs in the context of treatment for non-malignant pain. An electronic search on: MEDLINE, EMBASE, PsycINFO, PsycARTICLES, Cochrane Library and Web of Science identified relevant papers (February 2015). The inclusion criteria were: focused on implementing PROMs into clinical practice, adults, and primary data studies. Critical interpretive synthesis was used to synthesise qualitative and quantitative findings into a theoretical argument. Thirteen eligible studies were identified. Synthesis suggested that PROMs may be included in the initial consultation to assess patients and for shared decision-making regarding patient care. During the course of treatment, PROMs can be used to track progress, evaluate treatment, and change the course of care; using PROMs may also influence the therapeutic relationship. Post-treatment, using PROMs might directly influence other outcomes such as pain and patient satisfaction. However, although studies have investigated these areas, evidence is weak and inconclusive. Due to the poor quality, lack of generalisability and heterogeneity of these studies, it is not possible to provide a comprehensive understanding of how PROMs may impact clinical treatment of non-malignant pain. The literature suggests that PROMs enable pain assessment, decision-making, the therapeutic relationship, evaluation of treatment and may influence outcomes. Further research is needed to provide better evidence as to whether PROMs do indeed have any effects on these domains.

  20. Nursing students' perspectives on clinical instructors' effective teaching strategies: A descriptive study.

    Science.gov (United States)

    Valiee, Sina; Moridi, Glorokh; Khaledi, Shahnaz; Garibi, Fardin

    2016-01-01

    An important factor contributing to the quality of clinical education is instructors' teaching performance. The aim of this study was to identify clinical instructors' most effective teaching strategies from nursing and midwifery students' perspectives. This was a descriptive cross-sectional study. All third- and fourth-year bachelor's nursing and midwifery students studying at the Nursing and Midwifery Faculty of Kurdistan University of Medical Sciences were recruited to the study by using the census method. The study instrument consisted of a demographic questionnaire and the self-report 30-item Clinical Instructors' Effective Teaching Strategies Inventory. The SPSS v.16.0 was used for data analysis. The most effective teaching strategies of clinical instructors from nursing and midwifery students' perspectives were respectively 'treating students, clients, and colleagues with respect' and 'being eager for guiding students and manage their problems'. Clinical instructors need to be eager for education and also be able to establish effective communication with students. Empowering clinical instructors in specialized and technical aspects of clinical education seems necessary. Copyright © 2015 Elsevier Ltd. All rights reserved.

  1. Effects of basic clinical skills training on objective structured clinical examination performance.

    Science.gov (United States)

    Jünger, Jana; Schäfer, Sybille; Roth, Christiane; Schellberg, Dieter; Friedman Ben-David, Miriam; Nikendei, Christoph

    2005-10-01

    The aim of curriculum reform in medical education is to improve students' clinical and communication skills. However, there are contradicting results regarding the effectiveness of such reforms. A study of internal medicine students was carried out using a static group design. The experimental group consisted of 77 students participating in 7 sessions of communication training, 7 sessions of skills-laboratory training and 7 sessions of bedside-teaching, each lasting 1.5 hours. The control group of 66 students from the traditional curriculum participated in equally as many sessions but was offered only bedside teaching. Students' cognitive and practical skills performance was assessed using Multiple Choice Question (MCQ) testing and an objective structured clinical examination (OSCE), delivered by examiners blind to group membership. The experimental group performed significantly better on the OSCE than did the control group (P < 0.01), whereas the groups did not differ on the MCQ test (P < 0.15). This indicates that specific training in communication and basic clinical skills enabled students to perform better in an OSCE, whereas its effects on knowledge did not differ from those of the traditional curriculum. Curriculum reform promoting communication and basic clinical skills are effective and lead to an improved performance in history taking and physical examination skills.

  2. Interpreting patient-reported outcomes from clinical trials in COPD: a discussion

    Directory of Open Access Journals (Sweden)

    Jones PW

    2016-12-01

    Full Text Available Paul W Jones,1,2 Stephen Rennard,3,4 Maggie Tabberer,5 John H Riley,2 Mitra Vahdati-Bolouri,2 Neil C Barnes2,6 1Institute for Infection and Immunity, University of London, London, 2Global Respiratory Franchise, GlaxoSmithKline, Uxbridge, UK; 3Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha, NE, USA; 4Clinical Discovery Unit, AstraZeneca, Cambridge, 5Global R&D, GlaxoSmithKline, Uxbridge, 6William Harvey Institute, Bart’s and the London School of Medicine and Dentistry, London, UK Abstract: One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George’s Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of

  3. Promoting integrity of shift report by applying ISBAR principles among nursing students in clinical placement

    Directory of Open Access Journals (Sweden)

    Pang Weng Ian

    2017-01-01

    Full Text Available Shift report is an essential method for nursing staff to carry out health care communication. The most important purpose of the shift report is to ensure the safety of patients and to provide continuous care. Nursing students are inadequate of clinical experience and rational organization during patient care. They may not be able to handle the critically ill patients and pass the messages to the following nursing staff. ISBAR (Identify, Situation, Background, Assessment and Recommendation tool is increasingly being utilized as a format for structured shift report communication. In this study, a scale of ISBAR principles is designed to provide students with self-assessment and teachers with evaluation, in a way to improve nursing students’ self-awareness of shift report. Hopefully, with the use of the scale of ISBAR, nursing students are able to complete shift report in systemic integrity and orderliness during clinical placement.

  4. Developing an instrument to measure effective factors on Clinical Learning.

    Science.gov (United States)

    Dadgaran, Ideh; Shirazi, Mandana; Mohammadi, Aeen; Ravari, Ali

    2016-07-01

    Although nursing students spend a large part of their learning period in the clinical environment, clinical learning has not been perceived by its nature yet. To develop an instrument to measure effective factors on clinical learning in nursing students. This is a mixed methods study performed in 2 steps. First, the researchers defined "clinical learning" in nursing students through qualitative content analysis and designed items of the questionnaire based on semi-structured individual interviews with nursing students. Then, as the second step, psychometric properties of the questionnaire were evaluated using the face validity, content validity, construct validity, and internal consistency evaluated on 227 students from fourth or higher semesters. All the interviews were recorded and transcribed, and then, they were analyzed using Max Qualitative Data Analysis and all of qualitative data were analyzed using SPSS 14. To do the study, we constructed the preliminary questionnaire containing 102 expressions. After determination of face and content validities by qualitative and quantitative approaches, the expressions of the questionnaire were reduced to 45. To determine the construct validity, exploratory factor analysis was applied. The results indicated that the maximum variance percentage (40.55%) was defined by the first 3 factors while the rest of the total variance percentage (59.45%) was determined by the other 42 factors. Results of exploratory factor analysis of this questionnaire indicated the presence of 3 instructor-staff, students, and educational related factors. Finally, 41 expressions were kept in 3 factor groups. The α-Cronbach coefficient (0.93) confirmed the high internal consistency of the questionnaire. Results indicated that the prepared questionnaire was an efficient instrument in the study of the effective factors on clinical learning as viewed by nursing students since it involves 41 expressions and properties such as instrument design based

  5. Health Equity Considerations for Developing and Reporting Patient-reported Outcomes in Clinical Trials

    DEFF Research Database (Denmark)

    Petkovic, Jennifer; Barton, Jennifer L; Flurey, Caroline

    2017-01-01

    , and (6) consideration of statistical power of subgroup analyses for outcome reporting. CONCLUSION: There is a need to (1) conduct a systematic review to assess how equity and population characteristics have been considered in PROM development and whether these differences influence the ranking...

  6. Effect of electronic report writing on the quality of nursing report recording

    Science.gov (United States)

    Heidarizadeh, Khadijeh; Rassouli, Maryam; Manoochehri, Houman; Tafreshi, Mansoureh Zagheri; Ghorbanpour, Reza Kashef

    2017-01-01

    Background and Aim Recording performed nursery actions is one of the main chores of nurses. The findings have shown that recorded reports are not qualitatively valid. Since electronic reports can be regarded as a base to write reports, this study aims at determining the effect of utilizing electronic nursing reports on the quality of the records. Methods This quasi-experimental study was conducted with the aim of applying an electronic system of nursing recording in the heart department of Shahid Rahimi Medical Center, Lorestan University of Medical Science. The samples were nursing reports on the hospitalized patients in the heart department, the basis of complete enumeration (census) during the fall of 2014. The subjects were sixteen employed nurses. To do the study, the software of nursing records was set based on the Clinical Care Classification system (CCC). The research’s tool was the checklist of the Standards of Nursing Documentation. Results The findings indicated that before and after the intervention, the amount of reports’ adaption with the written standards, respectively, was (21.8%) and (71.3%), and the most complete recording was medicine status (58%) and (100%). The worst complete recording before the intervention, acute changes was (99.1%) and nursing processes was (78%) and after, the medicine status, intake and output status and patient’s education (100%); while the nursing report structure was regarded in all cases (100%). The results showed that there is a significant difference in the quality of reporting before and after using CCC (pnurses are reminded to record the necessary parts and from the other point, the system does not allow the user to shut it down unless the necessary parameters are recorded. For this reason, the quality of recorded reports with electronic reporting improves. PMID:29238481

  7. Effect of Objective Structured Clinical Examination on Nursing Students' Clinical Skills

    Directory of Open Access Journals (Sweden)

    Seyedeh Narjes Mousavizadeh

    2018-01-01

    Full Text Available Considering the daily increasing changes in clinical training approaches, the necessity of using new evaluation methods in proportion with these approaches is also becoming more and more obvious for measuring all of the cognitive, emotional and psychomotor dimensions of students. The present study was designed and conducted for reviewing the effect of objective structured clinical examination method on the clinical skills of nursing students. In this quasi-experimental study, 48 nursing students have participated that were randomly assigned to two groups of intervention and control. The intervention group students were evaluated at the end of educational period of their clinical skills and principles course using objective structured clinical examination (OSCE. The OSCE included five core skills in this course: assessing and fulfilling patients’ basic needs, dressing up, injectable drug therapy, noninjectable drug therapy, infection control. The control group students were evaluated using the routine method. Both groups of students were followed up in the next semester and were compared in terms of learning enhancement in these five skills. Evaluation of procedures was based on valid and reliable check-lists made by the researcher. Results were analyzed using descriptive and inferential statistics (Chi-square, independent and paired T tests. The mean score of the final evaluation in the intervention group was significantly higher than that of the control group (P= 0.000. Final evaluation scores of the intervention group students showed a better performance than their previous semester (P= 0.000, while the final evaluation scores of the control group students showed a lack of progress in their skills (P<0.05. It seems that this evaluation method also is a support for students' learning and resulted in improvement of clinical skills among them. Accordingly, it is recommended that nursing education centers apply this method to assess students

  8. Recognizing and managing a deteriorating patient: a randomized controlled trial investigating the effectiveness of clinical simulation in improving clinical performance in undergraduate nursing students.

    Science.gov (United States)

    Stayt, Louise Caroline; Merriman, Clair; Ricketts, Barry; Morton, Sean; Simpson, Trevor

    2015-11-01

    To report the results of a randomized controlled trial which explored the effectiveness of clinical simulation in improving the clinical performance of recognizing and managing an adult deteriorating patient in hospital. There is evidence that final year undergraduate nurses may lack knowledge, clinical skills and situation awareness required to manage a deteriorating patient competently. The effectiveness of clinical simulation as a strategy to teach the skills required to recognize and manage the early signs of deterioration needs to be evaluated. This study was a two centre phase II single, randomized, controlled trial with single blinded assessments. Data were collected in July 2013. Ninety-eight first year nursing students were randomized either into a control group, where they received a traditional lecture, or an intervention group where they received simulation. Participants completed a pre- and postintervention objective structured clinical examination. General Perceived Self Efficacy and Self-Reported Competency scores were measured before and after the intervention. Student satisfaction with teaching was also surveyed. The intervention group performed significantly better in the post-objective structured clinical examination. There was no significant difference in the postintervention General Perceived Self Efficacy and Self-Reported Competency scores between the control and intervention group. The intervention group was significantly more satisfied with their teaching method. Simulation-based education may be an effective educational strategy to teach nurses the skills to effectively recognize and manage a deteriorating patient. © 2015 John Wiley & Sons Ltd.

  9. What are the effective ways to translate clinical leadership into health care quality improvement?

    Directory of Open Access Journals (Sweden)

    McSherry R

    2016-02-01

    Full Text Available Robert McSherry,1 Paddy Pearce2 1School of Health and Social Care, University of Teesside, Middlesbrough, 2PKP Consulting, Yarm, United Kingdom Abstract: The presence and/or absence of effective leaders in health care can have a stark consequence on the quality and outcomes of care. The delivery of safe, quality, compassionate health care is dependent on having effective clinical leaders at the frontline. In light of the Kirkup and Francis reports, this article explores some ways of translating clinical leadership into health care quality improvement. This is achieved by exploring what is clinical leadership and why and how this is important to health care quality improvement, clinical leadership, and a duty of candor, along with the importance clinical leadership plays in the provision of quality care improvement and outcomes. Clinical leaders are not predefined roles but emerge from the complex clinical setting by gaining an acquired expertise and from how they then internalize this to develop and facilitate sound relationships within a team. Clinical leaders are effective in facilitating innovation and change through improvement. This is achieved by recognizing, influencing, and empowering individuals through effective communication in order to share and learn from and with each other in practice. The challenge for health care organizations in regard to creating organizational cultures where a duty of candor exists is not to reinvent the wheel by turning something that is simple into something complex, which can become confusing to health care workers, patients, and the public. By focusing on the clinical leader's role and responsibilities we would argue they play a crucial and pivotal role in influencing, facilitating, supporting, and monitoring that this duty of candor happens in practice. This may be possible by highlighting where and how the duty of candor can be aligned within existing clinical governance frameworks. Keywords: governance

  10. What are the effective ways to translate clinical leadership into health care quality improvement?

    Science.gov (United States)

    McSherry, Robert; Pearce, Paddy

    2016-01-01

    The presence and/or absence of effective leaders in health care can have a stark consequence on the quality and outcomes of care. The delivery of safe, quality, compassionate health care is dependent on having effective clinical leaders at the frontline. In light of the Kirkup and Francis reports, this article explores some ways of translating clinical leadership into health care quality improvement. This is achieved by exploring what is clinical leadership and why and how this is important to health care quality improvement, clinical leadership, and a duty of candor, along with the importance clinical leadership plays in the provision of quality care improvement and outcomes. Clinical leaders are not predefined roles but emerge from the complex clinical setting by gaining an acquired expertise and from how they then internalize this to develop and facilitate sound relationships within a team. Clinical leaders are effective in facilitating innovation and change through improvement. This is achieved by recognizing, influencing, and empowering individuals through effective communication in order to share and learn from and with each other in practice. The challenge for health care organizations in regard to creating organizational cultures where a duty of candor exists is not to reinvent the wheel by turning something that is simple into something complex, which can become confusing to health care workers, patients, and the public. By focusing on the clinical leader's role and responsibilities we would argue they play a crucial and pivotal role in influencing, facilitating, supporting, and monitoring that this duty of candor happens in practice. This may be possible by highlighting where and how the duty of candor can be aligned within existing clinical governance frameworks.

  11. Clinical effect of combined ulinastatin and continuous renal ...

    African Journals Online (AJOL)

    Purpose: To explore the effect of a combination of ulinastatin and continuous renal replacement therapy (CRRT) for the treatment of severe sepsis with acute kidney injury (SAKI). Methods: Clinical data for 106 patients diagnosed with SAKI from April 2013 to May 2015 in the intensive care unit (ICU) of Affiliated Hospital of ...

  12. The effect of an interprofessional clinical simulation on medical ...

    African Journals Online (AJOL)

    Five themes emerged from the reflections: (i) difficulties with implementing knowledge and skills; (ii) importance of teamwork; (iii) skills necessary for teamwork; (iv) effect of being observed by peers; and (v) IPE in the curriculum. Conclusions. Medical students gained clinical knowledge during the simulation and became ...

  13. Clinical effects of low-molecular-weight heparin combined with ...

    African Journals Online (AJOL)

    Purpose: To explore the clinical effects of low-molecular-weight heparin (LMWH) combined with ulinastatin (UTI) in children with acute pancreatitis. Methods: In total, 560 patients with severe acute pancreatitis treated at Binzhou People's Hospital, Shandong, China, from April 2012 to June 2014 were enrolled in this study.

  14. Case report: clinical and postmortem findings in four cows with rib fracture.

    Science.gov (United States)

    Braun, Ueli; Warislohner, Sonja; Hetzel, Udo; Nuss, Karl

    2017-02-06

    Published reports of rib fractures in adult cattle are limited to the occurrence of chronic rib swellings caused by calluses, which are unremarkable from a clinical standpoint, whereas studies identifying clinical signs of rib fractures were not found in a literature search. This report describes the clinical and postmortem findings in four cows with rib fractures. The 13th rib was fractured in three cows and the 11th rib in the remaining cow; three fractures were on the right and one on the left side. Clinical and postmortem findings varied considerably, and percussion of the rib cage elicited a pain response in only one cow. One cow had generalised peritonitis because of perforation of the rumen by the fractured rib. One cow was recumbent because of pain and became a downer cow, and two other cows had bronchopneumonia, which was a sequel to osteomyelitis of the fracture site in one. In the absence of a history of trauma, the diagnosis of rib fracture based on clinical signs alone is difficult. Although rib fractures undoubtedly are very painful, the four cases described in this report suggest that they are difficult to diagnose in cattle because associated clinical signs are nonspecific.

  15. Developing the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual for creation of clinical study reports in the era of clinical trial transparency.

    Science.gov (United States)

    Hamilton, Samina; Bernstein, Aaron B; Blakey, Graham; Fagan, Vivien; Farrow, Tracy; Jordan, Debbie; Seiler, Walther; Shannon, Anna; Gertel, Art

    2016-01-01

    Interventional clinical studies conducted in the regulated drug research environment are reported using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E3 on the structure and content of clinical study reports (CSRs) published in 1995 and ICH E3 supplementary Questions & Answers (Q & A) published in 2012.Since the ICH guidance documents were published, there has been heightened awareness of the importance of disclosure of clinical study results. The use of the CSR as a key source document to fulfil emerging obligations has resulted in a re-examination of how ICH guidelines are applied in CSR preparation. The dynamic regulatory and modern drug development environments create emerging reporting challenges. Regulatory medical writing and statistical professionals developed Clarity and Openness in Reporting: E3-based (CORE) Reference over a 2-year period. Stakeholders contributing expertise included a global industry association, regulatory agency, patient advocate, academic and Principal Investigator representatives. CORE Reference should help authors navigate relevant guidelines as they create CSR content relevant for today's studies. It offers practical suggestions for developing CSRs that will require minimum redaction and modification prior to public disclosure.CORE Reference comprises a Preface, followed by the actual resource. The Preface clarifies intended use and underlying principles that inform resource utility. The Preface lists references contributing to development of the resource, which broadly fall into 'regulatory' and 'public disclosure' categories. The resource includes ICH E3 guidance text, ICH E3 Q & A 2012-derived guidance text and CORE Reference text, distinguished from one another through the use of shading. Rationale comments are used throughout for clarification purposes.A separate mapping tool comparing ICH E3 sectional structure and CORE Reference sectional structure is also provided.Together, CORE Reference

  16. [Electronic cigarettes - effects on health. Previous reports].

    Science.gov (United States)

    Napierała, Marta; Kulza, Maksymilian; Wachowiak, Anna; Jabłecka, Katarzyna; Florek, Ewa

    2014-01-01

    Currently very popular in the market of tobacco products have gained electronic cigarettes (ang. E-cigarettes). These products are considered to be potentially less harmful in compared to traditional tobacco products. However, current reports indicate that the statements of the producers regarding to the composition of the e- liquids not always are sufficient, and consumers often do not have reliable information on the quality of the product used by them. This paper contain a review of previous reports on the composition of e-cigarettes and their impact on health. Most of the observed health effects was related to symptoms of the respiratory tract, mouth, throat, neurological complications and sensory organs. Particularly hazardous effects of the e-cigarettes were: pneumonia, congestive heart failure, confusion, convulsions, hypotension, aspiration pneumonia, face second-degree burns, blindness, chest pain and rapid heartbeat. In the literature there is no information relating to passive exposure by the aerosols released during e-cigarette smoking. Furthermore, the information regarding to the use of these products in the long term are not also available.

  17. The effect of respiratory disorders on clinical pharmacokinetic variables.

    Science.gov (United States)

    Taburet, A M; Tollier, C; Richard, C

    1990-12-01

    Respiratory disorders induce several pathophysiological changes involving gas exchange and acid-base balance, regional haemodynamics, and alterations of the alveolocapillary membrane. The consequences for the absorption, distribution and elimination of drugs are evaluated. Drug absorption after inhalation is not significantly impaired in patients. With drugs administered by this route, an average of 10% of the dose reaches the lungs. It is not completely clear whether changes in pulmonary endothelium in respiratory failure enhance lung absorption. The effects of changes in blood pH on plasma protein binding and volume of distribution are discussed, but relevant data are not available to explain the distribution changes observed in acutely ill patients. Lung diffusion of some antimicrobial agents is enhanced in patients with pulmonary infections. Decreased cardiac output and hepatic blood flow in patients under mechanical ventilation cause an increase in the plasma concentration of drugs with a high hepatic extraction ratio, such as lidocaine (lignocaine). On a theoretical basis, hypoxia should lead to decreased biotransformation of drugs with a low hepatic extraction ratio, but in vivo data with phenazone (antipyrine) or theophylline are conflicting. The effects of disease on the lung clearance of drugs are discussed but clinically relevant data are lacking. The pharmacokinetics of drugs in patients with asthma or chronic obstructive pulmonary disease are reviewed. Stable asthma and chronic obstructive pulmonary disease do not appear to affect the disposition of theophylline or beta 2-agonists such as salbutamol (albuterol) or terbutaline. Important variations in theophylline pharmacokinetics have been reported in critically ill patients, the causes of which are more likely to be linked to the poor condition of the patients than to a direct effect of hypoxia or hypercapnia. Little is known regarding the pharmacokinetics of cromoglycate, ipratropium, corticoids or

  18. Clinical trial registration and reporting: a survey of academic organizations in the United States.

    Science.gov (United States)

    Mayo-Wilson, Evan; Heyward, James; Keyes, Anthony; Reynolds, Jesse; White, Sarah; Atri, Nidhi; Alexander, G Caleb; Omar, Audrey; Ford, Daniel E

    2018-05-02

    Many clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, "The Final Rule" (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting requirements. We sought to identify policies, procedures, and resources to support trial registration and reporting at academic organizations. We conducted an online survey from November 21, 2016 to March 1, 2017, before organizations were expected to comply with The Final Rule. We included active Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a "University/Organization" in the USA. PRS administrators manage information on ClinicalTrials.gov. We invited one PRS administrator to complete the survey for each organization account, which was the unit of analysis. Eligible organization accounts (N = 783) included 47,701 records (e.g., studies) in August 2016. Participating organizations (366/783; 47%) included 40,351/47,701 (85%) records. Compared with other organizations, Clinical and Translational Science Award (CTSA) holders, cancer centers, and large organizations were more likely to participate. A minority of accounts have a registration (156/366; 43%) or results reporting policy (129/366; 35%). Of those with policies, 15/156 (11%) and 49/156 (35%) reported that trials must be registered before institutional review board approval is granted or before beginning enrollment, respectively. Few organizations use computer software to monitor compliance (68/366; 19%). One organization had penalized an investigator for non-compliance. Among the 287/366 (78%) accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements, the median number of full-time equivalent staff is 0.08 (interquartile range = 0.02-0.25). Because of non-response and

  19. Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year

    Directory of Open Access Journals (Sweden)

    Bradley Ryan

    2012-04-01

    Full Text Available Abstract Background Several small, uncontrolled studies have found improvements in self-care behaviors and reductions in clinical risk in persons with type 2 diabetes who received care from licensed naturopathic physicians. To extend these findings and determine the feasibility and promise of a randomized clinical trial, we conducted a prospective study to measure the effects of adjunctive naturopathic care (ANC in primary care patients with inadequately controlled type 2 diabetes. Methods Forty patients with type 2 diabetes were invited from a large integrated health care system to receive up to eight ANC visits for up to one year. Participants were required to have hemoglobin A1c (HbA1c values between 7.5-9.5 % and at least one additional cardiovascular risk factor (i.e., hypertension, hyperlipidemia or overweight. Standardized instruments were administered by telephone to collect outcome data on self-care, self-efficacy, diabetes problem areas, perceived stress, motivation, and mood. Changes from baseline scores were calculated at 6- and 12-months after entry into the study. Six and 12-month changes in clinical risk factors (i.e., HbA1c, lipid and blood pressure were calculated for the ANC cohort, and compared to changes in a cohort of 329 eligible, non-participating patients constructed using electronic medical records data. Between-cohort comparisons were adjusted for age, gender, baseline HbA1c, and diabetes medications. Six months was pre-specified as the primary endpoint for outcome assessment. Results Participants made 3.9 ANC visits on average during the year, 78 % of which occurred within six months of entry into the study. At 6-months, significant improvements were found in most patient-reported measures, including glucose testing (P = 0.001, diet (P = 0.001, physical activity (P = 0.02, mood (P = 0.001, self-efficacy (P = 0.0001 and motivation to change lifestyle (P = 0.003. Improvements in glucose testing, mood, self-efficacy and

  20. Minimum reporting standards for clinical research on groin pain in athletes

    DEFF Research Database (Denmark)

    Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M

    2015-01-01

    Groin pain in athletes is a priority area for sports physiotherapy and sports medicine research. Heterogeneous studies with low methodological quality dominate research related to groin pain in athletes. Low-quality studies undermine the external validity of research findings and limit the ability...... to generalise findings to the target patient population. Minimum reporting standards for research on groin pain in athletes are overdue. We propose a set of minimum reporting standards based on best available evidence to be utilised in future research on groin pain in athletes. Minimum reporting standards...... are provided in relation to: (1) study methodology, (2) study participants and injury history, (3) clinical examination, (4) clinical assessment and (5) radiology. Adherence to these minimum reporting standards will strengthen the quality and transparency of research conducted on groin pain in athletes...

  1. Strategies for maximizing clinical effectiveness in the treatment of schizophrenia.

    Science.gov (United States)

    Tandon, Rajiv; Targum, Steven D; Nasrallah, Henry A; Ross, Ruth

    2006-11-01

    The ultimate clinical objective in the treatment of schizophrenia is to enable affected individuals to lead maximally productive and personally meaningful lives. As with other chronic diseases that lack a definitive cure, the individual's service/recovery plan must include treatment interventions directed towards decreasing manifestations of the illness, rehabilitative services directed towards enhancing adaptive skills, and social support mobilization aimed at optimizing function and quality of life. In this review, we provide a conceptual framework for considering approaches for maximizing the effectiveness of the array of treatments and other services towards promoting recovery of persons with schizophrenia. We discuss pharmacological, psychological, and social strategies that decrease the burden of the disease of schizophrenia on affected individuals and their families while adding the least possible burden of treatment. In view of the multitude of treatments necessary to optimize outcomes for individuals with schizophrenia, effective coordination of these services is essential. In addition to providing best possible clinical assessment and pharmacological treatment, the psychiatrist must function as an effective leader of the treatment team. To do so, however, the psychiatrist must be knowledgeable about the range of available services, must have skills in clinical-administrative leadership, and must accept the responsibility of coordinating the planning and delivery of this multidimensional array of treatments and services. Finally, the effectiveness of providing optimal individualized treatment/rehabilitation is best gauged by measuring progress on multiple effectiveness domains. Approaches for efficient and reliable assessment are discussed.

  2. Generalization and extrapolation of treatment effects from clinical studies in rheumatoid arthritis

    NARCIS (Netherlands)

    Nair, S.C.; Kievit, W.; Janse, R.W.; Bijlsma, J.W.J.; Fransen, J.; Lafeber, F.P.J.G.; Welsing, P.M.J.

    2014-01-01

    OBJECTIVE: Pragmatic clinical trials have been proposed as a solution for nongeneralizability of randomized clinical trial (RCT) results. We investigated whether treatment effects of pragmatic clinical trials are indeed generalizable to clinical practice and how efficacy estimates from published

  3. Assessing quality of reports on randomized clinical trials in nursing journals.

    Science.gov (United States)

    Parent, Nicole; Hanley, James A

    2009-01-01

    Several surveys have presented the quality of reports on randomized clinical trials (RCTs) published in general and specialty medical journals. The aim of these surveys was to raise scientific consciousness on methodological aspects pertaining to internal and external validity. These reviews have suggested that the methodological quality could be improved. We conducted a survey of reports on RCTs published in nursing journals to assess their methodological quality. The features we considered included sample size, flow of participants, assessment of baseline comparability, randomization, blinding, and statistical analysis. We collected data from all reports of RCTs published between January 1994 and December 1997 in Applied Nursing Research, Heart & Lung and Nursing Research. We hand-searched the journals and included all 54 articles in which authors reported that individuals have been randomly allocated to distinct groups. We collected data using a condensed form of the Consolidated Standards of Reporting Trials (CONSORT) statement for structured reporting of RCTs (Begg et al., 1996). Sample size calculations were included in only 22% of the reports. Only 48% of the reports provided information about the type of randomization, and a mere 22% described blinding strategies. Comparisons of baseline characteristics using hypothesis tests were abusively produced in more than 76% of the reports. Excessive use and unstructured reports of significance testing were common (59%), and all reports failed to provide magnitude of treatment differences with confidence intervals. Better methodological quality in reports of RCTs will contribute to increase the standards of nursing research.

  4. The reliability of manual reporting of clinical events in an anesthesia information management system (AIMS).

    Science.gov (United States)

    Simpao, Allan F; Pruitt, Eric Y; Cook-Sather, Scott D; Gurnaney, Harshad G; Rehman, Mohamed A

    2012-12-01

    Manual incident reports significantly under-report adverse clinical events when compared with automated recordings of intraoperative data. Our goal was to determine the reliability of AIMS and CQI reports of adverse clinical events that had been witnessed and recorded by research assistants. The AIMS and CQI records of 995 patients aged 2-12 years were analyzed to determine if anesthesia providers had properly documented the emesis events that were observed and recorded by research assistants who were present in the operating room at the time of induction. Research assistants recorded eight cases of emesis during induction that were confirmed with the attending anesthesiologist at the time of induction. AIMS yielded a sensitivity of 38 % (95 % confidence interval [CI] 8.5-75.5 %), while the sensitivity of CQI reporting was 13 % (95 % CI 0.3-52.7 %). The low sensitivities of the AIMS and CQI reports suggest that user-reported AIMS and CQI data do not reliably include significant clinical events.

  5. Pharmacological effect on pyeloureteric dynamics with a clinical perspective

    DEFF Research Database (Denmark)

    Jung, Helene U; Frimodt-Møller, Poul C; Osther, Palle J

    2006-01-01

    We searched to review experimental and clinical trials concerning the capabilities of impacting on the ureteric and pelvic activity by means of pharmacological stimulation. Ureteropyeloscopy may cause high renal pelvic pressure. The normal pressure is in the range of 5-15 mmHg whereas pressure...... an increased risk of several complications related to endourological procedures including bleeding, perforation and infection. In other words, means by which intrarenal pressure could be lowered during endourological procedures might be beneficial with respect to clinical outcomes. In vitro experiments support...... systemic side effects. In vivo human studies are necessary to clarify the exact dose-response relationship and the degree of urothelial absorption of a drug before clinical use may be adopted....

  6. 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.

  7. Hydroxyurea revisited: a decade of clinical effects studies

    International Nuclear Information System (INIS)

    Sinclair, W.K.

    1981-01-01

    Over a decade ago hydroxyurea was shown to selectively kill cells in the S phase in a proliferating cell population and to block cells at the G 1 -S border. Consequently, blocked cells became sensitized to irradiation and were further sensitized when the drug was present after exposure. In the ensuing decade, many in vivo studies on hydroxyurea have confirmed that the main properties of hydroxyurea identified in the dish are also evident in vivo. During a period of about ten years, a considerable number of clinical studies have been performed, the results of which have been mixed, ranging from indeterminate to encouraging, depending to some extent on the site treated and whether careful randomized studies were done. The question arises whether the clinical studies have represented adequate tests, by laboratory standards, of the likely effectiveness of the drug in clinical circumstances. The clinical studies with hydroxyurea have been examined in this light, since the results might also bear on the use of many other such agents in combination therapy. This examination revealed that no attempts have been made to determine the concentration of hydroxyurea in the tumor and other relevant tissues as a function of time or to assess the cell kinetic features of the tumor and thus estimate the appropriate dose regimen. It would seem that a wide gap still exists between laboratory research and clinical application

  8. Clinical research on peri-implant diseases: consensus report of Working Group 4.

    LENUS (Irish Health Repository)

    Sanz, Mariano

    2012-02-01

    Two systematic reviews have evaluated the quality of research and reporting of observational studies investigating the prevalence of, the incidence of and the risk factors for peri-implant diseases and of experimental clinical studies evaluating the efficacy of preventive and therapeutic interventions.

  9. Posterior open occlusion management by registration of overlay removable partial denture: A clinical report

    Science.gov (United States)

    Nosouhian, Saeid; Davoudi, Amin; Derhami, Mohammad

    2015-01-01

    This clinical report describes prosthetic rehabilitation of posterior open bite relationship in a patient with several missing teeth and skeletal Class III malocclusion. Primary diagnostic esthetic evaluations were performed by mounting casts in centric relation and estimating lost vertical dimension of occlusion. Exclusive treatments were designated by applying overlay removable partial denture with external attachment systems for higher retentions. PMID:26929544

  10. Seasonal and socio-economic variations in clinical and self-reported ...

    African Journals Online (AJOL)

    Seasonal and socio-economic variations in clinical and self-reported malaria in Accra, Ghana: Evidence from facility data and a community survey. ... Conclusions: Understanding these seasonal and geographic patterns have implications for both prevention and treatment of malaria-like morbidity in both children and adults ...

  11. A Report of Six Clinical Cases of Lowered Blood Cholesterol Profile ...

    African Journals Online (AJOL)

    Purpose: To assess six patients with Diabegard® supplementation with reference to cholesterol profiles. Methods: We report the clinical courses of six individuals taking Diabegard® supplementation at 60 and 120 mg/day for 8 weeks. Results: Patients had a maximum of 52.13 % reduction in low-density lipoprotein (LDL) ...

  12. First report of clinical presentation of a bite by a running spider ...

    African Journals Online (AJOL)

    This article describes the clinical progression of symptoms over a period of 5 days of a bite inflicted by a Philodromus sp. spider. Commonly known as 'running spiders', these are not considered to be harmful to humans. This report, however, is the first description of an actual bite by a member of this group of spiders ...

  13. Faculty Workshop on Clinical Instruction for Podiatric Medical Education. Final Report and Proceedings (June 30, 1979).

    Science.gov (United States)

    American Association of Colleges of Podiatric Medicine, Washington, DC.

    A faculty workshop is reported that assessed in great detail the present state of podiatric medicine, its educational system, and its role in health care. Alternative methods to plan, implement, and evaluate changes in the clinical curriculum were explored carefully. Four major questions were considered: (1) What is the profession of podiatric…

  14. Creating guidance for the use of patient reported outcome measures (PROMS) in clinical palliatieve care.

    NARCIS (Netherlands)

    Vliet, L.M. van; Harding, R.; Bausewein, C.; Payne, S.; Higginson, I.J.

    2014-01-01

    Introduction: Routine use of Patient Reported Outcome Measures (PROMs) in clinical practice can influence care but is not always achieved. One reason for this seems to be a lack of guidance on how to use PROMs in palliative care practice. This project aimed to provide such guidance. Aim(s) and

  15. Training clinicians in how to use patient-reported outcome measures in routine clinical practice

    NARCIS (Netherlands)

    Santana, Maria J.; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina

    2015-01-01

    Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs

  16. 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

  17. Research and Clinical Center for Child Development Annual Report, 1995-1996, No. 19.

    Science.gov (United States)

    Wakai, Kunio, Ed.; Chen, Shing-Jen, Ed.; Furutsuka, Takashi, Ed.; Shirotani, Yukari, Ed.

    This annual report discusses several topics related to the work of the Research and Clinical Center for Child Development at Hokkaido University in Japan. The articles are: (1) "Heart to Heart (Inter "Jo") Resonance: Taking Japanese Concept of Intersubjectivity Out of Everyday Life" (Shigeru Nakano); (2) "Intersubjectivity…

  18. Prosthetic and Surgical Approach for Oral Rehabilitation in a Patient with Amelogenesis Imperfecta: A Clinical Report

    Directory of Open Access Journals (Sweden)

    H. Sazegara

    2007-06-01

    Full Text Available Amelogenesis imperfecta is a heterogeneous group of hereditary disorders. Its treatment continues throughout the patients’ childhood and adolescence and consists of advanced restorative care in severe cases.A thorough prosthodontic treatment plan including orthognatic surgery, full veneer crowns and all ceramic anterior crowns is presented in this clinical report.

  19. The Moessbauer effect data center: A report

    International Nuclear Information System (INIS)

    Stevens, J.G.

    1990-01-01

    The Moessbauer Effect Data Center is unique in its operation and the kind of information services that it provides. It is probably the only user-supported information center in the basic sciences. This has been primarily possible due to the broad support and encouragement the center receives from the international Moessbauer community. This report also discusses the demographics of the Moessbauer community: identifying such items as the most active areas of research in Moessbauer Spectroscopy, where is this research being done and who is doing it. Also, examined is where Moessbauer research investigations are being published. BITNET and other forms of electronic mail are being widely used in the scientific community. This is also the case in the Moessbauer community. Directories and list-servers are being established. (orig.)

  20. Pleiotropic effects of niacin: Current possibilities for its clinical use

    Directory of Open Access Journals (Sweden)

    Zeman Miroslav

    2016-12-01

    Full Text Available Niacin was the first hypolipidemic drug to significantly reduce both major cardiovascular events and mortality in patients with cardiovascular disease. Niacin favorably influences all lipoprotein classes, including lipoprotein[a],and belongs to the most potent hypolipidemic drugs for increasing HDL-C. Moreover, niacin causes favorable changes to the qualitative composition of lipoprotein HDL. In addition to its pronounced hypolipidemic action, niacin exerts many other, non-hypolipidemic effects (e.g., antioxidative, anti-inflammatory, antithrombotic, which favorably influence the development and progression of atherosclerosis. These effects are dependent on activation of the specific receptor HCA2. Recent results published by the two large clinical studies, AIM-HIGH and HPS2-THRIVE, have led to the impugnation of niacin’s role in future clinical practice. However, due to several methodological flaws in the AIM-HIGH and HPS2-THRIVE studies, the pleiotropic effects of niacin now deserve thorough evaluation. This review summarizes the present and possible future use of niacin in clinical practice in light of its newly recognized pleiotropic effects.

  1. Effects of Disclosing Financial Interests on Attitudes Toward Clinical Research

    Science.gov (United States)

    Hall, Mark A.; Dinan, Michaela A.; DePuy, Venita; Friedman, Joëlle Y.; Allsbrook, Jennifer S.; Sugarman, Jeremy

    2008-01-01

    Background The effects of disclosing financial interests to potential research participants are not well understood. Objective To examine the effects of financial interest disclosures on potential research participants’ attitudes toward clinical research. Design and Participants Computerized experiment conducted with 3,623 adults in the United States with either diabetes mellitus or asthma, grouped by lesser and greater severity. Respondents read a description of a hypothetical clinical trial relevant to their diagnosis that included a financial disclosure statement. Respondents received 1 of 5 disclosure statements. Measurements Willingness to participate in the hypothetical clinical trial, relative importance of information about the financial interest, change in trust after reading the disclosure statement, surprise regarding the financial interest, and perceived effect of the financial interest on the quality of the clinical trial. Results Willingness to participate in the hypothetical clinical trial did not differ substantially among the types of financial disclosures. Respondents viewed the disclosed information as less important than other factors in deciding to participate. Disclosures were associated with some respondents trusting the researchers less, although trust among some respondents increased. Most respondents were not surprised to learn of financial interests. Researchers owning equity were viewed as more troubling than researchers who were compensated for the costs of research through per capita payments. Conclusions Aside from a researcher holding an equity interest, the disclosure to potential research participants of financial interests in research, as recommended in recent policies, is unlikely to affect willingness to participate in research. Electronic supplementary material The online version of this article (doi:10.1007/s11606-008-0590-4) contains supplementary material, which is available to authorized users. PMID:18386101

  2. Effectiveness and clinical inertia in patients with antidiabetic therapy.

    Science.gov (United States)

    Machado-Duque, Manuel Enrique; Ramírez-Riveros, Adriana Carolina; Machado-Alba, Jorge Enrique

    2017-06-01

    To establish the effectiveness of antidiabetic therapy and the frequency of clinical inertia in the management of type 2 diabetes mellitus in Colombia. A cross-sectional study with follow-up of patients who had been treated for at least 1 year and were receiving medical consultation for antidiabetic treatment. Effectiveness was established when haemoglobin-A1c levels were inertia was reached, which was defined as no therapeutic modifications despite not achieving management controls. Sociodemographic, clinical and pharmacological variables were evaluated, and multivariate analyses were performed. In total, 363 patients with type 2 diabetes mellitus were evaluated, with a mean age of 62.0±12.2 years. A total of 1,016 consultations were evaluated, and the therapy was effective at the end of the follow-up in 57.9% of cases. Clinical inertia was found in 56.8% of patients who did not have metabolic control. The most frequently prescribed medications were metformin (84.0%), glibenclamide (23.4%) and insulin glargine (20.7%). Moreover, 57.6% of the patients were treated with two or more antidiabetic medications. Having metabolic control in the first consult of the follow-up was a protective factor against clinical inertia in the subsequent consultations (OR: 0.08; 95%CI: 0.04-0.15; Pinertia was identifiable and quantifiable and found in similar proportions to other countries. Clinical inertia is a relevant condition given that it interferes with the possibility of controlling this pathology. © 2017 John Wiley & Sons Ltd.

  3. Reported Sildenafil Side Effects in Pediatric Pulmonary Hypertension Patients

    Directory of Open Access Journals (Sweden)

    Stephanie Leigh Siehr

    2015-03-01

    Full Text Available Background: Sildenafil, a phosphodiestase type 5 inhibitor, was approved in 2005 for the treatment of pulmonary arterial hypertension (PAH in adults, and is commonly used off-label for pediatric patients. Little is known, however, about sildenafil’s side effects in this population.Methods: Single institution, longitudinal survey-based study performed in an outpatient pediatric cardiology clinic. Pediatric patients on sildenafil (alone or in combination with other PH therapies completed questionnaires regarding frequency of vascular, gastrointestinal, neurologic and hematologic side effects. Results: Between January 2011 and May 2014, 66 pediatric patients with PH on sildenafil filled out 214 surveys, 32 patients (96 surveys on monotherapy, and 43 patients (118 surveys on sildenafil plus an endothelin receptor antagonist (bosentan or ambrisentan and/or a prostacyclin (epoprostenol or treprostinil. Overall, 30% of respondents identified at least one side effect. For all patients on sildenafil, incidence of side effects by system was 37% gastrointestinal, 35% vascular and 22% neurologic. For patients on sildenafil monotherapy, incidence of side effects by system was 24% gastrointestinal, 21% vascular and 18% neurologic compared to patients on combination therapy who reported an incidence of 48% gastrointestinal, 45% vascular and 25% neurologic.Conclusion: Incidence of vascular, gastrointestinal and neurologic side effect in pediatric patients on sildenafil therapy for pulmonary arterial hypertension was 30%. Side effects were more common in patients on combination therapy with an endothelin receptor antagonist and/or prostacyclin than in patients on sildenafil monotherapy.

  4. Clinical Effects of Fenfluramine in Ten Autistic Subjects. Brief Report.

    Science.gov (United States)

    Klykylo, William M.; And Others

    1985-01-01

    Use of the drug Fenfluramine, which reduces blood serotonin levels and possible problem behaviors, was evaluated. Nine of 10 Ss showed reduced serotonin; none showed significant differences on intelligence tests; and at least two Ss showed marked behavioral changes in less echolalia, perseveration, and motoric disturbance and more increases in…

  5. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

    2016-01-01

    BACKGROUND: Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe......Med and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about...

  6. The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications

    DEFF Research Database (Denmark)

    Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

    2014-01-01

    randomized clinical trials indexed in PubMed in 2010. Two authors read the trial publications and extracted data independently. RESULTS: Twenty-four trial publications, or 8% (95% confidence interval [CI], 5, 12%), explicitly reported the risk of unblinding, of which 16 publications, or 5% (95% CI, 3, 8......%), reported compromised blinding; and 8 publications, or 3% (95% CI, 1, 5%), intact blinding. The reporting on risk of unblinding in the 24 trial publications was generally incomplete. The median proportion of assessments per trial affected by unblinding was 3% (range 1-30%). The most common mechanism...

  7. Effectiveness of manual therapies: the UK evidence report.

    Science.gov (United States)

    Bronfort, Gert; Haas, Mitch; Evans, Roni; Leininger, Brent; Triano, Jay

    2010-02-25

    The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions. The conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs), widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet included in the first three categories. The strength/quality of the evidence regarding effectiveness was based on an adapted version of the grading system developed by the US Preventive Services Task Force and a study risk of bias assessment tool for the recent RCTs. By September 2009, 26 categories of conditions were located containing RCT evidence for the use of manual therapy: 13 musculoskeletal conditions, four types of chronic headache and nine non-musculoskeletal conditions. We identified 49 recent relevant systematic reviews and 16 evidence-based clinical guidelines plus an additional 46 RCTs not yet included in systematic reviews and guidelines.Additionally, brief references are made to other effective non-pharmacological, non-invasive physical treatments. Spinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and dysmenorrhea when compared to sham manipulation, or for Stage 1

  8. Effectiveness of manual therapies: the UK evidence report

    Directory of Open Access Journals (Sweden)

    Leininger Brent

    2010-02-01

    Full Text Available Abstract Background The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions. Methods The conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs, widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet included in the first three categories. The strength/quality of the evidence regarding effectiveness was based on an adapted version of the grading system developed by the US Preventive Services Task Force and a study risk of bias assessment tool for the recent RCTs. Results By September 2009, 26 categories of conditions were located containing RCT evidence for the use of manual therapy: 13 musculoskeletal conditions, four types of chronic headache and nine non-musculoskeletal conditions. We identified 49 recent relevant systematic reviews and 16 evidence-based clinical guidelines plus an additional 46 RCTs not yet included in systematic reviews and guidelines. Additionally, brief references are made to other effective non-pharmacological, non-invasive physical treatments. Conclusions Spinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and

  9. Clinical Data Warehouse: An Effective Tool to Create Intelligence in Disease Management.

    Science.gov (United States)

    Karami, Mahtab; Rahimi, Azin; Shahmirzadi, Ali Hosseini

    Clinical business intelligence tools such as clinical data warehouse enable health care organizations to objectively assess the disease management programs that affect the quality of patients' life and well-being in public. The purpose of these programs is to reduce disease occurrence, improve patient care, and decrease health care costs. Therefore, applying clinical data warehouse can be effective in generating useful information about aspects of patient care to facilitate budgeting, planning, research, process improvement, external reporting, benchmarking, and trend analysis, as well as to enable the decisions needed to prevent the progression or appearance of the illness aligning with maintaining the health of the population. The aim of this review article is to describe the benefits of clinical data warehouse applications in creating intelligence for disease management programs.

  10. Measuring Effects on the Clinical Practice from a Configured EHR

    DEFF Research Database (Denmark)

    Møller-Jensen, John; Simonsen, Jesper; K. Iversen, Rikke

    2006-01-01

    during a series of workshops with the clinicians after which the XML configuration files were written and deployed. In parallel with this, the participants from the University specified a number of effects related to the clinical practice to be measured. Measurements were focused on the requested effects......The objective of the project was to measure the clinical usability of an EHR configured by use of participatory design with clinicians from a neurological stroke unit in order to get input to the County’s future strategy for incremental implementation of EHR. The content of the EHR was defined...... and acquired using various techniques including questionnaires, interviews, observations, and Task Load Index (TLX) ratings. In total, 15 nursing handovers, 8 ward rounds, and 11 patient conferences involving a total of 35 patients and more than 20 clinicians were included in the measurements. Data from...

  11. Developing an instrument to measure effective factors on clinical learning

    Directory of Open Access Journals (Sweden)

    IDEH DADGARAN

    2016-07-01

    Full Text Available Introduction: Although nursing students spend a large part of their learning period in the clinical environment, clinical learning has not been perceived by its nature yet. To develop an instrument to measure effective factors on clinical learning in nursing students. Methods: This is a mixed methods study performed in 2 steps. First, the researchers defined “clinical learning” in nursing students through qualitative content analysis and designed items of the questionnaire based on semi-structured individual interviews with nursing students. Then, as the second step, psychometric properties of the questionnaire were evaluated using the face validity, content validity, construct validity, and internal consistency evaluated on 227 students from fourth or higher semesters. All the interviews were recorded and transcribed, and then, they were analyzed using Max Qualitative Data Analysis and all of qualitative data were analyzed using SPSS 14. Results: To do the study, we constructed the preliminary questionnaire containing 102 expressions. After determination of face and content validities by qualitative and quantitative approaches, the expressions of the questionnaire were reduced to 45. To determine the construct validity, exploratory factor analysis was applied. The results indicated that the maximum variance percentage (40.55% was defined by the first 3 factors while the rest of the total variance percentage (59.45% was determined by the other 42 factors. Results of exploratory factor analysis of this questionnaire indicated the presence of 3 instructor-staff, students, and educational related factors. Finally, 41 expressions were kept in 3 factor groups. The α-Cronbach coefficient (0.93 confirmed the high internal consistency of the questionnaire. Conclusion: Results indicated that the prepared questionnaire was an efficient instrument in the study of the effective factors on clinical learning as viewed by nursing students since it

  12. Intraductal papillary mucinous neoplasms of the pancreas: reporting clinically relevant features.

    Science.gov (United States)

    Del Chiaro, Marco; Verbeke, Caroline

    2017-05-01

    Intraductal papillary mucinous neoplasms (IPMNs) of the pancreas can exhibit a wide spectrum of macroscopic and microscopic appearances. This not only causes occasional difficulties for the reporting pathologist in distinguishing these tumours from other lesions, but is also relevant clinically. As evidence accumulates, it becomes clear that multiple macroscopic and histological features of these neoplasms are relevant to the risk for malignant transformation and, consequently, of prime importance for clinical patient management. The need for detailed reporting is therefore increasing. This review discusses the panoply of gross and microscopic features of IPMN as well as the recommendations from recent consensus meetings regarding the pathology reporting on this tumour entity. © 2016 John Wiley & Sons Ltd.

  13. Bactericidal effects of bioactive glasses on clinically important aerobic bacteria.

    Science.gov (United States)

    Munukka, Eveliina; Leppäranta, Outi; Korkeamäki, Mika; Vaahtio, Minna; Peltola, Timo; Zhang, Di; Hupa, Leena; Ylänen, Heimo; Salonen, Jukka I; Viljanen, Matti K; Eerola, Erkki

    2008-01-01

    Bioactive glasses (BAGs) have been studied for decades for clinical use, and they have found many dental and orthopedic applications. BAGs have also been shown to have an antibacterial effect e.g., on some oral microorganisms. In this extensive work we show that six powdered BAGs and two sol-gel derived materials have a clear antibacterial effect on 29 clinically important bacterial species. We also incorporated a rapid and accurate flow cytometric (FCM) method to calculate and standardize the numbers of viable bacteria inoculated in the suspensions used in the tests for antibacterial activity. In all materials tested growth inhibition could be demonstrated, although the concentration and time needed for the effect varied depending on the BAG. The most effective glass was S53P4, which had a clear growth-inhibitory effect on all pathogens tested. The sol-gel derived materials CaPSiO and CaPSiO II also showed a strong antibacterial effect. In summary, BAGs were found to clearly inhibit the growth of a wide selection of bacterial species causing e.g., infections on the surfaces of prostheses in the body after implantation.

  14. The impact of a structured clinical training course on interns' self-reported confidence with core clinical urology skills.

    Science.gov (United States)

    Browne, C; Norton, S; Nolan, J M; Whelan, C; Sullivan, J F; Quinlan, M; Sheikh, M; Mc Dermott, T E D; Lynch, T H; Manecksha, R P

    2018-02-01

    Undergraduate training in core urology skills is lacking in many Irish training programmes. Our aim was to assess newly qualified doctors' experience and confidence with core urological competencies. A questionnaire survey covering exposure to urology and confidence with core clinical skills was circulated to all candidates. The group then attended a skills course covering male/female catheterisation, insertion of three-way catheters, bladder irrigation and management of long-term suprapubic catheters. The groups were re-surveyed following the course. Forty-five interns completed the pre-course questionnaire (group 1) and 27 interns completed the post-course questionnaire (group 2). 24/45 (53%) had no experience of catheter insertion on a patient during their undergraduate training. 26/45 (58%) were unsupervised during their first catheter insertion. 12/45 (27%) had inserted a female catheter. 18/45 (40%) had inserted a three-way catheter. 12/45 (27%) had changed a suprapubic catheter. 40/45 (89%) in group 1 reported 'good' or 'excellent' confidence with male urinary catheterisation, compared to 25/27 (92.5%) in group 2. 18/45 (40%) in group 1 reported 'none' or 'poor' confidence with female catheterisation, compared to 7/27 (26%) in group 2. 22/45 (49%) in group 1 reported 'none' or 'poor' confidence with insertion of three-way catheters, compared to 2/27 (7%) in group 2. 32/45 (71%) in group 1 reported 'none' or 'poor' confidence in changing long-term suprapubic catheters, falling to 3/27 (11%) in group 2. This study raises concerns about newly qualified doctors' practical experience in urology. We suggest that this course improves knowledge and confidence with practical urology skills and should be incorporated into intern induction.

  15. Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting.

    Science.gov (United States)

    Pandis, Nikolaos; Shamseer, Larissa; Kokich, Vincent G; Fleming, Padhraig S; Moher, David

    2014-09-01

    To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials. The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009. Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011-2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable. Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. Case Reports of Cat Scratch Disease with Typical and Atypical Clinical Manifestations: A Literature Review

    Directory of Open Access Journals (Sweden)

    Gulshan Umbreen

    2017-04-01

    Full Text Available Cat scratch disease (CSD is the most well-known zoonotic disease spread by domestic animals like cats. Cats are the source of Bartonella henselae. Most patients more than ninety percent 3-12 days after a scratch from a cat, undoubtedly a little cat with insects present with one or more erythematous injuries at the site of inoculation, the sore is typically a crusted papule or, once in a while, a pustule. More than half of cases in one study show that the systemic indications went with the lymphadenopathy. These may incorporate fever, discomfort, migraine and anorexia and frequently happen in immunocompromised patients. Atypically clinical manifestations happen are altered mental status, perplexity, prolonged fever, respiratory protestations (atypical pneumonitis, Joint pain, synovitis, Back agony is uncommon. The hypothesis of the study to find out that cat scratch disease cause typical and atypical clinical manifestation. Study was conducted July 2015 to September 2015. The methodology sections of a review article are listed all of the databases and citation indexes that were searched such as Web of Science and PubMed and any individual journals that were searched. Various case reports were mentioned in the study. Case reports of cat scratch diseases with typical and atypical clinical manifestation included in the study. The objective of review of these reporting cases is to make physicians aware about cat scratch diseases and also need to create awareness about cat scratch disease in pet owner. Although it is self-limiting needs to report to health authorities. There are few cases reported in which mostly cases reported in twain, japan, Brazil, Texas, United States, Dhaka, Spain with typical and atypical clinical manifestation

  17. LDRD report: Smoke effects on electrical equipment

    International Nuclear Information System (INIS)

    TANAKA, TINA J.; BAYNES, EDWARD E. JR.; NOWLEN, STEVEN P.; BROCKMANN, JOHN E.; GRITZO, LOUIS A.; SHADDIX, Christopher R.

    2000-01-01

    Smoke is known to cause electrical equipment failure, but the likelihood of immediate failure during a fire is unknown. Traditional failure assessment techniques measure the density of ionic contaminants deposited on surfaces to determine the need for cleaning or replacement of electronic equipment exposed to smoke. Such techniques focus on long-term effects, such as corrosion, but do not address the immediate effects of the fire. This document reports the results of tests on the immediate effects of smoke on electronic equipment. Various circuits and components were exposed to smoke from different fields in a static smoke exposure chamber and were monitored throughout the exposure. Electrically, the loss of insulation resistance was the most important change caused by smoke. For direct current circuits, soot collected on high-voltage surfaces sometimes formed semi-conductive soot bridges that shorted the circuit. For high voltage alternating current circuits, the smoke also tended to increase the likelihood of arcing, but did not accumulate on the surfaces. Static random access memory chips failed for high levels of smoke, but hard disk drives did not. High humidity increased the conductive properties of the smoke. The conductivity does not increase linearly with smoke density as first proposed; however, it does increase with quantity. The data can be used to give a rough estimate of the amount of smoke that will cause failures in CMOS memory chips, dc and ac circuits. Comparisons of this data to other fire tests can be made through the optical and mass density measurements of the smoke

  18. The effectiveness of an educational programme on occupational disease reporting

    NARCIS (Netherlands)

    Smits, P. B. A.; de Boer, A. G. E. M.; Kuijer, P. P. F. M.; Braam, I.; Spreeuwers, D.; Lenderink, A. F.; Verbeek, J. H. A. M.; van Dijk, F. J. H.

    2008-01-01

    Background: Occupational diseases are under reported. Targeted education of occupational physicians (OPs) may improve their rate of reporting occupational diseases. Aim: To study the effectiveness of an active multifaceted workshop aimed at improving OPs' reporting of occupational diseases. Methods:

  19. Augmenting retention and stability of an occlusal device for a partially dentate patient using existing extracoronal attachments: a clinical report.

    Science.gov (United States)

    Al-Rowaieh, Saleh A

    2011-04-01

    Occlusal devices are a valid treatment modality in certain clinical situations. For an occlusal device to be effective, sufficient retention and stability should be derived from coverage of the occlusal and incisal surfaces of the teeth. In the absence of most or all of the posterior teeth, the effectiveness of the device could become compromised as the incisal portions of the anterior teeth are typically not conducive to adequately retaining and stabilizing the device. This clinical report describes an approach to improving the retention and stability of an occlusal device for a patient with shortened dental arches by use of the patient's existing extracoronal attachments. Copyright © 2011 The Editorial Council of the Journal of Prosthetic Dentistry. Published by Mosby, Inc. All rights reserved.

  20. Restoration-Guided Implant Rehabilitation of the Complex Partial Edentulism: a Clinical Report

    Directory of Open Access Journals (Sweden)

    Nikitas Sykaras

    2010-01-01

    Full Text Available Background: The hard and soft tissue deficiency is a limiting factor for the prosthetic restoration and any surgical attempt to correct the anatomic foundation needs to be precisely executed for optimal results. The purpose of this paper is to describe the clinical steps that are needed to confirm the treatment plan and allow its proper execution.Methods: Team work and basic principles are emphasized in a step-by-step description of clinical methods and techniques. This clinical report describes the interdisciplinary approach in the rehabilitation of a partially edentulous patient. The importance of the transitional restoration which sets the guidelines for the proper execution of the treatment plan is especially emphasized along with all the steps that have to be followed.Results: The clinical report describes the diagnostic arrangement of teeth, the ridge augmentation based on the diagnostic evaluation of the removable prosthesis, the implant placement with a surgical guide in the form of the removable partial denture duplicate and finally the special 2-piece design of the final fixed prosthesis.Conclusions: Clinical approach and prosthesis design described above offers a predictable way to restore partial edentulism with a fixed yet retrievable prosthesis, restoring soft tissue and teeth and avoiding an implant supported overdenture.

  1. Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report.

    Science.gov (United States)

    Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

    2016-09-27

    Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  2. Rehabilitation and multiple limb amputations: A clinical report of patients injured in combat.

    Science.gov (United States)

    Melcer, Ted; Pyo, Jay; Walker, Jay; Quinn, Kimberly; Lebedda, Martin; Neises, Kamaran; Nguyen, Christina; Galarneau, Michael

    2016-01-01

    This clinical report describes the outpatient rehabilitation program for patients with multiple limb amputations enrolled in the Comprehensive Combat and Complex Casualty Care facility at the Naval Medical Center San Diego. Injury-specific data for 29 of these patients wounded by blast weaponry in Afghanistan in 2010 or 2011 were captured by the Expeditionary Medical Encounter Database at the Naval Health Research Center and were reviewed for this report. Their median Injury Severity Score was 27 (N = 29; range, 11-54). Patients averaged seven moderate to serious injuries (Abbreviated Injury Scale scores ≥2), including multiple injuries to lower limbs and injuries to the torso and/or upper limbs. All patients received care from numerous clinics, particularly physical therapy during the first 6 mo postinjury. Clinic use generally declined after the first 6 mo with the exception of prosthetic devices and repairs. The clinical team implemented the Mayo-Portland Adaptability Inventory, 4th Revision (MPAI-4) to assess functioning at outpatient program initiation and discharge (n = 23). At program discharge, most patients had improved scores for the MPAI-4 items assessing mobility, pain, and transportation, but not employment. Case reports described rehabilitation for two patients with triple amputations and illustrated multispecialty care and contrasting solutions for limb prostheses.

  3. European Academy of Allergy and Clinical Immunology task force report on 'dose-response relationship in allergen-specific immunotherapy'.

    Science.gov (United States)

    Calderón, M A; Larenas, D; Kleine-Tebbe, J; Jacobsen, L; Passalacqua, G; Eng, P A; Varga, E M; Valovirta, E; Moreno, C; Malling, H J; Alvarez-Cuesta, E; Durham, S; Demoly, P

    2011-10-01

    For a century, allergen-specific immunotherapy (SIT) has proven to be an effective treatment for allergic rhinitis, asthma, and insect sting allergy. However, as allergen doses are frequently adapted to the individual patient, there are few data on dose-response relationship in SIT. Allergen products for SIT are being increasingly required to conform to regulatory requirements for human medicines, which include the need to demonstrate dose-dependent effects. This report, produced by a Task Force of the EAACI Immunotherapy Interest Group, evaluates the currently available data on dose-response relationships in SIT and aims to provide recommendations for the design of future studies. Fifteen dose-ranging studies fulfilled the inclusion criteria and twelve reported a dose-response relationship for clinical efficacy. Several studies also reported a dose-response relationship for immunological and safety endpoints. Due to the use of different reference materials and methodologies for the determination of allergen content, variations in study design, and choice of endpoints, no comparisons could be made between studies and, as a consequence, no general dosing recommendations can be made. Despite recently introduced guidelines on the standardization of allergen preparations and study design, the Task Force identified a need for universally accepted standards for the measurement of allergen content in SIT preparations, dosing protocols, and selection of clinical endpoints to enable dose-response effects to be compared across studies. © 2011 John Wiley & Sons A/S.

  4. Neurofeedback for the treatment of children and adolescents with ADHD: a randomized and controlled clinical trial using parental reports

    Directory of Open Access Journals (Sweden)

    Duric Nezla S

    2012-08-01

    Full Text Available Abstract Background A randomized and controlled clinical study was performed to evaluate the use of neurofeedback (NF to treat attention-deficit/hyperactivity disorder (ADHD in children and adolescents. Methods The ADHD population was selected from an outpatient clinic for Child and Adolescent Mental Health in Norway. Ninety-one of the 275 children and adolescents ranging in age from 6 to 18 years (10.5 years participated in 30 sessions of an intensive NF program. The reinforcement contingency was based on the subjects’ production of cortical beta1 activity (15–18 Hz. The ADHD participants were randomized into three groups, with 30 in the NF group, 31 controls in a group that was given methylphenidate, and 30 in a group that received NF and methylphenidate. ADHD core symptoms were reported by parents using the parent form of the Clinician’s Manual for Assessment by Russell A. Barkley. Results Ninety-one children and adolescents were effectively randomized by age, sex, intelligence and distribution of ADHD core symptoms. The parents reported significant effects of the treatments, but no significant differences between the treatment groups were observed. Conclusions NF was as effective as methylphenidate at treating the attentional and hyperactivity symptoms of ADHD, based on parental reports. Trial registration Current Controlled Trials NCT01252446

  5. Clinical effect of venlafaxine combined with methylphenidate hydrochloride on narcolepsy

    Directory of Open Access Journals (Sweden)

    YAN Bin

    2013-11-01

    Full Text Available This study aims to explore the clinical effect of venlafaxine sustained-release capsules combined with methylphenidate hydrochloride tablets on narcolepsy. Thirty-eight cases of narcoleptic patients were randomly divided into venlafaxine combined with methylphenidate hydrochloride treatment group (observation group, N = 19 and methylphenidate hydrochloride and clomipramine treatment group (control group, N = 19. After a total of 12-week treatment, clinical curative effect and adverse drug reactions were observed in 2 groups of patients. The results showed that effective rate of the treatment for excessive daytime sleepiness (EDS in observation group was higher than that of the control group (15/19 vs 8/19, P = 0.044, and effective rate of the treatment for cataplexy in observation group was higher than that of the control group (13/19 vs 6/19, P = 0.048. The rate of adverse drug reactions in observation group was lower than that in the control group (χ2 = 8.889, P = 0.003. It was indicated that venlafaxine combined with methylphenidate had good curative effect on narcolepsy with EDS and cataplexy symptoms.

  6. Positive expiratory pressure - Common clinical applications and physiological effects.

    Science.gov (United States)

    Fagevik Olsén, Monika; Lannefors, Louise; Westerdahl, Elisabeth

    2015-03-01

    Breathing out against resistance, in order to achieve positive expiratory pressure (PEP), is applied by many patient groups. Pursed lips breathing and a variety of devices can be used to create the resistance giving the increased expiratory pressure. Effects on pulmonary outcomes have been discussed in several publications, but the expected underlying physiology of the effect is seldom discussed. The aim of this article is to describe the purpose, performance, clinical application and underlying physiology of PEP when it is used to increase lung volumes, decrease hyperinflation or improve airway clearance. In clinical practice, the instruction how to use an expiratory resistance is of major importance since it varies. Different breathing patterns during PEP increase or reduce expiratory flow, result in movement of EPP centrally or peripherally and can increase or decrease lung volume. It is therefore necessary to give the right instructions to obtain the desired effects. As the different PEP techniques are being used by diverse patient groups it is not possible to give standard instructions. Based on the information given in this article the instructions have to be adjusted to give the optimal effect. There is no consensus regarding optimal treatment frequency and number of cycles included in each treatment session and must also be individualized. In future research, more precise descriptions are needed about physiological aims and specific instructions of how the treatments have been performed to assure as good treatment quality as possible and to be able to evaluate and compare treatment effects. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. The spatial context of clinic-reported sexually transmitted infection in Hong Kong.

    Science.gov (United States)

    Lee, Shui-Shan; Ho, King-Man; Cheung, Georgiana M T

    2010-09-21

    The incidence and prevalence of sexually transmitted infection (STI) in China has been on the rise in the past decade. Delineation of epidemiologic pattern is often hampered by its uneven distribution. Spatial distribution is often a neglected aspect of STI research, the description of which may enhance epidemiologic surveillance and inform service development. Over a one month-period, all first time attendees of 6 public STI clinics in Hong Kong were interviewed before clinical consultation using a standard questionnaire to assess their demographic, clinical and behavioural characteristics. A GIS (geographic information system)-based approach was adopted with mapping performed. The cases attending the clinics in different locations were profiled. A comparison was made between neighbourhood cases (patients living near a clinic) and distant cases (those farther off), by calculating the odds ratio for demographic, behavioural and geographic characteristics. Of the 1142 STI patients evaluated, the residence locations of 1029 (90.1%) could be geocoded, of which 95.6% were ethnic Chinese and 63.4% male. Geographically only about a quarter lived in the same district as the clinic. STI patients aged 55 or above were more likely to be living in the vicinity of the clinic, located in the same or adjacent tertiary planning unit (a small geographic unit below district level). A majority of patients came from locations a few kilometers from the clinic, the distance of which varies between clinics. Overall, more syphilis cases were reported in patients residing in the same or adjacent tertiary planning unit, while distant cases tended to give a higher risk of inconsistent condom use. There were otherwise no significant clinical and epidemiologic differences between neighbourhood and distant STI cases. There was no specific relationship between STI and the residence location of patients as regards their clinical and epidemiologic characteristics in the territory of Hong Kong

  8. The spatial context of clinic-reported sexually transmitted infection in Hong Kong

    Directory of Open Access Journals (Sweden)

    Cheung Georgiana MT

    2010-09-01

    Full Text Available Abstract Background The incidence and prevalence of sexually transmitted infection (STI in China has been on the rise in the past decade. Delineation of epidemiologic pattern is often hampered by its uneven distribution. Spatial distribution is often a neglected aspect of STI research, the description of which may enhance epidemiologic surveillance and inform service development. Methods Over a one month-period, all first time attendees of 6 public STI clinics in Hong Kong were interviewed before clinical consultation using a standard questionnaire to assess their demographic, clinical and behavioural characteristics. A GIS (geographic information system-based approach was adopted with mapping performed. The cases attending the clinics in different locations were profiled. A comparison was made between neighbourhood cases (patients living near a clinic and distant cases (those farther off, by calculating the odds ratio for demographic, behavioural and geographic characteristics. Results Of the 1142 STI patients evaluated, the residence locations of 1029 (90.1% could be geocoded, of which 95.6% were ethnic Chinese and 63.4% male. Geographically only about a quarter lived in the same district as the clinic. STI patients aged 55 or above were more likely to be living in the vicinity of the clinic, located in the same or adjacent tertiary planning unit (a small geographic unit below district level. A majority of patients came from locations a few kilometers from the clinic, the distance of which varies between clinics. Overall, more syphilis cases were reported in patients residing in the same or adjacent tertiary planning unit, while distant cases tended to give a higher risk of inconsistent condom use. There were otherwise no significant clinical and epidemiologic differences between neighbourhood and distant STI cases. Conclusions There was no specific relationship between STI and the residence location of patients as regards their clinical and

  9. Evaluating the effects of cognitive support on psychiatric clinical comprehension.

    Science.gov (United States)

    Dalai, Venkata V; Khalid, Sana; Gottipati, Dinesh; Kannampallil, Thomas; John, Vineeth; Blatter, Brett; Patel, Vimla L; Cohen, Trevor

    2014-10-01

    Clinicians' attention is a precious resource, which in the current healthcare practice is consumed by the cognitive demands arising from complex patient conditions, information overload, time pressure, and the need to aggregate and synthesize information from disparate sources. The ability to organize information in ways that facilitate the generation of effective diagnostic solutions is a distinguishing characteristic of expert physicians, suggesting that automated systems that organize clinical information in a similar manner may augment physicians' decision-making capabilities. In this paper, we describe the design and evaluation of a theoretically driven cognitive support system (CSS) that assists psychiatrists in their interpretation of clinical cases. The system highlights, and provides the means to navigate to, text that is organized in accordance with a set of diagnostically and therapeutically meaningful higher-level concepts. To evaluate the interface, 16 psychiatry residents interpreted two clinical case scenarios, with and without the CSS. Think-aloud protocols captured during their interpretation of the cases were transcribed and analyzed qualitatively. In addition, the frequency and relative position of content related to key higher-level concepts in a verbal summary of the case were evaluated. In addition the transcripts from both groups were compared to an expert derived reference standard using latent semantic analysis (LSA). Qualitative analysis showed that users of the system better attended to specific clinically important aspects of both cases when these were highlighted by the system, and revealed ways in which the system mediates hypotheses generation and evaluation. Analysis of the summary data showed differences in emphasis with and without the system. The LSA analysis suggested users of the system were more "expert-like" in their emphasis, and that cognitive support was more effective in the more complex case. Cognitive support impacts

  10. The effects of Clinical Pilates exercises on patients with shoulder pain: A randomised clinical trial.

    Science.gov (United States)

    Atılgan, Esra; Aytar, Aydan; Çağlar, Aslıcan; Tığlı, Ayça Aytar; Arın, Gamze; Yapalı, Gökmen; Kısacık, Pınar; Berberoğlu, Utku; Şener, Hülya Özlem; Ünal, Edibe

    2017-10-01

    The purpose of this study was to determine the effect of Clinical Pilates exercises on patients with shoulder pain. Thirty-three patients, experiencing shoulder pain continuously for at least four weeks were selected as study subjects. The patients were randomly divided into two groups, namely Clinical Pilates exercise (n = 17) group and conventional exercise (n = 16) group. The patients were treated for five days a week, the total treatment being carried out for 10 days. The assessment of pain and disability amongst the patients were done at the baseline and at the end of the treatment sessions, using Visual Analogue Scale (VAS) and Shoulder Pain and Disability Index (SPADI). The clinical Pilates exercise group showed a significant improvement in all scores used for assessment (p Pilates exercise group (p Pilates exercise is an efficient technique for patients experiencing shoulder pain, as it helps reduce pain and disability among them. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Exploring the context for effective clinical governance in infection control.

    Science.gov (United States)

    Halton, Kate; Hall, Lisa; Gardner, Anne; MacBeth, Deborough; Mitchell, Brett G

    2017-03-01

    Effective clinical governance is necessary to support improvements in infection control. Historically, the focus has been on ensuring that infection control practice and policy is based on evidence, and that there is use of surveillance and auditing for self-regulation and performance feedback. There has been less exploration of how contextual and organizational factors mediate an infection preventionists (IP's) ability to engage with evidence-based practice and enact good clinical governance. A cross sectional Web-based survey of IPs in Australia and New Zealand was undertaken. Questions focused on engagement in evidence-based practice and perceptions about the context, culture, and leadership within the infection control team and organization. Responses were mapped against dimensions of Scally and Donaldson's clinical governance framework. Three hundred surveys were returned. IPs appear well equipped at an individual level to undertake evidence-based practice. The most serious set of perceived challenges to good clinical governance related to a lack of leadership or active resistance to infection control within the organization. Additional challenges included lack of information technology solutions and poor access to specialist expertise and financial resources. Focusing on strengthening contextual factors at the organizational level that otherwise undermine capacity to implement evidence-based practice is key to sustaining current infection control successes and promoting further practice improvements. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

  12. MR imaging of pregnancy luteoma: a case report and correlation with the clinical features

    Energy Technology Data Exchange (ETDEWEB)

    Kao, Hung Wen; Wu, Ching Jiunn; Chung, Kuo Teng; Wang, Sheng Ru; Chen, Cheng Yu [Tri-Service General Hospital, National Defense Medical Center, Taipei (Taiwan)

    2005-03-15

    We report here on a 26-year-old pregnant female who developed hirsutism and virilization during her third trimester along with a significantly elevated serum testosterone level. Abdominal US and MR imaging studies were performed, and they showed unique imaging features that may suggest the diagnosis of pregnancy luteoma in the clinical context. After the delivery, the serum testosterone level continued to decrease, and it returned to normal three weeks postpartum. The follow-up imaging findings were closely correlated with the clinical presentation.

  13. Avoiding pitfalls in diagnosing basilar artery occlusive disease: clinical and imaging clues - case report

    Directory of Open Access Journals (Sweden)

    Adriana Bastos Conforto

    Full Text Available CONTEXT: The aim of this paper was to report on the characteristics that aid in establishing the diagnosis of basilar artery occlusive disease (BAOD among patients with hemiparesis and few or minor symptoms of vertebrobasilar disease. CASE REPORT: This report describes two cases in a public university hospital in São Paulo, Brazil. We present clinical and imaging findings from two patients with hemiparesis and severe BAOD, but without clinically relevant carotid artery disease (CAD. One patient presented transient ischemic attacks consisting of spells of right hemiparesis that became progressively more frequent, up to twice a week. The neurological examination revealed slight right hemiparesis and right homonymous hemianopsia. Magnetic resonance imaging (MRI revealed pontine and occipital infarcts. Magnetic resonance angiography and digital subtraction angiography revealed severe basilar artery stenosis. The other patient presented sudden left-side hemiparesis and hypoesthesia. One year earlier, she had reported sudden onset of vertigo that, at that time, was attributed to peripheral vestibulopathy and was not further investigated. MRI showed a right-side pontine infarct and an old infarct in the right cerebellar hemisphere. Basilar artery occlusion was diagnosed. Both patients presented their symptoms while receiving aspirin, and became asymptomatic after treatment with warfarin. CONCLUSIONS: Misdiagnosing asymptomatic CAD as the cause of symptoms in BAOD can have disastrous consequences, such as unnecessary carotid endarterectomy and exposure to this surgical risk while failing to offer the best available treatment for BAOD. Clinical and imaging features provided important clues for diagnosis in the cases presented.

  14. Clinical Evaluation of Ocular Antiviral Effect of Garcinia Kolanut ...

    African Journals Online (AJOL)

    Background: The claim of an Octogenarian on Garcinia kolanuts crude water extract on his open angle glaucoma has opened up a series of researchers into the native nuts as to their pharmocotherapeutic properties. Some of these have been reported as pressure lowering effects on laboratory animals and as antibacterials ...

  15. Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report.

    Science.gov (United States)

    Benjamin, Katy; Vernon, Margaret K; Patrick, Donald L; Perfetto, Eleanor; Nestler-Parr, Sandra; Burke, Laurie

    Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing

  16. Methods to Succeed in Effective Knowledge Translation in Clinical Practice.

    Science.gov (United States)

    Kitson, Alison L; Harvey, Gillian

    2016-05-01

    To explore the evidence around facilitation as an intervention for the successful implementation of new knowledge into clinical practice. The revised version of the Promoting Action on Research Implementation in Health Services (PARIHS) framework, called the integrated or i-PARIHS framework, is used as the explanatory framework. This framework posits that evidence is a multidimensional construct embedded within innovation and operationalized by clinicians (individuals and within teams), working across multiple layers of context. Facilitation is the active ingredient that promotes successful implementation. An emerging body of evidence supports facilitation as a mechanism to getting new knowledge into clinical practice. Facilitation roles are divided into beginner, experienced, and expert facilitators. Facilitators can be internal or external to the organization they work in, and their skills and attributes complement other knowledge translation (KT) roles. Complex KT projects require facilitators who are experienced in implementation methods. Facilitation is positioned as the active ingredient to effectively introduce new knowledge into a clinical setting. Levels of facilitation experience are assessed in relation to the complexity of the KT task. Three core facilitation roles are identified, and structured interventions are established taking into account the nature and novelty of the evidence, the receptiveness of the clinicians, and the context or setting where the new evidence is to be introduced. Roles such as novice, experienced, and expert facilitators have important and complementary parts to play in enabling the successful translation of evidence into everyday practice in order to provide effective care for patients. © 2016 Sigma Theta Tau International.

  17. Clinical findings and effect of sodium hydrogen carbonate in patients with glutathione synthetase deficiency.

    Science.gov (United States)

    Gündüz, Mehmet; Ünal, Özlem; Kavurt, Sumru; Türk, Emrecan; Mungan, Neslihan Önenli

    2016-04-01

    Glutathione synthetase (GS) deficiency is a rare inborn error of glutathione (GSH) metabolism manifested by severe metabolic acidosis, hemolytic anemia, neurological problems and massive excretion of pyroglutamic acid (5-oxoproline) in the urine. The disorder has mild, moderate, and severe clinical variants. We aimed to report clinical and laboratory findings of four patients, effect of sodium hydrogen carbonate treatment and long-term follow up of three patients. Urine organic acid analysis was performed with gas chromatography-mass spectrometry. Molecular genetic analysis was performed in three patients, mutation was found in two of them. Enzyme analysis was performed in one patient. Clinical and laboratory findings of four patients were evaluated. One patient died at 4 months old, one patient's growth and development are normal, two patients have developed intellectual disability and seizures in the long term follow up period. Three patients benefited from sodium hydrogen carbonate treatment. The clinical picture varies from patient to patient, so it is difficult to predict the prognosis and the effectiveness of treatment protocols. We reported long term follow up of four patients and demonstrated that sodium hydrogen carbonate is effective for treatment of chronic metabolic acidosis in GS deficieny.

  18. Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

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

  19. The Pharmacologic and Clinical Effects of Illicit Synthetic Cannabinoids.

    Science.gov (United States)

    White, C Michael

    2017-03-01

    This article presents information on illicitly used synthetic cannabinoids. Synthetic cannabinoids are structurally heterogeneous and commonly used drugs of abuse that act as full agonists of the cannabinoid type-1 receptor but have a variety of additional pharmacologic effects. There are numerous cases of patient harm and death in the United States, Europe, and Australia with many psychological, neurological, cardiovascular, pulmonary, and renal adverse events. Although most users prefer using cannabis, there are convenience, legal, and cost reasons driving the utilization of synthetic cannabinoids. Clinicians should be aware of pharmacologic and clinical similarities and differences between synthetic cannabinoid and cannabis use, the limited ability to detect synthetic cannabinoids in the urine or serum, and guidance to treat adverse events. © 2016, The American College of Clinical Pharmacology.

  20. The long-term use of zygomatic implants: a 10-year clinical and radiographic report.

    Science.gov (United States)

    Aparicio, Carlos; Manresa, Carolina; Francisco, Karen; Ouazzani, Wafaa; Claros, Pedro; Potau, Josep M; Aparicio, Arnau

    2014-06-01

    The zygoma implant has been an effective option in the short-term management of the atrophic edentulous maxilla. To report on long-term outcomes in the rehabilitation of the atrophic maxilla using zygomatic (ZI) and regular implants (RI). 22 consecutive zygomatic patients in a maintenance program were included. Cumulative survival rate (CSR) of ZI, RI, prostheses, and complications were recorded during, at least, 10 years of loading. Implant mobility was tested using Periotest(®). Sinus health was radiographically and clinically assessed according to Lund-Mackay (L-M) score and Lanza and Kennedy survey, respectively. A satisfaction questionnaire and anatomical measurements were also performed. Patients received 22 prostheses, anchored on 172 implants. Forty-one were ZI. Three RI failed (10 years CSR = 97.71%). Two ZI were partly removed due to perimplant infection (10 years CSR = 95.12%). All patients maintained functional prostheses. One patient fractured framework twice. Loosening or fracturing screws happened in 11 patients. Seven patients fractured occlusal material. Four ZI abutments in two patients were disconnected because of uncomfortable prostheses. Alveolar height at the ZI head level on the right and left sides was 2.64 mm and 2.25 mm, respectively. Mean distance of ZI head center to ridge center, on the right and left sides was 4.54 mm and 5.67 mm, respectively. Mean Periotest values (PTv) of ZI were -4.375 PTv and -4.941 PTv before prostheses placement and after 10 years, respectively. Six patients experienced sinusitis 14-127 months postoperatively. 54.55% of the L-M scores did not present opacification (L-M = 0) in any sinus. Osteomeatal obstruction happened in eight patients (two bilateral). Two (9.09%) were diagnosed with sinusitis. Eighty-four percent reported satisfaction levels above 80%. 31.81% reported maximum satisfaction score (100%). The long-term rehabilitation of the severely atrophic maxillae using ZI is a predictable procedure. © 2012

  1. Patient-reported Outcomes in Randomised Controlled Trials of Prostate Cancer: Methodological Quality and Impact on Clinical Decision Making

    Science.gov (United States)

    Efficace, Fabio; Feuerstein, Michael; Fayers, Peter; Cafaro, Valentina; Eastham, James; Pusic, Andrea; Blazeby, Jane

    2014-01-01

    Context Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. Objective The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. Evidence acquisition A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. Evidence synthesis Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n = 29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. Conclusions Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient

  2. The effect of tax reporting in financial reporting

    Directory of Open Access Journals (Sweden)

    Shqipe Xhaferri

    2015-07-01

    Full Text Available This paper analyzes the importance of building financial statements and their compliance with the activities by running an entity, primarily for micro units. Main objective of this paper is to present the necessity of the implementation of legal frameworks in the field of accounting and the application of accounting standards for financial reporting. National Accounting Standards are significant factors to increase the quality of financial information, bringing new technologies, increased competition and culture of service etc. National Accounting Standards help in the sustainable economic development of the country and integration into the EU. This paper analyzes a series of articles in the field of research in the field of accounting. This paper presents the theoretical and practical aspects of a company’s long-term assets, treating the amortization calculated according to accounting standards. An important point is the appearance of these items in the balance sheet. According to the empirical viewpoint, various studies give different results. Also, the entities as a primary source of economic development are part of this paper. The application of accounting standards began in Albania on 1 January 2009. From these date all the units are obliged to draw up financial statements according to national and international standards of accounting. Actually nowadays (starting from the fiscal year 2014 the submission of balance sheet is made electronically.

  3. Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT): modifying the CONSORT statement.

    Science.gov (United States)

    2014-10-01

    Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which creates a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant after ≥20 weeks' gestation) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples

  4. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement

    Science.gov (United States)

    MacPherson, Hugh; Altman, Douglas G; Hammerschlag, Richard; Li, Youping; Wu, Taixiang; White, Adrian; Moher, David

    2010-01-01

    The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word ‘controlled’ in STRICTA is replaced by ‘clinical’, to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture. PMID:20615861

  5. The effects of implementing synoptic pathology reporting in cancer diagnosis: a systematic review.

    Science.gov (United States)

    Sluijter, Caro E; van Lonkhuijzen, Luc R C W; van Slooten, Henk-Jan; Nagtegaal, Iris D; Overbeek, Lucy I H

    2016-06-01

    Pathology reporting is evolving from a traditional narrative report to a more structured synoptic report. Narrative reporting can cause misinterpretation due to lack of information and structure. In this systematic review, we evaluate the impact of synoptic reporting on completeness of pathology reports and quality of pathology evaluation for solid tumours. Pubmed, Embase and Cochrane databases were systematically searched to identify studies describing the effect of synoptic reporting implementation on completeness of reporting and quality of pathology evaluation of solid malignant tumours. Thirty-three studies met the inclusion criteria. All studies, except one, reported an increased overall completeness of pathology reports after introduction of synoptic reporting (SR). Most frequently studied cancers were breast (n = 9) and colorectal cancer (n = 16). For breast cancer, narrative reports adequately described 'tumour type' and 'nodal status'. Synoptic reporting resulted in improved description of 'resection margins', 'DCIS size', 'location' and 'presence of calcifications'. For colorectal cancer, narrative reports adequately reported 'tumour type', 'invasion depth', 'lymph node counts' and 'nodal status'. Synoptic reporting resulted in increased reporting of 'circumferential margin', 'resection margin', 'perineural invasion' and 'lymphovascular invasion'. In addition, increased numbers of reported lymph nodes were found in synoptic reports. Narrative reports of other cancer types described the traditional parameters adequately, whereas for 'resection margins' and '(lympho)vascular/perineural invasion', implementation of synoptic reporting was necessary. Synoptic reporting results in improved reporting of clinical relevant data. Demonstration of clinical impact of this improved method of pathology reporting is required for successful introduction and implementation in daily pathology practice.

  6. Trichotillomania: a case report with clinical and dermatoscopic differential diagnosis with alopecia areata.

    Science.gov (United States)

    Pinto, Ana Cecília Versiani Duarte; Andrade, Tatiana Cristina Pedro Cordeiro de; Brito, Fernanda Freitas de; Silva, Gardênia Viana da; Cavalcante, Maria Lopes Lamenha Lins; Martelli, Antonio Carlos Ceribelli

    2017-01-01

    Trichotillomania is a psychodermatologic disorder characterized by uncontrollable urge to pull one's own hair. Differential diagnoses include the most common forms of alopecia such as alopecia areata. It is usually associated with depression and obsessive-compulsive disorder. Trichotillomania treatment standardization is a gap in the medical literature. Recent studies demonstrated the efficacy of N-acetylcysteine (a glutamate modulator) for the treatment of the disease. We report the clinical case of a 12-year-old female patient who received the initial diagnosis of alopecia areata, but presented with clinical and dermoscopic features of trichotillomania. She was treated with the combination of psychotropic drugs and N-acetylcysteine with good clinical response. Due to the chronic and recurring nature of trichotillomania, more studies need to be conducted for the establishment of a formal treatment algorithm.

  7. Clinical findings in two cases of atypical scrapie in sheep: a case report

    Directory of Open Access Journals (Sweden)

    Chaplin Melanie

    2007-02-01

    Full Text Available Abstract Background Atypical scrapie is a recently recognised form of transmissible spongiform encephalopathy of sheep that differs from classical scrapie in its neuropathological and biochemical features. Most cases are detected in apparently healthy sheep and information on the clinical presentation is limited. Case presentation This report describes the clinical findings in two sheep notified as scrapie suspects and confirmed as atypical scrapie cases by immunohistochemistry and Western immunoblotting. Although both sheep displayed signs suggestive of a cerebellar dysfunction there was considerable variation in the individual clinical signs, which were similar to classical scrapie. Conclusion Any sheep presenting with neurological gait deficits should be assessed more closely for other behavioural, neurological and physical signs associated with scrapie and their presence should lead to the suspicion of scrapie.

  8. Clinical Overlap and Psychiatric Comorbidity in Autism Spectrum Disorder in Adulthood: A Case Report

    Directory of Open Access Journals (Sweden)

    João Picoito

    2018-01-01

    Full Text Available Background: Autism Spectrum Disorder (ASD is an early neurodevelopmental disorder that accompanies the individual throughout life. There is a significant clinical overlap of ASD with other psychiatric disorders including personality disorders, psychotic disorders, obsessive-compulsive disorder and depression. Additionally, the presence of high rates of psychiatric comorbidity, often with atypical presentations, delays the ASD diagnosis and makes it more difficult to manage. Aims: To illustrate the complexity of ASD diagnosis and approach in adults. Methods: Report of a clinical case and review of the literature. Results and Conclusion: This paper presents the case of a 46-year-old patient, with ASD, with a long history of interpersonal difficulties and psychiatric symptomatology. Over the years, different diagnoses have been made, particularly schizoid and schizotypal personality disorders, psychosis not otherwise specified and paranoid schizophrenia, which led to poor adherence to treatment, and prevented a full understanding of the patient’s clinical presentation and lifelong struggles.

  9. Phelan-McDermid syndrome data network: Integrating patient reported outcomes with clinical notes and curated genetic reports.

    Science.gov (United States)

    Kothari, Cartik; Wack, Maxime; Hassen-Khodja, Claire; Finan, Sean; Savova, Guergana; O'Boyle, Megan; Bliss, Geraldine; Cornell, Andria; Horn, Elizabeth J; Davis, Rebecca; Jacobs, Jacquelyn; Kohane, Isaac; Avillach, Paul

    2017-09-01

    The heterogeneity of patient phenotype data are an impediment to the research into the origins and progression of neuropsychiatric disorders. This difficulty is compounded in the case of rare disorders such as Phelan-McDermid Syndrome (PMS) by the paucity of patient clinical data. PMS is a rare syndromic genetic cause of autism and intellectual deficiency. In this paper, we describe the Phelan-McDermid Syndrome Data Network (PMS_DN), a platform that facilitates research into phenotype-genotype correlation and progression of PMS by: a) integrating knowledge of patient phenotypes extracted from Patient Reported Outcomes (PRO) data and clinical notes-two heterogeneous, underutilized sources of knowledge about patient phenotypes-with curated genetic information from the same patient cohort and b) making this integrated knowledge, along with a suite of statistical tools, available free of charge to authorized investigators on a Web portal https://pmsdn.hms.harvard.edu. PMS_DN is a Patient Centric Outcomes Research Initiative (PCORI) where patients and their families are involved in all aspects of the management of patient data in driving research into PMS. To foster collaborative research, PMS_DN also makes patient aggregates from this knowledge available to authorized investigators using distributed research networks such as the PCORnet PopMedNet. PMS_DN is hosted on a scalable cloud based environment and complies with all patient data privacy regulations. As of October 31, 2016, PMS_DN integrates high-quality knowledge extracted from the clinical notes of 112 patients and curated genetic reports of 176 patients with preprocessed PRO data from 415 patients. © 2017 The Authors. American Journal of Medical Genetics Part B: Neuropsychiatric Genetics Published by Wiley Periodicals, Inc.

  10. Characteristic clinical features of Aspergillus appendicitis: Case report and literature review.

    Science.gov (United States)

    Gjeorgjievski, Mihajlo; Amin, Mitual B; Cappell, Mitchell S

    2015-11-28

    This work aims to facilitate diagnosing Aspergillus appendicitis, which can be missed clinically due to its rarity, by proposing a clinical pentad for Aspergillus appendicitis based on literature review and one new case. The currently reported case of pathologically-proven Aspergillus appendicitis was identified by computerized search of pathology database at William Beaumont Hospital, 1999-2014. Prior cases were identified by computerized literature search. Among 10980 pathology reports of pathologically-proven appendicitis, one case of Aspergillus appendicitis was identified (rate = 0.01%). A young boy with profound neutropenia, recent chemotherapy, and acute myelogenous leukemia presented with right lower quadrant pain, pyrexia, and generalized malaise. Abdominal computed tomography scan showed a thickened appendiceal wall and periappendiceal inflammation, suggesting appendicitis. Emergent laparotomy showed an inflamed, thickened appendix, which was resected. The patient did poorly postoperatively with low-grade-fevers while receiving antibacterial therapy, but rapidly improved after initiating amphotericin therapy. Microscopic examination of a silver stain of the appendectomy specimen revealed fungi with characteristic Aspergillus morphology, findings confirmed by immunohistochemistry. Primary Aspergillus appendicitis is exceptionally rare, with only 3 previously reported cases. All three cases presented with (1)-neutropenia, (2)-recent chemotherapy, (3)-acute leukemia, and (4)-suspected appendicitis; (5)-the two prior cases initially treated with antibacterial therapy, fared poorly before instituting anti-Aspergillus therapy. The current patient satisfied all these five criteria. Based on these four cases, a clinical pentad is proposed for Aspergillus appendicitis: clinically-suspected appendicitis, neutropenia, recent chemotherapy, acute leukemia, and poor clinical response if treated solely by antibacterial/anti-candidial therapy. Patients presenting with

  11. Feasibility of the collection of patient-reported outcomes in an ambulatory neurology clinic.

    Science.gov (United States)

    Moura, Lidia M V R; Schwamm, Eli; Moura Junior, Valdery; Seitz, Michael P; Hsu, John; Cole, Andrew J; Schwamm, Lee H

    2016-12-06

    To determine whether patients could self-report physical and mental health assessments in the waiting room and whether these assessments would be associated with modified Rankin Scale (mRS) and Quality of Life in Epilepsy (QOLIE-10) scores. We offered iPad-based surveys to consecutive adult neurology patients at check-in to collect patient-reported outcome measures (PROMs). We collected demographic and clinical data on 6,075 patients through survey or administrative claims and PROMs from participating patients. We compared demographic characteristics of participants and nonparticipants and tested associations between physical and mental health scores and mRS and QOLIE-10. Of 6,075 patients seen by neurologists during the study period, 2,992 (49.3%) participated in the survey. Compared to nonparticipating patients, participating patients more often were privately insured (53.5% vs 42.7%, p neurology (nonsubspecialty) clinics (53.1% vs 46.6%, p Neurology.

  12. Weightbath hydrotraction treatment: application, biomechanics, and clinical effects

    Directory of Open Access Journals (Sweden)

    Márta Kurutz

    2010-04-01

    Full Text Available Márta Kurutz1, Tamás Bender21Department of Structural Mechanics, Budapest University of Technology and Economics, Hungary; 2Department of Physical Medicine, Polyclinic and Hospital of the Hospitaller Brothers of St. John of God, Budapest, Medical University of Szeged, HungaryBackground and purpose: Weightbath hydrotraction treatment (WHT is a simple noninvasive effective method of hydro- or balneotherapy to stretch the spine or lower limbs, applied successfully in hospitals and health resort sanitaria in Hungary for more than fifty years. This study aims to introduce WHT with its biomechanical and clinical effects. History, development, equipment, modes of application, biomechanics, spinal traction forces and elongations, indications and contraindications of WHT are precented.Subjects and methods: The calculation of traction forces acting along the spinal column during the treatment is described together with the mode of suspension and the position of extra weight loads applied. The biomechanics of the treatment are completed by in vivo measured elongations of lumbar segments using a special underwater ultrasound measuring method. The clinical effects, indications, and contraindications of the treatment are also presented.Results: In the underwater cervical suspension of a human body, approximately 25 N stretching load occurs in the cervical spine, and about 11 N occurs in the lumbar spine. By applying extra weights, the above tensile forces along the spinal column can be increased. Thus, the traction effect can be controlled by applying such loads during the treatment. Elongations of segments L3–L4, L4–L5, and L5–S1 were measured during the usual WHT of patients suspended cervically in water for 20 minutes, loaded by 20–20 N lead weights on the ankles. The mean initial elastic elongations of spinal segments were about 0.8 mm for patients aged under 40 years, 0.5 mm between 40–60 years, and 0.2 mm for patients over 60 years. The mean

  13. Clinically lesser known entity in India: A Report of two cases of Melioidosis.

    Science.gov (United States)

    Barman, Purabi; Kaur, Ravneet; Kumar, Kamlesh

    2013-01-01

    Melioidosis is endemic in the South Asian regions, like Thailand, Singapore Malaysia and Australia. The disease is more pronounced in the southern part of the country. It is caused by Burkholderia pseudomallei which causes systemic involvement, morbidity and mortality associated with the disease is high. Due to highly varied clinical presentation, and low general awareness this infection is largely underdiagnosed and under reported in our country. Most laboratories in the country still rely on conventional culturing methods with their low sensitivity, adding to the under reporting. To enhance physician awareness we describe here two cases who presented to our institute after months of misdiagnosis.

  14. Characterization of Change and Significance for Clinical Findings in Radiology Reports Through Natural Language Processing.

    Science.gov (United States)

    Hassanpour, Saeed; Bay, Graham; Langlotz, Curtis P

    2017-06-01

    We built a natural language processing (NLP) method to automatically extract clinical findings in radiology reports and characterize their level of change and significance according to a radiology-specific information model. We utilized a combination of machine learning and rule-based approaches for this purpose. Our method is unique in capturing different features and levels of abstractions at surface, entity, and discourse levels in text analysis. This combination has enabled us to recognize the underlying semantics of radiology report narratives for this task. We evaluated our method on radiology reports from four major healthcare organizations. Our evaluation showed the efficacy of our method in highlighting important changes (accuracy 99.2%, precision 96.3%, recall 93.5%, and F1 score 94.7%) and identifying significant observations (accuracy 75.8%, precision 75.2%, recall 75.7%, and F1 score 75.3%) to characterize radiology reports. This method can help clinicians quickly understand the key observations in radiology reports and facilitate clinical decision support, review prioritization, and disease surveillance.

  15. Documentation of functional and clinical effects of infant nutrition

    DEFF Research Database (Denmark)

    Koletzko, Berthold; Szajewska, Hania; Ashwell, Margaret

    2012-01-01

    The Early Nutrition Academy and the Child Health Foundation, in collaboration with the Committee on Nutrition, European Society for Paediatric Gastroenterology, Hepatology and Nutrition, held a workshop in March 2011 to explore guidance on acquiring evidence on the effects of nutritional interven......The Early Nutrition Academy and the Child Health Foundation, in collaboration with the Committee on Nutrition, European Society for Paediatric Gastroenterology, Hepatology and Nutrition, held a workshop in March 2011 to explore guidance on acquiring evidence on the effects of nutritional...... interventions in infants and young children. The four objectives were to (1) provide guidance on the quality and quantity of evidence needed to justify conclusions on functional and clinical effects of nutrition in infants and young children aged...

  16. Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.

    Science.gov (United States)

    Wehrlen, Leslie; Krumlauf, Mike; Ness, Elizabeth; Maloof, Damiana; Bevans, Margaret

    2016-05-01

    Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings. Published by Elsevier Inc.

  17. Prosthetic rehabilitation of edentulous patient with limited oral access: A clinical report

    Directory of Open Access Journals (Sweden)

    Sandeep Kumar

    2012-01-01

    Full Text Available Microstomia may result from surgical treatment of orofacial neoplasms, cleft lips, maxillofacial trauma, burns, radiotherapy or scleroderma. A maximal oral opening that is smaller than the size of a complete denture can make prosthetic treatment challenging. This clinical report presents the prosthodontic management of a total edentulous patient with microstomia. Sectional mandibular and maxillary trays and foldable mandibular and maxillary denture were fabricated for the total edentulous patient.

  18. A fiber-reinforced composite prosthesis restoring a lateral midfacial defect: a clinical report.

    Science.gov (United States)

    Kurunmäki, Hemmo; Kantola, Rosita; Hatamleh, Muhanad M; Watts, David C; Vallittu, Pekka K

    2008-11-01

    This clinical report describes the use of a glass fiber-reinforced composite (FRC) substructure to reinforce the silicone elastomer of a large facial prosthesis. The FRC substructure was shaped into a framework and embedded into the silicone elastomer to form a reinforced facial prosthesis. The prosthesis is designed to overcome the disadvantages associated with traditionally fabricated prostheses; namely, delamination of the silicone of the acrylic base, poor marginal adaptation over time, and poor simulation of facial expressions.

  19. A clinical case report of Hashimoto's thyroiditis and its impact on the treatment of chronic periodontitis.

    Science.gov (United States)

    Patil, B S; Giri, G R

    2012-01-01

    Periodontitis is a multifactorial disease with microbial dental plaque as the initiator of periodontal disease. However, the manifestation and progression of the disease is influenced by a wide variety of determinants and factors. The strongest type of causal relationship is the association of systemic and periodontal disease. Hashimoto's thyroiditis has also been considered as one of the causes of periodontal disease. This clinical case report highlights the impact of Hashimoto's thyroiditis on the outcome of periodontal therapy.

  20. Communicating clinical trial outcomes: Effects of presentation method on physicians' evaluations of new treatments

    Directory of Open Access Journals (Sweden)

    Francesco Marcatto

    2013-01-01

    Full Text Available Physicians expect a treatment to be more effective when its clinical outcomes are described as relative rather than as absolute risk reductions. We examined whether effects of presentation method (relative vs. absolute risk reduction remain when physicians are provided the baseline risk information, a vital piece of statistical information omitted in previous studies. Using a between-subjects design, ninety five physicians were presented the risk reduction associated with a fictitious treatment for hypertension either as an absolute risk reduction or as a relative risk reduction, with or without including baseline risk information. Physicians reported that the treatment would be more effective and that they would be more willing to prescribe it when its risk reduction was presented to them in relative rather than in absolute terms. The relative risk reduction was perceived as more effective than absolute risk reduction even when the baseline risk information was explicitly reported. We recommend that information about absolute risk reduction be made available to physicians in the reporting of clinical outcomes. Moreover, health professionals should be cognizant of the potential biasing effects of risk information presented in relative risk terms.

  1. Anti-N-Methyl-d-Aspartate receptor (NMDAR encephalitis during pregnancy: Clinical analysis of reported cases

    Directory of Open Access Journals (Sweden)

    Yan-Chao Shi

    2017-06-01

    Conclusions: Clinical analysis of the data indicates that most patients respond to first-line immunotherapy. A second-line immunotherapy is effective when first-line immunotherapy fails. It has also been found that most mothers and newborns can have good outcomes.

  2. Influence of the slice thickness in CT to clinical effect

    International Nuclear Information System (INIS)

    Kimura, Kazue; Katakura, Toshihiko; Ito, Masami; Okuaki, Okihisa; Suzuki, Kenji

    1980-01-01

    CT is a kind of tomography. Therefore, what thickness of tissue is being observed in the picture - this is important in the clinical application of CT. The influence of slice thickness on the pictures, especially its clinical effect, was examined. The apparatus used is EMI CT 5005. For varying the slice thickness, it cannot be any larger than the thickness essential to the apparatus. Therefore, to make it thinner than the essential 14 mm, collimators were specially prepared, which were used on the sides of an X-ray tube and a detector. As basic observation, the revelation ability of form owing to the difference of slice thickness using acryl pipes, and the revelation ability of slice face owing to the difference of slice thickness, were examined. About clinical observation, the results for certain cases of cancer were compared with the CT images for the slice thickness of 14 mm essential to EMI CT 5005 and the slice thickness of 7 mm achieved by means of the collimators. (J.P.N.)

  3. Clinical report of one case of intestinal form of acute radiation sickness

    International Nuclear Information System (INIS)

    Yu Changlin; Qiao Jianhui; Luo Weidong; Guo Mei; Wang Danhong; Sun Qiyun; Zhang Shi; Chen Jiankui; Li Xiaobing; Ai Huisheng

    2007-01-01

    Objective: To summarize the irradiation course, estimation of radiation dosage, clinical course, diagnosis and treatment of the patient A in a 60 Co radiation accident on October 21, 2004 in Jining, Shandong Province, China. Methods: According to the simulated test of the scene, chromosome aberration analysis, clinical course and tooth enamel ESR measurement, the total body dose of A was 20-25 Gy and diagnosed as intestinal form of acute radiation sickness. The patient was transferred to our hospital on day 3 post- irradiation, total environmental protection (TEP), antibiotics and emergency HLA-typing from his elder sister were given. On day 7 HLA haplo-identical peripheral blood stem cell transplantation was performed. Results: On day 10 post-transplant (+ 10 d), the counts of WBC began to increase and up to 5.1 x 10 9 /L on + 12 d. Bone marrow feature showed hematopoietic recovery of the three lineage blood cells. Continuous detection of the implantation ratio of donor's cells by STR-PCR showed stable 100% donor-derived chimera. On day 13, severe acute peritonitis and intestinal obstruction occurred; imipenem was much effective to control intestinal bacteria infection. Three days later, hematopoiesis reconstructed rapidly, peritonitis and intestinal obstruction were cured. On day 19, chest X-ray picture and CT scanning suggested that pulmonary mixed infection of bacteria and fungi appeared. The most severe skin irradiation burn damage occurred on day 25 which occupied the 14% of whole body skin surface. The functions of lung, heart and kidney were deteriorated sequentially. On day 30, tracheotomy had to be conducted and respirator was used. The patient died of multiple organ failure (MOF) on day 33. Conclusions: Patient A was exposed to relative well-distributed high dose and high dose rate of irradiation up to 20-25 Gy. This is the first case report of successful HLA haplo-identical peripheral blood stem cell transplantation for intestinal form of acute

  4. Generated effect modifiers (GEM's) in randomized clinical trials.

    Science.gov (United States)

    Petkova, Eva; Tarpey, Thaddeus; Su, Zhe; Ogden, R Todd

    2017-01-01

    In a randomized clinical trial (RCT), it is often of interest not only to estimate the effect of various treatments on the outcome, but also to determine whether any patient characteristic has a different relationship with the outcome, depending on treatment. In regression models for the outcome, if there is a non-zero interaction between treatment and a predictor, that predictor is called an "effect modifier". Identification of such effect modifiers is crucial as we move towards precision medicine, that is, optimizing individual treatment assignment based on patient measurements assessed when presenting for treatment. In most settings, there will be several baseline predictor variables that could potentially modify the treatment effects. This article proposes optimal methods of constructing a composite variable (defined as a linear combination of pre-treatment patient characteristics) in order to generate an effect modifier in an RCT setting. Several criteria are considered for generating effect modifiers and their performance is studied via simulations. An example from a RCT is provided for illustration. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  5. Generated effect modifiers (GEM’s) in randomized clinical trials

    Science.gov (United States)

    Petkova, Eva; Tarpey, Thaddeus; Su, Zhe; Ogden, R. Todd

    2017-01-01

    In a randomized clinical trial (RCT), it is often of interest not only to estimate the effect of various treatments on the outcome, but also to determine whether any patient characteristic has a different relationship with the outcome, depending on treatment. In regression models for the outcome, if there is a non-zero interaction between treatment and a predictor, that predictor is called an “effect modifier”. Identification of such effect modifiers is crucial as we move towards precision medicine, that is, optimizing individual treatment assignment based on patient measurements assessed when presenting for treatment. In most settings, there will be several baseline predictor variables that could potentially modify the treatment effects. This article proposes optimal methods of constructing a composite variable (defined as a linear combination of pre-treatment patient characteristics) in order to generate an effect modifier in an RCT setting. Several criteria are considered for generating effect modifiers and their performance is studied via simulations. An example from a RCT is provided for illustration. PMID:27465235

  6. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study.

    Science.gov (United States)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

    2014-06-04

    To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Clinical study reports obtained from the EMA in 2011. Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the listings of adverse events for individual patients and narratives

  7. 'Trial Exegesis': Methods for Synthesizing Clinical and Patient Reported Outcome (PRO Data in Trials to Inform Clinical Practice. A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Angus G K McNair

    Full Text Available The CONSORT extension for patient reported outcomes (PROs aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the 'take home' message for clinicians to use in practice.The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice.From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a "detailed", "general", or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30% and 6 (16% combined papers reported "detailed" PRO rationale and integrated interpretation of results although only 2 (14% and 1 (7% primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73% and 3 (20% achieving "detailed" rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2.It is recommended that single papers, with detailed PRO rationale and integrated PRO and

  8. Self-Reported Non-Celiac Wheat Sensitivity in High School Students: Demographic and Clinical Characteristics

    Directory of Open Access Journals (Sweden)

    Antonio Carroccio

    2017-07-01

    Full Text Available Background: Non-Celiac Wheat Sensitivity (NCWS has recently been included among the gluten-related disorders. As no biomarkers of this disease exist, its frequency has been estimated based on self-reported symptoms, but to date no data are available about self-reported NCWS in teenagers. Aim: To explore the prevalence of self-reported NCWS in a group of high school students and to study their demographic and clinical characteristics. Methods: The study was performed between April 2015 and January 2016 in two high schools of a coastal town in the south of Sicily (Italy. A total of 555 students (mean age 17 years, 191 male, 364 female completed a modified validated questionnaire for self-reported NCWS. The subjects who self-reported NCWS were then compared with all the others. Results: Seven individuals (1.26% had an established diagnosis of CD. The prevalence of self-reported NCWS was 12.2%, and 2.9% were following a gluten-free diet (GFD. Only 15 out of 68 (23% NCWS self-reporters had consulted a doctor for this problem and only nine (14% had undergone serological tests for celiac disease. The NCWS self-reporters very often had IBS symptoms (44%. Conclusions: Self-reported NCWS was found to be common in teenagers, with a frequency of 12.2%; the frequency of GFD use was 2.9%, which was much higher than the percentage of known CD in the same population (1.26%. A greater awareness of the possible implications on the part of the subjects involved, and a more thorough medical approach to the study of self-reported wheat-induced symptoms are required.

  9. Population-based open-label clinical effectiveness assessment of the cysteinyl leukotriene receptor antagonist pranlukast

    Directory of Open Access Journals (Sweden)

    Gen Tamura

    2000-01-01

    Full Text Available Although the efficacy of cysteinyl leukotriene receptor antagonists in asthma therapy has been established through controlled clinical trials, there are no data concerning the effectiveness of their use in clinical practice, in which there is no rigid selection based on specific inclusion and exclusion criteria. The aim of the present study was to evaluate the effectiveness of pranlukast in clinical practice. More than 2500 outpatients with mild to severe persistent asthma answered an input questionnaire, which consisted of 33 items assessing asthma symptoms in terms of six activities of daily living during the previous 2 weeks. Of these patients, 1138 received treatment with pranlukast and answered the same questionnaire 4–6 weeks after the start of treatment. In 923 of these 1138 patients, we examined the impact of concomitantly used inhaled steroids, β2-adrenergic agonists or sustained-release theophylline on the effectiveness of pranlukast treatment. One hundred and sixty-seven control patients completed the questionnaire twice but did not receive pranlukast treatment. We found a significant decrease in the number of asthma symptoms reported among both the 1138 patients treated with pranlukast and the 167 control patients. However, the magnitude of the decrease in symptoms was significantly (P < 0.001 greater with pranlukast treatment. Moreover, pranlukast was equally efficacious in the presence and absence of concomitantly used inhaled steroids, β2-adrenergic agonists or sustained-release theophylline. In conclusion, pranlukast was shown to have clinical effectiveness in the treatment of mild to severe persistent asthma symptoms.

  10. Resident's Morning Report: An Opportunity to Reinforce Principles of Biomedical Science in a Clinical Context

    Science.gov (United States)

    Brass, Eric P.

    2013-01-01

    The principles of biochemistry are core to understanding cellular and tissue function, as well as the pathophysiology of disease. However, the clinical utility of biochemical principles is often obscure to clinical trainees. Resident's Morning Report is a common teaching conference in which residents present clinical cases of interest to a…

  11. Effect of prehospital ultrasound on clinical outcomes of non-trauma patients

    DEFF Research Database (Denmark)

    Rudolph, Søren Steemann; Sørensen, Martin Kryspin; Svane, Christian

    2014-01-01

    BACKGROUND: Advances in technology have made prehospital ultrasound (US) examination available. Whether US in the prehospital setting can lead to improvement in clinical outcomes is yet unclear. OBJECTIVE: The aim of this systematic review was to assess whether prehospital US improves clinical...... studies for additional relevant studies. We then performed a risk of bias analysis and descriptive data analysis. RESULTS: We identified 1707 unique citations and included ten studies with a total of 1068 patients undergoing prehospital US examination. Included publications ranged from case series to non...... studies were of large heterogeneity and all showed a high risk of bias. We were thus unable to assess the effect of prehospital US on clinical outcomes. However, consistent reports suggested that US may improve patient management with respect to diagnosis, treatment, and hospital referral....

  12. Cardioprotective effects of cocoa: clinical evidence from randomized clinical intervention trials in humans.

    Science.gov (United States)

    Arranz, Sara; Valderas-Martinez, Palmira; Chiva-Blanch, Gemma; Casas, Rosa; Urpi-Sarda, Mireia; Lamuela-Raventos, Rosa M; Estruch, Ramon

    2013-06-01

    Cocoa is an important source of polyphenols, which comprise 12-18% of its total dry weight. The major phenolic compounds in cocoa and cocoa products are mainly flavonoids such as epicatechin, catechin, and proanthocyanidins. These products contain higher amounts of flavonoids than other polyphenol-rich foods. However, the bioavailability of these compounds depends on other food constituents and their interactions with the food matrix. Many epidemiological and clinical intervention trials have concluded that the ingestion of flavonoids reduces the risk factors of developing cardiovascular disease. This review summarizes the new findings regarding the effects of cocoa and chocolate consumption on cardiovascular risk factors. The mechanisms involved in the cardioprotective effects of cocoa flavonoids include reduction of oxidative stress, inhibition of low-density lipoproteins oxidation and platelet aggregation, vasodilatation of blood vessels, inhibition of the adherence of monocytes to vascular endothelium, promotion of fibrinolysis, and immunomodulatory and anti-inflammatory activity. Scientific evidence supports a cause and effect relationship between consumption of cocoa flavonoids and the maintenance of normal endothelium-dependent vasodilation, which contributes to normal blood flow. However, larger randomized trials are required to definitively establish the impact of cocoa and cocoa products consumption on hard cardiovascular outcomes. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  13. Correlation between self-reported and clinically based diagnoses of bruxism in temporomandibular disorders patients.

    Science.gov (United States)

    Paesani, D A; Lobbezoo, F; Gelos, C; Guarda-Nardini, L; Ahlberg, J; Manfredini, D

    2013-11-01

    The present investigation was performed in a population of patients with temporomandibular disorders (TMD), and it was designed to assess the correlation between self-reported questionnaire-based bruxism diagnosis and a diagnosis based on history taking plus clinical examination. One-hundred-fifty-nine patients with TMD underwent an assessment including a questionnaire investigating five bruxism-related items (i.e. sleep grinding, sleep grinding referral by bed partner, sleep clenching, awake clenching, awake grinding) and an interview (i.e. oral history taking with specific focus on bruxism habits) plus a clinical examination to evaluate bruxism signs and symptoms. The correlation between findings of the questionnaire, viz., patients' report, and findings of the interview/oral history taking plus clinical examination, viz., clinicians' diagnosis, was assessed by means of φ coefficient. The highest correlations were achieved for the sleep grinding referral item (φ = 0·932) and for the awake clenching item (φ = 0·811), whilst lower correlation values were found for the other items (φ values ranging from 0·363 to 0·641). The percentage of disagreement between the two diagnostic approaches ranged between 1·8% and 18·2%. Within the limits of the present investigation, it can be suggested that a strong positive correlation between a self-reported and a clinically based approach to bruxism diagnosis can be achieved as for awake clenching, whilst lower levels of correlation were detected for sleep-time activities. © 2013 John Wiley & Sons Ltd.

  14. Radiation effects on clinical examination data in Japanese radiological technologists

    International Nuclear Information System (INIS)

    Kondo, Hisayoshi; Okumura, Yutaka; Sugahara, Tsutomu; Aoyama, Takashi; Hashimoto, Tetsuaki; Yamamoto, Yoichi.

    1992-01-01

    Health survey for 1014 radiological technologists was undertaken in 10 districts in Japan. Estimated radiation doses were based on work duration, the status of radiation protection, X-ray equipments to be used, and exposure conditions. Two hundred and eighty-three technologists aged between 45 and 59 were enrolled in this study. Exposure doses ranged from 2 cGy to 337 cGy. According to exposure doses of either 40 cGy, smoking habits, and drinking habits, the subjects were classified into 7 groups. Clinical laboratory data, in addition to systolic and diastolic blood pressures, were analyzed. In comparing the sole effect of irradiation with that of smoking or drinking, the degree of irradiation effect was less than the other two factors. Smoking had a higher synergistic action than irradiation and drinking. (N.K.)

  15. The effects of aging on clinical vestibular evaluations

    Directory of Open Access Journals (Sweden)

    Maxime eMaheu

    2015-09-01

    Full Text Available Balance disorders are common issues for aging populations due to the effects of normal aging on peripheral vestibular structures. These changes affect the results of vestibular function evaluations and make the interpretation of these results more difficult. The objective of this article is to review the current state of knowledge of clinically relevant vestibular measures. We will first focus on otolith function assessment methods cVEMP and oVEMP, then the caloric and vHIT methods for semi-circular canals assessment. cVEMP and oVEMP are useful methods, though research on the effects of age for some parameters are still inconclusive. vHIT results are largely independent of age as compared to caloric stimulation and should therefore be preferred for the evaluation of the semi-circular canals function.

  16. Aloe vera: A review of toxicity and adverse clinical effects.

    Science.gov (United States)

    Guo, Xiaoqing; Mei, Nan

    2016-04-02

    The Aloe plant is employed as a dietary supplement in a variety of foods and as an ingredient in cosmetic products. The widespread human exposure and its potential toxic and carcinogenic activities raise safety concerns. Chemical analysis reveals that the Aloe plant contains various polysaccharides and phenolic chemicals, notably anthraquinones. Ingestion of Aloe preparations is associated with diarrhea, hypokalemia, pseudomelanosis coli, kidney failure, as well as phototoxicity and hypersensitive reactions. Recently, Aloe vera whole leaf extract showed clear evidence of carcinogenic activity in rats, and was classified by the International Agency for Research on Cancer as a possible human carcinogen (Group 2B). This review presents updated information on the toxicological effects, including the cytotoxicity, genotoxicity, carcinogenicity, and adverse clinical effects of Aloe vera whole leaf extract, gel, and latex.

  17. Effect, Feasibility, and Clinical Relevance of Cell Enrichment in Large Volume Fat Grafting

    DEFF Research Database (Denmark)

    Rasmussen, Bo Sonnich; Lykke Sørensen, Celine; Vester-Glowinski, Peter Viktor

    2017-01-01

    Large volume fat grafting is limited by unpredictable volume loss; therefore, methods of improving graft retention have been developed. Fat graft enrichment with either stromal vascular fraction (SVF) cells or adipose tissue-derived stem/stromal cells (ASCs) has been investigated in several animal...... and human studies, and significantly improved graft retention has been reported. Improvement of graft retention and the feasibility of these techniques are equally important in evaluating the clinical relevance of cell enrichment. We conducted a systematic search of PubMed to identify studies on fat graft...... enrichment that used either SVF cells or ASCs, and only studies reporting volume assessment were included. A total of 38 articles (15 human and 23 animal) were included to investigate the effects of cell enrichment on graft retention as well as the feasibility and clinical relevance of cell-enriched fat...

  18. Racial and ethnic variations in one-year clinical and patient-reported outcomes following breast reconstruction.

    Science.gov (United States)

    Berlin, Nicholas L; Momoh, Adeyiza O; Qi, Ji; Hamill, Jennifer B; Kim, Hyungjin M; Pusic, Andrea L; Wilkins, Edwin G

    2017-08-01

    Existing studies evaluating racial and ethnic disparities focus on describing differences in procedure type and the proportion of women who undergo reconstruction following mastectomy. This study seeks to examine racial and ethnic variations in clinical and patient-reported outcomes (PROs) following breast reconstruction. The Mastectomy Reconstruction Outcomes Consortium is an 11 center, prospective cohort study collecting clinical and PROs following autologous and implant-based breast reconstruction. Mixed-effects regression models, weighted to adjust for non-response, were performed to evaluate outcomes at one-year postoperatively. The cohort included 2703 women who underwent breast reconstruction. In multivariable models, Hispanic or Latina patients were less likely to experience any complications and major complications. Black or African-American women reported greater improvements in psychosocial and sexual well-being. Despite differences in pertinent clinical and socioeconomic variables, racial and ethnic minorities experienced equivalent or better outcomes. These findings provide reassurance in the context of numerous racial and ethnic health disparities and build upon our understanding of the delivery of surgical care to women with or at risk for developing breast cancer. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. Effectiveness of faculty training to enhance clinical evaluation of student competence in ethical reasoning and professionalism.

    Science.gov (United States)

    Christie, Carole; Bowen, Denise; Paarmann, Carlene

    2007-08-01

    This study evaluated the short- and long-term effectiveness of faculty training to enhance clinical evaluation of ethical reasoning and professionalism in a baccalaureate dental hygiene program. Ethics, values, and professionalism are best measured in contexts comparable to practice; therefore, authentic evaluation is desirable for assessing these areas of competence. Methods were the following: 1) a faculty development workshop implementing a core values-based clinical evaluation system for assessing students' professional judgment; 2) subsequent evaluation of the clinical faculty's use of core values for grading and providing written comments related to students' professional judgment during patient care for three academic years; and 3) evaluation of program outcomes assessments regarding clinical learning experiences related to ethics and professionalism domains. Results revealed the clinical faculty's evaluation of professional judgment during patient care was enhanced by training; written comments more frequently related to core values defined in the American Dental Hygienists' Association (ADHA) Code of Ethics; and faculty members reported more confidence and comfort evaluating professional judgment after implementation of this evaluation system and receiving training in its application. Students were more positive in outcomes assessments about their competency and learning experiences related to professionalism and ethics. This article shares one approach for enhancing clinical faculty's authentic evaluation of student competence in ethical reasoning and professionalism.

  20. [Clinical effect of clarithromycin therapy in patients with chronic rhinosinusitis].

    Science.gov (United States)

    Luo, Qing; Deng, Jie; Xu, Rui; Zuo, Kejun; Li, Huabin; Shi, Jianbo

    2014-02-01

    To evaluate the efficacy of clarithromycin (CAM) treatment in adult Chinese patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP) or without nasal polyps (CRSsNP). A prospective, open and self-controlled clinical trial on patients with CRS was conducted. Fifty patients met inclusion criteria. Of 50 patients, there were 33 patients with CRSsNP and 17 patients with CRSwNP. CAM was administered at 250 mg/d and the duration of administration was 12 weeks. Outcome measures included assessments of visual analogue scale (VAS), the sino-nasal outcome test-20(SNOT-20), the medical outcomes study short-form 36 items(SF-36), Lund-Kennedy endoscopy score, and Lund-Mackay computed tomography score. Before starting the treatment, 2 months after treatment and at the end of treatment, each patient had to complete all the measures except Lund-Mackay computed tomography score, which was only conducted before and after treatment. In order to evaluate the safety of CAM, liver function and renal function in all patients were detected before and after treatment. SPSS 16.0 software was used to analyze the data. Forty-five patients completed 3 months follow-up and 5 patients withdrew due to different reasons. The results were as follows: (1) Thirty-three patients with CRSsNP's VAS scores of four time point were 5.81 ± 1.69, 3.76 ± 1.94, 2.98 ± 1.95, 2.06 ± 2.13, respectively, there were statistically significant improvements in turn (t values were 5.910, 8.090, 8.932, all P 0.05). Endoscopy score of four time point were 10.65 ± 1.77, 9.35 ± 1.93, 8.65 ± 2.76, 8.47 ± 2.76, respectively, there were statistically significant improvements in turn(t values were 4.068, 4.863, 5.156, all P CAM treatment, 1 patient reported a tolerable headache and weakness and 1 patient had abdominal pain after two months treatment, all the symptoms disappeared while they were asked to stop the drug. Liver function and renal function were detected in 40 patients, the differences

  1. Evaluation of Cases Applying to Child and Adolescent Psychiatry Outpatient Clinic to Receive Medical Board Report

    Directory of Open Access Journals (Sweden)

    Sibelnur Avcil

    2017-11-01

    Full Text Available Objective: The aim of this study was to evaluate socio-demographic characteristics, application reasons and diagnoses of cases applying to child and adolescent psychiatry outpatient clinic in order to receive a medical board report. Materials and Methods: File data of 405 cases in the child and adolescent group (0-18 years, who applied to Child and Adolescent Psychiatry Outpatient clinics of Adnan Menderes University Faculty of Medicine between 1 November 2014 and 31 October 2015 in order to receive a medical board report, were retrospectively examined. Results: Average age of the cases was determined as 6.32±4.62 years, and 42.7% (173 were female and 57.3% (232 were male. When reasons of applications to medical board for the disabled were examined, it was found that the most frequent reason of application is to make them receive special education or to continue their special education at the rate of 66%; when diagnosis distribution of the cases was examined, the most frequent diagnoses included mild mental retardation (28.3%, borderline intellectual functioning (23.5%, attention-deficit/hyperactivity disorder (13.6%, and learning disorder (12.6%. Conclusion: In our study, it was determined that the most frequent diagnosis in children applying to receive a medical board report was mild mental retardation and the most frequent reason of application was to receive special education report. The studies to be conducted with relation to cases applying to medical board for the disabled will help in formation of healthy demographic data about pathologies in our field and in approaching clinically to such cases.

  2. Sildenafil (Viagra for male erectile dysfunction: a meta-analysis of clinical trial reports

    Directory of Open Access Journals (Sweden)

    McQuay HJ

    2002-05-01

    Full Text Available Abstract Background Evaluation of company clinical trial reports could provide information for meta-analysis at the commercial introduction of a new technology. Methods Clinical trial reports of sildenafil for erectile dysfunction from September 1997 were used for meta-analysis of randomised trials (at least four weeks duration and using fixed or dose optimisation regimens. The main outcome sought was an erection, sufficiently rigid for penetration, followed by successful intercourse, and conducted at home. Results Ten randomised controlled trials fulfilled the inclusion criteria (2123 men given sildenafil and 1131 placebo. NNT or NNH were calculated for important efficacy, adverse event and discontinuation outcomes. Dose optimisation led to at least 60% of attempts at sexual intercourse being successful in 49% of men, compared with 11% with placebo; the NNT was 2.7 (95% confidence interval 2.3 to 3.3. For global improvement in erections the NNT was 1.7 (1.6 to 1.9. Treatment-related adverse events occurred in 30% of men on dose optimised sildenafil compared with 11% on placebo; the NNH was 5.4 (4.3 to 7.3. All cause discontinuations were less frequent with sildenafil (10% than with placebo (20%. Sildenafil dose optimisation gave efficacy equivalent to the highest fixed doses, and adverse events equivalent to the lowest fixed doses. Conclusion This review of clinical trial reports available at the time of licensing agreed with later reviews that had many more trials and patients. Making reports submitted for marketing approval available publicly would provide better information when it was most needed, and would improve evidence-based introduction of new technologies.

  3. Improving clinical cognitive testing: report of the AAN Behavioral Neurology Section Workgroup.

    Science.gov (United States)

    Daffner, Kirk R; Gale, Seth A; Barrett, A M; Boeve, Bradley F; Chatterjee, Anjan; Coslett, H Branch; D'Esposito, Mark; Finney, Glen R; Gitelman, Darren R; Hart, John J; Lerner, Alan J; Meador, Kimford J; Pietras, Alison C; Voeller, Kytja S; Kaufer, Daniel I

    2015-09-08

    To evaluate the evidence basis of single-domain cognitive tests frequently used by behavioral neurologists in an effort to improve the quality of clinical cognitive assessment. Behavioral Neurology Section members of the American Academy of Neurology were surveyed about how they conduct clinical cognitive testing, with a particular focus on the Neurobehavioral Status Exam (NBSE). In contrast to general screening cognitive tests, an NBSE consists of tests of individual cognitive domains (e.g., memory or language) that provide a more comprehensive diagnostic assessment. Workgroups for each of 5 cognitive domains (attention, executive function, memory, language, and spatial cognition) conducted evidence-based reviews of frequently used tests. Reviews focused on suitability for office-based clinical practice, including test administration time, accessibility of normative data, disease populations studied, and availability in the public domain. Demographic and clinical practice data were obtained from 200 respondents who reported using a wide range of cognitive tests. Based on survey data and ancillary information, between 5 and 15 tests in each cognitive domain were reviewed. Within each domain, several tests are highlighted as being well-suited for an NBSE. We identified frequently used single-domain cognitive tests that are suitable for an NBSE to help make informed choices about clinical cognitive assessment. Some frequently used tests have limited normative data or have not been well-studied in common neurologic disorders. Utilizing standardized cognitive tests, particularly those with normative data based on the individual's age and educational level, can enhance the rigor and utility of clinical cognitive assessment. © 2015 American Academy of Neurology.

  4. Look local: the value of cancer surveillance and reporting by American Indian clinics.

    Science.gov (United States)

    Creswell, Paul D; Strickland, Rick; Stephenson, Laura; Pierce-Hudson, Kimmine; Matloub, Jacqueline; Waukau, Jerry; Adams, Alexandra; Kaur, Judith; Remington, Patrick L

    2013-11-27

    Cancer incidence and mortality rates for American Indians in the Northern Plains region of the United States are among the highest in the nation. Reliable cancer surveillance data are essential to help reduce this burden; however, racial data in state cancer registries are often misclassified, and cases are often underreported. We used a community-based participatory research approach to conduct a retrospective ascertainment of cancer cases in clinic medical records over a 9-year period (1995-2003) and compared the results with the state cancer registry to evaluate missing or racially misclassified cases. Six tribal and/or urban Indian clinics participated in the study. The project team consisted of participating clinics, a state cancer registry, a comprehensive cancer center, an American Indian/Alaska Native Leadership Initiative on Cancer, and a set of diverse organizational partners. Clinic personnel were trained by project staff to accurately identify cancer cases in clinic records. These records were then matched with the state cancer registry to assess misclassification and underreporting. Forty American Indian cases were identified that were either missing or misclassified in the state registry. Adding these cases to the registry increased the number of American Indian cases by 21.3% during the study period (P = .05). Our results indicate that direct reporting of cancer cases by tribal and urban Indian health clinics to a state cancer registry improved the quality of the data available for cancer surveillance. Higher-quality data can advance the efforts of cancer prevention and control stakeholders to address disparities in Native communities.

  5. Clinical effect of platelet rich fibrin in the treatment of periodontal intrabony defects. Systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Heber Arbildo.

    2017-05-01

    Full Text Available Background: There is currently no gold standard biomaterial for the treatment of periodontal intrabony defects (PIDs. One of the current options is the use of platelet-rich fibrin (PRF. Objective: To determine the clinical effect of PRF in the treatment of PID through a systematic review and meta-analysis. Materials and Methods: A literature search was conducted up to February 2017 in the following biomedical databases: Pubmed, Embase, Scielo, Science Direct, SIGLE, LILACS and in the Cochrane Central Register of Clinical Trials. The selection criteria included: randomized clinical trials published in the last 5 years, reporting clinical effects (probing depth, clinical insertion level or gingival recession, with a follow-up time equal to or greater than 6 months, and sample size larger than or equal to 10 patients reporting the use of PRF as a treatment for PID. The methodological quality of the studies was analyzed using the Cochrane Handbook of Systematic Reviews of Interventions as a reference. Results: The search strategy yielded 20 articles. A reduction in probing depth and an increase in clinical insertion level or a reduction in gingival recession is reported, when using PRF alone or in combination with another biomaterial or substance that stimulates tissue regeneration. Conclusion: The literature suggests that the use of PRF in the treatment of PIDs has a beneficial clinical effect when compared to control treatments.

  6. Pathological and Clinical Correlation between Celiac Disease and Helicobacter Pylori Infection; a Review of Controversial Reports.

    Science.gov (United States)

    Rostami-Nejad, Mohammad; Javad Ehsani-Ardakani, Mohammad; Assadzadeh, Hamid; Shahbazkhani, Bijan; Ierardi, Enzo; Losurdo, Giuseppe; Zojaji, Homayon; Alizadeh, Amirhoshang Mohammad; Naderi, Nosratollah; Sadeghi, Amir; Zali, Mohammad Reza

    2016-04-01

    There are overwhelming reports and descriptions about celiac associated disorders. Although there is a clear genetic association between celiac disease (CD) and some gastrointestinal disorders, there are controversial reports claiming an association between CD and Helicobacter pylori (H. pylori) infection. Different studies indicated the possible association between lymphocytic gastritis and both CD and H. pylori infection, although this evidence is not consistently accepted. Also it was shown that an increase in intraepithelial lymphocytes count is associated with both H. pylori infection and celiac disease. Therefore the following questions may raise: how far is this infection actually related to CD?, which are the underlying patho-mechanisms for these associations? what are the clinical implications? what is the management? and what would be the role of gluten free diet in treating these conditions? PubMed (PubMed Central), Ovid, ISI of web knowledge, and Google scholar were searched for full text articles published between 1985 and 2015. The associated keywords were used, and papers described particularly the impact of pathological and clinical correlation between CD and H. pylori infection were identified. In this review we tried to answer the above questions and discussed some of the recent developments in the pathological and clinical aspects of CD and H. pylori infection.

  7. The 7q11.23 Microduplication Syndrome: A Clinical Report with Review of Literature

    Science.gov (United States)

    Abbas, Elham; Cox, Devin M.; Smith, Teri; Butler, Merlin G.

    2016-01-01

    We report a 14-year-old adolescent girl with selective mutism (SM) and a 7q11.23 microduplication detected by chromosomal microarray (CMA) analysis and reviewed the literature from 18 published clinical reports. Our patient had specific phobias, SM, extreme anxiety, obesity, cutis marmorata, and a round appearing face with a short neck and over folded ears. We reviewed the published clinical, cognitive, behavioral, and cytogenetic findings grouped by speech and language delay, growth and development, craniofacial, clinical, and behavior and cognitive features due to the 7q11.23 microduplication. This microduplication syndrome is characterized by speech delay (91%), social anxiety (42%), attention deficit hyperactivity disorder (ADHD, 37%), autism spectrum disorder (29%), and separation anxiety (13%). Other findings include abnormal brain imaging (80%), congenital heart and vascular defects (54%), and mild intellectual disability (38%). We then compared the phenotype with Williams–Beuren syndrome (WBS) which is due to a deletion of the same chromosome region. Both syndromes have abnormal brain imaging, hypotonia, delayed motor development, joint laxity, mild intellectual disability, ADHD, autism, and poor visuospatial skills but opposite or dissimilar findings regarding speech and behavioral patterns, cardiovascular problems, and social interaction. Those with WBS are prone to have hyperverbal speech, lack of stranger anxiety, and supravalvular aortic stenosis while those with the 7q11.23 microduplication have speech delay, SM, social anxiety, and are prone to aortic dilatation. PMID:27617154

  8. Added Value of Patient-Reported Outcome Measures in Stroke Clinical Practice.

    Science.gov (United States)

    Katzan, Irene L; Thompson, Nicolas R; Lapin, Brittany; Uchino, Ken

    2017-07-21

    There is uncertainty regarding the clinical utility of the data obtained from patient-reported outcome measures (PROMs) for patient care. We evaluated the incremental information obtained by PROMs compared to the clinician-reported modified Rankin Scale (mRS). This was an observational study of 3283 ischemic stroke patients seen in a cerebrovascular clinic from September 14, 2012 to June 16, 2015 who completed the routinely collected PROMs: Stroke Impact Scale-16 (SIS-16), EQ-5D, Patient Health Questionnaire-9, PROMIS Physical Function, and PROMIS fatigue. The amount of variation in the PROMs explained by mRS was determined using r 2 after adjustment for age and level of stroke impairment. The proportion with meaningful change was calculated for patients with ≥2 visits. Concordance with change in the other scales and the ability to discriminate changes in health state as measured by c-statistic was evaluated for mRS versus SIS-16. Correlation between PROMs and mRS was highest for SIS-16 ( r =-0.64, P measures. PROMs provide additional valuable information compared to the mRS alone in stroke patients seen in the ambulatory setting. SIS-16 may have a better ability to identify change than mRS in health status of relevance to the patient. PROMs may be a useful addition to mRS in the assessment of health status in clinical practice. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  9. Idiopathic granulomatous lobular mastitis - report of 43 cases from iran; introducing a preliminary clinical practice guideline.

    Science.gov (United States)

    Omranipour, Ramesh; Mohammadi, S-Farzad; Samimi, Parisa

    2013-12-01

    We aimed to report a large series of idiopathic granulomatous lobular mastitis (IGLM) from Iran and sketch preliminary clinical practice guidelines (CPG) for approaching an inflammatory breast mass. In a retrospective records review, 43 consecutive IGLM cases were studied. Data on baseline, clinical, imaging, and pathologic characteristics were collected. The mean age of the women was 33.5 years. All but 1 were married and had given birth. 16% had a cancer-like presentation. Inflammatory signs, architectural distortion, and a nodular pattern were the most common findings clinically, mammographically and ultrasonographically, respectively. 29.5% of the pathological reports indicated necrosis which was more common in younger subjects (p = 0.016); microabscesses were associated with a shorter lactation course (p = 0.006). Corticosteroids had been used as the initial treatment modality in 51%, immunosuppressive agents had not been administered, and a 16% relapse rate was recorded. We recognized the need for a multidisciplinary approach covering radiology, oncology, and surgery to best handle diagnostic and therapeutic issues and manage relevant infections as well as the major differential diagnosis, i.e. malignancy. We hypothesized that a shorter lactation period may cause more milk stasis and extravasation and be contributory to IGLM. CPGs are needed to incorporate the needed multidisciplinary approach and to standardize IGLM care. We present one such guideline.

  10. MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

    Science.gov (United States)

    Staats, Peter S; Benyamin, Ramsin M

    2016-02-01

    Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each

  11. Cost-Effectiveness of a Clinical Childhood Obesity Intervention.

    Science.gov (United States)

    Sharifi, Mona; Franz, Calvin; Horan, Christine M; Giles, Catherine M; Long, Michael W; Ward, Zachary J; Resch, Stephen C; Marshall, Richard; Gortmaker, Steven L; Taveras, Elsie M

    2017-11-01

    To estimate the cost-effectiveness and population impact of the national implementation of the Study of Technology to Accelerate Research (STAR) intervention for childhood obesity. In the STAR cluster-randomized trial, 6- to 12-year-old children with obesity seen at pediatric practices with electronic health record (EHR)-based decision support for primary care providers and self-guided behavior-change support for parents had significantly smaller increases in BMI than children who received usual care. We used a microsimulation model of a national implementation of STAR from 2015 to 2025 among all pediatric primary care providers in the United States with fully functional EHRs to estimate cost, impact on obesity prevalence, and cost-effectiveness. The expected population reach of a 10-year national implementation is ∼2 million children, with intervention costs of $119 per child and $237 per BMI unit reduced. At 10 years, assuming maintenance of effect, the intervention is expected to avert 43 000 cases and 226 000 life-years with obesity at a net cost of $4085 per case and $774 per life-year with obesity averted. Limiting implementation to large practices and using higher estimates of EHR adoption improved both cost-effectiveness and reach, whereas decreasing the maintenance of the intervention's effect worsened the former. A childhood obesity intervention with electronic decision support for clinicians and self-guided behavior-change support for parents may be more cost-effective than previous clinical interventions. Effective and efficient interventions that target children with obesity are necessary and could work in synergy with population-level prevention strategies to accelerate progress in reducing obesity prevalence. Copyright © 2017 by the American Academy of Pediatrics.

  12. An official American thoracic society workshop report: developing performance measures from clinical practice guidelines.

    Science.gov (United States)

    Kahn, Jeremy M; Gould, Michael K; Krishnan, Jerry A; Wilson, Kevin C; Au, David H; Cooke, Colin R; Douglas, Ivor S; Feemster, Laura C; Mularski, Richard A; Slatore, Christopher G; Wiener, Renda Soylemez

    2014-05-01

    Many health care performance measures are either not based on high-quality clinical evidence or not tightly linked to patient-centered outcomes, limiting their usefulness in quality improvement. In this report we summarize the proceedings of an American Thoracic Society workshop convened to address this problem by reviewing current approaches to performance measure development and creating a framework for developing high-quality performance measures by basing them directly on recommendations from well-constructed clinical practice guidelines. Workshop participants concluded that ideally performance measures addressing care processes should be linked to clinical practice guidelines that explicitly rate the quality of evidence and the strength of recommendations, such as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process. Under this framework, process-based performance measures would only be developed from strong recommendations based on high- or moderate-quality evidence. This approach would help ensure that clinical processes specified in performance measures are both of clear benefit to patients and supported by strong evidence. Although this approach may result in fewer performance measures, it would substantially increase the likelihood that quality-improvement programs based on these measures actually improve patient care.

  13. Pragmatic characteristics of patient-reported outcome measures are important for use in clinical practice.

    Science.gov (United States)

    Kroenke, Kurt; Monahan, Patrick O; Kean, Jacob

    2015-09-01

    Measures for assessing patient-reported outcomes (PROs) that may have initially been developed for research are increasingly being recommended for use in clinical practice as well. Although psychometric rigor is essential, this article focuses on pragmatic characteristics of PROs that may enhance uptake into clinical practice. Three sources were drawn on in identifying pragmatic criteria for PROs: (1) selected literature review including recommendations by other expert groups; (2) key features of several model public domain PROs; and (3) the authors' experience in developing practical PROs. Eight characteristics of a practical PRO include: (1) actionability (i.e., scores guide diagnostic or therapeutic actions/decision making); (2) appropriateness for the relevant clinical setting; (3) universality (i.e., for screening, severity assessment, and monitoring across multiple conditions); (4) self-administration; (5) item features (number of items and bundling issues); (6) response options (option number and dimensions, uniform vs. varying options, time frame, intervals between options); (7) scoring (simplicity and interpretability); and (8) accessibility (nonproprietary, downloadable, available in different languages and for vulnerable groups, and incorporated into electronic health records). Balancing psychometric and pragmatic factors in the development of PROs is important for accelerating the incorporation of PROs into clinical practice. Published by Elsevier Inc.

  14. Case Report: Clinically amyopathic dermatomyositis presenting acutely with isolated facial edema [version 2; referees: 2 approved

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    Efthymia Pappa

    2018-03-01

    Full Text Available A 45-year-old Asian man presented with acute-onset periorbital and facial edema associated with pyrexia. Muscle weakness was absent. Initial laboratory investigations showed an inflammatory reaction, while screening for infections was negative. Serum muscle enzyme levels were normal. He was hospitalized and treated empirically with antibiotics and corticosteroids, pending the result of facial skin and muscle biopsy. He showed a good clinical and laboratory response but an attempt to discontinue corticosteroids led to a prompt relapse of facial edema and pyrexia, associated with rising laboratory indices of inflammation. Biopsy findings were typical of dermatomyositis. Reintroduction of corticosteroid treatment resulted in complete clinical and laboratory remission. Facial edema as the sole clinical manifestation of dermatomyositis is extremely rare. There have been no previous reports of isolated facial edema in the setting of acute, clinically amyopathic dermatomyositis in adults. A high level of suspicion is required to make the diagnosis in the absence of myopathy and the hallmark cutaneous manifestations of the disease (heliotrope rash, Gottron papules.

  15. Treatment of malignant gastric outlet obstruction with stents: An evaluation of the reported variables for clinical outcome

    Directory of Open Access Journals (Sweden)

    Medhus Asle W

    2009-06-01

    Full Text Available Abstract Background Malignant gastric outlet obstruction (GOO is commonly seen in patients with advanced gastric-, pancreatic-, duodenal, hepatobiliary or metastatic malignancies. Ten to 25% of patients with pancreatic cancer will develop duodenal obstruction during the course of the disease. Duodenal stenting with self-expandable metal stents is an alternative treatment to surgical bypass procedures. Our aim was to review the published literature regarding treatment of malignant GOO with stents to reveal whether the information provided is sufficient to evaluate the clinical effects of this treatment Methods A literature search from 2000 – 2007 was conducted in Pub Med, Embase, and Cochrane library, combining the following search terms: duodenal stent, malignant duodenal obstruction, gastric outlet obstruction, SEMS, and gastroenteroanastomosis. All publications presenting data with ≥ 15 patients and only articles written in English were included and a review focusing on the following parameters were conducted: 1 The use of graded scoring systems evaluating clinical success; 2 Assessment of Quality of life (QoL before and after treatment; 3 Information on stent-patency; 4 The use of objective criteria to evaluate the stent effect. Results 41 original papers in English were found; no RCT's. 16 out of 41 studies used some sort of graded scoring system. No studies had objectively evaluated QoL before or after stent treatment, using standardized QoL-questionnaires, 32/41 studies reported on stent patency and 9/41 performed an oral contrast examination after stent placement. Objective quantitative tests of gastric emptying had not been performed. Conclusion Available reports do not provide sufficient relevant information of the clinical outcome of duodenal stenting. In future studies, these relevant issues should be addressed to allow improved evaluation of the effect of stent treatment.

  16. Distribution of cow-calf producers' beliefs about reporting cattle with clinical signs of foot-and-mouth disease to a veterinarian before or during a hypothetical outbreak.

    Science.gov (United States)

    Delgado, Amy H; Norby, Bo; Scott, H Morgan; Dean, Wesley; McIntosh, W Alex; Bush, Eric

    2014-12-01

    Understanding the prevalence of cattle producers' beliefs regarding disease reporting can help officials improve surveillance programs with passive data collection. A cross-sectional survey was conducted in Texas in 2008 and 2009 to determine beliefs about reporting cattle with clinical signs consistent with foot-and-mouth disease (FMD) either prior to (scenario 1) or during an on-going outbreak of FMD (scenario 2). Two questionnaires were developed and distributed to Texas cow-calf producers in order to evaluate their behavioral, control, and normative beliefs related to disease reporting. The context for each behavior was provided through the use of scenarios, and belief strength was measured using a 7-point Likert-like scale. Beliefs were compared across scenarios and demographic categories, and the effect of scenario on belief examined using ordinal logistic regression. Respondents agreed that reporting clinically suspect cases would have positive economic and emotional consequences; however, when an outbreak was known to be present, producers were less likely to agree with many of the positive outcomes of reporting. Important barriers to disease reporting indicated by producers included a lack of knowledge related to clinical signs of highly contagious cattle diseases and which cattle are at risk of contracting FMD. In general, beliefs about barriers to reporting did not differ based on scenario. Veterinarians and regulatory authorities were the groups perceived to most strongly expect disease reporting, regardless of the scenario. Risk education for producers related to clinical signs of reportable livestock diseases, post-reporting procedures, and an understanding of FMD introduction and spread may improve the reporting of cattle with clinical signs consistent with FMD. Published by Elsevier B.V.

  17. Multi-morbidities of allergic rhinitis in adults: European Academy of Allergy and Clinical Immunology Task Force Report.

    Science.gov (United States)

    Cingi, C; Gevaert, P; Mösges, R; Rondon, C; Hox, V; Rudenko, M; Muluk, N B; Scadding, G; Manole, F; Hupin, C; Fokkens, W J; Akdis, C; Bachert, C; Demoly, P; Mullol, J; Muraro, A; Papadopoulos, N; Pawankar, R; Rombaux, P; Toskala, E; Kalogjera, L; Prokopakis, E; Hellings, P W; Bousquet, J

    2017-01-01

    This report has been prepared by the European Academy of Allergy and Clinical Immunology Task Force on Allergic Rhinitis (AR) comorbidities. The aim of this multidisciplinary European consensus document is to highlight the role of multimorbidities in the definition, classification, mechanisms, recommendations for diagnosis and treatment of AR, and to define the needs in this neglected area by a literature review. AR is a systemic allergic disease and is generally associated with numerous multi-morbid disorders, including asthma, eczema, food allergies, eosinophilic oesophagitis (EoE), conjunctivitis, chronic middle ear effusions, rhinosinusitis, adenoid hypertrophy, olfaction disorders, obstructive sleep apnea, disordered sleep and consequent behavioural and educational effects. This report provides up-to-date usable information to: (1) improve the knowledge and skills of allergists, so as to ultimately improve the overall quality of patient care; (2) to increase interest in this area; and (3) to present a unique contribution to the field of upper inflammatory disease.

  18. Management of bruxism-induced complications in removable partial denture wearers using specially designed dentures: a clinical report.

    Science.gov (United States)

    Baba, Kazuyoshi; Aridome, Kumiko; Pallegama, Ranjith Wasantha

    2008-01-01

    In patients with a limited number of remaining teeth, bruxism force can be destructive for both the remaining teeth and periodontal structures. This paper reports the successful management of four such patients with severe sleep bruxism, using conventional removable partial dentures and specially designed, splint-like removable partial dentures called a night denture. The night denture was fabricated in two different designs, which depended upon the pattern of the remaining tooth contacts. The patients were followed up for 2-6 years using a night denture in either of the two designs. Within the limitations of these four reports of clinical cases, the night denture appeared to be effective in managing the problems related to sleep bruxism.

  19. Use of quantification in cardiac reporting: How does it change the clinical result?

    International Nuclear Information System (INIS)

    Gnanasegaran, G.; Hilson, A.J.W.; Buscombe, J.R.

    2005-01-01

    Many gamma camera systems are now sold with cardiac quantification packages. These are said to increase the accuracy of reporting. However the use of such quantification packages may change the clinical report as read from the tomographic slices. The aim of this study was to quantify the differences between qualitative visual reporting and quantification. The stress and rest myocardial perfusion studies were quantitatively reported in 37 patients comprising 333 segments of the heart (9 segments/patient). A defect was defined by a reduction in activity of >50% in each of the segments. For the tomographic qualitative reporting the data was reconstructed using iterative reconstruction with a Wiener smoothing filter. Quantification used an Emory bull's eye system with gender and age matched normal controls. Number of abnormal segments noted by qualitative reading of data were 119 at stress and 79 at rest. For the bull's eye plot 98 abnormal segments were seen at stress and 76 at rest. Thirty-three segments (10%) were abnormal on the qualitative reading of data alone and 7 (2%) were abnormal on bull's eye alone. Of the 55 segments reported as ischaemic qualitative reading of data, 26 (48%) were normal on bull's eye, 13 of these in the right coronary artery (RCA) territory segments. Of the 67 segments reported on the qualitative reading of data as infarct, 10 (13%) were normal on bull's eye, 7 of these in the territory of the RCA segments. There are significant differences in the results of reporting scans using a bull's eye plot especially in identifying inferior wall ischaemia. Therefore before using such a quantification method a full assessment of the accuracy of each method should be performed. (author)

  20. A Real-Time Safety and Quality Reporting System: Assessment of Clinical Data and Staff Participation

    International Nuclear Information System (INIS)

    Rahn, Douglas A.; Kim, Gwe-Ya; Mundt, Arno J.; Pawlicki, Todd

    2014-01-01

    Purpose: To report on the use of an incident learning system in a radiation oncology clinic, along with a review of staff participation. Methods and Materials: On September 24, 2010, our department initiated an online real-time voluntary reporting system for safety issues, called the Radiation Oncology Quality Reporting System (ROQRS). We reviewed these reports from the program's inception through January 18, 2013 (2 years, 3 months, 25 days) to assess error reports (defined as both near-misses and incidents of inaccurate treatment). Results: During the study interval, there were 60,168 fractions of external beam radiation therapy and 955 brachytherapy procedures. There were 298 entries in the ROQRS system, among which 108 errors were reported. There were 31 patients with near-misses reported and 27 patients with incidents of inaccurate treatment reported. These incidents of inaccurate treatment occurred in 68 total treatment fractions (0.11% of treatments delivered during the study interval). None of these incidents of inaccurate treatment resulted in deviation from the prescription by 5% or more. A solution to the errors was documented in ROQRS in 65% of the cases. Errors occurred as repeated errors in 22% of the cases. A disproportionate number of the incidents of inaccurate treatment were due to improper patient setup at the linear accelerator (P<.001). Physician participation in ROQRS was nonexistent initially, but improved after an education program. Conclusions: Incident learning systems are a useful and practical means of improving safety and quality in patient care

  1. A Real-Time Safety and Quality Reporting System: Assessment of Clinical Data and Staff Participation

    Energy Technology Data Exchange (ETDEWEB)

    Rahn, Douglas A.; Kim, Gwe-Ya; Mundt, Arno J.; Pawlicki, Todd, E-mail: tpawlicki@ucsd.edu

    2014-12-01

    Purpose: To report on the use of an incident learning system in a radiation oncology clinic, along with a review of staff participation. Methods and Materials: On September 24, 2010, our department initiated an online real-time voluntary reporting system for safety issues, called the Radiation Oncology Quality Reporting System (ROQRS). We reviewed these reports from the program's inception through January 18, 2013 (2 years, 3 months, 25 days) to assess error reports (defined as both near-misses and incidents of inaccurate treatment). Results: During the study interval, there were 60,168 fractions of external beam radiation therapy and 955 brachytherapy procedures. There were 298 entries in the ROQRS system, among which 108 errors were reported. There were 31 patients with near-misses reported and 27 patients with incidents of inaccurate treatment reported. These incidents of inaccurate treatment occurred in 68 total treatment fractions (0.11% of treatments delivered during the study interval). None of these incidents of inaccurate treatment resulted in deviation from the prescription by 5% or more. A solution to the errors was documented in ROQRS in 65% of the cases. Errors occurred as repeated errors in 22% of the cases. A disproportionate number of the incidents of inaccurate treatment were due to improper patient setup at the linear accelerator (P<.001). Physician participation in ROQRS was nonexistent initially, but improved after an education program. Conclusions: Incident learning systems are a useful and practical means of improving safety and quality in patient care.

  2. Adolescent Idiopathic Scoliosis – case report of a patient with clinical deterioration after surgery

    Directory of Open Access Journals (Sweden)

    Weiss Hans-Rudolf

    2007-12-01

    Full Text Available Abstract Background Although there is no evidence that the long-term effects of scoliosis surgery are superior to the long-term effects of Adolescent Idiopathic Scoliosis (AIS itself, patients can fear the consequences of not under going this surgery due to incorrect or insufficient information. The main indication for surgical treatment in patients with AIS, is cosmetic. However spinal surgery may, along with other negative side effects, actually cause postoperative clinical deterioration. This complication of surgery has not yet been described in international literature. Case presentation A 15-year old female patient originally presenting with a well-compensated double curve pattern scoliosis. The patient was advised to undergo surgery due to the long-term negative impact of signs and symptoms of scoliosis upon her health. The patient agreed to surgery, which was performed in one of Germanys leading centres for spinal surgery. The thoracolumbar curve was corrected and fused, while the thoracic curve, clearly showing wedged vertebrae, defined as structural scoliosis, remained untreated. This operation left the patient with an unbalanced appearance, with radiological and clinical imbalance to the right. The clinical appearance of the patient though clearly deteriorated post-surgery. Furthermore, the wedged disc space below the fusion area indicates future problems with possible destabilisation accompanied probably by low back pain. Conclusion Scoliosis surgery for patients with AIS is mainly indicated for cosmetic or psychological reasons. Therefore the treatment leading to the best possible clinical appearance and balance has to be chosen. Patients should be informed that surgery will not necessarily improve their health status. Clinical deterioration after surgery may occur, and such information is crucial for an adequate informed consent.

  3. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop.

    Science.gov (United States)

    Jabs, Douglas A; Nussenblatt, Robert B; Rosenbaum, James T

    2005-09-01

    To begin a process of standardizing the methods for reporting clinical data in the field of uveitis. Consensus workshop. Members of an international working group were surveyed about diagnostic terminology, inflammation grading schema, and outcome measures, and the results used to develop a series of proposals to better standardize the use of these entities. Small groups employed nominal group techniques to achieve consensus on several of these issues. The group affirmed that an anatomic classification of uveitis should be used as a framework for subsequent work on diagnostic criteria for specific uveitic syndromes, and that the classification of uveitis entities should be on the basis of the location of the inflammation and not on the presence of structural complications. Issues regarding the use of the terms "intermediate uveitis," "pars planitis," "panuveitis," and descriptors of the onset and course of the uveitis were addressed. The following were adopted: standardized grading schema for anterior chamber cells, anterior chamber flare, and for vitreous haze; standardized methods of recording structural complications of uveitis; standardized definitions of outcomes, including "inactive" inflammation, "improvement'; and "worsening" of the inflammation, and "corticosteroid sparing," and standardized guidelines for reporting visual acuity outcomes. A process of standardizing the approach to reporting clinical data in uveitis research has begun, and several terms have been standardized.

  4. Oral rehabilitation of a patient with amelogenesis imperfecta using removable overlay denture: a clinical report.

    Science.gov (United States)

    Ghodsi, S; Rasaeipour, S; Vojdani, M

    2012-03-01

    The aim of this study was oral rehabilitation of 17-year old patient with amelogenesis imperfecta using removable overlay denture in order to satisfy her esthetic and functional expectations and enhance her self-image. Amelogenesis imperfecta (AI) is a group of genetic disorders that primarily affect the quality and quantity of amelogenesis in both primary and permanent dentitions. The main clinical characteristics are severe attrition, tooth sensitivity and unesthetic appearance. This clinical report illustrates the oral rehabilitation of a 17-year-old girl with hypoplastic-hypomature type of AI with cobalt-chromium (Co-Cr) overlay removable partial denture (ORPD) that is one of the most economical and biocompatible replacements for noble metal and nickel-chromium (Ni-Cr) alloy. The presented case report suggests that Co-Cr ORPD can be a good temporary or even permanent treatment option for AI patients with limited budget, low esthetic concerns or medical limitations. There are major advantages in cast metal ORPDs; they are simpler, less traumatic and less expensive than fixed prosthetic options. This case report supports their use in patients with amelogenesis imperfecta.

  5. Radiographic and clinical aspects of endodonty of the central incisor, in maxilla: a case report

    International Nuclear Information System (INIS)

    Panella, J.; Freitas, A. de; Freitas, C. de

    1989-01-01

    The authors in the current report introduce a study of the present features when of agenesis of dental elements on the maxilla-mandibular complex. They relate a case of right upper central incisor's hypodontia, describing its clinical and radiographic appearances. Through a large revision of literature about this field, they found out that a disappearance of this element on the human dentition is rare, associating for this: genetic, familiar, nutrient, hormonal, infections and traumatic agents. Finally, they alert for the fact that an accurate clinical examination, complemented by a exact radiographic survey, will make possible a precocious diagnosis and execution of more efficient therapeutic manipulations that reduce the problems of functional, esthetic and phonetics order. (author)

  6. Synergism of clinical evaluation and penile sonographic imaging in diagnosis of penile fracture: a case report

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    Bello Jibril

    2012-09-01

    Full Text Available Abstract Introduction Penile fracture is an uncommon urologic emergency, and is the traumatic rupture of the tunica albuginea covering the corpus cavernosa. This usually occurs following blunt trauma sustained during coitus, masturbation or self-manipulations to hide or suppress an erection. Clinical diagnosis can often be easily made with typical history and examination findings. However, the patient may present atypically and/or with a suspicion of associated urethral injury. The roles of various diagnostic investigations are being evaluated in these situations. Case presentation We report the case of a 31-year-old African man with penile fracture and suspected associated urethral injury that occurred after self-manipulations to hide an erection. Conclusions Penile ultrasound and sonourethrography provide useful additional diagnostic information to supplement clinical history and physical examination findings and can be performed easily, at low cost and with no delays to surgery.

  7. Isolated persistent left superior vena cava: A case report and its clinical implications

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    Samarjit Bisoyi

    2017-01-01

    Full Text Available The venous anomaly of a persistent left superior vena cava (PLSVC affects 0.3%-0.5% of the general population. PLSVC with absent right superior vena cava, also termed as "isolated PLSVC," is an extremely rare venous anomaly. Almost half of the patients with isolated PLSVC have cardiac anomalies in the form of atrial septal defect, endocardial cushion defects, or tetralogy of Fallot. Isolated PLSVC is usually innocuous. Its discovery, however, has important clinical implications. It can pose clinical difficulties with central venous access, cardiothoracic surgeries, and pacemaker implantation. When it drains to the left atrium, it may create a right to left shunt. In this case report, we present the incidental finding of isolated PLSVC in a patient who underwent aortic valve replacement. Awareness about this condition and its variations is important to avoid complications.

  8. Reactive Retinal Astrocytic Tumor (Focal Nodular Gliosis): Report of the Clinical Spectrum of 3 Cases.

    Science.gov (United States)

    Singh, Arun D; Soto, Hansell; Bellerive, Claudine; Biscotti, Charles V

    2017-09-01

    To report 3 cases providing insight into clinical progression of reactive retinal astrocytic tumor. The clinical, imaging, and when available, the cytologic features of 3 cases of reactive retinal astrocytic tumor (focal nodular gliosis) were reviewed. A 6-year-old female, a 49-year-old man, and a 39-year-old man each developed a white retinal mass associated with laser photocoagulation, lattice degeneration, and treatment of a presumed vascular tumor, respectively. All tumors were white, circumscribed retinal masses that tended to be associated with exudation and either initially or eventually minimal vascularity. Reactive retinal astrocytic tumor can be observed in response to a degenerative, inflammatory, or ischemic retinal insult. Such tumors may progress after therapeutic intervention.

  9. Cauda equina syndrome as the initial presenting clinical feature of medulloblastoma: a case report

    Directory of Open Access Journals (Sweden)

    Al-Otaibi Faisal

    2012-05-01

    Full Text Available Abstract Introduction Medulloblastoma is one of the most common pediatric brain malignancies. The usual presenting clinical features are related to posterior fossa syndrome or/and hydrocephalus. Cauda equina syndrome is a very rare presentation for this disease. Case presentation We describe the case of a three-year-old boy with cauda equina syndrome as the initial presenting clinical feature for medulloblastoma. He was initially diagnosed as having a spinal tumor by magnetic resonance imaging scan. Subsequently, a cranial magnetic resonance imaging scan revealed a posterior fossa tumor with features of dissemination. He had substantial improvement after treatment. This case report is complemented by a literature review related to this unusual presentation. Conclusions Medulloblastoma primarily presenting with cauda equina syndrome is very rare. However, spinal drop metastasis should be considered in the pediatric age group to avoid suboptimal management.

  10. Between Clinic and Experiment: Wilder Penfield's Stimulation Reports and the Search for Mind, 1929-55.

    Science.gov (United States)

    Guenther, Katja

    In medicine, the realm of the clinic and the realm of experimentation often overlap and conflict, and physicians have to develop practices to negotiate their differences. The work of Canadian neurosurgeon Wilder Penfield (1891-1976) is a case in point. Engaging closely with the nearly 5,000 pages of unpublished and hitherto unconsidered reports of electrical cortical stimulation that Penfield compiled between 1929 and 1955, I trace how Penfield's interest shifted from the production of hospital-based records designed to help him navigate the brains of individual patients to the construction of universal brain maps to aid his search for an ever-elusive "mind." Reading the developments of Penfield's operation records over time, I examine the particular ways in which Penfield straddled the individual and the universal while attempting to align his clinical and scientific interests, thereby exposing his techniques to standardize and normalize his brain maps.

  11. The Coronary Artery Disease-Reporting and Data System (CAD-RADS): Prognostic and Clinical Implications Associated With Standardized Coronary Computed Tomography Angiography Reporting.

    Science.gov (United States)

    Xie, Joe X; Cury, Ricardo C; Leipsic, Jonathon; Crim, Matthew T; Berman, Daniel S; Gransar, Heidi; Budoff, Matthew J; Achenbach, Stephan; Ó Hartaigh, Bríain; Callister, Tracy Q; Marques, Hugo; Rubinshtein, Ronen; Al-Mallah, Mouaz H; Andreini, Daniele; Pontone, Gianluca; Cademartiri, Filippo; Maffei, Erica; Chinnaiyan, Kavitha; Raff, Gilbert; Hadamitzky, Martin; Hausleiter, Joerg; Feuchtner, Gudrun; Dunning, Allison; DeLago, Augustin; Kim, Yong-Jin; Kaufmann, Philipp A; Villines, Todd C; Chow, Benjamin J W; Hindoyan, Niree; Gomez, Millie; Lin, Fay Y; Jones, Erica; Min, James K; Shaw, Leslee J

    2018-01-01

    This study sought to assess clinical outcomes associated with the novel Coronary Artery Disease-Reporting and Data System (CAD-RADS) scores used to standardize coronary computed tomography angiography (CTA) reporting and their potential utility in guiding post-coronary CTA care. Clinical decision support is a major focus of health care policies aimed at improving guideline-directed care. Recently, CAD-RADS was developed to standardize coronary CTA reporting and includes clinical recommendations to facilitate patient management after coronary CTA. In the multinational CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) registry, 5,039 patients without known coronary artery disease (CAD) underwent coronary CTA and were stratified by CAD-RADS scores, which rank CAD stenosis severity as 0 (0%), 1 (1% to 24%), 2 (25% to 49%), 3 (50% to 69%), 4A (70% to 99% in 1 to 2 vessels), 4B (70% to 99% in 3 vessels or ≥50% left main), or 5 (100%). Kaplan-Meier and multivariable Cox models were used to estimate all-cause mortality or myocardial infarction (MI). Receiver-operating characteristic (ROC) curves were used to compare CAD-RADS to the Duke CAD Index and traditional CAD classification. Referrals to invasive coronary angiography (ICA) after coronary CTA were also assessed. Cumulative 5-year event-free survival ranged from 95.2% to 69.3% for CAD-RADS 0 to 5 (p data, 57% of CAD-RADS 3 patients who received 30-day ICA were either asymptomatic or not receiving antianginal therapy at baseline, whereas only 32% had angina and were receiving medical therapy. CAD-RADS effectively identified patients at risk for adverse events. Frequent ICA use was observed among patients without severe CAD, many of whom were asymptomatic or not taking antianginal drugs. Incorporating CAD-RADS into coronary CTA reports may provide a novel opportunity to promote evidence-based care post-coronary CTA. Copyright © 2018 American College of Cardiology

  12. Confidence Intervals for Effect Sizes: Compliance and Clinical Significance in the "Journal of Consulting and Clinical Psychology"

    Science.gov (United States)

    Odgaard, Eric C.; Fowler, Robert L.

    2010-01-01

    Objective: In 2005, the "Journal of Consulting and Clinical Psychology" ("JCCP") became the first American Psychological Association (APA) journal to require statistical measures of clinical significance, plus effect sizes (ESs) and associated confidence intervals (CIs), for primary outcomes (La Greca, 2005). As this represents the single largest…

  13. Case Reports, Case Series - From Clinical Practice to Evidence-Based Medicine in Graduate Medical Education.

    Science.gov (United States)

    Sayre, Jerry W; Toklu, Hale Z; Ye, Fan; Mazza, Joseph; Yale, Steven

    2017-08-07

    Case reports and case series or case study research are descriptive studies that are prepared for illustrating novel, unusual, or atypical features identified in patients in medical practice, and they potentially generate new research questions. They are empirical inquiries or investigations of a patient or a group of patients in a natural, real-world clinical setting. Case study research is a method that focuses on the contextual analysis of a number of events or conditions and their relationships. There is disagreement among physicians on the value of case studies in the medical literature, particularly for educators focused on teaching evidence-based medicine (EBM) for student learners in graduate medical education. Despite their limitations, case study research is a beneficial tool and learning experience in graduate medical education and among novice researchers. The preparation and presentation of case studies can help students and graduate medical education programs evaluate and apply the six American College of Graduate Medical Education (ACGME) competencies in the areas of medical knowledge, patient care, practice-based learning, professionalism, systems-based practice, and communication. A goal in graduate medical education should be to assist residents to expand their critical thinking, problem-solving, and decision-making skills. These attributes are required in the teaching and practice of EBM. In this aspect, case studies provide a platform for developing clinical skills and problem-based learning methods. Hence, graduate medical education programs should encourage, assist, and support residents in the publication of clinical case studies; and clinical teachers should encourage graduate students to publish case reports during their graduate medical education.

  14. The effect of clinical academic service contracts on surgeon satisfaction.

    Science.gov (United States)

    Clifton, Joanne; Bradley, Christine; Cadeliña, Rachel; Hsiang, York

    2007-06-01

    The purpose of this study was to determine the satisfaction of members of an academic department who are funded by a Clinical Academic Service Contract (CASC), compared with those who are not. We mailed a satisfaction questionnaire designed to examine surgeons' perceived effect of CASCs on their participation in their division or department and on professional activities (research, teaching, clinical) to members of the surgery department who perform operative interventions. We analyzed responses from CASC and non-CASC members, using t tests for continuous variables and chi-square tests for categorical variables. Four of 9 operative divisions (cardiac, thoracic, neurosurgery, pediatric surgery) are CASC-funded, and 5 are not (general, plastic, otolaryngology, urology, vascular). The response rate after 3 mailings was 59%. CASC responders agreed on the need for the following: improved focus and resolution of issues (p academic and administrative activities (p leisure time (p < 0.004). Responders disagreed that morale was low (p < 0.001). They were satisfied with the following: professional activities (p < 0.019), increased research activities (p < 0.001), quality of research (p < 0.001), more presentations (p < 0.025), increased teaching time (p < 0.004) and ability to care for their patients (p < 0.001). CASC responders were significantly more satisfied with their professional activities and more optimistic in their divisional roles than were non-CASC responders. Based on these results, all departmental members who perform operative interventions should consider being on a CASC.

  15. Improving the reporting of clinical trials of infertility treatments (IMPRINT): modifying the CONSORT statement†‡.

    Science.gov (United States)

    Legro, Richard S; Wu, Xiaoke; Barnhart, Kurt T; Farquhar, Cynthia; Fauser, Bart C J M; Mol, Ben

    2014-10-10

    Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and result in a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which create a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant ≥20 weeks gestations) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and during the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and

  16. Impact of the CONSORT Statement endorsement in the completeness of reporting of randomized clinical trials in restorative dentistry.

    Science.gov (United States)

    Sarkis-Onofre, Rafael; Poletto-Neto, Victório; Cenci, Maximiliano Sérgio; Pereira-Cenci, Tatiana; Moher, David

    2017-03-01

    The aim of this study was to assess if journal endorsement of the CONSORT Statement is associated with improved completeness of reporting of randomized controlled trials (RCTs) in restorative dentistry. RCTs in restorative dentistry published in two journals that have (Journal of Dentistry and Clinical Oral Investigations) and have not (Operative Dentistry and Journal of Prosthetic Dentistry) endorsed the CONSORT Statement were selected. We compared the completeness of reporting between comparison groups (endorsers versus non-endorsers, before versus after endorsement) using a risk ratio (RR) with a 99% confidence interval for each outcome of CONSORT 2010. Also, the risk of bias of each study was evaluated. The electronic search retrieved a total of 3701 records. After the title and abstract evaluation, 169 full texts were screened and 79 RCTs identified. Considering CONSORT-endorsing journals before and after CONSORT endorsement, six items had effect estimates indicating a relatively higher proportion of completely reported RCTs published after CONSORT endorsement. Considering CONSORT-endorsing journals compared to non-endorsing journals, twelve items indicated a relatively higher proportion of completely reported RCTs published in CONSORT-endorsing journals. In both analyses the overall evidence did not present statistical significance. Although CONSORT endorsement has been linked with some improvement in the completeness of RCTs reports in the biomedical literature, this was not reflected in the present analysis confined to restorative dentistry. More innovative and involved approaches to enhancing reported may therefore be required. Inadequate reporting of randomized controlled trials can produce important consequences for all stakeholders including waste of resources and implication on healthcare decisions. A broad understandment of the use of reporting guidelines is necessary to lead to better results. Copyright © 2017 Elsevier Ltd. All rights reserved.

  17. Diclofenac Potassium in Acute Postoperative Pain and Dysmenorrhoea: Results from Comprehensive Clinical Trial Reports

    Directory of Open Access Journals (Sweden)

    R. Andrew Moore

    2018-01-01

    Full Text Available We compared the efficacy of diclofenac potassium in unpublished clinical study reports (CSRs and published reports to examine publication bias, industry bias, and comprehensiveness. Novartis provided CSRs of randomised double-blind trials of diclofenac potassium involving postoperative patients following third molar extraction (3 trials, n=519, gynaecological surgery (3 trials, n=679, and dysmenorrhoea (2 trials, n=711 conducted in 1988–1990. Searches identified published reports of 6 trials. Information from 599/1909 patients was not published; trials with 846/1909 patients were published in a defunct journal. Greater methodological information in CSRs contributed to lesser risk of bias than published trials. Numbers needed to treat (NNT from CSRs for all six postoperative trials for at least 50% of maximum pain relief over 6 h were 2.2 (95% confidence interval, 1.9–2.6 and 2.1 (1.8–2.4 for 50 and 100 mg diclofenac potassium, respectively. A Cochrane review of published trial data reported NNTs of 2.1 and 1.9, and one comprehensive analysis reported NNTs of 2.2 and 2.1, respectively. All analyses had similar results for patients remedicating within 8 h. No data from dysmenorrhoea CSRs appeared in a Cochrane review. CSRs provide useful information and increase confidence. Stable efficacy estimates with standard study designs reduce the need for updating reviews.

  18. Gender bias in clinical case reports: A cross-sectional study of the "big five" medical journals.

    Directory of Open Access Journals (Sweden)

    Pascale Allotey

    Full Text Available Gender bias in medical journals can affect the science and the benefit to patients. It has never been investigated in clinical case reports. The oversight is important because of the role clinical case reports play in hypothesis generation and medical education. We investigated contemporary gender bias in case reports for the highest ranked journals in general and internal medicine.PubMed case reports data from 2011 to 2016 were extracted for the Annals of Internal Medicine, British Medical Journal, the Journal of the American Medical Association, The Lancet, and New England Journal of Medicine. The gender of the patients were identified and a text analysis of the Medical Subject Headings conducted.A total of 2,742 case reports were downloaded and 2,582 (95.6% reports contributed to the final analysis. A pooled analysis showed a statistically significant gender bias against female case reports (0.45; 95%CI: 0.43-0.47. The Annals of Internal Medicine was the only journal with a point estimate (non significant in the direction of a bias against male patients. The text analysis identified no substantive difference in the focus of the case reports and no obvious explanation for the bias.Gender bias, previously identified in clinical research and in clinical authorship, extends into the patients presented in clinical case reports. Whether it is driven by authors or editors is not clear, but it likely contributes to and supports an overall male bias of clinical medicine.

  19. Clinical effect of Dilazep on ischemic heart disease

    International Nuclear Information System (INIS)

    Tsuda, Takashi; Hayashi, Senji; Shibata, Akira; Hama, Hitoshi; Mitani, Tohru.

    1982-01-01

    Dilazep tablets (300 mg/day) were administered to 9 patients with ischemic heart disease for more than 2 months. Stress myocardial scintigraphy was performed before and after the treatment to examine the clinical effect of this drug on the heart. The improvement rate of subjective symptoms was 57% (4/7 cases). No significant difference was observed in double product by the ergometer before and after the treatment, nor were any significant changes observed in ST by Master's two-step exercise test in any patient. The pre- to posttreatment improvement rate of myocardial uptake, demonstrated by stress myocardial scintigraphy, was 89% (8/9 cases). Thus, Dilazep tablets seemed to increase the blood flow in the ischemic area of the myocardium during exercise in ischemic heart disease. (Chiba, N.)

  20. A novel speech prosthesis for mandibular guidance therapy in hemimandibulectomy patient: A clinical report

    Directory of Open Access Journals (Sweden)

    Raghavendra Adaki

    2016-01-01

    Full Text Available Treating diverse maxillofacial patients poses a challenge to the maxillofacial prosthodontist. Rehabilitation of hemimandibulectomy patients must aim at restoring mastication and other functions such as intelligible speech, swallowing, and esthetics. Prosthetic methods such as palatal ramp and mandibular guiding flange reposition the deviated mandible. Such prosthesis can also be used to restore speech in case of patients with debilitating speech following surgical resection. This clinical report gives detail of a hemimandibulectomy patient provided with an interim removable dental speech prosthesis with composite resin flange for mandibular guidance therapy.

  1. [Ethical issues in a market dispute between clinical laboratories and a health plan: case report].

    Science.gov (United States)

    Pinheiro, Malone Santos; de Brito, Ana Maria Guedes; Jeraldo, Verônica de Lourdes Sierpe; Pinheiro, Kariny Souza

    2011-01-01

    In Brazil the private health plans appear as an alternative to the public health assistance. This segment suffered great intensification in the seventies and eighties, culminating in the entry of large insurance company in the scenario of supplementary medicine. Quickly, the service providers associated with these insurance companies, consolidating them in the market and triggering a relationship of dependency. This article analyzed, in the form of a case report, a marketing dispute between clinical laboratories and a health plan, emphasizing the moral and ethical aspects involved in this episode.

  2. [Clinical effect of atomoxetine hydrochloride in 66 children with narcolepsy].

    Science.gov (United States)

    Zhang, Shen; Ding, Changhong; Wu, Husheng; Fang, Fang; Wang, Xiaohui; Ren, Xiaotun

    2015-10-01

    To observe the efficacy and safety of atomoxetine hydrochloride in children with narcolepsy. Totally 66 patients with narcolepsy who were conformed international classification of sleep disturbances (ICSD-2) diagnostic criteria treated with atomoxetine hydrochloride seen from November 2010 to December 2014 were enrolled into this study, 42 of them were male and 24 female, mean age of onset was 7.5 years (3.75-13.00 years), mean duration before diagnosis was 1.75 years (0.25-5.00 years). Complete blood count, liver and kidney function, multiple sleep latency test (MSLT), polysomnography (PGS), neuroimaging and electroencephalography (EEG) were performed for each patient. For some of the children HLA-DR2 gene and serum markers of infection were tested. The 66 cases were followed up from 2 to 49 months (average 18 months) to observe the clinical efficacy and adverse reactions. In 62 cases excessive daytime sleepiness was improved, in 11 cases (16.7%) it was controlled (16.7%), in 29 cases (43.9%) the treatment was obviously effective and in 22 (33.3%) it was effective; cataplexy occurred in 54 cases, in 18 (33.3%) it was controlled, in 19 (35.2%) the treatment was obviously effective and in 10 (18.5%) effective; night sleep disorders existed in 55 cases, in 47 cases it was improved, in 14 (25.5%) it was controlled, in 20 (36.4%) the treatment was obviously effective and in 13 (23.6%) effective; hypnagogic or hypnopompic hallucination was present in 13 cases, in only 4 these symptoms were controlled. Sleep paralysis existed in 4 cases, it was controlled in only 1 case. In 18 cases attention and learning efficiency improved.Anorexia occurred in 18 cases, mood disorder in 5 cases, depression in 2 cases, nocturia, muscle tremors, involuntary tongue movement each occurred in 1 case. P-R interval prolongation and atrial premature contraction were found in 1 case. Atomoxetine hydrochloride showed good effects in patients with narcolepsy on excessive daytime sleepiness

  3. The effects of thermal stimulation on clinical and experimental itch.

    Science.gov (United States)

    Fruhstorfer, H; Hermanns, M; Latzke, L

    1986-02-01

    In order to substantiate accidental observations on the influence of skin temperature on itch, and to elucidate a possible involvement of thermoreceptors in itch generation, the effects of thermostimulation on clinical and experimental itch were studied. Eighteen patients with atopic dermatitis rated the intensity of spontaneous itch on one of their forearms before, during, and after its immersion in a waterbath of either 10 degrees C or 45 degrees C. In 40 normal subjects itch was elicited by histamine topically applied to a 7 cm2 skin area of the volar forearm. Before and after histamine application thermal thresholds were recorded. Then the skin area was heated or cooled at a rate of 0.5 degrees C/sec and itch intensity was continuously rated. Cooling abolished itch in all patients and in most of the normal subjects. Heating produced less clear effects: in two-thirds of both patients and normal subjects itch disappeared or was reduced whereas in the others itch was aggravated. Usually after the end of thermostimulation the opposite changes in itch intensity occurred. In the normal subjects thermal thresholds were not significantly influenced by histamine. Over a certain temperature range itch and thermal sensations could coexist as separate modalities. The results indicate that changes in skin temperature have a marked influence on itch intensity. Whereas cooling seems to act directly on the sensory receptors mediating itch, warm stimuli could have a central inhibitory effect. A direct role of thermoreceptors in the generation of itch is improbable.

  4. Reports of chronic pain in childhood and adolescence among patients at a tertiary care pain clinic.

    Science.gov (United States)

    Hassett, Afton L; Hilliard, Paul E; Goesling, Jenna; Clauw, Daniel J; Harte, Steven E; Brummett, Chad M

    2013-11-01

    Although chronic pain in childhood can last into adulthood, few studies have evaluated the characteristics of adults with chronic pain who report childhood chronic pain. Thus, 1,045 new patients (mean age, 49.5 ± 15.4) at an academic tertiary care pain clinic were prospectively evaluated using validated self-report questionnaires. Patients also responded to questions about childhood pain. We found that almost 17% (n = 176) of adult chronic pain patients reported a history of chronic pain in childhood or adolescence, with close to 80% indicating that the pain in childhood continues today. Adults reporting childhood chronic pain were predominantly female (68%), commonly reported widespread pain (85%), and had almost 3 times the odds of meeting survey criteria for fibromyalgia (odds ratio [OR] = 2.94, 95% confidence interval [CI] = 2.04-4.23) than those denying childhood chronic pain. Similarly, those with childhood pain had twice the odds of having biological relatives with chronic pain (OR = 2.03, 95% CI = 1.39-2.96) and almost 3 times the odds of having relatives with psychiatric illness (OR = 2.85, 95% CI = 1.97-4.11). Lastly, compared to patients who did not report childhood chronic pain, those who did were more likely to use neuropathic descriptors for their pain (OR = 1.82, 95% CI = 1.26-2.64), have slightly worse functional status (B = -2.12, t = -3.10, P = .002), and have increased anxiety (OR = 1.77, 95% CI = 1.24-2.52). Our study revealed that 1 in 6 adult pain patients reported pain that dated back to childhood or adolescence. In such patients, evidence suggested that their pain was more likely to be widespread, neuropathic in nature, and accompanied by psychological comorbidities and decreased functional status. Copyright © 2013 American Pain Society. Published by Elsevier Inc. All rights reserved.

  5. Quality of Reporting of Randomized Clinical Trials in Tai Chi Interventions—A Systematic Review

    Directory of Open Access Journals (Sweden)

    Jing-Yi Li

    2011-01-01

    Full Text Available Objectives. To evaluate the reporting quality of published randomized clinical trials (RCTs in the Tai Chi literature following the publication of the CONSORT guidelines in 2001. Data Sources. The OVID MEDLINE and PUBMED databases. Review Methods. To survey the general characteristics of Tai Chi RCTs in the literature, we included any report if (i it was an original report of the trial; (ii its design was RCT; (iii one of the treatments being tested was Tai Chi; and (iv it was in English. In addition, we assessed the reporting quality of RCTs that were published between 2002 and 2007, using a modified CONSORT checklist of 40 items. The adequate description of Tai Chi interventions in these trials was examined against a 10-item checklist adapted from previous reviews. Results. The search yielded 31 Tai Chi RCTs published from 2002 to 2007 and only 11 for 1992–2001. Among trials published during 2002–2007, the most adequately reported criteria were related to background, participant eligibility and interpretation of the study results. Nonetheless, the most poorly reported items were associated with randomization allocation concealment, implementation of randomization and the definitions of period of recruitment and follow-up. In addition, only 23% of RCTs provided adequate details of Tai Chi intervention used in the trials. Conclusion. The findings in this review indicated that the reporting quality of Tai Chi intervention trials is sub-optimal. Substantial improvement is required to meet the CONSORT guidelines and allow assessment of the quality of evidence. We believe that not only investigators, but also journal editors, reviewers and funding agencies need to follow the CONSORT guidelines to improve the standards of research and strengthen the evidence base for Tai Chi and for complementary and alternative medicine.

  6. Mobile physician reporting of clinically significant events-a novel way to improve handoff communication and supervision of resident on call activities.

    Science.gov (United States)

    Nabors, Christopher; Peterson, Stephen J; Aronow, Wilbert S; Sule, Sachin; Mumtaz, Arif; Shah, Tushar; Eskridge, Etta; Wold, Eric; Stallings, Gary W; Burak, Kathleen Kelly; Goldberg, Randy; Guo, Gary; Sekhri, Arunabh; Mathew, George; Khera, Sahil; Montoya, Jessica; Sharma, Mala; Paudel, Rajiv; Frishman, William H

    2014-12-01

    Reporting of clinically significant events represents an important mechanism by which patient safety problems may be identified and corrected. However, time pressure and cumbersome report entry procedures have discouraged the full participation of physicians. To improve the process, our internal medicine training program developed an easy-to-use mobile platform that combines the reporting process with patient sign-out. Between August 25, 2011, and January 25, 2012, our trainees entered clinically significant events into i-touch/i-phone/i-pad based devices functioning in wireless-synchrony with our desktop application. Events were collected into daily reports that were sent from the handoff system to program leaders and attending physicians to plan for rounds and to correct safety problems. Using the mobile module, residents entered 31 reportable events per month versus the 12 events per month that were reported via desktop during a previous 6-month study period. Advances in information technology now permit clinically significant events that take place during "off hours" to be identified and reported (via handoff) to next providers and to supervisors via collated reports. This information permits hospital leaders to correct safety issues quickly and effectively, while attending physicians are able to use information gleaned from the reports to optimize rounding plans and to provide additional oversight of trainee on call patient management decisions.

  7. Effectiveness of nurse-led clinics on service delivery and clinical outcomes in adults with chronic ear, nose and throat complaints: a systematic review.

    Science.gov (United States)

    Whiteford, Caroline; White, Sarahlouise; Stephenson, Matthew

    2016-04-01

    waiting times were shorter in nurse led clinics. The other service delivery outcomes were not addressed. Clinical and health outcomes findings were that lower pain/discomfort levels were demonstrated in nurse led clinics but other clinical/health outcomes were not addressed. Financial outcomes findings were that nurse-led clinics were cost effective when compared with medical-led clinics. While all studies reported evidence of the effectiveness of nurse-led clinics in service delivery and clinical outcomes in adults with chronic ear, nose and throat complaints, most of the data was self-reported and many of the outcomes of interest were not considered. The lack of experimental trials means that the level of evidence is low and further research is needed. There was also not enough detail in the financial outcomes from which clear conclusions of the cost benefit of nurse-led clinics could be drawn. Evidence from included studies indicated higher levels of patient satisfaction, cost benefits and lower levels of pain/discomfort in nurse-led clinics, which suggests that nurse-led ear, nose and throat clinics may be considered in the management of adult patients with ear, nose and throat complaints. Currently there is little evidence examining the effectiveness of nurse-led ear, nose and throat clinics. Areas to be addressed by future research should include: levels of patient education, booking queues, levels of self-treatment change in presentation to clinic episodes, reinfection rates, prevention and cure and representation of patients at clinics for same complaint.

  8. Primary tuberculous gingival enlargement - A rare clinical entity: Case report and brief review of the literature

    Directory of Open Access Journals (Sweden)

    Suhail Majid Jan

    2014-01-01

    Full Text Available Tuberculosis (TB is a chronic specific granulomatous disease and a major cause of death in developing countries. The clinical presentation of TB lesions of the oral cavity varies widely and can manifest as ulcerations, diffuse inflammatory lesions, granulomas and fissures. Oral lesions generally appear secondary to primary TB infection elsewhere, although primary infection of the oral mucosa by Mycobacterium tuberculosis has also been described. We hereby report a case of primary TB of the gingiva manifesting as gingival enlargement. Diagnosis was based on histopathological examination, complete blood count, X-ray chest and immunological investigations with detection of antibodies against M. tuberculosis. Anti-tuberculous therapy was carried out for over 6 months and was followed by surgical excision of the residual enlargement under local anesthesia. After 1-year follow-up, there was no recurrence of the disease. This case report emphasizes the need for dentists to include TB in the differential diagnosis of various types of gingival enlargements.

  9. 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...

  10. A trabecular metal implant 4 months after placement: clinical-histologic case report.

    Science.gov (United States)

    Spinato, Sergio; Zaffe, Davide; Felice, Pietro; Checchi, Luigi; Wang, Hom-Lay

    2014-02-01

    The aim of this case report was to histologically evaluate the behavior of a trabecular metal (TM) implant composed of titanium and spatial 3-dimensional tantalum (Ta) trabeculae. This study is the first human histologic case report of this implant. A TM implant was placed in a 54-year-old woman exhibiting moderate chronic periodontitis. After periodontal treatment, the implant was inserted under favorable clinical conditions. Patient was not seen for 4 months because of unrelated breast reduction surgery. At the surgical reopening, periimplant inflammation affecting the coronal third of the implant was observed 4 months after implant placement. With patient's consent, the implant was removed for histologic analysis. Histology highlighted a greater amount of bone in close contact with Ta trabeculae than titanium surfaces. The finding of bone formation around the Ta trabeculae suggests that trabecular metal material promotes bone ingrowth for secondary implant stability. Additional evidence is needed to confirm this observation.

  11. Effect, Feasibility, and Clinical Relevance of Cell Enrichment in Large Volume Fat Grafting: A Systematic Review.

    Science.gov (United States)

    Rasmussen, Bo Sonnich; Lykke Sørensen, Celine; Vester-Glowinski, Peter Viktor; Herly, Mikkel; Trojahn Kølle, Stig-Frederik; Fischer-Nielsen, Anne; Drzewiecki, Krzysztof Tadeusz

    2017-07-01

    Large volume fat grafting is limited by unpredictable volume loss; therefore, methods of improving graft retention have been developed. Fat graft enrichment with either stromal vascular fraction (SVF) cells or adipose tissue-derived stem/stromal cells (ASCs) has been investigated in several animal and human studies, and significantly improved graft retention has been reported. Improvement of graft retention and the feasibility of these techniques are equally important in evaluating the clinical relevance of cell enrichment. We conducted a systematic search of PubMed to identify studies on fat graft enrichment that used either SVF cells or ASCs, and only studies reporting volume assessment were included. A total of 38 articles (15 human and 23 animal) were included to investigate the effects of cell enrichment on graft retention as well as the feasibility and clinical relevance of cell-enriched fat grafting. Improvements in graft retention, the SVF to fat (SVF:fat) ratio, and the ASC concentration used for enrichment were emphasized. We proposed an increased retention rate greater than 1.5-fold relative to nonenriched grafts and a maximum SVF:fat ratio of 1:1 as the thresholds for clinical relevance and feasibility, respectively. Nine studies fulfilled these criteria, whereof 6 used ASCs for enrichment. We found no convincing evidence of a clinically relevant effect of SVF enrichment in humans. ASC enrichment has shown promising results in enhancing graft retention, but additional clinical trials are needed to substantiate this claim and also determine the optimal concentration of SVF cells/ASCs for enrichment. 4. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  12. Educational effects using a robot patient simulation system for development of clinical attitude.

    Science.gov (United States)

    Abe, S; Noguchi, N; Matsuka, Y; Shinohara, C; Kimura, T; Oka, K; Okura, K; Rodis, O M M; Kawano, F

    2017-11-01

    The aim of this study was to assess the effectiveness of improving the attitude of dental students towards the use of a full-body patient simulation system (SIMROID) compared to the traditional mannequin (CLINSIM) for dental clinical education. The participants were 10 male undergraduate dental students who had finished clinical training in the university hospital 1 year before this study started. They performed a crown preparation on an upper pre-molar tooth using SIMROID and CLINSIM as the practical clinical trials. The elapsed time for preparation was recorded. The taper of the abutment teeth was measured using a 3-dimensional shape-measuring device after this trial. In addition, a self-reported questionnaire was collected that included physical pain, treatment safety and maintaining a clean area for each simulator. Qualitative data analysis of a free format report about SIMROID was performed using text mining analysis. This trial was performed twice at 1-month intervals. The students considered physical pain, treatment safety and a clean area for SIMROID significantly better than that for CLINSIM (P mining analysis, most of the students wrote that SIMROID was similar to real patients. The use of SIMROID was proven to be effective in improving the attitude of students towards patients, thereby giving importance to considerations for actual patients during dental treatment. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  13. The effect of a preanaesthesia clinic consultation on adult patient ...

    African Journals Online (AJOL)

    reduce anxiety however current studies on anxiety and the preanaesthesia clinic have not quantified this reduction. Objective: ... Disadvantages of the preoperative clinic may include ad- ditional consultation costs and longer hospital waiting.

  14. Clinical effect of Fuzheng quyu therapy in patients undergoing ...

    African Journals Online (AJOL)

    Tropical Journal of Pharmaceutical Research January 2017; 16 (1): 219-224 ... cervical carcinoma surgery, thus suggesting its potential clinical applications. ..... surgery. However, further clinical investigations before it can be recommended for ...

  15. The effectiveness of educational supervisors from the viewpoints of nurse managers and clinical nurses

    Directory of Open Access Journals (Sweden)

    M Khodayarian

    2012-09-01

    Full Text Available Introduction: The educational supervisors should attempt to plan and implement nurses’ development programs according to the principles of educational process. The present study was conducted to assess the effectiveness of educational supervisors from the viewpoints of clinical nurses and nurse managers in 2007. Methods : 97 clinical nurses and 33 nurse managers in educational hospitals of Yazd participated in this cross sectional study. The questionnaire including 56 items related to expected professional competencies of educational supervisor was prepared and its validity and reliability was confirmed. Overall Cronbach’s alpha was 0.97 ranging from 0.77 to 0.96 for different dimensions which indicated internal consistency of the questionnaire. Results: The results showed 42.3% of nurses considered the function of their hospital as effective, 52.6% as ineffective, and 5.2% as relatively effective. One hundred percent of metrons considered the function of educational supervisors as effective. All the educational supervisors considered their function effective. The study samples reported that all the listed criteria were important in the effectiveness of educational supervisors’ function. Conclusion: In order to improve the effectiveness of educational supervisors’ function their management and leadership competencies should be developed. Competency-based approach is suggested in preparing educational supervisors for implementing the educational process from the problem solving skills. This will help nurse managers to make their work environments a learning and educational institute.

  16. Clinical effect of platelet rich plasma in the treatment of periodontal intrabony defects.Systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Heber Arbildo

    2017-04-01

    Full Text Available Introduction: One of the consequences of periodontitis is periodontal intrabony defects (PID. Various biomaterials have been used for its treatment, but there is still no biomaterial considered as the gold standard. Current research is focused on the use of platelet-rich plasma (PRP for the treatment of PID. Objective: To determine the clinical effect of PRP in the treatment of PID through a systematic review with meta-analysis. Materials and Methods: A literature search was conducted until February 2017 in the biomedical databases: Pubmed, Embase, Scielo, Science Direct, SIGLE, LILACS, IBECS, and the Cochrane Central Register of Clinical Trials. The criteria for the selection of the studies, which were randomized clinical trials, were the following: articles or papers published in the last 5 years, reporting clinical effects, with a follow-up time equal to or greater than 6 months, and a sample size equal to or greater than 10 patients reporting the use of PRP as a treatment for PID. The methodological quality of the studies was analyzed using the Cochrane Handbook of Systematic Reviews of Interventions as a reference. Results: The search strategy yielded nine articles reporting a reduction in probing depth and gingival recession, and an increase in clinical insertion level when using PRP alone or in combination with another biomaterial. Conclusion: The reviewed literature suggests that the use of PRP in the treatment of PID has a positive clinical effect.

  17. Effects of gonadal irradiation in clinical radiation therapy: a review

    International Nuclear Information System (INIS)

    Lushbaugh, C.C.; Casarett, G.W.

    1976-01-01

    Recent improvements in radiation therapy of some malignancies in lower abdominal sites are leading to prolongation of life in persons of child-bearing age. These successes require an evaluation of the possible undesirable consequences of the unavoidable gonadal irradiation that occurs in these cases. A review of radiobiological data from experimental animal studies and retrospective clinical studies suggests that in most instances human gonadal exposures in both sexes are insufficient to cause permanent sterility, because the exposures are fractionated and the total gonadal dose is much less than 600 rads. As a consequence, return of fertility must be anticipated, and the worrisome questions of radiation-induced genetic damage in subsequent pregnancies must be addressed. This review did not substantiate this fear, because no case reports could be found of malformed infants among the progency of previously irradiated parents. Some experimental studies suggest that radiation-damaged spermatogonia are self-destructive, but any evidence for this phenomenon in the ovary is nonexistent. We suggest that the difference between fact and theory here may be the mathematical result of the interplay of low probability for occurrences and the few patients who until now have survived long enough for study

  18. Characteristics of Patients Who Report Confusion After Reading Their Primary Care Clinic Notes Online.

    Science.gov (United States)

    Root, Joseph; Oster, Natalia V; Jackson, Sara L; Mejilla, Roanne; Walker, Jan; Elmore, Joann G

    2016-01-01

    Patient access to online electronic medical records (EMRs) is increasing and may offer benefits to patients. However, the inherent complexity of medicine may cause confusion. We elucidate characteristics and health behaviors of patients who report confusion after reading their doctors' notes online. We analyzed data from 4,528 patients in Boston, MA, central Pennsylvania, and Seattle, WA, who were granted online access to their primary care doctors' clinic notes and who viewed at least one note during the 1-year intervention. Three percent of patients reported confusion after reading their visit notes. These patients were more likely to be at least 70 years of age (p education (p reading visit notes (relative risk [RR] 4.83; confidence interval [CI] 3.17, 7.36) compared to patients who were not confused. In adjusted analyses, they were less likely to report feeling more in control of their health (RR 0.42; CI 0.25, 0.71), remembering their care plan (RR 0.26; CI 0.17, 0.42), and understanding their medical conditions (RR 0.32; CI 0.19, 0.54) as a result of reading their doctors' notes compared to patients who were not confused. Patients who were confused by reading their doctors' notes were less likely to report benefits in health behaviors. Understanding this small subset of patients is a critical step in reducing gaps in provider-patient communication and in efforts to tailor educational approaches for patients.

  19. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

    DEFF Research Database (Denmark)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff

    2016-01-01

    Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are anal......Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures...... are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient......-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes...

  20. Cutaneous epidermoid carcinoma (spinocellular carcinoma): clinical practice recommendations for diagnosis and therapy. Full report

    International Nuclear Information System (INIS)

    Martin, Ludovic; Bonerandi, Jean-Jacques; Brugneaux, Julie; Beauvillain, Claude; Chassagne, Jean-Francois; Clavere, Pierre; Grolleau, Jean-Louis; Grossin, Maggy; Sei, Jean-Francois; Caquant, Ludovic; Chaussade, Veronique; Desouches, Christophe; Garnier, Francois; Jourdain, Alain; Lemonnier, Jean-Yves; Maillard, Herve; Ortonne, Nicolas; Rio, Emmanuel; Simon, Etienne

    2009-01-01

    This guide aims at providing practitioners taking into care patients presenting a cutaneous cancer with recommendations based on scientific evidences or expert agreements. More precisely, the objectives are to clarify the terminology used to describe the different forms of cutaneous epidermoid carcinoma (CEC) and of their precursors (actinic keratosis, Bowen's disease), to propose a prognosis classification of CECs adapted to the previously identified prognosis factors, to optimise the diagnosis and therapy of actinic keratosis and Bowen's disease according to recent publications, and to recall the principles of a primary prevention of CECs and of their precursors, and of screening of high risk individuals. Thus, the different parts of this report address the following issues: anatomic-clinical forms and epidemiology of CECs and of their precursors, prognosis factors of CECs, means of treatment of CECs and of their precursors (medical, physical, surgical, radiation-based, and chemical treatments). Radiotherapy notably comprises external radiotherapy and interstitial brachytherapy. Indications for radiotherapy are discussed with respect to existing guides and to the clinical situation. The authors address the care of CECs and of their precursors (prevention, screening and clinical diagnosis, care of invasive CECs, keratoacanthoma treatment). They finally discuss quality criteria aimed at practice improvement, and perspectives regarding the evolution of this guide and studies to be performed

  1. Implant-supported titanium prostheses following augmentation procedures: a clinical report.

    Science.gov (United States)

    Knabe, C; Hoffmeister, B

    2003-03-01

    This report describes a novel technique for fabricating retrievable implant-supported titanium (Ti) prostheses in patients requiring a comprehensive treatment plan involving the combined efforts of maxillofacial surgery and implant prosthodontics. Following bone graft reconstructive surgery and implant placement prosthetic treatment was initiated by inserting ITI-Octa abutments. An impression was made, and a framework was fabricated by fusing Ti-cast frameworks to prefabricated titanium copings by laser-welding. This was followed by veneering or fabrication of a removable denture with Ti metal re-enforcement. Favourable clinical results have been achieved using these screw-retained Ti implant-supported restorations for patients treated with reconstructive bone graft-surgery, with clinical observation periods ranging from three to four years. The present observations suggest that these screw-retained implant-supported Ti prostheses may be a meaningful contribution to implant prosthodontics, facilitating retrievable restorations of optimum biocompatibility, good marginal precision and with a good esthetic result. However, controlled clinical studies are needed to establish the long-term serviceability of these Ti restorations.

  2. Undiagnosed tuberculosis as clinical, epidemiological and medicolegal problem: Report of two cases

    Directory of Open Access Journals (Sweden)

    Savić Slobodan

    2006-01-01

    Full Text Available The authors present two cases of undiagnosed tuberculosis in order to point out clinical, epidemiological and medicolegal importance of such cases. The first patient was a 29- year old woman, who died after 10-day hospital treatment, but true nature of her disease remained undiscovered. Due to her known marital problems, as well as numerous bruises developed as a consequence of hemorrhagic syndrome, violent death caused by injuries inflicted by her husband was suspected. Medicolegal autopsy and microscopic examination revealed fatal tuberculosis of the lungs, and small and large intestines. In another case, a 35-year old male died suddenly and unexpectedly, being found dead in his flat where numerous blood traces were noticed during the scene investigation. Therefore, possible homicide was suspected. Medicolegal investigation proved pulmonary tuberculosis as a cause of natural death. Presented cases point out the fact that even nowadays both pulmonary and extrapulmonary tuberculosis may remain clinically undiscovered, even when this disease is a cause of death. Hence, physicians should always keep in mind possible tuberculosis, especially in patients with long-lasting typical symptoms and signs. In both reported cases, the individuals suffered from cavernous pulmonary tuberculosis being thus a permanent source of infection. From medicolegal point of view, described cases represent examples of so called suspicious natural death. On the other hand, the fact that fatal tuberculosis remained clinically undiagnosed may make physicians be accused of medical negligence and malpractice.

  3. Patient- and Physician-reported Satisfaction With Systemic Lupus Erythematosus Treatment in US Clinical Practice.

    Science.gov (United States)

    Pascoe, Katie; Lobosco, Steve; Bell, David; Hoskin, Ben; Chang, David J; Pobiner, Bonnie; Ramachandran, Sulabha

    2017-09-01

    This two-part study comprised two descriptive, cross-sectional surveys to evaluate treatment satisfaction among patients with systemic lupus erythematosus (SLE) and their physicians from US clinical practices. The Lupus Plus Project (LPP; part one) involved belimumab-containing regimens; the Disease Specific Program (DSP; part two) included all treatments and was designed to build on the body of evidence from part one. The LPP recruited patients receiving belimumab, and comprised 2 paper questionnaires: a patient self-completion questionnaire (PSC) and a patient record form (PRF) completed by the physician. The DSP enrolled patients with SLE receiving any treatment and comprised four parts: a PSC, a PRF completed by the physician after patient consultation, face-to-face physician interviews, and a workload form completed by the physicians to indicate their total SLE patient workload. The key objective of this study was to assess physician and patient satisfaction with current treatment. From the PSCs, data regarding patient-reported satisfaction with current treatment were available for 263 patients who were receiving belimumab combination therapy (LPP) and 250 patients who were receiving non-belimumab treatment (DSP). The majority of patients (belimumab, 86.3% [227/263]; non-belimumab, 78.4% [196/250]) responded positively (at least "somewhat satisfied") when asked about current treatment satisfaction, as did physicians (belimumab, 82.9% [311/375]; non-belimumab, 74.3% [326/439]). In multivariate analysis, factors most strongly associated with patient-reported satisfaction for patients receiving belimumab were patient-reported improvements in leisure activities since taking belimumab (odds ratio [OR] = 4.66), physician-reported improvements in fatigue (OR = 3.72), patient-reported improvements in general symptoms (OR = 3.02), and pain/achiness (OR = 2.71). Physician satisfaction was associated with clinical outcome such as improvements in pain/achiness (OR = 6

  4. The effect of blinding on estimates of mortality in randomised clinical trials of intensive care interventions

    DEFF Research Database (Denmark)

    Anthon, Carl Thomas; Granholm, Anders; Perner, Anders

    2017-01-01

    INTRODUCTION: Evidence exists that unblinded randomised clinical trials (RCTs) overestimate intervention effects compared with blinded RCTs. It has been suggested that this is less pronounced for objective (ie, not subject to interpretation) outcome measures, including mortality. This may not apply......(s). For each intervention, we will compare summary mortality effect estimates in blinded versus unblinded trials. ETHICS AND DISSEMINATION: This research does not require ethical approval as we will use summary data from trials already approved by relevant ethical institutions. We will report the results...... in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement and submit the final paper to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: PROSPERO, registration number: CRD42017056212....

  5. First clinical case report of Cytauxzoon sp. infection in a domestic cat in France.

    Science.gov (United States)

    Legroux, Jean-Pierre; Halos, Lénaïg; René-Martellet, Magalie; Servonnet, Marielle; Pingret, Jean-Luc; Bourdoiseau, Gilles; Baneth, Gad; Chabanne, Luc

    2017-03-29

    Feline cytauxzoonosis is an emerging infection caused by tick-transmitted apicomplexan parasites of the genus Cytauxzoon. The association of clinical disease with Cytauxzoon infection appears to be limited to C. felis infections in the Americas. Sporadic infections of wild and domestic felids with Cytauxzoon sp. were recently described in European countries but clinical reports of the infection are rare and incomplete. This case report brings new interesting information on cytauxzoonosis expression in Europe. A 9-years-old castrated European shorthair cat living in rural area of north-eastern France (Saint Sauveur, Bourgogne-Franche-Comté region), without any travel history was presented for consultation due to hyperthermia, anorexia, depression and prolonged fever that didn't respond to antibiotic therapy. The cat had outdoor access with a history of vagrancy and was adequately vaccinated (core vaccines and FeLV vaccine). During biological investigations, intraerythrocytic inclusions were observed on blood smear and were further investigated by PCR analysis and sequencing. Molecular analyses confirmed Cytauxzoon sp. infection. The cat was treated with a subcutaneous injection of imidocarb dipropionate (3.5 mg/kg). One week after treatment, the cat improved clinically, although parasitic inclusions within erythrocytes persisted, and only a mild lymphocytosis was found. Two weeks after treatment, the cat appeared in excellent health, appetite was normal and parasitemia was negative. However, one month after treatment the cat relapsed with hyperthermia, anorexia, and depression. Blood smears and PCR were once again positive. Subsequently, the cat received an additional dose of imidocarb dipropionate (3.5 mg/kg SC) and recovered rapidly without other clinical signs. Two weeks after the second imidocarb injection, the cat was hit by a car and died. This case provides the first clinical description of infection by Cytauxzoon sp. in a domestic cat in France. These

  6. Miniplate for osteosynthesis in a 9-year-old with symphysis fracture: clinical report.

    Science.gov (United States)

    Srinivasan, Ila; Kumar, Naveen; Jaganathan, Udhya; Bhandari, Arihant

    2013-09-01

    Osteosynthesis using minimum material in pediatric mandibular fractures is the key, due to the limited space available in the mandible, especially in the mental foramen and apical region. There is an important role of open reduction and rigid internal fixation in re-establishing facial height, width and projection. During the early years of growth and development, there is a high osteogenic potential of the bones. The thick periosteum allows for rapid consolidation and remodeling at the site of fracture. Primary teeth have short, bulbous crowns which compromise stable maxillomandibular fixation during fracture reduction and stabilization using traditional methods. Further, stability of the fractured segments may be hampered because of the displaced or mobile permanent anterior teeth in the mixed dentition along the line of fracture. This clinical report outlines the use of miniplate with monocortical screws in a 9-year-old boy with symphysis fracture. How to cite this article: Srinivasan I, Kumar N, Jaganathan U, Bhandari A. Miniplate for Osteosynthesis in a 9-Year-Old with Symphysis Fracture: Clinical Report. Int J Clin Pediatr Dent 2013;6(3):213-216.

  7. Surgical Treatment of Peri-Implantitis: A 17-Year Follow-Up Clinical Case Report

    Directory of Open Access Journals (Sweden)

    Fabrizio Bassi

    2015-01-01

    Full Text Available The purpose of the present case report was to describe the surgical treatment of a peri-implantitis lesion associated with a regenerative approach. A 48-year-old patient came to authors’ attention 36 months after the placement of a dental implant (ITI-Bonefit Straumann, Waldenburg, Switzerland in position 46. A swelling of the peri-implant soft tissues was observed, associated with bleeding on probing and probing depth > 10 mm. A significant peri-implant bone loss was clearly visible on the periapical radiograph. A nonsurgical periodontal supportive therapy was firstly conducted to reduce the inflammation, followed by the surgical treatment of the defect. After mechanical and chemical decontamination with tetracycline solution, a regenerative approach consisting in the application of deproteinized bovine bone mineral (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland and a collagen membrane (Bio-Gide, Geistlich Pharma AG, Wolhusen, Switzerland was performed. An antibiotic therapy was associated with the treatment. The 17-year follow-up showed a physiological probing depth with no clinical signs of peri-implant inflammation and bleeding on probing. No further radiographic bone loss was observed. The treatment described in the present case report seemed to show improved clinical results up to a relevant follow-up period.

  8. Clinical features and endodontic treatment of two-rooted mandibular canines: Report of four cases

    Directory of Open Access Journals (Sweden)

    Stojanac Igor

    2014-01-01

    Full Text Available Introduction. Predictable endodontic treatment depends on the dentist’s knowledge about root canal morphology and its possible anatomic variations. The majority of mandibular canines have one root and root canal, but 15% may have two canals and a smaller number may have two distinct roots. The following clinical reports describe endodontic treatment of mandibular canines with two roots and two root canals. Outline of Cases. Four clinical case reports are presented to exemplify anatomical variation in the human mandibular canine. Detailed analysis of the preoperative radiographs and careful examination of the pulp chamber floor detected the presence of two root canal orifices in all canines. Working length was determined with an electronic apex locator and biomechanical preparation was carried out by using engine driven BioRaCe Ni-Ti rotary instruments in a crown-down manner, followed by copious irrigation with 1% sodium hypochlorite. Definitive obturation was performed using cold lateral condensation with gutta-percha cones and Top Seal paste. The treatment outcome was evaluated using postoperative radiographs. Conclusion. Endodontists should be aware of anatomical variations of the treated teeth, and should never presume that canal systems are simple. [Projekat Ministarstva nauke Republike Srbije, br. 174005: Viscoelasticity of fractional type and optimization of shape in rod theory

  9. Management of children and young people (CYP) with asthma: a clinical audit report.

    Science.gov (United States)

    Levy, Mark L; Ward, Angela; Nelson, Sara

    2018-05-21

    An asthma attack or exacerbation signals treatment failure. Most attacks are preventable and failure to recognize risk of asthma attacks are well recognized as risk factors for future attacks and even death. Of the 19 recommendations made by the United Kingdom National Review of Asthma Deaths (NRAD) (1) only one has been partially implemented-a National Asthma Audit; however, this hasn't reported yet. The Harrow Clinical Commissioning Group (CCG) in London implemented a clinical asthma audit on 291 children and young people aged under 19 years (CYP) who had been treated for asthma attacks in 2016. This was funded as a Local Incentive Scheme (LIS) aimed at improving quality health care delivery. Two years after the publication of the NRAD report it is surprising that risks for future attacks were not recognized, that few patients were assessed objectively during attacks and only 10% of attacks were followed up within 2 days. However, it is encouraging that CYP hospital admissions following the audit were reduced by 16%, with clear benefit for patients, their families and the local health economy. This audit has provided an example of how clinicians can focus learning on patients who have had asthma attacks and utilize these events as a catalyst for active reflection in particular on modifiable risk factors. Through identification of these risks and active optimization of management, preventable asthma attacks could become 'never events'.

  10. Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports.

    Science.gov (United States)

    Sharma, Tarang; Guski, Louise Schow; Freund, Nanna; Gøtzsche, Peter C

    2016-01-27

    To study serious harms associated with selective serotonin and serotonin-norepinephrine reuptake inhibitors.Design Systematic review and meta-analysis. Mortality and suicidality. Secondary outcomes were aggressive behaviour and akathisia. Clinical study reports for duloxetine, fluoxetine, paroxetine, sertraline, and venlafaxine obtained from the European and UK drug regulators, and summary trial reports for duloxetine and fluoxetine from Eli Lilly's website. Double blind placebo controlled trials that contained any patient narratives or individual patient listings of harms. Two researchers extracted data independently; the outcomes were meta-analysed by Peto's exact method (fixed effect model). We included 70 trials (64,381 pages of clinical study reports) with 18,526 patients. These trials had limitations in the study design and discrepancies in reporting, which may have led to serious under-reporting of harms. For example, some outcomes appeared only in individual patient listings in appendices, which we had for only 32 trials, and we did not have case report forms for any of the trials. Differences in mortality (all deaths were in adults, odds ratio 1.28, 95% confidence interval 0.40 to 4.06), suicidality (1.21, 0.84 to 1.74), and akathisia (2.04, 0.93 to 4.48) were not significant, whereas patients taking antidepressants displayed more aggressive behaviour (1.93, 1.26 to 2.95). For adults, the odds ratios were 0.81 (0.51 to 1.28) for suicidality, 1.09 (0.55 to 2.14) for aggression, and 2.00 (0.79 to 5.04) for akathisia. The corresponding values for children and adolescents were 2.39 (1.31 to 4.33), 2.79 (1.62 to 4.81), and 2.15 (0.48 to 9.65). In the summary trial reports on Eli Lilly's website, almost all deaths were noted, but all suicidal ideation events were missing, and the information on the remaining outcomes was incomplete. Because of the shortcomings identified and having only partial access to appendices with no access to case report forms, the harms

  11. Liver Effects of Clinical Drugs Differentiated in Human Liver Slices

    Directory of Open Access Journals (Sweden)

    Alison E. M. Vickers

    2017-03-01

    Full Text Available Drugs with clinical adverse effects are compared in an ex vivo 3-dimensional multi-cellular human liver slice model. Functional markers of oxidative stress and mitochondrial function, glutathione GSH and ATP levels, were affected by acetaminophen (APAP, 1 mM, diclofenac (DCF, 1 mM and etomoxir (ETM, 100 μM. Drugs targeting mitochondria more than GSH were dantrolene (DTL, 10 μM and cyclosporin A (CSA, 10 μM, while GSH was affected more than ATP by methimazole (MMI, 500 μM, terbinafine (TBF, 100 μM, and carbamazepine (CBZ 100 μM. Oxidative stress genes were affected by TBF (18%, CBZ, APAP, and ETM (12%–11%, and mitochondrial genes were altered by CBZ, APAP, MMI, and ETM (8%–6%. Apoptosis genes were affected by DCF (14%, while apoptosis plus necrosis were altered by APAP and ETM (15%. Activation of oxidative stress, mitochondrial energy, heat shock, ER stress, apoptosis, necrosis, DNA damage, immune and inflammation genes ranked CSA (75%, ETM (66%, DCF, TBF, MMI (61%–60%, APAP, CBZ (57%–56%, and DTL (48%. Gene changes in fatty acid metabolism, cholestasis, immune and inflammation were affected by DTL (51%, CBZ and ETM (44%–43%, APAP and DCF (40%–38%, MMI, TBF and CSA (37%–35%. This model advances multiple dosing in a human ex vivo model, plus functional markers and gene profile markers of drug induced human liver side-effects.

  12. Graves' disease: cost-effectiveness of clinical and radioiodine treatments

    International Nuclear Information System (INIS)

    Cruz junior, Antonio F.; Takahashi, Miriam H.; Albino, Claudio C.

    2005-01-01

    Full text: In this study, we set out to evaluate the costs and effectiveness of the two most used therapies in Graves' disease: antithyroid drugs (ATD) and radioiodine (RAI). Twenty-tree patients, 7 men and 16 women, with a mean age of 35.4 years, treated with ATD and 35 patients, 5 men and 30 women, mean age of 39.4 years, treated with RAI were studied. After 2 years receiving ATD, 21 patients achieved euthyroidism and 2 remained hyperthyroid. In the RAI group, 21 patients presented hypothyroidism and 13 became euthyroid. To calculate the costs of each therapy, we analysed the number of visits during this period, the laboratory data and the drugs needed, such as tiamazol and/or thyroxine. The group treated only with ATD needed a higher number of visits and laboratory measurements, with the mean total cost of U$ 791.65, while the RAI group spent a mean amount of U$ 366.44. Therefore, the costs of the RAI treatment were 53,7 % lower than clinical therapy with ATD. Conclusion: The present study demonstrates that RAI treatment has a lower cost than ATD, being very effective in controlling the hyperthyroidism of Graves' disease. (author)

  13. Critical value reporting: a survey of 36 clinical laboratories in South Africa.

    Science.gov (United States)

    Schapkaitz, Elise; Mafika, Zipho

    2013-10-11

    Critical value policies are used by clinical laboratories to decide when to notify caregivers of life-threatening results. Despite their widespread use, critical value policies have not been published locally. A survey was designed to determine critical value policies for haematology tests in South Africa. A survey was carried out on 136 identified laboratories across South Africa in January 2013. Of these, 36 responded. Data collected included critical value policies, critical values for haematology parameters, and critical value reporting. Of the 36 laboratories surveyed, 11.1% (n=4) were private, 33.3% (n=12) were affiliated to academic institutions and 55.6% (n=20) were peripheral or regional National Health Laboratory Service laboratories. All the laboratories confirmed that they had a critical value policy, and 83.3% of such policies were derived from local clinical opinion. Mean low and high critical limits for the most frequently listed tests were as follows: haemoglobin 20 g/dl, platelet count 1 000 ×10(9)/l, white cell count 46 ×10(9)/l, activated partial thromboplastin time >101 seconds, and international normalised ratio >6. In almost all cases critical value reporting was performed by the technologist on duty (97.2%). The majority of laboratories required that the person notified of the critical value be the doctor who ordered the test or the caregiver directly involved in the patient's care (83.3%); 73.3% of laboratories indicated that they followed an algorithm if the doctor/caregiver could not be reached. Each laboratory is responsible for establishing clinically relevant critical limits. Clinicians should be involved in developing the laboratory's critical value policy. The findings of this survey may be of value to local laboratories that are in the process of establishing or reviewing critical value policies.

  14. Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms

    Directory of Open Access Journals (Sweden)

    Ramakrishnan K

    2013-12-01

    Full Text Available Karthik Ramakrishnan,1 T Christopher Bond,1 Ami Claxton,1 Vipan C Sood,2 Maria Kootsikas,2 Wendy Agnese,2 Scott Sibbel11DaVita Clinical Research, Minneapolis, MN, USA; 2Mitsubishi Tanabe Pharma Corporation, Jersey City, NJ, USAAbstract: One of the most common conditions affecting end-stage renal disease (ESRD patients undergoing hemodialysis (HD is pruritus. Studies report that itchy and dry skin, symptoms of pruritus, affect 40%–90% of ESRD patients. Yet, in clinical practice the condition is often underdiagnosed resulting in inadequate management and an underappreciated impact on patient outcomes. Two retrospective analyses were conducted: a preliminary analysis of ESRD patients with pruritus symptoms (n=73,124 undergoing HD or peritoneal dialysis at a large dialysis provider and a subsequent detailed analysis of a homogenous subset of patients undergoing in-center HD (n=38,315. The goal was to better understand the clinical burden of pruritus as it relates to patient characteristics, quality of life, medication use, and HD compliance. This population is commonly burdened by multiple comorbidities and related polypharmaceutical management; identifying the relationship of pruritus to these ailments can help guide future research and resource allocation. The detailed analysis confirmed trends observed in the preliminary analysis: 30% reported being "moderately" to "extremely bothered" by itchiness. The HD patient population with the highest severity of self-reported pruritus also had a consistent trend in overall increased resource utilization – higher monthly doses of erythropoietin-stimulating agents (53,397.1 to 63,405.4 units and intravenous (IV iron (237.2 to 247.6 units and higher use of IV antibiotics (14.1% to 20.7%, as well as poorer quality-of-life measures (25-point reductions in Burden of Disease Score and Effects on Daily Life subscales of the Kidney Disease Quality of Life-36 survey. These results highlight the need to better

  15. Nocardia keratitis: clinical course and effect of corticosteroids.

    Science.gov (United States)

    Lalitha, Prajna; Srinivasan, Muthiah; Rajaraman, Revathi; Ravindran, Meenakshi; Mascarenhas, Jeena; Priya, Jeganathan Lakshmi; Sy, Aileen; Oldenburg, Catherine E; Ray, Kathryn J; Zegans, Michael E; McLeod, Stephen D; Lietman, Thomas M; Acharya, Nisha R

    2012-12-01

    To compare the clinical course of Nocardia species keratitis with keratitis resulting from other bacterial organisms and to assess the effect of corticosteroids as adjunctive therapy using data collected from the Steroids for Corneal Ulcers Trial. Subgroup analysis of a randomized controlled trial. setting: Multicenter randomized controlled trial. study population: Five hundred patients with bacterial keratitis randomized 1:1 to topical corticosteroid or placebo who had received at least 48 hours of topical moxifloxacin. intervention/observation procedure: Topical prednisolone phosphate 1% or placebo and clinical course of Nocardia keratitis. main outcome measures: Best spectacle-corrected visual acuity and infiltrate or scar size at 3 months from enrollment. Of 500 patients enrolled in the trial, 55 (11%) had a Nocardia corneal ulcer. Patients with Nocardia ulcers had better presentation visual acuity compared with non-Nocardia ulcers (median Snellen visual acuity, 20/45, compared with 20/145; P < .001) and comparable 3-month visual acuity (median, 20/25, vs 20/40; P = .25). Nocardia ulcers had approximately 2 lines less of improvement in visual acuity compared with non-Nocardia ulcers (0.21 logarithm of the minimal angle of resolution; 95% confidence interval, 0.09 to 0.33 logarithm of the minimal angle of resolution; P = .001). This difference may reflect the better starting visual acuity in patients with Nocardia ulcers. In Nocardia ulcers, corticosteroids were associated with an average 0.4-mm increase in 3-month infiltrate or scar size (95% confidence interval, 0.03 to 0.77 mm; P = .03). Nocardia ulcers responded well to treatment. They showed less overall improvement in visual acuity than non-Nocardia ulcers, but had better presentation acuity. Corticosteroids may be associated with worse outcomes. Copyright © 2012 Elsevier Inc. All rights reserved.

  16. [Clinical effectiveness and economical evaluation of preventive vaccination].

    Science.gov (United States)

    Vaz Carneiro, António; Belo, Ana Isabel; Gouveia, Miguel; Costa, João; Borges, Margarida

    2011-01-01

    The value of mass vaccination as a preventive measure for infectious diseases is one of the most important advances of modern Medicine. The impact on incidence of several infectious diseases, until recently responsible for significant morbidity and mortality at world level, is well proved in a series of high quality epidemiological studies. In this scientific review we aimed firstly to briefly resume the history of mass vaccination and its scientists, responsible for synthesis and marketing of these drugs. In second place we present a group of a few disease preventable by vaccines as well as the Portuguese National Vaccination Plan and its benefits. In third place we identified groups of subjects in which a well structured vaccination plan is particularly important, as well as the correspondent diseases to be covered by vaccination. Fourthly, we discussed the ethical considerations of vaccination, and its tensions between subject autonomy and society advantages in com pulsive programs. Fifthly, we analyzed clinical effectiveness of vaccines through the concept of herd immunity, clinical evaluation of immune response to vaccines and some examples of systematic reviews on three relevant diseases (influenza, meningococcal and pneumococcal infections). In sixth place we discussed vaccine safety presenting monitoring methods of vaccination risks, as well as discussing the public myths concerning vaccines. Finally we present a economic analysis of preventive vaccination with a review of some published literature on specific diseases. We conclude that mass vaccination is a efficacious preventive measure, as well as a economic rational choice, and that this public health intervention should be a pillar of a modern preventive system.

  17. The natural history of conducting and reporting clinical trials: interviews with trialists.

    Science.gov (United States)

    Smyth, Rebecca M D; Jacoby, Ann; Altman, Douglas G; Gamble, Carrol; Williamson, Paula R

    2015-01-26

    To investigate the nature of the research process as a whole, factors that might influence the way in which research is carried out, and how researchers ultimately report their findings. Semi-structured qualitative telephone interviews with authors of trials, identified from two sources: trials published since 2002 included in Cochrane systematic reviews selected for the ORBIT project; and trial reports randomly sampled from 14,758 indexed on PubMed over the 12-month period from August 2007 to July 2008. A total of 268 trials were identified for inclusion, 183 published since 2002 and included in the Cochrane systematic reviews selected for the ORBIT project and 85 randomly selected published trials indexed on PubMed. The response rate from researchers in the former group was 21% (38/183) and in the latter group was 25% (21/85). Overall, 59 trialists were interviewed from the two different sources. A number of major but related themes emerged regarding the conduct and reporting of trials: establishment of the research question; identification of outcome variables; use of and adherence to the study protocol; conduct of the research; reporting and publishing of findings. Our results reveal that, although a substantial proportion of trialists identify outcome variables based on their clinical experience and knowing experts in the field, there can be insufficient reference to previous research in the planning of a new trial. We have revealed problems with trial recruitment: not reaching the target sample size, over-estimation of recruitment potential and recruiting clinicians not being in equipoise. We found a wide variation in the completeness of protocols, in terms of detailing study rationale, outlining the proposed methods, trial organisation and ethical considerations. Our results confirm