Childhood adversity and social functioning in psychosis: Exploring clinical and cognitive mediators.

PubMed

Palmier-Claus, Jasper; Berry, Katherine; Darrell-Berry, Hannah; Emsley, Richard; Parker, Sophie; Drake, Richard; Bucci, Sandra

2016-04-30

Childhood adversity may increase risk of impaired social functioning across the continuum of psychosis. However, the pathways by which adversity dictates functional outcome remain underexplored. This study investigated the association between childhood adversity and social functioning, and the clinical and cognitive mediators of this relationship. Fifty-four clinical (20 chronic, 20 first episode, 14 at ultra-high risk) and 120 non-clinical participants completed standardised questionnaires, semi-structured interviews and tests of theory of mind ability. The authors used multiple group structural equation modelling to fit mediation models allowing for differential relationships between the clinical and non-clinical samples. When examining each pathway separately, depression, paranoia and anxious attachment mediated the effect of childhood adversity on social functioning. In a combined model, depression was the only significant mediating variable with greater adversity predicting lower mood across groups. Childhood adversity did not significantly predict theory of mind ability in any of the models. This is the first study to indicate that childhood adversity acts on social functioning by increasing levels of depression, suggesting a common mechanism across the spectrum of psychosis. Clinical interventions should target low mood in order to improve social functioning at all stages of psychotic disorder. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A systematic review of the evidence of reduced allergenicity and clinical benefit of food hydrolysates in dogs with cutaneous adverse food reactions.

PubMed

Olivry, Thierry; Bizikova, Petra

2010-02-01

Several hydrolysate-based diets have been commercialized for helping diagnose or treat dogs with cutaneous adverse food reactions (CAFR). This systematic review was performed to examine the evidence in favour of reduced immunological and clinical allergenicity of hydrolysates in dogs with CAFR. Citation databases, meeting abstracts and article bibliographies were scanned for relevant citations, and companies were contacted to provide unpublished reports. Eleven studies relevant to this study were identified. Some evidence of reduced serum IgE binding to a soy hydrolysate (1 study) and decreased intradermal test reactivity to hydrolysed proteins (three studies) was found. In four reports, the feeding of dogs suspected of having CAFR with hydrolysate-based diets reduced or eliminated clinical signs in a variable proportion of subjects. The percentage of dogs with CAFR that still reacted to these hydrolysate-based diets could not be assessed, however. Importantly, up to 50% of dogs with CAFR enrolled in three controlled studies exhibited increases in clinical signs after ingesting partial hydrolysates derived from foods to which they were hypersensitive. In conclusion, the limited number of studies undertaken point to reduced - but not eliminated - immunological and clinical allergenicity of hydrolysate-based commercial diets. A variable proportion of dogs with CAFR will exhibit a worsening of clinical signs when fed partial hydrolysates. Clinicians must weigh the clinical benefit of these diets versus their high cost and low risk of reduced appetence or gastrointestinal sign development. At this time, hydrolysate-containing diets are probably best used in dogs suspected not to be hypersensitive to their individual components.

Adverse Reactions to Field Vaccination Against Lumpy Skin Disease in Jordan.

PubMed

Abutarbush, S M; Hananeh, W M; Ramadan, W; Al Sheyab, O M; Alnajjar, A R; Al Zoubi, I G; Knowles, N J; Bachanek-Bankowska, K; Tuppurainen, E S M

2016-04-01

Lumpy skin disease (LSD) is an emerging disease in the Middle East region and has been recently reported in Jordan. The aim of this study was to investigate the adverse reactions that were reported after vaccine administration. Geographical areas enrolled in the study were free of the disease and away from the outbreak governorate. Sixty-three dairy cattle farms, with a total of 19,539 animals, were included in the study. Of those, 56 farms reported adverse clinical signs after vaccine administration. The duration between vaccine administration and appearance of adverse clinical signs ranged from 1 to 20 days (Mean = 10.3, SD ± 3.9). Clinical signs were similar to those observed with natural cases of lumpy skin disease. These were mainly fever, decreased feed intake, decreased milk production and variable sized cutaneous nodules (a few millimetres to around 2 cm in diameter) that could be seen anywhere on the body (head, neck, trunk, perineum), udder, and/or teats. Nodules were raised and firm initially and then formed dry scabs that could be peeled off the skin. The characteristic deep 'sit fast' appearance was rarely seen and most lesions were superficial. Some cattle had swollen lymph nodes, while a few pregnant animals aborted. The percentage of affected cattle ranged from 0.3 to 25% (Mean = 8, SD ± 5.1). Fever, decreased feed intake, and decreased milk production were seen in 83.9, 85.7, and 94.6% in cattle on the affected farms, respectively. All affected cattle displayed skin nodules over their entire bodies, while 33.9 and 7.1% of the affected farms reported nodular lesions present on the udders and teats, respectively. No mortalities were reported due to vaccine adverse reactions. Duration (course) of clinical signs ranged from 3 to 20 days (Mean = 13.7, SD ± 4.1). Two types of LSD vaccines were used by the farmers in this study. The first one was a sheep pox virus (SPPV) vaccine derived from the RM65 isolate [Jovivac, manufactured by Jordan

The reporting of clinical signs in laboratory animals: FELASA Working Group Report.

PubMed

Fentener van Vlissingen, J M; Borrens, M; Girod, A; Lelovas, P; Morrison, F; Torres, Y Saavedra

2015-10-01

Observing and reporting clinical signs in laboratory animals is necessary for many reasons: the assessment of animal welfare, compliance with the principle of refinement (e.g. humane endpoints), regulatory compliance (e.g. reporting severity) and, importantly, as a scientific outcome, e.g. in animal models of disease or safety studies. Developments in the reporting of clinical signs will enhance the scientific value gained from animal experiments and further address the ethical cost. This paper discusses systematic approaches to the observation and reporting of clinical signs in animals (to be) used for research. Glossaries from public and corporate institutions have been consulted and a reference glossary has been set up, providing terminology to be tailored for institutional or project-specific use. The clinical examination of animals must be carried out by competent and specifically trained staff in a systematic way and repeated at adequate intervals and clinical observations must be registered effectively to allow this information to be used. The development of institutional or project-specific glossaries and the use of handwritten records or automated databases are discussed in detail. Among the users are animal care staff, veterinarians and researchers who will need to agree on a given set of clinical signs to be monitored routinely or as a scientific read-out and to train for the proper application. The paper introduces a long list of clinical signs with scientific terminology, descriptions and explanations as a reference glossary to be published and maintained online as a living document supported by the authors as an editorial committee. © The Author(s) 2015.

Palliation of clinical signs in 48 dogs with nasal carcinomas treated with coarse-fraction radiation therapy.

PubMed

Gieger, Tracy; Rassnick, Kenneth; Siegel, Sheri; Proulx, David; Bergman, Philip; Anderson, Christine; LaDue, Tracy; Smith, Annette; Northrup, Nicole; Roberts, Royce

2008-01-01

Data from 48 dogs with nasal carcinomas treated with palliative radiation therapy (PRT) were retrospectively reviewed. Factors potentially influencing resolution of clinical signs and survival after PRT were evaluated. Clinical signs completely resolved in 66% of dogs for a median of 120 days. The overall median survival time was 146 days. Duration of response to PRT was shorter in dogs that had clinical signs for <90 days before PRT. Survival times were shorter in dogs that had partial or no resolution of clinical signs after PRT than in dogs that had complete resolution of clinical signs.

The impact of childhood adversity on suicidality and clinical course in treatment-resistant depression.

PubMed

Tunnard, Catherine; Rane, Lena J; Wooderson, Sarah C; Markopoulou, Kalypso; Poon, Lucia; Fekadu, Abebaw; Juruena, Mario; Cleare, Anthony J

2014-01-01

Childhood adversity is a risk factor for the development of depression and can also affect clinical course. We investigated this specifically in treatment-resistant depression (TRD). One hundred and thirty-seven patients with TRD previously admitted to an inpatient affective disorders unit were included. Clinical, demographic and childhood adversity (physical, sexual, emotional abuse; bullying victimization, traumatic events) data were obtained during admission. Associations between childhood adversity, depressive symptoms and clinical course were investigated. Most patients had experienced childhood adversity (62%), with traumatic events (35%) and bullying victimization (29%) most commonly reported. Childhood adversity was associated with poorer clinical course, including earlier age of onset, episode persistence and recurrence. Logistic regression analyses revealed childhood adversity predicted lifetime suicide attempts (OR 2.79; 95% CI 1.14, 6.84) and childhood physical abuse predicted lifetime psychosis (OR 3.42; 95% CI 1.00, 11.70). The cross-sectional design and retrospective measurement of childhood adversity are limitations of the study. Childhood adversity was common amongst these TRD patients and was associated with poor clinical course, psychosis and suicide attempts. Routine assessment of early adversity may help identify at risk individuals and inform clinical intervention. Copyright © 2013 Elsevier B.V. All rights reserved.

Pediatric Patients Discharged from the Emergency Department with Abnormal Vital Signs.

PubMed

Winter, Josephine; Waxman, Michael J; Waterman, George; Ata, Ashar; Frisch, Adam; Collins, Kevin P; King, Christopher

2017-08-01

Children often present to the emergency department (ED) with minor conditions such as fever and have persistently abnormal vital signs. We hypothesized that a significant portion of children discharged from the ED would have abnormal vital signs and that those discharged with abnormal vital signs would experience very few adverse events. We performed a retrospective chart review encompassing a 44-month period of all pediatric patients (aged two months to 17 years) who were discharged from the ED with an abnormal pulse rate, respiratory rate, temperature, or oxygen saturation. We used a local quality assurance database to identify pre-defined adverse events after discharge in this population. Our primary aim was to determine the proportion of children discharged with abnormal vital signs and the frequency and nature of adverse events. Additionally, we performed a sub-analysis comparing the rate of adverse events in children discharged with normal vs. abnormal vital signs, as well as a standardized review of the nature of each adverse event. Of 33,185 children discharged during the study period, 5,540 (17%) of these patients had at least one abnormal vital sign. There were 24/5,540 (0.43%) adverse events in the children with at least one abnormal vital sign vs. 47/27,645 (0.17%) adverse events in the children with normal vital signs [relative risk = 2.5 (95% confidence interval, 1.6 to 2.4)].However, upon review of each adverse event we found only one case that was related to the index visit, was potentially preventable by a 23-hour hospital observation, and caused permanent disability. In our study population, 17% of the children were discharged with at least one abnormal vital sign, and there were very few adverse (0.43%) events associated with this practice. Heart rate was the most common abnormal vital sign leading to an adverse event. Severe adverse events that were potentially related to the abnormal vital sign(s) were exceedingly rare. Additional research is

OAE: The Ontology of Adverse Events.

PubMed

He, Yongqun; Sarntivijai, Sirarat; Lin, Yu; Xiang, Zuoshuang; Guo, Abra; Zhang, Shelley; Jagannathan, Desikan; Toldo, Luca; Tao, Cui; Smith, Barry

2014-01-01

A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health. The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to standardize and integrate data relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term 'adverse event' denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data. For example, using the data extracted from the Vaccine Adverse Event Reporting System (VAERS), OAE was used to analyse vaccine adverse events associated with the administrations of different types of influenza vaccines. OAE has also been used to represent and classify the vaccine adverse events cited in package inserts of FDA-licensed human vaccines in the USA. OAE is a biomedical ontology that logically defines and classifies various adverse events occurring after medical interventions. OAE has successfully been applied in several adverse event studies. The OAE ontological framework provides a platform for systematic representation and analysis of adverse events and of the factors (e

Derivation and Validation of Predictive Factors for Clinical Deterioration after Admission in Emergency Department Patients Presenting with Abnormal Vital Signs Without Shock

PubMed Central

Henning, Daniel J.; Oedorf, Kimie; Day, Danielle E.; Redfield, Colby S.; Huguenel, Colin J.; Roberts, Jonathan C.; Sanchez, Leon D.; Wolfe, Richard E.; Shapiro, Nathan I.

2015-01-01

Introduction Strategies to identify high-risk emergency department (ED) patients often use markedly abnormal vital signs and serum lactate levels. Risk stratifying such patients without using the presence of shock is challenging. The objective of the study is to identify independent predictors of in-hospital adverse outcomes in ED patients with abnormal vital signs or lactate levels, but who are not in shock. Methods We performed a prospective observational study of patients with abnormal vital signs or lactate level defined as heart rate ≥130 beats/min, respiratory rate ≥24 breaths/min, shock index ≥1, systolic blood pressure <90mm/Hg, or lactate ≥4mmole/L. We excluded patients with isolated atrial tachycardia, seizure, intoxication, psychiatric agitation, or tachycardia due to pain (ie: extremity fracture). The primary outcome was deterioration, defined as development of acute renal failure (creatinine 2× baseline), non-elective intubation, vasopressor requirement, or mortality. Independent predictors of deterioration after hospitalization were determined using logistic regression. Results Of 1,152 consecutive patients identified with abnormal vital signs or lactate level, 620 were excluded, leaving 532 for analysis. Of these, 53/532 (9.9±2.5%) deteriorated after hospital admission. Independent predictors of in-hospital deterioration were: lactate >4.0mmol/L (OR 5.1, 95% CI [2.1–12.2]), age ≥80 yrs (OR 1.9, CI [1.0–3.7]), bicarbonate <21mEq/L (OR 2.5, CI [1.3–4.9]), and initial HR≥130 (OR 3.1, CI [1.5–6.1]). Conclusion Patients exhibiting abnormal vital signs or elevated lactate levels without shock had significant rates of deterioration after hospitalization. ED clinical data predicted patients who suffered adverse outcomes with reasonable reliability. PMID:26759655

Adverse reactions of α2-adrenoceptor agonists in cats reported in 2003-2013 in Finland.

PubMed

Raekallio, Marja R; Virtanen, Marika; Happonen, Irmeli; Vainio, Outi M

2017-07-01

To describe suspected adverse drug reactions in cats associated with use of α 2 -adrenoceptor agonists. Retrospective study. A total of 90 cats. Data were collected from reports on adverse reactions to veterinary medicines sent to the Finnish Medicines Agency during 2003-2013. All reports of suspected adverse reactions associated with use of α 2 -adrenoceptor agonists in cats were included. Probable pulmonary oedema was diagnosed based on post mortem or radiological examination, or presence of frothy or excess fluid from the nostrils or trachea. If only dyspnoea and crackles on auscultation were reported, possible pulmonary oedema was presumed. Pulmonary oedema was suspected in 61 cases. Of these cats, 37 were categorised as probable and 24 as possible pulmonary oedema. The first clinical signs had been noted between 1 minute and 2 days (median, 15 minutes) after α 2 -adrenoceptor agonist administration. Many cats probably had no intravenous overhydration when the first clinical signs were detected, as either they presumably had no intravenous cannula or the signs appeared before, during or immediately after cannulation. Of the 61 cats, 43 survived, 14 died and for four the outcome was not clearly stated. Pulmonary oedema is a perilous condition that may appear within minutes of an intramuscular administration of sedative or anaesthetic agent in cats. The symptoms were not caused by intravenous overhydration, at least in cats having no venous cannula when the first clinical signs were detected. Copyright © 2017 Association of Veterinary Anaesthetists and American College of Veterinary Anesthesia and Analgesia. Published by Elsevier Ltd. All rights reserved.

[Clinical symptoms and signs in Kimmerle anomaly].

PubMed

Split, Wojciech; Sawrasewicz-Rybak, Małgorzata

2002-01-01

The aim of the study was to consider Kimmerle anomaly (ponticulus posterior of the atlas) as an anatomic variant, which can cause a set of clinical symptoms and signs. A hundred and eight patients, 58 females and 50 males at the age of 18-59 years (M. 36.9 years, SD = 9.6) with radiologically verified Kimmerle anomaly were examined. A control group comprised 40 healthy subjects at the similar age range. The diagnosis of headaches was based on the criteria proposed by the IHS. A character of headaches, their localization, frequency, duration, number of days with headaches per year, circumstances associated with their onset and concomitant symptoms were evaluated. All the patients were subjected to electrophysiological studies (ENG, EEG and VEP). The results were statistically analyzed using a SPSS/PC+ computer system. It was revealed that clinical symptoms and signs in Kimmerle anomaly occurred most frequently in the third and fourth decade of life (65% of cases). These were most often tension-type headaches (50% of cases with headaches), vascular headaches (26% of cases) and neuralgia (24% of cases). Intensity of headaches was high. Headaches were accompanied by other complaints like vertigo (59% of cases) and in one third of cases--nausea. About 10% of patients also suffered from vomiting, paresthesia, dizziness, short periods of loss of consciousness. Sporadically--tinitus, drop attack, and vegetative symptoms. In cases without pain the most frequent signs were short periods of loss of consciousness, dizziness, and also nausea and dizziness. The EEG examination revealed pathology in 40% of patients with Kimmerle anomaly. The ENG examination in more than 33% of anomaly cases showed injury in the central part of vestibular system. Improper answers were reported in about 75% of the patients during the VEP examination.

Adverse event reporting in cancer clinical trial publications.

PubMed

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.

Standard Information Models for Representing Adverse Sensitivity Information in Clinical Documents.

PubMed

Topaz, M; Seger, D L; Goss, F; Lai, K; Slight, S P; Lau, J J; Nandigam, H; Zhou, L

2016-01-01

Adverse sensitivity (e.g., allergy and intolerance) information is a critical component of any electronic health record system. While several standards exist for structured entry of adverse sensitivity information, many clinicians record this data as free text. This study aimed to 1) identify and compare the existing common adverse sensitivity information models, and 2) to evaluate the coverage of the adverse sensitivity information models for representing allergy information on a subset of inpatient and outpatient adverse sensitivity clinical notes. We compared four common adverse sensitivity information models: Health Level 7 Allergy and Intolerance Domain Analysis Model, HL7-DAM; the Fast Healthcare Interoperability Resources, FHIR; the Consolidated Continuity of Care Document, C-CDA; and OpenEHR, and evaluated their coverage on a corpus of inpatient and outpatient notes (n = 120). We found that allergy specialists' notes had the highest frequency of adverse sensitivity attributes per note, whereas emergency department notes had the fewest attributes. Overall, the models had many similarities in the central attributes which covered between 75% and 95% of adverse sensitivity information contained within the notes. However, representations of some attributes (especially the value-sets) were not well aligned between the models, which is likely to present an obstacle for achieving data interoperability. Also, adverse sensitivity exceptions were not well represented among the information models. Although we found that common adverse sensitivity models cover a significant portion of relevant information in the clinical notes, our results highlight areas needed to be reconciled between the standards for data interoperability.

Clinical signs in the Wernicke-Korsakoff complex: a retrospective analysis of 131 cases diagnosed at necropsy.

PubMed Central

Harper, C G; Giles, M; Finlay-Jones, R

1986-01-01

A recent necropsy study has shown that 80% of patients with the Wernicke-Korsakoff syndrome were not diagnosed as such during life. Review of the clinical signs of these cases revealed that only 16% had the classical clinical triad and 19% had no documented clinical signs. The incidence of clinical signs in this and other retrospective pathological studies is very different from that of prospective clinical studies. This discrepancy may relate to "missed" clinical signs but the magnitude of the difference suggests that at least some cases of the Wernicke-Korsakoff syndrome may be the end result of repeated subclinical episodes of vitamin B1 deficiency. In order to make the diagnosis, clinicians must maintain a high index of suspicion in the "at risk" group of patients, particularly alcoholics. Investigations of thiamine status may be helpful and if the diagnosis is suspected, parenteral thiamine should be given. PMID:3701343

Oral adverse effects due to the use of Nevirapine.

PubMed

Moura, Mariela Dutra Gontijo; Senna, Maria Inês Barreiros; Madureira, Davidson Fróis; Fonseca, Linaena Merícy Silva; Mesquita, Ricardo Alves

2008-01-01

The aim of this article is to present the clinical characteristics and management of an oral adverse effect stemming from the use of the antiretroviral medication Nevirapine (NVP). NVP is a non-nucleoside reverse transcriptase inhibitor used in the treatment of Human Immunodeficiency Virus (HIV) infection. A 29-year-old black man, HIV-infected since 1996, began highly active antiretroviral therapy (HAART) with zidovudine, lamivudine, and indinavir. From 1996 to 2002 several medications were changed due to their adverse effects: indinavir (renal colic and fever), nelfinavir (cutaneous rash), and efavirenz (nausea and temporary memory loss). When the patient presented to our service he was taking NVP, zidovudine, and lamivudine. A whitish plaque in the lips and bilateral buccal mucosa, burning, taste disturbance, and xerostomia were observed. The discontinuation of HAART led to the complete resolution of signs and symptoms. The patient has received follow-up treatment for three years and five months without local or systemic effects observed. Unfortunately, the clinical features of the oral adverse effect from NVP are not well known. This paper contributed to the identification of possible reactions in the oral cavity due to antiretroviral medication. Although HAART is very important in the treatment of HIV, its side effects are responsible for patients' non-adherence to medications. While more studies are needed to better understand the mechanism of action after suspending HAART, the complete resolution of the signs and symptoms was observed. Therefore, physicians and dentists alike must understand how to identify and prevent these adverse effects in order to further improve HIV patient treatments.

[Determination of hyperregeneratory esophagopathy in dogs with clinical signs attributable to esophageal disease].

PubMed

Münster, M; Kook, P; Araujo, R; Hörauf, A; Vieth, M

2015-01-01

It was hypothesized that typical characteristics of hyperregeneratory esophagopathy (HRE) in humans such as basal cell hyperplasia and elongation of stromal papillae are also histologically detectable in canine esophageal epithelium, and that these changes are associated with clinical signs and endoscopic findings suggesting gastroesophageal reflux (GER). Sixty-five adult dogs with clinical signs attributable to esophageal disease underwent esophagoscopy and biopsy. Clinical signs suggesting GER (regurgitation, ptyalism, painful discomfort) were prospectively evaluated through a questionnaire. Endoscopic mucosal alterations suggesting GER such as minimal endoscopic changes and obvious mucosal defects were assessed via video endoscopy. Biopsy specimens obtained from the esophageal squamous epithelium were evaluated histologically. The squamous epithelium's substructures of esophageal biopsies were quantitatively assessed through microscopic morphometry. Esophageal squamous epithelium was considered normal in 48 dogs, and HRE was detected histologically in 17 dogs; both pathognomonic changes (basal cell hyperplasia, elongation of stromal papillae) were consistently present. Morphometrically assessed stromal papillary length and basal cell layer thickness was significantly (each, p < 0.0001) higher in the 17 dogs with HRE than in the 48 dogs without HRE, respectively. Overall, clinical signs suggesting GER were significantly (p = 0.02) more frequently encountered and regurgitation was significantly (p = 0.009) more common in the 17 dogs with HRE than in the 48 dogs without HRE. Similarly, endoscopic changes were significantly (p = 0.002) more frequently observed and minimal endoscopic changes suggesting GER were significantly (p = 0.004) more common in 17 dogs with HRE than in the 48 dogs without HRE. Typical characteristics of hyperregeneratory esophagopathy in humans are also histologically detectable in canine esophageal epithelium. Histological changes are

Childhood adversities and clinical symptomatology in first-episode psychosis.

PubMed

Lindgren, Maija; Mäntylä, Teemu; Rikandi, Eva; Torniainen-Holm, Minna; Morales-Muñoz, Isabel; Kieseppä, Tuula; Mantere, Outi; Suvisaari, Jaana

2017-12-01

In addition to severe traumatic experiences, milder, more common childhood adversities reflecting psychosocial burden may also be common in people with psychotic disorders and have an effect on symptomatology and functioning. We explored eleven negative childhood experiences and their influence on clinical symptoms among young adults with first-episode psychosis (FEP, n = 75) and matched population controls (n = 51). Individuals with FEP reported more adversities than controls. Specifically serious conflicts within the family, bullying at school, maternal mental health problems, and one's own and parents' serious illness during childhood were experienced by the patients more often than by controls. In the FEP group, the severity of adversity was associated with increased anxiety, manic, and obsessive-compulsive symptoms, but not with the severity of positive psychotic symptoms. Adversity produced a more pronounced effect on symptoms in male patients than in female patients. To conclude, in line with earlier studies of more chronic psychosis, a majority of the participants with FEP reported exposure to childhood adversities, with the FEP group reporting more adversities than controls. High levels of mood and anxiety symptoms in patients with FEP may be related to cumulative exposure to childhood adversities. This should be taken into account in the treatment for FEP. Copyright © 2017 Elsevier B.V. All rights reserved.

About signs and symptoms: can semiotics expand the view of clinical medicine?

PubMed

Nessa, J

1996-12-01

Semiotics, the theory of sign and meaning, may help physicians complement the project of interpreting signs and symptoms into diagnoses. A sign stands for something. We communicate indirectly through signs, and make sense of our world by interpreting signs into meaning. Thus, through association and inference, we transform flowers into love, Othello into jealousy, and chest pain into heart attack. Medical semiotics is part of general semiotics, which means the study of life of signs within society. With special reference to a case story, elements from general semiotics, together with two theoreticians of equal importance, the Swiss linguist Ferdinand de Saussure and the American logician Charles Sanders Peirce, are presented. Two different modes of understanding clinical medicine are contrasted to illustrate the external link between what we believe or suggest, on the one hand, and the external reality on the other hand.

The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

PubMed

Schmitt, Jochen; Spuls, Phyllis I; Thomas, Kim S; Simpson, Eric; Furue, Masutaka; Deckert, Stefanie; Dohil, Magdalene; Apfelbacher, Christian; Singh, Jasvinder A; Chalmers, Joanne; Williams, Hywel C

2014-10-01

The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Clinical and forensic signs related to opioids abuse.

PubMed

Dinis-Oliveira, Ricardo Jorge; Carvalho, Felix; Moreira, Roxana; Duarte, Jose Alberto; Proenca, Jorge Brandao; Santos, Agostinho; Magalhaes, Teresa

2012-12-01

For a good performance in Clinical and Forensic Toxicology it is important to be aware of the biological and non-biological signs and symptoms related to xenobiotic exposure. This manuscript highlights and analyzes clinical and forensic imaging related to opioids abuse critically. Particularly, respiratory depression, track marks and hemorrhages, skin "popping", practices of phlebotomy, tissue necrosis and ulceration, dermatitis, tongue hyperpigmentation, "coma blisters", intra-arterial administration, candidiasis, wounds associated with anthrax or clostridium contaminated heroin, desomorphine related lesions and characteristic non-biological evidences are some commonly reported findings in opioids abuse, which will be discussed. For this purpose, clinical and forensic cases from our database (National Institute of Legal Medicine and Forensic Sciences, North Branch, Portugal), in addition to literature data, are reviewed.

A clinical sign to detect root avulsions of the posterior horn of the medial meniscus.

PubMed

Seil, Romain; Dück, Klaus; Pape, Dietrich

2011-12-01

The goal of the present report was to describe a new clinical sign to make a clinical diagnosis of meniscal extrusion related to medial meniscal root avulsion. Description of an easy clinical sign to detect extrusion of the medial meniscus at the anteromedial joint line. A varus stress test was applied in full extension before and after transosseous repair of an isolated traumatic avulsion of the posterior root of the medial meniscus in a 21-year-old patient. The clinical sign was verified by sectioning of the meniscotibial ligament during knee arthroplasty surgery in 3 patients. With a deficient posterior root, the clinical sign was positive, showing anteromedial extrusion under varus stress. After repair and at clinical follow-up, extrusion was normalized. Making the clinical diagnosis of medial meniscus extrusion after knee injury by applying a simple varus stress test to the knee and palpating the anteromedial meniscal extrusion might help physicians to suspect a medial meniscus root tear in the early stages after the injury as well as to evaluate its reduction after repair. A varus stress test in full extension should be performed systematically in patients where a root tear of the medial meniscus is suspected as well as after surgery to evaluate the success of the repair.

Late-onset immune-mediated adverse effects after poly-L-lactic acid injection in non-HIV patients: clinical findings and long-term follow-up.

PubMed

Alijotas-Reig, Jaume; Garcia-Gimenez, Victor; Vilardell-Tarres, Miquel

2009-01-01

It has been thought that poly-L-lactic acid (PLLA) injections do not have inflammatory side effects. Recent evidence shows that local/regional/systemic delayed adverse effects may appear with its use. To evaluate the clinical complaints, treatment response and long-term follow-up of non-HIV patients with delayed immune-mediated adverse effects related to PLLA injections. Prospective, case series study of 10 patients with delayed adverse effects related to PLLA injections. The inclusion criterion was defined as the onset at least 6 months after PLLA use, with 1 or more of the following clinical signs: oedema, skin induration, swelling/tender nodules with or without discharge of pus or filler material. Several systemic manifestations were also included. Patients with immediate side effects were excluded. Patients underwent clinical management and long-term follow-up. The average latency period to the onset of symptoms was 19.2 months (range: 6-60). Tender, inflammatory nodules and facial oedema were commonly seen. One case presented a systemic granulomatous disorder as a complication. After 50.2 months of average follow-up (range: 38-78), 5 patients are in remission, 4 have recurrent bouts and the last case has been lost to follow-up. Although infrequently, local and/or regional and/or systemic delayed and recurrent granulomatous reactions may complicate PLLA gel injections. Copyright 2009 S. Karger AG, Basel.

Clinical signs and outcome of dogs treated medically for degenerative lumbosacral stenosis: 98 cases (2004-2012).

PubMed

De Decker, Steven; Wawrzenski, Lauren A; Volk, Holger A

2014-08-15

To compare clinical signs of dogs treated medically or surgically for degenerative lumbosacral stenosis (DLSS) and assess outcome after medical treatment. Retrospective case series. Client-owned dogs treated medically (n = 49) or surgically (49) for DLSS. Medical records from 2004 to 2012 were reviewed. Dogs were included if they had clinical signs, clinical examination findings, and MRI abnormalities consistent with DLSS. Several variables were compared between surgically and medically treated dogs: age, sex, duration of clinical signs, presence or absence of neurologic deficits, urinary and fecal incontinence, concurrent medical conditions, and medical treatment before referral. Medical treatment after obtaining a final diagnosis of DLSS consisted of restricted exercise in combination with anti-inflammatory and analgesic drugs. Surgical treatment consisted of dorsal lumbosacral laminectomy. Outcome for medically treated dogs was obtained via a standardized questionnaire. Neurologic deficits were observed significantly more often in surgically treated dogs. Surgically treated dogs had unsuccessful medical treatment before referral significantly more often than did medically treated dogs. Thirty-one of 49 (63.3%) medically treated dogs were available for follow-up evaluation. Of these 31 dogs, 17 (55%) were managed successfully, 10 (32.3%) were managed unsuccessfully and underwent surgical treatment, 3 (9.7%) were euthanized because of progression of clinical signs, and 1 (3.2%) was alive but had an increase in severity of clinical signs after medical management. Clinical signs differed in dogs treated medically or surgically for DLSS. Medical treatment for dogs with DLSS was associated with a fair prognosis.

Tetralogy of Fallot with infective endocarditis: an echocardiographic explanation of misleading clinical signs.

PubMed

Goel, Pravin K; Moorthy, Nagaraja; Bhatia, Tanuj

2012-04-01

Echocardiography has a known key role in the diagnosis of infective endocarditis, the diagnosis of complications, follow-up evaluation after therapy, and prognostic assessment Habib (Eur J Echocardiogr 11:202-219, 3). This report describes a boy with tetralogy of Fallot who presented with infective endocarditis and large vegetation occluding the ventricular septal defect, thus resulting in a hemodynamically restrictive ventriculoseptal defect with misleading clinical signs. This case illustrates the role of echocardiography in both explaining clinical signs and providing hemodynamic data.

The predictive value of the clinical sign of limited hip abduction for developmental dysplasia of the hip (DDH).

PubMed

Čustović, Svemir; Šadić, Sahmir; Vujadinović, Aleksandar; Hrustić, Asmir; Jašarević, Mahir; Čustović, Amer; Krupić, Ferid

2018-08-01

Aim To assess the relationship between the clinical sign of limited hip abduction and developmental dysplasia of the hip (DDH). Methods A research was conducted on 450 newborns at the Neonatal Unit at the Clinic of Gynaecology and Obstetrics and the Orthopaedics and Traumatology Clinic of the University Clinical Centre, Tuzla, between 30th August 2011 and 30th April 2012. Clinical (degree of hip abduction) and ultrasound examination of all newborns' hips were performed using the Graf method on their first day of life. Results Clinical sign of limited hip abduction showed significant predictive value for DDH. There were 67 (14.7%) newborns with the clinical sign of limited hip abduction, of which 26 (5.7%) were on the left hip, 11 (2.4%) on the right hip and 30 (6.6%) on both hips. Limited hip abduction had a positive predictive value (PPV) of 40.3% and a negative predictive value (NPV) of 80.4% for DDH. Conclusion Limited hip abduction, especially unilateral, is a useful and important clinical sign of DDH. Doctors, who perform the first examination of the child after birth, would have to pay attention to this clinical sign. Newborns with this clinical sign would have to go to an ultrasound examination of the hips for further diagnosis. Copyright© by the Medical Assotiation of Zenica-Doboj Canton.

Nasal flaring as a clinical sign of respiratory acidosis in patients with dyspnea.

PubMed

Zorrilla-Riveiro, José Gregorio; Arnau-Bartés, Anna; Rafat-Sellarés, Ramón; García-Pérez, Dolors; Mas-Serra, Arantxa; Fernández-Fernández, Rafael

2017-04-01

To determine whether the presence of nasal flaring is a clinical sign of respiratory acidosis in patients attending emergency departments for acute dyspnea. Single-center, prospective, observational study of patients aged over 15 requiring urgent attention for dyspnea, classified as level II or III according to the Andorran Triage Program and who underwent arterial blood gas test on arrival at the emergency department. The presence of nasal flaring was evaluated by two observers. Demographic and clinical variables, signs of respiratory difficulty, vital signs, arterial blood gases and clinical outcome (hospitalization and mortality) were recorded. Bivariate and multivariate analyses were performed using logistic regression models. The sample comprised 212 patients, mean age 78years (SD=12.8), of whom 49.5% were women. Acidosis was recorded in 21.2%. Factors significantly associated with the presence of acidosis in the bivariate analysis were the need for pre-hospital medical care, triage level II, signs of respiratory distress, presence of nasal flaring, poor oxygenation, hypercapnia, low bicarbonates and greater need for noninvasive ventilation. Nasal flaring had a positive likelihood ratio for acidosis of 4.6 (95% CI 2.9-7.4). In the multivariate analysis, triage level II (aOR 5.16; 95% CI: 1.91 to 13.98), the need for oxygen therapy (aOR 2.60; 95% CI: 1.13-5.96) and presence of nasal flaring (aOR 6.32; 95% CI: 2.78-14.41) were maintained as factors independently associated with acidosis. Nasal flaring is a clinical sign of severity in patients requiring urgent care for acute dyspnea, which has a strong association with acidosis and hypercapnia. Copyright © 2016 Elsevier Inc. All rights reserved.

[Recording and reporting adverse reactions in clinical trials. New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)].

PubMed

Eckhardt, K; Cremer-Schaeffer, P; König, J; Paeschke, N

2005-02-01

With the 12th Law Amending the German Drug Law and the Ordinance on GCP (GCPV), new legal provisions for clinical trials came into force in August 2004. These include specific definitions and differentiated reporting obligations affecting investigators, sponsors, authorities and ethics committees concerning pharmacovigilance in clinical trials. The definitions according to section sign3 (6-8) GCP-V make clear that these provisions focus on those adverse events and adverse drug reactions, which are related to investigational medicinal products. In the GCP-V for the first time legally binding provisions for investigators are laid down defining obligations to report all serious adverse events to the sponsor. The sponsor of clinical trials plays a decisive role concerning the evaluation, documentation and reporting to the competent higher authorities, ethics committees and investigators involved in the clinical trial. In the GCP-V different time limits concerning the reporting for sponsors are laid down. The requirements concerning expedited reporting focus on suspected unexpected serious adverse reactions (SUSARs), i. e. those adverse serious reactions, which are not described in the information on the investigational medicinal product. The time limit for reporting SUSARs leading to death or life-threatening SUSARs is 7 days, while for other SUSARs the time limit is 15 days. Besides the responsibilities on expedited reporting the sponsor has to submit a line listing of all serious adverse reactions which occurred during the clinical trial and a report on the safety of the trial subjects on an annual basis or on request. On the European level the harmonisation concerning the provisions on pharmacovigilance in clinical trials according to the Directive 2001/20/EC and the Eudravigilance database should contribute to reach a faster and more effective exchange of safety information related to clinical trials between the different competent authorities of the EU member

Defining clinical deterioration.

PubMed

Jones, Daryl; Mitchell, Imogen; Hillman, Ken; Story, David

2013-08-01

To review literature reporting adverse events and physiological instability in order to develop frameworks that describe and define clinical deterioration in hospitalised patients. Literature review of publications from 1960 to August 2012. Conception and refinement of models to describe clinical deterioration based on prevailing themes that developed chronologically in adverse event literature. We propose four frameworks or models that define clinical deterioration and discuss the utility of each. Early attempts used retrospective chart review and focussed on the end result of deterioration (adverse events) and iatrogenesis. Subsequent models were also retrospective, but used discrete complications (e.g. sepsis, cardiac arrest) to define deterioration, had a more clinical focus, and identified the concept of antecedent physiological instability. Current models for defining clinical deterioration are based on the presence of abnormalities in vital signs and other clinical observations and attempt to prospectively assist clinicians in predicting subsequent risk. However, use of deranged vital signs in isolation does not consider important patient-, disease-, or system-related factors that are known to adversely affect the outcome of hospitalised patients. These include pre-morbid function, frailty, extent and severity of co-morbidity, nature of presenting illness, delays in responding to deterioration and institution of treatment, and patient response to therapy. There is a need to develop multiple-variable models for deteriorating ward patients similar to those used in intensive care units. Such models may assist clinician education, prospective and real-time patient risk stratification, and guide quality improvement initiatives that prevent and improve response to clinical deterioration. Crown Copyright © 2013. Published by Elsevier Ireland Ltd. All rights reserved.

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan

Clinical Significance of the Champagne Bottle Neck Sign in the Extracranial Carotid Arteries of Patients with Moyamoya Disease.

PubMed

Yasuda, C; Arakawa, S; Shimogawa, T; Kanazawa, Y; Sayama, T; Haga, S; Morioka, T

2016-05-26

The champagne bottle neck sign represents a rapid reduction in the extracranial ICA diameters and is a characteristic feature of Moyamoya disease. However, the clinical significance of the champagne bottle neck sign is unclear. We investigated the relationship between the champagne bottle neck sign and the clinical and hemodynamic stages of Moyamoya disease. We analyzed 14 patients with Moyamoya disease before revascularization (5 men, 9 women; age, 43.2 ± 19.3 years). The ratio of the extracranial ICA and common carotid artery diameters was determined using carotid ultrasonography or cerebral angiography; a ratio of < 0.5 was considered champagne bottle neck sign-positive. The clinical disease stage was determined using the Suzuki angiographic grading system. CBF and cerebral vasoreactivity also were measured. The ICA/common carotid artery ratio (expressed as median [interquartile range]) decreased as the clinical stage advanced (stages I-II, 0.71 [0.60-0.77]; stages III-IV, 0.49 [0.45-0.57]; stages V-VI, 0.38 [0.34-0.47]; P < .001). Lower ICA/common carotid artery ratio tended to occur in symptomatic versus asymptomatic arteries (0.47 [0.40-0.53] versus 0.57 [0.40-0.66], respectively; P = .06). Although the ICA/common carotid artery ratio was not related to cerebral perfusion, it decreased as cerebral vasoreactivity decreased (P < .01). All champagne bottle neck sign-positive arteries were classified as Suzuki stage ≥III, 73% were symptomatic, and 89% exhibited reduced cerebral vasoreactivity. In contrast, all champagne bottle neck sign-negative arteries were Suzuki stage ≤III, 67% were asymptomatic, and all showed preserved cerebral vasoreactivity. The champagne bottle neck sign was related to advanced clinical stage, clinical symptoms, and impaired cerebral vasoreactivity. Thus, detection of the champagne bottle neck sign might be useful in determining the clinical and hemodynamic stages of Moyamoya disease. © 2016 American Society of Neuroradiology.

Clinical signs of early osteoarthritis: reproducibility and relation to x ray changes in 541 women in the general population.

PubMed Central

Hart, D J; Spector, T D; Brown, P; Wilson, P; Doyle, D V; Silman, A J

1991-01-01

The definition and classification of early clinically apparent osteoarthritis both in clinical situations and in epidemiological surveys remains a problem. Few data exist on the between-observer reproducibility of simple clinical methods of detecting hand and knee osteoarthritis in the population and their sensitivity and specificity as compared with radiography. Two observers first studied the reproducibility of a number of clinical signs in 41 middle aged women. Good rates of agreement were found for most of the clinical signs tested (kappa = 0.54-1.0). The more reproducible signs were then tested on a population of 541 women, aged 45-65, drawn from general practice, screening centres, and patients previously attending hospital for non-rheumatic problems. The major clinical signs used had a high specificity (87-99%) and lower sensitivity (20-49%) when compared with radiographs graded on the Kellgren and Lawrence scale (2+ = positive). When analysis was restricted to symptomatic radiographic osteoarthritis, levels of sensitivity were increased and specificity was lowered. These data show that certain physical signs of osteoarthritis are reproducible and may be used to identify clinical disease. They are not a substitute for radiographs, however, if radiographic change is regarded as the 'gold standard' of diagnosis. As the clinical signs tested seemed specific for osteoarthritis they may be of value in screening populations for clinical disease. PMID:1877852

Continuous distal migration and internal rotation of the C-stem prosthesis without any adverse clinical effects: an RSA study of 33 primary total hip arthroplasties followed for up to ten years.

PubMed

von Schewelov, T; Carlsson, A; Sanzén, L; Besjakov, J

2014-05-01

In 2005, we demonstrated that the polished triple-tapered C-stem at two years had migrated distally and rotated internally. From that series, 33 patients have now been followed radiologically, clinically and by radiostereometric analysis (RSA) for up to ten years. The distal migration within the cement mantle had continued and reached a mean of 2 mm (0.5 to 4.0) at ten years. Internal rotation, also within the cement mantle, was a mean 3.8° (external 1.6° to internal 6.6°) The cement mantle did not show any sign of migration or loosening in relation to the femoral bone. There were no clinical or radiological signs indicating that the migration or rotation within the cement mantle had had any adverse effects for the patients.

The predictive effect of insight on adverse clinical outcomes in bipolar I disorder: a two-year prospective study.

PubMed

Yen, Cheng-Fang; Chen, Cheng-Sheng; Yen, Ju-Yu; Ko, Chih-Hung

2008-05-01

Research has revealed that a lack of insight is associated with poorer clinical outcomes in schizophrenia; however, the predictive value of insight on adverse clinical outcomes among bipolar patients is quite understudied. The aim of this prospective study was to examine the impact of insight on adverse clinical outcomes among the patients with bipolar I disorder over a 2-year period. Sixty-five remitted bipolar I disorder patients received follow-up assessments at 3, 6, 9, 12, 18, and 24 months to detect the adverse clinical outcomes defined by the incidence of bipolar-related psychiatric hospitalization, emergency room visits, violent or suicidal behavior. The Schedule of Assessment of Insight was used to provide a baseline insight score. Cox regression analysis was used to examine the predictive value of insight on the adverse clinical outcomes. Impaired insight into treatment and a greater number of previous hospitalizations significantly increased the risk of adverse clinical outcomes with bipolar disorder in the 2-year period. However, insight into recognition of the illness and re-labeling of psychotic phenomena did not have any significant effect on adverse clinical outcomes. Bipolar patients' insight into treatment is an independent predictor of adverse clinical outcomes. Improving insight into treatment might be a promising target for a better outcome.

Relationship between clinical signs and postmortem test status in cattle experimentally infected with the bovine spongiform encephalopathy agent

PubMed Central

2010-01-01

Background Various clinical protocols have been developed to aid in the clinical diagnosis of classical bovine spongiform encephalopathy (BSE), which is confirmed by postmortem examinations based on vacuolation and accumulation of disease-associated prion protein (PrPd) in the brain. The present study investigated the occurrence and progression of sixty selected clinical signs and behaviour combinations in 513 experimentally exposed cattle subsequently categorised postmortem as confirmed or unconfirmed BSE cases. Appropriate undosed or saline inoculated controls were examined similarly and the data analysed to explore the possible occurrence of BSE-specific clinical expression in animals unconfirmed by postmortem examinations. Results Based on the display of selected behavioural, sensory and locomotor changes, 20 (67%) orally dosed and 17 (77%) intracerebrally inoculated pathologically confirmed BSE cases and 21 (13%) orally dosed and 18 (6%) intracerebrally inoculated but unconfirmed cases were considered clinical BSE suspects. None of 103 controls showed significant signs and were all negative on diagnostic postmortem examinations. Signs indicative of BSE suspects, particularly over-reactivity and ataxia, were more frequently displayed in confirmed cases with vacuolar changes in the brain. The display of several BSE-associated signs over time, including repeated startle responses and nervousness, was significantly more frequent in confirmed BSE cases compared to controls, but these two signs were also significantly more frequent in orally dosed cattle unconfirmed by postmortem examinations. Conclusions The findings confirm that in experimentally infected cattle clinical abnormalities indicative of BSE are accompanied by vacuolar changes and PrPd accumulation in the brainstem. The presence of more frequently expressed signs in cases with vacuolar changes is consistent with this pathology representing a more advanced stage of disease. That BSE-like signs or sign

Self-perceived sensory responses to soap and synthetic detergent bars correlate with clinical signs of irritation.

PubMed

Simion, F A; Rhein, L D; Morrison, B M; Scala, D D; Salko, D M; Kligman, A M; Grove, G L

1995-02-01

Epidemiologic studies indicate that after using soaps and other personal care products, many consumers experience irritation. In 50% of the cases the feelings of skin dryness, itching, and stinging occur in the absence of visible signs of irritation. We sought to determine the relation between self-perceived sensory responses of panelists to cleansing products and clinical signs of irritation. A combination of exaggerated arm-washing methods was designed to induce clinical signs of irritation with psychometric techniques developed to quantify sensations. Two studies demonstrated that panelists could reproducibly differentiate between products on the basis of the sensations they felt and that there was a significant correlation (frequently r > 0.80) between these and the observable signs. In the case of skin dryness panelists differentiated products several washing cycles before observable differences were detected. Sensory evaluations of irritation yield additional information on soap and detergent irritancy beyond clinical observations and expand understanding of the irritation process.

Disc displacement without reduction: a retrospective study of a clinical diagnostic sign.

PubMed

Giraudeau, Anne; Jeany, Marion; Ehrmann, Elodie; Déjou, Jacques; Ouni, Imed; Orthlieb, Jean-Daniel

2017-03-01

The purpose of this retrospective study is to evaluate a clinical diagnostic sign for disc displacement without reduction (DDWR), the absence of additional condylar translation during opening compared with protrusion. Thirty-eight electronic axiographic and magnetic resonance imaging (MRI) examinations of the TMJ were analyzed in order to compare the opening/protrusion ratio of condylar translation between non-painful DDWR and non-DDWR. According to the Mann-Whitney U test, the opening/protrusion ratio in non-painful DDWR differs significantly from non-DDWR (p < 0.0001). Among non-painful DDWR, there is no additional condylar translation during opening in comparison with protrusion, and this is probably also the case for DDWR without limited opening, which is a subtype that has not been validated by the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Comparative condylar palpation can analyze this sign, and therefore, further comparative investigations between MRI and clinical examination are needed to validate the corresponding clinical test.

Performance of clinical signs in the diagnosis of dehydration in children with acute gastroenteritis.

PubMed

Hoxha, Teuta; Xhelili, Luan; Azemi, Mehmedali; Avdiu, Muharrem; Ismaili-Jaha, Vlora; Efendija-Beqa, Urata; Grajcevci-Uka, Violeta

2015-02-01

Acute evaluation and treatment of children presenting with dehydration represent one of the most common situation in the pediatric emergency department. To identify dehydration in infants and children before treatment, a number of symptoms and clinical signs have been evaluated. The aim of the study was to describe the performance of clinical signs in detecting dehydration in children. Two hundred children aged 1 month to 5 year were involved in our prospective study. The clinical assessment consisted of the ten clinical signs of dehydration, including those recommended by WHO (World Health Organization), heart rate, and capillary refill time. Two hundred patients with diarrhea were enrolled in the study. The mean age was 15.62±9.03 months and 57.5% were male. Of these 121 had a fluid deficit of < 5%, 68 had a deficit of 5 to 9% and 11(5.5%) had a deficit of 10% or more. Patients classified as having no or mild, moderate, and severe dehydration were found to have the following respective gains in percent weight at the end of illness: 2.44±0.3, 6.05± 1.01 and, 10.66± 0.28, respectively. All clinical signs were found more frequently with increasing amounts of dehydration(p<0.001, One-way ANOVA). The median number of findings among subjects with no or mild dehydration (deficit <5%) was 3; among those with moderate dehydration (deficit 5% to 9%) was 6.5 and among those with severe dehydration (deficit >10%) the median was 9 (p<0.0001, Kruskal-Wallis test). Using stepwise linear regression and a p value of <0.05 for entry into the model, a four-variable model including sunken eyes, skin elasticity, week radial pulse, and general appearance was derived. None of the 10 findings studied, is sufficiently accurate to be used in isolation. When considered together, sunken eyes, decreased skin turgor, weak pulse and general appearance provide the best explanatory power of the physical signs considered.

OA01.24. A study of effect of neem oil on clinical signs of canine atopy

PubMed Central

Joshi, Shraddha

2012-01-01

Purpose: Due to growing nuclear nature of urban families, pets like dogs are becoming popular companions. A skin disorder is common in dogs and is a concern for human coming in contact. Natural remedies need to be assessed for long term safety of dogs and humans. There is evidence that in dogs, Neem oil can help with fleas, ticks, intestinal parasites and mange mites. According to Ayurvedic medicine. Neem oil improves the clinical signs of skin disorders. To study its action in canines, further work was required on the efficacy of Neem oil in the treatment of canine atopy. Method: Effect of a preparation of Neem oil on canine atopy was assessed in a open, placebo-controlled trial. Privately owned dogs were used and the clinical signs of atopic dermatitis were evaluated by the owners. For a period of 3 weeks, the dogs daily received application with Neem oil (n = 9) or vehicle (n = 8). During the trial, all dogs were cleaned with the use of regular bathing shampoo in order to maintain hygiene. To assess the severity of atopic dermatitis, the clinical signs scored were itching, redness, scaling, thickening and stripping of skin. The severity of the signs of atopic dermatitis was scored by the owners by marking with a cross a 10cm, horizontal line. Result: For all five clinical signs, the group-mean improvement, expressed as change of severity score over time, was greater in the test group than in the controls. Within each group, the changes for the five clinical signs were added up to arrive at an overall index of improvement of atopic dermatitis. The extra improvement caused by the application of Neem oil was significant. Conclusion: Neem oil can be considered as effective and is beneficial for dogs with atopic dermatitis.

The SIGN nail for knee fusion: technique and clinical results

PubMed Central

Anderson, Duane Ray; Anderson, Lucas Aaron; Haller, Justin M.; Feyissa, Abebe Chala

2016-01-01

Purpose: Evaluate the efficacy of using the SIGN nail for instrumented knee fusion. Methods: Six consecutive patients (seven knees, three males) with an average age of 30.5 years (range, 18–50 years) underwent a knee arthrodesis with SIGN nail (mean follow-up 10.7 months; range, 8–14 months). Diagnoses included tuberculosis (two knees), congenital knee dislocation in two knees (one patient), bacterial septic arthritis (one knee), malunited spontaneous fusion (one knee), and severe gout with 90° flexion contracture (one knee). The nail was inserted through an anteromedial entry point on the femur and full weightbearing was permitted immediately. Results: All knees had clinical and radiographic evidence of fusion at final follow-up and none required further surgery. Four of six patients ambulated without assistive device, and all patients reported improved overall physical function. There were no post-operative complications. Conclusion: The technique described utilizing the SIGN nail is both safe and effective for knee arthrodesis and useful for austere environments with limited fluoroscopy and implant options. PMID:27163095

The SIGN nail for knee fusion: technique and clinical results.

PubMed

Anderson, Duane Ray; Anderson, Lucas Aaron; Haller, Justin M; Feyissa, Abebe Chala

2016-02-05

Evaluate the efficacy of using the SIGN nail for instrumented knee fusion. Six consecutive patients (seven knees, three males) with an average age of 30.5 years (range, 18-50 years) underwent a knee arthrodesis with SIGN nail (mean follow-up 10.7 months; range, 8-14 months). Diagnoses included tuberculosis (two knees), congenital knee dislocation in two knees (one patient), bacterial septic arthritis (one knee), malunited spontaneous fusion (one knee), and severe gout with 90° flexion contracture (one knee). The nail was inserted through an anteromedial entry point on the femur and full weightbearing was permitted immediately. All knees had clinical and radiographic evidence of fusion at final follow-up and none required further surgery. Four of six patients ambulated without assistive device, and all patients reported improved overall physical function. There were no post-operative complications. The technique described utilizing the SIGN nail is both safe and effective for knee arthrodesis and useful for austere environments with limited fluoroscopy and implant options.

Meningitis With a Negative Cerebrospinal Fluid Gram Stain in Adults: Risk Classification for an Adverse Clinical Outcome

PubMed Central

Khoury, Nabil T.; Hossain, Md Monir; Wootton, Susan H.; Salazar, Lucrecia; Hasbun, Rodrigo

2012-01-01

Objective To derive and validate a risk score for an adverse clinical outcome in adults with meningitis and a negative cerebrospinal fluid (CSF) Gram stain. Patients and Methods We conducted a retrospective study of 567 adults from Houston, Texas, with meningitis evaluated between January 1, 2005, and January 1, 2010. The patients were divided into derivation (N=292) and validation (N=275) cohorts. An adverse clinical outcome was defined as a Glasgow Outcome Scale score of 4 or less. Results Of the 567 patients, 62 (11%) had an adverse clinical outcome. A predictive model was created using 3 baseline variables that were independently associated with an adverse clinical outcome (P<.05): age greater than 60 years, abnormal findings on neurologic examination (altered mental status, focal neurologic deficits, or seizures), and CSF glucose level of less than 2.4975 mmol/L (to convert CSF glucose to mmol/L, multiply by 0.05551). The model classified patients into 2 categories of risk for an adverse clinical outcome—derivation sample: low risk, 0.6% and high risk, 32.8%; P<.001; and validation sample: low risk, 0.5% and high risk, 21.1%; P<.001. Conclusion Adults with meningitis and a negative CSF Gram stain can be accurately stratified for the risk of an adverse clinical outcome using clinical variables available at presentation. PMID:23218086

Long-term outcome of Cavalier King Charles spaniel dogs with clinical signs associated with Chiari-like malformation and syringomyelia.

PubMed

Plessas, I N; Rusbridge, C; Driver, C J; Chandler, K E; Craig, A; McGonnell, I M; Brodbelt, D C; Volk, H A

2012-11-17

The disease complex Chiari-like malformation (CM) and syringomyelia (SM) has been associated with the development of neuropathic pain (NeP), and commonly affects Cavalier King Charles spaniels (CKCS). This prospective cohort study followed 48 CKCSs with CM and/or SM and clinical signs suggestive of NeP for a period of 39 (±14.3) months from diagnosis. At the end of the study, 36 dogs were still alive; five dogs died of an unrelated or unknown cause, and seven were euthanased due to severe clinical signs suggestive of NeP. During the follow-up period, the clinical signs of scratching, facial rubbing behaviour, vocalisation and exercise ability were evaluated. Nine out of 48 dogs stopped scratching (P<0.001), but there was no statistically significant change in the number of dogs exhibiting exercise intolerance, vocalisation or facial rubbing behaviour. The overall severity of clinical signs based on a visual analogue scale (VAS) (0 mm: no clinical signs 100 mm: severe clinical signs) increased (from median 75 mm (interquartile ranges (IQR) 68-84) to 84 mm (IQR 71.5-91), P<0.001). A quarter of the dogs were static or improved. In general, the majority of the owners felt that the quality of life of their dogs was acceptable. Medical treatments received were gabapentin or pregabalin and/or intermittently, carprofen. The owner's perception of their animal's progress, and progress based on VAS, had strong positive correlation (Spearman's rank correlation (s(r)) 0.74, P<0.001). Overall, this study suggests that clinical signs suggestive of NeP progress in three-quarters of CKCSs with CM and/or SM.

Clinical roundtable monograph. New alternatives in CLL therapy: managing adverse events.

PubMed

Chanan-Khan, Asher; Kipps, Thomas; Stilgenbauer, Stephan

2010-08-01

Chronic lymphocytic leukemia (CLL) is a B-cell leukemia mainly affecting older adults. Historically, CLL has been regarded as an incurable disease, and treatment has been confined to cytotoxic chemotherapy regimens. However, prognosis for patients treated with these agents remained poor, prompting the development of new, targeted agents. The introduction of rituximab, a CD20-targeted monoclonal antibody, revolutionized the treatment for this disease. Rituximab in combination with fludarabine improved response rates and length of progression-free survival. The success of rituximab in this setting has prompted the development of many more investigational agents for CLL, including other antibody agents. However, as with any medication, the potential benefit achieved with CLL therapies is mitigated by the safety risk for the patient. These agents have been associated with adverse events such as immunosuppression, reactivation of cytomegalovirus, and infusion-related reactions that can occur with antibody administration. Adverse events can greatly affect the patient’s quality of life and ability to tolerate therapy. Management of adverse events is a critical component of the overall treatment strategy for CLL, particularly in elderly patients. In this clinical roundtable monograph, 3 expert physicians discuss the latest clinical studies evaluating the treatment of CLL, focusing on the adverse events associated with each agent and the potential interventions that can be used to manage their occurrence.

Clinical significance of the "galaxy sign" in patients with pulmonary sarcoidosis in a Japanese single-center cohort.

PubMed

Koide, Takashi; Saraya, Takeshi; Tsukahara, Yayoi; Bonella, Francesco; Börner, Eda; Ishida, Manabu; Ogawa, Yukari; Hirukawa, Ichiro; Oda, Miku; Shimoda, Masafumi; Ohkuma, Kosuke; Fujiwara, Masachika; Takata, Saori; Yokoyama, Takuma; Kurai, Daisuke; Ishii, Haruyuki; Goto, Hajime; Takizawa, Hajime

2016-10-07

The galaxy sign is an irregularly marginated pulmonary nodule formed by a confluence of multiple small nodules, and it is a diagnostic radiological finding for pulmonary sarcoidosis. However, the clinical significance of the galaxy sign for sarcoidosis has been poorly investigated. This study aimed to investigate the clinical significance and detailed radiological features of the galaxy sign in patients with pulmonary sarcoidosis. We retrospectively reviewed 87 patients with biopsy-proven sarcoidosis and 108 patients with pulmonary tuberculosis. Galaxy sign incidence was assessed on thoracic high-resolution computed tomography (HRCT) images from each group. Correlations of galaxy sign with clinical characteristics and disease outcomes were evaluated for patients with sarcoidosis. HRCT findings were available for 65 of 87 patients with pulmonary sarcoidosis and all 108 patients with pulmonary tuberculosis. Galaxy sign incidence was significantly higher in patients with pulmonary sarcoidosis (n=15, 23.1%) than in those with pulmonary tuberculosis (n=2, 1.9%, p<0.001). Among the 65 patients with pulmonary sarcoidosis, those with galaxy signs (n=15) were significantly younger (median: 32 years, interquartile range [IQR] 28-38 years) than those without (n=50) (median: 62 years, IQR 37.7-73 years). The CD4/CD8 ratio in bronchoalveolar lavage fluid (BALF) was also significantly lower in the former group (median: 2.6, IQR 2.0-3.9 vs. median 5.8, IQR 3.7-8.6, p<0.001). Galaxy signs are associated with younger age and low BALF CD4/CD8 ratio but not disease severity.

Hip Dysplasia: Clinical Signs and Physical Examination Findings.

PubMed

Syrcle, Jason

2017-07-01

Hip dysplasia is a common developmental disorder of the dog, consisting of varying degrees of hip laxity, progressive remodeling of the structures of the hip, and subsequent development of osteoarthritis. It is a juvenile-onset condition, with clinical signs often first evident at 4 to 12 months of age. A tentative diagnosis of hip dysplasia can be made based on signalment, history, and physical examination findings. The Ortolani test is a valuable tool for identifying juvenile dogs affected with this condition. Further diagnostics can then be prioritized, contributing to prompt diagnosis and appropriate treatment. Copyright © 2017 Elsevier Inc. All rights reserved.

Solar exposure(s) and facial clinical signs of aging in Chinese women: impacts upon age perception.

PubMed

Flament, Frederic; Bazin, Roland; Qiu, Huixia; Ye, Chengda; Laquieze, Sabine; Rubert, Virginie; Decroux, Aurelie; Simonpietri, Elisa; Piot, Bertrand

2015-01-01

A new reference clinical atlas of facial signs dedicated to photoaging was applied to 301 Chinese women of various ages through standardized photographs. Such approach aimed at better describing the facial changes induced by both real/chronological age and sun exposure and their respective impact on two subcohorts of different behavior with regard to sun exposure. A total of 28 various facial signs were individually graded according to their severity by a panel of experts, and a perceived apparent age of each subject was assessed. Results showed that the severity of major signs significantly increased rather linearly with age, with a higher rate in sun-exposed subjects as compared with subjects who regularly avoid sun exposure. The severity of facial signs, all impacted by sun exposure, better correlated with perceived apparent age than real/chronological age. The protocol used in the present work, similar to that previously applied to two cohorts of French women, assigned a greater impact of sun exposure in the facial aging signs of Asian women - all clinical signs are influenced by extrinsic factors - as compared with Caucasian women of comparable ages, likely related to much more intense ultraviolet (UV) radiation.

Clinical profile and warning sign finding in children with severe dengue and non-severe dengue

NASA Astrophysics Data System (ADS)

Adam, A. S.; Pasaribu, S.; Wijaya, H.; Pasaribu, A. P.

2018-03-01

Dengue fever is one of the most important emerging vector-borne viral diseases. Approximately 500,000 out of 100 million cases develop to severe dengue infection. Patient with severe dengue (SD) can be predicted by clinical profile, laboratory and warning sign which could be saved by early interventions.This was a retrospective descriptive-analytic study to investigate clinical manifestations, laboratory and warning signs ofchildren with dengue infection in Haji Adam Malik hospital during January 2014–May 2016. Through medical records, we had selected 140 cases which fulfilled research criteria.Cases were classified as SD (n=28) and NSD (n=112). Most common clinical manifestations for NSD were abdominal pain (39.3%), myalgia (39.3%), headache (37.1%), mucosal bleeding (36.4%) while for SD were shock (15.7%), mucosal bleeding (15.7%), clinical fluid accumulation (15%), shortness of breath (14.3%). SGPT >1000IU/L (5 cases), SGOT >1000IU/L (9 cases), PT (10 cases) and aPTT (16 cases) were abnormal in SD. Severe dengue was frequently found in the range of white cell count 1000-4000/L and platelet count 20,000-50,000mm/uL. Clinical manifestations, warning sign, and laboratoryfinding, were different between SD and NSD.

Suspected adverse reactions to oral administration of a praziquantel-pyrantel combination in captive cheetahs (Acinonyx jubatus).

PubMed

Whitehouse-Tedd, Katherine M; Smith, Liesl; Budd, Jane A; Lloyd, Christopher G

2017-11-15

OBJECTIVE To characterize adverse reactions to oral administration of a combination of praziquantel and pyrantel embonate or pyrantel pamoate, with or without oxantel embonate, in captive cheetahs (Acinonyx jubatus). DESIGN Retrospective case series and case-control study. ANIMALS 16 captive cheetahs with signs of adverse reaction to oral administration of praziquantel and pyrantel, with or without oxantel embonate (affected group), and 27 cheetahs without such reactions (unaffected group), all from 3 independent facilities. PROCEDURES Medical records and postmortem findings for affected cheetahs were reviewed and compared with those of unaffected animals. Anthelmintic doses administered, age, and sex of cheetahs were compared between groups. RESULTS 3 reactions in affected cheetahs were fatal, whereas the remainder ranged from mild to severe. Postmortem examination failed to reveal any disease processes or conditions to explain the deaths. No differences in anthelmintic dose were identified between affected and unaffected cheetahs for all facilities combined, and no correlation existed between dose and reaction severity. No association with sex was detected, but affected cheetahs were significantly younger than unaffected cheetahs. This difference was not significant after controlling for facility. CONCLUSIONS AND CLINICAL RELEVANCE Cheetahs were concluded to have had an adverse reaction to the praziquantel-pyrantel combination because of temporal proximity of onset of clinical signs to dose administration, similarity of signs to those reported for toxicosis in other species for these drugs, and a lack of other disease process or environmental explanatory factors. A highly cautious approach to the use of this drug combination is recommended for cheetahs.

Validity and reliability of haemoglobin colour scale and its comparison with clinical signs in diagnosing anaemia in pregnancy in Ahmedabad, India.

PubMed

Bala, D V; Vyas, S; Shukla, A; Tiwari, H; Bhatt, G; Gupta, K

2012-07-01

This study compared the validity of the haemoglobin colour scale (HCS) and clinical signs in diagnosing anaemia against Sahli's haemoglobinometer method as the gold standard, and assessed the reliability of HCS. The sample comprised 129 pregnant women recruited from 6 urban health centres in Ahmedabad. The prevalence of anaemia was 69.8% by Sahli's method, 78.3% by HCS and 89.9% by clinical signs; there was no statistically significant difference between Sahli's method and HCS whereas there was between Sahlis method and clinical signs. The mean haemoglobin level by Sahli's method and HCS differed significantly. The sensitivity, specificity, positive predictive value and negative predictive value of HCS was 83.3%, 33.3%, 74.3% and 46.4% respectively and that of clinical signs was 91.1%, 12.8%, 70.7% and 38.5% respectively. Interobserver agreement for HCS was moderate (K = 0.43). Clinical signs are better than HCS for diagnosing anaemia. HCS can be used in the field provided assessors are adequately trained.

Contact lens deposits, adverse responses, and clinical ocular surface parameters.

PubMed

Zhao, Zhenjun; Naduvilath, Thomas; Flanagan, Judith L; Carnt, Nicole A; Wei, Xiaojia; Diec, Jennie; Evans, Vicki; Willcox, Mark D P

2010-09-01

To correlate clinical responses during contact lens wear with the amount of protein or cholesterol extracted from lenses after wear. Clinical parameters, including adverse response rates and corneal staining, and symptomatology rating during lens wear were collected from a series of clinical tests comprising four different silicone hydrogel lenses with four different multipurpose solutions. To test for correlates, the amount of total protein or cholesterol extracted from lenses after daily wear were compared statistically to clinical parameters. The amount of protein (p = 0.008) or cholesterol (p = 0.01) extracted from lenses was higher for those subjects who showed solution-induced corneal staining. Amount of protein extracted was correlated (p < 0.01) with conjunctival staining (R = -0.23), lens front surface wetting (r = 0.14), and lens fit tightness (R = -0.20). These clinical parameters accounted for 48% of lens protein deposition. The amount of cholesterol extracted from lenses was much more weakly associated with clinical variables. Amount of protein or cholesterol extracted from lenses was not associated with the production of any corneal infiltrative or mechanical adverse event during wear and was only very weakly correlated with insertion comfort of lenses. These results suggest that there may be no physiologically relevant consequence of cholesterol depositing on silicone hydrogel lenses. The amount of protein that deposits onto silicone hydrogel lenses during wear may have more affect on lens performance on-eye. However, the correlations were generally small and may still not indicate any causative relevant physiological response. Further work is required to determine whether there is any direct causative effect to support these correlative findings.

45 CFR 60.11 - Reporting adverse actions on clinical privileges.

Code of Federal Regulations, 2012 CFR

2012-10-01

... (5 U.S.C. 552a note), (v) Date of birth, (vi) Name of each professional school attended and year of... 45 Public Welfare 1 2012-10-01 2012-10-01 false Reporting adverse actions on clinical privileges. 60.11 Section 60.11 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION...

45 CFR 60.11 - Reporting adverse actions on clinical privileges.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (5 U.S.C. 552a note), (v) Date of birth, (vi) Name of each professional school attended and year of... 45 Public Welfare 1 2010-10-01 2010-10-01 false Reporting adverse actions on clinical privileges. 60.11 Section 60.11 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION...

45 CFR 60.11 - Reporting adverse actions on clinical privileges.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (5 U.S.C. 552a note), (v) Date of birth, (vi) Name of each professional school attended and year of... 45 Public Welfare 1 2011-10-01 2011-10-01 false Reporting adverse actions on clinical privileges. 60.11 Section 60.11 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION...

Incomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials

PubMed Central

Derry, Sheena; Kong Loke, Yoon; Aronson, Jeffrey K

2001-01-01

Background We would expect information on adverse drug reactions in randomised clinical trials to be easily retrievable from specific searches of electronic databases. However, complete retrieval of such information may not be straightforward, for two reasons. First, not all clinical drug trials provide data on the frequency of adverse effects. Secondly, not all electronic records of trials include terms in the abstract or indexing fields that enable us to select those with adverse effects data. We have determined how often automated search methods, using indexing terms and/or textwords in the title or abstract, would fail to retrieve trials with adverse effects data. Methods We used a sample set of 107 trials known to report frequencies of adverse drug effects, and measured the proportion that (i) were not assigned the appropriate adverse effects indexing terms in the electronic databases, and (ii) did not contain identifiable adverse effects textwords in the title or abstract. Results Of the 81 trials with records on both MEDLINE and EMBASE, 25 were not indexed for adverse effects in either database. Twenty-six trials were indexed in one database but not the other. Only 66 of the 107 trials reporting adverse effects data mentioned this in the abstract or title of the paper. Simultaneous use of textword and indexing terms retrieved only 82/107 (77%) papers. Conclusions Specific search strategies based on adverse effects textwords and indexing terms will fail to identify nearly a quarter of trials that report on the rate of drug adverse effects. PMID:11591220

Clinical and neurophysiological investigation of a large family with dominant Charcot-Marie-Tooth type 2 disease with pyramidal signs.

PubMed

Neves, Eduardo Luis de Aquino; Kok, Fernando

2011-06-01

Charcot-Marie-Tooth (CMT) disease is a hereditary neuropathy of motor and sensory impairment with distal predominance. Atrophy and weakness of lower limbs are the first signs of the disease. It can be classified, with the aid of electromyography and nerve conduction studies, as demyelinating (CMT1) or axonal (CMT2). Clinical and neurophysiological investigation of a large multigenerational family with CMT2 with autosomal dominant mode of transmission. Fifty individuals were evaluated and neurophysiological studies performed in 22 patients. Thirty individuals had clinical signs of motor-sensory neuropathy. Babinski sign was present in 14 individuals. Neurophysiological study showed motor-sensory axonal polyneuropathy. The clinical and neurophysiological characteristics of this family does not differ from those observed with other forms of CMT, except for the high prevalence of Babinski sign.

Clinical and histologic features of acute-onset erythroderma in dogs with gastrointestinal disease: 18 cases (2005-2015).

PubMed

Cain, Christine L; Bradley, Charles W; Mauldin, Elizabeth A

2017-12-15

OBJECTIVE To describe the clinical and histologic features of acute erythroderma in dogs with gastrointestinal disease. DESIGN Retrospective case series. ANIMALS 18 dogs with erythroderma and gastrointestinal disease. PROCEDURES Medical records and biopsy specimens were reviewed. Information collected from medical records included signalment, clinical signs, physical examination and diagnostic test results, treatment, and outcome. The Naranjo algorithm was used to estimate the probability of an adverse drug reaction for each dog. RESULTS All dogs had an acute onset of erythematous macules or generalized erythroderma. Histologic features of skin biopsy specimens had 3 patterns representing a progressive spectrum of inflammation. Most dogs had vomiting (n = 17) and hematochezia (10). Signs of gastrointestinal disease became evident before, after, or concurrent with the onset of skin lesions in 10, 3, and 5 dogs, respectively. Inflammatory bowel disease, pancreatitis, and adverse food reaction were diagnosed in 5, 3, and 3 dogs, respectively. The cause of the gastrointestinal signs was not identified for 8 dogs. Eight dogs had a Naranjo score consistent with a possible adverse drug reaction. Treatment of skin lesions included drug withdrawal (n = 15), antihistamines (16), and corticosteroids (14). Signs of gastrointestinal disease and skin lesions resolved at a mean of 4.6 days and 20.8 days, respectively, after onset. CONCLUSIONS AND CLINICAL RELEVANCE Results indicated acute erythroderma may be associated with > 1 gastrointestinal disease or an adverse drug reaction in some dogs. Recognition of the clinical and histologic features of this syndrome is essential for accurate diagnosis.

Knowledge of neonatal danger signs among mothers attending well baby clinic in Nakuru Central District, Kenya: cross sectional descriptive study.

PubMed

Kibaru, Elizabeth Gathoni; Otara, Amos Magembe

2016-10-25

Neonatal mortality has remained high in Kenya despite various efforts being applied to reduce this negative trend. Early detection of neonatal illness is an important step towards improving new born survival. Toward this end there is need for the mothers to be able to identify signs in neonates that signifies severe neonatal illnesses. The objective of the study was to determine the level of knowledge of mothers attending well baby clinics on postnatal neonatal danger signs and determine the associated factors. Cross sectional descriptive study. Purposive sampling of Health care facilities that provide antenatal, delivery and postnatal services were identified. In each of the selected health facility structured questionnaires were administered to mothers with children aged six weeks to nine months attending well baby clinics. Frequencies, Chi square and multivariate logistic regression were determined using the SPSS software (version 20). During the period of study 414 mothers attending well baby clinics were interviewed. Information on neonatal dangers was not provided to 237 (57.2%) of the postnatal mothers during their antenatal clinic attendance by the health care providers. Majority of mothers 350 (84.5%) identified less than three neonatal danger signs. Hotness of the body (fever) was the commonly recognized danger sign by 310 (74.9%) postnatal mothers. Out of 414 mothers 193 (46.6%), 166 (40.1%), 146 (35.3%) and 24 (5.8%) identified difficulty in breathing, poor sucking, jaundice and lethargy/unconsciousness as new born danger signs respectively. Only 46 (11.1%) and 40 (9.7%) identified convulsion and hypothermia as new born danger signs respectively. Education Level, PNC accompaniment by Spouse, Danger signs information to Mother, Explanation of MCH booklet by Care provider during ANC and Mother read MCH Booklet were factors positively associated with improved knowledge of neonatal danger sign. In multivariate logistic regression none of the factors tested

[Are non-clinical studies predictive of adverse events in humans?].

PubMed

Claude, N

2007-09-01

The predictibility of adverse events induced by drugs in non-clinical safety studies performed on in vitro and/or in vivo models is a key point for the safety of humans exposed to pharmaceuticals. The strength and the weakness of animal studies to predict human toxicity were assessed by an international study on the concordance of the toxicity of 150 pharmaceuticals observed in humans with that observed in experimental animals. The results showed a good correlation (70% of the adverse events in humans were detected in animal studies) and an early time to first appearance of concordant animal toxicity: 94% were first observed in studies of 1 month or less in duration. The highest incidence of overall concordance was seen in hematological and cardiovascular adverse effects and the least was seen in cutaneous and ophthalmological adverse effects. These studies, scientifically and regulatory standardized, need, in some cases to be adapted to specific problems linked to sensitive populations (young, old or with a pathology which could be worsened by the drug), or specific pharmaceuticals (produced by biotechnology). Some severe adverse events are not detected in conventional animal models (immuno-allergy, idiosyncrasy). Taken together, these elements support the value of toxicology studies to predict many human toxic events associated with pharmaceuticals. Nevertheless, a part of human toxicity is not detected by these experimental approaches, and new tools developed through progress in biology and bio-informatics should reduce this uncertainly margin.

Modelling physiological deterioration in post-operative patient vital-sign data.

PubMed

Pimentel, Marco A F; Clifton, David A; Clifton, Lei; Watkinson, Peter J; Tarassenko, Lionel

2013-08-01

Patients who undergo upper-gastrointestinal surgery have a high incidence of post-operative complications, often requiring admission to the intensive care unit several days after surgery. A dataset comprising observational vital-sign data from 171 post-operative patients taking part in a two-phase clinical trial at the Oxford Cancer Centre, was used to explore the trajectory of patients' vital-sign changes during their stay in the post-operative ward using both univariate and multivariate analyses. A model of normality based vital-sign data from patients who had a "normal" recovery was constructed using a kernel density estimate, and tested with "abnormal" data from patients who deteriorated sufficiently to be re-admitted to the intensive care unit. The vital-sign distributions from "normal" patients were found to vary over time from admission to the post-operative ward to their discharge home, but no significant changes in their distributions were observed from halfway through their stay on the ward to the time of discharge. The model of normality identified patient deterioration when tested with unseen "abnormal" data, suggesting that such techniques may be used to provide early warning of adverse physiological events.

Medical Device Integrated Vital Signs Monitoring Application with Real-Time Clinical Decision Support.

PubMed

Moqeem, Aasia; Baig, Mirza; Gholamhosseini, Hamid; Mirza, Farhaan; Lindén, Maria

2018-01-01

This research involves the design and development of a novel Android smartphone application for real-time vital signs monitoring and decision support. The proposed application integrates market available, wireless and Bluetooth connected medical devices for collecting vital signs. The medical device data collected by the app includes heart rate, oxygen saturation and electrocardiograph (ECG). The collated data is streamed/displayed on the smartphone in real-time. This application was designed by adopting six screens approach (6S) mobile development framework and focused on user-centered approach and considered clinicians-as-a-user. The clinical engagement, consultations, feedback and usability of the application in the everyday practices were considered critical from the initial phase of the design and development. Furthermore, the proposed application is capable to deliver rich clinical decision support in real-time using the integrated medical device data.

Pirfenidone and nintedanib for pulmonary fibrosis in clinical practice: Tolerability and adverse drug reactions.

PubMed

Galli, Jonathan A; Pandya, Aloknath; Vega-Olivo, Michelle; Dass, Chandra; Zhao, Huaqing; Criner, Gerard J

2017-08-01

The real-world tolerability of pirfenidone and nintedanib in non-clinical trial patients is unknown. Many patients with pulmonary fibrosis have significant medical co-morbidities or baseline characteristics that exclude them from clinical trial participation. We conducted a retrospective chart review study on subjects prescribed nintedanib or pirfenidone for pulmonary fibrosis treatment (any aetiology) from September 2014 to February 2016. A total of 186 subjects were included: 129 received pirfenidone and 57 were prescribed nintedanib and followed up for mean observation periods of 52 ± 17 weeks for pirfenidone and 41 ± 15 weeks for nintedanib. The primary outcome was drug discontinuation as a result of an adverse event. Subjects had significant respiratory impairment at baseline, 63% required home oxygen therapy and mean diffusion capacity of carbon monoxide (DLCO) was 36 ± 14% predicted. Drug discontinuation as a result of an adverse event occurred in 20.9% of subjects on pirfenidone and 26.3% on nintedanib. Drug discontinuation rates for both pirfenidone and nintedanib did not significantly differ from corresponding large clinical trials (ASCEND/CAPACITY and INPULSIS 1 and 2, respectively). Adverse events that occurred with highest frequency on pirfenidone were nausea (26.4%), rash/photosensitivity (14.7%) and dyspepsia/gastroesophageal reflux disease (GERD) (12.4%). Diarrhoea (52.6%) and nausea (29.8%) were reported most often with nintedanib therapy. Patients with pulmonary fibrosis treated with nintedanib or pirfenidone in routine clinical practice had drug tolerability and adverse event profiles comparable with subjects enrolled in clinical trials despite having a greater degree of respiratory impairment and a high prevalence of co-morbid medical conditions. © 2017 Asian Pacific Society of Respirology.

Adverse interactions between herbal and dietary substances and prescription medications: a clinical survey.

PubMed

Bush, Thomas M; Rayburn, Keith S; Holloway, Sandra W; Sanchez-Yamamoto, Deanna S; Allen, Blaine L; Lam, Tiffany; So, Brian K; Tran, De H; Greyber, Elizabeth R; Kantor, Sophia; Roth, Larry W

2007-01-01

Patients often combine prescription medications with herbal and dietary substances (herein referred to as herbal medicines). A variety of potential adverse herb-drug interactions exist based on the pharmacological properties of herbal and prescription medications. To determine the incidence of potential and observed adverse herb-drug interactions in patients using herbal medicines with prescription medications. Consecutive patients were questioned about their use of herbal medicines in 6 outpatient clinics. Patients reporting use of these products provided a list of their prescription medications, which were reviewed for any potential adverse herb-drug interactions using a comprehensive natural medicine database. Any potential adverse herb-drug interactions prompted a review of the patient's chart for evidence of an observed adverse herb-drug interaction. The rate of potential and observed adverse herb-drug interactions. Eight hundred four patients were surveyed, and 122 (15%) used herbal medicines. Eighty-five potential adverse herb-drug interactions were found in 49 patients (40% of herbal medicine users). Twelve possible adverse herb-drug interactions in 8 patients (7% of herbal medicine users) were observed. In all 12 cases, the severity scores were rated as mild, including 8 cases of hypoglycemia in diabetics taking nopal (prickly pear cactus). A substantial number of potential adverse herb-drug interactions were detected and a small number of adverse herb-drug interactions observed, particularly in diabetics taking nopal. Screening for herbal medicine usage in 804 patients did not uncover any serious adverse interactions with prescription medications.

Association of clinical signs with endoscopic findings in horses with nasopharyngeal cicatrix syndrome: 118 cases (2003-2008).

PubMed

Norman, Tracy E; Chaffin, M Keith; Bisset, Wesley T; Thompson, James A

2012-03-15

To characterize the associations between clinical signs of nasopharyngeal cicatrix syndrome (NCS) and endoscopic findings in horses. Retrospective, case-control study. 239 horses (118 case horses and 121 control horses). Medical records of horses that had an endoscopic evaluation of the upper airway performed between January 2003 and December 2008 were reviewed. Clinical signs and the appearance and anatomic locations of lesions identified during endoscopic evaluation were reviewed and recorded for each horse. The associations between clinical signs and endoscopic findings were evaluated by the use of a prospective logistic model that used a Bayesian method for inference and was implemented by a Markov chain Monte Carlo method. Nasal discharge was associated with acute inflammation of the pharynx and larynx. Exercise intolerance was associated with circumferential pharyngeal lesions. Respiratory noise was associated with chronic scarring of the pharynx, a combination of pharyngeal and laryngeal scarring, and circumferential scarring of the pharynx. Respiratory distress was associated with acute inflammation of all portions of the airway, especially when there was preexisting scarring and narrowing of the airway by ≥ 50%. Cough did not have any significant association with NCS, compared with results in control horses. Associations between the endoscopic appearance of NCS lesions and relevant clinical signs will help practitioners identify horses with NCS and allow them to select appropriate treatment.

Clinical outcomes and adverse effect monitoring in allergic rhinitis.

PubMed

Juniper, Elizabeth F; Ståhl, Elisabeth; Doty, Richard L; Simons, F Estelle R; Allen, David B; Howarth, Peter H

2005-03-01

The subjective recording in diary cards of symptoms of itch, sneeze, nose running, and blockage, with the use of a rating scale to indicate the level of severity, is usual for clinical trials in allergic rhinitis. The primary outcome measure is usually a composite score that enables a single total symptoms score endpoint. It is appreciated, however, that rhinitis has a greater effect on the individual than is reflected purely by the recording of anterior nasal symptoms. Nasal obstruction is troublesome and may lead to sleep disturbance in addition to impaired daytime concentration and daytime sleepiness. These impairments affect school and work performance. Individuals with rhinitis find it socially embarrassing to be seen sneezing, sniffing, or blowing their nose. To capture these and other aspects of the disease-specific health-related quality of life, questionnaires such as the Rhinoconjunctivitis Quality of Life Questionnaire have been developed and validated for clinical trial use. The adoption of health-related quality of life questionnaires into clinical trials broadens the information obtained regarding the effect of the therapeutic intervention and helps focus on issues relevant to the individual patient. It must be appreciated that it is not only the disease that may adversely affect health-related quality of life; administered therapy, although intended to be beneficial, may also cause health impairment. Adverse-event monitoring is thus essential in clinical trials. The first-generation H 1 -histamines, because of their effect on central H 1 -receptors, are classically associated with central nervous system (CNS) effects such as sedation. Although this is not always perceived by the patient, it is clearly evident with objective performance testing, and positron emission tomography scanning has directly demonstrated the central H 1 -receptor occupancy. The second-generation H 1 -antihistamines have reduced central H 1 -receptor occupancy and considerably

[Analysis of rational clinical uses of traditional Chinese medicine injections and factors influencing adverse drug reactions].

PubMed

Sun, Shi-Guang; Li, Zi-Feng; Xie, Yan-Ming; Liu, Jian; Lu, Yan; Song, Yi-Fei; Han, Ying-Hua; Liu, Li-Da; Peng, Ting-Ting

2013-09-01

To rationalize the clinical use and safety are some of the key issues in the surveillance of traditional Chinese medicine injections (TCMIs). In this 2011 study, 240 medical records of patients who had been discharged following treatment with TCMIs between 1 and 12 month previously were randomly selected from hospital records. Consistency between clinical use and the description of TCMIs was evaluated. Research on drug use and adverse drug reactions/events using logistic regression analysis was carried out. There was poor consistency between clinical use and best practice advised in manuals on TCMIs. Over-dosage and overly concentrated administration of TCMIs occurred, with the outcome of modifying properties of the blood. Logistic regression analysis showed that, drug concentration was a valid predictor for both adverse drug reactions/events and benefits associated with TCMIs. Surveillance of rational clinical use and safety of TCMIs finds that clinical use should be consistent with technical drug manual specifications, and drug use should draw on multi-layered logistic regression analysis research to help avoid adverse drug reactions/events.

Cheyletiella infestation in the dog: observations on diagnostic methods and clinical signs.

PubMed

Saevik, B K; Bredal, W; Ulstein, T L

2004-10-01

The aims of this study were to evaluate the ability of diagnostic methods to detect naturally occurring Cheyletiella infestation in dogs, and to quantify and relate the number of mites and eggs present to clinical signs. Privately owned dogs with skin problems were eligible for inclusion in the study. Four diagnostic tests were performed on each dog in the following order: tape impression, hair plucking, skin scraping and vacuum cleaning. Dogs with positive test results for Cheyletiella infestation in at least one of the tests under evaluation were included in the study (n=27). The severity of pruritus and scaling was graded on a four-point fixed scale. The diagnostic findings in vacuum cleaning samples provided a semiquantitative measure of the grade of infestation. The vacuum cleaning test gave a positive test result in all dogs and was significantly more efficient than the other tests evaluated (P<0.01). The number of diagnostic findings varied considerably among the different vacuum samples. No significant relationship between the number of diagnostic findings and severity of clinical signs was detected.

Intervertebral disk width in dogs with and without clinical signs of disk associated cervical spondylomyelopathy

PubMed Central

2012-01-01

Background Disk-associated cervical spondylomyelopathy (DA-CSM) is a multifactorial neurological disorder in which progressive caudal cervical spinal cord compression is mainly caused by one or more intervertebral disk protrusions. The Doberman pinscher breed seems predisposed for this condition. The underlying cause and pathophysiology of DA-CSM are currently unknown. Recently, wider intervertebral disks have been put forward as a risk factor for development of clinically relevant DA-CSM. However, little is known about other factors affecting intervertebral disk width. Therefore the aim of this study was to assess the association between intervertebral disk width, measured on magnetic resonance imaging (MRI), and clinical status, age, gender and intervertebral disk location in dogs with and without clinical signs of DA-CSM. Methods Doberman pinschers with clinical signs of DA-CSM (N=17),clinically normal Doberman pinschers (N=20), and clinically normal English Foxhounds (N=17), underwent MRI of the cervical vertebral column. On sagittal T2-weighted images, intervertebral disk width was measured from C2-C3 to C6-C7. Intra –and interobserver agreement were assessed on a subset of 20 of the 54 imaging studies. Results Intervertebral disk width was not significantly different between Doberman pinschers with clinical signs of DA-CSM, clinically normal Doberman pinschers or clinically normal English Foxhounds (p=0.43). Intervertebral disk width was positively associated with increasing age (p=0.029). Each monthly increase in age resulted in an increase of disk width by 0.0057mm. Intervertebral disk width was not significantly affected by gender (p=0.056), but was significantly influenced by intervertebral disk location (p <0.0001). The assessed measurements were associated with a good intra –and interobserver agreement. Conclusions The present study does not provide evidence that wider intervertebral disks are associated with clinical status in dogs with and without

Scoring clinical signs can help diagnose canine visceral leishmaniasis in a highly endemic area in Brazil

PubMed Central

da Silva, Kleverton Ribeiro; de Mendonça, Vitor Rosa Ramos; Silva, Kellen Matuzzy; do Nascimento, Leopoldo Fabrício Marçal; Mendes-Sousa, Antonio Ferreira; de Pinho, Flaviane Alves; Barral-Netto, Manoel; Barral, Aldina Maria Prado; Cruz, Maria do Socorro Pires e

2017-01-01

Canine visceral leishmaniasis (CVL) diagnosis is still a challenge in endemic areas with limited diagnostic resources. This study proposes a score with the potential to distinguish positive CVL cases from negative ones. We studied 265 dogs that tested positive for CVL on ELISA and parasitological tests. A score ranging between 0 and 19 was recorded on the basis of clinical signs. Dogs with CVL had an overall higher positivity of the majority of clinical signs than did dogs without CVL or with ehrlichiosis. Clinical signs such as enlarged lymph nodes (83.93%), muzzle/ear lesions (55.36%), nutritional status (51.79%), bristle condition (57.14%), pale mucosal colour (48.21%), onychogryphosis (58.93%), skin lesion (39.28%), bleeding (12.50%), muzzle depigmentation (41.07%), alopecia (39.29%), blepharitis (21.43%), and keratoconjunctivitis (42.86%) were more frequent in dogs with CVL than in dogs with ehrlichiosis or without CVL. Moreover, the clinical score increased according to the positivity of all diagnostic tests (ELISA, p < 0.001; parasite culture, p = 0.0021; and smear, p = 0.0003). Onychogryphosis (long nails) [odds ratio (OR): 3.529; 95% confidence interval (CI): 1.832-6.796; p < 0.001], muzzle depigmentation (OR: 4.651; 95% CI: 2.218-9.750; p < 0.001), and keratoconjunctivitis (OR: 5.400; 95% CI: 2.549-11.441; p < 0.001) were highly associated with CVL. Interestingly, a score cut-off value ≥ 6 had an area under the curve of 0.717 (p < 0.0001), sensitivity of 60.71%, and specificity of 73.64% for CVL diagnosis. The clinical sign-based score for CVL diagnosis suggested herein can help veterinarians reliably identify dogs with CVL in endemic areas with limited diagnostic resources. PMID:28076469

Scoring clinical signs can help diagnose canine visceral leishmaniasis in a highly endemic area in Brazil.

PubMed

Silva, Kleverton Ribeiro da; Mendonça, Vitor Rosa Ramos de; Silva, Kellen Matuzzy; Nascimento, Leopoldo Fabrício Marçal do; Mendes-Sousa, Antonio Ferreira; Pinho, Flaviane Alves de; Barral-Netto, Manoel; Barral, Aldina Maria Prado; Cruz, Maria do Socorro Pires E

2017-01-01

Canine visceral leishmaniasis (CVL) diagnosis is still a challenge in endemic areas with limited diagnostic resources. This study proposes a score with the potential to distinguish positive CVL cases from negative ones. We studied 265 dogs that tested positive for CVL on ELISA and parasitological tests. A score ranging between 0 and 19 was recorded on the basis of clinical signs. Dogs with CVL had an overall higher positivity of the majority of clinical signs than did dogs without CVL or with ehrlichiosis. Clinical signs such as enlarged lymph nodes (83.93%), muzzle/ear lesions (55.36%), nutritional status (51.79%), bristle condition (57.14%), pale mucosal colour (48.21%), onychogryphosis (58.93%), skin lesion (39.28%), bleeding (12.50%), muzzle depigmentation (41.07%), alopecia (39.29%), blepharitis (21.43%), and keratoconjunctivitis (42.86%) were more frequent in dogs with CVL than in dogs with ehrlichiosis or without CVL. Moreover, the clinical score increased according to the positivity of all diagnostic tests (ELISA, p < 0.001; parasite culture, p = 0.0021; and smear, p = 0.0003). Onychogryphosis (long nails) [odds ratio (OR): 3.529; 95% confidence interval (CI): 1.832-6.796; p < 0.001], muzzle depigmentation (OR: 4.651; 95% CI: 2.218-9.750; p < 0.001), and keratoconjunctivitis (OR: 5.400; 95% CI: 2.549-11.441; p < 0.001) were highly associated with CVL. Interestingly, a score cut-off value ≥ 6 had an area under the curve of 0.717 (p < 0.0001), sensitivity of 60.71%, and specificity of 73.64% for CVL diagnosis. The clinical sign-based score for CVL diagnosis suggested herein can help veterinarians reliably identify dogs with CVL in endemic areas with limited diagnostic resources.

[Implementation of bedside training and advanced objective structured clinical examination (OSCE) trial to learn and confirm about pharmacy clinical skills].

PubMed

Tokunaga, Jin; Takamura, Norito; Ogata, Kenji; Setoguchi, Nao; Sato, Keizo

2013-01-01

Bedside training for fourth-year students, as well as seminars in hospital pharmacy (vital sign seminars) for fifth-year students at the Department of Pharmacy of Kyushu University of Health and Welfare have been implemented using patient training models and various patient simulators. The introduction of simulation-based pharmaceutical education, where no patients are present, promotes visually, aurally, and tactilely simulated learning regarding the evaluation of vital signs and implementation of physical assessment when disease symptoms are present or adverse effects occur. A patient simulator also promotes the creation of training programs for emergency and critical care, with which basic as well as advanced life support can be practiced. In addition, an advanced objective structured clinical examination (OSCE) trial has been implemented to evaluate skills regarding vital signs and physical assessments. Pharmacists are required to examine vital signs and conduct physical assessment from a pharmaceutical point of view. The introduction of these pharmacy clinical skills will improve the efficacy of drugs, work for the prevention or early detection of adverse effects, and promote the appropriate use of drugs. It is considered that simulation-based pharmaceutical education is essential to understand physical assessment, and such education will ideally be applied and developed according to on-site practices.

Mirror movements in parkinsonism: evaluation of a new clinical sign

PubMed Central

Espay, A; Li, J; Johnston, L; Chen, R; Lang, A

2005-01-01

Background: Mirror movements (MM) are not widely appreciated in parkinsonism and no report has evaluated this clinical sign in detail. Objectives: To define the parkinsonian clinical features associated with MM in patients with early, asymmetric parkinsonism. Methods: Twenty seven patients with early Parkinson's disease were evaluated using a standardised videotaping protocol. MM were scored from blinded video assessment using a clinical scale that rates the amplitude, distribution, and proportion of mirroring in the less affected limb. Parkinsonian features were combined into axial and lateralised scores using related items of the Unified Parkinson's Disease Rating Scale. Results: MM were present in 24 of 27 patients. There was a significant linear correlation between the degree of asymmetry of motor deficits and MM on the less affected side. The effect of asymmetry was greater when the proportional rather than the absolute motor difference between sides was largest. Asymmetry in leg rigidity was the most important examination feature in the prediction of contralateral foot mirroring. Conclusions: MM are a clinical feature of the unaffected or less affected side in mild asymmetric parkinsonism. Their presence may be a useful clinical finding in early parkinsonism. PMID:16170075

Challenges in Coding Adverse Events in Clinical Trials: A Systematic Review

PubMed Central

Schroll, Jeppe Bennekou; Maund, Emma; Gøtzsche, Peter C.

2012-01-01

Background Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation. Adverse events are categorised by a predefined dictionary, e.g. MedDRA, which is updated biannually with many new categories. The objective of this paper is to study interobserver variation and other challenges of coding. Methods Systematic review using PRISMA. We searched PubMed, EMBASE and The Cochrane Library. All studies were screened for eligibility by two authors. Results Our search returned 520 unique studies of which 12 were included. Only one study investigated interobserver variation. It reported that 12% of the codes were evaluated differently by two coders. Independent physicians found that 8% of all the codes deviated from the original description. Other studies found that product summaries could be greatly affected by the choice of dictionary. With the introduction of MedDRA, it seems to have become harder to identify adverse events statistically because each code is divided in subgroups. To account for this, lumping techniques have been developed but are rarely used, and guidance on when to use them is vague. An additional challenge is that adverse events are censored if they already occurred in the run-in period of a trial. As there are more than 26 ways of determining whether an event has already occurred, this can lead to bias, particularly because data analysis is rarely performed blindly. Conclusion There is a lack of evidence that coding of adverse events is a reliable, unbiased and reproducible process. The increase in categories has made detecting adverse events harder, potentially compromising safety. It is crucial that readers of medical publications are aware of these challenges. Comprehensive interobserver studies are needed. PMID

Severe Cutaneous Adverse Reactions: The Pharmacogenomics from Research to Clinical Implementation

PubMed Central

Su, Shih-Chi; Hung, Shuen-Iu; Fan, Wen-Lang; Dao, Ro-Lan; Chung, Wen-Hung

2016-01-01

Severe cutaneous adverse reactions (SCARs), previously thought to be idiosyncratic or unpredictable, are a deadly form of adverse drug reactions with skin manifestations. Current pharmacogenomic studies of SCARs have made important strides, as the prevention of SCARs, to some extent, appears attainable with the identification of genetic variants for genes encoding drug-metabolizing enzymes and human leukocyte antigens (HLAs). Despite the improvement of incidence, a treatment guideline for this devastating condition is still unavailable, highlighting the inadequacy of contemporary accepted therapeutic interventions. As such, prompt withdrawal of causative drugs is believed to be a priority of patient management. In this review, we discuss recent cutting-edge findings concerning the discovery of biomarkers for SCARs and their clinical utilities in the better prediction and early diagnosis of this disease. The knowledge compiled herein provides clues for future investigations on deciphering additional genetic markers for SCARs and the design of clinical trials for the prospective identification of subjects at genetic risk for this condition, ultimately personalizing the medicine. PMID:27854302

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

PubMed

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

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

PubMed Central

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 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. 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 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. Conclusion 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

Clinical and imaging features in lung torsion and description of a novel imaging sign.

PubMed

Hammer, Mark M; Madan, Rachna

2018-04-01

We set out to identify the clinical and imaging features seen in lung torsion, a rare but emergent diagnosis leading to vascular compromise of a lobe or entire lung. We retrospectively identified 10 patients with torsion who underwent chest CT. We evaluated each case for the presence of bronchial obstruction and abnormal fissure orientation. In seven patients who underwent contrast-enhanced CTs, we assessed for the presence of the antler sign, a novel sign seen on axial images demonstrating abnormal curvature of the artery and branches originating on one side. Five patients had right middle lobe (RML) torsion after right upper lobectomy, and the remaining occurred following thoracentesis, aortic surgery, or spontaneously. Chest CTs demonstrated bronchial obstruction in eight cases and presence of abnormal fissure orientation in four patients. The antler sign was present in three patients with whole-lung torsion and one patient with lobar torsion; vascular swirling was seen on 3-D images in all seven patients with contrast-enhanced CTs. Lung parenchymal imaging findings in lung torsion may be non-specific. Identification of the antler sign on contrast-enhanced chest CT, in combination with other signs such as bronchial obstruction and abnormal fissure orientation, indicates rotation of the bronchovascular pedicle. The presence of this sign should prompt further evaluation with 3-dimensional reconstructions.

[Adverse effects of oxcarbazepine].

PubMed

Fang, Shu; Gong, Zhi-Cheng

2015-04-01

Oxcarbazepine is a new antiepileptic drug. The results of clinical trials suggest that oxcarbazepine is well tolerated and has less drug interactions. It is being used more and more widely in clinical practice, but its adverse effects should not be ignored. The most common adverse effects of oxcarbazepine are usually related to the central nervous system and digestive system, including fatigue, drowsiness, diplopia, dizziness, nausea and vomit. The common skin adverse reaction is rash. Long-term use of oxcarbazepine may also cause hyponatremia. This article reviews the literature from China and overseas about the adverse effets of oxcarbazepine over the last 10 years in order to find information about rational clinical use of oxcarbazepine.

Clinical signs of impending death in cancer patients.

PubMed

Hui, David; dos Santos, Renata; Chisholm, Gary; Bansal, Swati; Silva, Thiago Buosi; Kilgore, Kelly; Crovador, Camila Souza; Yu, Xiaoying; Swartz, Michael D; Perez-Cruz, Pedro Emilio; Leite, Raphael de Almeida; Nascimento, Maria Salete de Angelis; Reddy, Suresh; Seriaco, Fabiola; Yennu, Sriram; Paiva, Carlos Eduardo; Dev, Rony; Hall, Stacy; Fajardo, Julieta; Bruera, Eduardo

2014-06-01

The physical signs of impending death have not been well characterized in cancer patients. A better understanding of these signs may improve the ability of clinicians to diagnose impending death. We examined the frequency and onset of 10 bedside physical signs and their diagnostic performance for impending death. We systematically documented 10 physical signs every 12 hours from admission to death or discharge in 357 consecutive patients with advanced cancer admitted to two acute palliative care units. We examined the frequency and median onset of each sign from death backward and calculated their likelihood ratios (LRs) associated with death within 3 days. In total, 203 of 357 patients (52 of 151 in the U.S., 151 of 206 in Brazil) died. Decreased level of consciousness, Palliative Performance Scale ≤20%, and dysphagia of liquids appeared at high frequency and >3 days before death and had low specificity (<90%) and positive LR (<5) for impending death. In contrast, apnea periods, Cheyne-Stokes breathing, death rattle, peripheral cyanosis, pulselessness of radial artery, respiration with mandibular movement, and decreased urine output occurred mostly in the last 3 days of life and at lower frequency. Five of these signs had high specificity (>95%) and positive LRs for death within 3 days, including pulselessness of radial artery (positive LR: 15.6; 95% confidence interval [CI]: 13.7-17.4), respiration with mandibular movement (positive LR: 10; 95% CI: 9.1-10.9), decreased urine output (positive LR: 15.2; 95% CI: 13.4-17.1), Cheyne-Stokes breathing (positive LR: 12.4; 95% CI: 10.8-13.9), and death rattle (positive LR: 9; 95% CI: 8.1-9.8). We identified highly specific physical signs associated with death within 3 days among cancer patients. ©AlphaMed Press.

In-hospital death and adverse clinical events in elderly patients according to disease clustering: the REPOSI study.

PubMed

Marengoni, A; Bonometti, F; Nobili, A; Tettamanti, M; Salerno, F; Corrao, S; Iorio, A; Marcucci, M; Mannucci, P M

2010-08-01

The aim of the study was to recognize clusters of diseases among hospitalized elderly and to identify groups of patients at risk of in-hospital death and adverse clinical events according to disease clustering. This was a cross-sectional study conducted in 38 internal medicine and geriatric wards in Italy participating in the Registro Politerapie SIMI (REPOSI) study during 2008. The subjects were 1,332 inpatients aged 65 years or older. Clusters of diseases (i.e., two or more co-occurrent diseases) were identified using the odds ratios (OR) for the associations between pairs of conditions, followed by cluster analysis. Logistic regression models were used to evaluate the effect of disease clusters on in-hospital death and adverse clinical events. A total of 86.7% of the patients were discharged, 8.3% were transferred to another hospital unit, and 5.0% died during hospitalization; 36.4% of the patients had at least one adverse clinical event. Patients affected by the clusters, including heart failure (HF) and either chronic renal failure (CRF) or chronic obstructive pulmonary disease, had a significant association with in-hospital death (OR, 4.3;95% confidence interval [CI], 1.6-11.5; OR, 2.9; 95% CI, 1.1-8.3, respectively), as well as patients affected by CRF and anemia (OR, 6.1; 95% CI, 2.3-16.2). The cluster including HF and CRF was also associated with adverse clinical events (OR, 3.5; 95% CI, 1.5-7.8). The effect of both HF and CRF and anemia and CRF on in-hospital death was additive. Several groups of older patients at risk of in-hospital death and adverse clinical events were identified according to disease clustering. Knowledge of the relationship among co-occurring diseases may help developing strategies to improve clinical practice and preventative interventions.

Evaluation of clinically significant adverse events in patients discharged from a tertiary-care emergency department in Taiwan

PubMed Central

Wang, Lee-Min; How, Chorng-Kuang; Yang, Ming-Chin; Su, Syi

2013-01-01

Objective To investigate the reasons for the occurrence of clinically significant adverse events (CSAEs) in emergency department-discharged patients through emergency physicians' (EPs) subjective reasoning and senior EPs' objective evaluation. Design This was a combined prospective follow-up and retrospective review of cases of consecutive adult non-traumatic patients who presented to a tertiary-care emergency department in Taiwan between 1 September 2005 and 31 July 2006. Data were extracted from ‘on-duty EPs' subjective reasoning for discharging patients with CSAEs (study group) and without CSAEs (control group)’ and ‘objective evaluation of CSAEs by senior EPs, using clinical evidences such as recording history, physical examinations, laboratory/radiological examinations and observation of inadequacies in the basic management process (such as recording history, physical examinations, laboratory/radiological examinations and observation) as the guide’. Subjective reasons for discharging patients’ improvement of symptoms, and the certainty of safety of the discharge were compared in the two groups using χ2 statistics or t test. Results Of the 20 512 discharged cases, there were 1370 return visits (6.7%, 95% CI 6.3% to 7%) and 165 CSAEs due to physicians' factors (0.82%, 95% CI 0.75% to 0.95%). In comparisons between the study group and the control group, only some components of discharge reasoning showed a significant difference (p<0.001). Inadequacies in the basic management process were the main cause of CSAEs (164/165). Conclusion The authors recommended that EP follow-up of the basic management processes (including history record, physical examination, laboratory and radiological examinations, clinical symptoms/signs and treatment) using clinical evidence as a guideline should be made mandatory. PMID:22433586

The value of vital sign trends for detecting clinical deterioration on the wards

PubMed Central

Churpek, Matthew M; Adhikari, Richa; Edelson, Dana P

2016-01-01

Aim Early detection of clinical deterioration on the wards may improve outcomes, and most early warning scores only utilize a patient’s current vital signs. The added value of vital sign trends over time is poorly characterized. We investigated whether adding trends improves accuracy and which methods are optimal for modelling trends. Methods Patients admitted to five hospitals over a five-year period were included in this observational cohort study, with 60% of the data used for model derivation and 40% for validation. Vital signs were utilized to predict the combined outcome of cardiac arrest, intensive care unit transfer, and death. The accuracy of models utilizing both the current value and different trend methods were compared using the area under the receiver operating characteristic curve (AUC). Results A total of 269,999 patient admissions were included, which resulted in 16,452 outcomes. Overall, trends increased accuracy compared to a model containing only current vital signs (AUC 0.78 vs. 0.74; p<0.001). The methods that resulted in the greatest average increase in accuracy were the vital sign slope (AUC improvement 0.013) and minimum value (AUC improvement 0.012), while the change from the previous value resulted in an average worsening of the AUC (change in AUC −0.002). The AUC increased most for systolic blood pressure when trends were added (AUC improvement 0.05). Conclusion Vital sign trends increased the accuracy of models designed to detect critical illness on the wards. Our findings have important implications for clinicians at the bedside and for the development of early warning scores. PMID:26898412

The value of vital sign trends for detecting clinical deterioration on the wards.

PubMed

Churpek, Matthew M; Adhikari, Richa; Edelson, Dana P

2016-05-01

Early detection of clinical deterioration on the wards may improve outcomes, and most early warning scores only utilize a patient's current vital signs. The added value of vital sign trends over time is poorly characterized. We investigated whether adding trends improves accuracy and which methods are optimal for modelling trends. Patients admitted to five hospitals over a five-year period were included in this observational cohort study, with 60% of the data used for model derivation and 40% for validation. Vital signs were utilized to predict the combined outcome of cardiac arrest, intensive care unit transfer, and death. The accuracy of models utilizing both the current value and different trend methods were compared using the area under the receiver operating characteristic curve (AUC). A total of 269,999 patient admissions were included, which resulted in 16,452 outcomes. Overall, trends increased accuracy compared to a model containing only current vital signs (AUC 0.78 vs. 0.74; p<0.001). The methods that resulted in the greatest average increase in accuracy were the vital sign slope (AUC improvement 0.013) and minimum value (AUC improvement 0.012), while the change from the previous value resulted in an average worsening of the AUC (change in AUC -0.002). The AUC increased most for systolic blood pressure when trends were added (AUC improvement 0.05). Vital sign trends increased the accuracy of models designed to detect critical illness on the wards. Our findings have important implications for clinicians at the bedside and for the development of early warning scores. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Pulsed versus continuous wave low-level light therapy on osteoarticular signs and symptoms in limited scleroderma (CREST syndrome): a case report

NASA Astrophysics Data System (ADS)

Barolet, Daniel

2014-11-01

Limited cutaneous systemic sclerosis (lcSSc) was formerly known as CREST syndrome in reference to the associated clinical features: calcinosis, Raynaud's phenomenon, esophageal dysfunction, sclerodactyly, and telangiectasias. The transforming growth factor beta has been identified as a major player in the pathogenic process, where low-level light therapy (LLLT) has been shown to modulate this cytokine superfamily. This case study was conducted to assess the efficacy of 940 nm using millisecond pulsing and continuous wave (CW) modes on osteoarticular signs and symptoms associated with lcSSc. The patient was treated two to three times a week for 13 weeks using a sequential pulsing mode on one elbow and a CW mode on the other. Efficacy assessments included inflammation, symptoms, pain, health scales, patient satisfaction, clinical global impression, and adverse effects monitoring. Considerable functional and morphologic improvements were observed after LLLT, with the best results seen with the pulsing mode. No adverse effects were noted. Pulsed LLLT represents a treatment alternative for osteoarticular signs and symptoms in limited scleroderma (CREST syndrome).

Vital signs monitoring and nurse-patient interaction: A qualitative observational study of hospital practice.

PubMed

Cardona-Morrell, M; Prgomet, M; Lake, R; Nicholson, M; Harrison, R; Long, J; Westbrook, J; Braithwaite, J; Hillman, K

2016-04-01

High profile safety failures have demonstrated that recognising early warning signs of clinical and physiological deterioration can prevent or reduce harm resulting from serious adverse events. Early warning scoring systems are now routinely used in many places to detect and escalate deteriorating patients. Timely and accurate vital signs monitoring are critical for ensuring patient safety through providing data for early warning scoring systems, but little is known about current monitoring practices. To establish a profile of nurses' vital signs monitoring practices, related dialogue, and adherence to health service protocol in New South Wales, Australia. Direct observations of nurses' working practices were conducted in two wards. The observations focused on times of the day when vital signs were generally measured. Patient interactions were recorded if occurring any time during the observation periods. Participants (n=42) included nursing staff on one chronic disease medical and one acute surgical ward in a large urban teaching hospital in New South Wales. We observed 441 patient interactions. Measurement of vital signs occurred in 52% of interactions. The minimum five vital signs measures required by New South Wales Health policy were taken in only 6-21% of instances of vital signs monitoring. Vital signs were documented immediately on 93% of vitals-taking occasions and documented according to the policy in the patient's chart on 89% of these occasions. Nurse-patient interactions were initiated for the purpose of taking vital signs in 49% of interactions, with nurse-patient discourse observed during 88% of all interactions. Nurse-patient dialogue led to additional care being provided to patients in 12% of interactions. The selection of appropriate vital signs measured and responses to these appears to rely on nurses' clinical judgement or time availability rather than on policy-mandated frequency. The prevalence of incomplete sets of vital signs may limit

The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis.

PubMed

Rolfes, Leàn; van Hunsel, Florence; van der Linden, Laura; Taxis, Katja; van Puijenbroek, Eugène

2017-07-01

Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients. The aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional. A retrospective analysis of all ADR reports on the same case, i.e., cases with a report from both the patient and the patient's healthcare professional, selected from the database of the Dutch Pharmacovigilance Center Lareb, was conducted. The extent to which relevant clinical information was reported was assessed by trained pharmacovigilance assessors, using a structured tool. The following four domains were assessed: ADR, chronology, suspected drug, and patient characteristics. For each domain, the proportion of reported information in relation to information deemed relevant was calculated. An average score of all relevant domains was determined and categorized as poorly (≤45%), moderately (from 46 to 74%) or well (≥75%) reported. Data were analyzed using a paired sample t test and Wilcoxon signed rank test. A total of 197 cases were included. In 107 cases (54.3%), patients and healthcare professionals reported a similar level of clinical information. Statistical analysis demonstrated no overall differences between the groups (p = 0.126). In a unique study of cases of ADRs reported by patients and healthcare professionals, we found that patients report clinical information at a similar level as their healthcare professional. For an optimal pharmacovigilance, both healthcare professionals and patient should be encouraged to report.

New Toronto clinic for men may be sign of growing entrepreneurship within medicine.

PubMed Central

Lowry, F

1995-01-01

A Toronto physician has opened a new clinic for male patients, particularly highly stressed executives, who pay to have their physical, mental and nutritional health assessed. The Health Institute for Men, which opened in January, is located close to the Toronto Stock Exchange. It charges $450 for the initial visit, which includes a complete history, mental-assessment exam and thorough physical. The chair of the CMA Board of Directors considers the clinic a sign of growing entrepreneurship within Canadian medicine. Images p204-a p204-b PMID:7600471

Outbreak of Adverse Reactions Associated with Contaminated Heparin

PubMed Central

Blossom, David B.; Kallen, Alexander J.; Patel, Priti R.; Elward, Alexis; Robinson, Luke; Gao, Ganpan; Langer, Robert; Perkins, Kiran M.; Jaeger, Jennifer L.; Kurkjian, Katie M.; Jones, Marilyn; Schillie, Sarah F.; Shehab, Nadine; Ketterer, Daniel; Venkataraman, Ganesh; Kishimoto, Takashi Kei; Shriver, Zachary; McMahon, Ann W.; Austen, K. Frank; Kozlowski, Steven; Srinivasan, Arjun; Turabelidze, George; Gould, Carolyn V.; Arduino, Matthew J.; Sasisekharan, Ram

2013-01-01

BACKGROUND In January 2008, the Centers for Disease Control and Prevention began a nationwide investigation of severe adverse reactions that were first detected in a single hemodialysis facility. Preliminary findings suggested that heparin was a possible cause of the reactions. METHODS Information on clinical manifestations and on exposure was collected for patients who had signs and symptoms that were consistent with an allergic-type reaction after November 1, 2007. Twenty-one dialysis facilities that reported reactions and 23 facilities that reported no reactions were included in a case–control study to identify facility-level risk factors. Unopened heparin vials from facilities that reported reactions were tested for contaminants. RESULTS A total of 152 adverse reactions associated with heparin were identified in 113 patients from 13 states from November 19, 2007, through January 31, 2008. The use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions (present in 100.0% of case facilities vs. 4.3% of control facilities, P<0.001). Vials of heparin manufactured by Baxter from facilities that reported reactions contained a contaminant identified as oversulfated chondroitin sulfate (OSCS). Adverse reactions to the OSCS-contaminated heparin were often characterized by hypotension, nausea, and shortness of breath occurring within 30 minutes after administration. Of 130 reactions for which information on the heparin lot was available, 128 (98.5%) occurred in a facility that had OSCS-contaminated heparin on the premises. Of 54 reactions for which the lot number of administered heparin was known, 52 (96.3%) occurred after the administration of OSCS-contaminated heparin. CONCLUSIONS Heparin contaminated with OSCS was epidemiologically linked to adverse reactions in this nationwide outbreak. The reported clinical features of many of the cases further support the conclusion that contamination of heparin with OSCS was the cause

From vital signs to clinical outcomes for patients with sepsis: a machine learning basis for a clinical decision support system

PubMed Central

Gultepe, Eren; Green, Jeffrey P; Nguyen, Hien; Adams, Jason; Albertson, Timothy; Tagkopoulos, Ilias

2014-01-01

Objective To develop a decision support system to identify patients at high risk for hyperlactatemia based upon routinely measured vital signs and laboratory studies. Materials and methods Electronic health records of 741 adult patients at the University of California Davis Health System who met at least two systemic inflammatory response syndrome criteria were used to associate patients’ vital signs, white blood cell count (WBC), with sepsis occurrence and mortality. Generative and discriminative classification (naïve Bayes, support vector machines, Gaussian mixture models, hidden Markov models) were used to integrate heterogeneous patient data and form a predictive tool for the inference of lactate level and mortality risk. Results An accuracy of 0.99 and discriminability of 1.00 area under the receiver operating characteristic curve (AUC) for lactate level prediction was obtained when the vital signs and WBC measurements were analysed in a 24 h time bin. An accuracy of 0.73 and discriminability of 0.73 AUC for mortality prediction in patients with sepsis was achieved with only three features: median of lactate levels, mean arterial pressure, and median absolute deviation of the respiratory rate. Discussion This study introduces a new scheme for the prediction of lactate levels and mortality risk from patient vital signs and WBC. Accurate prediction of both these variables can drive the appropriate response by clinical staff and thus may have important implications for patient health and treatment outcome. Conclusions Effective predictions of lactate levels and mortality risk can be provided with a few clinical variables when the temporal aspect and variability of patient data are considered. PMID:23959843

Adverse reactions to two intravenous antibiotics (Augmentin and Zinacef) used for surgical prophylaxis in dogs.

PubMed

Gosling, Mark James; Martínez-Taboada, Fernando

2018-01-20

Antibiotic prophylaxis in dogs undergoing surgical procedures frequently involves the administration of a product without a veterinary licence. Two drugs commonly used for this purpose are the clavulanate amoxicillin Augmentin and the cefuroxime Zinacef. This prospective observational study aims to compare the incidence of adverse events associated with these two antibiotics in a clinical setting. The authors hypothesised that a higher incidence of adverse effects would be observed with Augmentin. Sixty-five dogs were included in the study and adverse events were recorded using a modified scoring system. A significantly higher incidence of adverse events to Augmentin (8/22; 36 per cent) was observed compared with Zinacef (1/43; 2 per cent) (P=0.0003). The majority of these adverse events involved cutaneous signs and/or hypotension. These findings might be taken into consideration when selecting one of these intravenous antibiotics for prophylaxis in anaesthetised dogs undergoing surgery. © British Veterinary Association (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

How to improve vital sign data quality for use in clinical decision support systems? A qualitative study in nine Swedish emergency departments.

PubMed

Skyttberg, Niclas; Vicente, Joana; Chen, Rong; Blomqvist, Hans; Koch, Sabine

2016-06-04

Vital sign data are important for clinical decision making in emergency care. Clinical Decision Support Systems (CDSS) have been advocated to increase patient safety and quality of care. However, the efficiency of CDSS depends on the quality of the underlying vital sign data. Therefore, possible factors affecting vital sign data quality need to be understood. This study aims to explore the factors affecting vital sign data quality in Swedish emergency departments and to determine in how far clinicians perceive vital sign data to be fit for use in clinical decision support systems. A further aim of the study is to provide recommendations on how to improve vital sign data quality in emergency departments. Semi-structured interviews were conducted with sixteen physicians and nurses from nine hospitals and vital sign documentation templates were collected and analysed. Follow-up interviews and process observations were done at three of the hospitals to verify the results. Content analysis with constant comparison of the data was used to analyse and categorize the collected data. Factors related to care process and information technology were perceived to affect vital sign data quality. Despite electronic health records (EHRs) being available in all hospitals, these were not always used for vital sign documentation. Only four out of nine sites had a completely digitalized vital sign documentation flow and paper-based triage records were perceived to provide a better mobile workflow support than EHRs. Observed documentation practices resulted in low currency, completeness, and interoperability of the vital signs. To improve vital sign data quality, we propose to standardize the care process, improve the digital documentation support, provide workflow support, ensure interoperability and perform quality control. Vital sign data quality in Swedish emergency departments is currently not fit for use by CDSS. To address both technical and organisational challenges, we propose

Disclosing clinical adverse events to patients: can practice inform policy?

PubMed Central

Sorensen, Ros; Iedema, Rick; Piper, Donella; Manias, Elizabeth; Williams, Allison; Tuckett, Anthony

2009-01-01

Abstract Objectives  To understand patients’ and health professionals’ experience of Open Disclosure and how practice can inform policy. Background  Open Disclosure procedures are being implemented in health services worldwide yet empirical evidence on which to base models of patient–clinician communication and policy development is scant. Design, setting and participants  A qualitative method was employed using semi‐structured open‐ended interviews with 154 respondents (20 nursing, 49 medical, 59 clinical/administrative managerial, 3 policy coordinators, 15 patients and 8 family members) in 21 hospitals and health services in four Australian states. Results  Both patients and health professionals were positive about Open Disclosure, although each differed in their assessments of practice effectiveness. We found that five major elements influenced patients’ and professionals’ experience of openly disclosing adverse events namely: initiating the disclosure, apologizing for the adverse event, taking the patient’s perspective, communicating the adverse event and being culturally aware. Conclusions  Evaluating the impact of Open Disclosure refines policy implementation because it provides an evidence base to inform policy. Health services can use specific properties relating to each of the five Open Disclosure elements identified in this study as training standards and to assess the progress of policy implementation. However, health services must surmount their sensitivity to revealing the extent of error so that research into patient experiences can inform practice and policy development. PMID:19804555

Clinical signs and clinicopathologic abnormalities in dogs with clinical spirocercosis: 39 cases (1996-2004).

PubMed

Mylonakis, Mathios E; Rallis, Tim; Koutinas, Alexander F; Leontides, Leonidas S; Patsikas, Michail; Florou, Marianna; Papadopoulos, Elias; Fytianou, Anna

2006-04-01

To determine clinical signs and clinicopathologic abnormalities in dogs with naturally occurring clinical spirocercosis. Retrospective case series. 39 dogs with spirocercosis. Medical records were reviewed, and information on signalment, residence (rural vs urban), owner complaints, physical examination findings, clinicopathologic abnormalities, radiographic and endoscopic findings, and concurrent systemic diseases was recorded. Hellenic hounds and mixed-breed dogs were overrepresented, compared with a group of 117 control dogs without spirocercosis that were examined because of gastrointestinal tract disease, and mean body weight of dogs with spirocercosis was significantly higher than mean body weight of control dogs. Odynophagia (34 [87%]), regurgitation (24 [62%]), and excessive salivation (14 [36%]) were the most common clinical findings. The most common radiographic abnormalities were a mass in the caudodorsal aspect of the mediastinum (15/35 [43%]) and spondylitis of the caudal thoracic vertebrae (10 [29%]). Parasitic nodules were seen during esophagoscopy in all 39 dogs. Normocytic, normochromic, nonregenerative anemia; neutrophilic leukocytosis; hyperproteinemia; and high alkaline phosphatase activity were significantly more common in dogs with spirocercosis than in a control group of 56 healthy dogs. Concurrent systemic diseases, mainly leishmaniosis, dirofilariosis, and monocytic ehrlichiosis, were documented in 14 (36%) dogs. Results suggest that clinical spirocercosis occurs more often in young-adult, large-breed dogs. Nonregenerative anemia, neutrophilic leukocytosis, hyperproteinemia, and high alkaline phosphatase activity may be useful clinicopathologic indicators of this disease.

Clinical signs associated with ingestion of black walnut tree (Juglans nigra) wood, nuts, and hulls in dogs: 93 cases (2001-2012).

PubMed

Coleman, Adrienne E; Merola, Valentina

2016-01-15

To identify clinical signs associated with oral exposure to black walnut tree (Juglans nigra) wood, nuts, or nut hulls in dogs and to compare clinical syndromes between dogs that ingested wood and dogs that ingested the walnuts or nut hulls. Retrospective case series. 93 dogs. Records of dogs with oral exposure to black walnut wood, nuts, or nut hulls between November 2001 and December 2012 were retrieved from the Animal Poison Control Center database. Records were reviewed, and data regarding signalment; exposure; time of onset, type, and duration of clinical signs; serum biochemical abnormalities; treatment; and response to treatment were collected. Results were compared statistically between dogs that ingested wood and those that ingested nut components. 28 cases involved exposure to wood, and 65 involved exposure to nuts or hulls. Spontaneous vomiting was commonly observed (13/28 [46%] and 31/65 [48%] dogs that ingested wood and nut components, respectively). Neurologic or musculoskeletal signs were significantly more common in dogs that ingested wood (26/28 [93%]) than in those that ingested nuts or hulls (15/65 [23%]). Relative risk of developing neurologic signs after ingestion of wood was approximately 4 times that after ingestion of nuts or hulls. Ingestion of black walnut wood by dogs resulted in a clinical syndrome in which neurologic or musculoskeletal signs were most frequently reported, whereas ingestion of black walnuts or their hulls was most commonly associated with vomiting. To our knowledge, this is the first report describing 2 different clinical syndromes associated with exposure to black walnut tree components in dogs.

Cerebellar Ataxia with Bilateral Vestibulopathy: Description of a Syndrome and Its Characteristic Clinical Sign

ERIC Educational Resources Information Center

Migliaccio, Americo A.; Halmagyi, G. Michael; McGarvie, Leigh A.; Cremer, Phillip D.

2004-01-01

We report four patients with the syndrome of cerebellar ataxia with bilateral vestibulopathy (CABV) and, using search coil oculography, we validate its characteristic clinical sign, namely impairment of the visually enhanced vestibulo-ocular reflex (VVOR) or doll's head reflex. In our four patients, CABV began in the sixth decade of life; they are…

Predicting caregiver burden in general veterinary clients: Contribution of companion animal clinical signs and problem behaviors.

PubMed

Spitznagel, M B; Jacobson, D M; Cox, M D; Carlson, M D

2018-06-01

Caregiver burden, found in many clients with a chronically or terminally ill companion animal, has been linked to poorer psychosocial function in the client and greater utilization of non-billable veterinary services. To reduce client caregiver burden, its determinants must first be identified. This study examined if companion animal clinical signs and problem behaviors predict veterinary client burden within broader client- and patient-based risk factor models. Data were collected in two phases. Phase 1 included 238 companion animal owners, including those with a sick companion animal (n=119) and matched healthy controls (n=119) recruited online. Phase 2 was comprised of 602 small animal general veterinary hospital clients (n=95 with a sick dog or cat). Participants completed cross-sectional online assessments of caregiver burden, psychosocial resources (social support, active coping, self-mastery), and an item pool of companion animal clinical signs and problem behaviors. Several signs/behaviors correlated with burden, most prominently: weakness, appearing sad/depressed or anxious, appearing to have pain/discomfort, change in personality, frequent urination, and excessive sleeping/lethargy. Within patient-based risk factors, caregiver burden was predicted by frequency of the companion animal's signs/behaviors (P<.01). Within client-based factors, potentially modifiable factors of client reaction to the animal's signs/behaviors (P=.01), and client sense of control (P<.04) predicted burden. Understanding burden may enhance veterinarian-client communication, and is important due to potential downstream effects of client burden, such as higher workload for the veterinarian. Supporting the client's sense of control may help alleviate burden when amelioration of the companion animal's presentation is not feasible. Copyright © 2018 Elsevier Ltd. All rights reserved.

Computed tomographic findings in 205 dogs with clinical signs compatible with middle ear disease: a retrospective study.

PubMed

Belmudes, Audrey; Pressanti, Charline; Barthez, Paul Y; Castilla-Castaño, Eloy; Fabries, Lionel; Cadiergues, Marie C

2018-02-01

Computed tomography (CT) is considered to be the reference method to evaluate middle ear structures. To evaluate the presence and severity of CT changes in the middle ear and establish if any specific clinical presentations are associated with otitis media. Medical records of animals referred for CT with history and clinical signs consistent with middle ear disease. Retrospective evaluation of CT examinations of tympanic bullae performed over a six year period. Medical records were reviewed for signalment, clinical signs and cytological evaluation of the external ear canal. Dogs were divided into three clinical groups: chronic otitis externa (Group 1), peripheral vestibular disorder (Group 2) and other clinical presentations (Group 3). Group 1 - Of 214 ears, 87 (40.7%) had CT abnormalities: 38 of 87 (17.7%) had material-filled bullae, 42 of 87 (19.6%) had thickened bullae walls and seven of 87 (3.2%) had lysis of the bulla. Abnormalities were significantly more frequent in dogs with suppurative otitis than in erythemato-ceruminous otitis (57% and 23%, respectively; P = 0.003). Proliferative otitis, particularly in French bulldogs, was associated with severe otitis media. Group 2 - Of the 106 ears, 91 (85.8%) had normal tympanic bullae. Group 3 - Of the 26 ears from deaf dogs, 17 had filled bullae; all nine affected dogs were Cavalier King Charles spaniels. All dogs with Claude Bernard Horner syndrome or head tilt had normal tympanic bullae. CT is useful for canine chronic otitis externa, particularly in suppurative or proliferative otitis, even in the absence of associated neurological signs. © 2017 ESVD and ACVD.

The value of 'positive' clinical signs for weakness, sensory and gait disorders in conversion disorder: a systematic and narrative review.

PubMed

Daum, Corinna; Hubschmid, Monica; Aybek, Selma

2014-02-01

Experts in the field of conversion disorder have suggested for the upcoming DSM-V edition to put less weight on the associated psychological factors and to emphasise the role of clinical findings. Indeed, a critical step in reaching a diagnosis of conversion disorder is careful bedside neurological examination, aimed at excluding organic signs and identifying 'positive' signs suggestive of a functional disorder. These positive signs are well known to all trained neurologists but their validity is still not established. The aim of this study is to provide current evidence regarding their sensitivity and specificity. We conducted a systematic search on motor, sensory and gait functional signs in Embase, Medline, PsycINfo from 1965 to June 2012. Studies in English, German or French reporting objective data on more than 10 participants in a controlled design were included in a systematic review. Other relevant signs are discussed in a narrative review. Eleven controlled studies (out of 147 eligible articles) describing 14 signs (7 motor, 5 sensory, 2 gait) reported low sensitivity of 8-100% but high specificity of 92-100%. Studies were evidence class III, only two had a blinded design and none reported on inter-rater reliability of the signs. Clinical signs for functional neurological symptoms are numerous but only 14 have been validated; overall they have low sensitivity but high specificity and their use should thus be recommended, especially with the introduction of the new DSM-V criteria.

Correction to: Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials.

PubMed

Ballow, Mark; Wasserman, Richard L; Jolles, Stephen; Chapel, Helen; Berger, Mel; Misbah, Siraj A

2018-04-27

The article Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials, written by Mark Ballow, Richard L. Wasserman, Stephen Jolles, Helen Chapel, Mel Berger, Siraj A. Misbah, was originally published Online First without open access.

GILBERT'S SYNDROME - A CONCEALED ADVERSITY FOR PHYSICIANS AND SURGEONS.

PubMed

Rasool, Ahsan; Sabir, Sabir; Ashlaq, Muhammad; Farooq, Umer; Khan, Muhammad Zatmar; Khan, Faisal Yousaf

2015-01-01

Gilbert's syndrome (often abbreviated as GS) is most common hereditary cause of mild unconjugated (indirect) hyperbilirubinemia. Various studies have been published depicting clinical and pharmacological effects of Gilbert's syndrome (GS). However GS as a sign of precaution for physician and surgeons has not been clearly established. A systematic study of the available literature was done. Key words of Gilbert's syndrome, hyperbilirubinemia and clinical and pharmacological aspects of GS were searched using PubMed as search engine. Considering the study done in last 40 years, 375 articles were obtained and their abstracts were studied. The criterion for selecting the articles for through study was based on their close relevance with the topic. Thus 40 articles and 2 case reports were thoroughly studied. It was concluded that Gilbert's syndrome has immense clinical importance because the mild hyperbilirubinemia can be mistaken for a sign of occult, chronic, or progressive liver disease. GS is associated with lack of detoxification of few drugs. It is related with spherocytosis, cholithiasis, haemolytic anaemia, intra-operative toxicity, irinotecan toxicity, schizophrenia and problems in morphine metabolism. It also has profound phenotypic effect as well. The bilirubin level of a GS individual can rise abnormally high in various conditions in a person having Gilbert's syndrome. This can mislead the physicians and surgeons towards false diagnosis. Therefore proper diagnosis of GS should be ascertained in order to avoid the concealed adversities of this syndrome.

CLINICAL SIGNS AND SYMPTOMS OF SEXUALLY TRANSMITTED INFECTIONS COMMUNICATED IN LIBRAS.

PubMed

França, Inacia Sátiro Xavier de; Magalhães, Isabella Medeiros de Oliveira; Sousa, Francisco Stélio de; Coura, Alexsandro Silva; Silva, Arthur Felipe Rodrigues; Baptista, Rosilene Santos

2016-01-01

To validate a video containing image representations of clinical signs and symptoms of sexually transmitted infections expressed in Libras. Methodology development study conducted in an audio communication school. Thirty-six deaf people were selected. A video containing image representations of clinical signs and symptoms of sexually transmitted infections expressed in Libras was produced. Semantic validation was performed by deaf students and content validation by three judges who are Libras experts. The validation results were subjected to the Content Validity Index, where an index score > 0.80/80% was considered as agreement among judges. Seven signs and symptoms related to sexually transmitted infections were validated and obtained satisfactory Content Validity Indexes, most of them with 100% representativeness and agreement. The validation process made the expressions of signs and symptoms related to sexually transmitted infections represented in Libras valid for establishing effective communication in the area of the study, turning it into a care tool that facilitates and standardizes communication with deaf people through Libras. Validar um vídeo contendo as representações imagéticas de sinais e sintomas clínicos de infecções sexualmente transmissíveis expressas em Libras. Estudo de desenvolvimento metodológico, realizado em uma escola de audiocomunicação. Selecionou-se uma amostra de 36 surdos. Elaborou-se um vídeo contendo a representação imagética de sinais e sintomas de infecções sexualmente transmissíveis expressos em Libras. A validação semântica foi realizada pelos surdos e a validação de conteúdo por três juízes experts em Libras. Os resultados da validação foram submetidos ao Índice de Validade de Conteúdo, considerando-se o escore do índice > 0,80/80% de concordância entre os juízes. Foram validados sete sinais e sintomas relacionados às infecções sexualmente transmissíveis que obtiveram Índices de Validade de

The reliability and validity of video analysis for the assessment of the clinical signs of concussion in Australian football.

PubMed

Makdissi, Michael; Davis, Gavin

2016-10-01

The objective of this study was to determine the reliability and validity of identifying clinical signs of concussion using video analysis in Australian football. Prospective cohort study. All impacts and collisions potentially resulting in a concussion were identified during 2012 and 2013 Australian Football League seasons. Consensus definitions were developed for clinical signs associated with concussion. For intra- and inter-rater reliability analysis, two experienced clinicians independently assessed 102 randomly selected videos on two occasions. Sensitivity, specificity, positive and negative predictive values were calculated based on the diagnosis provided by team medical staff. 212 incidents resulting in possible concussion were identified in 414 Australian Football League games. The intra-rater reliability of the video-based identification of signs associated with concussion was good to excellent. Inter-rater reliability was good to excellent for impact seizure, slow to get up, motor incoordination, ragdoll appearance (2 of 4 analyses), clutching at head and facial injury. Inter-rater reliability for loss of responsiveness and blank and vacant look was only fair and did not reach statistical significance. The feature with the highest sensitivity was slow to get up (87%), but this sign had a low specificity (19%). Other video signs had a high specificity but low sensitivity. Blank and vacant look (100%) and motor incoordination (81%) had the highest positive predictive value. Video analysis may be a useful adjunct to the side-line assessment of a possible concussion. Video analysis however should not replace the need for a thorough multimodal clinical assessment. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Dogs attending primary-care practice in England with clinical signs suggestive of Chiari-like malformation/syringomyelia.

PubMed

Sanchis-Mora, S; Pelligand, L; Thomas, C L; Volk, H A; Abeyesinghe, S M; Brodbelt, D C; Church, D B; Thomson, P C; McGreevy, P D; O'Neill, D G

2016-10-29

Chiari-like malformation/syringomyelia (CM/SM) in dogs describes a developmental disorder that can cause pain and reduced quality of life. This retrospective study aimed to report the period prevalence, clinical signs and risk factors for diagnosis of symptomatic CM/SM in the veterinary primary-care setting using a cross-sectional design. The study population included all dogs within the VetCompass Programme (September 1, 2009-June 13, 2014). Overall, the period prevalence of symptomatic CM/SM was 0.05 per cent (95 per cent CI 0.04 per cent to 0.06 per cent) for all breeds. The period prevalence in the Cavalier King Charles Spaniel (CKCS) was 1.6 per cent (95 per cent CI 1.2 to 2.06). Other breeds at increased odds included the King Charles Spaniel (KCS), Affenpinscher, Chihuahua and Pomeranian. Insured dogs had 4.6 times the odds (95 per cent CI 2.95 to 7.17) of having a diagnosis of CM/SM compared with uninsured dogs. Pain was the most commonly associated clinical sign (67 dogs, 72 per cent). Analgesics were prescribed to 72 (77.4 per cent) of the symptomatic dogs. Despite its low overall period prevalence, the high proportion of affected dogs identified with chronic pain suggests a significant welfare issue. Financial implications could impede the diagnostic process and lead to underestimation of the true prevalence. This study may help to inform clinicians about the clinical relevance and the need for improved awareness of clinical signs, particularly in high-risk breeds, to optimise the management of CM/SM in primary-care practice. British Veterinary Association.

Eponymous signs in dermatology

PubMed Central

Madke, Bhushan; Nayak, Chitra

2012-01-01

Clinical signs reflect the sheer and close observatory quality of an astute physician. Many new dermatological signs both in clinical and diagnostic aspects of various dermatoses are being reported and no single book on dermatology literature gives a comprehensive list of these “signs” and postgraduate students in dermatology finds it difficult to have access to the description, as most of these resident doctor do not have access to the said journal articles. “Signs” commonly found in dermatologic literature with a brief discussion and explanation is reviewed in this paper. PMID:23189246

Comparison of clinical signs and outcomes between dogs with presumptive ischemic myelopathy and dogs with acute noncompressive nucleus pulposus extrusion.

PubMed

Fenn, Joe; Drees, Randi; Volk, Holger A; De Decker, Steven

2016-10-01

OBJECTIVE To compare clinical signs and outcomes between dogs with presumptive ischemic myelopathy and dogs with presumptive acute noncompressive nucleus pulposus extrusion (ANNPE). DESIGN Retrospective study. ANIMALS 51 dogs with ischemic myelopathy and 42 dogs with ANNPE examined at 1 referral hospital. PROCEDURES Medical records and MRI sequences were reviewed for dogs with a presumptive antemortem diagnosis of ischemic myelopathy or ANNPE. Information regarding signalment, clinical signs at initial examination, and short-term outcome was retrospectively retrieved from patient records. Long-term outcome information was obtained by telephone communication with referring or primary-care veterinarians and owners. RESULTS Compared with the hospital population, English Staffordshire Bull Terriers and Border Collies were overrepresented in the ischemic myelopathy and ANNPE groups, respectively. Dogs with ANNPE were significantly older at disease onset and were more likely to have a history of vocalization at onset of clinical signs, have spinal hyperesthesia during initial examination, have a lesion at C1-C5 spinal cord segments, and be ambulatory at hospital discharge, compared with dogs with ischemic myelopathy. Dogs with ischemic myelopathy were more likely to have a lesion at L4-S3 spinal cord segments and have long-term fecal incontinence, compared with dogs with ANNPE. However, long-term quality of life and outcome did not differ between dogs with ischemic myelopathy and dogs with ANNPE. CONCLUSIONS AND CLINICAL RELEVANCE Results revealed differences in clinical signs at initial examination between dogs with ischemic myelopathy and dogs with ANNPE that may aid clinicians in differentiating the 2 conditions.

Vital signs monitoring on general wards: clinical staff perceptions of current practices and the planned introduction of continuous monitoring technology.

PubMed

Prgomet, Mirela; Cardona-Morrell, Magnolia; Nicholson, Margaret; Lake, Rebecca; Long, Janet; Westbrook, Johanna; Braithwaite, Jeffrey; Hillman, Ken

2016-09-01

Early detection of patient deterioration and prevention of adverse events are key challenges to patient safety. This study investigated clinical staff perceptions of current monitoring practices and the planned introduction of continuous monitoring devices on general wards. Multi-method study comprising structured surveys, in-depth interviews and device trial with log book feedback. Two general wards in a large urban teaching hospital in Sydney, Australia. Respiratory and neurosurgery nursing staff and two doctors. Nurses were confident about their abilities to identify patients at risk of deterioration, using a combination of vital signs and visual assessment. There were concerns about the accuracy of current vital signs monitoring equipment and frequency of intermittent observation. Both the nurses and the doctors were enthusiastic about the prospect of continuous monitoring and perceived it would allow earlier identification of patient deterioration; provide reassurance to patients; and support interdisciplinary communication. There were also reservations about continuous monitoring, including potential decrease in bedside nurse-patient interactions; increase in inappropriate escalations of patient care; and discomfort to patients. While continuous monitoring devices were seen as a potentially positive tool to support the identification of patient deterioration, drawbacks, such as the potential for reduced patient contact, revealed key areas that will require close surveillance following the implementation of devices. Training and improved interdisciplinary communication were identified as key requisites for successful implementation. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Ultrasonographic, endoscopic and histological appearances of the caecum in cats presenting with chronic clinical signs of caecocolic disease.

PubMed

Hahn, Harriet; Pey, Pascaline; Baril, Aurélie; Charpentier, Julie; Desquilbet, Loic; Le Poder, Sophie; Château-Joubert, Sophie; Laloy, Eve; Freiche, Valerie

2017-02-01

Objectives This study aimed to describe the ultrasonographic, endoscopic and histological characteristics of the caecum and ileocaecocolic junction in cats suffering from chronic clinical signs compatible with caecocolic disease. Methods Cats presenting with clinical signs suggestive of a caecocolic disease were prospectively recruited. All cats underwent an ultrasonographic examination of the caecum, ileum, colon, ileocolic lymph nodes and local mesenteric fat, in addition to comprehensive abdominal ultrasonography. This was followed by a colonoscopy with a macroscopic assessment of the caecocolic mucosa; caecocolic tissue samples were systematically collected for histologic analysis. Results Eighteen cats were included. Eleven of 18 cats had ultrasonographic abnormalities adjacent to the ileocaecocolic junction (lymphadenopathy, local steatitis) and 13/18 cats had abnormalities directly related to the junction (wall thickening, loss of wall layering). Seventeen of 18 cats had at least one ultrasonographic abnormality. Endoscopically, hyperaemia, oedema, discoloration and/or erosions were found in all cats. Each cat was classified as having mild or moderate-to-severe lesions according to endoscopic results; no classification could be established statistically for ultrasonographic results. The accentuation of the dimpled pattern tended to be inversely related to the severity of endoscopic lesion scoring. Histologically, a large proportion of cats showed typhlitis (13/16), one had lymphoma and two were normal. All cats with typhlitis also had colitis. There was only slight agreement between endoscopic and histological caecal results regarding the severity of lesions. Loss of caecal wall layering on ultrasound was found in 7/18 cats and, surprisingly, did not appear as a reliable predictor of the severity of inflammation or of malignancy; neither did local steatitis nor lymph node size. Conclusions and relevance Ultrasonography and endoscopy should not be used as the

Long-term survival and quality of life in dogs with clinical signs associated with a congenital portosystemic shunt after surgical or medical treatment.

PubMed

Greenhalgh, Stephen N; Reeve, Jenny A; Johnstone, Thurid; Goodfellow, Mark R; Dunning, Mark D; O'Neill, Emma J; Hall, Ed J; Watson, Penny J; Jeffery, Nick D

2014-09-01

To compare long-term survival and quality of life data in dogs with clinical signs associated with a congenital portosystemic shunt (CPSS) that underwent medical or surgical treatment. Prospective cohort study. 124 client-owned dogs with CPSS. Dogs received medical or surgical treatment without regard to signalment, clinical signs, or clinicopathologic results. Survival data were analyzed with a Cox regression model. Quality of life information, obtained from owner questionnaires, included frequency of CPSS-associated clinical signs (from which a clinical score was derived), whether owners considered their dog normal, and (for surgically treated dogs) any ongoing medical treatment for CPSS. A Mann-Whitney U test was used to compare mean clinical score data between surgically and medically managed dogs during predetermined follow-up intervals. 97 dogs underwent surgical treatment; 27 were managed medically. Median follow-up time for all dogs was 1,936 days. Forty-five dogs (24 medically managed and 21 surgically managed) died or were euthanized during the follow-up period. Survival rate was significantly improved in dogs that underwent surgical treatment (hazard ratio, 8.11; 95% CI, 4.20 to 15.66) than in those treated medically for CPSS. Neither age at diagnosis nor shunt type affected survival rate. Frequency of clinical signs was lower in surgically versus medically managed dogs for all follow-up intervals, with a significant difference between groups at 4 to 7 years after study entry. Surgical treatment of CPSS in dogs resulted in significantly improved survival rate and lower frequency of ongoing clinical signs, compared with medical management. Age at diagnosis did not affect survival rate and should not influence treatment choice.

The Japanese Postmarketing Adverse Event Relief System: A Confluence of Regulatory Science, the Legal System, and Clinical Pharmacology.

PubMed

Tominaga, T; Miyazaki, S; Oniyama, Y; Weber, A D; Kondo, T

2017-08-01

The Japanese Postmarketing Relief System provides for compensation to patients with adverse reactions, based on the acknowledgment that unpredicted adverse events occur inevitably once a drug is marketed. The system also provides new knowledge about the benefit-risk profile of a drug that may be incorporated into product labeling. The system relies on causality assessments that are based on sound clinical pharmacology principles. The system may serve as a model for other countries' healthcare systems. © 2016 American Society for Clinical Pharmacology and Therapeutics.

Adverse Effects of Iodine-derived Intravenous Radiopaque Contrast Media.

PubMed

Matthews, Eric P

2015-01-01

Although the advent of nonionic low-osmolar contrast agents has reduced the probability of a reaction to radiopaque contrast media derived from tri-iodinated benzoic acid, reactions still occur. Radiologic technologists must understand and know how to manage adverse effects of contrast media. Prompt attention to patients who exhibit the early signs of an adverse reaction can help to ensure the reaction does not progress to become severe or life-threatening.

Endophthalmitis in eyes presenting with orbital signs: a case-control study.

PubMed

Rishi, Pukhraj; Rishi, Ekta; Nandi, Krishnendu; Khan, Balbir

2010-03-01

The purpose of this study was to assess the clinical profile and treatment outcomes in eyes with endophthalmitis presenting with orbital signs. A case-control study of 24 eyes with endophthalmitis and orbital signs at presentation (defined as ocular motility restriction and/or presence of " inverted perpendicular" sign on ultrasonography) was conducted between January 2000 and December 2006. The control group was constituted of 40 age- and sex-matched eyes with endophthalmitis presenting without orbital signs. Optimal structural outcome was defined as resolution of inflammation and infection. Adverse structural outcome was defined as development of phthisis bulbi or need for evisceration or development of retinal detachment. Optimal functional outcome was defined as improvement in postoperative visual acuity to 3/60 or better. The Pearson chi-square test was used with appropriate significance (P < or = 0.05) to compare the mean visual acuity before and after treatment. Twenty-four patients with a mean age of 46.4 years and a mean follow-up of 14.6 months were included. Treatment options included intravitreal antibiotics, vitrectomy, evisceration, and systemic antibiotics. Optimal structural outcome was achieved in 6 (25%) eyes. A total of 70.8% eyes had no light perception, whereas 4 (16.66%) patients regained ambulatory vision (>3/60). There was a statistically significant poor visual (P = 0.05) and structural outcome (P = 0.004), whereas in the control group, 25 patients (62.5%) had vision 3/60 or better (P = 0.001). Orbital signs are independent risk factors for poor structural and visual outcomes in eyes with endophthalmitis.

Warning Signs for Suicide: Theory, Research, and Clinical Applications

ERIC Educational Resources Information Center

Rudd, M. David; Berman, Alan L.; Joiner, Thomas E., Jr.; Nock, Matthew K.; Silverman, Morton M.; Mandrusiak, Michael; Van Orden, Kimberly; Witte, Tracy

2006-01-01

The current article addresses the issue of warning signs for suicide, attempting to differentiate the construct from risk factors. In accordance with the characteristic features discussed, a consensus set of warning signs identified by the American Association of Suicidology working group are presented, along with a discussion of relevant clinical…

Clinical signs of dysphagia in infants with acute viral bronchiolitis☆

PubMed Central

Barbosa, Lisiane De Rosa; Gomes, Erissandra; Fischer, Gilberto Bueno

2014-01-01

Objective: To determine the occurrence of clinical signs of dysphagia in infants with acute viral bronchiolitis, to compare the respiratory parameters during deglutition, and to ensure the intra- and inter- examiners agreement, as well as to accomplish intra and interexaminators concordance of the clinical evaluation of the deglutition. Methods: This was a cross-sectional study of 42 infants aged 0-12 months. The clinical evaluation was accompanied by measurements of respiratory rate and pulse oximetry. A score of swallowing disorders was designed to establish associations with other studied variables and to ensure the intra- and interrater agreement of clinical feeding assessments. Caregivers also completed a questionnaire about feeding difficulties. Significance was set at p<0.05. Results: Changes in the oral phase (prolonged pauses) and pharyngeal phase (wheezing, coughing and gagging) of swallowing were found. A significant increase in respiratory rate between pre- and post-feeding times was found, and it was determined that almost half of the infants had tachypnea. An association was observed between the swallowing disorder scores and a decrease in oxygen saturation. Infants whose caregivers reported feeding difficulties during hospitalization stated a significantly greater number of changes in the swallowing evaluation. The intra-rater agreement was considered to be very good. Conclusions: Infants with acute viral bronchiolitis displayed swallowing disorders in addition to changes in respiratory rate and measures of oxygen saturation. It is suggested, therefore, that infants displaying these risk factors have a higher probability of dysphagia. PMID:25479843

Unintended adverse consequences of a clinical decision support system: two cases.

PubMed

Stone, Erin G

2018-05-01

Many institutions have implemented clinical decision support systems (CDSSs). While CDSS research papers have focused on benefits of these systems, there is a smaller body of literature showing that CDSSs may also produce unintended adverse consequences (UACs). Detailed here are 2 cases of UACs resulting from a CDSS. Both of these cases were related to external systems that fed data into the CDSS. In the first case, lack of knowledge of data categorization in an external pharmacy system produced a UAC; in the second case, the change of a clinical laboratory instrument produced the UAC. CDSSs rely on data from many external systems. These systems are dynamic and may have changes in hardware, software, vendors, or processes. Such changes can affect the accuracy of CDSSs. These cases point to the need for the CDSS team to be familiar with these external systems. This team (manager and alert builders) should include members in specific clinical specialties with deep knowledge of these external systems.

Diagnosis of smear-negative pulmonary tuberculosis based on clinical signs in the Republic of Congo.

PubMed

Linguissi, Laure Stella Ghoma; Vouvoungui, Christevy Jeannhey; Poulain, Pierre; Essassa, Gaston Bango; Kwedi, Sylvie; Ntoumi, Francine

2015-12-18

The diagnosis of pulmonary tuberculosis (PTB) and smear-negative pulmonary tuberculosis (SNPT) in resource-limited countries is often solely based on clinical signs, chest X-ray radiography and sputum smear microscopy. We investigated currently used methods for the routine diagnosis of SNPT in the Republic of Congo (RoC) among TB suspected patients. The specific case of HIV positive patients was also studied. A cross-sectional study was conducted at the anti-tuberculosis center (CAT) of Brazzaville, RoC. Tuberculosis suspects were examined for physical signs of TB. Clinical signs, results from sputum smear microscopy, tuberculin skin test (TST) and chest X-ray were recorded. Of the 772 enrolled participants, 372 were diagnosed PTB. Cough was a common symptom for PTB and no PTB patients. Pale skin, positive TST, weight loss and chest X-ray with abnormalities compatible with PTB (PTB-CXR) were significant indicators of PTB. Thirty-six percent of PTB patients were diagnosed SNPT. This category of patients presented less persistent cough and less PTB-CXR. Anorexia and asthenia were significant indicators of SNPT. In the case of HIV+ patients, 57% were SNPT with anorexia, asthenia and shorter cough being strong indicators of SNPT. Chest X-ray abnormalities, weight loss, pale skin and positive TST were significant indicators of PTB. Anorexia and asthenia showed good diagnostic performance for SNPT, which deserve to be recommended as index indicators of SNPT diagnosis. Duration of cough is also a relevant indicator, especially for HIV+ patients.

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

PubMed Central

Federer, Callie; Yoo, Minjae

2016-01-01

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

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

PubMed

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

2016-12-01

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

Analysis of the adverse events reported to the office of the clinical director at a dental school in Bogotá, Colombia.

PubMed

Huertas, María F; Gonzalez, Juliana; Camacho, Sandra; Sarralde, Ana L; Rodríguez, Adriana

2017-04-01

Dentistry is interested in identifying and controlling adverse events, understood as involuntary injuries to the patient during dental care. The aim of this study was to analyze the adverse events reported to the Office of the Clinical Director at the School of Dentistry at Pontificia Universidad Javeriana (Colombia) during 2011-2012. It was an observational, descriptive study that evaluated 227 dental clinical records of patients who filed a complaint with the Office of the Clinical Director. Of these, 43 were adverse events and were used as the basis for this study. Of the 16,060 patients who received care during 2011 - 2012, 0.26% (43) filed a complaint involving an adverse event, of which 97.7 % were considered preventable. Most of these (76.18%, n= 32) occurred during clinical management of treatments in different specialties, 9.5% (4) were the result of deficient external dental laboratory quality, and 14.32% (6) were due to failure in document management, soft tissue injury, misdiagnosis and swallowing foreign objects. Of the patients involved, 65.2% (28) received care from postgraduate students, with the highest number of cases in the Oral Rehabilitation speciality. The occurrence of adverse events during dental care, indicates the need for information about their origin in order to establish protection barriers and prevent their incidence, particularly in the educational area under the student dental clinic service model. Sociedad Argentina de Investigación Odontológica.

Clinical impact and value of workstation single sign-on.

PubMed

Gellert, George A; Crouch, John F; Gibson, Lynn A; Conklin, George S; Webster, S Luke; Gillean, John A

2017-05-01

CHRISTUS Health began implementation of computer workstation single sign-on (SSO) in 2015. SSO technology utilizes a badge reader placed at each workstation where clinicians swipe or "tap" their identification badges. To assess the impact of SSO implementation in reducing clinician time logging in to various clinical software programs, and in financial savings from migrating to a thin client that enabled replacement of traditional hard drive computer workstations. Following implementation of SSO, a total of 65,202 logins were sampled systematically during a 7day period among 2256 active clinical end users for time saved in 6 facilities when compared to pre-implementation. Dollar values were assigned to the time saved by 3 groups of clinical end users: physicians, nurses and ancillary service providers. The reduction of total clinician login time over the 7day period showed a net gain of 168.3h per week of clinician time - 28.1h (2.3 shifts) per facility per week. Annualized, 1461.2h of mixed physician and nursing time is liberated per facility per annum (121.8 shifts of 12h per year). The annual dollar cost savings of this reduction of time expended logging in is $92,146 per hospital per annum and $1,658,745 per annum in the first phase implementation of 18 hospitals. Computer hardware equipment savings due to desktop virtualization increases annual savings to $2,333,745. Qualitative value contributions to clinician satisfaction, reduction in staff turnover, facilitation of adoption of EHR applications, and other benefits of SSO are discussed. SSO had a positive impact on clinician efficiency and productivity in the 6 hospitals evaluated, and is an effective and cost-effective method to liberate clinician time from repetitive and time consuming logins to clinical software applications. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Student nurses' recognition of early signs of abnormal vital sign recordings.

PubMed

Leonard, Martha M; Kyriacos, Una

2015-09-01

There is increasing urgency for nurses to recognize early signs of deterioration in patients and to take appropriate action to prevent serious adverse effects. To assess respondents' ability to identify abnormal recordings for respiratory and heart rate, oxygen saturation level, systolic blood pressure, level of consciousness, urinary output and normal temperature. A descriptive observational survey. A nursing college in Cape Town, South Africa. A sample of 77/212 (36.3%) fourth year students. A self-administered adapted questionnaire was employed to collect demographic data and respondents' selections of recorded physiological values for the purpose of deciding when to call for more skilled help. The median age for 62/77 (80.5%) of the respondents was 25years; 3/76 (3.9%) had a previous certificate in nursing. Most respondents were female (66/76, 85.7%). Afrikaans was the first language preference of 33 (42.9%) respondents, followed by isiXhosa (31/77, 40.3%) and English (10/77, 13.0%). Most respondents (48/77, 62.3%) recognized a normal temperature reading (35-38.4°C). However, overall there would have been delays in calling for more skilled assistance in 288/416 (69.2%) instances of critical illness for a high-score MEWS of 3 and in 226/639 (35.4%) instances at a medium-score MEWS of 2 for physiological parameters. In 96/562 (17.1%) instances, respondents would have called for assistance for a low-score MEWS of 1. Non-recognition of deterioration in patients' clinical status and delayed intervention by nurses has implications for the development of serious adverse events. The MEWS is recommended as a track-and-trigger system for nursing curricula in South Africa and for implementation in practice. Copyright © 2015. Published by Elsevier Ltd.

Prevalence of serum thyroid hormone autoantibodies in dogs with clinical signs of hypothyroidism.

PubMed

Nachreiner, Raymond F; Refsal, Kent R; Graham, Peter A; Bowman, Mark M

2002-02-15

To determine prevalence of thyroid hormone autoantibodies (THAA) in serum of dogs with clinical signs of hypothyroidism. Cohort study. 287,948 serum samples from dogs with clinical signs consistent with hypothyroidism. Serum THAA were detected by use of a radiometric assay. Correlation and chi2 analyses were used to determine whether prevalence varied with breed, age, sex, or body weight. Only breeds for which > or = 50 samples had been submitted were used for analysis of breed prevalence. Thyroid hormone autoantibodies were detected in 18,135 (6.3%) samples. The 10 breeds with the highest prevalence of THAA were the Pointer, English Setter, English Pointer, Skye Terrier, German Wirehaired Pointer, Old English Sheepdog, Boxer, Maltese, Kuvasz, and Petit Basset Griffon Vendeen. Prevalence was significantly correlated with body weight and was highest in dogs between 2 and 4 years old. Females were significantly more likely to have THAA than were males. Thyroid hormone autoantibodies may falsely increase measured triiodothyronine (T3) and thyroxine (T4) concentrations in dogs; results suggest that T3 concentration may be falsely increased in approximately 57 of 1,000 dogs with hypothyroidism and that T4 concentration may be falsely increased in approximately 17 of 1,000 dogs with hypothyroidism. Results also suggested that dogs of certain breeds were significantly more or less likely to have THAA than were dogs in general.

Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

PubMed

Mohtadi, Nicholas; Barber, Rhamona; Chan, Denise; Paolucci, Elizabeth Oddone

2016-05-01

Complications/adverse events of anterior cruciate ligament (ACL) surgery are underreported, despite pooled level 1 data in systematic reviews. All adverse events/complications occurring within a 2-year postoperative period after primary ACL reconstruction, as part of a large randomized clinical trial (RCT), were identified and described. Prospective, double-blind randomized clinical trial. Patients and the independent trained examiner were blinded to treatment allocation. University-based orthopedic referral practice. Three hundred thirty patients (14-50 years; 183 males) with isolated ACL deficiency were intraoperatively randomized to ACL reconstruction with 1 autograft type. Graft harvest and arthroscopic portal incisions were identical. Patients were equally distributed to patellar tendon (PT), quadruple-stranded hamstring tendon (HT), and double-bundle (DB) hamstring autograft ACL reconstruction. Adverse events/complications were patient reported, documented, and diagnoses confirmed. Two major complications occurred: pulmonary embolism and septic arthritis. Twenty-four patients (7.3%) required repeat surgery, including 25 separate operations: PT = 7 (6.4%), HT = 9 (8.2%), and DB = 8 (7.3%). Repeat surgery was performed for meniscal tears (3.6%; n = 12), intra-articular scarring (2.7%; n = 9), chondral pathology (0.6%; n = 2), and wound dehiscence (0.3%; n = 1). Other complications included wound problems, sensory nerve damage, muscle tendon injury, tibial periostitis, and suspected meniscal tears and chondral lesions. Overall, more complications occurred in the HT/DB groups (PT = 24; HT = 31; DB = 45), but more PT patients complained of moderate or severe kneeling pain (PT = 17; HT = 9; DB = 4) at 2 years. Overall, ACL reconstructive surgery is safe. Major complications were uncommon. Secondary surgery was necessary 7.3% of the time for complications/adverse events (excluding graft reinjury or revisions) within the first 2 years. Level 1 (therapeutic studies

Signs Indicating Imminent Death in Escherichia coli-Infected Broilers.

PubMed

Matthijs, M G R; Nieuwenhuis, J F; Dwars, R M

2017-09-01

Broilers were observed during 9 days for clinical signs after intratracheal inoculation at 8 days of age with 10 7 E. coli 506. It was determined if these signs were predictive for imminent death. Hourly observations were made daily from a distance of 1-2 m and nightly by camera observation, with respect to the following parameters: level of attention, locomotory activity, posture and appearance, interaction, and impairment of respiration. For deviations of the normal state for these five parameters (i.e., typical clinical signs of disease), scores were defined in up to four classes. The periods of time elapsing from attaining a score for the first time to death were registered per bird for each score for each parameter. Of 114 birds, 85 did not present typical signs of illness as described, and 29 presented the following clinical history: 25 died after presenting signs of illness, 2 died without previous signs, 1 fell ill but survived, and 1 fell ill and recovered. Extended clinical examination was performed in birds presenting clinical signs; temperature, heart rate, respiratory rate, and subcutaneous capillary refill time were measured. The level of attention, and posture and appearance were affected most often in ill birds; 25% of these birds died within 5 and 4 hr, respectively; 50% died within 12 hr; and 75% died within 20 and 19 hr, respectively. Any of these typical signs of illness visible from 1-2 m indicated imminent death, with 75% of the birds dying within 20 hr. Measurements resulting from extended clinical examination proved of lesser predictive value. From these observations, a protocol for intervention to prevent animal suffering may be designed.

Ivy Sign on Fluid-Attenuated Inversion Recovery Images in Moyamoya Disease: Correlation with Clinical Severity and Old Brain Lesions.

PubMed

Seo, Kwon-Duk; Suh, Sang Hyun; Kim, Yong Bae; Kim, Ji Hwa; Ahn, Sung Jun; Kim, Dong-Seok; Lee, Kyung-Yul

2015-09-01

Leptomeningeal collateral, in moyamoya disease (MMD), appears as an ivy sign on fluid-attenuated inversion-recovery (FLAIR) images. There has been little investigation into the relationship between presentation of ivy signs and old brain lesions. We aimed to evaluate clinical significance of ivy signs and whether they correlate with old brain lesions and the severity of clinical symptoms in patients with MMD. FLAIR images of 83 patients were reviewed. Each cerebral hemisphere was divided into 4 regions and each region was scored based on the prominence of the ivy sign. Total ivy score (TIS) was defined as the sum of the scores from the eight regions and dominant hemispheric ivy sign (DHI) was determined by comparing the ivy scores from each hemisphere. According to the degree of ischemic symptoms, patients were classified into four subgroups: 1) nonspecific symptoms without motor weakness, 2) single transient ischemic attack (TIA), 3) recurrent TIA, or 4) complete stroke. TIS was significantly different as follows: 4.86±2.55 in patients with nonspecific symptoms, 5.89±3.10 in patients with single TIA, 9.60±3.98 in patients with recurrent TIA and 8.37±3.39 in patients with complete stroke (p=0.003). TIS associated with old lesions was significantly higher than those not associated with old lesions (9.35±4.22 vs. 7.49±3.37, p=0.032). We found a significant correlation between DHI and motor symptoms (p=0.001). Because TIS has a strong tendency with severity of ischemic motor symptom and the presence of old lesions, the ivy sign may be useful in predicting severity of disease progression.

[Clinical signs of dysphagia in infants with acute viral bronchiolitis].

PubMed

Barbosa, Lisiane De Rosa; Gomes, Erissandra; Fischer, Gilberto Bueno

2014-09-01

To determine the occurrence of clinical signs of dysphagia in infants with acute viral bronchiolitis, to compare the respiratory parameters during deglutition, and to ensure the intra- and inter- examiners agreement, as well as to accomplish intra and interexaminators concordance of the clinical evaluation of the deglutition. This was a cross-sectional study of 42 infants aged 0-12 months. The clinical evaluation was accompanied by measurements of respiratory rate and pulse oximetry. A score of swallowing disorders was designed to establish associations with other studied variables and to ensure the intra- and interrater agreement of clinical feeding assessments. Caregivers also completed a questionnaire about feeding difficulties. Significance was set at p<0.05. Changes in the oral phase (prolonged pauses) and pharyngeal phase (wheezing, coughing and gagging) of swallowing were found. A significant increase in respiratory rate between pre- and post-feeding times was found, and it was determined that almost half of the infants had tachypnea. An association was observed between the swallowing disorder scores and a decrease in oxygen saturation. Infants whose caregivers reported feeding difficulties during hospitalization stated a significantly greater number of changes in the swallowing evaluation. The intra-rater agreement was considered to be very good. Infants with acute viral bronchiolitis displayed swallowing disorders in addition to changes in respiratory rate and measures of oxygen saturation. It is suggested, therefore, that infants displaying these risk factors have a higher probability of dysphagia. Copyright © 2014 Sociedade de Pediatria de São Paulo. Publicado por Elsevier Editora Ltda. All rights reserved.

Association of clinical signs after acute Schmallenberg virus infection with milk production and fertility in Swiss dairy cows.

PubMed

Lechner, Isabel; Wüthrich, Marianne; Meylan, Mireille; van den Borne, Bart H P; Schüpbach-Regula, Gertraud

2017-10-01

Since its first occurrence in August 2011 in Germany and the Netherlands, the Schmallenberg virus (SBV) spread rapidly across Europe, where it caused production losses and abortions in ruminants as well as congenital malformations in the offspring of affected animals. Several studies have investigated the impact of SBV on fertility and production parameters in dairy cows at herd level. However, the impact of clinical disease at the animal level remained undetermined. This study aimed at estimating the impact of clinical disease during and after an infection with SBV on production and fertility parameters in individual Swiss dairy cows. Sixty-seven case and twenty-four control herds were selected according to whether cows had been showing clinical signs indicative of SBV during the epidemic from July to December 2012 in Switzerland. Of these 91 farms, production and fertility data from 388 cows with clinical signs from case herds were collected over a time period of four years, and compared to data from 932 cows without clinical signs originating from case or control herds. Milk yield, somatic cell count, number of inseminations and non-return at day 56 were analysed by means of hierarchical multivariable regression analysis. A significant drop in milk yield was observed in all groups during the SBV epidemic compared to the time before the infection, which amounted to 1.9kg per test day for clinical animals, 1.1kg for non-clinical animals from case herds and 0.6kg for non-clinical animals from control herds. A prolonged effect on milk yield was observed in clinical cows for about one year, suggesting that animals with clinical disease might not return to their previous milk production level in the current lactation after an acute infection with SBV. Clinical animals showed a significantly higher somatic cell count during the epidemic compared to the time before the infection. The number of inseminations per cow and production cycle was higher for clinical animals

Pilot Study to Evaluate the Effect of Topical Dimethicone on Clinical Signs and Skin Barrier Function in Dogs with Naturally Occurring Atopic Dermatitis

PubMed Central

Pellicoro, C.; Marsella, R.; Ahrens, K.

2013-01-01

This study investigated the effects of a skin protectant solution (dimethicone 2%) on clinical signs and skin barrier function in canine atopic dermatitis (AD). Eighteen dogs with AD were randomly divided into two groups, one received dimethicone and the other received the vehicle (cyclomethicone) on selected areas (pinnae, groin, and axillae) daily for 4 weeks. Owners and investigators were blinded regarding group allocation. Clinical efficacy was evaluated using a scoring system and skin barrier by measuring the transepidermal water loss. Twelve dogs completed the study (50% drop rate in the vehicle and 20% in the dimethicone). For clinical signs, analysis of variance showed an effect of time (P < 0.005; day 0 > day 28) and region (axillae < groin < pinnae) but no effect of group or group × time interaction. For transepidermal water loss, analysis of variance showed only a main effect of region (axillae > pinnae > groin). Pearson found no correlation between transepidermal water loss and clinical scores. In this pilot study dimethicone had no significant effect on clinical signs and transepidermal water loss in canine atopic dermatitis. PMID:23710417

Systematic drug repositioning through mining adverse event data in ClinicalTrials.gov.

PubMed

Su, Eric Wen; Sanger, Todd M

2017-01-01

Drug repositioning (i.e., drug repurposing) is the process of discovering new uses for marketed drugs. Historically, such discoveries were serendipitous. However, the rapid growth in electronic clinical data and text mining tools makes it feasible to systematically identify drugs with the potential to be repurposed. Described here is a novel method of drug repositioning by mining ClinicalTrials.gov. The text mining tools I2E (Linguamatics) and PolyAnalyst (Megaputer) were utilized. An I2E query extracts "Serious Adverse Events" (SAE) data from randomized trials in ClinicalTrials.gov. Through a statistical algorithm, a PolyAnalyst workflow ranks the drugs where the treatment arm has fewer predefined SAEs than the control arm, indicating that potentially the drug is reducing the level of SAE. Hypotheses could then be generated for the new use of these drugs based on the predefined SAE that is indicative of disease (for example, cancer).

Semantic Fluency in Deaf Children Who Use Spoken and Signed Language in Comparison with Hearing Peers

ERIC Educational Resources Information Center

Marshall, C. R.; Jones, A.; Fastelli, A.; Atkinson, J.; Botting, N.; Morgan, G.

2018-01-01

Background: Deafness has an adverse impact on children's ability to acquire spoken languages. Signed languages offer a more accessible input for deaf children, but because the vast majority are born to hearing parents who do not sign, their early exposure to sign language is limited. Deaf children as a whole are therefore at high risk of language…

Overview of the Clinical Consult Case Review of Adverse Events Following Immunization: Clinical Immunization Safety Assessment Network (CISA) 2004-2009

PubMed Central

Williams, S Elizabeth; Klein, Nicola P; Halsey, Neal; Dekker, Cornelia L; Baxter, Roger P; Marchant, Colin D; LaRussa, Philip S; Sparks, Robert C; Tokars, Jerome I; Pahud, Barbara A; Aukes, Laurie; Jakob, Kathleen; Coronel, Silvia; Choi, Howard; Slade, Barbara A; Edwards, Kathryn M

2016-01-01

Background In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations. PMID:21801776

New definitions of 6 clinical signs of perceptual disorder in children with cerebral palsy: an observational study through reliability measures.

PubMed

Ferrari, A; Sghedoni, A; Alboresi, S; Pedroni, E; Lombardi, F

2014-12-01

Recently authors have begun to emphasize the non-motor aspects of Cerebral Palsy and their influence on motor control and recovery prognosis. Much has been written about single clinical signs (i.e., startle reaction) but so far no definitions of the six perceptual signs presented in this study have appeared in literature. This study defines 6 signs (startle reaction, upper limbs in startle position, frequent eye blinking, posture freezing, averted eye gaze, grimacing) suggestive of perceptual disorders in children with cerebral palsy and measures agreement on sign recognition among independent observers and consistency of opinions over time. Observational study with both cross-sectional and prospective components. Fifty-six videos presented to observers in random order. Videos were taken from 19 children with a bilateral form of cerebral palsy referred to the Children Rehabilitation Unit in Reggio Emilia. Thirty-five rehabilitation professionals from all over Italy: 9 doctors and 26 physiotherapists. Measure of agreement among 35 independent observers was compiled from a sample of 56 videos. Interobserver reliability was determined using the K index of Fleiss and reliability intra-observer was calculated by the Spearman correlation index between ranks (rho - ρ). Percentage of agreement between observers and Gold Standard was used as criterion validity. Interobserver reliability was moderate for startle reaction, upper limb in startle position, adverted eye gaze and eye-blinking and fair for posture freezing and grimacing. Intraobserver reliability remained consistent over time. Criterion validity revealed very high agreement between independent observer evaluation and gold standard. Semiotics of perceptual disorders can be used as a specific and sensitive instrument in order to identify a new class of patients within existing heterogeneous clinical types of bilateral cerebral palsy forms and could help clinicians in identifying functional prognosis. To provide

Ivy Sign on Fluid-Attenuated Inversion Recovery Images in Moyamoya Disease: Correlation with Clinical Severity and Old Brain Lesions

PubMed Central

Seo, Kwon-Duk; Suh, Sang Hyun; Kim, Yong Bae; Kim, Ji Hwa; Ahn, Sung Jun; Kim, Dong-Seok

2015-01-01

Purpose Leptomeningeal collateral, in moyamoya disease (MMD), appears as an ivy sign on fluid-attenuated inversion-recovery (FLAIR) images. There has been little investigation into the relationship between presentation of ivy signs and old brain lesions. We aimed to evaluate clinical significance of ivy signs and whether they correlate with old brain lesions and the severity of clinical symptoms in patients with MMD. Materials and Methods FLAIR images of 83 patients were reviewed. Each cerebral hemisphere was divided into 4 regions and each region was scored based on the prominence of the ivy sign. Total ivy score (TIS) was defined as the sum of the scores from the eight regions and dominant hemispheric ivy sign (DHI) was determined by comparing the ivy scores from each hemisphere. According to the degree of ischemic symptoms, patients were classified into four subgroups: 1) nonspecific symptoms without motor weakness, 2) single transient ischemic attack (TIA), 3) recurrent TIA, or 4) complete stroke. Results TIS was significantly different as follows: 4.86±2.55 in patients with nonspecific symptoms, 5.89±3.10 in patients with single TIA, 9.60±3.98 in patients with recurrent TIA and 8.37±3.39 in patients with complete stroke (p=0.003). TIS associated with old lesions was significantly higher than those not associated with old lesions (9.35±4.22 vs. 7.49±3.37, p=0.032). We found a significant correlation between DHI and motor symptoms (p=0.001). Conclusion Because TIS has a strong tendency with severity of ischemic motor symptom and the presence of old lesions, the ivy sign may be useful in predicting severity of disease progression. PMID:26256975

Adverse food reactions in dogs and cats.

PubMed

Gaschen, Frédéric P; Merchant, Sandra R

2011-03-01

Adverse food reactions (AFR) are a common problem that may cause cutaneous and/or gastrointestinal signs in dogs and cats. They comprise food intolerance, food intoxication, and food allergy. Response to a dietary elimination trial and recurrence of signs during dietary provocation remain the centerpiece of diagnosis and management of dogs and cats with AFR. Response to an elimination trial is frequently observed in dogs and cats with chronic idiopathic enteropathies. However, only a fraction of them relapse after a dietary challenge. These animals may have mild to enteritis and/or colitis and benefit from various additional properties of the elimination diet. Copyright © 2011 Elsevier Inc. All rights reserved.

Mitigation of adverse interactions in pairs of clinical practice guidelines using constraint logic programming.

PubMed

Wilk, Szymon; Michalowski, Wojtek; Michalowski, Martin; Farion, Ken; Hing, Marisela Mainegra; Mohapatra, Subhra

2013-04-01

We propose a new method to mitigate (identify and address) adverse interactions (drug-drug or drug-disease) that occur when a patient with comorbid diseases is managed according to two concurrently applied clinical practice guidelines (CPGs). A lack of methods to facilitate the concurrent application of CPGs severely limits their use in clinical practice and the development of such methods is one of the grand challenges for clinical decision support. The proposed method responds to this challenge. We introduce and formally define logical models of CPGs and other related concepts, and develop the mitigation algorithm that operates on these concepts. In the algorithm we combine domain knowledge encoded as interaction and revision operators using the constraint logic programming (CLP) paradigm. The operators characterize adverse interactions and describe revisions to logical models required to address these interactions, while CLP allows us to efficiently solve the logical models - a solution represents a feasible therapy that may be safely applied to a patient. The mitigation algorithm accepts two CPGs and available (likely incomplete) patient information. It reports whether mitigation has been successful or not, and on success it gives a feasible therapy and points at identified interactions (if any) together with the revisions that address them. Thus, we consider the mitigation algorithm as an alerting tool to support a physician in the concurrent application of CPGs that can be implemented as a component of a clinical decision support system. We illustrate our method in the context of two clinical scenarios involving a patient with duodenal ulcer who experiences an episode of transient ischemic attack. Copyright © 2013 Elsevier Inc. All rights reserved.

The range and prevalence of clinical signs and conformation associated with lameness in working draught donkeys in Pakistan.

PubMed

Reix, C E; Burn, C C; Pritchard, J C; Barr, A R S; Whay, H R

2014-11-01

Lameness is prevalent in working donkeys and has major welfare implications; however, a detailed study of the associated clinical signs is lacking. To describe the range and prevalence of clinical signs and conformation associated with lameness in working draught donkeys. Prospective, cross-sectional, observational study. Data were collected from 102 working draught donkeys in Pakistan. A lameness assessment adapted for working donkeys was used to record clinical signs of lameness, gait, limb conformation and pain responses in the feet, limbs and spine using observation, palpation and manipulation. Lameness at the walk was scored from 0 to 10 (sound to nonweightbearing). Every donkey examined had gait abnormalities, with 5% having a nonweightbearing limb. Lameness was significantly more severe with older age, lower body condition score and forward-at-the-knee conformation. More severe lameness was also associated with pain responses in the hoof walls, palpation of limb joints and spinal flexion. Joint, tendon and foot pathology was highly prevalent, as well as pain responses to joint flexion and spinal manipulation. Conformational abnormalities showed lateral asymmetries. Over 98% of the world's 42.2 million donkeys are in low-income countries, most being used for work. The high prevalence of lameness, pain and multiple limb and spinal abnormalities in working donkeys is of great welfare concern and highlights the complexity of addressing this problem. This standardised lameness assessment can be used when implementing and monitoring interventions to reduce lameness prevalence in working donkeys. © 2014 EVJ Ltd.

Adverse reactions from essential oil-containing natural flea products exempted from Environmental Protection Agency regulations in dogs and cats.

PubMed

Genovese, Allison G; McLean, Mary Kay; Khan, Safdar A

2012-08-01

To describe adverse effects in dogs and cats exposed to Environmental Protection Agency exempted plant-derived flea preventatives containing mixtures of essential oils. Retrospective study from 2006 to 2008. Records of dog and cat cases were reviewed from the American Society for the Prevention of Cruelty to Animals, Animal Poison Control Center database. Thirty-nine cats and 9 dogs with history of exposure to natural flea preventatives. The following information was retrieved from each incident: number of animals, species involved, frequency, types, onset time, duration of clinical signs, exposure appropriateness, final outcome, and treatment information. Ninety-two percent of animals (n = 44) showed presence of one or more adverse effects. The frequency of adverse effects in dogs (n = 8; 89%) and cats (n = 36; 92%) was similar. Onset time of adverse effects in 39 of 44 animals occurred within 24 hours. The duration of signs in 24 animals ranged from 30 minutes to 149 hours. The products were used as per label in 77% animals (n = 37). Of 28 animals with known outcome, 50% (n = 14) recovered with bathing alone while others received intravenous fluids, muscle relaxants, and anticonvulsive medications. Death (1 cat; n = 1/28; 4%) or euthanasia (1 cat and 1 dog; n = 2/28; 7%) was reported in 3 animals. Dogs and cats can experience significant adverse effects when exposed to plant-derived flea preventatives even when used according to label directions. The number of reports of exposure in cats was higher than dogs, but the frequency of reported adverse effects was similar between the 2 species. Agitation and hypersalivation were common in cats, whereas lethargy and vomiting were common in dogs. © Veterinary Emergency and Critical Care Society 2012.

Usher syndrome clinical types I and II: could ocular symptoms and signs differentiate between the two types?

PubMed

Tsilou, Ekaterini T; Rubin, Benjamin I; Caruso, Rafael C; Reed, George F; Pikus, Anita; Hejtmancik, James F; Iwata, Fumino; Redman, Joy B; Kaiser-Kupfer, Muriel I

2002-04-01

Usher syndrome types I and II are clinical syndromes with substantial genetic and clinical heterogeneity. We undertook the current study in order to identify ocular symptoms and signs that could differentiate between the two types. Sixty-seven patients with Usher syndrome were evaluated. Based on audiologic and vestibular findings, patients were classified as either Usher type I or II. The severity of the ocular signs and symptoms present in each type were compared. Visual acuity, visual field area, electroretinographic amplitude, incidence of cataract and macular lesions were not significantly different between Usher types I and II. However, the ages when night blindness was perceived and retinitis pigmentosa was diagnosed differed significantly between the two types. There seems to be some overlap between types I and II of Usher syndrome in regard to the ophthalmologic findings. However, night blindness appears earlier in Usher type I (although the difference in age of appearance appears to be less dramatic than previously assumed). Molecular elucidation of Usher syndrome may serve as a key to understanding these differences and, perhaps, provide a better tool for use in clinical diagnosis, prognosis and genetic counseling.

Association between the findings on magnetic resonance imaging screening for syringomyelia in asymptomatic Cavalier King Charles spaniels and observation of clinical signs consistent with syringomyelia in later life.

PubMed

Ives, E J; Doyle, L; Holmes, M; Williams, T L; Vanhaesebrouck, A E

2015-01-01

A questionnaire-based study was used to investigate the association between the findings on magnetic resonance imaging (MRI) screening for syringomyelia (SM) in 79 asymptomatic Cavalier King Charles spaniels (CKCS) and the subsequent development of clinical signs consistent with SM in later life. Owners reported clinical signs consistent with SM in 13/79 (16%) dogs at the time of the questionnaire. A significantly greater proportion of CKCS with a syrinx visible on MRI screening showed clinical signs in later life (9/25, 36%) than dogs without a visible syrinx (4/54, 7%; odds ratio 6.9). Whether the findings of MRI screening can be used to indicate the likelihood of an asymptomatic CKCS developing clinical signs consistent with SM in later life warrants further prospective study in a larger cohort of dogs. Copyright © 2014 Elsevier Ltd. All rights reserved.

Impact of childhood adversity on the onset and course of subclinical psychosis symptoms--results from a 30-year prospective community study.

PubMed

Rössler, Wulf; Hengartner, Michael P; Ajdacic-Gross, Vladeta; Haker, Helene; Angst, Jules

2014-03-01

The study objective was to examine childhood adversity in association with intra-individual changes and inter-individual differences in subclinical psychosis in a representative community cohort over a 30-year period of observation. We analyzed two psychosis syndromes derived from the SCL-90-R - schizotypal signs and schizophrenia nuclear symptoms - in 335 participants. Participants were repeatedly assessed between 1978 (around age 20) and 2008 (around age 50). We focused specifically on inter-individual differences and intra-individual changes over time by applying structural equation modeling, generalized linear models, and generalized estimating equations. Several weak inter-individual differences revealed that increased schizotypal signs are related to various childhood adversities, such as being repeatedly involved in fights and parents having severe conflicts among themselves. We also found a significant positive association between schizotypal signs and the total number of adversities a subject experienced. This pointed toward a modest dose-response relationship. The intra-individual change in schizotypal signs over time was rather weak, although some adjustment did occur. In contrast, inter-individual schizophrenia nuclear symptoms were mainly unrelated to childhood adversity. However, some striking intra-individual changes in distress were noted over time, especially those linked with severe punishment and the total adversity score. In conclusion, we have confirmed previous positive findings about the association between childhood adversity and subsequent subclinical psychosis symptoms: An increase in adversity is weakly related to an increase of the psychosis symptom load. However, depending on the kind of adversity experienced the psychosis symptom load decreases gradually in adult life. Copyright © 2014 Elsevier B.V. All rights reserved.

Long-term exposure to methylmercury and neurologic signs in Minamata and neighboring communities.

PubMed

Yorifuji, Takashi; Tsuda, Toshihide; Takao, Soshi; Harada, Masazumi

2008-01-01

It is well known that large-scale poisonings caused by methylmercury occurred in Japan (Minamata, in the 1950s) and Iraq. However, in contrast to Iraq, there have been few sound epidemiologic studies in Minamata. We evaluated the effect of methylmercury on neurologic signs using data from a 1971 population-based study. Villages in 3 areas were selected for study: the Minamata area (a high-exposure area), the Goshonoura area (a medium-exposure area), and the Ariake area (a low-exposure area). We used place of residence as the exposure indicator. We examined associations between methylmercury exposure and the following neurologic signs measured on clinical examination: paresthesia of whole body, paresthesia of extremities, paresthesia around the mouth, ataxia, dysarthria, tremors, and pathologic reflexes. Total population was 1120 in the high-exposure villages, 1845 in the medium-exposure villages, and 1165 in the low-exposure villages. In the Minamata area, 87% (n=833) of the eligible population (age 10 years and older) participated in the 1971 investigations, in the Goshonoura area, 93% (n = 1450), and in the Ariake area, 77% (n = 755). Compared with subjects in the Ariake area, the subjects in the Minamata area manifested neurologic signs more frequently. The highest prevalence odds ratio was observed for paresthesia around the mouth (110; 95% confidence interval = 16-820). Although residents in the Goshonoura area had been exposed less heavily than those in the Minamata area, Goshonoura residents also had increased prevalence of neurologic signs. Long-term exposure to methylmercury has a strong adverse impact on neurologic signs among residents in a local community.

Bitopic Binding Mode of an M1 Muscarinic Acetylcholine Receptor Agonist Associated with Adverse Clinical Trial Outcomes

PubMed Central

Bradley, Sophie J.; Molloy, Colin; Bundgaard, Christoffer; Mogg, Adrian J.; Thompson, Karen J.; Dwomoh, Louis; Sanger, Helen E.; Crabtree, Michael D.; Brooke, Simon M.; Sexton, Patrick M.; Felder, Christian C.; Christopoulos, Arthur; Broad, Lisa M.

2018-01-01

The realization of the therapeutic potential of targeting the M1 muscarinic acetylcholine receptor (mAChR) for the treatment of cognitive decline in Alzheimer’s disease has prompted the discovery of M1 mAChR ligands showing efficacy in alleviating cognitive dysfunction in both rodents and humans. Among these is GSK1034702 (7-fluoro-5-methyl-3-[1-(oxan-4-yl)piperidin-4-yl]-1H-benzimidazol-2-one), described previously as a potent M1 receptor allosteric agonist, which showed procognitive effects in rodents and improved immediate memory in a clinical nicotine withdrawal test but induced significant side effects. Here we provide evidence using ligand binding, chemical biology and functional assays to establish that rather than the allosteric mechanism claimed, GSK1034702 interacts in a bitopic manner at the M1 mAChR such that it can concomitantly span both the orthosteric and an allosteric binding site. The bitopic nature of GSK1034702, together with the intrinsic agonist activity and a lack of muscarinic receptor subtype selectivity reported here, all likely contribute to the adverse effects of this molecule in clinical trials. Although they impart beneficial effects on learning and memory, we conclude that these properties are undesirable in a clinical candidate due to the likelihood of adverse side effects. Rather, our data support the notion that “pure” positive allosteric modulators showing selectivity for the M1 mAChR with low levels of intrinsic activity would be preferable to provide clinical efficacy with low adverse responses. PMID:29695609

Bitopic Binding Mode of an M1 Muscarinic Acetylcholine Receptor Agonist Associated with Adverse Clinical Trial Outcomes.

PubMed

Bradley, Sophie J; Molloy, Colin; Bundgaard, Christoffer; Mogg, Adrian J; Thompson, Karen J; Dwomoh, Louis; Sanger, Helen E; Crabtree, Michael D; Brooke, Simon M; Sexton, Patrick M; Felder, Christian C; Christopoulos, Arthur; Broad, Lisa M; Tobin, Andrew B; Langmead, Christopher J

2018-06-01

The realization of the therapeutic potential of targeting the M 1 muscarinic acetylcholine receptor (mAChR) for the treatment of cognitive decline in Alzheimer's disease has prompted the discovery of M 1 mAChR ligands showing efficacy in alleviating cognitive dysfunction in both rodents and humans. Among these is GSK1034702 (7-fluoro-5-methyl-3-[1-(oxan-4-yl)piperidin-4-yl]-1 H -benzimidazol-2-one), described previously as a potent M 1 receptor allosteric agonist, which showed procognitive effects in rodents and improved immediate memory in a clinical nicotine withdrawal test but induced significant side effects. Here we provide evidence using ligand binding, chemical biology and functional assays to establish that rather than the allosteric mechanism claimed, GSK1034702 interacts in a bitopic manner at the M 1 mAChR such that it can concomitantly span both the orthosteric and an allosteric binding site. The bitopic nature of GSK1034702, together with the intrinsic agonist activity and a lack of muscarinic receptor subtype selectivity reported here, all likely contribute to the adverse effects of this molecule in clinical trials. Although they impart beneficial effects on learning and memory, we conclude that these properties are undesirable in a clinical candidate due to the likelihood of adverse side effects. Rather, our data support the notion that "pure" positive allosteric modulators showing selectivity for the M 1 mAChR with low levels of intrinsic activity would be preferable to provide clinical efficacy with low adverse responses. Copyright © 2018 by The Author(s).

Identifying adverse drug event information in clinical notes with distributional semantic representations of context.

PubMed

Henriksson, Aron; Kvist, Maria; Dalianis, Hercules; Duneld, Martin

2015-10-01

For the purpose of post-marketing drug safety surveillance, which has traditionally relied on the voluntary reporting of individual cases of adverse drug events (ADEs), other sources of information are now being explored, including electronic health records (EHRs), which give us access to enormous amounts of longitudinal observations of the treatment of patients and their drug use. Adverse drug events, which can be encoded in EHRs with certain diagnosis codes, are, however, heavily underreported. It is therefore important to develop capabilities to process, by means of computational methods, the more unstructured EHR data in the form of clinical notes, where clinicians may describe and reason around suspected ADEs. In this study, we report on the creation of an annotated corpus of Swedish health records for the purpose of learning to identify information pertaining to ADEs present in clinical notes. To this end, three key tasks are tackled: recognizing relevant named entities (disorders, symptoms, drugs), labeling attributes of the recognized entities (negation, speculation, temporality), and relationships between them (indication, adverse drug event). For each of the three tasks, leveraging models of distributional semantics - i.e., unsupervised methods that exploit co-occurrence information to model, typically in vector space, the meaning of words - and, in particular, combinations of such models, is shown to improve the predictive performance. The ability to make use of such unsupervised methods is critical when faced with large amounts of sparse and high-dimensional data, especially in domains where annotated resources are scarce. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Overcoming the problem of diagnostic heterogeneity in applying measurement-based care in clinical practice: the concept of psychiatric vital signs.

PubMed

Zimmerman, Mark; Young, Diane; Chelminski, Iwona; Dalrymple, Kristy; Galione, Janine N

2012-02-01

Measurement-based care refers to the use of standardized scales to measure the outcome of psychiatric treatment. Diagnostic heterogeneity poses a challenge toward the adoption of a measurement-based care approach toward outcome evaluation in clinical practice. In the present article, we propose adopting the concept of psychiatric vital signs to facilitate measurement-based care. Medical vital signs are measures of basic physiologic functions that are routinely determined in medical settings. Vital signs are often a primary outcome measure, and they are also often adjunctive measurements. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services project, we examined the frequency of depression and anxiety in a diagnostically heterogeneous group of psychiatric outpatients to determine the appropriateness of considering their measurement as psychiatric vital signs. Three thousand psychiatric outpatients were interviewed with the Structured Clinical Interview for DSM-IV supplemented with items from the Schedule for Affective Disorders and Schizophrenia. We determined the frequency of depression and anxiety evaluated according to the Schedule for Affective Disorders and Schizophrenia items. In the entire sample of 3000 patients, 79.3% (n = 2378) reported clinically significant depression of at least mild severity, 64.4% (n = 1932) reported anxiety of at least mild severity, and 87.4% (n = 2621) reported either anxiety or depression. In all 10 diagnostic categories examined, most patients had clinically significant anxiety or depression of at least mild severity. These findings support the routine assessment of anxiety and depression in clinical practice because almost all patients will have these problems as part of their initial presentation. Even for those patients without depression or anxiety, the case could be made that the measurement of depression and anxiety is relevant and analogous to measuring certain physiologic

Exploratory study of factors associated with adverse clinical features in patients presenting with non-fatal drug overdose/self-poisoning to the ambulance service.

PubMed

Gwini, Stella May; Shaw, Deborah; Iqbal, Mohammad; Spaight, Anne; Siriwardena, Aloysius Niroshan

2011-10-01

To investigate the factors associated with adverse clinical features presented by drug overdose/self-poisoning patients and the treatments provided. Historical patient records collected over 3 months from ambulance crews attending non-fatal overdoses/self-poisoning incidents were reviewed. Logistic regression was used to investigate predictors of adverse clinical features (reduced consciousness, obstructed airway, hypotension or bradycardia, hypoglycaemia) and treatment. Of 22,728 calls attended to over 3 months, 585 (rate 26/1000 calls) were classified as overdose or self-poisoning. In the 585 patients identified, paracetamol-containing drugs were most commonly involved (31.5%). At least one adverse clinical feature occurred in 103 (17.7%) patients, with higher odds in men and opiate overdose or illegal drugs. Older patients and patients with reduced consciousness were more likely to receive oxygen. The latter also had a greater chance of receiving saline. Non-fatal overdose/self-poisoning accounted for 2.6% of patients attended by an ambulance. Gender, illegal drugs or opiates were important predictors of adverse clinical features. The treatments most often provided to patients were oxygen and saline.

Boomerang sign: Clinical significance of transient lesion in splenium of corpus callosum.

PubMed

Malhotra, Hardeep Singh; Garg, Ravindra Kumar; Vidhate, Mukund R; Sharma, Pawan Kumar

2012-04-01

Transient signal abnormality in the splenium of corpus callosum on magnetic resonance imaging (MRI) is occasionally encountered in clinical practice. It has been reported in various clinical conditions apart from patients with epilepsy. We describe 4 patients with different etiologies presenting with signal changes in the splenium of corpus callosum. They were diagnosed as having progressive myoclonic epilepsy (case 1), localization-related epilepsy (case 2), hemicrania continua (case 3), and postinfectious parkinsonism (case 4). While three patients had complete involvement of the splenium on diffusion-weighted image ("boomerang sign"), the patient having hemicrania continua showed semilunar involvement ("mini-boomerang") on T2-weighted and FLAIR image. All the cases had noncontiguous involvement of the splenium. We herein, discuss these cases with transient splenial involvement and stress that such patients do not need aggressive diagnostic and therapeutic interventions. An attempt has been made to review the literature regarding the pathophysiology, etiology, and outcome of such lesions.

Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles.

PubMed

Tang, Eve; Ravaud, Philippe; Riveros, Carolina; Perrodeau, Elodie; Dechartres, Agnes

2015-08-14

The reporting of serious adverse events (SAEs) in clinical trials is crucial to assess the balance between benefits and risks. For trials with serious adverse events posted at ClinicalTrials.gov, we assessed the consistency between SAEs posted at ClinicalTrials.gov and those published in corresponding journal articles. All records from ClinicalTrials.gov up to February 2014 were automatically exported in XML format. Among these, we identified all phase III or IV randomized controlled trials with at least one SAE posted. For a random sample of 300 of these trials, we searched for corresponding publications using MEDLINE via PubMed and extracted safety results from the articles. Among the sample of 300 trials with SAEs posted at ClinicalTrials.gov, 78 (26%) did not have a corresponding publication, and 20 (7%) had a publication that did not match the ClinicalTrials.gov record. For the 202 remaining trials, 26 published articles (13%) did not mention SAEs, 4 (2%) reported no SAEs, and 33 (16%) did not report the total number of SAEs per treatment group. Among the remaining 139 trials, for 44 (32%), the number of SAEs per group published did not match those posted at ClinicalTrials.gov. For 31 trials, the number of SAEs was greater at ClinicalTrials.gov than in the published article, with a difference ≥30 % for at least one group for 21. Only 33 trials (11%) had a publication reporting matching numbers of SAE and describing the type of SAE. Many trials with SAEs posted at ClinicalTrials.gov are not yet published, omit the reporting of these SAEs in corresponding publications, or report a discrepant number of SAEs as compared with ClinicalTrials.gov. These results underline the need to consult ClinicalTrials.gov for more information on serious harms.

Clinical signs and symptoms cannot reliably predict Plasmodium falciparum malaria infection in pregnant women living in an area of high seasonal transmission.

PubMed

Tahita, Marc C; Tinto, Halidou; Menten, Joris; Ouedraogo, Jean-Bosco; Guiguemde, Robert T; van Geertruyden, Jean Pierre; Erhart, Annette; D'Alessandro, Umberto

2013-12-27

Malaria in pregnancy is a major public health problem in endemic countries. Though the signs and symptoms of malaria among pregnant women have been already described, clinical presentation may vary according to intensity of transmission and local perceptions. Therefore, determining common signs and symptoms among pregnant women with a malaria infection may be extremely useful to identify those in need of further investigation by rapid diagnostic test or microscopy. Six hundred pregnant women attending the maternity clinic of Nanoro District Hospital, Burkina Faso were recruited, 200 with suspected clinical malaria and 400 as controls. Cases were matched with controls by gestational age and parity. Signs and symptoms were collected and a blood sample taken for rapid diagnostic test, microscopy and haemoglobin measurement. A multivariate model was used to assess the predictive value of signs and symptoms for malaria infection. The overall prevalence of malaria was 42.6% (256/600) while anaemia was found in 60.8% (365/600) of the women. Nearly half (49%) of the cases and 39.5% of the controls had a malaria infection (p = 0.03). The most common signs and symptoms among the cases were fever (36%,72/200), history of fever (29%,58/200) and headache (52%,104/200). The positive predictive value for fever was 53% (95% CI:41-64), history of fever 58% (95% CI:37-63) and headache 51% (95% CI:41-61). Signs and symptoms suggestive of malaria are frequent among pregnant women living in areas of intense transmission. Common malaria symptoms are not strong predictors of infection. For a better management of malaria in pregnancy, active screening to detect and treat malaria infection early should be performed on all pregnant women attending a health facility.

Minimizing Adverse Events While Maintaining Clinical Improvement in a Pediatric Attention-Deficit/Hyperactivity Disorder Crossover Trial with Dextroamphetamine and Methylphenidate

PubMed Central

Aabech, Henning S.; Sundet, Kjetil

2014-01-01

Abstract Objective: The purpose of this study was to investigate whether the availability of both dextroamphetamine and methylphenidate provides an opportunity to minimize adverse events in a pediatric attention-deficit/hyperactivity disorder (ADHD) stimulant trial. Methods: Thirty-six medication-naïve children 9–14 years of age, diagnosed with ADHD, were enrolled for 6 weeks in a crossover trial, with 2 weeks of methylphenidate, dextroamphetamine, and a placebo in a randomly assigned, counterbalanced sequence. Barkley's Side-Effect Rating Scale (SERS), rated by parents, was used to assess adverse events. SERS were available for 34 children, and data were analyzed both at the group and the single-subject level. Results: The side-effect profiles of dextroamphetamine and methylphenidate appeared similar at the group level. Overall, insomnia and decreased appetite were the only adverse events associated with the stimulants as compared with placebo. No significant increase from placebo to stimulant conditions was detected on SERS items reflecting emotional symptoms. Furthermore, dextroamphetamine and methylphenidate did not differ from each other on any SERS item, except that dextroamphetamine was associated with higher severity of “insomnia” and a higher prevalence of “unusually happy.” Single-subject analyses showed that one or more adverse events were reported in 14 children (41%), and were evenly distributed between those with dextroamphetamine as the drug that showed the greatest reduction in their ADHD symptoms (“best drug”) and those with methylphenidate as their best drug. Among children in whom both stimulants were associated with a decrease in ADHD symptoms, a clinically valid difference between the two stimulants in total adverse events score was found in 7 (39%) of the 18 cases. In these children, the availability of both stimulants provided an opportunity to minimize adverse events, while maintaining a reduction in ADHD symptoms. Conclusions

[Clinical signs in late pregnant mares].

PubMed

Neuhauser, Stefanie; Gösele, Patricia; Handler, Johannes

2018-06-01

During the peripartal period, interpretation of basic clinical signs may be challenging. In the present study, heart rate (HR), respiratory rate (RR) and body temperature (BT) were evaluated in healthy mares of different breed types and compared to reference values for adult horses from the literature. During daily physical exams of periparturient mares, the HR, RR and BT were evaluated. Differences according to the horse's size were investigated and in large breeds, the influence of dystocia or retained placenta was analysed. During the last weeks before parturition (a. p.), the HR significantly increased and was clearly lower after parturition (p. p.; p < 0.05). In larger horses, the RR increased a. p. and decreased p. p. (p < 0.05). The BT underwent changes in all groups during the periparturient period and was higher p. p. (p < 0.05). In general, values for HR, RR and BT were highest in ponies (p < 0.05) while the lowest RR was measured in large horses (p < 0.05). There was no difference in the HR between mares with eutocia or with dystocia (p > 0.05). By contrast, the RR was significantly higher in mares with dystocia on day 1 p. p. (p < 0.05). Differences in the BT a. p. and p. p. occurred only in mares with eutocia (p < 0.05) and remained within the normal values. Mares with retained placenta did not exhibit significant changes in the HR (p > 0.05), but the BT was higher on day 1 p. p. (p < 0.05). Increased HR, RR and BT in mares during late pregnancy suggest a distinct physical performance for a prolonged period of time. Interpretation of these parameters in relation to the mare's reproductive state is essential to diagnose potential disorders and to determine whether therapy is required. Schattauer GmbH.

Effect of RAAS blockers on adverse clinical outcomes in high CVD risk subjects with atrial fibrillation

PubMed Central

Chaugai, Sandip; Sherpa, Lhamo Yanchang; Sepehry, Amir A.; Arima, Hisatomi; Wang, Dao Wen

2016-01-01

Abstract Recent studies have demonstrated that atrial fibrillation significantly increases the risk of adverse clinical outcomes in high cardiovascular disease risk subjects. Application of renin–angiotensin–aldosterone system blockers for prevention of recurrence of atrial fibrillation and adverse clinical outcomes in subjects with atrial fibrillation is a theoretically appealing concept. However, results of clinical trials evaluating the effect of renin–angiotensin–aldosterone blockers on adverse clinical outcomes in high cardiovascular disease risk subjects with atrial fibrillation remain inconclusive. A pooled study of 6 randomized controlled trials assessing the efficacy of renin–angiotensin–aldosterone blockers on subjects with atrial fibrillation was performed. A total of 6 randomized controlled trials enrolled a total of 53,510 patients followed for 1 to 5 years. RAAS blockade therapy was associated with 14% reduction in the incidence of heart failure (OR: 0.86, [95%CI: 0.76– 0.97], P=0.018) and 17% reduction in the incidence of CVE (OR: 0.83, [95%CI: 0.70–0.99], P = 0.038). The corresponding decline in absolute risk against heart failure (ARR: 1.4%, [95%CI: 0.2–2.6%], P = 0.018) and CVE (ARR: 3.5%, [95%CI: 0.0–6.9%], P = 0.045) in the AF group was much higher than the non-AF group for heart failure (ARR: 0.4%, [95%CI: 0.0–0.7%], P = 0.057) and CVE (ARR: 1.6%, [95%CI: –0.1% to 3.3%], P = 0.071). No significant effect was noted on all-cause or cardiovascular mortality, stroke, or myocardial infarction. This study suggests that RAAS blockade offers protection against heart failure and cardiovascular events in high cardiovascular disease risk subjects with atrial fibrillation. PMID:27368043

[About the signs of malignant pheochromocytoma].

PubMed

Simonenko, V B; Makanin, M A; Dulin, P A; Vasilchenko, M I; Lesovik, V S

2012-01-01

Morphological criteria for malignant pheochromocytoma remain to be developed According to the WHO recommendations, the sole absolute criteria is the presence of metastases in the organs normally containing no chromaffin tissue. Such signs as cellular and nuclear polymorphism, mytotic activity, vascular invasion, capsular ingrowth are not sufficient to describe a pheochromocytoma as malignant. It is equally dfficult to differentiate between malignant and benign tumours based on histological data since histologically mature neoplasms can produce metastases. Based on the results of original studies, the authors believe that such histological features as vascular and capsular invasion do not necessarily suggest unfavourable prognosis. Therefore, the conclusion of malignancy based on such features can not be regarded as absolute. Probably such neoplasms should be called "pheochromocytomas with morphological signs of malignant growths". They should be referred to the tumours with uncertain malignancy potential based on the known discrepancy between morphological structure and biological activity of neoplasms. Comparative studies of clinical and morphological features of pheochromocytomas showed that their histological type (alveolar; solid, dyscomplexed, trabecular) and morphological signs of malignant growth influence both the clinical picture and arterial hypertension. There are no significant relationship between the above morphological signs, timour mass and clinical manifestations of pheochromocytomas.

Clinical Signs and Subjective Symptoms of Temporomandibular Disorders in Instrumentalists

PubMed Central

Jang, Jae-Young; Kwon, Jeong-Seung; Lee, Debora H.; Bae, Jung-Hee

2016-01-01

Purpose Most of the reports on instrumentalists' experiences of temporomandibular disorders (TMD) have been reported not by clinical examinations but by subjective questionnaires. The aim of this study was to investigate the clinical signs and subjective symptoms of TMD in a large number of instrumentalists objectively. Materials and Methods A total of 739 musicians from a diverse range of instrument groups completed a TMD questionnaire. Among those who reported at least one symptom of TMD, 71 volunteers underwent clinical examinations and radiography for diag-nosis. Results Overall, 453 participants (61.3%) reported having one or more symptoms of TMD. The most frequently reported symptom was a clicking or popping sound, followed by temporomandibular joint (TMJ) pain, muscle pain, crepitus, and mouth opening limitations. Compared with lower-string instrumentalists, a clicking or popping sound was about 1.8 and 2 times more frequent in woodwind and brass instrumentalists, respectively. TMJ pain was about 3.2, 2.8, and 3.2 times more frequent in upper-string, woodwind, and brass instrumentalists, respectively. Muscle pain was about 1.5 times more frequent in instrumentalists with an elevated arm position than in those with a neutral arm position. The most frequent diagnosis was myalgia or myofascial pain (MFP), followed by disc displacement with reduction. Myalgia or MFP was 4.6 times more frequent in those practicing for no less than 3.5 hours daily than in those practicing for less than 3.5 hours. Conclusion The results indicate that playing instruments can play a contributory role in the development of TMD. PMID:27593881

Clinical Signs and Subjective Symptoms of Temporomandibular Disorders in Instrumentalists.

PubMed

Jang, Jae Young; Kwon, Jeong Seung; Lee, Debora H; Bae, Jung Hee; Kim, Seong Taek

2016-11-01

Most of the reports on instrumentalists' experiences of temporomandibular disorders (TMD) have been reported not by clinical examinations but by subjective questionnaires. The aim of this study was to investigate the clinical signs and subjective symptoms of TMD in a large number of instrumentalists objectively. A total of 739 musicians from a diverse range of instrument groups completed a TMD questionnaire. Among those who reported at least one symptom of TMD, 71 volunteers underwent clinical examinations and radiography for diag-nosis. Overall, 453 participants (61.3%) reported having one or more symptoms of TMD. The most frequently reported symptom was a clicking or popping sound, followed by temporomandibular joint (TMJ) pain, muscle pain, crepitus, and mouth opening limitations. Compared with lower-string instrumentalists, a clicking or popping sound was about 1.8 and 2 times more frequent in woodwind and brass instrumentalists, respectively. TMJ pain was about 3.2, 2.8, and 3.2 times more frequent in upper-string, woodwind, and brass instrumentalists, respectively. Muscle pain was about 1.5 times more frequent in instrumentalists with an elevated arm position than in those with a neutral arm position. The most frequent diagnosis was myalgia or myofascial pain (MFP), followed by disc displacement with reduction. Myalgia or MFP was 4.6 times more frequent in those practicing for no less than 3.5 hours daily than in those practicing for less than 3.5 hours. The results indicate that playing instruments can play a contributory role in the development of TMD.

[Symptoms and signs of heart failure in the Russian clinical guidelines of 2016: lost and displaced].

PubMed

Bel'diev, S N; Platonov, D Y; Gavrilenko, N G; Myasnikova, T S

Using the example of Russian and European clinical guidelines on diagnosis and treatment of heart failure the article addressed issues, which may arise from word-for-word or component-wise translation to Russian of some English medical terms, such as bendopnea (or flexodyspnea, a symptom of shortness of breath when bending forward), a symptom (subjective symptom), and a sign (objective symptom).

Pasireotide treatment significantly improves clinical signs and symptoms in patients with Cushing's disease: results from a Phase III study.

PubMed

Pivonello, Rosario; Petersenn, Stephan; Newell-Price, John; Findling, James W; Gu, Feng; Maldonado, Mario; Trovato, Andrew; Hughes, Gareth; Salgado, Luiz R; Lacroix, André; Schopohl, Jochen; Biller, Beverly M K

2014-09-01

Signs and symptoms of Cushing's disease are associated with high burden of illness. In this analysis, we evaluated the effect of pasireotide treatment on signs and symptoms in patients with Cushing's disease. Phase III study with double-blind randomization of two pasireotide doses. Patients (n = 162) with persistent/recurrent or de novo Cushing's disease and urinary free cortisol (UFC) levels ≥1·5× upper limit of normal (ULN) were randomized to receive subcutaneous pasireotide (600/900 μg bid). At month 3, patients with UFC ≤2 × ULN and not exceeding the baseline value continued their randomized dose; all others received 300 μg bid uptitration. At month 6, patients could enter an open-label phase until month 12 with a maximal dose of 1200 μg bid. Changes in signs and symptoms of hypercortisolism over 12 months' treatment in patients still enroled in the study and with evaluable measurements were assessed in relation to degree of UFC control. Reductions in blood pressure were observed even without full UFC control and were greatest in patients who did not receive antihypertensive medications during the study. Significant reductions in total cholesterol and low-density lipoprotein (LDL)-cholesterol were observed in patients who achieved UFC control. Reductions in BMI, weight and waist circumference occurred during the study even without full UFC control. Adverse effects were typical of somatostatin analogues except for hyperglycaemia-related events, which were experienced by 72·8% of patients. In the largest Phase III study of medical therapy in Cushing's disease, significant improvements in signs and symptoms were seen during 12 months of pasireotide treatment, as UFC levels decreased. © 2014 John Wiley & Sons Ltd.

"Symptom-based insulin adjustment for glucose normalization" (SIGN) algorithm: a pilot study.

PubMed

Lee, Joyce Yu-Chia; Tsou, Keith; Lim, Jiahui; Koh, Feaizen; Ong, Sooim; Wong, Sabrina

2012-12-01

Lack of self-monitoring of blood glucose (SMBG) records in actual practice settings continues to create therapeutic challenges for clinicians, especially in adjusting insulin therapy. In order to overcome this clinical obstacle, a "Symptom-based Insulin adjustment for Glucose Normalization" (SIGN) algorithm was developed to guide clinicians in caring for patients with uncontrolled type 2 diabetes who have few to no SMBG records. This study examined the clinical outcome and safety of the SIGN algorithm. Glycated hemoglobin (HbA1c), insulin usage, and insulin-related adverse effects of a total of 114 patients with uncontrolled type 2 diabetes who refused to use SMBG or performed SMBG once a day for less than three times per week were studied 3 months prior to the implementation of the algorithm and prospectively at every 3-month interval for a total of 6 months after the algorithm implementation. Patients with type 1 diabetes, nonadherence to diabetes medications, or who were not on insulin therapy at any time during the study period were excluded from this study. Mean HbA1c improved by 0.29% at 3 months (P = 0.015) and 0.41% at 6 months (P = 0.006) after algorithm implementation. A slight increase in HbA1c was observed when the algorithm was not implemented. There were no major hypoglycemic episodes. The number of minor hypoglycemic episodes was minimal with the majority of the cases due to irregular meal habits. The SIGN algorithm appeared to offer a viable and safe approach when managing uncontrolled patients with type 2 diabetes who have few to no SMBG records.

Diverse Clinical Signs of Ocular Involvement in Cat Scratch Disease.

PubMed

Oray, Merih; Önal, Sumru; Koç Akbay, Aylin; Tuğal Tutkun, İlknur

2017-01-01

To describe ocular manifestations, diagnosis, and treatment of cat scratch disease. Clinical records of patients with ocular cat scratch disease were reviewed. Thirteen eyes of 10 patients (7 female, 3 male) with a mean age of 26.9±18.5 years were included. Nine patients had a history of cat contact and had systemic symptoms associated with cat scratch disease 2-90 days prior to the ocular symptoms. Ocular signs were: neuroretinitis in 4 eyes (associated with serous retinal detachment in the inferior quadrant in 1 eye), optic neuropathy in 2 eyes (1 papillitis and optic disc infiltration, 1 optic neuritis), retinal infiltrates in 6 eyes, retinochoroiditis in 1 eye, branch retinal arteriolar occlusion in 3 eyes, and endophthalmitis in 1 eye. Visual acuities at presentation were 1.0 in 7 eyes, 0.3 in 1 eye, ≤0.1 in 4 eyes, and light perception in 1 eye. Bartonella henselae immunoglobulin (Ig) M and/or IgG were positive in all patients. Systemic antibiotic therapy was administered in all patients. Systemic corticosteroid treatment (15-40 mg/day) was added to the therapy in 4 patients, following 5 days of intravenous pulse methylprednisolone in 2 patients. Treatment was ongoing for 1 patient and the mean treatment duration of the other 9 patients was 47±14.5 days. Visual acuities at final visit were 1.0 in 9 eyes, 0.8 in 1 eye, 0.4 in 1 eye, and no light perception in 1 eye. Cat scratch disease may present with different ocular signs and should be considered in the differential diagnosis in patients with such presentations.

Preadoption adversity, MAOA, and behavioral adjustment in internationally adopted Chinese girls.

PubMed

Li, Jun; Tan, Tony Xing; Camras, Linda A; Chen, Chuansheng; Moyzis, Robert K

2014-10-01

We studied postinstitutionalized adopted Chinese girls to determine whether those with different variants of the MAOA gene promoter region (MAOA-VNTR) differed in their internalizing and externalizing behavior problems and whether the MAOA genotype moderated the relation between preadoption adversity and current behavior problems. MAOA genotyping was obtained for 94 girls (mean age: 9.2 years) and the number of 4-repeat (4R) alleles was determined (zero, one, or two). The adoptive mothers rated several indicators of preadoption adversity shortly after adoption (mean age at adoption 15.8 months) and completed the Child Behavior Checklist when the children were 8.1 years on average. No main effects were found for preadoption adversity. However, the MAOA genotype had a nominally significant effect (P<0.05) on internalizing problems. Regression analyses controlling for age, household income, authoritarian parenting, and family problems showed that among children with no physical signs of preadoption adversity, those carrying a greater number of 4R alleles scored significantly lower (P<0.01) on internalizing problems than those with fewer 4R alleles. Differences in internalizing scores related to the MAOA genotype were not observed for children who showed one or more physical signs of adversity at the time of adoption. A similar pattern was found for externalizing problems, although the results did not reach conventional levels of significance. Our results suggest that higher MAOA activity may be protective with respect to internalizing problems in internationally adopted Chinese girls, but that this protective effect decreases at higher levels of preadoption adversity. A similar pattern may exist for externalizing problems.

Cinnamon: A systematic review of adverse events.

PubMed

Hajimonfarednejad, Mahdie; Ostovar, Mohadeseh; Raee, Mohammad Javad; Hashempur, Mohammad Hashem; Mayer, Johannes Gottfried; Heydari, Mojtaba

2018-04-05

Cinnamon, from the genus Cinnamomum and Lauraceae family, has been used as a popular spice for thousands of years around the world. Many studies have shown therapeutic effects of cinnamon including its antimicrobial, antiviral, antifungal, antioxidant, antitumor, antihypertensive, antilipemic, antidiabetic, gastroprotective, and immunomodulatory effects. Due to popular use of cinnamon and several human reports on adverse events associated with short or long term use of cinnamon, we aimed to systematically review its human reports of adverse event. Databases including Medline, Scopus, Science Direct, Embase, PubMed Central and Google scholar were searched using the key words "cinnamon" or "cinnamomum" for clinical trials, case reports and case series. Also spontaneous reports about adverse effects of cinnamon were collected from five national and international spontaneous reporting schemes. Thirty eight clinical trials were found, five of them reported adverse events. Twenty case reports and seven case series, as well as, spontaneous reports including 160 adverse events were also included. The most frequent adverse events were gastrointestinal disorders and allergic reactions which were self-limiting in the majority of cases. The available data suggests that despite the safety of cinnamon use as a spice and/or flavoring agent, its use may be associated with significant adverse effects in medicinal uses with larger doses or longer duration of use and should be clinically monitored. Copyright © 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Clinical Signs of Radiologic Pneumonia in Under-Five Hypokalemic Diarrheal Children Admitted to an Urban Hospital in Bangladesh

PubMed Central

Chisti, Mohammod Jobayer; Salam, Mohammed Abdus; Ashraf, Hasan; Faruque, Abu S. G.; Bardhan, Pradip Kumar; Das, Sumon Kumar; Shahunja, K. M.; Shahid, Abu S. M. S. B.; Ahmed, Tahmeed

2013-01-01

Background Clinical signs of pneumonia are often veiled in under-five diarrheal children presenting with hypokalemia, making clinical diagnosis of pneumonia very difficult in such population. However, there is no published report that describes the influences of hypokalemia on the clinical signs of pneumonia in diarrheal children. Our objective was to assess the influences of hypokalemia, and their outcome in such children. Methods We prospectively enrolled all under-five diarrheal children (n = 180) admitted to the Special Care Ward of the Dhaka Hospital of icddr,b from September-December 2007 with radiological pneumonia who also had their serum potassium estimated. We compared the clinical features and outcome of the diarrheal children having pneumonia with (cases = 55) and without hypokalemia (controls = 125). Results The case-fatality among the cases was 2 times higher compared to the controls, but the difference was not statistically significant (p = 0.202). In logistic regression analysis, after adjusting for potential confounders such as age of the patient, clinical dehydration, severe wasting, abnormally sleepy, lower chest wall in-drawing, nasal flaring and inability to drink on admission, under-five diarrheal children with pneumonia who presented with nutritional edema had 3 times more risk to have hypokalemia compared to those without nutritional edema (OR = 2.76, 95% CI = 1.01–7.51) and these hypokalemic children were 64% less likely to present with fast breathing (OR = 0.36, 95% CI = 0.17–0.74). Conclusion and significance The results of our analysis are simple but may have great public health implications and underscore the importance of diligent assessment for pneumonia in under-five diarrheal children having risk of hypokalemia as in children with nutritional edema even in absence of fast breathing, a useful sign of pneumonia. This may help for early initiation of first dose of parental antibiotics along with

Aloe vera: A review of toxicity and adverse clinical effects.

PubMed

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.

Minimizing adverse events while maintaining clinical improvement in a pediatric attention-deficit/hyperactivity disorder crossover trial with dextroamphetamine and methylphenidate.

PubMed

Ramtvedt, Bjørn E; Aabech, Henning S; Sundet, Kjetil

2014-04-01

The purpose of this study was to investigate whether the availability of both dextroamphetamine and methylphenidate provides an opportunity to minimize adverse events in a pediatric attention-deficit/hyperactivity disorder (ADHD) stimulant trial. Thirty-six medication-naïve children 9-14 years of age, diagnosed with ADHD, were enrolled for 6 weeks in a crossover trial, with 2 weeks of methylphenidate, dextroamphetamine, and a placebo in a randomly assigned, counterbalanced sequence. Barkley's Side-Effect Rating Scale (SERS), rated by parents, was used to assess adverse events. SERS were available for 34 children, and data were analyzed both at the group and the single-subject level. The side-effect profiles of dextroamphetamine and methylphenidate appeared similar at the group level. Overall, insomnia and decreased appetite were the only adverse events associated with the stimulants as compared with placebo. No significant increase from placebo to stimulant conditions was detected on SERS items reflecting emotional symptoms. Furthermore, dextroamphetamine and methylphenidate did not differ from each other on any SERS item, except that dextroamphetamine was associated with higher severity of "insomnia" and a higher prevalence of "unusually happy." Single-subject analyses showed that one or more adverse events were reported in 14 children (41%), and were evenly distributed between those with dextroamphetamine as the drug that showed the greatest reduction in their ADHD symptoms ("best drug") and those with methylphenidate as their best drug. Among children in whom both stimulants were associated with a decrease in ADHD symptoms, a clinically valid difference between the two stimulants in total adverse events score was found in 7 (39%) of the 18 cases. In these children, the availability of both stimulants provided an opportunity to minimize adverse events, while maintaining a reduction in ADHD symptoms. The availability of both dextroamphetamine and methylphenidate

Adverse Effects of Grape Seed Extract Supplement: A Clinical Case and Long-Term Follow-Up.

PubMed

Berry, Andrew C; Nakshabendi, Rahman; Abidali, Hussein; Atchaneeyasakul, Kunakorn; Dholaria, Kevin; Johnson, Cassandra; Kishore, Varsha A; Baltz, Aaron C

2016-01-01

Grape seed extract (GSE) supplement use is becoming more popular today for its potential chemopreventive and chemotherapeutic role. We report a 49-year-old male who presented with recurrent nausea, vomiting, diarrhea, and acute weakness following GSE use. A thorough medical workup ensued and no causes were identified clinically, procedurally, or with imaging. Symptoms resolved after GSE discontinuation and the patient remained symptom-free 5 years later. This case illustrates the paucity of documented detailed clinical cases and lack of controlled trials detailing a thorough and reproducible adverse effect profile of GSE supplement.

Polymorphism of DC-SIGN (CD209) promoter in association with clinical symptoms of dengue fever.

PubMed

Oliveira, Layanna Freitas de; Lima, Clayton Pereira Silva de; Azevedo, Raimunda do Socorro Silva; Mendonça, Dafne Silva Furtado de; Rodrigues, Sueli Guerreiro; Carvalho, Valéria Lima; Pinto, Eliana Vieira; Maia, Andreza Lopes; Maia, Maria Helena Thomaz; Vasconcelos, Janaina Mota; Silva, Andrea Luciana Soares da; Nunes, Márcio Roberto Teixeira; Sena, Leonardo; Vasconcelos, Pedro Fernando; Santos, Eduardo José Melo dos

2014-06-01

C-type lectin DC-SIGN receptor, encoded by CD209, plays a key role in the infection of dendritic cells by dengue virus (DENV). Because the -336A/G SNP (rs4804803) polymorphism in the promoter of CD209 modulates DC-SIGN expression, we investigated the putative association of this polymorphism with DENV infection and its pathogenesis. A control sample of 72 individuals, rigorously selected through a clinical investigation for absence of past dengue fever (DF) was compared to a sample of 168 patients (156 classical DF; 12 dengue hemorrhagic fever), all residents from Pará, Brazil. However, the prevalence of symptoms showed a trend higher in the AA genotype (Wilcoxon test; Z=2.02; p=0.04). Hence, our findings indicate that the G allele downregulates the spectrum of symptoms during the early acute phase of DENV infection, putatively decreasing the viremia, as suggested in the literature.

Phasic jaw motor episodes in healthy subjects with or without clinical signs and symptoms of sleep bruxism: a pilot study.

PubMed

Yoshizawa, Shuichiro; Suganuma, Takeshi; Takaba, Masayuki; Ono, Yasuhiro; Sakai, Takuro; Yoshizawa, Ayako; Kawana, Fusae; Kato, Takafumi; Baba, Kazuyoshi

2014-03-01

To investigate the association between each clinical diagnosis criterion for sleep bruxism (SB) and the frequency of jaw motor events during sleep. Video-polysomnography was performed on 17 healthy adult subjects (mean age, 26.7 ± 2.8 years), with at least one of the following clinical signs and symptoms of SB: (1) a report of frequent tooth grinding, (2) tooth attrition with dentine exposure through at least three occlusal surfaces, (3) morning masticatory muscle symptoms, and (4) masseter muscle hypertrophy. Episodes of rhythmic masticatory muscle activity (RMMA) and isolated tonic activity were scored visually. These variables were compared with regards to the presence or absence of each clinical sign and symptom. In 17 subjects, 4.0 ± 2.5/h (0.1-10.2) RMMA and 1.0 ± 0.8/h (0-2.4) isolated tonic episodes were observed (total episodes: 5.0 ± 2.4/h (1.2-11.6)). Subjects with self-reported grinding sounds (n=7) exhibited significantly higher numbers of RMMA episodes (5.7 ± 2.3/h) than those without (n=10; 2.8 ± 1.8/h) (p=0.011). Similarly, subjects with tooth attrition (n=6) showed significantly higher number of RMMA episodes (5.6 ± 3.1/h) than those without (n=11; 3.2 ± 1.6/h) (p=0.049). The occurrence of RMMA did not differ between the presence and absence of morning masticatory muscle symptoms or muscle hypertrophy. Clinical signs and symptoms frequently used for diagnosing SB can represent different clinical and physiological aspects of jaw motor activity during sleep.

Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting.

PubMed

Baker, Meghan A; Kaelber, David C; Bar-Shain, David S; Moro, Pedro L; Zambarano, Bob; Mazza, Megan; Garcia, Crystal; Henry, Adam; Platt, Richard; Klompas, Michael

2015-09-15

Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values, and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the MetroHealth System, an integrated healthcare system in Ohio. We queried the VAERS database to determine MetroHealth's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. In the 8 months following implementation, 91 622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2%) messages, responded to 209 (15.1%), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95% confidence interval, 9.52-95.5) times greater than the odds during the comparable preimplementation period. An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society

Adverse Drug Reactions (ADR) and Emergencies.

PubMed

Schurig, A Marlen; Böhme, Miriam; Just, Katja S; Scholl, Catharina; Dormann, Harald; Plank-Kiegele, Bettina; Seufferlein, Thomas; Gräff, Ingo; Schwab, Matthias; Stingl, Julia C

2018-04-13

Adverse drug reactions (ADR) are a common reason for emergency room visits and for hospitalization. An ADR is said to have occurred when the patient's symptoms and signs are considered to be possibly, probably, or definitely related to the intake of a drug. In four large hospital emergency departments, one in each of four German cities ( Ulm, Fürth, Bonn, and Stuttgart), the percentage of suspected ADR cases among all patients presenting to the emergency room was determined during a 30-day period of observation. ADRs were ascertained by screening the digital records of all patients seen in the emergency room; causality was assessed as specified by the WHO-UMC (Uppsala Monitoring Center). ADR were sought in a total of 10 174 emergency department visits. 665 cases of suspected ADR were found, yielding a prevalence of 6.5%. The prevalence of ADR among patients with documented drug intake was 11.6%. Among the patients with documented suspected ADRs, 89% were hospitalized (in contrast to the 43.7% hospitalization rate in the entire group of 10 174 emergency department visits). A possible causal relationship between the patient's symptoms and signs and the intake of a drug was found in 74-84% of cases. Patients with ADR were found to be taking a median of 7 different drugs simultaneously. Adverse drug reactions are a relevant cause of emergency department visits, accounting for 6.5% of the total visits in this study, and often lead to hospital admission. The ADRED (Adverse Drug Reactions in Emergency Departments) study, which is now being conducted, is intended to shed further light on their causes, patient risk factors, and potential avoidability.

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

PubMed

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

2015-01-01

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

Predicting the clinical efficacy and potential adverse effects of a humanized anticocaine monoclonal antibody

PubMed Central

Norman, Andrew B; Ball, William J

2012-01-01

The effects of a humanized monoclonal antibody (mAb) having high affinity and specificity for cocaine in animal models are reviewed. The mAb reduced the concentration of cocaine in the brain of mice after intravenous injection of cocaine. In addition, the mAb increased the concentration of cocaine required to reinstate cocaine self-administration. These effects may predict clinical efficacy of a passive immunotherapy for reducing the probability of cocaine-induced relapse. However, in the presence of the mAb, once cocaine self-administration was reinstated, the consumption rate of cocaine was increased. This effect is hypothesized to result from a pharmacokinetic/pharmacodynamic interaction. A humanized mAb should minimize adverse events related to the immunogenicity of the mAb protein, and the specificity for cocaine should avoid adverse events related to interactions with physiologically relevant endogenous proteins. PMID:22401638

Adverse Reactions to Hallucinogenic Drugs.

ERIC Educational Resources Information Center

Meyer, Roger E. , Ed.

This reports a conference of psychologists, psychiatrists, geneticists and others concerned with the biological and psychological effects of lysergic acid diethylamide and other hallucinogenic drugs. Clinical data are presented on adverse drug reactions. The difficulty of determining the causes of adverse reactions is discussed, as are different…

Comparison of the adverse event profiles of levofloxacin 500 mg and 750 mg in clinical trials for the treatment of respiratory infections.

PubMed

Khashab, Mohammed M; Xiang, Jim; Kahn, James B

2006-10-01

To compare safety data with levofloxacin 500 mg and 750 mg from clinical trials for the treatment of respiratory infections. We compared adverse event data for levofloxacin 500 mg and 750 mg from clinical trials in acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia. Adverse events occurring after the initiation of therapy were classified as treatment-emergent adverse events (TEAE); drug-related adverse events (DRAE) were TEAE assessed by the clinical investigator as definitely/very likely or probably related to levofloxacin therapy. Overall, the safety profile of the two doses was similar but not identical. TEAE occurred in 49.0% (1601/3268) of those treated with 500 mg and in 45.5% (519/1141) of those treated with 750 mg (p = 0.042); the corresponding rates of DRAE were 7.6% (248/3268) and 8.0% (91/1141) (p = 0.699). There was no statistically significant difference in terms of overall TEAE and DRAE rates within each of the three infectious conditions, but there were in specific events, all of which are expected with levofloxacin therapy. The limitations of this analysis include that it utilized a subset of available safety data, that it includes data only from clinical trials, and that we report primarily on events occurring in > or = 2% of patients. Given similar adverse event profiles and the advantages of higher dose therapy, including shorter courses of therapy and potential impact on preventing resistance, clinicians should consider utilizing the 750 mg dose of levofloxacin when choosing between dosage strengths for treatment of indicated infections.

The effect of the quality of vital sign recording on clinical decision making in a regional acute care trauma ward.

PubMed

Keene, Claire M; Kong, Victor Y; Clarke, Damian L; Brysiewicz, Petra

2017-10-01

Recording vital signs is important in the hospital setting and the quality of this documentation influences clinical decision making. The Modified Early Warning Score (MEWS) uses vital signs to categorise the severity of a patient's physiological derangement and illustrates the clinical impact of vital signs in detecting patient deterioration and making management decisions. This descriptive study measured the quality of vital sign recordings in an acute care trauma setting, and used the MEWS to determine the impact the documentation quality had on the detection of physiological derangements and thus, clinical decision making. Vital signs recorded by the nursing staff of all trauma patients in the acute care trauma wards at a regional hospital in South Africa were collected from January 2013 to February 2013. Investigator-measured values taken within 2 hours of the routine observations and baseline patient information were also recorded. A MEWS for each patient was calculated from the routine and investigator-measured observations. Basic descriptive statistics were performed using EXCEL. The details of 181 newly admitted patients were collected. Completion of recordings was 81% for heart rate, 88% for respiratory rate, 98% for blood pressure, 92% for temperature and 41% for GCS. The recorded heart rate was positively correlated with the investigator's measurement (Pearson's correlation coefficient of 0.76); while the respiratory rate did not correlate (Pearson's correlation coefficient of 0.02). In 59% of patients the recorded respiratory rate (RR) was exactly 20 breaths per minute and 27% had a recorded RR of exactly 15. Seven percent of patients had aberrant Glasgow Coma Scale readings above the maximum value of 15. The average MEWS was 2 for both the recorded (MEWS(R)) and investigator (MEWS(I)) vitals, with the range of MEWS(R) 0-7 and MEWS(I) 0-9. Analysis showed 59% of the MEWS(R) underestimated the physiological derangement (scores were lower than the MEWS

Medications and Adverse Voice Effects.

PubMed

Nemr, Kátia; Di Carlos Silva, Ariana; Rodrigues, Danilo de Albuquerque; Zenari, Marcia Simões

2017-08-16

To identify the medications used by patients with dysphonia, describe the voice symptoms reported on initial speech-language pathology (SLP) examination, evaluate the possible direct and indirect effects of medications on voice production, and determine the association between direct and indirect adverse voice effects and self-reported voice symptoms, hydration and smoking habits, comorbidities, vocal assessment, and type and degree of dysphonia. This is a retrospective cross-sectional study. Fifty-five patients were evaluated and the vocal signs and symptoms indicated in the Dysphonia Risk Protocol were considered, as well as data on hydration, smoking and medication use. We analyzed the associations between type of side effect and self-reported vocal signs/symptoms, hydration, smoking, comorbidities, type of dysphonia, and auditory-perceptual and acoustic parameters. Sixty percent were women, the mean age was 51.8 years, 29 symptoms were reported on the screening, and 73 active ingredients were identified with 8.2% directly and 91.8% indirectly affecting vocal function. There were associations between the use of drugs with direct adverse voice effects, self-reported symptoms, general degree of vocal deviation, and pitch deviation. The symptoms of dry throat and shortness of breath were associated with the direct vocal side effect of the medicine, as well as the general degree of vocal deviation and the greater pitch deviation. Shortness of breath when speaking was also associated with the greatest degree of vocal deviation. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Searching for Signs, Symbols, and Icons: Effects of Time of Day, Visual Complexity, and Grouping

ERIC Educational Resources Information Center

McDougall, Sine; Tyrer, Victoria; Folkard, Simon

2006-01-01

Searching for icons, symbols, or signs is an integral part of tasks involving computer or radar displays, head-up displays in aircraft, or attending to road traffic signs. Icons therefore need to be designed to optimize search times, taking into account the factors likely to slow down visual search. Three factors likely to adversely affect visual…

Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

PubMed

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

2016-08-01

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 the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed 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 adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of seven papers

Adverse reactions in a population of Sydney pet rabbits vaccinated against rabbit calicivirus.

PubMed

Tung, T; Phalen, D; Toribio, J-Alml

2015-11-01

To determine the general clinical presentation and incidence of adverse reactions to Cylap® RCD vaccinations, of a nature serious enough for veterinary attention, in a Sydney population of pet rabbits. A retrospective survey using hospital databases. Nine veterinary hospitals in Sydney participated in a database search for the number of rabbits vaccinated within a 2-year period. The hospitals involved had an identified interest in rabbit medicine and included general, specialist and teaching hospitals. Details of the rabbit, vaccination event and any possible reaction were collected and analysed. Of 933 events recorded in 705 rabbits, 17 (1.8%) adverse reactions were observed. Of the adverse events, local injection site reactions (alopecia, abrasions and scabbing) were most common. Other reactions, including systemic signs of gastrointestinal tract stasis, lethargy and forelimb lameness, were also documented. Overall, rabbits presented for vaccination were mostly male (57.7%) and desexed (71.3%), with an average age of 28.1 months (median 19.0, range 1.4-149.8 months) and an average weight at first vaccination of 2.12 kg (median 2.08 kg, range 0.18-5.6 kg). A significant association between increasing age and decreased incidence of adverse events was demonstrated (P value, 0.038). The benefits of vaccination against RCV outweigh the risks of an adverse reaction occurring. Data from this study show that adverse reactions occur infrequently, are generally mild and self-resolving, and decrease in incidence with increasing age. These results are similar to previous field research on wild rabbit colonies and reports from government and industry. © 2015 Australian Veterinary Association.

The Meaning of Signs:

PubMed Central

Stein, Claudia

2006-01-01

This article reconstructs the diagnostic act of the French pox in the French-disease hospital of sixteenth-century Augsburg. It focuses on how the participants in the clinical encounter imagined the configuration of the pox and its localization in the human body. Of central importance for answering this question is the early modern conception of physical signs. It has been argued that it was due to a specific understanding of bodily signs and their relationship to a disease and its causes, that disease definition and classification in the early modern period showed a high degree of flexibility and fluidity. This paper looks at how the sixteenth-century theoretical conception of physical signs not only shaped the diagnosis and treatment of the pox but also reflected the overall organization of institutions. PMID:17242549

SkQ1 Ophthalmic Solution for Dry Eye Treatment: Results of a Phase 2 Safety and Efficacy Clinical Study in the Environment and During Challenge in the Controlled Adverse Environment Model.

PubMed

Petrov, Anton; Perekhvatova, Natalia; Skulachev, Maxim; Stein, Linda; Ousler, George

2016-01-01

This Phase 2 clinical trial assessed the efficacy and safety of the novel antioxidative, renewable compound SkQ1 for topical treatment of dry eye signs and symptoms. In a single-center, randomized, double-masked, placebo-controlled, 29-day study, 91 subjects with mild to moderate dry eye instilled the study drug twice daily and recorded dry eye symptoms daily. Subjects were randomized 1:1:1 into one of three ophthalmic solution treatment groups: SkQ1 1.55 µg/mL, SkQ1 0.155 µg/mL, or 0.0 µg/mL (placebo). Subjects were exposed to a controlled adverse environment chamber at 3 of the 4 study visits (Day -7, Day 1, and Day 29). Investigator assessments occurred at all study visits. SkQ1 was safe and efficacious in treating dry eye signs and symptoms. Statistically significant improvements with SkQ1 compared to placebo occurred for the dry eye signs of corneal fluorescein staining and lissamine green staining in the central region and lid margin redness, and for the dry eye symptoms of ocular discomfort, dryness, and grittiness. In addition, SkQ1 demonstrated greater efficacy compared to placebo, although the differences were not statistically significant, for corneal fluorescein staining in other regions and/or time points (total staining score, central region, corneal sum score, and temporal region), lissamine green staining for the central and nasal regions, and blink rate scores. This Phase 2 study indicated that SkQ1 is safe and efficacious for the treatment of dry eye signs and symptoms and supported previous study results. Clinicaltrials.gov identifier: NCT02121301. Miotech S.A.

Adverse Childhood Experiences among Veterinary Medical Students: A Multi-Site Study.

PubMed

Strand, Elizabeth B; Brandt, Jennifer; Rogers, Kenita; Fonken, Laurie; Chun, Ruthanne; Conlon, Peter; Lord, Linda

This research explores Adverse Childhood Experiences (ACEs) among veterinary medical students across six academic institutions of veterinary medicine, and their relationship with depression, stress, and desire to become a veterinarian. Between April 1, 2016, and May 23, 2016, 1,118 veterinary medical students in all 4 years of the curriculum (39% response rate) completed an anonymous web-based questionnaire about ACEs, depression using the Center for Epidemiological Studies Depression scale (CESD), stress using the Perceived Stress Scale (PSS), and the age at which they wanted to become a veterinarian. Sixty-one percent (677) of respondents reported having at least one ACE. The most prevalent ACE reported was living with a household member with a mental illness (31%). Students who had experienced four or more ACEs had an approximately threefold increase in signs of clinical depression and higher than average stress when compared to students who had experienced no ACEs. The number of ACEs showed an overall graded relationship to signs of clinical depression and higher than average stress. There was no statistically significant relationship between age at which a student wanted to become a veterinarian and exposure to ACEs. Veterinary students report being exposed to ACEs before age 18 at a rate similar to that of other population-based studies. These findings do not suggest that veterinary students enter the veterinary medical education system more at risk for poor mental health due to ACEs than the general population.

Comparing early signs and basic symptoms as methods for predicting psychotic relapse in clinical practice.

PubMed

Eisner, Emily; Drake, Richard; Lobban, Fiona; Bucci, Sandra; Emsley, Richard; Barrowclough, Christine

2018-02-01

Early signs interventions show promise but could be further developed. A recent review suggested that 'basic symptoms' should be added to conventional early signs to improve relapse prediction. This study builds on preliminary evidence that basic symptoms predict relapse and aimed to: 1. examine which phenomena participants report prior to relapse and how they describe them; 2. determine the best way of identifying pre-relapse basic symptoms; 3. assess current practice by comparing self- and casenote-reported pre-relapse experiences. Participants with non-affective psychosis were recruited from UK mental health services. In-depth interviews (n=23), verbal checklists of basic symptoms (n=23) and casenote extracts (n=208) were analysed using directed content analysis and non-parametric statistical tests. Three-quarters of interviewees reported basic symptoms and all reported conventional early signs and 'other' pre-relapse experiences. Interviewees provided rich descriptions of basic symptoms. Verbal checklist interviews asking specifically about basic symptoms identified these experiences more readily than open questions during in-depth interviews. Only 5% of casenotes recorded basic symptoms; interviewees were 16 times more likely to report basic symptoms than their casenotes did. The majority of interviewees self-reported pre-relapse basic symptoms when asked specifically about these experiences but very few casenotes reported these symptoms. Basic symptoms may be potent predictors of relapse that clinicians miss. A self-report measure would aid monitoring of basic symptoms in routine clinical practice and would facilitate a prospective investigation comparing basic symptoms and conventional early signs as predictors of relapse. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

The association of admission hyperglycaemia and adverse clinical outcome in medical emergencies: the multinational, prospective, observational TRIAGE study.

PubMed

Kutz, A; Struja, T; Hausfater, P; Amin, D; Amin, A; Haubitz, S; Bernard, M; Huber, A; Mueller, B; Schuetz, P

2017-07-01

The clinical relevance of hyperglycaemia in an emergency department population remains incompletely understood. We investigated the association between admission blood glucose levels and adverse clinical outcomes in a large emergency department cohort. We prospectively enrolled 7132 adult medical patients seeking emergency department care in three tertiary care hospitals in Switzerland, France and the USA. We used adjusted multivariable logistic regression models to examine the association between admission blood glucose levels and 30-day mortality, as well as adverse clinical course stratified by pre-existing diabetes and principal medical diagnoses. In 6044 people without diabetes (84.7%), severe hyperglycaemia, defined as a glucose level of > 11.1 mmol/l (200 mg/dl), was associated with a doubling in the risk of 30-day mortality [adjusted odds ratio (OR) 1.9; 95% confidence interval (95% CI), 1.1 to 3.3; P = 0.018] and a three-fold increase in the risk of intensive care unit admission (adjusted OR 3.0; 95% CI, 1.9 to 4.9; P < 0.001). These associations were similar among different diagnoses. In the population with diabetes (n = 1088), no association with 30-day mortality was found (adjusted OR 1.0; 95% CI, 0.6 to 1.8; P for interaction = 0.001), whereas the association with intensive care unit admission was weaker (adjusted OR 2.4; 95% CI, 1.5 to 4.1; P for interaction = 0.011). Overall 30-day mortality was higher in those with diabetes than in those without (6.1 vs. 4.4%, P = 0.015). In this large medical emergency department patient cohort, admission hyperglycaemia was strongly associated with adverse clinical course in people without diabetes. (Clinical Trial Registry No: NCT01768494). © 2017 Diabetes UK.

Are there clinical signs and symptoms of infection to indicate the presence of multidrug-resistant bacteria in venous ulcers?

PubMed

Dos Santos, Silvana de Lima Vieira; Martins, Marlene Andrade; do Prado, Marinésia Aparecida; Soriano, José Verdú; Bachion, Maria Márcia

2017-12-01

The selection of topical and systemic therapies for the treatment of venous ulcers with signs of infection is challenging and should be accompanied by specific precautionary measures to protect against cross-contamination in the presence of multidrug-resistant microorganisms. However, there are still no clinical indicators for this situation, and confirmation of resistant strains occurs through culture and sensitivity, which can take up to 14 days. During this period, protective measures may no longer be taken, contributing to the spread of these pathogens. This study aimed to analyze the relationship between clinical signs and symptoms of infection in venous ulcers and the presence of antimicrobial-resistant Staphylococcus aureus and/or Pseudomonas spp. A cross-sectional study was developed including 69 patients with 98 venous ulcers. Clinical observation protocol was applied to detect infection indicators established by the European Wound Management Association and microbiological analysis of samples of the lesions. Fisher's exact test and χ 2 were used for analyses (P < 0.05). Two indicators of infection predominated (f >70%): discoloration of the opaque type and/or dark brick red and increased exudate volume; 31 (31.6%) ulcer samples showed positive culture for the bacteria studied. There was no relationship between signs and symptoms of infection and the presence of multidrug-resistant microorganisms. Taking into account the percentage of lesions with resistant strains, for safe care, contact precautionary measures should be implemented in the treatment rooms, in addition to standard precautions. Copyright © 2017 Society for Vascular Nursing, Inc. Published by Elsevier Inc. All rights reserved.

On the System of Person-Denoting Signs in Estonian Sign Language: Estonian Name Signs

ERIC Educational Resources Information Center

Paales, Liina

2010-01-01

This article discusses Estonian personal name signs. According to study there are four personal name sign categories in Estonian Sign Language: (1) arbitrary name signs; (2) descriptive name signs; (3) initialized-descriptive name signs; (4) loan/borrowed name signs. Mostly there are represented descriptive and borrowed personal name signs among…

Visuoperceptual repetition priming and progression of parkinsonian signs in aging

PubMed Central

Fleischman, Debra A.; Buchman, Aron S.; Bienias, Julia L.; Bennett, David A.

2009-01-01

Parkinsonian signs in older persons are associated with numerous adverse health outcomes, however there is limited information about factors which predict progression of these signs. Using generalized linear models, we examined the association between efficiency in visuoperceptual and conceptual processing, measured by repetition priming, and rate of change in parkinsonian signs in a large sample of older persons without cognitive impairment or Parkinson’s disease. Subjects with better visuoperceptual priming, measured by threshold word-identification and word-stem completion, at study baseline, progressed more slowly during follow-up of up to 11 years. Conceptual priming was not associated with change in parkinsonian signs. The findings demonstrate that individual differences in visuoperceptual efficiency, measured by repetition priming, occur in older persons without cognitive impairment and predict important changes in motor function. Reduced visuoperceptual priming in aging may be an early signal of vulnerability in a corticostrial circuit that contributes to sensorimotor integration. PMID:17709154

Chlamydia felis: Lack of association between clinical signs and the presence of the cryptic plasmid.

PubMed

Gonsales, F F; Brandão, P E; Melville, P A; Zuniga, E; Benites, N R

2016-08-01

Chlamydia felis is an obligate intracellular bacterial pathogen that infects cats, causing severe conjunctivitis associated with upper respiratory tract disease (URTD). In the present study, 186 cats from three non-commercial catteries in São Paulo, SP, Brazil were evaluated. The detection of Chlamydia felis was performed by PCR. The clinical severity was scored from 1 to 4, with a score of 4 as the most severe manifestation. The total occurrence of C. felis was of 18.82% (35/186) of cats overall, but notably, 58.06% (18/31) of infected cats originated from a single cattery. All animals harboring C. felis had URTD clinical signs and higher scores (3 and 4). In addition, C. felis occurrence was associated with the presence of cryptic plasmid. However, the virulence and clinical severity were not correlated. Copyright © 2016 Elsevier Ltd. All rights reserved.

How to Improve Time to Diagnosis in Acute Heart Failure - Clinical Signs and Chest X-ray.

PubMed

Allen, Christopher J; Guha, Kaushik; Sharma, Rakesh

2015-10-01

Acute heart failure (AHF) is a leading cause of hospitalisation in developed nations with stubbornly poor outcomes in both the short and long term. Furthermore, alongside an ageing population the incidence continues to increase. Contemporary practice guidelines accordingly emphasise the importance of early recognition of heart failure in the acute setting to facilitate the timely instigation of key investigations, appropriate management and access to specialist care; all of which improve outcome. However, the diagnosis of AHF is often challenging, with no gold standard diagnostic test and presenting clinical features that may be non-specific, particularly in the elderly where they may be atypical, or masked by co-morbidity. This short review explores the main clinical signs and radiographic changes in patients with AHF relevant to clinical practice in accordance with the best available evidence.

A clinical decision-making mechanism for context-aware and patient-specific remote monitoring systems using the correlations of multiple vital signs.

PubMed

Forkan, Abdur Rahim Mohammad; Khalil, Ibrahim

2017-02-01

In home-based context-aware monitoring patient's real-time data of multiple vital signs (e.g. heart rate, blood pressure) are continuously generated from wearable sensors. The changes in such vital parameters are highly correlated. They are also patient-centric and can be either recurrent or can fluctuate. The objective of this study is to develop an intelligent method for personalized monitoring and clinical decision support through early estimation of patient-specific vital sign values, and prediction of anomalies using the interrelation among multiple vital signs. In this paper, multi-label classification algorithms are applied in classifier design to forecast these values and related abnormalities. We proposed a completely new approach of patient-specific vital sign prediction system using their correlations. The developed technique can guide healthcare professionals to make accurate clinical decisions. Moreover, our model can support many patients with various clinical conditions concurrently by utilizing the power of cloud computing technology. The developed method also reduces the rate of false predictions in remote monitoring centres. In the experimental settings, the statistical features and correlations of six vital signs are formulated as multi-label classification problem. Eight multi-label classification algorithms along with three fundamental machine learning algorithms are used and tested on a public dataset of 85 patients. Different multi-label classification evaluation measures such as Hamming score, F1-micro average, and accuracy are used for interpreting the prediction performance of patient-specific situation classifications. We achieved 90-95% Hamming score values across 24 classifier combinations for 85 different patients used in our experiment. The results are compared with single-label classifiers and without considering the correlations among the vitals. The comparisons show that multi-label method is the best technique for this problem

[Deficient identification of signs and symptoms in Streptoccoci amigdalitis].

PubMed

Carranza-Martínez, Martha Imelda; Valdés-Croda, Oscar; Jaspersen-Gastelum, Víctor; Chavolla-Magaña, Rogelio; Villaseñor-Sierra, Alberto

2006-01-01

To evaluate the degree of identification of main signs and symptoms of streptococcal pharyngitis by resident doctors, general practitioners, family physicians and pediatricians. A prospective, cross-sectional and comparative study was done. A validated questionnaire was applied including the following topics: social demographic, main signs and symptoms, clinical cases; and clinical pictures. We interviewed resident doctors (n = 40), general physicians (n = 21), family physicians (n = 35) and pediatricians (n = 19) from different institutions (SSa, ISSSTE, IMSS) in Guadalajara, Mexico, from March to August 2005. Scores were interpreted as very good, good, regular and poor, and these scores were related with the specialty and clinical years of experience. chi2, student t test and linear regression. This study included 115 physicians between 22 to 60 years old (mean = 39) and with 0 to 31 (mean = 10) clinical years of experience. Regarding the conceptual identification of main signs and symptoms, tonsil exudates were recognized by 33 to 61% of physicians, and a clinical case of streptococcal tonsillitis was recognized by 50 to 70%. A clinical picture of tonsil caseum was misinterpreted as streptococcal tonsillitis by 13 to 35% of the physicians. There was no association between years of clinical experience and the scores obtained in clinical cases (r = 0.20) or clinical pictures (r = 0.09). The clinical identification of streptococcal tonsillitis was regular to poor among all the interviewed physicians, and there had no correlation with the years of clinical experience. The reinforcement in teaching to recognize the key signs and symptoms of streptococcal tonsillitis at medical school would result in better recognition, more rational use of antimicrobials and reduction in health institutions costs.

Grey matter volume loss is associated with specific clinical motor signs in Huntington's disease.

PubMed

Coppen, Emma M; Jacobs, Milou; van den Berg-Huysmans, Annette A; van der Grond, Jeroen; Roos, Raymund A C

2018-01-01

Motor disturbances are clinical hallmarks of Huntington's disease (HD) and involve chorea, dystonia, hypokinesia and visuomotor dysfunction. Investigating the association between specific motor signs and different regional volumes is important to understand the heterogeneity of HD. To investigate the motor phenotype of HD and associations with subcortical and cortical grey matter volume loss. Structural T1-weighted MRI scans of 79 HD patients and 30 healthy controls were used to calculate volumes of seven subcortical structures including the nucleus accumbens, hippocampus, thalamus, caudate nucleus, putamen, pallidum and amygdala. Multiple linear regression analyses, corrected for age, gender, CAG, MRI scan protocol and normalized brain volume, were performed to assess the relationship between subcortical volumes and different motor subdomains (i.e. eye movements, chorea, dystonia, hypokinesia/rigidity and gait/balance). Voxel-based morphometry analysis was used to investigate the relationship between cortical volume changes and motor signs. Subcortical volume loss of the accumbens nucleus, caudate nucleus, putamen, and pallidum were associated with higher chorea scores. No other subcortical region was significantly associated with motor symptoms after correction for multiple comparisons. Voxel-based cortical grey matter volume reductions in occipital regions were related with an increase in eye movement scores. In HD, chorea is mainly associated with subcortical volume loss, while eye movements are more related to cortical volume loss. Both subcortical and cortical degeneration has an impact on motor impairment in HD. This implies that there is a widespread contribution of different brain regions resulting in the clinical motor presentation seen in HD patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

PubMed

Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

2016-01-01

Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs.

Are vital signs indicative for bacteremia in newborns?

PubMed

Yapıcıoğlu, Hacer; Özlü, Ferda; Sertdemir, Yaşar

2015-01-01

Neonatal systemic infection is a leading cause of morbidity and mortality both in industrialized and developing countries. The aim of this prospective study was to evaluate if vital signs had a predictive power in neonatal sepsis as an early marker. This study was designed as a matched case-control study. Vital signs were monitorized prior to infection in newborns that had healthcare-associated blood stream infection (BSI). Maximum and minimum values of the vital signs (blood pressure, heart rate, respiratory rate and temperature) of the babies at rest were recorded from the nurse observation charts five days prior to clinical sepsis and compared with vital signs of healthy, age-matched babies. Maximum mean heart rates, respiratory rates and systolic blood pressure levels of the patients in BSI group were significantly higher than the control group in the past three days prior to clinical deterioration. Monitoring vital signs closely might be helpful in a newborn infant to define a BSI. In future, a respiratory and blood pressure predictive monitoring system such as heart rate variability index may be developed for newborn patients with sepsis.

Effect of Massage Therapy on Vital Signs and GCS Scores of ICU Patients: A Randomized Controlled Clinical Trial.

PubMed

Vahedian-Azimi, Amir; Ebadi, Abbas; Asghari Jafarabadi, Mohammad; Saadat, Soheil; Ahmadi, Fazlollah

2014-08-01

Unalleviated complications related to hospitalization, including stress, anxiety, and pain, can easily influence different structures, like the neural system, by enhancing the stimulation of sympathetic nervous pathways and causing unstable vital signs and deterioration in the level of consciousness. The purpose of this study was to determine the effects of massage therapy by family members on vital signs and Glasgow Coma Scale Score (GCS) of patients hospitalized in the Intensive Care Unit (ICU). This randomized controlled clinical trial was conducted at the ICU of the Shariati Hospital during 2012; 45 ICU patients and 45 family members in the experimental group and the same number of patients and family members in the control group were consecutively selected . The data collection instrument consisted of two parts. The first part included demographic data (age, marital status and Body Mass Index) and the second part included a checklist to record the patient's vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), pulse rate (PR)) and GCS. All measurements were done at the same time in both groups before the intervention (full body massage therapy), and 1 hour, 2 hours, 3 hours, and 4 hours after intervention. The patients were provided with a 60-minute full body massage The massage protocol included static, surface tension, stretching, superficial lymph unload, transverse friction, and myofacial releasing techniques. Significant differences were observed between experimental and control groups in the SBP at 1 hour, SBP 2 hours, and SBP 3 hours, and also in GCS at 1 hour to GCS at 4 hours (P < 0.05). Multivariate analysis revealed a significant difference between experimental and control groups in SBP at all time points (P < 0.05). Massage via family members had several positive effects on the patients' clinical conditions, and therefore, it should be recognized as one of the most important clinical considerations in

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.

PubMed

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.

Genomic scar signatures associated with homologous recombination deficiency predict adverse clinical outcomes in patients with ovarian clear cell carcinoma.

PubMed

Chao, Angel; Lai, Chyong-Huey; Wang, Tzu-Hao; Jung, Shih-Ming; Lee, Yun-Shien; Chang, Wei-Yang; Yang, Lan-Yang; Ku, Fei-Chun; Huang, Huei-Jean; Chao, An-Shine; Wang, Chin-Jung; Chang, Ting-Chang; Wu, Ren-Chin

2018-05-03

We investigated whether genomic scar signatures associated with homologous recombination deficiency (HRD), which include telomeric allelic imbalance (TAI), large-scale transition (LST), and loss of heterozygosity (LOH), can predict clinical outcomes in patients with ovarian clear cell carcinoma (OCCC). We enrolled patients with OCCC (n = 80) and high-grade serous carcinoma (HGSC; n = 92) subjected to primary cytoreductive surgery, most of whom received platinum-based adjuvant chemotherapy. Genomic scar signatures based on genome-wide copy number data were determined in all participants and investigated in relation to prognosis. OCCC had significantly lower genomic scar signature scores than HGSC (p < 0.001). Near-triploid OCCC specimens showed higher TAI and LST scores compared with diploid tumors (p < 0.001). While high scores of these genomic scar signatures were significantly associated with better clinical outcomes in patients with HGSC, the opposite was evident for OCCC. Multivariate survival analysis in patients with OCCC identified high LOH scores as the main independent adverse predictor for both cancer-specific (hazard ratio [HR] = 3.22, p = 0.005) and progression-free survival (HR = 2.54, p = 0.01). In conclusion, genomic scar signatures associated with HRD predict adverse clinical outcomes in patients with OCCC. The LOH score was identified as the strongest prognostic indicator in this patient group. Genomic scar signatures associated with HRD are less frequent in OCCC than in HGSC. Genomic scar signatures associated with HRD have an adverse prognostic impact in patients with OCCC. LOH score is the strongest adverse prognostic factor in patients with OCCC.

Ocular Adverse Events Associated with Antibody–Drug Conjugates in Human Clinical Trials

PubMed Central

Miller, Paul E.; Mannis, Mark J.

2015-01-01

Abstract This article reviews ocular adverse events (AEs) reported in association with administration of antibody–drug conjugates (ADCs) in human clinical trials. References reporting ocular toxicity or AEs associated with ADCs were collected using online publication searches. Articles, abstracts, or citations were included if they cited ocular toxicities or vision-impairing AEs with a confirmed or suspected association with ADC administration. Twenty-two references were found citing ocular or vision-impairing AEs in association with ADC administration. All references reported use of ADCs in human clinical trials for treatment of various malignancies. The molecular target and cytotoxic agent varied depending on the ADC used. Ocular AEs affected a diversity of ocular tissues. The most commonly reported AEs involved the ocular surface and included blurred vision, dry eye, and corneal abnormalities (including microcystic corneal disease). Most ocular AEs were not severe (≤ grade 2) or dose limiting. Clinical outcomes were not consistently reported, but when specified, most AEs improved or resolved with cessation of treatment or with ameliorative therapy. A diverse range of ocular AEs are reported in association with administration of ADCs for the treatment of cancer. The toxicologic mechanism(s) and pathogenesis of such events are not well understood, but most are mild in severity and reversible. Drug development and medical professionals should be aware of the clinical features of these events to facilitate early recognition and intervention in the assessment of preclinical development programs and in human clinical trials. PMID:26539624

The effect of abnormal colour vision on the ability to identify and outline coloured clinical signs and to count stained bacilli in sputum.

PubMed

Campbell, John L; Griffin, Lewis; Spalding, J Anthony B; Mir, Fraz A

2005-11-01

To determine if medical practitioners with congenital colour vision deficiencies (CCVD) are less able to identify and delineate the extent of coloured abnormal signs than those with normal colour vision. Twenty-two medical practitioners with CCVD and 17 with normal colour vision, matched for age and gender, were shown 10 photographs. They were asked to identify and outline the extent of the clinical sign in eight that were of vomit or stool (six of these showing fresh blood), one of a skin rash and for one to mark the position of bacilli in sputum stained by the Ziehl-Neelsen method. There were statistically significant differences between the CCVD practitioners and those with normal colour vision in their ability to outline abnormalities in five of the six photographs that showed fresh blood, in the photograph of a rash and in marking the position of bacilli in the photograph of a stained slide. Medical practitioners with CCVD are handicapped in their evaluation of the presence and extent of coloured clinical signs. Medical schools should ensure that students with CCVD are aware of their deficiency and know its severity, so they can take special care in clinical practice.

The ''hot patella'' sign: is it of any clinical significance. Concise communication

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

Fogelman, I.; McKillop, J.H.; Gray, H.W.

1983-04-01

The presence of the ''hot patella'' sign was evaluated in a prospective study of 200 consecutive bone scans, and in a review of scans from 148 patients with various metabolic bone disorders and 61 patients with lung carcinoma. The incidence was found to be 31%, 26% and 31% respectively. This sign is an extremely common scan finding and may be seen in association with a wide variety of disorders. It is concluded that this sign cannot be considered to be of diagnostic value.

Influence of vestibulovaginal stenosis, pelvic bladder, and recessed vulva on response to treatment for clinical signs of lower urinary tract disease in dogs: 38 cases (1990-1999).

PubMed

Crawford, Jason T; Adams, William M

2002-10-01

To determine influence of vestibulovaginal stenosis, pelvic bladder, and recessed vulva on response to treatment for clinical signs of lower urinary tract disease in dogs. Retrospective study. 38 spayed female dogs. Medical records and client follow-up were reviewed for dogs evaluated via excretory urography because of clinical signs of lower urinary tract disease. Clinical signs, results of radiography, and response to surgical or medical treatment were analyzed. Clinical signs included urinary tract infection (n = 24), urinary incontinence (20), vaginitis (11), pollakiuria or stranguria (10), and perivulvar dermatitis (4). Vaginocystourethrographic findings included vestibulovaginal stenosis (n = 28), pelvic bladder (17), and ureteritis or pyelonephritis (4). Ten dogs had a vestibulovaginal ratio of < 0.20 (severe stenosis), 9 dogs had a ratio of 0.20 to 0.25 (moderate stenosis), 9 dogs had a ratio of 0.26 to 0.35 (mild stenosis), and 10 dogs had a ratio of > 0.35 (anatomically normal). Lower urinary tract infection, incontinence, and pelvic bladder were not associated with response to treatment for recessed vulva. Vestibulovaginal stenosis with a ratio < 0.20 was significantly associated negatively with response to treatment. Dogs without severe vestibulovaginal stenosis that received vulvoplasty for a recessed vulva responded well to treatment. Vestibulovaginal stenosis is likely an important factor in dogs with vestibulovaginal ratio < 0.20. Vaginectomy or resection and anastomosis should be considered in dogs with severe vestibulovaginal stenosis and signs of lower urinary tract disease.

Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting.

PubMed

Bruland, Philipp; McGilchrist, Mark; Zapletal, Eric; Acosta, Dionisio; Proeve, Johann; Askin, Scott; Ganslandt, Thomas; Doods, Justin; Dugas, Martin

2016-11-22

Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR) offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems. Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

The current deconstruction of paradoxes: one sign of the ongoing methodological "revolution".

PubMed

Porta, Miquel; Vineis, Paolo; Bolúmar, Francisco

2015-10-01

The current deconstruction of paradoxes is one among several signs that a profound renewal of methods for clinical and epidemiological research is taking place; perhaps for some basic life sciences as well. The new methodological approaches have already deconstructed and explained long puzzling apparent paradoxes, including the (non-existent) benefits of obesity in diabetics, or of smoking in low birth weight. Achievements of the new methods also comprise the elucidation of the causal structure of long-disputed and highly complex questions, as Berkson's bias and Simpson's paradox, and clarifying reasons for deep controversies, as those on estrogens and endometrial cancer, or on adverse effects of hormone replacement therapy. These are signs that the new methods can go deeper and beyond the methods in current use. A major example of a highly relevant idea is: when we condition on a common effect of a pair of variables, then a spurious association between such pair is likely. The implications of these ideas are potentially vast. A substantial number of apparent paradoxes may simply be the result of collider biases, a source of selection bias that is common not just in epidemiologic research, but in many types of research in the health, life, and social sciences. The new approaches develop a new framework of concepts and methods, as collider, instrumental variables, d-separation, backdoor path and, notably, Directed Acyclic Graphs (DAGs). The current theoretical and methodological renewal-or, perhaps, "revolution"-may be changing deeply how clinical and epidemiological research is conceived and performed, how we assess the validity and relevance of findings, and how causal inferences are made. Clinical and basic researchers, among others, should get acquainted with DAGs and related concepts.

Usefulness of a topical combination of dinotefuran and pyriproxyfen for long-term control of clinical signs of allergic dermatitis in privately-owned cats in Ile-de-France region.

PubMed

Crosaz, Odile; Bonati, Silvia; Briand, Amaury; Chapelle, Elodie; Cochet-Faivre, Noëlle; Ka, Diane; Darmon-Hadjaje, Céline; Varloud, Marie; Guillot, Jacques

2017-08-23

The present study assessed the activity of a combination of dinotefuran and pyriproxyfen (Vectra® Felis) for long-term control (3 months) of allergic dermatitis (AD) in privately-owned cats under common household conditions in Ile-de-France region. This was an open pre-treatment vs post-treatment study. Twenty-eight client-owned cats with clinical signs of AD were enrolled in the study. They received topical application of the combination of dinotefuran and pyriproxyfen on days 0, 28, 56 and 84. Two parameters (clinical signs and pruritus severity) were used to assess the animals' condition on days 0, 28 and 84. Fleas were counted if they were observed. Of the 28 cats initially enrolled, 26 were presented on day 28 and 20 for the final evaluation on day 84. A significant improvement in clinical signs and pruritus was observed in cats for which fleas and/or flea feces were detected on day 0. Globally, the post-treatment AD clinical scores on days 28 and 84 were different from that of the pre-treatment on day 0, with a reduction of 30% and 71%, respectively. For cats with fleas and/or flea feces, the reduction on days 28 and 84 was 33% and 85%, respectively. The improvement of clinical signs and pruritus was not significant in cats with no visible fleas and no flea feces at the beginning of the trial (n = 8). The present study indicated that the treatment with a combination of dinotefuran and pyriproxyfen should be considered as useful in controlling fleas on cats without additional environmental treatment and useful for long-term control of clinical signs and pruritus in allergic cats.

Meta-analysis of associations between childhood adversity and hippocampus and amygdala volume in non-clinical and general population samples.

PubMed

Calem, Maria; Bromis, Konstantinos; McGuire, Philip; Morgan, Craig; Kempton, Matthew J

2017-01-01

Studies of psychiatric populations have reported associations between childhood adversity and volumes of stress-related brain structures. This meta-analysis investigated these associations in non-clinical samples and therefore independent of the effects of severe mental health difficulties and their treatment. The MEDLINE database was searched for magnetic resonance imaging studies measuring brain structure in adults with and without childhood adversity. Fifteen eligible papers (1781 participants) reporting hippocampal volumes and/or amygdala volumes were pooled using a random effects meta-analysis. Those with childhood adversity had lower hippocampus volumes (hedges g = - 0.15, p  = 0.010). Controlling for gender, this difference became less evident (hedges g = - 0.12, p  = 0.124). This association differed depending on whether studies included participants with some psychopathology, though this may be due to differences in the type of adversity these studies examined. There was no strong evidence of any differences in amygdala volume. Childhood adversity may have only a modest impact on stress-related brain structures in those without significant mental health difficulties.

Clinical review: insulin pump-associated adverse events in adults and children.

PubMed

Ross, P L; Milburn, J; Reith, D M; Wiltshire, E; Wheeler, B J

2015-12-01

Insulin pumps are a vital and rapidly developing tool in the treatment of type 1 diabetes mellitus in both adults and children. Many studies have highlighted outcomes and assessed their potential advantages, but much of the data on adverse outcomes are limited and often based on outdated technology. We aimed to review and summarize the available literature on insulin pump-associated adverse events in adults and children. A literature search was undertaken using PubMed, EMBASE, and the Cochrane library. Articles were then screened by title, followed by abstract, and full text as needed. A by-hand search of reference lists in identified papers was also utilised. All searches were limited to English language material, but no time limits were used. Current and past literature regarding insulin pump-associated adverse events is discussed, including potential metabolic and non-metabolic adverse events, in particular: pump malfunction; infusion set/site issues; and cutaneous problems. We show that even with modern technology, adverse events are common, occurring in over 40 % of users per year, with a minority, particularly in children, requiring hospital management. Hyperglycaemia and ketosis are now the most common consequences of adverse events and are usually associated with infusion set failure. This differs from older technology where infected infusion sites predominated. This timely review covers all potential insulin pump-associated adverse events, including their incidence, features, impacts, and contributory factors such as the pump user. The importance of ongoing anticipatory education and support for patients and families using this intensive insulin technology is highlighted, which if done well should improve the overall experience of pump therapy for users, and hopefully reduce the incidence and impact of severe adverse events.

The costs associated with adverse event procedures for an international HIV clinical trial determined by activity-based costing.

PubMed

Chou, Victoria B; Omer, Saad B; Hussain, Hamidah; Mugasha, Christine; Musisi, Maria; Mmiro, Francis; Musoke, Philippa; Jackson, J Brooks; Guay, Laura A

2007-12-01

To determine costs for adverse event (AE) procedures for a large HIV perinatal trial by analyzing actual resource consumption using activity-based costing (ABC) in an international research setting. The AE system for an ongoing clinical trial in Uganda was evaluated using ABC techniques to determine costs from the perspective of the study. Resources were organized into cost categories (eg, personnel, patient care expenses, laboratory testing, equipment). Cost drivers were quantified, and unit cost per AE was calculated. A subset of time and motion studies was performed prospectively to observe clinic personnel time required for AE identification. In 18 months, there were 9028 AEs, with 970 (11%) reported as serious adverse events. Unit cost per AE was $101.97. Overall, AE-related costs represented 32% ($920,581 of $2,834,692) of all study expenses. Personnel ($79.30) and patient care ($11.96) contributed the greatest proportion of component costs. Reported AEs were predominantly nonserious (mild or moderate severity) and unrelated to study drug(s) delivery. Intensive identification and management of AEs to conduct clinical trials ethically and protect human subjects require expenditure of substantial human and financial resources. Better understanding of these resource requirements should improve planning and funding of international HIV-related clinical trials.

Predictors of local adverse effects caused by topical tretinoin cream 0·1% in the Veterans Affairs Topical Tretinoin Chemoprevention trial.

PubMed

Pomerantz, H; Weinstock, M A

2014-09-01

Topical tretinoin is commonly prescribed, but its frequent adverse effects are barriers to use. Predictors of resistance or susceptibility to retinoid irritation are not known. To identify baseline patient characteristics associated with adverse effects of topical tretinoin. This cohort study used data collected from 324 participants in the Veterans Affairs Topical Tretinoin Chemoprevention trial who were randomized to apply tretinoin cream on the face and ears. Univariate and multivariate logistic regression models were used to examine the associations between baseline characteristics and local adverse effects. One hundred and ninety-seven patients (61% of those randomized to tretinoin) reported local adverse effects within 6 months. Clinical signs of severe photodamage at baseline [odds ratio (OR) 0·15, 95% confidence interval (CI) 0·04-0·54] and history of acne (OR 0·46, 95% CI 0·27-0·77) were associated with a decreased risk of adverse effects to tretinoin. The use of other topical medications at enrolment (OR 1·88, 95% CI 1·15-3·08) predicted an increase in adverse effects. In this study population, the common indications of topical tretinoin treatment were associated with lower risks of adverse effects. The concurrent use of other topical medications may worsen irritation caused by tretinoin. © 2014 British Association of Dermatologists.

[Similarity of Clinically Significant Neuropsychiatric Adverse Reactions Listed in Package Inserts between the Anti-influenza Drugs Oseltamivir and Amantadine (Possibility Attributable to Common Pharmacological Effects)].

PubMed

Ono, Hideki; Okamura, Maya; Fukushima, Akihiro

2018-06-20

  The anti-influenza virus drug oseltamivir has been reported to have several pharmacological actions including blocking of nicotinic acetylcholine receptor channels and activation of the dopaminergic system. These pharmacological actions highly overlap those of amantadine, another anti-influenza virus drug authorized in Japan, and ester-type local anesthetics. Moreover, oseltamivir and amantadine can clinically induce similar adverse neuropsychiatric reactions. In the present study, from the database of the Pharmaceuticals and Medical Devices Agency (PMDA), we surveyed 2,576 drugs for which neuropsychiatric side effects similar to those of oseltamivir, amantadine and local anesthetics (abnormal behavior, confusion, consciousness disturbance, convulsion, delirium, delusion, hallucination, myoclonus, tremor) are listed as "clinically significant adverse reactions", and found 327 that had at least one of these adverse reactions. Other neuraminidase inhibitors (laninamivir, peramivir and zanamivir) did not elicit such adverse reactions. By discussing the pharmacological effects of drugs that elicit these adverse reactions, we propose that the similarity of adverse neuropsychiatric reactions between oseltamivir and amantadine is possibly attributable to their common pharmacological effects.

Does erosion progress differently on teeth already presenting clinical signs of erosive tooth wear than on sound teeth? An in vitro pilot trial.

PubMed

Carvalho, Thiago Saads; Baumann, Tommy; Lussi, Adrian

2016-07-07

Erosive tooth wear (ETW) is clinically characterized by a loss of tooth surface, and different enamel depths may have different susceptibility to demineralization. Therefore, the aim of this in vitro pilot study was to assess if the progression of erosive demineralization is faster on teeth already presenting signs of ETW when compared to originally sound teeth. We selected 23 central incisors: 14 were clinically sound (Sound) and 9 presented clinical signs of early erosive tooth wear (ETW-teeth). The teeth were embedded in resin, leaving an uncovered window of native enamel (6.69 ± 2.30 mm(2)) on the incisal half of the labial surface. We measured enamel surface reflection intensity (SRI) initially and after each consecutive erosive challenge (1 % citric acid, total of 4, 8, 12, 16, 20 and 24 min). Calcium released to the citric acid was measured with an atomic absorption spectrometer. We observed higher initial SRI values in ETW-teeth than in Sound teeth (p = 0.007). During in vitro erosive demineralization, we observed that erosion on originally Sound teeth progressed significantly slower (p = 0.033) than on ETW-teeth: SRI decreased by 75 % (from 100 to 25 %) on Sound teeth, and by 89 % (from 100 to 11 %) on ETW-teeth. Calcium release increased during erosion, but presented no significant differences (p = 0.643) between originally Sound (0.031 μmol/mm(2)) and ETW-teeth (0.032 μmol/mm(2)). There was satisfactory correlation between calcium release and rSRI values (r s  = -0.66). The optical reflectometer distinguished originally sound teeth from those with signs of ETW, and the results suggest that acid demineralization progresses differently on teeth already presenting clinical signs of ETW than on sound teeth.

Evaluation of an asynchronous physician voicemail sign-out for emergency department admissions.

PubMed

Horwitz, Leora I; Parwani, Vivek; Shah, Nidhi R; Schuur, Jeremiah D; Meredith, Thom; Jenq, Grace Y; Kulkarni, Raghavendra G

2009-09-01

internists reporting at least 1 perceived adverse event relating to transfer from the ED decreased a nonsignificant 10% after the intervention (95% confidence interval -27% to 6%), from 44% preintervention (32/72) to 34% postintervention (23/67). Voicemail sign-out for ED-internal medicine communication was easier than oral sign-out without any change in early ICU transfers or the perception of major adverse events. However, interaction among participants was reduced. Voicemail sign-out may be an efficient means of improving sign-out communication for stable ED admissions.

Clinical outcome assessment in malignant glioma trials: measuring signs, symptoms, and functional limitations.

PubMed

Blakeley, Jaishri O; Coons, Stephen Joel; Corboy, John R; Kline Leidy, Nancy; Mendoza, Tito R; Wefel, Jeffrey S

2016-03-01

The shared goal of all parties developing therapeutics against malignant gliomas is to positively impact the lives of people affected by these cancers. Clinical outcome assessment (COA) tools, including measures of patient-reported outcome, performance outcome, clinician-reported outcome, and observer-reported outcome, allow patient-focused assessments to complement traditional efficacy measures such as overall survival and radiographic endpoints. This review examines the properties of various COA measures used in malignant glioma clinical trials to date and cross references their content to the priority signs, symptoms, and functional limitations defined through a community survey conducted by the National Brain Tumor Society. The overarching goal of this initiative is to identify COA measures that are feasible and have appropriate psychometric properties for use in this patient population as well as highlight where further development is needed. Published by Oxford University Press on behalf of the Society for Neuro-Oncology 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Bromfenac 0.09% bioavailability in aqueous humor, prophylactic effect on cystoid macular edema, and clinical signs of ocular inflammation after phacoemulsification in a Mexican population

PubMed Central

Palacio, Claudia; Fernández De Ortega, Lourdes; Bustos, Francisco R; Chávez, Eduardo; Oregon-Miranda, Aldo A; Mercado-Sesma, Arieh R

2016-01-01

Purpose The purpose of this study was to evaluate the aqueous humor bioavailability and clinical efficacy of bromfenac 0.09% vs nepafenac on the presence of cystoid macular edema (CME) after phacoemulsification. Material and methods A Phase II, double-blind, masked, active-controlled, multicenter, clinical trial of 139 subjects, randomized to either a bromfenac 0.09% ophthalmic solution (n=69) or nepafenac 0.1% (n=70). Subjects instilled a drop three times a day for a period of 30 days. Follow-up visits were on days 2, 7, 15, 30, and 60. Biomicroscopy, clinical ocular signs, and assessment of posterior segment were performed. The primary efficacy endpoints included the presence of CME evaluated by optical coherence tomography. Safety evaluation included intraocular pressure, transaminase enzymes, lissamine green, and fluorescein stain. Results The demographic and efficacy variables were similar between groups at baseline. The presence of pain, photophobia, conjunctival hyperemia, chemosis, cellularity, and corneal edema disappeared by day 30 in both groups. The central retinal thickness did not show significant changes after treatment when compared to baseline as follows: in the bromfenac group (247.2±32.9 vs 252.0±24.9 μm; P=0.958) and in nepafenac group (250.8±34 vs 264.0±34.1 μm; P=0.137), respectively. A statistically significant difference was observed between bromfenac and nepafenac group: (252.0±24.9 vs 264.0±34.1 μm; P=0.022), at day 30, respectively; even though there was no clinical relevance in the presentation of CME. There were no significant alterations in intraocular pressure, either lissamine green or fluorescein stains. The adverse events were not related to the interventions. Conclusion Bromfenac 0.09% ophthalmic solution showed similar clinical efficacy to reduce the presentation of CME after phacoemulsification compared to nepafenac 0.01%. PMID:26869758

Bromfenac 0.09% bioavailability in aqueous humor, prophylactic effect on cystoid macular edema, and clinical signs of ocular inflammation after phacoemulsification in a Mexican population.

PubMed

Palacio, Claudia; Fernández De Ortega, Lourdes; Bustos, Francisco R; Chávez, Eduardo; Oregon-Miranda, Aldo A; Mercado-Sesma, Arieh R

2016-01-01

The purpose of this study was to evaluate the aqueous humor bioavailability and clinical efficacy of bromfenac 0.09% vs nepafenac on the presence of cystoid macular edema (CME) after phacoemulsification. A Phase II, double-blind, masked, active-controlled, multicenter, clinical trial of 139 subjects, randomized to either a bromfenac 0.09% ophthalmic solution (n=69) or nepafenac 0.1% (n=70). Subjects instilled a drop three times a day for a period of 30 days. Follow-up visits were on days 2, 7, 15, 30, and 60. Biomicroscopy, clinical ocular signs, and assessment of posterior segment were performed. The primary efficacy endpoints included the presence of CME evaluated by optical coherence tomography. Safety evaluation included intraocular pressure, transaminase enzymes, lissamine green, and fluorescein stain. The demographic and efficacy variables were similar between groups at baseline. The presence of pain, photophobia, conjunctival hyperemia, chemosis, cellularity, and corneal edema disappeared by day 30 in both groups. The central retinal thickness did not show significant changes after treatment when compared to baseline as follows: in the bromfenac group (247.2±32.9 vs 252.0±24.9 μm; P=0.958) and in nepafenac group (250.8±34 vs 264.0±34.1 μm; P=0.137), respectively. A statistically significant difference was observed between bromfenac and nepafenac group: (252.0±24.9 vs 264.0±34.1 μm; P=0.022), at day 30, respectively; even though there was no clinical relevance in the presentation of CME. There were no significant alterations in intraocular pressure, either lissamine green or fluorescein stains. The adverse events were not related to the interventions. Bromfenac 0.09% ophthalmic solution showed similar clinical efficacy to reduce the presentation of CME after phacoemulsification compared to nepafenac 0.01%.

Intensive Blood Pressure Reduction and Spot Sign in Intracerebral Hemorrhage: A Secondary Analysis of a Randomized Clinical Trial.

PubMed

Morotti, Andrea; Brouwers, H Bart; Romero, Javier M; Jessel, Michael J; Vashkevich, Anastasia; Schwab, Kristin; Afzal, Mohammad Rauf; Cassarly, Christy; Greenberg, Steven M; Martin, Renee Hebert; Qureshi, Adnan I; Rosand, Jonathan; Goldstein, Joshua N

2017-08-01

The computed tomographic angiography (CTA) spot sign is associated with intracerebral hemorrhage (ICH) expansion and may mark those patients most likely to benefit from intensive blood pressure (BP) reduction. To investigate whether the spot sign is associated with ICH expansion across a wide range of centers and whether intensive BP reduction decreases hematoma expansion and improves outcome in patients with ICH and a spot sign. SCORE-IT (Spot Sign Score in Restricting ICH Growth) is a preplanned prospective observational study nested in the Antihypertensive Treatment of Acute Cerebral Hemorrhage II (ATACH-II) randomized clinical trial. Participants included consecutive patients with primary ICH who underwent a CTA within 8 hours from onset at 59 sites from May 15, 2011, through December 19, 2015. Data were analyzed for the present study from July 1 to August 31, 2016. Patients in ATACH-II were randomized to intensive (systolic BP target, <140 mm Hg) vs standard (systolic BP target, <180 mm Hg) BP reduction within 4.5 hours from onset. Expansion of ICH was defined as hematoma growth of greater than 33%, and an unfavorable outcome was defined as a 90-day modified Rankin Scale score of 4 or greater (range, 0-6). The association among BP reduction, ICH expansion, and outcome was investigated with multivariable logistic regression. A total of 133 patients (83 men [62.4%] and 50 women [37.6%]; mean [SD] age, 61.9 [13.1] years) were included. Of these, 53 (39.8%) had a spot sign, and 24 of 123 without missing data (19.5%) experienced ICH expansion. The spot sign was associated with expansion with sensitivity of 0.54 (95% CI, 0.34-0.74) and specificity of 0.63 (95% CI, 0.53-0.72). After adjustment for potential confounders, intensive BP treatment was not associated with a significant reduction of ICH expansion (relative risk, 0.83; 95% CI, 0.27-2.51; P = .74) or improved outcome (relative risk of 90-day modified Rankin Scale score ≥4, 1.24; 95% CI, 0.53-2.91; P�

Can corneal pannus with trachomatous inflammation--follicular be used in combination as an improved specific clinical sign for current ocular Chlamydia trachomatis infection?

PubMed

Derrick, Tamsyn; Holland, Martin J; Cassama, Eunice; Markham-David, Rod; Nabicassa, Meno; Marks, Michael; Bailey, Robin L; Last, Anna R

2016-01-27

Trachoma is a blinding disease caused by conjunctival infection with Chlamydia trachomatis (Ct). Mass drug administration (MDA) for trachoma control is administered based on the population prevalence of the clinical sign of trachomatis inflammation - follicular (TF). However, the prevalence of TF is often much higher than the prevalence of Ct infection. The addition of a clinical sign specific for current ocular Ct infection to TF could save resources by preventing unnecessary additional rounds of MDA. Study participants were aged between 1-9 years and resided on 7 islands of the Bijagos Archipelago, Guinea Bissau. Clinical grades for trachoma and corneal pannus and ocular swab samples were taken from 80 children with TF and from 81 matched controls without clinical evidence of trachoma. Ct infection testing was performed using droplet digital PCR. New pannus was significantly associated with Ct infection after adjustment for TF (P = 0.009, OR = 3.65 (1.4-9.8)). Amongst individuals with TF, individuals with new pannus had significantly more Ct infection than individuals with none or old pannus (75.0% vs 45.5%, Chi(2) P = 0.01). TF and new pannus together provide a highly specific (91.7%), but a poorly sensitive (51.9%) clinical diagnostic test for Ct infection. As we move towards trachoma elimination it may be desirable to use a combined clinical sign (new pannus in addition to TF) that is highly specific for current ocular Ct infection. This would allow national health systems to obtain a more accurate estimate of Ct population prevalence to inform further need for MDA without the expense of Ct molecular diagnostics, which are currently unaffordable in programmatic contexts.

Dictionary construction and identification of possible adverse drug events in Danish clinical narrative text.

PubMed

Eriksson, Robert; Jensen, Peter Bjødstrup; Frankild, Sune; Jensen, Lars Juhl; Brunak, Søren

2013-01-01

Drugs have tremendous potential to cure and relieve disease, but the risk of unintended effects is always present. Healthcare providers increasingly record data in electronic patient records (EPRs), in which we aim to identify possible adverse events (AEs) and, specifically, possible adverse drug events (ADEs). Based on the undesirable effects section from the summary of product characteristics (SPC) of 7446 drugs, we have built a Danish ADE dictionary. Starting from this dictionary we have developed a pipeline for identifying possible ADEs in unstructured clinical narrative text. We use a named entity recognition (NER) tagger to identify dictionary matches in the text and post-coordination rules to construct ADE compound terms. Finally, we apply post-processing rules and filters to handle, for example, negations and sentences about subjects other than the patient. Moreover, this method allows synonyms to be identified and anatomical location descriptions can be merged to allow appropriate grouping of effects in the same location. The method identified 1 970 731 (35 477 unique) possible ADEs in a large corpus of 6011 psychiatric hospital patient records. Validation was performed through manual inspection of possible ADEs, resulting in precision of 89% and recall of 75%. The presented dictionary-building method could be used to construct other ADE dictionaries. The complication of compound words in Germanic languages was addressed. Additionally, the synonym and anatomical location collapse improve the method. The developed dictionary and method can be used to identify possible ADEs in Danish clinical narratives.

[Direct costs and clinical aspects of adverse drug reactions in patients admitted to a level 3 hospital internal medicine ward].

PubMed

Tribiño, Gabriel; Maldonado, Carlos; Segura, Omar; Díaz, Jorge

2006-03-01

Adverse drug reactions (ADRs) occur frequently in hospitals and increase costs of health care; however, few studies have quantified the clinical and economic impact of ADRs in Colombia. These impacts were evaluated by calculating costs associated with ADRs in patients hospitalized in the internal medicine ward of a Level 3 hospital located in Bogotá, Colombia. In addition, salient clinical features of ADRs were identified and characterized. Intensive follow-ups for a cohort of patients were conducted for a five month period in order to detect ADRs; different ways to classify them, according to literature, were considered as well. Information was collected using the INVIMA reporting format, and causal probability was evaluated with the Naranjo algorithm. Direct costs were calculated from the perspective of payer, based on the following costs: additional hospital stay, medications, paraclinical tests, additional procedures, patient displacement to intermediate or intensive care units, and other costs. Of 836 patients admitted to the service, 268 adverse drug reactions were detected in 208 patients (incidence proportion 25.1%, occurence rate 0.32). About the ADRs found, 74.3% were classified as probable, 92.5% were type A, and 81.3% were moderate. The body system most often affected was the circulatory system (33.9%). Drugs acting on the blood were most frequently those ones associated with adverse reactions (37.6%). The costs resulting from medical care of adverse drug reactions varied from COL dollar 93,633,422 (USD dollar 35,014.92) to COL dollar 122,155,406 (USD dollar 45,680.94), according to insurance type, during the study period. Adverse drug reactions have a significant negative health and financial impact on patient welfare. Because of the substantial resources required for their medical care and the significant proportion of preventable adverse reactions, active programs of institutional pharmacovigilance are highly recommended.

[Virus detection, clinical signs, and laboratory findings in dogs with acute hemorrhagic diarrhea: a retrospective study of 935 cases].

PubMed

Kempf, C; Schulz, B S; Strauch, C; Sauter-Louis, C; Truyen, U; Hartmann, K

2010-01-01

The study evaluated which viruses can be detected in dogs with acute hemorrhagic diarrhea and compared signalment, clinical signs, and laboratory abnormalities among groups of dogs infected with different viruses and those that tested virus-negative. Fecal samples from 935 dogs with acute hemorrhagic diarrhea were examined by electron microscopy. The medical records of these patients were retrospectively evaluated for clinical and laboratory parameters. Virus was detected in 44.2% of the dogs presented with acute bloody diarrhea. The highest prevalence for a virus infection was demonstrated for canine parvovirus (19.9%), followed by coronavirus (17.3%), and paramyxovirus (13.9%). More than one virus species was detected in 6.5% of all fecal samples. Dogs with a virus-positive fecal sample were significantly younger than dogs that tested negative on electron microscopy. Among virus-positive dogs, dogs with parvovirus infection were significantly younger when compared to dogs infected with other enteric viruses. Parvovirus-infected patients also showed significantly lower leukocyte and erythrocyte counts as well as hematocrit, total protein, and albumin levels compared to all other groups. No significant differences were seen when evaluating sex, clinical parameters, character of diarrhea or vomiting among all groups. Young dogs are more likely to suffer from viral enteritis. Based on clinical parameters it is not possible to differentiate a virus-positive from a virus-negative dog or to diagnose a certain virus species. Besides the young age, parvovirus infection is associated with typical changes in laboratory parameters, but not with specific clinical signs. A virologic fecal examination is always indicated.

Adverse reactions associated with acetylcysteine.

PubMed

Sandilands, E A; Bateman, D N

2009-02-01

Paracetamol (acetaminophen) is one of the most common agents deliberately ingested in self-poisoning episodes and a leading cause of acute liver failure in the western world. Acetylcysteine is widely acknowledged as the antidote of choice for paracetamol poisoning, but its use is not without risk. Adverse reactions, often leading to treatment delay, are frequently associated with both intravenous and oral acetylcysteine and are a common source of concern among treating physicians. A systematic literature review investigating the incidence, clinical features, and mechanisms of adverse effects associated with acetylcysteine. A variety of adverse reactions to acetylcysteine have been described ranging from nausea to death, most of the latter due to incorrect dosing. The pattern of reactions differs with oral and intravenous dosing, but reported frequency is at least as high with oral as intravenous. The reactions to the intravenous preparation result in similar clinical features to true anaphylaxis, including rash, pruritus, angioedema, bronchospasm, and rarely hypotension, but are caused by nonimmunological mechanisms. The precise nature of this reaction remains unclear. Histamine now seems to be an important mediator of the response, and there is evidence of variability in patient susceptibility, with females, and those with a history of asthma or atopy are particularly susceptible. Quantity of paracetamol ingestion, measured through serum paracetamol concentration, is also important as higher paracetamol concentrations protect patients against anaphylactoid effects. Most anaphylactoid reactions occur at the start of acetylcysteine treatment when concentrations are highest. Acetylcysteine also affects clotting factor activity, and this affects the interpretation of minor disturbances in the International Normalized Ratio in the context of paracetamol overdose. This review discusses the incidence, clinical features, underlying pathophysiological mechanisms, and

Intestinal Microbiota-Dependent Phosphatidylcholine Metabolites, Diastolic Dysfunction and Adverse Clinical Outcomes in Chronic Systolic Heart Failure

PubMed Central

Wilson Tang, W. H.; Wang, Zeneng; Shrestha, Kevin; Borowski, Allen G; Wu, Yuping; Troughton, Richard W; Klein, Allan L; Hazen, Stanley L

2014-01-01

Background Trimethylamine-N-oxide (TMAO) has been linked to increased cardiovascular risk. We aim to determine the prognostic value of TMAO and its dietary precursors, choline and betaine, in heart failure (HF). Methods and Results In 112 patients with chronic systolic HF with comprehensive echocardiographic evaluation, we measured plasma TMAO, choline, and betaine by mass spectrometry. Median TMAO levels, choline, and betaine levels were 5.8 [3.6, 12.1] μM, 10.9 [8.4, 14.0] μM, 43.8 [37.1, 53.0] μM, respectively, and were correlated with each other (all p<0.0001 for both). TMAO levels were significantly higher in patients with diabetes mellitus (9.4 [4.9, 13.2] vs 4.8 [3.4, 9.8] μM, p=0.005) and in subjects with New York Heart Association (NYHA) class III or greater (7.0 [4.7, 14.8] vs 4.7 [3.4, 11.3] μM, p=0.02). Elevated TMAO, choline, and betaine levels were each associated with higher plasma NT-proBNP levels and more advanced left ventricular diastolic dysfunction, but not systolic dysfunction or inflammatory and endothelial biomarkers. Higher choline (Hazard ratio (HR) 1.64 [95% CI: 1.22 2.20], p=0.001), betaine (HR 1.51 [1.10–2.08], p=0.01), and TMAO (HR 1.48 [1.10–1.96], p=0.01) predicted increased risk for 5-year adverse clinical events (death/transplant). Only higher TMAO levels predicted incident adverse clinical events independent of age, eGFR, mitral E/septal Ea, and NT-proBNP levels (HR 1.46 [1.03 2.14], p=0.03). Conclusion Elevated plasma TMAO, choline and betaine levels are each associated with more advanced left ventricular diastolic dysfunction and portend poorer long-term adverse clinical outcomes in chronic systolic HF. However, only higher plasma TMAO levels was associated with poor prognosis after adjustment for cardio-renal indices. PMID:25459686

Intestinal microbiota-dependent phosphatidylcholine metabolites, diastolic dysfunction, and adverse clinical outcomes in chronic systolic heart failure.

PubMed

Tang, W H Wilson; Wang, Zeneng; Shrestha, Kevin; Borowski, Allen G; Wu, Yuping; Troughton, Richard W; Klein, Allan L; Hazen, Stanley L

2015-02-01

Trimethylamine-N-oxide (TMAO) has been linked to increased cardiovascular risk. We aimed to determine the prognostic value of TMAO and its dietary precursors, choline and betaine, in heart failure (HF). In 112 patients with chronic systolic HF with comprehensive echocardiographic evaluation, we measured plasma TMAO, choline, and betaine by mass spectrometry. Median (interquartile range) TMAO levels, choline, and betaine levels were 5.8 (3.6-12.1) μmol/L, 10.9 (8.4-14.0) μmol/L, and 43.8 (37.1-53.0) μmol/L, respectively, and were correlated with each other (all P < .0001 for both). TMAO levels were significantly higher in patients with diabetes mellitus (9.4 [4.9-13.2] vs 4.8 [3.4-9.8] μmol/L; P = .005) and in subjects with New York Heart Association functional class III or greater (7.0 [4.7-14.8] vs 4.7 [3.4-11.3] μmol/L; P = .02). Elevated TMAO, choline, and betaine levels were each associated with higher plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and more advanced left ventricular diastolic dysfunction, but not systolic dysfunction or inflammatory and endothelial biomarkers. Higher choline (hazard ratio [HR] 1.64, 95% CI 1.22-2.20; P = .001), betaine (HR 1.51, 95% CI 1.10-2.08; P = .01), and TMAO (HR 1.48, 95% CI 1.10-1.96; P = .01) predicted increased risk for 5-year adverse clinical events (death/transplantation). Only higher TMAO levels predicted incident adverse clinical events independently from age, estimated glomerular filtration rate, mitral E/septal Ea, and NT-proBNP levels (HR 1.46, 95% CI 1.03-2.14; P = .03). Elevated plasma TMAO, choline, and betaine levels are each associated with more advanced left ventricular diastolic dysfunction and portend poorer long-term adverse clinical outcomes in chronic systolic HF. However, only higher plasma TMAO was associated with poor prognosis after adjustment for cardiorenal indices. Copyright © 2015 Elsevier Inc. All rights reserved.

Signalment, clinical signs, and prognostic indicators associated with high-grade second- or third-degree atrioventricular block in dogs: 124 cases (January 1, 1997-December 31, 1997).

PubMed

Schrope, Donald P; Kelch, William J

2006-06-01

To evaluate signalment, clinical signs, and prognosis associated with high-grade second- or third-degree atrioventricular block (AVB) in dogs. Retrospective case series. 124 dogs. Data were gathered from ECGs, veterinarian questionnaires, echocardiograms, and radiographs submitted for review; compared with data from a large control group; and examined for association between variables and duration of survival. A new classification system for AVB was evaluated. Afghan, Catahoula Leopard Dog, Chow Chow, Cocker Spaniel, German Wirehaired Pointer, and Labrador Retriever breeds were predisposed to high-grade second- or third-degree AVB. Heavier, older, and sexually intact female dogs were overrepresented in the study group. Weakness, lethargy, exercise intolerance, and syncope were the most common clinical signs. The presence of clinical signs was not associated with duration of survival. Dogs with high-grade second-degree AVB had a duration of survival similar to that of dogs with third-degree AVB. Dogs with high-grade second- or third-degree AVB were at high risk for sudden death in the first 6 months after diagnosis. High ventricular escape rhythm rate and narrow escape-complex QRS width were negatively associated with duration of survival. Pacemaker implantation had a significant positive association with survival. Pacemaker implantation should be strongly considered in all dogs with high-grade second- or third-degree AVB regardless of whether clinical signs are evident. If medical treatment is warranted, vagolytic medications may be the best choice. A new classification system for AVB may merit further investigation.

Systematic Review and Meta-Analysis of the Clinical Efficacy and Adverse Effects of Chinese Herbal Decoction for the Treatment of Gout

PubMed Central

Liu, Xiaoyu; Chen, Pinyi; Liu, Ling; Zhang, Yanqi; Wu, Yazhou; Pettigrew, Julia Christine; Cheng, Dixiang; Yi, Dong

2014-01-01

Background In East Asia, numerous reports describe the utilization of traditional Chinese herbal decoctions to treat gout. However, the reported clinical effects vary. Objectives In this study, we reviewed and analyzed a large number of randomized controlled clinical trials to systematically assess the clinical efficacy and adverse reactions of Chinese herbal decoctions for treating gout. Methods We performed a comprehensive search of databases, such as PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, Chinese biomedical literature database, et al. In addition, we manually searched the relevant meeting information in the library of the Third Military Medical University. Results Finally, 17 randomized controlled trials with a sample size of 1,402 cases met the criteria and were included in the study. The results of the meta-analysis showed that when gout had progressed to the stage of acute arthritis, there was no significant difference in clinical efficacy between Chinese herbal decoctions and traditional Western medicine, as indicated based on the following parameters: serum uric acid (standardized mean difference (SMD):0.35, 95% confidence interval (CI): 0.03 to 0.67), C reactive protein (SMD: 0.25, 95% CI: −0.18 to 0.69), erythrocyte sedimentation rate (SMD: 0.21, 95% CI: −0.02 to 0.45) and overall clinical response (relative risk (RR): 1.05, 95% CI: 1.01 to 1.10). However, the Chinese herbal decoction was significantly better than traditional Western medicine in controlling adverse drug reactions (RR: 0.06, 95% CI: 0.03 to 0.13). Conclusions Through a systematic review of the clinical efficacy and safety of Chinese herbal decoctions and traditional Western medicine for the treatment of gout, we found that Chinese herbal decoction and traditional Western medicine led to similar clinical efficacy, but the Chinese herbal decoctions were superior to Western medicine in terms of controlling adverse drug reactions. PMID:24465466

The Tendril Plot-a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials.

PubMed

Karpefors, Martin; Weatherall, James

2018-03-21

In contrast to efficacy, safety hypotheses of clinical trials are not always pre-specified, and therefore, the safety interpretation work of a trial tends to be more exploratory, often reactive, and the analysis more statistically and graphically challenging. We introduce a new means of visualizing the adverse event data across an entire clinical trial. The approach overcomes some of the current limitations of adverse event analysis and streamlines the way safety data can be explored, interpreted and analyzed. Using a phase II study, we describe and exemplify how the tendril plot effectively summarizes the time-resolved safety profile of two treatment arms in a single plot and how that can provide scientists with a trial safety overview that can support medical decision making. To our knowledge, the tendril plot is the only way to graphically show important treatment differences with preserved temporal information, across an entire clinical trial, in a single view.

Evaluation of radiographs, clinical signs and symptoms associated with pulp canal obliteration: an aid to treatment decision.

PubMed

Oginni, Adeleke O; Adekoya-Sofowora, Comfort A; Kolawole, Kikelomo A

2009-12-01

Pulp canal obliteration (PCO) is a sequela of tooth trauma. The dental clinician faced with this condition has to make a difficult decision. The aim of this study was to evaluate the clinical signs and symptoms associated with teeth with PCO and to assess the status of the periapical tissues using the periapical index (PAI) as an aid in making a treatment decision. The study included teeth diagnosed with PCO in patients with a history of traumatic injury to the involved teeth. Histories of associated signs and symptoms including pain, swelling and drainage from a sinus tract were elicited. Tooth color, sensibility to electric pulp testing, mobility and percussion tenderness were recorded. The periapical status was assessed using the PAI. Two hundred and seventy-six teeth were diagnosed with PCO. One hundred and fifty-seven (56.9%) and 119 (43.1%) demonstrated partial or total PCO, respectively. Yellow discoloration presented most frequently, occurring in 186 (67.4%) teeth. Sixty-two (33.3%) of these had developed periapical lesions and reacted negatively to sensibility testing. Fifty-seven (30.7%) of these teeth presented radiographically with a normal periapical appearance and reacted normally to sensibility testing, whereas 67 (36.0%) presented with small changes in the periapical bone pattern and reacted in the high normal range to sensibility testing. Teeth with PAI scores < or =2 presented with occasional spontaneous pain. Teeth with PAI scores > or =3 presented with clinical symptoms and signs ranging from pain on percussion to spontaneous pain, and slight swelling to sinus tract drainage. Based on the findings of this study, endodontic treatment should be initiated in teeth with tenderness to percussion, PAI scores > or =3 and a negative response to sensibility testing.

Manual signing in adults with intellectual disability: influence of sign characteristics on functional sign vocabulary.

PubMed

Meuris, Kristien; Maes, Bea; De Meyer, Anne-Marie; Zink, Inge

2014-06-01

The purpose of this study was to investigate the influence of sign characteristics in a key word signing (KWS) system on the functional use of those signs by adults with intellectual disability (ID). All 507 signs from a Flemish KWS system were characterized in terms of phonological, iconic, and referential characteristics. Phonological and referential characteristics were assigned to the signs by speech-language pathologists. The iconicity (i.e., transparency, guessing the meaning of the sign; and translucency, rating on a 6-point scale) of the signs were tested in 467 students. Sign functionality was studied in 119 adults with ID (mean mental age of 50.54 months) by means of a questionnaire, filled out by a support worker. A generalized linear model with a negative binomial distribution (with log-link) showed that semantic category was the factor with the strongest influence on sign functionality, with grammatical class, referential concreteness, and translucency also playing a part. No sign phonological characteristics were found to be of significant influence on sign use. The meaning of a sign is the most important factor regarding its functionality (i.e., whether a sign is used in everyday communication). Phonological characteristics seem only of minor importance.

Effect of Massage Therapy on Vital Signs and GCS Scores of ICU Patients: A Randomized Controlled Clinical Trial

PubMed Central

Vahedian-Azimi, Amir; Ebadi, Abbas; Asghari Jafarabadi, Mohammad; Saadat, Soheil; Ahmadi, Fazlollah

2014-01-01

Background: Unalleviated complications related to hospitalization, including stress, anxiety, and pain, can easily influence different structures, like the neural system, by enhancing the stimulation of sympathetic nervous pathways and causing unstable vital signs and deterioration in the level of consciousness. Objectives: The purpose of this study was to determine the effects of massage therapy by family members on vital signs and Glasgow Coma Scale Score (GCS) of patients hospitalized in the Intensive Care Unit (ICU). Patients and Methods: This randomized controlled clinical trial was conducted at the ICU of the Shariati Hospital during 2012; 45 ICU patients and 45 family members in the experimental group and the same number of patients and family members in the control group were consecutively selected . The data collection instrument consisted of two parts. The first part included demographic data (age, marital status and Body Mass Index) and the second part included a checklist to record the patient’s vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), pulse rate (PR)) and GCS. All measurements were done at the same time in both groups before the intervention (full body massage therapy), and 1 hour, 2 hours, 3 hours, and 4 hours after intervention. The patients were provided with a 60-minute full body massage The massage protocol included static, surface tension, stretching, superficial lymph unload, transverse friction, and myofacial releasing techniques. Results: Significant differences were observed between experimental and control groups in the SBP at 1 hour, SBP 2 hours, and SBP 3 hours, and also in GCS at 1 hour to GCS at 4 hours (P < 0.05). Multivariate analysis revealed a significant difference between experimental and control groups in SBP at all time points (P < 0.05). Conclusions: Massage via family members had several positive effects on the patients’ clinical conditions, and therefore, it should

Adverse health effects in Canada geese (Branta canadensis) associated with waste from zinc and lead mines in the Tri-State Mining District (Kansas, Oklahoma, and Missouri, USA).

PubMed

van der Merwe, Deon; Carpenter, James W; Nietfeld, Jerome C; Miesner, John F

2011-07-01

Lead and zinc poisoning have been recorded in a variety of bird species, including migrating waterfowl such as Canada Geese (Branta canadensis), at sites contaminated with mine waste from lead and zinc mines in the Tri-State Mining District, Kansas, Oklahoma, and Missouri, USA. The adverse health impacts from mine waste on these birds may, however, be more extensive than is apparent from incidental reports of clinical disease. To characterize health impacts from mine waste on Canada Geese that do not have observable signs of poisoning, four to eight apparently healthy birds per site were collected from four contaminated sites and an uncontaminated reference site, and examined for physical and physiologic evidence of metals poisoning. Tissue concentrations of silver, aluminum, arsenic, barium, cadmium, cobalt, chromium, copper, iron, magnesium, manganese, molybdenum, nickel, lead, selenium, thallium, vanadium, and zinc were determined by inductively coupled plasma mass spectroscopy. Adverse health effects due to lead were characterized by assessing blood δ-aminolevulinic acid dehydratase (ALAD) enzyme activity. Adverse effects associated with zinc poisoning were determined from histologic examination of pancreas tissues. Elevated tissue lead concentrations and inhibited blood ALAD enzyme activities were consistently found in birds at all contaminated sites. Histopathologic signs of zinc poisoning, including fibrosis and vacuolization, were associated with elevated pancreatic zinc concentrations at one of the study sites. Adverse health effects associated with other analyzed elements, or tissue concentrations indicating potentially toxic exposure levels to these elements, were not observed.

[Laennec and the creation of auscultation signs].

PubMed

Merino, José G

2003-01-01

Toward the end of the 18th century, clinical diagnosis in medicine shifted its focus from reliance on symptoms, which translates to subjective experience of illness, to signs, objective manifestations of pathologic changes. Several techniques were developed to elicit signs in clinical practice, and Laennec used them routinely. He palpated and prodded his patients to get an idea of changes in internal organs. He also applied his ear directly to his patient's chest to hear their heartbeat. On one occassion, he was unable to use these techniques and had the happy occurrence of rolling up a notebook to hear his patient's chest. This led him to hear a great number of new sounds. Through detailed observations, he was able to describe, classify, and correlate these sounds with autopsy findings, thus creating a new semiology of chest diseases. In this essay explore how in which Laennec created his instrument and system of signs of chest diseases, and how he was able to transmit his inventions to his colleagues.

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.

PubMed

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.

[What should we know about cardiac amyloidosis? From clinical signs to treatment].

PubMed

Földeák, Dóra; Nemes, Attila; Kalapos, Anita; Domsik, Péter; Kormányos, Árpád; Krenács, László; Bagdi, Enikő; Borbényi, Zita

2017-11-01

Systemic amyloidosis is a rare disease, in which the heart involvement is rather frequent and determines survival remarkably. Regarding the disease and organ involvement, new diagnostic procedures help to establish the diagnosis and to start the adequate treatment as soon as possible. Cardiac involvement is more likely to be characterised by monoclonal immunglobulin free light chain (AL amyloidosis) type and transthyretin type. In case of AL amyloidosis, heart involvement can lead to serious consequences. Biomarker assessments for cardiac function are important to determine disease severity at the beginning and to measure response to the treatment. In case of amyloidosis, the incidence of the heart involvement grows with age. The prevalence is not known exactly, but probably there are more cases than recognised. The authors present the clinical signs and diagnostic methods, emphasizing the importance of the cardiac examination methods. Orv Hetil. 2017; 158(46): 1811-1818.

Pulsed vs. CW low level light therapy on osteoarticular signs and symptoms in limited scleroderma (CREST syndrome)

NASA Astrophysics Data System (ADS)

Barolet, Daniel

2012-03-01

Limited cutaneous systemic sclerosis (lcSSc) was formerly known as CREST syndrome in reference to the associated clinical features: Calcinosis, Raynaud's phenomenon, Esophageal dysfunction, Sclerodactyly, and Telangiectasias. The transforming growth factor beta (TGF-β) has been identified has a major player in the pathogenic process, while low level light therapy (LLLT) has been shown to modulate this cytokine superfamily. This case study was conducted to assess the efficacy of 940nm using microsecond domain pulsing and continuous wave mode (CW) on osteoarticular signs and symptoms associated with lcSSc. The patient was treated two to three times a week for 13 weeks, using a sequential pulsing mode on one elbow, and a CW mode on the other. Efficacy assessments included inflammation, symptoms, pain, and health scales, patient satisfaction, clinical global impression, and adverse effects monitoring. Significant functional and morphologic improvements were observed after LLLT, with best results seen with the pulsing mode. No significant adverse effects were noted. Two mechanisms of action may be at play. The 940nm wavelength provides inside-out heating possibly vasodilating capillaries which in turn increases catabolic processes leading to a reduction of in situ calcinosis. LLLT may also improve symptoms by triggering a cascade of cellular reactions, including the modulation of inflammatory mediators.

Legal and Ethical Imperatives for Using Certified Sign Language Interpreters in Health Care Settings: How to "Do No Harm" When "It's (All) Greek" (Sign Language) to You.

PubMed

Nonaka, Angela M

2016-09-01

Communication obstacles in health care settings adversely impact patient-practitioner interactions by impeding service efficiency, reducing mutual trust and satisfaction, or even endangering health outcomes. When interlocutors are separated by language, interpreters are required. The efficacy of interpreting, however, is constrained not just by interpreters' competence but also by health care providers' facility working with interpreters. Deaf individuals whose preferred form of communication is a signed language often encounter communicative barriers in health care settings. In those environments, signing Deaf people are entitled to equal communicative access via sign language interpreting services according to the Americans with Disabilities Act and Executive Order 13166, the Limited English Proficiency Initiative. Yet, litigation in states across the United States suggests that individual and institutional providers remain uncertain about their legal obligations to provide equal communicative access. This article discusses the legal and ethical imperatives for using professionally certified (vs. ad hoc) sign language interpreters in health care settings. First outlining the legal terrain governing provision of sign language interpreting services, the article then describes different types of "sign language" (e.g., American Sign Language vs. manually coded English) and different forms of "sign language interpreting" (e.g., interpretation vs. transliteration vs. translation; simultaneous vs. consecutive interpreting; individual vs. team interpreting). This is followed by reviews of the formal credentialing process and of specialized forms of sign language interpreting-that is, certified deaf interpreting, trilingual interpreting, and court interpreting. After discussing practical steps for contracting professional sign language interpreters and addressing ethical issues of confidentiality, this article concludes by offering suggestions for working more effectively

Interactive associations of depression and sleep apnea with adverse clinical outcomes after acute myocardial infarction

PubMed Central

Hayano, Junichiro; Carney, Robert M.; Watanabe, Eiichi; Kawai, Kiyohiro; Kodama, Itsuo; Stein, Phyllis K.; Watkins, Lana L.; Freedland, Kenneth E.; Blumenthal, James A.

2012-01-01

Objective Depression and sleep apnea (SA) are common among patients after acute myocardial infarction (AMI), and both are associated with increased risk for adverse outcomes. We tested the hypothesis that there is an interaction between depression and SA in relation to prognosis in post-AMI patients. Methods Participants were 337 depressed and 379 nondepressed post-AMI patients who participated in a substudy of the Enhancing Recovery in Coronary Heart Disease (ENRICHD) clinical trial. SA was identified from Holter ECG at the entry by an algorithm that detects cyclic variation of heart rate. Results During a median follow-up of 25 months, 43 (6.0%) of patients died and 83 (11.6%) either died or experienced a recurrent AMI. Among 94 patients with both depression and SA, these endpoints occurred in 20 (21.3%) and 25 (26.6%), the prevalence that was 6.9 and 3.9 times higher than predicted probabilities by ENRICHD clinical risk scores (P <.001 for both). In the patients with depression alone, SA alone, or neither, the frequencies did not differ significantly from the predicted probability. Although both depression and SA predicted death and the combined endpoint, we observed depression by SA interactions (P = .03 and .02). SA independently predicted these endpoints in depressed (P <.001 and P = .001), but not in nondepressed patients (P = .73 and .84). Similarly, depression independently predicted these endpoints in SA (P <.001 for both), but not in non-SA patients (P = .61 and .12). Conclusion The combination of depression and SA estimated by CVHR is associated with long-term adverse clinical outcomes after AMI. PMID:23023681

An outbreak of tuberculosis in Lleyn sheep in the UK associated with clinical signs.

PubMed

van der Burgt, G M; Drummond, F; Crawshaw, T; Morris, S

2013-01-19

This case report describes an outbreak of Mycobacterium bovis infection a Lleyn sheep flock associated with clinical signs of illthrift. There was no known direct contact with tuberculous cattle although bovine tuberculosis (bTB) is endemic in the area. The spoligotype isolated from the diseased sheep was the local spoligotype. The repeated use of the comparative intradermal tuberculin test, and the subsequent removal of reactor animals, resulted in apparent elimination of bTB from the flock. Lesions caused by M bovis in sheep may contain very few acid-fast bacilli, and gross lesions may resemble those found in cases of Caseous Lymphadenitis. Routine meat inspection may, therefore, not always easily detect this notifiable disease.

Cardiovascular adverse effects of phenytoin.

PubMed

Guldiken, B; Rémi, J; Noachtar, Soheyl

2016-05-01

Phenytoin is an established drug in the treatment of acute repetitive seizures and status epilepticus. One of its main advantages over benzodiazepines is the less sedative effect. However, the possibility of cardiovascular adverse effects with the intravenous use of phenytoin cause a reluctance to its usage, and this has lead to a search for safer anticonvulsant drugs. In this study, we aimed to review the studies which evaluated the safety of phenytoin with respect to cardiovascular adverse effects. The original clinical trials and case reports listed in PUBMED in English language between the years of 1946-2014 were evaluated. As the key words, "phenytoin, diphenylhydantoin, epilepsy, seizure, cardiac toxicity, asystole, arrhythmia, respiratory arrest, hypotension, death" were used. Thirty-two clinical trials and ten case reports were identified. In the case reports, a rapid infusion rate (>50 mg/min) of phenytoin appeared as the major cause of increased mortality. In contrast, no serious cardiovascular adverse effects leading to death were met in the clinical trials which applied the recommended infusion rate and dosages. An infusion rate of 50 mg/min was reported to be safe for young patients. For old patients and patients with a cardiovascular co-morbidity, a slower infusion rate was recommended with a careful follow-up of heart rhythm and blood pressure. No cardiovascular adverse effect was reported in oral phenytoin overdoses except one case with a very high serum phenytoin level and hypoalbuminemia. Phenytoin is an effective and well tolerated drug in the treatment of epilepsy. Intravenous phenytoin is safe when given at recommended infusion rates and doses.

Psychiatric adverse events during treatment with brodalumab: Analysis of psoriasis clinical trials.

PubMed

Lebwohl, Mark G; Papp, Kim A; Marangell, Lauren B; Koo, John; Blauvelt, Andrew; Gooderham, Melinda; Wu, Jashin J; Rastogi, Shipra; Harris, Susan; Pillai, Radhakrishnan; Israel, Robert J

2018-01-01

Individuals with psoriasis are at increased risk for psychiatric comorbidities, including suicidal ideation and behavior (SIB). To distinguish between the underlying risk and potential for treatment-induced psychiatric adverse events in patients with psoriasis being treated with brodalumab, a fully human anti-interleukin 17 receptor A monoclonal antibody. Data were evaluated from a placebo-controlled, phase 2 clinical trial; the open-label, long-term extension of the phase 2 clinical trial; and three phase 3, randomized, double-blind, controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3) and their open-label, long-term extensions of patients with moderate-to-severe psoriasis. The analysis included 4464 patients with 9161.8 patient-years of brodalumab exposure. The follow-up time-adjusted incidence rates of SIB events were comparable between the brodalumab and ustekinumab groups throughout the 52-week controlled phases (0.20 vs 0.60 per 100 patient-years). In the brodalumab group, 4 completed suicides were reported, 1 of which was later adjudicated as indeterminate; all patients had underlying psychiatric disorders or stressors. There was no comparator arm past week 52. Controlled study periods were not powered to detect differences in rare events such as suicide. Comparison with controls and the timing of events do not indicate a causal relationship between SIB and brodalumab treatment. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

A randomized clinical trial on the effects of remote intercessory prayer in the adverse outcomes of pregnancies.

PubMed

da Rosa, Maria Inês; Silva, Fabio Rosa; Silva, Bruno Rosa; Costa, Luciana Carvalho; Bergamo, Angela Mendes; Silva, Napoleão Chiaramonte; Medeiros, Lidia Rosi de Freitas; Battisti, Iara Denise Endruweit; Azevedo, Rafael

2013-08-01

The scope of this article was to investigate whether intercessory prayer (IP) influences the adverse outcomes of pregnancies. A double-blind, randomized clinical trial was conducted with 564 pregnant women attending a prenatal public health care service. The women were randomly assigned to an IP group or to a control group (n = 289 per group). They were simultaneously and randomly assigned to practice prayer off-site or not. The following parameters were evaluated: Apgar scores, type of delivery and birth weight. The mean age of the women was 25.1 years of age (± 7.4), and the average gestational age was 23.4 weeks (± 8.1). The average number of years of schooling for the women was 8.1 years (± 3.1). The women in the IP and control groups presented a similar number of adverse medical events with non-significant p. No significant differences were detected in the frequency of adverse outcomes in pregnant women who practiced IP and those in the control group.

The metoclopramide black box warning for tardive dyskinesia: effect on clinical practice, adverse event reporting, and prescription drug lawsuits.

PubMed

Ehrenpreis, Eli D; Deepak, Parakkal; Sifuentes, Humberto; Devi, Radha; Du, Hongyan; Leikin, Jerrold B

2013-06-01

We examined the effects of the black box warning about the risk of tardive dyskinesia (TD) with chronic use of metoclopramide on management of gastroparesis within a single clinical practice, and on reporting of adverse events. Medical records of gastroparesis patients were evaluated for physician management choices. The FDA Adverse Event Reporting System (FAERS) was analyzed for event reports, and for lawyer-initiated reports, with metoclopramide from 2004 to 2010. Google Scholar was searched for court opinions against metoclopramide manufacturers. Before the black box warning, 69.8% of patients received metoclopramide for gastroparesis, compared with 23.7% after the warning. Gastroenterologists prescribed domperidone more often after than before the warning. Metoclopramide prescriptions decreased after 2008. Adverse event reporting increased after the warning. Only 3.6% of all FAERS reports but 70% of TD reports were filed by lawyers, suggesting a distortion in signal. Forty-seven legal opinions were identified, 33 from 2009-2010. The black box warning for metoclopramide has decreased its usage and increased its rate of adverse event reporting. Lawyer-initiated reports of TD hinder pharmacovigilance.

Dictionary construction and identification of possible adverse drug events in Danish clinical narrative text

PubMed Central

Eriksson, Robert; Jensen, Peter Bjødstrup; Frankild, Sune; Jensen, Lars Juhl; Brunak, Søren

2013-01-01

Objective Drugs have tremendous potential to cure and relieve disease, but the risk of unintended effects is always present. Healthcare providers increasingly record data in electronic patient records (EPRs), in which we aim to identify possible adverse events (AEs) and, specifically, possible adverse drug events (ADEs). Materials and methods Based on the undesirable effects section from the summary of product characteristics (SPC) of 7446 drugs, we have built a Danish ADE dictionary. Starting from this dictionary we have developed a pipeline for identifying possible ADEs in unstructured clinical narrative text. We use a named entity recognition (NER) tagger to identify dictionary matches in the text and post-coordination rules to construct ADE compound terms. Finally, we apply post-processing rules and filters to handle, for example, negations and sentences about subjects other than the patient. Moreover, this method allows synonyms to be identified and anatomical location descriptions can be merged to allow appropriate grouping of effects in the same location. Results The method identified 1 970 731 (35 477 unique) possible ADEs in a large corpus of 6011 psychiatric hospital patient records. Validation was performed through manual inspection of possible ADEs, resulting in precision of 89% and recall of 75%. Discussion The presented dictionary-building method could be used to construct other ADE dictionaries. The complication of compound words in Germanic languages was addressed. Additionally, the synonym and anatomical location collapse improve the method. Conclusions The developed dictionary and method can be used to identify possible ADEs in Danish clinical narratives. PMID:23703825

Influence of Clinical Status on the Association Between Plasma Total and Unbound Bilirubin and Death or Adverse Neurodevelopmental Outcomes in Extremely Low Birth Weight Infants

PubMed Central

Oh, William; Stevenson, David K.; Tyson, Jon E.; Morris, Brenda H.; Ahlfors, Charles E.; Bender, G. Jesse; Wong, Ronald J.; Perritt, Rebecca; Vohr, Betty R.; Van Meurs, Krista P.; Vreman, Hendrik J.; Das, Abhik; Phelps, Dale L.; O’Shea, T. Michael; Higgins, Rosemary D.

2010-01-01

Objectives To assess the influence of clinical status on the association between total plasma bilirubin and unbound bilirubin on death or adverse neurodevelopmental outcomes at 18–22 months corrected age in extremely low birth weight infants. Method Total plasma biirubin and unbound biirubin were measured in 1,101 extremely low birth weight infants at 5±1 day of age. Clinical criteria were used to classify infants as clinically stable or unstable. Survivors were examined at 18–22 months corrected age by certified examiners. Outcome variables were death or neurodevelopmental impairment, death or cerebral palsy, death or hearing loss, and death prior to follow-up. For all outcomes, the interaction between bilirubin variables and clinical status was assessed in logistic regression analyses adjusted for multiple risk factors. Results Regardless of clinical status, an increasing level of unbound bilirubin was associated with higher rates of death or neurodevelopmental impairment, death or cerebral palsy, death or hearing loss and death before follow-up. Total plasma bilirubin values were directly associated with death or neurodevelopmental impairment, death or cerebral palsy, death or hearing loss, and death before follow-up in unstable infants, but not in stable infants. An inverse association between total plasma bilirubin and death or cerebral palsy was found in stable infants. Conclusions In extremely low birth weight infants, clinical status at 5 days of age affects the association between total plasma and unbound bilirubin and death or adverse neurodevelopmental outcomes at 18–22 months of corrected age. An increasing level of UB is associated a higher risk of death or adverse neurodevelopmental outcomes regardless of clinical status. Increasing levels of total plasma bilirubin are directly associated with increasing risk of death or adverse neurodevelopmental outcomes in unstable, but not in stable infants. PMID:20105142

Comparison of smartphone application-based vital sign monitors without external hardware versus those used in clinical practice: a prospective trial.

PubMed

Alexander, John C; Minhajuddin, Abu; Joshi, Girish P

2017-08-01

Use of healthcare-related smartphone applications is common. However, there is concern that inaccurate information from these applications may lead patients to make erroneous healthcare decisions. The objective of this study is to study smartphone applications purporting to measure vital sign data using only onboard technology compared with monitors used routinely in clinical practice. This is a prospective trial comparing correlation between a clinically utilized vital sign monitor (Propaq CS, WelchAllyn, Skaneateles Falls, NY, USA) and four smartphone application-based monitors Instant Blood Pressure, Instant Blood Pressure Pro, Pulse Oximeter, and Pulse Oximeter Pro. We performed measurements of heart rate (HR), systolic blood pressures (SBP), diastolic blood pressure (DBP), and oxygen saturation (SpO 2 ) using standard monitor and four smartphone applications. Analysis of variance was used to compare measurements from the applications to the routine monitor. The study was completed on 100 healthy volunteers. Comparison of routine monitor with the smartphone applications shows significant differences in terms of HR, SpO 2 and DBP. The SBP values from the applications were not significantly different from those from the routine monitor, but had wide limits of agreement signifying a large degree of variation in the compared values. The degree of correlation between monitors routinely used in clinical practice and the smartphone-based applications studied is insufficient to recommend clinical utilization. This lack of correlation suggests that the applications evaluated do not provide clinically meaningful data. The inaccurate data provided by these applications can potentially contribute to patient harm.

Sign Lowering and Phonetic Reduction in American Sign Language.

PubMed

Tyrone, Martha E; Mauk, Claude E

2010-04-01

This study examines sign lowering as a form of phonetic reduction in American Sign Language. Phonetic reduction occurs in the course of normal language production, when instead of producing a carefully articulated form of a word, the language user produces a less clearly articulated form. When signs are produced in context by native signers, they often differ from the citation forms of signs. In some cases, phonetic reduction is manifested as a sign being produced at a lower location than in the citation form. Sign lowering has been documented previously, but this is the first study to examine it in phonetic detail. The data presented here are tokens of the sign WONDER, as produced by six native signers, in two phonetic contexts and at three signing rates, which were captured by optoelectronic motion capture. The results indicate that sign lowering occurred for all signers, according to the factors we manipulated. Sign production was affected by several phonetic factors that also influence speech production, namely, production rate, phonetic context, and position within an utterance. In addition, we have discovered interesting variations in sign production, which could underlie distinctions in signing style, analogous to accent or voice quality in speech.

Modifiable Resilience Factors to Childhood Adversity for Clinical Pediatric Practice.

PubMed

Traub, Flora; Boynton-Jarrett, Renée

2017-05-01

Childhood adversity is highly prevalent and associated with risk for poor health outcomes in childhood and throughout the life course. Empirical literature on resilience over the past 40 years has identified protective factors for traumatized children that improve health outcomes. Despite these empirical investigations of resilience, there is limited integration of these findings into proactive strategies to mitigate the impact of adverse childhood experiences. We review the state of resilience research, with a focus on recent work, as it pertains to protecting children from the health impacts of early adversity. We identify and document evidence for 5 modifiable resilience factors to improve children's long- and short-term health outcomes, including fostering positive appraisal styles in children and bolstering executive function, improving parenting, supporting maternal mental health, teaching parents the importance of good self-care skills and consistent household routines, and offering anticipatory guidance about the impact of trauma on children. We conclude with 10 recommendations for pediatric practitioners to leverage the identified modifiable resilience factors to help children withstand, adapt to, and recover from adversity. Taken together, these recommendations constitute a blueprint for a trauma-informed medical home. Building resilience in pediatric patients offers an opportunity to improve the health and well-being of the next generation, enhance national productivity, and reduce spending on health care for chronic diseases. Copyright © 2017 by the American Academy of Pediatrics.

Prototyping sensor network system for automatic vital signs collection. Evaluation of a location based automated assignment of measured vital signs to patients.

PubMed

Kuroda, T; Noma, H; Naito, C; Tada, M; Yamanaka, H; Takemura, T; Nin, K; Yoshihara, H

2013-01-01

Development of a clinical sensor network system that automatically collects vital sign and its supplemental data, and evaluation the effect of automatic vital sensor value assignment to patients based on locations of sensors. The sensor network estimates the data-source, a target patient, from the position of a vital sign sensor obtained from a newly developed proximity sensing system. The proximity sensing system estimates the positions of the devices using a Bluetooth inquiry process. Using Bluetooth access points and the positioning system newly developed in this project, the sensor network collects vital sign and its 4W (who, where, what, and when) supplemental data from any Bluetooth ready vital sign sensors such as Continua-ready devices. The prototype was evaluated in a pseudo clinical setting at Kyoto University Hospital using a cyclic paired comparison and statistical analysis. The result of the cyclic paired analysis shows the subjects evaluated the proposed system is more effective and safer than POCS as well as paper-based operation. It halves the times for vital signs input and eliminates input errors. On the other hand, the prototype failed in its position estimation for 12.6% of all attempts, and the nurses overlooked half of the errors. A detailed investigation clears that an advanced interface to show the system's "confidence", i.e. the probability of estimation error, must be effective to reduce the oversights. This paper proposed a clinical sensor network system that relieves nurses from vital signs input tasks. The result clearly shows that the proposed system increases the efficiency and safety of the nursing process both subjectively and objectively. It is a step toward new generation of point of nursing care systems where sensors take over the tasks of data input from the nurses.

[Nonspecific clinical signs in pigs and use of exclusion diagnosis for classical swine fever: a survey among pig farmers and veterinary practitioners].

PubMed

Elbers, A R W; Gorgievski-Duijvesteijn, M J; van der Velden, P G; Loeffen, W L A

2007-05-01

Outbreaks of Classical Swine Fever (CSF) occurred in spring 2006 in Germany close to the Dutch border. On 6th April Dutch pig farmers were given the possibility to submit blood samples directly via their veterinary practitioner to the National Reference Laboratory for CSF if their pigs had non-specific clinical symptoms or if pigs were being treated with antibiotics. The pig farm was not quarantined and was not visited by the veterinary authorities. Over a period of 9 weeks 156 pig farmers submitted whole blood samples via 50 different veterinary practices. All samples tested negative in the PCR test. These pig farmers and veterinary practitioners were asked to respond to a postal questionnaire with questions regarding their experience with this new diagnostic possibility, the distribution of the costs involved, a comparison with other instruments, such as official notification or use of a leukocyte count test, and their knowledge of clinical signs of CSF. 65 pig farmers (42%) and 33 veterinary practices (66%) returned the questionnaire. The main results indicated that pig farmers (72%) would use this type of exclusion diagnostics sooner than that they would approach the veterinary authorities (practitioners: 86%). Moreover the respondents considered the fact that the farm was not quarantined immediately to be an advantage (pig farmers, 79%; practitioners, 88%). 32 percent of the pig farmers were not aware that they were required to submit blood samples if pigs were being treated with antibiotics (practitioners: 11%). The majority of pig farmers and practitioners were not satisfied with the current distribution of the costs involved: in their opinion the costs of the PCR test, the costs of the veterinary practitioner and the costs for shipping the samples to the reference laboratory should be paid out of the Animal Health Fund (50% government and 50% industry) or by the government. If the current distribution of the costs is not changed, a large proportion of the

Examination of Neurological Subtle Signs in ADHD as a Clinical Tool for the Diagnosis and Their Relationship to Spatial Working Memory

ERIC Educational Resources Information Center

Ferrin, Maite; Vance, Alasdair

2012-01-01

Background: Neurological subtle signs (NSS) are minor neurological abnormalities that have been shown to be increased in a number of neurodevelopmental conditions. For attention deficit/hyperactivity disorder (ADHD), it remains unclear whether NSS may aid the clinical diagnostic process. Methods: This study explored the association of total and…

A prospective, randomized, double blind, placebo-controlled evaluation of the effects of eicosapentaenoic acid and docosahexaenoic acid on the clinical signs and erythrocyte membrane polyunsaturated fatty acid concentrations in dogs with osteoarthritis.

PubMed

Mehler, Stephen J; May, Lauren R; King, Crystal; Harris, William S; Shah, Zubin

2016-06-01

Osteoarthritis (OA) in dogs is a prevalent and serious condition. The most common treatment for the clinical signs of OA in dogs is the administration of nonsteroidal antiiflammatory pharmaceuticals. Omega-3 (n-3) fatty acids have been shown to reduce the clinical signs of osteoarthritis in dogs. The primary goals of this study were 1) to determine the effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on the clinical signs of OA in dogs, 2) to evaluate the effects of supplementation on the arachadonic acid (ARA)/ (EPA+DHA) algorithm and 3) to correlate alterations in the ARA/(EPA+DHA) with changes in the clinical signs of canine OA. Seventy-eight client owned dogs were enrolled in a prospective, randomized, double-blind, placebo controlled clinical trial. Dogs were randomized to placebo oil or triglyceride n-3 oil (providing an average dose of 69mg EPA+DHA/kg/day). Orthopedic examinations and blood analyses were performed at baseline, day 42, and day 84. A single investigator confirmed a diagnosis of OA of the coxofemoral joints and/or stifle joints in all dogs. Seventy-four dogs completed the trial. All clinical outcomes for measuring discomfort, lameness, and joint severity at day 84 and all blood metrics at day 42 and day 84 significantly (p<0.05) improved compared with placebo. No major side effects were observed. This study demonstrated that the daily supplementation of a dogs diet with EPA and DHA shifts the blood fatty acid concentrations correlating to relief of clinical signs associated with OA in dogs. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Magnetic resonance imaging features of Great Danes with and without clinical signs of cervical spondylomyelopathy.

PubMed

Martin-Vaquero, Paula; da Costa, Ronaldo C

2014-08-15

To characterize and compare the MRI morphological features of the cervical vertebral column of Great Danes with and without clinical signs of cervical spondylomyelopathy (CSM). Prospective cohort study. 30 Great Danes (15 clinically normal and 15 CSM-affected). All dogs underwent MRI of the cervical vertebral column (C2-3 through T1-2). Features evaluated included sites of subarachnoid space compression, spinal cord compression, or both; degree, cause, and direction of compression; MRI signal changes of the spinal cord; articular process (facet) joint characteristics; internal vertebral venous plexus visibility; and presence of extradural synovial cysts as well as presence and degree of intervertebral disk degeneration and foraminal stenosis. Clinically normal and CSM-affected dogs had 11 and 61 compressive sites, respectively, detected with MRI. All CSM-affected dogs had ≥ 1 site of spinal cord compression. No signal changes were observed in spinal cords of normal dogs, whereas 14 sites of hyperintensity were found in 9 CSM-affected dogs. Foraminal stenosis was present in 11 clinically normal and all CSM-affected dogs. The number of stenotic foraminal sites was significantly greater in the CSM-affected group, and severe stenosis appeared to be more common in this group than in the clinically normal group. Significant differences were identified between clinically normal and CSM-affected dogs with regard to amount of synovial fluid evident, regularity of articular surfaces, degree of articular process joint proliferation, and internal vertebral venous plexus visibility. Abnormalities were detected with MRI in several clinically normal Great Danes. Severe spinal cord compression, number of stenotic foraminal sites, and signal changes within the spinal cord distinguished CSM-affected from clinically normal Great Danes.

Predictive Value of CTA Spot Sign on Hematoma Expansion in Intracerebral Hemorrhage Patients

PubMed Central

Peng, Wen-Jie; Reis, Cesar; Reis, Haley

2017-01-01

Hematoma expansion (HE) occurs in approximately one-third of patients with intracerebral hemorrhage and leads to high rates of mortality and morbidity. Currently, contrast extravasation within hematoma, termed the spot sign on computed tomography angiography (CTA), has been identified as a strong independent predictor of early hematoma expansion. Past studies indicate that the spot sign is a dynamic entity and is indicative of active hemorrhage. Furthermore, to enhance the spot sign's accuracy of predicting HE, spot parameters observed on CTA or dynamic CTA were used for its quantification. In addition, spot signs detected on multiphase CTA and dynamic CTA are shown to have higher sensitivity and specificity when compared with simple standardized spot sign detection in recent studies. Based on the spot sign, novel methods such as leakage sign and rate of contrast extravasation were explored to redefine HE prediction in combination with clinical characteristics and spot sign on CTA to assist clinical judgment. The spot sign is an accepted independent predictor of active hemorrhage and is used in both secondary intracerebral hemorrhage and the process of surgical assessment for hemorrhagic risk in patients with ischemic stroke. Spot sign predicts patients at high risk for hematoma expansion. PMID:28852647

Predictive Value of CTA Spot Sign on Hematoma Expansion in Intracerebral Hemorrhage Patients.

PubMed

Peng, Wen-Jie; Reis, Cesar; Reis, Haley; Zhang, John; Yang, Jun

2017-01-01

Hematoma expansion (HE) occurs in approximately one-third of patients with intracerebral hemorrhage and leads to high rates of mortality and morbidity. Currently, contrast extravasation within hematoma, termed the spot sign on computed tomography angiography (CTA), has been identified as a strong independent predictor of early hematoma expansion. Past studies indicate that the spot sign is a dynamic entity and is indicative of active hemorrhage. Furthermore, to enhance the spot sign's accuracy of predicting HE, spot parameters observed on CTA or dynamic CTA were used for its quantification. In addition, spot signs detected on multiphase CTA and dynamic CTA are shown to have higher sensitivity and specificity when compared with simple standardized spot sign detection in recent studies. Based on the spot sign, novel methods such as leakage sign and rate of contrast extravasation were explored to redefine HE prediction in combination with clinical characteristics and spot sign on CTA to assist clinical judgment. The spot sign is an accepted independent predictor of active hemorrhage and is used in both secondary intracerebral hemorrhage and the process of surgical assessment for hemorrhagic risk in patients with ischemic stroke. Spot sign predicts patients at high risk for hematoma expansion.

Revisiting physical examination: Abadie's sign and Achilles intratendinous changes in subjects with diabetes.

PubMed

Abate, Michele; Schiavone, Cosima; Salini, Vincenzo; Andia, Isabel

2014-01-01

The aim of this study was to evaluate whether or not the positivity of Abadie's sign could be an indicator of asymptomatic Achilles intratendinous changes. A total of 18 patients (36 tendons) suffering from diabetes, with at least 1 Achilles tendon positive to Abadie's sign, were compared to matched subjects with diabetes bilaterally negative to Abadie's sign. Anthropometric measures and the Toronto Clinical Neuropathy Score were registered. Echotexture was evaluated and degenerative features classified as absent, mild, moderate and severe. The frequencies of structural abnormalities, according to both Abadie's sign and the Toronto Clinical Neuropathy Score, were determined. In the first group 26 out of 36 tendons (72.2%) showed positive Abadie's sign and a significantly higher frequency of moderate and severe (65.3%) structural abnormalities compared to Achilles tendons with negative sign (4.3%; p < 0.0001). This frequency was similar to that observed in the subjects with the highest Toronto Clinical Neuropathy Score (64.2%). This study showed that Abadie's sign was a useful tool for assisting in the diagnosis of asymptomatic Achilles intratendinous changes, which, when detected early, could help prevent unexpected tendon rupture. The concordance between Abadie's sign and Achilles sonographic abnormalities needs to be evaluated in a larger sample to consider it useful for practical purposes. © 2013 S. Karger AG, Basel.

Swan-neck sign of the big toe - association with hypocalcaemia.

PubMed

Agarwal, Kishore S; Baijal, Noopur; Tiwari, Lokesh; Verma, Neeraj; Sahni, Mohit; Puliyel, Jacob M

2007-10-01

The sensitivity and specificity of a new clinical sign of hypocalcaemia were evaluated. The Swan-neck sign, wherein infants with symptomatic hypocalcaemia keep their big toe hyperextended at the metatarsophalangeal joint and flexed at the interphalangeal joint, was looked for in 25 infants presenting with non-febrile seizures, alongside their serum calcium levels. The study showed that the sign had a sensitivity of 63.6% and specificity of 66.6%. (Predictive values of positive and negative tests were 93.3% and 20%, respectively.) This is compared with the standard Trousseau and Chvostek signs.

Clinical picture, epidemiology and outcome of Loa-associated serious adverse events related to mass ivermectin treatment of onchocerciasis in Cameroon

PubMed Central

Boussinesq, Michel; Gardon, Jacques; Gardon-Wendel, Nathalie; Chippaux, Jean-Philippe

2003-01-01

In August 2002, 65 cases of Loa-associated neurological Serious Adverse Events were reported after ivermectin treatment. The first signs, occurring within the 12–24 hours following treatment, included fatigue, generalized arthralgia, and sometimes agitation, mutism, and incontinence. Disorders of consciousness, including coma, generally appeared between 24 and 72 hours, and showed a rapid variation with time. The most frequent objective neurological signs were extrapyramidal. The patients presented with haemorrhages of the conjunctiva and of the retina. Biological examinations showed a massive Loa microfilaruria, the passage of Loa microfilariae into the cerebrospinal fluid, haematuria, and an increase in the C-reactive protein, all of which have been correlated with the high intensity of the initial Loa microfilaraemia. Eosinophil counts decreased dramatically within the first 24 hours, and then rose again rapidly. Electroencephalograms suggested the existence of a diffuse pathological process within the first weeks; the abnormalities disappearing after 3–6 months. Death may occur when patients are not properly managed, i.e. in the absence of good nursing. However, some patients who recovered showed sequelae such as aphasia, episodic amnesia, or extrapyramidal signs. The main risk factor for these encephalopathies is the intensity of the initial Loa microfilaraemia. The disorders of consciousness may occur when there are >50,000 Loa microfilariae per ml. The possible roles of co-factors, such as Loa strains, genetic predisposition of individuals, co-infestations with other parasites, or alcohol consumption, seem to be minor but they should be considered. The mechanisms of the post-ivermectin Loa-related encephalopathies should be investigated to improve the management of patients developing the condition. PMID:14975061

Adversity and psychosis: a 10-year prospective study investigating synergism between early and recent adversity in psychosis.

PubMed

Lataster, J; Myin-Germeys, I; Lieb, R; Wittchen, H-U; van Os, J

2012-05-01

Recent studies have suggested that early adverse events, such as childhood trauma, may promote enduring liability for psychosis whereas more recent adverse events may act as precipitants. Examination of these environmental dynamics, however, requires prospective studies in large samples. This study examines whether the association between recent adverse events and psychosis is moderated by exposure to early adversity. A random regional representative population sample of 3021 adolescents and young adults in Munich, Germany, was assessed three times over a period of up to 10 years, collecting information on sociodemographic factors, environmental exposures, and measures of psychopathology and associated clinical relevance. Evidence of statistical non-additivity between early adversity (two levels) and more recent adversity (four levels) was assessed in models of psychotic symptoms. Analyses were a priori corrected for age, gender, cannabis use, and urbanicity. Early and recent adversity were associated with each other (RR = 1.32, 95% CI 1.06-1.66; P = 0.014) and displayed statistical non-additivity at the highest level of exposure to recent adversity (χ(2) = 4.59; P = 0.032). The findings suggest that early adversity may impact on later expression of psychosis either by increasing exposure to later adversity and/or by rendering individuals more sensitive to later adversity if it is severe. © 2011 John Wiley & Sons A/S.

271 Evaluation of Adverse Events Associated to Administration of Omalizumab

PubMed Central

Gomez, R. Maximiliano; Vinuesa, Miguel; Teijeiro, Alvaro; Ivancevich, Juan Carlos; Jares, Edgardo; Baena-Cagnani, Carlos E.

2012-01-01

Background Anti IgE therapy is the ultimate therapeutic option for severe atopic conditions, not controlled by conventional treatment. Its efficacy and safety was described in several peer reviewed publications. Here we report on the events temporally related to the administration of almost 4 hundred doses of the only monoclonal Anti IgE antibody approved in our country for the treatment of severe asthma. Methods Descriptive retrospective analysis of clinical charts of patients receiving omalizumab because of Severe Uncontrolled Asthma, considering those events presented in the 72 hours after administration of it, which was not present before the procedure or as a concomitant condition of the patient. Vital signs, respiratory and cardiovascular evaluation, and dermatological inspection were performed in the hour after administration of corresponding doses. Patients having any kind of complaint were evaluated in unscheduled visits. Results 384 doses of 150 mg omalizumab were given to from April 2007 to June 2011, to nine severe asthmatic patients. One of them received treatment for over 4 years, and two for over 3 years. Conclusions Our records from patients receiving omalizumab have not registered severe adverse events in almost four hundred doses given. The moderate adverse events of nausea and tachycardia resulted in discontinuation of treatment in this unique patient. Overall, omalizumab demonstrated a very acceptable safety profile in our patients.

Predictors of Discordance between Symptoms and Signs in Dry Eye Disease.

PubMed

Vehof, Jelle; Sillevis Smitt-Kamminga, Nicole; Nibourg, Simone A; Hammond, Christopher J

2017-03-01

To investigate predictors of discordance between symptoms and signs in dry eye disease (DED). Cross-sectional association study. A total of 648 patients with dry eye from the Groningen LOngitudinal Sicca StudY (GLOSSY), a tertiary dry eye clinic patient cohort from the Netherlands. Patient symptoms were assessed using the Ocular Surface Disease Index (OSDI) questionnaire. Dry eye signs were assessed by tear osmolarity, Schirmer test, tear breakup time, corneal and conjunctival staining, and meibomian gland dysfunction, all in both eyes, and a composite dry eye signs severity score was calculated from these 6 tests for each patient. Linear regression analysis was used to test the association of discordance between symptoms and signs with a wide range of independent variables (demographic and environmental variables, systemic diseases, ocular traits, and medications). Predictors of discordance between symptoms and signs in DED, defined by the difference between the rank score of the OSDI and the rank score of the dry eye signs severity score. Of the 648 subjects in this cohort, 536 (82.7%) were female and the mean age was 55.8 years (standard deviation, 15.6 years). Significant predictors of greater symptoms than signs were the presence of a chronic pain syndrome, atopic diseases, a known allergy, the use of antihistamines (all P < 0.001), depression (P = 0.003), osteoarthritis (P = 0.008), and the use of antidepressants (P = 0.02). Predictors of lesser symptoms than signs were increased age (P < 0.001) and the presence of Sjögren's disease (P < 0.001) (primary Sjögren's disease, P < 0.001) more than secondary Sjögren's disease (P = 0.08), and graft-versus-host disease (P = 0.04). Furthermore, greater symptoms compared with signs were highly associated with lower self-perceived health (P < 0.001). This large clinical study has shown that discordance between symptoms and signs in DED is an indicator of self-perceived health. The study found important

Adverse events related to blood transfusion

PubMed Central

Sahu, Sandeep; Hemlata; Verma, Anupam

2014-01-01

The acute blood transfusion reactions are responsible for causing most serious adverse events. Awareness about various clinical features of acute and delayed transfusion reactions with an ability to assess the serious reactions on time can lead to a better prognosis. Evidence-based medicine has changed today's scenario of clinical practice to decrease adverse transfusion reactions. New evidence-based algorithms of transfusion and improved haemovigilance lead to avoidance of unnecessary transfusions perioperatively. The recognition of adverse events under anaesthesia is always challenging. The unnecessary blood transfusions can be avoided with better blood conservation techniques during surgery and with anaesthesia techniques that reduce blood loss. Better and newer blood screening methods have decreased the infectious complications to almost negligible levels. With universal leukoreduction of red blood cells (RBCs), selection of potential donors such as use of male donors only plasma and restriction of RBC storage, most of the non-infectious complications can be avoided. PMID:25535415

Magnetic resonance imaging features of Great Danes with and without clinical signs of cervical spondylomyelopathy

PubMed Central

Martin-Vaquero, Paula; da Costa, Ronaldo C.

2014-01-01

Objective To characterize and compare the MRI morphological features of the cervical vertebral column of Great Danes with and without clinical signs of cervical spondylomyelopathy (CSM). Design Prospective cohort study. Animals 30 Great Danes (15 clinically normal and 15 CSM-affected). Procedures All dogs underwent MRI of the cervical vertebral column (C2–3 through T1–2). Features evaluated included sites of subarachnoid space compression, spinal cord compression, or both; degree, cause, and direction of compression; MRI signal changes of the spinal cord; articular process (facet) joint characteristics; internal vertebral venous plexus visibility; and presence of extradural synovial cysts as well as presence and degree of intervertebral disk degeneration and foraminal stenosis. Results Clinically normal and CSM-affected dogs had 11 and 61 compressive sites, respectively, detected with MRI. All CSM-affected dogs had ≥ 1 site of spinal cord compression. No signal changes were observed in spinal cords of normal dogs, whereas 14 sites of hyperintensity were found in 9 CSM-affected dogs. Foraminal stenosis was present in 11 clinically normal and all CSM-affected dogs. The number of stenotic foraminal sites was significantly greater in the CSM-affected group, and severe stenosis appeared to be more common in this group than in the clinically normal group. Significant differences were identified between clinically normal and CSM-affected dogs with regard to amount of synovial fluid evident, regularity of articular surfaces, degree of articular process joint proliferation, and internal vertebral venous plexus visibility. Conclusions and Clinical Relevance Abnormalities were detected with MRI in several clinically normal Great Danes. Severe spinal cord compression, number of stenotic foraminal sites, and signal changes within the spinal cord distinguished CSM-affected from clinically normal Great Danes. PMID:25075822

Adverse reactions to methylphenidate treatment for attention-deficit/hyperactivity disorder: structure and associations with clinical characteristics and symptom control.

PubMed

Sonuga-Barke, Edmund J S; Coghill, David; Wigal, Timothy; DeBacker, Marc; Swanson, James

2009-12-01

Methylphenidate (MPH)-related adverse events are well characterized. Their predictors and their relationship with therapeutic effects are less well understood. Here we examine these issues in relation to two long-acting formulations. Comparison of Methylphenidates in the Analog Classroom Setting (COMACS) was made in a large (n = 184) placebo-controlled trial comparing Equasym XL/Metadate CD, Concerta, and placebo (PLA) using a Laboratory School protocol. Therapeutic effects were measured using direct observation, scores on a simple math productivity task and parent ratings. Parents also completed the Barkley Stimulant Side Effect Rating Scale (BSSERS). The BSSERS had six factors: Emotionality, sleep/appetite, disengaged, dizzy, uninterested, and aches. Treatment effects were seen only for emotionality (which improved) and sleep and appetite (which worsened). Adverse events were not predictable from personal and clinical characteristics of patients. Sleep/appetite adverse events were not associated with therapeutic effects. Improvements in attention-deficit/hyperactivity disorder (ADHD) and emotionality were correlated. The results support a narrow conceptualization of MPH adverse events with problems restricted to appetite and sleep. These effects were not predictable on the basis of available information and may be due to an underlying mechanism rather distinct from those determining therapeutic effects.

Feasibility of Patient Reporting of Symptomatic Adverse Events via the PRO-CTCAE in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

PubMed Central

Basch, Ethan; Pugh, Stephanie L; Dueck, Amylou C; Mitchell, Sandra A; Berk, Lawrence; Fogh, Shannon; Rogak, Lauren J; Gatewood, Marcha; Reeve, Bryce B; Mendoza, Tito R; O’Mara, Ann; Denicoff, Andrea; Minasian, Lori; Bennett, Antonia V; Setser, Ann; Schrag, Deborah; Roof, Kevin; Moore, Joan K; Gergel, Thomas; Stephans, Kevin; Rimner, Andreas; DeNittis, Albert; Bruner, Deborah Watkins

2017-01-01

Purpose To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials Patients enrolled in Trial XXXX (XXXX) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly x4 during treatment; 12-weeks post-treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results Among 226 study sites participating in Trial XXXX, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients of which 34 (43%) required tablet computers to be provided. All 152 patients in Trial XXXX agreed to self-report using the PRO-CTCAE (median age 66; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range 30–240), and median time for CRAs to teach a patient to self-report was 10 minutes (range 2–60). Compliance was high, particularly during active treatment when patients self-reported at 86% of expected time points, although compliance was lower post-treatment (72%). Common reasons for non-compliance were institutional errors such as forgetting to provide computers to participants; patients missing clinic visits; internet connectivity; and patients feeling “too sick”. Conclusions Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic adverse events at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between-visits, and by employing central compliance monitoring. These approaches are being incorporated

On the creation of a clinical gold standard corpus in Spanish: Mining adverse drug reactions.

PubMed

Oronoz, Maite; Gojenola, Koldo; Pérez, Alicia; de Ilarraza, Arantza Díaz; Casillas, Arantza

2015-08-01

The advances achieved in Natural Language Processing make it possible to automatically mine information from electronically created documents. Many Natural Language Processing methods that extract information from texts make use of annotated corpora, but these are scarce in the clinical domain due to legal and ethical issues. In this paper we present the creation of the IxaMed-GS gold standard composed of real electronic health records written in Spanish and manually annotated by experts in pharmacology and pharmacovigilance. The experts mainly annotated entities related to diseases and drugs, but also relationships between entities indicating adverse drug reaction events. To help the experts in the annotation task, we adapted a general corpus linguistic analyzer to the medical domain. The quality of the annotation process in the IxaMed-GS corpus has been assessed by measuring the inter-annotator agreement, which was 90.53% for entities and 82.86% for events. In addition, the corpus has been used for the automatic extraction of adverse drug reaction events using machine learning. Copyright © 2015 Elsevier Inc. All rights reserved.

Adverse effects of orthodontic treatment: A clinical perspective

PubMed Central

Talic, Nabeel F.

2011-01-01

Orthodontic treatment is associated with a number of adverse effects, such as root resorption, pain, pulpal changes, periodontal disease, and temporomandibular dysfunction (TMD). Orthodontists should be aware of these effects and associated risk factors. Risk factors linked to root resorption include the duration of treatment, length, and shape of the root, trauma history, habits, and genetic predisposition. PMID:24151415

Factors associated with adverse clinical outcomes among obstetric trainees

PubMed Central

Aiken PhD, Catherine E.; Aiken, Abigail; Park, Hannah; Brockelsby, Jeremy C.; Prentice, Andrew

2016-01-01

Objective To determine whether UK obstetric trainees transitioning from directly to indirectly-supervised practice have a higher likelihood of adverse patient outcomes from operative deliveries compared to other indirectly supervised trainees and to examine whether performing more procedures under direct supervision is associated with fewer adverse outcomes in initial indirect practice. Methods We examined all deliveries (13,861) conducted by obstetricians at a single centre over 5 years (2008-2013). Mixed-effects logistic regression models were used to compare estimated blood loss, maternal trauma, umbilical arterial pH, delayed neonatal respiration, failed instrumental delivery, and critical incidents for trainees in their first indirectly-supervised year with trainees in all other years of indirect practice. Outcomes for trainees in their first indirectly-supervised 3 months were compared to their outcomes for the remainder of the year. Linear regression was used to examine the relationship between number of procedures performed under direct supervision and initial outcomes under indirect supervision. Results Trainees in their first indirectly-supervised year had a higher likelihood of >2 litres estimated blood loss at any delivery (OR 1.32;CI(1.01-1.64) p<0.05) and of failed instrumental delivery (OR 2.33;CI(1.37-3.29) p<0.05) compared with other indirectly-supervised trainees. Other measured outcomes showed no significant differences. Within the first three months of indirect supervision, the likelihood of operative vaginal deliveries with >1litre estimated blood loss (OR 2.54;CI(1.88-3.20) p<0.05) was higher compared to the remainder of the first year. Performing more deliveries under direct supervision prior to beginning indirectly-supervised training was associated with decreased risk of >1litre estimated blood loss (p<0.05). Conclusions Obstetric trainees in their first year of indirectly-supervised practice have a higher likelihood of immediate adverse

Lameness associated with tarsal haemarthrosis as the sole clinical sign of idiopathic immune-mediated thrombocytopenia in a dog.

PubMed

Walton, M B; Mardell, E; Spoor, M; Innes, J

2014-01-01

A four-year-old, male Cocker Spaniel was presented for investigation of pelvic limb stiffness. There was palpable effusion of both tarsi, and analysis of synovial fluid from these joints indicated previous haemorrhage. After further investigation a diagnosis of idiopathic immune-mediated thrombocytopenia was made. The dog responded to treatment with prednisolone and azathioprine. To the authors' knowledge, this is the first reported case of confirmed haemarthrosis as the sole presenting clinical sign for canine idiopathic immune-mediated thrombocytopenia.

Childhood adversity and midlife suicidal ideation.

PubMed

Stansfeld, S A; Clark, C; Smuk, M; Power, C; Davidson, T; Rodgers, B

2017-01-01

Childhood adversity predicts adolescent suicidal ideation but there are few studies examining whether the risk of childhood adversity extends to suicidal ideation in midlife. We hypothesized that childhood adversity predicts midlife suicidal ideation and this is partially mediated by adolescent internalizing disorders, externalizing disorders and adult exposure to life events and interpersonal difficulties. At 45 years, 9377 women and men from the UK 1958 British Birth Cohort Study participated in a clinical survey. Childhood adversity was prospectively assessed at the ages of 7, 11 and 16 years. Suicidal ideation at midlife was assessed by the depressive ideas subscale of the Revised Clinical Interview Schedule. Internalizing and externalizing disorders were measured by the Rutter scales at 16 years. Life events, periods of unemployment, partnership separations and alcohol dependence were measured through adulthood. Illness in the household, paternal absence, institutional care, parental divorce and retrospective reports of parental physical and sexual abuse predicted suicidal ideation at 45 years. Three or more childhood adversities were associated with suicidal ideation at 45 years [odds ratio (OR) 4.31, 95% confidence interval (CI) 2.67-6.94]. Psychological distress at 16 years partially mediated the associations of physical abuse (OR 3.41, 95% CI 2.29-5.75), sexual abuse (OR 4.99, 95% CI 2.90-11.16) with suicidal ideation. Adult life events partially mediated the association of parental divorce (OR 6.34, 95% CI -7.16 to 36.75) and physical (OR 9.59, 95% CI 4.97-27.88) and sexual abuse (OR 6.59, 95% CI 2.40-38.36) with suicidal ideation at 45 years. Adversity in childhood predicts suicidal ideation in midlife, partially mediated by adolescent internalizing and externalizing disorders, adult life events and interpersonal difficulties. Understanding the pathways from adversity to suicidal ideation can inform suicide prevention and the targeting of preventive

Ebola Virus Disease Outbreak in Isiro, Democratic Republic of the Congo, 2012: Signs and Symptoms, Management and Outcomes

PubMed Central

Kratz, Thomas; Roddy, Paul; Tshomba Oloma, Antoine; Jeffs, Benjamin; Pou Ciruelo, Diana; de la Rosa, Olimpia; Borchert, Matthias

2015-01-01

Data collected during the 2012 Ebola virus disease (EVD) epidemic in the Democratic Republic of the Congo were analysed for clinical signs, symptoms and case fatality of EVD caused by Bundibugyo virus (BDBV), establishment of differential diagnoses, description of medical treatment and evaluation of the quality of clinical documentation. In a quantitative observational prospective study, global epidemiological data from 52 patients (34 patients within the community, 18 patients treated in the Ebola Treatment Centre) were entered anonymously into a database, subsequently matched and analysed. Relevant findings include an over-representation of females among community EVD cases (85.3%) and of community EVD cases in the age group of 15-54 years (82.4%). All ETC patients had fever (55.6% of all 18 ETC patients during their hospital stay) or self-reported fever (88.2% upon admission) at some point of time during their illness. Major symptoms of ETC patients during hospital stay included asthenia (82.4%), anorexia (82.4%), myalgia (70.6%), sore throat/difficulty swallowing (70.6%), arthralgia (76.5%) and nausea (70.6%). Gastrointestinal signs and symptoms (nausea, diarrhoea, vomiting) (76.4%) as well as general pain (94.1%) were frequent in ETC patients. The median duration of EVD was 18 days, while the mean incubation period was 11.3 days. Differential diagnosis of EVD included malaria (28.3%), intestinal parasitosis (10.9%), and infectious syndrome (10.9%). There was also an important variation in clinical evolvement. Quality of documentation was adversely affected by the way patient file contents were transferred from inside to outside the high-risk zone, entailing a mean mismatch value of 27.3% between patient file contents inside vs. outside the high-risk zone. This study adds further description of EVD (frequently non-specific signs and symptoms, non frequent bleeding, a long incubation period, long duration of disease) and emphasizes the need for improving

Projecting adverse event incidence rates using empirical Bayes methodology.

PubMed

Ma, Guoguang Julie; Ganju, Jitendra; Huang, Jing

2016-08-01

Although there is considerable interest in adverse events observed in clinical trials, projecting adverse event incidence rates in an extended period can be of interest when the trial duration is limited compared to clinical practice. A naïve method for making projections might involve modeling the observed rates into the future for each adverse event. However, such an approach overlooks the information that can be borrowed across all the adverse event data. We propose a method that weights each projection using a shrinkage factor; the adverse event-specific shrinkage is a probability, based on empirical Bayes methodology, estimated from all the adverse event data, reflecting evidence in support of the null or non-null hypotheses. Also proposed is a technique to estimate the proportion of true nulls, called the common area under the density curves, which is a critical step in arriving at the shrinkage factor. The performance of the method is evaluated by projecting from interim data and then comparing the projected results with observed results. The method is illustrated on two data sets. © The Author(s) 2013.

Manual Signing in Adults with Intellectual Disability: Influence of Sign Characteristics on Functional Sign Vocabulary

ERIC Educational Resources Information Center

Meuris, Kristien; Maes, Bea; De Meyer, Anne-Marie; Zink, Inge

2014-01-01

Purpose: The purpose of this study was to investigate the influence of sign characteristics in a key word signing (KWS) system on the functional use of those signs by adults with intellectual disability (ID). Method: All 507 signs from a Flemish KWS system were characterized in terms of phonological, iconic, and referential characteristics.…

Metabolic syndrome and adverse clinical outcomes in patients with bipolar disorder.

PubMed

Bai, Ya-Mei; Li, Cheng-Ta; Tsai, Shih-Jen; Tu, Pei-Chi; Chen, Mu-Hong; Su, Tung-Ping

2016-12-15

Metabolic syndrome (MetS) is highly prevalent among patients with bipolar disorder. MetS may cause complications in the brain, but studies investigating MetS-associated clinical psychiatric outcomes remain scant. We enrolled clinically stable outpatients with bipolar disorder aged 18-65 years and performed anthropometric and fasting biochemical assessments to investigate MetS prevalence. We then performed clinical assessments by using the Young Mania Rating Scale for manic symptoms, the Montgomery-Åsberg Depression Rating Scale for depressive symptoms, the Positive and Negative Symptom Scale for psychotic symptoms, the Involuntary Movement Scale for tardive dyskinesia, the Barnes Akathisia Rating Scale for akathisia, the Udvalg for Kliniske Undersogelser for general side effects, the Schedule for Assessment of Insight for insight, the Global Assessment of Functioning scale for global functioning, and the Wisconsin Card Sorting Test (WCST) for cognitive executive function. In total, 143 patients were enrolled and had a MetS prevalence of 29.4%. The patients treated with atypical antipsychotics plus mood stabilizers (36.3%) and atypical antipsychotics alone (36.0%) had a significantly higher prevalence of MetS than did those treated with mood stabilizers alone (10.5%; p = 0.012). According to multivariate regression analyses adjusted for age, sex, smoking status, bipolar disorder subtype (I or II), pharmacological treatment duration, and psychiatric medication, compared with patients without MetS, those with MetS had significantly more previous hospitalizations (p = 0.036), severer tardive dyskinesia (p = 0.030), poorer insight (p = 0.036), poorer global function (p = 0.046), and more impaired executive function (conceptual level response on the WCST; p = 0.042). Our results indicated that patients with comorbid bipolar disorder and MetS have more adverse clinical outcomes than those without, with more hospitalizations, severer tardive

Association between patterns of jaw motor activity during sleep and clinical signs and symptoms of sleep bruxism.

PubMed

Yoshida, Yuya; Suganuma, Takeshi; Takaba, Masayuki; Ono, Yasuhiro; Abe, Yuka; Yoshizawa, Shuichiro; Sakai, Takuro; Yoshizawa, Ayako; Nakamura, Hirotaka; Kawana, Fusae; Baba, Kazuyoshi

2017-08-01

The aim of this study was to investigate the association between patterns of jaw motor activity during sleep and clinical signs and symptoms of sleep bruxism. A total of 35 university students and staff members participated in this study after providing informed consent. All participants were divided into either a sleep bruxism group (n = 21) or a control group (n = 14), based on the following clinical diagnostic criteria: (1) reports of tooth-grinding sounds for at least two nights a week during the preceding 6 months by their sleep partner; (2) presence of tooth attrition with exposed dentin; (3) reports of morning masticatory muscle fatigue or tenderness; and (4) presence of masseter muscle hypertrophy. Video-polysomnography was performed in the sleep laboratory for two nights. Sleep bruxism episodes were measured using masseter electromyography, visually inspected and then categorized into phasic or tonic episodes. Phasic episodes were categorized further into episodes with or without grinding sounds as evaluated by audio signals. Sleep bruxism subjects with reported grinding sounds had a significantly higher total number of phasic episodes with grinding sounds than subjects without reported grinding sounds or controls (Kruskal-Wallis/Steel-Dwass tests; P < 0.05). Similarly, sleep bruxism subjects with tooth attrition exhibited significantly longer phasic burst durations than those without or controls (Kruskal-Wallis/Steel-Dwass tests; P < 0.05). Furthermore, sleep bruxism subjects with morning masticatory muscle fatigue or tenderness exhibited significantly longer tonic burst durations than those without or controls (Kruskal-Wallis/Steel-Dwass tests; P < 0.05). These results suggest that each clinical sign and symptom of sleep bruxism represents different aspects of jaw motor activity during sleep. © 2016 European Sleep Research Society.

Adverse neurological outcomes in Nigerian children with sickle cell disease.

PubMed

Lagunju, I A; Brown, B J

2012-12-01

Sickle cell disease (SCD) is reported to be the most common genetic disorder affecting Nigerians. Children with SCD are at a high risk of neurological morbidity. The main objective of this study was to determine the pattern of adverse neurological outcomes among a cohort of Nigerian children with SCD. All children with SCD seen in the Department of Paediatrics, University College Hospital, Ibadan, Nigeria, over a period of 2 years were carefully evaluated for symptoms and signs of neurological complications, defined as clinical outcomes referable to the central nervous system. Of the 214 children evaluated, 187 were diagnosed with Hb SS disease and 27 with Hb SC disease. Neurological complications were identified in 78 (36.4 %) of the cases. The most common complications were headache (17.8 %), seizure (9.3 %) and stroke (8.4 %). Other less frequent complications included bacterial meningitis (2.8 %), spontaneous visual loss (1.4 %), paraplegia (0.9 %) and transient ischaemic attacks (0.9 %). Neurological complications occurred more frequently in children with sickle cell anaemia than in those with Hb SC disease (P = 0.002, 95 % CI 1.450-82.870). Adverse neurological events are common in Nigerian children with SCD, with a significantly higher risk in Hb SS than Hb SC disease. Stroke represents a major underlying cause of symptomatic epilepsy in SCD. Institution of primary preventive measures for stroke in SCD will significantly reduce the burden of stroke and epilepsy associated with SCD in Nigeria.

Parkinsonian signs are a risk factor for falls.

PubMed

Dahodwala, Nabila; Nwadiogbu, Chinwe; Fitts, Whitney; Partridge, Helen; Karlawish, Jason

2017-06-01

Parkinsonian signs are common, non-specific findings in older adults and associated with increased rates of dementia and mortality. It is important to understand which motor outcomes are associated with parkinsonian signs. To determine the role of parkinsonian signs on fall rates among older adults. We conducted a longitudinal study of primary care patients from the University of Pennsylvania Health System. Adults over 55 years were assessed at baseline through surveys and a neurological examination. We recorded falls over the following 2 years. Parkinsonian signs were defined as the presence of 2 of 4 cardinal signs. Incident falls were compared between subjects with and without parkinsonian signs, and modified Poisson regression used to adjust for potential confounders in the relationship between parkinsonian signs and falls. 982 subjects with a mean age of 68 (s.d. 8.8) years participated. 29% of participants fell and 12% exhibited parkinsonian signs at baseline. The unadjusted RR for falls among individuals with parkinsonian signs was 1.36 (95% CI 1.05-1.76, p=0.02). After adjusting for age, cognitive function, urinary incontinence, depression, diabetes, stroke and arthritis, individuals with parkinsonian signs were still 38% more likely to fall than those without parkinsonian signs (RR 1.38, 95% CI 1.04-1.82; p=0.03). Falls among those with parkinsonian signs were more likely to lead to injury (53% vs 37%; p=0.04). Parkinsonian signs are a significant, independent risk factor for falls. Early detection of this clinical state is important in order to implement fall prevention programs among primary care patients. Copyright © 2017 Elsevier B.V. All rights reserved.

Medical diagnosis through semiotics. Giving meaning to the sign.

PubMed

Burnum, J F

1993-11-01

Physicians are engaged in incorporating quantitative methods for making clinical decisions into their practices. An acquaintance with semiotics, the doctrine of signs, may complement this project. A sign stands for something. We communicate indirectly through signs, and by interpreting what signs mean we make sense of our world and diagnose and understand our patients. Thus, through association and inference, we transform flowers into love, Othello into jealousy, and staring eyes into thyrotoxicosis. Characteristically in diagnosis, beginning with an unstable inference, we test and otherwise ask questions likely to produce signs that support (or discredit) our hypothesis. In a literary sense, we join with the author to clarify and rewrite the text; creative interpretation is the key. Diagnosis is concluded through narration, by the meaning that is revealed by telling the story of the patient. Diagnosis will succeed only to the extent that we respect the principles and caveats of sign interpretation. The sign is both the key to the unknown and the master impersonator. The sign and its meaning are usually not the same; meaning has to be inferred. Because interpretations are made subjectively, they are circumscribed by the experience and bias of the clinician. Moreover, the contexts in which the sign appears shape the meaning of the sign and may change it altogether.

A retrospective study of clinical signs and epidemiology of chronic valve disease in a group of 207 Dachshunds in Poland

PubMed Central

2013-01-01

Background Chronic mitral valve disease is frequently seen in the Dachshund. Dachshunds (n=207) made up 11.73% of the dogs admitted to the Cardiology Service at the Small Animal Clinic, Warsaw University of Life Sciences, Poland (first visits only). Results Of these, 35 dogs had no clinically detectable heart disease while 172 had chronic valve disease with the mitral valve affected most often (130 dogs), both mitral and tricuspid valves infrequently (39 dogs) and rarely the tricuspid valve (3 dogs). Males were affected more frequently than females and the average age of dogs with chronic valve disease was 11.9 years for females and 11.3 years for males. A majority of the diseased Dachshunds were classified as ISACHC 2 (79), followed by ISACHC 1 (60). Most frequent clinical signs noted by owners included coughing, exercise intolerance, dyspnea and tachypnea. Heart murmurs were generally louder with increased disease severity; however there were 20 dogs in the ISACHC 1 group with no audible heart murmurs. The most frequent electrocardiographic abnormalities included an increased P wave and QRS complex duration, increased R wave amplitude and tachycardia. With increased disease severity, echocardiography revealed an increase in heart size. A higher ISACHC class was related to increased heart size (based on echocardiography) and increased percentage of patients exhibiting enlargement of both left atrium and left ventricle (based on radiography). Conclusions The Dachshund is often affected by chronic mitral valvular disease with a late onset of associated clinical signs and few cardiac complications. PMID:23844824

10 Early Signs and Symptoms of Alzheimer's

MedlinePlus

... causes a slow decline in memory, thinking and reasoning skills. There are 10 warning signs and symptoms. ... may also increase your chances of participating in clinical drug trials that help advance research. > Learn more ...

Clinical signs and histologic findings in dogs with odontogenic cysts: 41 cases (1995-2010).

PubMed

Verstraete, Frank J M; Zin, Bliss P; Kass, Philip H; Cox, Darren P; Jordan, Richard C

2011-12-01

To characterize clinical signs and histologic findings in dogs with odontogenic cysts and determine whether histologic findings were associated with clinical features. Retrospective case series. 41 dogs. Medical records were reviewed to obtain clinical data, including breed, age, sex, and lesion location. Microscopic sections and results of diagnostic imaging were reviewed. Odontogenic cysts were identified in 41 dogs between 1995 and 2010. There were 29 dogs with dentigerous cysts, 1 with a radicular cyst, 1 with a lateral periodontal cyst, and 1 with a gingival inclusion cyst. In addition, 9 dogs with odontogenic cysts that had clinical and histologic features suggestive of, but not diagnostic for, odontogenic keratocysts seen in people were identified. In all 9 dogs, these cysts were located in the maxilla and surrounded the roots of normally erupted teeth. Of the 29 dogs with dentigerous cysts, 23 had a single cyst, 5 had 2 cysts, and 1 had 3 cysts. Six cysts were associated with an unerupted canine tooth, and 30 were associated with an unerupted first premolar tooth (1 cyst was associated both with an unerupted canine tooth and with an unerupted first premolar tooth). Dentigerous cysts were identified in a variety of breeds, but several brachycephalic breeds were overrepresented, compared with the hospital population during the study period. Results suggested that a variety of odontogenic cysts can occur in dogs. In addition, cysts that resembled odontogenic keratocysts reported in people were identified. We propose the term canine odontogenic parakeratinized cyst for this condition.

Systematic review of efficacy of nutraceuticals to alleviate clinical signs of osteoarthritis.

PubMed

Vandeweerd, J-M; Coisnon, C; Clegg, P; Cambier, C; Pierson, A; Hontoir, F; Saegerman, C; Gustin, P; Buczinski, S

2012-01-01

Various treatments of osteoarthritis (OA) have been described, including use of nutraceuticals. To review systematically the literature about the effects of nutraceuticals on clinical signs of pain or abnormal locomotion in horses, dogs, and cats, and to discuss methodological aspects of trials and systematic reviews. A systematic search of controlled trials evaluating the impact of nutraceuticals on OA in horses, dogs, and cats was performed, using Medline, CAB Abstracts, and Google Scholar. Scientific evidence was evaluated by means of criteria proposed by the Food and Drug Administration (FDA), and a scoring system adapted from both the CONsolidated Standards of Reporting Trials (CONSORT) statement and recommendations for assessing trials by the Center of Evidence Based Medicine of Oxford. Twenty-two papers were selected and reviewed, with 5 studies performed in horses, 16 in dogs, and 1 in cats. The strength of evidence was low for all nutraceuticals except for omega-3 fatty acid in dogs. There were limited numbers of rigorous randomized controlled trials and of participants in clinical trials. The evidence of efficacy of nutraceuticals is poor, with the exception of diets supplemented with omega-3 fatty acids in dogs. Greater access to systematic reviews must be part of the objectives of the veterinary science in the future. Their reporting would be improved by internationally agreed-upon criteria for standards and guidelines. Copyright © 2012 by the American College of Veterinary Internal Medicine.

Recording Adverse Events Following Joint Arthroplasty: Financial Implications and Validation of an Adverse Event Assessment Form.

PubMed

Lee, Matthew J; Mohamed, Khalid M S; Kelly, John C; Galbraith, John G; Street, John; Lenehan, Brian J

2017-09-01

In Ireland, funding of joint arthroplasty procedures has moved to a pay-by-results national tariff system. Typically, adverse clinical events are recorded via retrospective chart-abstraction methods by administrative staff. Missed or undocumented events not only affect the quality of patient care but also may unrealistically skew budgetary decisions that impact fiscal viability of the service. Accurate recording confers clinical benefits and financial transparency. The aim of this study was to compare a prospectively implemented adverse events form with the current national retrospective chart-abstraction method in terms of pay-by-results financial implications. An adverse events form adapted from a similar validated model was used to prospectively record complications in 51 patients undergoing total hip or knee arthroplasties. Results were compared with the same cohort using an existing data abstraction method. Both data sets were coded in accordance with current standards for case funding. Overall, 114 events were recorded during the study through prospective charting of adverse events, compared with 15 events documented by customary method (a significant discrepancy). Wound drainage (15.8%) was the most common complication, followed by anemia (7.9%), lower respiratory tract infections (7.9%), and cardiac events (7%). A total of €61,956 ($67,778) in missed funding was calculated as a result. This pilot study demonstrates the ability to improve capture of adverse events through use of a well-designed assessment form. Proper perioperative data handling is a critical aspect of financial subsidies, enabling optimal allocation of funds. Copyright © 2017 Elsevier Inc. All rights reserved.

Cutaneous Adverse Drug Reactions in Dogs Treated with Antiepileptic Drugs

PubMed Central

Koch, Tina; Mueller, Ralf S.; Dobenecker, Britta; Fischer, Andrea

2016-01-01

Epilepsy is one of the most common neurologic disorders in dogs and life-long treatment with antiepileptic drugs (AED) is frequently required. Adverse events of AED targeting the skin are only rarely reported in veterinary medicine and the true incidence and spectrum of cutaneous reactions in epileptic dogs remains unknown. In this study, we hypothesized that cutaneous reactions commonly occur in epileptic dogs and are related to AED treatment. A retrospective case review of 185 dogs treated for epilepsy identified 20.0% with simultaneous appearance of dermatologic signs. In a subsequent prospective case investigation (n = 137), we identified newly appearing or distinct worsening of skin lesions following initiation of AED therapy in 10.9% of dogs treated for epilepsy (95% CI 6.8–17.7%). Cutaneous lesions were classified as probably drug-induced in 40.0% of these cases. Patch testing and intradermal testing were further investigated as potential diagnostic methods to confirm AED hypersensitivity. They were of high specificity but sensitivity and positive predictive value appeared inappropriate to recommend their routine use in clinical practice. PMID:27148543

Existence of Normal Limbal Epithelium in Eyes with Clinical Signs of Total Limbal Stem Cell Deficiency

PubMed Central

Codriansky, Andres; Hong, Jiaxu; Xu, Jianjian; Deng, Sophie X.

2016-01-01

Purpose To report the presence of normal limbal epithelium detected by in vivo confocal laser scanning microscopy (IVCM) in three cases of clinically diagnosed total limbal stem cell deficiency (LSCD). Methods This is a retrospective case report consists of three patients who were diagnosed with total LSCD based on clinical exam and/or impression cytology. Clinical data including ocular history, presentation, slit-lamp examination, IVCM and impression cytology were reviewed. Results The etiology was chemical burn in three cases. One patient has two failed penetrating keratoplasty. Another had allogeneic keratolimbal transplantation but the graft failed one year after surgery. The third patient had failed amniotic membrane transplantation. These three patients presented with signs of total LSCD including the absence of normal Vogt palisades, complete superficial vascularization of the peripheral cornea, non-healing epithelial defects, and corneal scarring. Impression cytology was performed in two cases to confirm the presence of goblet cells in two cases. Each patient however still had distinct areas of corneal and/or limbal epithelial cells detected by IVCM. Conclusions Residual normal limbal epithelial cells could be present in eyes with clinical features of total LSCD. IVCM appears to be a more accurate method to evaluate the degree of LSCD. PMID:27362882

Combinations of early signs of critical illness predict in-hospital death-the SOCCER study (signs of critical conditions and emergency responses).

PubMed

Harrison, Gordon A; Jacques, Theresa; McLaws, Mary-Louise; Kilborn, Gabrielle

2006-12-01

Medical emergency team (MET) call criteria are late signs of a deteriorating clinical condition. Some early signs predict in-hospital death but have a high prevalence so their use as single sign call criteria could be wasteful of resources. This study searched a large database to explore the association of combinations of recordings of early signs (ES), or early with late signs (LS) with in-hospital death. A cross-sectional survey was undertaken of 3046 non-do not attempt resuscitation adult admissions in 5 hospitals without MET over 14 days. The medical records were reviewed for recordings of 26 ES and 21 LS and in-hospital death. Combinations of ES with or without LS were examined as predictors of death. Global modified early warning scores (GMEWS) were calculated. ES with LS, plus LS only, had higher odd ratios than ES alone. Four combinations of ES were strongly associated with death: cardiovascular plus respiratory with decrease in urinary output, cardiovascular plus respiratory with a decrease in consciousness, respiratory with decrease in urinary output, and cardiovascular plus respiratory. In other combinations, recordings of SpO2 90-95%, systolic blood pressure 80-100 mmHg or decrease in urinary output in turn occurring with one or more disturbed blood gas variable were associated with death. Compared with admissions whose GMEWS were 0-2, admissions with GMEWS 5-15 were 27.1 times more likely to die while those with GMEWS 3-4 were 6.5 times more likely. The results support the inclusion of early signs of a deteriorating clinical condition in sets of call criteria.

Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions.

PubMed

Ryu, JiHyeon; Lee, HeeYoung; Suh, JinUk; Yang, MyungSuk; Kang, WonKu; Kim, EunYoung

2015-01-01

We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions. Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary's teaching hospital, Daejeon, Korea) from 2010-2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton's preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed. Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p < 0.001), and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001). Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001) but not among contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization-Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p < 0.001). We found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse reactions. The World Health Organization

Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions

PubMed Central

Suh, JinUk; Yang, MyungSuk; Kang, WonKu; Kim, EunYoung

2015-01-01

Objective We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions. Methods Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary’s teaching hospital, Daejeon, Korea) from 2010–2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton’s preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed. Results Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p < 0.001), and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001). Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001) but not among contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization–Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p < 0.001). Conclusions We found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse

[CLINICAL AND IMMUNOLOGICAL CRITERIA FOR THE ADVERSE COURSE OF INFECTIOUS MONONUCLEOSIS IN CHILDREN].

PubMed

Kolesnik, Ya; Zharkova, T; Rzhevskaya, O; Kvaratskheliya, T; Sorokina, O

2018-05-01

The article presents the results of our own studies to determine the criteria for the adverse variants of the course of infectious mononucleosis (IM) in children. The study was conducted in the regional children's infectious clinical hospital in Kharkov. 161 children aged three to fifteen years were under observation with diagnosis of infectious moninucleosis. Out of 161 ill children, 140 (86.9%) had moderate severity of disease, and 21 (13.1%) had severe forms. All children were prescribed standard clinical and laboratory-instrumental examinations. The diagnosis of IM was verified by PCR (detection of VEB DNA in the blood) and ELISA (anti-VEB Ig M and Ig G). In 140 children (86.9%) IM proceeded sharply, smoothly (the first group), in 21 (13.1%) - unfavorably (wave and / or prolonged course) - the second group. The groups were comparable according to age, the severity of the disease and other parameters. All children received therapy according to approved protocols (Order of the Ministry of Health of Ukraine No. 354 of 09.07.2004). Immune status of children was assessed by determining the relative contents of CD3 +, CD4 +, CD8 +, CD16 +, CD19 + blood cells with appropriate monoclonal antibodies, serum IgA, IgM, IgG concentration by Mancini and interleukin (IL) -1β cytokine response and - 4, tumor necrosis factor (TNF α) is a solid-phase enzyme-linked immunosorbent assay. Based on the results of observations, it was established that the prognostically unfavorable criteria of IМ at the stages of manifestation of disease include: generalized lymphadenopathy involving 5-6 groups of lymph nodes and a significant increasing of them, purulent tonsillitis, marked increasing of size of liver and spleen on the background of anemia, thrombocytopenia, neutropenia and the absence of atypical mononuclears in the complete blood count. There is a depression of the cellular link and an increase in the humoral mechanisms of immune responses in case of development of adverse

Relationship between nighttime vital sign assessments and acute care transfers in the rehabilitation inpatient.

PubMed

Pellicane, Anthony J

2014-01-01

To investigate the role of nighttime vital sign assessment in predicting acute care transfers (ACT) from inpatient rehabilitation. Retrospective chart review. Fifty patients unexpectedly discharged to acute care underwent chart review to determine details of each ACT. Seven of 50 ACT possessed new vital sign abnormalities at the 11 pm vital sign assessment the night before ACT. None of these seven underwent ACT during the night shift the abnormalities were detected. Two of 50 ACT were transferred between 11 pm and 6:59 am; both demonstrating normal vital sign at the 11 pm assessment. During study period, an estimated 5,607 11 pm vital sign assessments were performed. Nighttime vital sign assessments do not seem to be a good screening tool for clinical instability in the rehabilitation hospital. Eliminating sleep disturbance is important to the rehabilitation inpatient as inadequate sleep hinders physical performance. Tailoring vital sign monitoring to fit patents' clinical presentation may benefit this population. © 2014 Association of Rehabilitation Nurses.

A double blind, randomized, placebo controlled trial of the efficacy, quality of life and safety of food allergen-specific sublingual immunotherapy in client owned dogs with adverse food reactions: a small pilot study.

PubMed

Maina, Elisa; Cox, Eric

2016-10-01

Food allergen-specific sublingual immunotherapy (FA-SLIT) has emerged as a novel and successful approach for desensitizing human patients to specific food allergens. It has not been tested in dogs. To investigate the efficacy, quality of life (QoL), tolerability and safety of FA-SLIT in dogs with adverse food reactions (AFR). Dogs with proven AFR were randomized to treatment (T group; n = 7) or placebo (P group; n = 6) to receive either FA-SLIT (based on the results of a food elimination trial) or glycerinated saline, respectively. The treatment was continued daily for 6 months with fortnightly dosage escalations. To evaluate the treatment, pruritus Visual Analog Scale (pVAS), Canine Atopic Dermatitis Extent and Severity Index (CADESI-04), QoL, faecal consistency scores, owner assessment, overall tolerability scores and blood analyses were assessed. Eleven dogs completed the study, two dogs in the T group were withdrawn by the owner after FA-SLIT exacerbated clinical signs of AFR. Statistical tests showed significant protection against food challenge induced clinical signs following FA-SLIT therapy, as indicated by reduced pVAS and CADESI scores (P < 0.05). The QoL did not differ between groups. The treatment was rated as effective or quite effective by 80% of the owners, whereas placebo was rated as ineffective by all owners. FA-SLIT was effective, well tolerated and safe. No severe adverse events were recorded; erythema and pruritus were reported in association with only 0.7% of the dispensed doses. Larger clinical trials with more extended maintenance immunotherapy periods will be needed to provide more precise estimates of efficacy and frequency of adverse events. © 2016 ESVD and ACVD.

Adverse drug events in the oral cavity.

PubMed

Yuan, Anna; Woo, Sook-Bin

2015-01-01

Adverse reactions to medications are common and may have a variety of clinical presentations in the oral cavity. Targeted therapies and the new biologic agents have revolutionized the treatment of cancers, autoimmune diseases, and inflammatory and rheumatologic diseases but have also been associated with adverse events in the oral cavity. Some examples include osteonecrosis, seen with not only bisphosphonates but also antiangiogenic agents, and the distinctive ulcers caused by mammalian target of rapamycin inhibitors. As newer therapeutic agents are approved, it is likely that more adverse drug events will be encountered. This review describes the most common clinical presentations of oral mucosal reactions to medications, namely, xerostomia, lichenoid reactions, ulcers, bullous disorders, pigmentation, fibrovascular hyperplasia, white lesions, dysesthesia, osteonecrosis, infection, angioedema, and malignancy. Oral health care providers should be familiar with such events, as they will encounter them in their practice. Copyright © 2015 Elsevier Inc. All rights reserved.

SynopSIS: integrating physician sign-out with the electronic medical record.

PubMed

Sarkar, Urmimala; Carter, Jonathan T; Omachi, Theodore A; Vidyarthi, Arpana R; Cucina, Russell; Bokser, Seth; van Eaton, Erik; Blum, Michael

2007-09-01

Safe delivery of care depends on effective communication among all health care providers, especially during transfers of care. The traditional medical chart does not adequately support such communication. We designed a patient-tracking tool that enhances provider communication and supports clinical decision making. To develop a problem-based patient-tracking tool, called Sign-out, Information Retrieval, and Summary (SynopSIS), in order to support patient tracking, transfers of care (ie, sign-outs), and daily rounds. Tertiary-care, university-based teaching hospital. SynopSIS compiles and organizes information from the electronic medical record to support hospital discharge and disposition decisions, daily provider decisions, and overnight or cross-coverage decisions. It reflects the provider's patient-care and daily work-flow needs. We plan to use Web-based surveys, audits of daily use, and interdisciplinary focus groups to evaluate SynopSIS's impact on communication between providers, quality of sign-out, patient continuity of care, and rounding efficiency. We expect SynopSIS to improve care by facilitating communication between care teams, standardizing sign-out, and automating daily review of clinical and laboratory trends. SynopSIS redesigns the clinical chart to better serve provider and patient needs. (c) 2007 Society of Hospital Medicine.

Perceived stress, pain and work performance among non-patient working personnel with clinical signs of temporomandibular or neck pain.

PubMed

Suvinen, T I; Ahlberg, J; Rantala, M; Nissinen, M; Lindholm, H; Könönen, M; Savolainen, A

2004-08-01

The aim of the present study was to assess the associations between different types of perceived stress, pain and work performance among non-patients with clinical signs of muscle pain in the head/neck region. One-fifth (n = 241) of the 1339 media employees who had participated in a previous survey (Ahlberg J. et al., J Psychosom Res 2002; 53: 1077-1081) were randomly selected for standardized clinical examinations. Altogether 49% (n = 118) of these subjects had clinical signs of temporomandibular and/or neck muscle pain and were enrolled in the present study. The mean age of the study sample was 46.9 years (s.d. 6.6) and the female to male distribution 2:1. Of the 118 employees 46.5% reported that the pain problem interfered with their ability to work. Perceived ability to work was not significantly associated with age, gender or work positions. According to logistic regression, reduced work performance was significantly positively associated with continuous pain [odds ratio (OR) 4.38; 95% CI 1.21-15.7], level of perceived pain severity (OR 1.30; 95% CI 1.04-1.63), and health stress (OR 2.08; 95% CI 1.22-3.54). The results of this study indicated an association between specific self-reported stress regarding health and work issues, pain and work performance. From a preventive perspective this indicates a need for increased awareness about these associations on not only individual level but also at the organizational level and in health care. Copyright 2004 Blackwell Publishing Ltd.

Adverse reactions to sulfites

PubMed Central

Yang, William H.; Purchase, Emerson C.R.

1985-01-01

Sulfites are widely used as preservatives in the food and pharmaceutical industries. In the United States more than 250 cases of sulfite-related adverse reactions, including anaphylactic shock, asthmatic attacks, urticaria and angioedema, nausea, abdominal pain and diarrhea, seizures and death, have been reported, including 6 deaths allegedly associated with restaurant food containing sulfites. In Canada 10 sulfite-related adverse reactions have been documented, and 1 death suspected to be sulfite-related has occurred. The exact mechanism of sulfite-induced reactions is unknown. Practising physicians should be aware of the clinical manifestations of sulfite-related adverse reactions as well as which foods and pharmaceuticals contain sulfites. Cases should be reported to health officials and proper advice given to the victims to prevent further exposure to sulfites. The food industry, including beer and wine manufacturers, and the pharmaceutical industry should consider using alternative preservatives. In the interim, they should list any sulfites in their products. PMID:4052897

Understanding Interrater Reliability and Validity of Risk Assessment Tools Used to Predict Adverse Clinical Events.

PubMed

Siedlecki, Sandra L; Albert, Nancy M

This article will describe how to assess interrater reliability and validity of risk assessment tools, using easy-to-follow formulas, and to provide calculations that demonstrate principles discussed. Clinical nurse specialists should be able to identify risk assessment tools that provide high-quality interrater reliability and the highest validity for predicting true events of importance to clinical settings. Making best practice recommendations for assessment tool use is critical to high-quality patient care and safe practices that impact patient outcomes and nursing resources. Optimal risk assessment tool selection requires knowledge about interrater reliability and tool validity. The clinical nurse specialist will understand the reliability and validity issues associated with risk assessment tools, and be able to evaluate tools using basic calculations. Risk assessment tools are developed to objectively predict quality and safety events and ultimately reduce the risk of event occurrence through preventive interventions. To ensure high-quality tool use, clinical nurse specialists must critically assess tool properties. The better the tool's ability to predict adverse events, the more likely that event risk is mediated. Interrater reliability and validity assessment is relatively an easy skill to master and will result in better decisions when selecting or making recommendations for risk assessment tool use.

Biomarkers of adverse drug reactions.

PubMed

Carr, Daniel F; Pirmohamed, Munir

2018-02-01

Adverse drug reactions can be caused by a wide range of therapeutics. Adverse drug reactions affect many bodily organ systems and vary widely in severity. Milder adverse drug reactions often resolve quickly following withdrawal of the casual drug or sometimes after dose reduction. Some adverse drug reactions are severe and lead to significant organ/tissue injury which can be fatal. Adverse drug reactions also represent a financial burden to both healthcare providers and the pharmaceutical industry. Thus, a number of stakeholders would benefit from development of new, robust biomarkers for the prediction, diagnosis, and prognostication of adverse drug reactions. There has been significant recent progress in identifying predictive genomic biomarkers with the potential to be used in clinical settings to reduce the burden of adverse drug reactions. These have included biomarkers that can be used to alter drug dose (for example, Thiopurine methyltransferase (TPMT) and azathioprine dose) and drug choice. The latter have in particular included human leukocyte antigen (HLA) biomarkers which identify susceptibility to immune-mediated injuries to major organs such as skin, liver, and bone marrow from a variety of drugs. This review covers both the current state of the art with regard to genomic adverse drug reaction biomarkers. We also review circulating biomarkers that have the potential to be used for both diagnosis and prognosis, and have the added advantage of providing mechanistic information. In the future, we will not be relying on single biomarkers (genomic/non-genomic), but on multiple biomarker panels, integrated through the application of different omics technologies, which will provide information on predisposition, early diagnosis, prognosis, and mechanisms. Impact statement • Genetic and circulating biomarkers present significant opportunities to personalize patient therapy to minimize the risk of adverse drug reactions. ADRs are a significant heath issue

Combining macula clinical signs and patient characteristics for age-related macular degeneration diagnosis: a machine learning approach.

PubMed

Fraccaro, Paolo; Nicolo, Massimo; Bonetto, Monica; Giacomini, Mauro; Weller, Peter; Traverso, Carlo Enrico; Prosperi, Mattia; OSullivan, Dympna

2015-01-27

To investigate machine learning methods, ranging from simpler interpretable techniques to complex (non-linear) "black-box" approaches, for automated diagnosis of Age-related Macular Degeneration (AMD). Data from healthy subjects and patients diagnosed with AMD or other retinal diseases were collected during routine visits via an Electronic Health Record (EHR) system. Patients' attributes included demographics and, for each eye, presence/absence of major AMD-related clinical signs (soft drusen, retinal pigment epitelium, defects/pigment mottling, depigmentation area, subretinal haemorrhage, subretinal fluid, macula thickness, macular scar, subretinal fibrosis). Interpretable techniques known as white box methods including logistic regression and decision trees as well as less interpreitable techniques known as black box methods, such as support vector machines (SVM), random forests and AdaBoost, were used to develop models (trained and validated on unseen data) to diagnose AMD. The gold standard was confirmed diagnosis of AMD by physicians. Sensitivity, specificity and area under the receiver operating characteristic (AUC) were used to assess performance. Study population included 487 patients (912 eyes). In terms of AUC, random forests, logistic regression and adaboost showed a mean performance of (0.92), followed by SVM and decision trees (0.90). All machine learning models identified soft drusen and age as the most discriminating variables in clinicians' decision pathways to diagnose AMD. Both black-box and white box methods performed well in identifying diagnoses of AMD and their decision pathways. Machine learning models developed through the proposed approach, relying on clinical signs identified by retinal specialists, could be embedded into EHR to provide physicians with real time (interpretable) support.

Neurocognitive and Neuroplastic Mechanisms of Novel Clinical Signs in CRPS.

PubMed

Kuttikat, Anoop; Noreika, Valdas; Shenker, Nicholas; Chennu, Srivas; Bekinschtein, Tristan; Brown, Christopher Andrew

2016-01-01

Complex regional pain syndrome (CRPS) is a chronic, debilitating pain condition that usually arises after trauma to a limb, but its precise etiology remains elusive. Novel clinical signs based on body perceptual disturbances have been reported, but their pathophysiological mechanisms remain poorly understood. Investigators have used functional neuroimaging techniques (including MEG, EEG, fMRI, and PET) to study changes mainly within the somatosensory and motor cortices. Here, we provide a focused review of the neuroimaging research findings that have generated insights into the potential neurocognitive and neuroplastic mechanisms underlying perceptual disturbances in CRPS. Neuroimaging findings, particularly with regard to somatosensory processing, have been promising but limited by a number of technique-specific factors (such as the complexity of neuroimaging investigations, poor spatial resolution of EEG/MEG, and use of modeling procedures that do not draw causal inferences) and more general factors including small samples sizes and poorly characterized patients. These factors have led to an underappreciation of the potential heterogeneity of pathophysiology that may underlie variable clinical presentation in CRPS. Also, until now, neurological deficits have been predominantly investigated separately from perceptual and cognitive disturbances. Here, we highlight the need to identify neurocognitive phenotypes of patients with CRPS that are underpinned by causal explanations for perceptual disturbances. We suggest that a combination of larger cohorts, patient phenotyping, the use of both high temporal, and spatial resolution neuroimaging methods, and the identification of simplified biomarkers is likely to be the most fruitful approach to identifying neurocognitive phenotypes in CRPS. Based on our review, we explain how such phenotypes could be characterized in terms of hierarchical models of perception and corresponding disturbances in recurrent processing

Neurocognitive and Neuroplastic Mechanisms of Novel Clinical Signs in CRPS

PubMed Central

Kuttikat, Anoop; Noreika, Valdas; Shenker, Nicholas; Chennu, Srivas; Bekinschtein, Tristan; Brown, Christopher Andrew

2016-01-01

Complex regional pain syndrome (CRPS) is a chronic, debilitating pain condition that usually arises after trauma to a limb, but its precise etiology remains elusive. Novel clinical signs based on body perceptual disturbances have been reported, but their pathophysiological mechanisms remain poorly understood. Investigators have used functional neuroimaging techniques (including MEG, EEG, fMRI, and PET) to study changes mainly within the somatosensory and motor cortices. Here, we provide a focused review of the neuroimaging research findings that have generated insights into the potential neurocognitive and neuroplastic mechanisms underlying perceptual disturbances in CRPS. Neuroimaging findings, particularly with regard to somatosensory processing, have been promising but limited by a number of technique-specific factors (such as the complexity of neuroimaging investigations, poor spatial resolution of EEG/MEG, and use of modeling procedures that do not draw causal inferences) and more general factors including small samples sizes and poorly characterized patients. These factors have led to an underappreciation of the potential heterogeneity of pathophysiology that may underlie variable clinical presentation in CRPS. Also, until now, neurological deficits have been predominantly investigated separately from perceptual and cognitive disturbances. Here, we highlight the need to identify neurocognitive phenotypes of patients with CRPS that are underpinned by causal explanations for perceptual disturbances. We suggest that a combination of larger cohorts, patient phenotyping, the use of both high temporal, and spatial resolution neuroimaging methods, and the identification of simplified biomarkers is likely to be the most fruitful approach to identifying neurocognitive phenotypes in CRPS. Based on our review, we explain how such phenotypes could be characterized in terms of hierarchical models of perception and corresponding disturbances in recurrent processing

Effect of central and ovarian endocrine disturbances on the female genital tract--clinical signs and symptoms.

PubMed

Sillem, M; Rabe, T; Runnebaum, B

1997-01-01

Disorders of the female genital tract caused by endocrine disturbances commonly lead to two presenting complaints: dysfunctional uterine bleeding and infertility. In oestrogen deficiency, sequelae of vaginal atrophy may also be present. The common pathogenic "turntable" of these clinical signs is an impaired ovarian function, for which primary (i.e. intraovarian) and secondary (i.e. resulting from dysfunctions of other endocrine systems) causes are known. Primary ovarian failure can be the result of gonadal dysgenesis or premature menopause. Secondary ovarian dysfunction may be caused by hypothalamic-pituitary dysregulation, hyperprolactinaemia, thyroid disorders, and hyperandrogenaemia, which often also has an intraovarian component. For clinical considerations, several severities of ovarian dysfunction can be distinguished, ranging from corpus luteum insufficiency which is only relevant for the selection of infertility treatment to the complete absence of ovarian steroidogenesis leading to severe long term sequelae of the skeletal, cardiovascular and probably central nervous systems. Diagnosis and differential diagnosis are made by clinical examination, vaginal ultrasound, hormone assays, curettage and laparoscopy. Rarely, additional techniques like magnetic resonance imaging of the pituitary or the adrenals, or sequential catheterization of the inferior vena cava are needed.

[Do pediatricians identify adverse drug reactions even when they do not report them?

PubMed

Morales-Ríos, Olga; Jasso-Gutiérrez, Luis; Garduño-Espinosa, Juan; Olivar-López, Víctor; Muñoz-Hernández, Onofre

Spontaneous notification depends on the ability of pediatricians to identify adverse drug reactions (ADRs) along with their habit of reporting these incidents. During the years 2008 and 2009, the frequency of reports of ADRs to the Electronic Program of Pharmacovigilance (SISFAR) in the Hospital Infantil of Mexico Federico Gomez (HIMFG) was low (0.44% and 0.20%, respectively). Because of the above, the ability of pediatricians from the Emergency Department (ED) to identify ADRs using the clinical chart review was evaluated in 2010 in this study. A descriptive, observational, cross-sectional retrospective study was conducted in the ED from March 1 to August 31. ADRs were classified and quantified as "ADRs identified by pediatricians" when there was evidence in the clinical chart that pediatricians associated a clinical sign, symptom and laboratory value with an ADR. The numbers of notifications reported in SISFAR were quantified. Descriptive analysis was done using SPSS v.18. Considering patients who were admitted to the ED, the frequency of ADRs was 21.8%. The frequency of ADRs identified by physicians in clinical charts was 86%. The pharmacist detected 14% of ADRs. The frequency of ADRs reported by physicians was 6.1%. Although identification of ADRs in the clinical charts by pediatricians was high, it is possible that some ADRs were undetected. Because underreporting was very high, it is necessary to take actions to improve the reporting process. Copyright © 2015. Publicado por Masson Doyma México S.A.

Adverse Effects Associated With Newer Diabetes Therapies.

PubMed

Akiyode, Oluwaranti F; Adesoye, Adebola A

2017-04-01

The increasing number of newer type 2 diabetes therapies has allowed providers an increased armamentarium for the optimal management of patients with diabetes. In fact, these newer agents have unique benefits in the management of type 2 diabetes. However, they are also associated with certain adverse effects. This review article aims to describe the notable adverse effects of these newer antidiabetic therapies including the glucagon-like peptide 1 receptor agonists, dipeptidyl peptidase-4 inhibitors, and the sodium-glucose cotransporter 2 inhibitors. The adverse effects reviewed herein include pancreatitis, medullary thyroid carcinoma, heart failure, gastrointestinal disturbances, renal impairment, and genitourinary infections. More clinical data are necessary to solidify the association of some of these adverse effects with the newer diabetes agents. However, it is important for health care practitioners to be well informed and prepared to properly monitor patients for these adverse effects.

The diagnostic value of the Clarke sign in assessing chondromalacia patella.

PubMed

Doberstein, Scott T; Romeyn, Richard L; Reineke, David M

2008-01-01

Various techniques have been described for assessing conditions that cause pain at the patellofemoral (PF) joint. The Clarke sign is one such test, but the diagnostic value of this test in assessing chondromalacia patella is unknown. To (1) investigate the diagnostic value of the Clarke sign in assessing the presence of chondromalacia patella using arthroscopic examination of the PF joint as the "gold standard," and (2) provide a historical perspective of the Clarke sign as a clinical diagnostic test. Validation study. All patients of one of the investigators who had knee pain or injuries unrelated to the patellofemoral joint and were scheduled for arthroscopic surgery were recruited for this study. A total of 106 otherwise healthy individuals with no history of patellofemoral pain or dysfunction volunteered. The Clarke sign was performed on the surgical knee by a single investigator in the clinic before surgery. A positive test was indicated by the presence of pain sufficient to prevent the patient from maintaining a quadriceps muscle contraction against manual resistance for longer than 2 seconds. The preoperative result was compared with visual evidence of chondromalacia patella during arthroscopy. Sensitivity was 0.39, specificity was 0.67, likelihood ratio for a positive test was 1.18, likelihood ratio for a negative test was 0.91, positive predictive value was 0.25, and negative predictive value was 0.80. Diagnostic validity values for the use of the Clarke sign in assessing chondromalacia patella were unsatisfactory, supporting suggestions that it has poor diagnostic value as a clinical examination technique. Additionally, an extensive search of the available literature for the Clarke sign reveals multiple problems with the test, causing significant confusion for clinicians. Therefore, the use of the Clarke sign as a routine part of a knee examination is not beneficial, and its use should be discontinued.

Monitoring Haloperidol Plasma Concentration and Associated Adverse Events in Critically Ill Children With Delirium: First Results of a Clinical Protocol Aimed to Monitor Efficacy and Safety.

PubMed

Slooff, Valerie D; van den Dungen, Desley K; van Beusekom, Babette S; Jessurun, Naomi; Ista, Erwin; Tibboel, Dick; de Wildt, Saskia N

2018-02-01

As delirium in critically ill children is increasingly recognized, more children are treated with the antipsychotic drug haloperidol, while current dosing guidelines are lacking solid evidence and appear to be associated with a high risk of adverse events. We aim to report on the safety and efficacy of a recently implemented clinical dose-titration protocol with active monitoring of adverse events. From July 2014 until June 2015, when a potential delirium was identified by regular delirium scores and confirmed by a child psychiatrist, haloperidol was prescribed according to the Dutch Pediatric Formulary. Daily, adverse events were systematically assessed, haloperidol plasma concentrations were measured, and delirium symptoms followed. Dependent on the clinical response, plasma concentration, and adverse event, the dose was adjusted. A 28-bed tertiary PICU in the Netherlands. All patients admitted to the PICU diagnosed with delirium. Treatment with haloperidol according to a dose-titration protocol MEASUREMENTS AND MAIN RESULTS:: Thirteen children (median age [range] 8.3 yr [0.4-13.8 yr]) received haloperidol, predominantly IV (median dose [range] 0.027 mg/kg/d [0.005-0.085 mg/kg/d]). In all patients, pediatric delirium resolved, but five of 13 patients developed possible adverse event. These were reversed after biperiden (n = 2), discontinuing (n = 3), and/or lowering the dose (n = 3). Plasma concentrations were all below the presumed therapeutic threshold of 3-12 µg/L. Prospective systematic monitoring of adverse event in critically ill children receiving haloperidol revealed a significant proportion of possible adverse events. Adverse event developed despite low plasma concentrations and recommended dose administration in the majority of the patients. Our data suggest that haloperidol can potentially improve pediatric delirium, but it might also put patients at risk for developing adverse events.

Attitudes towards vital signs monitoring in the detection of clinical deterioration: scale development and survey of ward nurses.

PubMed

Mok, Wenqi; Wang, Wenru; Cooper, Simon; Ang, Emily Neo Kim; Liaw, Sok Ying

2015-06-01

To develop and determine the psychometrics properties of an instrument (V-scale) and to explore nurses' attitudes towards vital signs monitoring in the detection of clinical deterioration in general wards. Scale development with psychometric testing and a descriptive quantitative survey. Tertiary acute care hospital. A total of 614 general ward nurses. Principal component analysis revealed a 16-item instrument in a five-factor solution (key indicators, knowledge, communication, workload and technology) that explained 56.27% of the variance. The internal consistency was sufficient with Cronbach's alpha of 0.71 and strong item subscale correlations (0.56-0.89). The test-retest reliability was adequate with an Intraclass Correlation Coefficient (ICC) of 0.85. Many nurses (56.9%) erroneously perceived blood pressure changes as the first indicator of deterioration, and 46% agreed that an altered respiratory rate was the least important indicator. Most nurses (59.8%) also reported relying on oxygen saturation to evaluate respiratory dysfunction, and 27.4% indicated that they make quick estimates of the respiratory rate. Current practices for vital signs monitoring were considered to be time consuming (21.0%) and overwhelming (35.3%). Nurses' attitudes were most significantly influenced by whether they had a degree qualification followed by whether they worked in a general ward with a specialty and had >5 years of experience. This exploratory study provides evidence for the psychometric properties of the V-scale. It reveals a need for continuous professional development to improve ward nurses' attitudes towards vital signs monitoring. Vital signs monitoring needs to be prioritized in workload planning. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Mitigating adverse event reporting bias in spine surgery.

PubMed

Auerbach, Joshua D; McGowan, Kevin B; Halevi, Marci; Gerling, Michael C; Sharan, Alok D; Whang, Peter G; Maislin, Greg

2013-08-21

Recent articles in the lay press and literature have raised concerns about the ability to report honest adverse event data from industry-sponsored spine surgery studies. To address this, clinical trials may utilize an independent Clinical Events Committee (CEC) to review adverse events and readjudicate the severity and relatedness accordingly. We are aware of no prior study that has quantified either the degree to which investigator bias is present in adverse event reporting or the effect that an independent CEC has on mitigating this potential bias. The coflex Investigational Device Exemption study is a prospective randomized controlled trial comparing coflex (Paradigm Spine) stabilization with lumbar spinal fusion to treat spinal stenosis and spondylolisthesis. Investigators classified the severity of adverse events (mild, moderate, or severe) and their relationship to the surgery and device (unrelated, unlikely, possibly, probably, or definitely). An independent CEC, composed of three spine surgeons without affiliation to the study sponsor, reviewed and reclassified all adverse event reports submitted by the investigators. The CEC reclassified the level of severity, relation to the surgery, and/or relation to the device in 394 (37.3%) of 1055 reported adverse events. The proportion of adverse events that underwent reclassification was similar in the coflex and fusion groups (37.9% compared with 36.0%, p = 0.56). The CEC was 5.3 (95% confidence interval [CI], 2.6 to 10.7) times more likely to upgrade than downgrade the adverse event. The CEC was 7.3 (95% CI, 5.1 to 10.6) times more likely to upgrade than downgrade the relationship to the surgery and 11.6 (95% CI, 7.5 to 18.8) times more likely to upgrade than downgrade the relationship to the device. The status of the investigator's financial interest in the company had little effect on the reclassification of adverse events. Thirty-seven percent of adverse events were reclassified by the CEC; the large majority

The lepton flavor violating decay {tau}{sup {+-}} {yields} Micro-Sign {sup {+-}} Micro-Sign {sup {+-}} Micro-Sign {sup Minus-Or-Plus-Sign} at LHCb

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

Keune, A., E-mail: anne.keune@epfl.ch

2012-09-15

The possibility of improving the limit on the branching fraction of the lepton flavor violating decay {tau}{sup {+-}} {yields} Micro-Sign {sup {+-}} Micro-Sign {sup {+-}} Micro-Sign {sup Minus-Or-Plus-Sign} at LHCb is discussed. It is shown that a simple, cut-based analysis is sufficient to improve the upper limit on this branching fraction within the lifetime of LHCb.

Clinical signs of pancreatitis.

PubMed

Penny, Steven M

2012-01-01

The pancreas consists of complex structures that perform vital functions. Radiologic technologists must comprehend its normal structure and function to perform functional imaging procedures in their daily practice, as well as to know how any deviation from normalcy can disrupt homeostasis. Because pancreatitis is a potentially life-threatening disease, a thorough understanding of the clinical manifestation and imaging characteristics of the various forms of the disease is crucial. This article reviews distinctive pancreatic function and discusses basic pancreas imaging. In addition, acute and chronic pancreatitis is explored, including the role of medical imaging in its diagnosis, complications, and prognosis.

Critically appraised topic on adverse food reactions of companion animals (1): duration of elimination diets.

PubMed

Olivry, Thierry; Mueller, Ralf S; Prélaud, Pascal

2015-08-28

Restrictive (i.e. elimination)-provocation dietary trials remain the standard of care to diagnose cutaneous adverse food reactions (CAFRs) in dogs and cats. There is currently no consensus on the duration of elimination diet trials that would permit the highest sensitivity of diagnosis of CAFR in companion animals. The search for, and review and analysis of the best evidence available as of December 14, 2014 suggests that, by 5 weeks in dogs and 6 weeks in cats after starting an elimination diet, more than 80 % of patients had achieved a remission of clinical signs of CAFR. Increasing the diet trial duration to 8 weeks leads to a complete remission in more than 90 % of dogs and cats with CAFR. For diagnosing CAFRs in more than 90 % of dogs and cats, elimination diet trials should last at least 8 weeks.

Towards first principle medical diagnostics: on the importance of disease-disease and sign-sign interactions

NASA Astrophysics Data System (ADS)

Ramezanpour, Abolfazl; Mashaghi, Alireza

2017-07-01

A fundamental problem in medicine and biology is to assign states, e.g. healthy or diseased, to cells, organs or individuals. State assignment or making a diagnosis is often a nontrivial and challenging process and, with the advent of omics technologies, the diagnostic challenge is becoming more and more serious. The challenge lies not only in the increasing number of measured properties and dynamics of the system (e.g. cell or human body) but also in the co-evolution of multiple states and overlapping properties, and degeneracy of states. We develop, from first principles, a generic rational framework for state assignment in cell biology and medicine, and demonstrate its applicability with a few simple theoretical case studies from medical diagnostics. We show how disease-related statistical information can be used to build a comprehensive model that includes the relevant dependencies between clinical and laboratory findings (signs) and diseases. In particular, we include disease-disease and sign-sign interactions and study how one can infer the probability of a disease in a patient with given signs. We perform comparative analysis with simple benchmark models to check the performances of our models. We find that including interactions can significantly change the statistical importance of the signs and diseases. This first principles approach, as we show, facilitates the early diagnosis of disease by taking interactions into accounts, and enables the construction of consensus diagnostic flow charts. Additionally, we envision that our approach will find applications in systems biology, and in particular, in characterizing the phenome via the metabolome, the proteome, the transcriptome, and the genome.

Spot Sign in Acute Intracerebral Hemorrhage in Dynamic T1-Weighted Magnetic Resonance Imaging.

PubMed

Schindlbeck, Katharina A; Santaella, Anna; Galinovic, Ivana; Krause, Thomas; Rocco, Andrea; Nolte, Christian H; Villringer, Kersten; Fiebach, Jochen B

2016-02-01

In computed tomographic imaging of acute intracerebral hemorrhage spot sign on computed tomographic angiography has been established as a marker for hematoma expansion and poor clinical outcome. Although, magnetic resonance imaging (MRI) can accurately visualize acute intracerebral hemorrhage, a corresponding MRI marker is lacking to date. We prospectively examined 50 consecutive patients with acute intracerebral hemorrhage within 24 hours of symptom onset. The MRI protocol consisted of a standard stroke protocol and dynamic contrast-enhanced T1-weighted imaging with a time resolution of 7.07 s/batch. Stroke scores were assessed at admission and at time of discharge. Volume measurements of hematoma size and spot sign were performed with MRIcron. Contrast extravasation within sites of the hemorrhage (MRI spot sign) was seen in 46% of the patients. Patients with an MRI spot sign had a significantly shorter time to imaging than those without (P<0.001). The clinical outcome measured by the modified Rankin Scale was significantly worse in patients with spot sign compared with those without (P≤0.001). Hematoma expansion was observed in the spot sign group compared with the nonspot sign group, although the differences were not significant. Spot sign can be detected using MRI on postcontrast T1-weighted and dynamic T1-weighted images. It is associated with worse clinical outcome. The time course of contrast extravasation in dynamic T1 images indicates that these spots represent ongoing bleeding. © 2015 American Heart Association, Inc.

Clinical signs, pathology and dose-dependent survival of adult wood frogs, Rana sylvatica, inoculated orally with frog virus 3 Ranavirus sp., Iridoviridae.

PubMed

Forzn, Mara J; Jones, Kathleen M; Vanderstichel, Raphal V; Wood, John; Kibenge, Frederick S B; Kuiken, Thijs; Wirth, Wytamma; Ariel, Ellen; Daoust, Pierre-Yves

2015-05-01

Amphibian populations suffer massive mortalities from infection with frog virus 3 FV3, genus Ranavirus, family Iridoviridae, a pathogen also involved in mortalities of fish and reptiles. Experimental oral infection with FV3 in captive-raised adult wood frogs, Rana sylvatica Lithobates sylvaticus, was performed as the first step in establishing a native North American animal model of ranaviral disease to study pathogenesis and host response. Oral dosing was successful LD50 was 10(2.93 2.423.44) p.f.u. for frogs averaging 35mm in length. Onset of clinical signs occurred 614days post-infection p.i. median 11 days p.i. and time to death was 1014 days p.i. median 12 days p.i.. Each tenfold increase in virus dose increased the odds of dying by 23-fold and accelerated onset of clinical signs and death by approximately 15. Ranavirus DNA was demonstrated in skin and liver of all frogs that died or were euthanized because of severe clinical signs. Shedding of virus occurred in faeces 710 days p.i. 34.5days before death and skin sheds 10 days p.i. 01.5days before death of some frogs dead from infection. Most common lesions were dermal erosion and haemorrhages haematopoietic necrosis in bone marrow, kidney, spleen and liver and necrosis in renal glomeruli, tongue, gastrointestinal tract and urinary bladder mucosa. Presence of ranavirus in lesions was confirmed by immunohistochemistry. Intracytoplasmic inclusion bodies probably viral were present in the bone marrow and the epithelia of the oral cavity, gastrointestinal tract, renal tubules and urinary bladder. Our work describes a ranaviruswood frog model and provides estimates that can be incorporated into ranavirus disease ecology models. © 2015 The Authors.

Adverse effects of neuromuscular blockers and their antagonists.

PubMed

Naguib, M; Magboul, M M

1998-02-01

Among all the drugs used for general anaesthesia, neuromuscular blockers appear to play a prominent role in the incidence of severe adverse reactions. It now seems likely that most serious adverse drug reactions occurring during anaesthesia are immunological in type. The frequency of life-threatening anaphylactic or anaphylactoid reactions occurring during anaesthesia has been estimated to be between 1 in 1000 and 1 in 25,000 anaesthetic procedures, with the neuromuscular blockers being involved in 80% of cases. The mortality from such serious reactions is reported to be in the range of 3.4 to 6%. The highly immunogenic drug, suxamethonium chloride (succinylcholine), was found to be the most hazardous agent. Drug-specific immunoglobulin E antibodies to suxamethonium chloride and other neuromuscular blockers have been demonstrated. This sensitivity to neuromuscular blockers seems to be a long-lasting phenomenon. During anaesthesia, the clinical features of an allergic reaction are often masked. Tachycardia and circulatory collapse may be the only signs of an allergic reaction, and they are easily misdiagnosed. Bronchospasm is reported to be present in about 40% of cases. Successful management of these patients includes stabilisation during the acute reaction and avoidance of future reactions. The latter is based on the identification of the causative drug and potentially cross-reacting compounds. The use of suxamethonium chloride is associated with many other adverse effects, such as fasciculations, myalgia, potassium release, changes in the heart rate, increases in intragastric and intraocular pressures, and malignant hyperthermia. Because of the dangers of hyperkalaemic cardiac arrest after suxamethonium chloride administration in children with unrecognised muscular dystrophy, there have now been moves to limit the use of this drug in children. Although neuromuscular blockers are designed to specifically block nicotinic cholinergic receptors at the neuromuscular

Adverse effects of neuromuscular blockers and their antagonists.

PubMed

Naguib, M; Magboul, M M

1998-06-01

Among all the drugs used for general anesthesia, neuromuscular blockers appear to play a prominent role in the incidence of severe adverse reactions. It now seems likely that most serious adverse drug reactions occurring during anesthesia are immunological in type. The frequency of life-threatening anaphylactic or anaphylactoid reactions occurring during anesthesia has been estimated to be between 1 in 1000 and 1 in 25,000 anesthetic procedures, with the neuromuscular blockers being involved in 80% of cases. The mortality from such serious reactions is reported to be in the range of 3.4 to 6%. The highly immunogenic drug, suxamethonium chloride (succinylcholine), was found to be the most hazardous agent. Drug-specific immunoglobulin E antibodies to suxamethonium chloride and other neuromuscular blockers have been demonstrated. This sensitivity to neuromuscular blockers seems to be a long-lasting phenomenon. During anesthesia, the clinical features of an allergic reaction are often masked. Tachycardia and circulatory collapse may be the only signs of an allergic reaction, and they are easily misdiagnosed. Bronchospasm is reported to be present in about 40% of cases. Successful management of these patients includes stabilisation during the acute reaction and avoidance of future reactions. The latter is based on the identification of the causative drug and potentially cross-reacting compounds. The use of suxamethonium chloride is associated with many other adverse effects, such as fasciculations, myalgia, potassium release, changes in the heart rate, increases in intragastric and intraocular pressures, and malignant hyperthermia. Because of the dangers of hyperkalemic cardiac arrest suxamethonium chloride administration in children with unrecognised muscular dystrophy, there have now been moves to limit the use of this drug in children. Although neuromuscular blockers are designed to specifically block nicotinic cholinergic receptors at the neuromuscular junction

Adverse drug reactions induced by valproic acid.

PubMed

Nanau, Radu M; Neuman, Manuela G

2013-10-01

Valproic acid is a widely-used first-generation antiepileptic drug, prescribed predominantly in epilepsy and psychiatric disorders. VPA has good efficacy and pharmacoeconomic profiles, as well as a relatively favorable safety profile. However, adverse drug reactions have been reported in relation with valproic acid use, either as monotherapy or polytherapy with other antiepileptic drugs or antipsychotic drugs. This systematic review discusses valproic acid adverse drug reactions, in terms of hepatotoxicity, mitochondrial toxicity, hyperammonemic encephalopathy, hypersensitivity syndrome reactions, neurological toxicity, metabolic and endocrine adverse events, and teratogenicity. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Remote sensing of multiple vital signs using a CMOS camera-equipped infrared thermography system and its clinical application in rapidly screening patients with suspected infectious diseases.

PubMed

Sun, Guanghao; Nakayama, Yosuke; Dagdanpurev, Sumiyakhand; Abe, Shigeto; Nishimura, Hidekazu; Kirimoto, Tetsuo; Matsui, Takemi

2017-02-01

Infrared thermography (IRT) is used to screen febrile passengers at international airports, but it suffers from low sensitivity. This study explored the application of a combined visible and thermal image processing approach that uses a CMOS camera equipped with IRT to remotely sense multiple vital signs and screen patients with suspected infectious diseases. An IRT system that produced visible and thermal images was used for image acquisition. The subjects' respiration rates were measured by monitoring temperature changes around the nasal areas on thermal images; facial skin temperatures were measured simultaneously. Facial blood circulation causes tiny color changes in visible facial images that enable the determination of the heart rate. A logistic regression discriminant function predicted the likelihood of infection within 10s, based on the measured vital signs. Sixteen patients with an influenza-like illness and 22 control subjects participated in a clinical test at a clinic in Fukushima, Japan. The vital-sign-based IRT screening system had a sensitivity of 87.5% and a negative predictive value of 91.7%; these values are higher than those of conventional fever-based screening approaches. Multiple vital-sign-based screening efficiently detected patients with suspected infectious diseases. It offers a promising alternative to conventional fever-based screening. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Characterization of the duplicate L-SIGN and DC-SIGN genes in miiuy croaker and evolutionary analysis of L-SIGN in fishes.

PubMed

Shu, Chang; Wang, Shanchen; Xu, Tianjun

2015-05-01

Dendritic cell-specific ICAM-3-grabbing non-integrin (DC-SIGN/CD209) and liver/lymph node-specific ICAM-grabbing non-integrin (L-SIGN/CD299) which are homologues of DC-SIGN are important members in C-type lectin receptors family as key molecules to recognize and eliminate pathogens in the innate immune system. DC-SIGN and L-SIGN have become hot topics in recent studies which both served as cell adhesion and phagocytic pathogen recognition receptors in mammals. However, there have been almost no studies of DC-SIGN and L-SIGN structure and characters in fish, only DC-SIGN in the zebrafish had been studied. In our study, we identified and characterized the full-length miiuy croaker (Miichthys miiuy) DC-SIGN (mmDC-SIGN) and L-SIGN (mmL-SIGN) genes. The sequence analysis results showed that mmDC-SIGN and mmL-SIGN have the same domains with other vertebrates except primates, and share some conserved motifs in CRD among all the vertebrates which play a crucial role in interacting with Ca(2+) and for recognizing mannose-containing motifs. Gene synteny of DC-SIGN and L-SIGN were analyzed for the first time and gene synteny of L-SIGN was conserved among the five fishes. Interestingly, one gene next to L-SIGN from gene synteny had high similarity with L-SIGN gene that was described as L-SIGN-like in fish species. While only one L-SIGN gene existed in other vertebrates, two L-SIGN in fish may be in consequence of the fish-specific genome duplication to adapt the specific environment. The evolutionary analysis showed that the ancestral lineages of L-SIGN gene in fishes experienced purifying selection and the current lineages of L-SIGN gene in fishes underwent positive selection, indicating that the ancestral lineages and current lineages of L-SIGN gene in fishes underwent different evolutionary patterns. Both mmDC-SIGN and mmL-SIGN were expressed in all tested tissues and ubiquitously up-regulated in infected liver, spleen and kidney at different sampling time points

Ergonomics and design: traffic sign and street name sign.

PubMed

Moroni, Janaina Luisa da Silva; Aymone, José Luís Farinatti

2012-01-01

This work proposes a design methodology using ergonomics and anthropometry concepts applied to traffic sign and street name sign projects. Initially, a literature revision on cognitive ergonomics and anthropometry is performed. Several authors and their design methodologies are analyzed and the aspects to be considered in projects of traffic and street name signs are selected and other specific aspects are proposed for the design methodology. A case study of the signs of "Street of Antiques" in Porto Alegre city is presented. To do that, interviews with the population are made to evaluate the current situation of signs. After that, a new sign proposal with virtual prototyping is done using the developed methodology. The results obtained with new interviews about the proposal show the user satisfaction and the importance of cognitive ergonomics to development of this type of urban furniture.

Sign language comprehension: the case of Spanish sign language.

PubMed

Rodríguez Ortiz, I R

2008-01-01

This study aims to answer the question, how much of Spanish Sign Language interpreting deaf individuals really understand. Study sampling included 36 deaf people (deafness ranging from severe to profound; variety depending on the age at which they learned sign language) and 36 hearing people who had good knowledge of sign language (most were interpreters). Sign language comprehension was assessed using passages of secondary level. After being exposed to the passages, the participants had to tell what they had understood about them, answer a set of related questions, and offer a title for the passage. Sign language comprehension by deaf participants was quite acceptable but not as good as that by hearing signers who, unlike deaf participants, were not only late learners of sign language as a second language but had also learned it through formal training.

Negative spot sign in primary intracerebral hemorrhage: potential impact in reducing imaging.

PubMed

Romero, Javier M; Hito, Rania; Dejam, Andre; Ballesteros, Laia Sero; Cobos, Camilo Jaimes; Liévano, J Ortiz; Ciura, Viesha A; Barnaure, Isabelle; Ernst, Marielle; Liberato, Afonso P; Gonzalez, Gilberto R

2017-02-01

Intracerebral hemorrhage (ICH) is one of the most devastating and costly diagnoses in the USA. ICH is a common diagnosis, accounting for 10-15 % of all strokes and affecting 20 out of 100,000 people. The CT angiography (CTA) spot sign, or contrast extravasation into the hematoma, is a reliable predictor of hematoma expansion, clinical deterioration, and increased mortality. Multiple studies have demonstrated a high negative predictive value (NPV) for ICH expansion in patients without spot sign. Our aim is to determine the absolute NPV of the spot sign and clinical characteristics of patients who had ICH expansion despite the absence of a spot sign. This information may be helpful in the development of a cost effective imaging protocol of patients with ICH. During a 3-year period, 204 patients with a CTA with primary intracerebral hemorrhage were evaluated for subsequent hematoma expansion during their hospitalization. Patients with intraventricular hemorrhage were excluded. Clinical characteristics and antithrombotic treatment on admission were noted. The number of follow-up NCCT was recorded. Of the resulting 123 patients, 108 had a negative spot sign and 7 of those patients subsequently had significant hematoma expansion, 6 of which were on antithrombotic therapy. The NPV of the CTA spot sign was calculated at 0.93. In patients without antithrombotic therapy, the NPV was 0.98. In summary, the negative predictive value of the CTA spot sign for expansion of ICH, in the absence of antithrombotic therapy and intraventricular hemorrhage (IVH) on admission, is very high. These results have the potential to redirect follow-up imaging protocols and reduce cost.

Development of a traffic sign inventory system : Sign Click.

DOT National Transportation Integrated Search

2006-07-01

A system is not currently in place to inventory traffic signs in Kentucky. A sign inventory database would be beneficial for those responsible for maintenance and management of signs. The overall safety provided the driving public could benefit from ...

Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians: a model process.

PubMed

Whitstock, Margaret T; Pearce, Christopher M; Ridout, Stephen C; Eckermann, Elizabeth J

2011-05-21

The study was undertaken to evaluate the contribution of a process which uses clinical trial data plus linked de-identified administrative health data to forecast potential risk of adverse events associated with the use of newly released drugs by older Australian patients. The study uses publicly available data from the clinical trials of a newly released drug to ascertain which patient age groups, gender, comorbidities and co-medications were excluded in the trials. It then uses linked de-identified hospital morbidity and medications dispensing data to investigate the comorbidities and co-medications of patients who suffer from the target morbidity of the new drug and who are the likely target population for the drug. The clinical trial information and the linked morbidity and medication data are compared to assess which patient groups could potentially be at risk of an adverse event associated with use of the new drug. Applying the model in a retrospective real-world scenario identified that the majority of the sample group of Australian patients aged 65 years and over with the target morbidity of the newly released COX-2-selective NSAID rofecoxib also suffered from a major morbidity excluded in the trials of that drug, indicating a substantial potential risk of adverse events amongst those patients. This risk was borne out in post-release morbidity and mortality associated with use of that drug. Clinical trial data and linked administrative health data can together support a prospective assessment of patient groups who could be at risk of an adverse event if they are prescribed a newly released drug in the context of their age, gender, comorbidities and/or co-medications. Communication of this independent risk information to prescribers has the potential to reduce adverse events in the period after the release of the new drug, which is when the risk is greatest.Note: The terms 'adverse drug reaction' and 'adverse drug event' have come to be used interchangeably

[High frequency of cutaneous adverse effects under infliximab. Geneva experience, 1999-2008].

PubMed

Seydtaghia, Floriane; De Saussure, Philippe; Hadengue, Antoine

2011-03-16

Geneva experience, 1999-2008 Infliximab has been used for 10 years in the treatment of chronic inflammatory bowel diseases in the gastroenterology and hepatology department at the University Hospitals of Geneva. This retrospective study shows the follow-up of these patients treated with infliximab and reveals a high rate of cutaneous adverse events, which, although often mild, can sign a definitive intolerance to treatment.

The "ugly duckling" sign: agreement between observers.

PubMed

Scope, Alon; Dusza, Stephen W; Halpern, Allan C; Rabinovitz, Harold; Braun, Ralph P; Zalaudek, Iris; Argenziano, Giuseppe; Marghoob, Ashfaq A

2008-01-01

To assess whether multiple observers can identify the same pigmented lesion(s) as being different from a patient's other moles ("ugly duckling" [UD] sign) and to explore whether the UD sign is sensitive for melanoma detection. Baseline back images of 12 patients were obtained from a database of standardized patient images. All patients had at least 8 atypical moles on the back, and in 5 patients, one of the lesions was a histologically confirmed melanoma. The overview back images were supplemented with close-up clinical images of lesions. Participants were asked to evaluate whether the images showed any lesions on the back that differed from other nevi. Dermatology clinic specializing in pigmented lesions. Images were evaluated by 34 participants, including 8 pigmented lesion experts, 13 general dermatologists, 5 dermatology nurses, and 8 nonclinical medical staff. A lesion was considered a generally apparent UD if it was perceived as different by at least two-thirds of the participants. Sensitivity was defined as the fraction of melanomas identified as different. All 5 melanomas (100%) and only 3 of 140 benign lesions (2.1%) were generally apparent as different. The sensitivity of the UD sign for melanoma detection was 0.9 for the whole group, 1.0 for experts, 0.89 for general dermatologists, 0.88 for nurses, and 0.85 for nonclinicians. A limitation of the study is that assessment was done in virtual settings. In the present study, melanomas were generally apparent as UDs. The potential of the UD sign for melanoma screening should be further assessed.

Ultrasound discloses entheseal involvement in inactive and low active inflammatory bowel disease without clinical signs and symptoms of spondyloarthropathy.

PubMed

Bandinelli, Francesca; Milla, Monica; Genise, Stefania; Giovannini, Leonardo; Bagnoli, Siro; Candelieri, Antonio; Collaku, Ledio; Biagini, Silvia; Cerinic, Marco Matucci

2011-07-01

To investigate the presence of lower limb entheseal abnormalities in IBD patients without clinical signs and symptoms of SpA and their correlation with IBD clinical variables. A total of 81 IBD patients [55 Crohn's disease (CD) and 26 ulcerative colitis (UC), 43 females and 38 males, mean age 41.3 (12.4) years, BMI 24 (2)] with low active (12) and inactive (67) disease were consecutively studied with US (LOGIQ5 General Electric 10-MHz linear array transducer) of lower limb entheses and compared with 40 healthy controls matched for sex, age and BMI. Quadriceps, patellar, Achilleon and plantar fascia entheses were scored according to the 0-36 Glasgow Ultrasound Enthesitis Scoring System (GUESS) and power Doppler (PD). Correlations of GUESS and PD with IBD features [duration, type (CD/UC) and activity (disease activity index for CD/Truelove score for UC)] were investigated. The intra- and inter-reader agreements for US were estimated in all images detected in patients and controls. Of the 81 patients, 71 (92.6%) presented almost one tendon alteration with mean GUESS 5.1 (3.5): 81.5% thickness (higher than controls P < 0.05), 67.9% enthesophytosis, 27.1% bursitis and 16.1% erosions. PD was positive in 13/81 (16%) patients. In controls, US showed only enthesophytes (5%) and no PD. GUESS and PD were independent of duration, activity or type (CD/UC) of IBD. The intra- and inter-reader agreements were high (>0.9 intra-class correlation variability). US entheseal abnormalities are present in IBD patients without clinical signs and symptoms of SpA. US enthesopathy is independent of activity, duration and type of gut disease.

Retraumatization Mediates the Effect of Adverse Childhood Experiences on Clinical Training-Related Secondary Traumatic Stress Symptoms.

PubMed

Butler, Lisa D; Maguin, Eugene; Carello, Janice

2018-01-01

Previous research (Butler, Carello, & Maguin, 2016) has found that exposure to trauma-related material in graduate clinical coursework and field training can put students at risk for reactivations of feelings/memories from negative past experiences (retraumatization) and for secondary traumatic stress (STS) symptoms. The present report sought to examine the role, if any, of adverse childhood experiences (ACEs) in these outcomes. Using the Butler et al. (2016) sample, we examined: (1) rates of ACEs in 195 graduate social work students, (2) whether the total number of ACEs was associated with training-related retraumatization (TRT) and/or STS symptoms, and (3) if TRT mediated the relationship between ACEs and STS symptoms. The results indicate that more than three quarters of the sample had experienced one or more ACEs before age 18 and almost one third endorsed 4 or more. The most commonly reported ACEs were household mental illness, parental separation/divorce, household alcohol/substance abuse, and emotional abuse or neglect by a parent or household member. Higher ACE scores were associated with increased likelihood of TRT experiences and STS symptoms during training. A mediation analysis confirmed that TRT mediated the effect of ACE scores on STS symptoms; this finding also provides support for the role of proximal emotional reactions in mediating the effects of distal adverse experiences on the development of trauma symptoms. In summary, despite the evident resilience of this graduate student sample, those with ACE histories were at heightened risk for training-related distress. These results underscore the need for a trauma-informed approach to clinical training.

Measurement of allergen-specific IgG in serum is of limited value for the management of dogs diagnosed with cutaneous adverse food reactions.

PubMed

Hagen-Plantinga, E A; Leistra, M H G; Sinke, J D; Vroom, M W; Savelkoul, H F J; Hendriks, W H

2017-02-01

Conflicting results have been reported in the literature in terms of the usefulness of serological testing for IgG against food allergens in dogs with cutaneous adverse food reaction (CAFR). The aim of the present study was to evaluate the suitability of a commercially available IgG ELISA for identifying food allergens in dogs, by challenging dogs with specific food ingredients, selected on the basis of IgG reactivity in serum samples. A total of 24 adult dogs with CAFR were enrolled into the study and 16 healthy dogs were included as a control group. Blood samples were obtained for measurement of specific IgG antibodies against 39 commonly used pet food ingredients by ELISA. Participating owners were surveyed to obtain information on their pet's dietary history. Eleven healthy control dogs and 12 dogs with CAFR were subsequently challenged in a blinded cross-over design experiment with both positive and negative food ingredients, selected on the basis of the ELISA test results. There was substantial individual variation in ELISA test results to the various food allergens, but no significant difference in IgG reactivity comparing the CAFR and control groups. None of the control dogs developed any clinical signs of an allergic reaction during the dietary challenge study. In the CAFR group, six of 12 dogs developed clinical signs after the negative challenge, and two of nine dogs developed clinical signs after the positive challenge. It was concluded that the ELISA test for dietary allergen-specific IgG is of limited value in the management of dogs with CAFR. Copyright © 2017 Elsevier Ltd. All rights reserved.

Outcome and clinical signs of arthroscopically graded patellar chondromalacia with or without lateral release.

PubMed

Korkala, O L; Isotalo, T M; Lavonius, M I; Niskanen, R O

1995-01-01

In a follow-up study of 67 patients with an arthroscopically diagnosed patellar chondromalacia, we compared the results of plain conservative treatment with those after an open lateral retinacular release. The mean follow-up was 35 months. In Grade I chondromalacia the lateral release did not affect the result, which was in all cases good or excellent. In Grade II to IV chondromalacia the lateral release appeared beneficial, although the difference did not reach statistical significance. We also examined the validity of three clinical signs in arthroscopically verified patellar chondromalacia. Patellar inhibition and tracking tests were clearly more sensitive than the lateral apprehension test, which often gave a false negative result. If the patellar inhibition test is positive and a Grade II to IV chondromalacia of the patella is found at arthroscopy, lateral release should be considered among other procedures, like patellar shaving or patellar resurfacing.

Adverse events in British hospitals: preliminary retrospective record review

PubMed Central

Vincent, Charles; Neale, Graham; Woloshynowych, Maria

2001-01-01

Objectives To examine the feasibility of detecting adverse events through record review in British hospitals and to make preliminary estimates of the incidence and costs of adverse events. Design Retrospective review of 1014 medical and nursing records. Setting Two acute hospitals in Greater London area. Main outcome measure Number of adverse events. Results 110 (10.8%) patients experienced an adverse event, with an overall rate of adverse events of 11.7% when multiple adverse events were included. About half of these events were judged preventable with ordinary standards of care. A third of adverse events led to moderate or greater disability or death. Conclusions These results suggest that adverse events are a serious source of harm to patients and a large drain on NHS resources. Some are major events; others are frequent, minor events that go unnoticed in routine clinical care but together have massive economic consequences. PMID:11230064

Adverse Effects of Plasma Transfusion

PubMed Central

Pandey, Suchitra; Vyas, Girish N.

2012-01-01

Plasma utilization has increased over the last two decades, and there is a growing concern that many plasma transfusions are inappropriate. Plasma transfusion is not without risk, and certain complications are more likely with plasma than other blood components. Clinical and laboratory investigations of the patients suffering reactions following infusion of fresh frozen plasma (FFP) define the etiology and pathogenesis of the panoply of adverse effects. We review here the pathogenesis, diagnosis, and management of the risks associated with plasma transfusion. Risks commonly associated with FFP include: (1) transfusion related acute lung injury; (2) transfusion associated circulatory overload, and (3) allergic/anaphylactic reactions. Other less common risks include (1) transmission of infections, (2) febrile non-hemolytic transfusion reactions, (3) RBC allo-immunization, and (4) hemolytic transfusion reactions. The affect of pathogen inactivation/reduction methods on these risks are also discussed. Fortunately, a majority of the adverse effects are not lethal and are adequately treated in clinical practice. PMID:22578374

Adverse health effects of non-medical cannabis use.

PubMed

Hall, Wayne; Degenhardt, Louisa

2009-10-17

For over two decades, cannabis, commonly known as marijuana, has been the most widely used illicit drug by young people in high-income countries, and has recently become popular on a global scale. Epidemiological research during the past 10 years suggests that regular use of cannabis during adolescence and into adulthood can have adverse effects. Epidemiological, clinical, and laboratory studies have established an association between cannabis use and adverse outcomes. We focus on adverse health effects of greatest potential public health interest-that is, those that are most likely to occur and to affect a large number of cannabis users. The most probable adverse effects include a dependence syndrome, increased risk of motor vehicle crashes, impaired respiratory function, cardiovascular disease, and adverse effects of regular use on adolescent psychosocial development and mental health.

Are adverse effects incorporated in economic models? An initial review of current practice.

PubMed

Craig, D; McDaid, C; Fonseca, T; Stock, C; Duffy, S; Woolacott, N

2009-12-01

To identify methodological research on the incorporation of adverse effects in economic models and to review current practice. Major electronic databases (Cochrane Methodology Register, Health Economic Evaluations Database, NHS Economic Evaluation Database, EconLit, EMBASE, Health Management Information Consortium, IDEAS, MEDLINE and Science Citation Index) were searched from inception to September 2007. Health technology assessment (HTA) reports commissioned by the National Institute for Health Research (NIHR) HTA programme and published between 2004 and 2007 were also reviewed. The reviews of methodological research on the inclusion of adverse effects in decision models and of current practice were carried out according to standard methods. Data were summarised in a narrative synthesis. Of the 719 potentially relevant references in the methodological research review, five met the inclusion criteria; however, they contained little information of direct relevance to the incorporation of adverse effects in models. Of the 194 HTA monographs published from 2004 to 2007, 80 were reviewed, covering a range of research and therapeutic areas. In total, 85% of the reports included adverse effects in the clinical effectiveness review and 54% of the decision models included adverse effects in the model; 49% included adverse effects in the clinical review and model. The link between adverse effects in the clinical review and model was generally weak; only 3/80 (< 4%) used the results of a meta-analysis from the systematic review of clinical effectiveness and none used only data from the review without further manipulation. Of the models including adverse effects, 67% used a clinical adverse effects parameter, 79% used a cost of adverse effects parameter, 86% used one of these and 60% used both. Most models (83%) used utilities, but only two (2.5%) used solely utilities to incorporate adverse effects and were explicit that the utility captured relevant adverse effects; 53% of

Adverse Effects of Electronic Cigarette Use: A Concept Mapping Approach

PubMed Central

Nasim, Aashir; Rosas, Scott

2016-01-01

Abstract Introduction: Electronic cigarette (ECIG) use has grown rapidly in popularity within a short period of time. As ECIG products continue to evolve and more individuals begin using ECIGs, it is important to understand the potential adverse effects that are associated with ECIG use. The purpose of this study was to examine and describe the acute adverse effects associated with ECIG use. Methods: This study used an integrated, mixed-method participatory approach called concept mapping (CM). Experienced ECIG users ( n = 85) provided statements that answered the focus prompt “A specific negative or unpleasant effect (ie, physical or psychological) that I have experienced either during or immediately after using an electronic cigarette device is…” in an online program. Participants sorted these statements into piles of common themes and rated each statement. Using multidimensional scaling and hierarchical cluster analysis, a concept map of the adverse effects statements was created. Results: Participants generated 79 statements that completed the focus prompt and were retained by researchers. Analysis generated a map containing five clusters that characterized perceived adverse effects of ECIG use: Stigma, Worry/Guilt, Addiction Signs, Physical Effects, and Device/Vapor Problems. Conclusions: ECIG use is associated with adverse effects that should be monitored as ECIGs continue to grow in popularity. If ECIGs are to be regulated, policies should be created that minimize the likelihood of user identified adverse effects. Implications: This article provides a list of adverse effects reported by experienced ECIG users. This article organizes these effects into a conceptual model that may be useful for better understanding the adverse outcomes associated with ECIG use. These identified adverse effects may be useful for health professionals and policy makers. Health professionals should be aware of potential negative health effects that may be associated with

The theoretical and practical determination of clinical cut-offs for the British Sign Language versions of PHQ-9 and GAD-7.

PubMed

Belk, Rachel A; Pilling, Mark; Rogers, Katherine D; Lovell, Karina; Young, Alys

2016-11-03

The PHQ-9 and the GAD-7 assess depression and anxiety respectively. There are standardised, reliability-tested versions in BSL (British Sign Language) that are used with Deaf users of the IAPT service. The aim of this study is to determine their appropriate clinical cut-offs when used with Deaf people who sign and to examine the operating characteristics for PHQ-9 BSL and GAD-7 BSL with a clinical Deaf population. Two datasets were compared: (i) dataset (n = 502) from a specialist IAPT service for Deaf people; and (ii) dataset (n = 85) from our existing study of Deaf people who self-reported having no mental health difficulties. Parameter estimates, with the precision of AUC value, sensitivity, specificity, positive predicted value (ppv) and negative predicted value (npv), were carried out to provide the details of the clinical cut-offs. Three statistical choices were included: Maximising (Youden: maximising sensitivity + specificity), Equalising (Sensitivity = Specificity) and Prioritising treatment (False Negative twice as bad as False Positive). Standard measures (as defined by IAPT) were applied to examine caseness, recovery, reliable change and reliable recovery for the first dataset. The clinical cut-offs for PHQ-9 BSL and GAD-7 BSL are 8 and 6 respectively. This compares with the original English version cut-offs in the hearing population of 10 and 8 respectively. The three different statistical choices for calculating clinical cut-offs all showed a lower clinical cut-off for the Deaf population with respect to the PHQ-9 BSL and GAD-7 BSL with the exception of the Maximising criteria when used with the PHQ-9 BSL. Applying the new clinical cut-offs, the percentage of Deaf BSL IAPT service users showing reliable recovery is 54.0 % compared to 63.7 % using the cut-off scores used for English speaking hearing people. These compare favourably with national IAPT data for the general population. The correct clinical cut-offs for the PHQ-9 BSL and

Warning Signs.

ERIC Educational Resources Information Center

Our Children, 1999

1999-01-01

Presents various signs that may indicate emotional problems in children or teens, noting that if children exhibit any of the warning signs, it is important to talk to a doctor, counselor, or mental-health professional. The warning signs are categorized as things that trouble the child, things that limit the child, behavior problems, and sudden…

Vital signs monitoring to detect patient deterioration: An integrative literature review.

PubMed

Mok, Wen Qi; Wang, Wenru; Liaw, Sok Ying

2015-05-01

Vital signs monitoring is an important nursing assessment. Yet, nurses seem to be doing it as part of a routine and often overlooking their significance in detecting patient deterioration. An integrative literature review was conducted to explore factors surrounding ward nursing practice of vital signs monitoring in detecting and reporting deterioration. Twenty papers were included. The structural component of a Nursing Role Effectiveness Model framework, which comprises of patient, nurse and organizational variables, was used to synthesize the review. Patient variables include signs of deterioration displayed by patients which include physical cues and abnormal vital signs. Nursing variables include clinical knowledge, roles and responsibilities, and reporting of deteriorating vital signs. Organizational variables include heavy workload, technology, and observation chart design. This review has highlighted current nursing practice in vital signs monitoring. A myriad of factors were found to surround ward practice of vital signs monitoring in detecting and reporting deterioration. © 2015 Wiley Publishing Asia Pty Ltd.

Can we improve the clinical utility of respiratory rate as a monitored vital sign?

PubMed

Chen, Liangyou; Reisner, Andrew T; Gribok, Andrei; McKenna, Thomas M; Reifman, Jaques

2009-06-01

Respiratory rate (RR) is a basic vital sign, measured and monitored throughout a wide spectrum of health care settings, although RR is historically difficult to measure in a reliable fashion. We explore an automated method that computes RR only during intervals of clean, regular, and consistent respiration and investigate its diagnostic use in a retrospective analysis of prehospital trauma casualties. At least 5 s of basic vital signs, including heart rate, RR, and systolic, diastolic, and mean arterial blood pressures, were continuously collected from 326 spontaneously breathing trauma casualties during helicopter transport to a level I trauma center. "Reliable" RR data were identified retrospectively using automated algorithms. The diagnostic performances of reliable versus standard RR were evaluated by calculation of the receiver operating characteristic curves using the maximum-likelihood method and comparison of the summary areas under the receiver operating characteristic curves (AUCs). Respiratory rate shows significant data-reliability differences. For identifying prehospital casualties who subsequently receive a respiratory intervention (hospital intubation or tube thoracotomy), standard RR yields an AUC of 0.59 (95% confidence interval, 0.48-0.69), whereas reliable RR yields an AUC of 0.67 (0.57-0.77), P < 0.05. For identifying casualties subsequently diagnosed with a major hemorrhagic injury and requiring blood transfusion, standard RR yields an AUC of 0.60 (0.49-0.70), whereas reliable RR yields 0.77 (0.67-0.85), P < 0.001. Reliable RR, as determined by an automated algorithm, is a useful parameter for the diagnosis of respiratory pathology and major hemorrhage in a trauma population. It may be a useful input to a wide variety of clinical scores and automated decision-support algorithms.

Toxoplasma gondii infections in captive black-footed ferrets (Mustela nigripes), 1992-1998: clinical signs, serology, pathology, and prevention.

PubMed

Burns, Roy; Williams, Elizabeth S; O'Toole, Donal; Dubey, J P

2003-10-01

An epizootic of toxoplasmosis occurred among 22 adult and 30 kit black-footed ferrets (Mustela nigripes) maintained under quarantine conditions at the Louisville Zoological Garden (Louisville, Kentucky, USA) in June, 1992. Black-footed ferrets appear to be highly susceptible to acute and chronic toxoplasmosis. Clinical signs were observed in 19 adults and six kits and included anorexia, lethargy, corneal edema, and ataxia. Two adults and six kits died with acute disease. High antibody titers to Toxoplasma gondii were detected by latex agglutination and modified agglutination assay in 10 black-footed ferrets. One adult and six kits that died with acute clinical signs were necropsied and T. gondii-like organisms were found microscopically in multiple organs. Diagnosis of toxoplasmosis was confirmed by immunohistochemical staining with anti-T. gondii antibodies and by ultrastructural examination. Although the source of T. gondii for black-footed ferrets was not identified, frozen uncooked rabbit was the most likely source. Chronic toxoplasmosis resulted in the death of at additional 13 black-footed ferrets that were adults during the epizootic. Affected animals developed chronic progressive posterior weakness and posterior ataxia 6-69 mo after the epizootic began. Meningoencephalitis or meningoencephalomyelitis associated with chronic toxoplasmosis were identified at necropsy in all 13 ferrets. Precautions to prevent introduction of pathogens into the colony were insufficient to exclude T. gondii. Although toxoplasmosis may cause significant mortality in mustelids, the high mortality of black-footed ferrets in this epizootic was of concern due to their endangered status. This is the first detailed report of toxoplasmosis in black-footed ferrets.

An open, self-controlled study on the efficacy of topical indoxacarb for eliminating fleas and clinical signs of flea-allergy dermatitis in client-owned dogs in Queensland, Australia.

PubMed

Fisara, Petr; Sargent, Roger M; Shipstone, Michael; von Berky, Andrew; von Berky, Janet

2014-06-01

Canine flea-allergy dermatitis (FAD), a hypersensitivity response to antigenic material in the saliva of feeding fleas, occurs worldwide and remains a common presentation in companion animal veterinary practice despite widespread availability of effective systemic and topical flea-control products. To evaluate the clinical response in dogs with FAD treated topically with indoxacarb, a novel oxadiazine insecticide. Twenty-five client-owned dogs in Queensland, Australia diagnosed with pre-existing FAD on the basis of clinical signs, flea-antigen intradermal and serological tests. An open-label, noncontrolled study, in which all dogs were treated with topical indoxacarb at 4 week intervals, three times over 12 weeks. Twenty-four dogs completed the study. Complete resolution of clinical signs of FAD was observed in 21 cases (87.5%), with nearly complete resolution or marked improvement in the remaining three cases. Mean clinical scores (Canine Atopic Dermatitis Extent and Severity Index-03) were reduced by 93.3% at week 12. Mean owner-assessed pruritus scores were reduced by 88% by week 12. Mean flea counts reduced by 98.7 and 100% in weeks 8 and 12, respectively. Topical indoxacarb treatment applied every 4 weeks for 12 weeks, without concomitant antipruritic or ectoparasiticide therapy, completely alleviated flea infestations in all dogs and associated clinical signs of FAD in a high proportion of this population of dogs in a challenging flea-infestation environment. © 2014 The Authors. Veterinary Dermatology published by John Wiley & Sons Ltd on behalf of the ESVD and the ACVD.

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

PubMed

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

2015-12-01

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

Development of a prehospital vital signs chart sharing system.

PubMed

Nakada, Taka-aki; Masunaga, Naohisa; Nakao, Shota; Narita, Maiko; Fuse, Takashi; Watanabe, Hiroaki; Mizushima, Yasuaki; Matsuoka, Tetsuya

2016-01-01

Physiological parameters are crucial for the caring of trauma patients. There is a significant loss of prehospital vital signs data of patients during handover between prehospital and in-hospital teams. Effective strategies for reducing the loss remain a challenging research area. We tested whether the newly developed electronic automated prehospital vital signs chart sharing system would increase the amount of prehospital vital signs data shared with a remote trauma center prior to hospital arrival. Fifty trauma patients, transferred to a level I trauma center in Japan, were studied. The primary outcome variable was the number of prehospital vital signs shared with the trauma center prior to hospital arrival. The prehospital vital signs chart sharing system significantly increased the number of prehospital vital signs, including blood pressure, heart rate, and oxygen saturation, shared with the in-hospital team at a remote trauma center prior to patient arrival at the hospital (P < .0001). There were significant differences in prehospital vital signs during ambulance transfer between patients who had severe bleeding and non-severe bleeding within 24 hours after injury onset. Vital signs data collected during ambulance transfer via patient monitors could be automatically converted to easily visible patient charts and effectively shared with the remote trauma center prior to hospital arrival. The prehospital vital signs chart sharing system increased the number of precise vital signs shared prior to patient arrival at the hospital, which can potentially contribute to better trauma care without increasing labor and reduce information loss during clinical handover. Copyright © 2015 Elsevier Inc. All rights reserved.

Home telemonitoring of vital signs--technical challenges and future directions.

PubMed

Celler, Branko G; Sparks, Ross S

2015-01-01

The telemonitoring of vital signs from the home is an essential element of telehealth services for the management of patients with chronic conditions, such as congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes, or poorly controlled hypertension. Telehealth is now being deployed widely in both rural and urban settings, and in this paper, we discuss the contribution made by biomedical instrumentation, user interfaces, and automated risk stratification algorithms in developing a clinical diagnostic quality longitudinal health record at home. We identify technical challenges in the acquisition of high-quality biometric signals from unsupervised patients at home, identify new technical solutions and user interfaces, and propose new measurement modalities and signal processing techniques for increasing the quality and value of vital signs monitoring at home. We also discuss use of vital signs data for the automated risk stratification of patients, so that clinical resources can be targeted to those most at risk of unscheduled admission to hospital. New research is also proposed to integrate primary care, hospital, personal genomic, and telehealth electronic health records, and apply predictive analytics and data mining for enhancing clinical decision support.

The Diagnostic Value of the Clarke Sign in Assessing Chondromalacia Patella

PubMed Central

Doberstein, Scott T; Romeyn, Richard L; Reineke, David M

2008-01-01

Context: Various techniques have been described for assessing conditions that cause pain at the patellofemoral (PF) joint. The Clarke sign is one such test, but the diagnostic value of this test in assessing chondromalacia patella is unknown. Objective: To (1) investigate the diagnostic value of the Clarke sign in assessing the presence of chondromalacia patella using arthroscopic examination of the PF joint as the “gold standard,” and (2) provide a historical perspective of the Clarke sign as a clinical diagnostic test. Design: Validation study. Setting: All patients of one of the investigators who had knee pain or injuries unrelated to the patellofemoral joint and were scheduled for arthroscopic surgery were recruited for this study. Patients or Other Participants: A total of 106 otherwise healthy individuals with no history of patellofemoral pain or dysfunction volunteered. Main Outcome Measure(s): The Clarke sign was performed on the surgical knee by a single investigator in the clinic before surgery. A positive test was indicated by the presence of pain sufficient to prevent the patient from maintaining a quadriceps muscle contraction against manual resistance for longer than 2 seconds. The preoperative result was compared with visual evidence of chondromalacia patella during arthroscopy. Results: Sensitivity was 0.39, specificity was 0.67, likelihood ratio for a positive test was 1.18, likelihood ratio for a negative test was 0.91, positive predictive value was 0.25, and negative predictive value was 0.80. Conclusions: Diagnostic validity values for the use of the Clarke sign in assessing chondromalacia patella were unsatisfactory, supporting suggestions that it has poor diagnostic value as a clinical examination technique. Additionally, an extensive search of the available literature for the Clarke sign reveals multiple problems with the test, causing significant confusion for clinicians. Therefore, the use of the Clarke sign as a routine part of a knee

Infection by rhinovirus: similarity of clinical signs included in the case definition of influenza IAn/H1N1.

PubMed

de Oña Navarro, Maria; Melón García, Santiago; Alvarez-Argüelles, Marta; Fernández-Verdugo, Ana; Boga Riveiro, Jose Antonio

2012-08-01

Although new influenza virus (IAn/H1N1) infections are mild and indistinguishable from any other seasonal influenza virus infections, there are few data on comparisons of the clinical features of infection with (IAn/H1N1) and with other respiratory viruses. The incidence, clinical aspects and temporal distribution of those respiratory viruses circulating during flu pandemic period were studied. Respiratory samples from patients with acute influenza-like symptoms were collected from May 2009 to December 2009. Respiratory viruses were detected by conventional culture methods and genome amplification techniques. Although IAn/H1N1 was the virus most frequently detected, several other respiratory viruses co-circulated with IAn/H1N1 during the pandemic period, especially rhinovirus. The similarity between clinical signs included in the clinical case definition for influenza and those caused by other respiratory viruses, particularly rhinovirus, suggest that a high percentage of viral infections were clinically diagnosed as case of influenza. Our study offers useful information to face future pandemics caused by influenza virus, indicating that differential diagnoses are required in order to not overestimate the importance of the pandemic. Copyright © 2011 Elsevier España, S.L. All rights reserved.

A new multivalent (DHPPi/L4R) canine combination vaccine prevents infection, shedding and clinical signs following experimental challenge with four Leptospira serovars.

PubMed

Wilson, Stephen; Stirling, Catrina; Thomas, Anne; King, Vickie; Plevová, Edita; Chromá, Ludmila; Siedek, Elisabeth; Illambas, Joanna; Salt, Jeremy; Sture, Gordon

2013-06-28

Although effective vaccines have been developed against the common Leptospira serovars, they are still reported in clinical cases, while others are increasingly prevalent. The results from four challenge studies following vaccination of dogs with a new combination vaccine (DHPPi/L4R) containing inactivated L. serovars, L. canicola, L. icterohaemorrhagiae, L. bratislava and L. grippotyphosa conducted to satisfy the requirements of the European Pharmacopoeia monograph (01/2008:0447), are reported. Six week old dogs received two vaccinations, three weeks apart, and were challenged 25 days later with different isolates of the L. serovars. Clinical observations were recorded, and blood, urine and tissue samples were collected for analysis. Following challenge, non-vaccinated dogs demonstrated various clinical signs, while no vaccinated dogs were affected; significant differences in mean clinical scores were observed. Measurable antibody titres to each Leptospira antigen were seen in vaccinated dogs 21 days following the first vaccination, with further increases in antibody titres observed following challenge with the respective Leptospira strain. Non-vaccinated dogs remained seronegative until challenge. Leptospira were re-isolated from the blood, urine, kidney and liver of all non-vaccinated dogs following challenge. In contrast no vaccinated dogs had Leptospira re-isolated from the same tissues. Significant differences were seen in number of days with positive isolation (blood and urine) and in number of dogs with positive samples (kidney and liver). In conclusion, vaccination of dogs with the new vaccine induces protective immunity 25 days after second vaccination with protection against infection, renal infection and clinical signs following challenge. Copyright © 2013 Elsevier Ltd. All rights reserved.

French national survey of inpatient adverse events prospectively assessed with ward staff.

PubMed

Michel, Philippe; Quenon, Jean Luc; Djihoud, Ahmed; Tricaud-Vialle, Sophie; de Sarasqueta, Anne Marie

2007-10-01

To estimate the incidence of adverse events in medical and surgical activity in public and private hospitals, and to assess the clinical situation of patients and the active errors. Prospective assessment of adverse events by external senior nursing and doctor investigators with ward staff. Random three-stage stratified cluster sampling of stays or fractions of stay in a 7-day observation period for each ward. 8754 patients observed in 292 wards in 71 hospitals, over 35,234 hospitalisation days. Number of adverse events in relation to number of days of hospitalisation. The incidence density of adverse events was 6.6 per 1000 days of hospitalisation (95% CI 5.7 to 7.5), of which 35% were preventable. Invasive procedures were the source of half the adverse events, of which 20% were preventable. Adverse events related to the psychological sphere and pain were mostly considered as preventable. Ward staff found it difficult to assess the role of care management in the occurrence of adverse events: 41% of adverse events were expected because of the disease itself, and could have occurred in the absence of the related medical management. At the national level in France, every year 120,000-190,000 adverse events during hospitalisation can be considered as preventable. Areas such as perioperative period and geriatric units should receive closer attention. As adverse events occurred more commonly in vulnerable patients, who are not specifically targeted by clinical guidance, practising evidence-based medicine is not likely to prevent all cases. Therefore clinical risk management should prioritize empowerment of local staff, provision of favourable conditions within the organisation, and staff training based on simple tools appropriate for ward-level identification and analysis of adverse events.

Images in pediatrics: the thymic sail sign and thymic wave sign.

PubMed

Alves, Nuno D; Sousa, Marta

2013-01-01

The authors present a radiographic image portraying the "thymic sail sign" and the "thymic wave sign," both normal findings in infant radiographs and present a short description of these signs. These are distinguished from pathologic findings such as the "spinnaker-sail sign" in pneumomediastinum.

Adverse childhood experiences in substance use disorder outpatients of a Lebanese addiction center.

PubMed

Naal, Hady; El Jalkh, Tatiana; Haddad, Ramzi

2018-05-02

Childhood adversities (CAs) are well reviewed in mental health and addiction research internationally. However, these variables have not been studied within the framework of addiction in the Middle East region. The present study reports the prevalence of Childhood Adversities in a sample of outpatients seeking treatment for Substance Use Disorder. We used the Adverse Childhood Experiences - International Questionnaire (ACE-IQ) to map out the prevalence of childhood adversities. The studied population was composed of a clinical outpatient sample that met criteria for substance use disorder (N = 144). Results indicated that almost all the sample reported having experienced at least 1 CA, whereby three quarters of the clinical sample reported experiencing 6 or more adversities. Childhood adversities are highly prevalent in a Lebanese substance use disorder population which raises the need for better screening strategies and more understanding of Adverse Childhood Experiences in this specific population.

Assignment of adverse event indexing terms in randomized clinical trials involving spinal manipulative therapy: an audit of records in MEDLINE and EMBASE databases.

PubMed

Gorrell, Lindsay M; Engel, Roger M; Lystad, Reidar P; Brown, Benjamin T

2017-03-14

Reporting of adverse events in randomized clinical trials (RCTs) is encouraged by the authors of The Consolidated Standards of Reporting Trials (CONSORT) statement. With robust methodological design and adequate reporting, RCTs have the potential to provide useful evidence on the incidence of adverse events associated with spinal manipulative therapy (SMT). During a previous investigation, it became apparent that comprehensive search strategies combining text words with indexing terms was not sufficiently sensitive for retrieving records that were known to contain reports on adverse events. The aim of this analysis was to compare the proportion of articles containing data on adverse events associated with SMT that were indexed in MEDLINE and/or EMBASE and the proportion of those that included adverse event-related words in their title or abstract. A sample of 140 RCT articles previously identified as containing data on adverse events associated with SMT was used. Articles were checked to determine if: (1) they had been indexed with relevant terms describing adverse events in the MEDLINE and EMBASE databases; and (2) they mentioned adverse events (or any related terms) in the title or abstract. Of the 140 papers, 91% were MEDLINE records, 85% were EMBASE records, 81% were found in both MEDLINE and EMBASE records, and 4% were not in either database. Only 19% mentioned adverse event-related text words in the title or abstract. There was no significant difference between MEDLINE and EMBASE records in the proportion of available papers (p = 0.078). Of the 113 papers that were found in both MEDLINE and EMBASE records, only 3% had adverse event-related indexing terms assigned to them in both databases, while 81% were not assigned an adverse event-related indexing term in either database. While there was effective indexing of RCTs involving SMT in the MEDLINE and EMBASE databases, there was a failure of allocation of adverse event indexing terms in both databases. We

Sign language in dental education-A new nexus.

PubMed

Jones, T; Cumberbatch, K

2017-08-14

The introduction of the landmark mandatory teaching of sign language to undergraduate dental students at the University of the West Indies (UWI), Mona Campus in Kingston, Jamaica, to bridge the communication gap between dentists and their patients is reviewed. A review of over 90 Doctor of Dental Surgery and Doctor of Dental Medicine curricula in North America, the United Kingdom, parts of Europe and Australia showed no inclusion of sign language in those curricula as a mandatory component. In Jamaica, the government's training school for dental auxiliaries served as the forerunner to the UWI's introduction of formal training of sign language in 2012. Outside of the UWI, a couple of dental schools have sign language courses, but none have a mandatory programme as the one at the UWI. Dentists the world over have had to rely on interpreters to sign with their deaf patients. The deaf in Jamaica have not appreciated the fact that dentists cannot sign and they have felt insulted and only go to the dentist in emergency situations. The mandatory inclusion of sign language in the Undergraduate Dental Programme curriculum at The University of the West Indies, Mona Campus, sought to establish a direct communication channel to formally bridge this gap. The programme of two sign language courses and a direct clinical competency requirement was developed during the second year of the first cohort of the newly introduced undergraduate dental programme through a collaborating partnership between two faculties on the Mona Campus. The programme was introduced in 2012 in the third year of the 5-year undergraduate dental programme. To date, two cohorts have completed the programme, and the preliminary findings from an ongoing clinical study have shown a positive impact on dental care access and dental treatment for deaf patients at the UWI Mona Dental Polyclinic. The development of a direct communication channel between dental students and the deaf that has led to increased dental

Validity and reliability of a novel immunosuppressive adverse effects scoring system in renal transplant recipients.

PubMed

Meaney, Calvin J; Arabi, Ziad; Venuto, Rocco C; Consiglio, Joseph D; Wilding, Gregory E; Tornatore, Kathleen M

2014-06-12

After renal transplantation, many patients experience adverse effects from maintenance immunosuppressive drugs. When these adverse effects occur, patient adherence with immunosuppression may be reduced and impact allograft survival. If these adverse effects could be prospectively monitored in an objective manner and possibly prevented, adherence to immunosuppressive regimens could be optimized and allograft survival improved. Prospective, standardized clinical approaches to assess immunosuppressive adverse effects by health care providers are limited. Therefore, we developed and evaluated the application, reliability and validity of a novel adverse effects scoring system in renal transplant recipients receiving calcineurin inhibitor (cyclosporine or tacrolimus) and mycophenolic acid based immunosuppressive therapy. The scoring system included 18 non-renal adverse effects organized into gastrointestinal, central nervous system and aesthetic domains developed by a multidisciplinary physician group. Nephrologists employed this standardized adverse effect evaluation in stable renal transplant patients using physical exam, review of systems, recent laboratory results, and medication adherence assessment during a clinic visit. Stable renal transplant recipients in two clinical studies were evaluated and received immunosuppressive regimens comprised of either cyclosporine or tacrolimus with mycophenolic acid. Face, content, and construct validity were assessed to document these adverse effect evaluations. Inter-rater reliability was determined using the Kappa statistic and intra-class correlation. A total of 58 renal transplant recipients were assessed using the adverse effects scoring system confirming face validity. Nephrologists (subject matter experts) rated the 18 adverse effects as: 3.1 ± 0.75 out of 4 (maximum) regarding clinical importance to verify content validity. The adverse effects scoring system distinguished 1.75-fold increased gastrointestinal adverse

Physical signs of dehydration in the elderly.

PubMed

Shimizu, Miyuki; Kinoshita, Kensuke; Hattori, Kazuya; Ota, Yoshio; Kanai, Takao; Kobayashi, Hiroyuki; Tokuda, Yasuharu

2012-01-01

Dehydration is a common condition and frequent cause of hospitalization in older people, despite the caregiver's high attention in attempt to avoid its occurrence. In this study, various physical signs were examined as clinical signs of dehydration in elderly. A prospective observational study was conducted in an acute care teaching hospital. Consecutive elderly patients who were admitted to the Department of Medicine were evaluated. Dehydration was defined as a calculated serum osmolality above 295 mOsm/L. The patients diagnosed as dehydrated or not dehydrated were observed for physical signs of dehydration. Data of blood and urine chemistry analysis were also compared between the two groups. A total of 27 elderly patients admitted with acute medical conditions were included in this study. For the physical signs, dry axilla had moderate sensitivity (44%) and excellent specificity (89%) to detect dehydration. Sunken eyes and delayed capillary refill time also showed relatively good specificity (83%). For laboratory data, the mean concentrations of serum sodium of the dehydrated group (146 mEq/L) was significantly higher (p<0.01) than those of the non-dehydrated group (134 mEq/L). Physical signs of dehydration in elderly showed relatively good specificity but poor sensitivity. The evaluation of the axillary moisture could help assess dehydration as well as laboratory data analysis such as serum sodium concentration.

Communication failures in patient sign-out and suggestions for improvement: a critical incident analysis.

PubMed

Arora, V; Johnson, J; Lovinger, D; Humphrey, H J; Meltzer, D O

2005-12-01

The transfer of care for hospitalized patients between inpatient physicians is routinely mediated through written and verbal communication or "sign-out". This study aims to describe how communication failures during this process can lead to patient harm. In interviews employing critical incident technique, first year resident physicians (interns) described (1) any adverse events or near misses due to suboptimal preceding patient sign-out; (2) the worst event due to suboptimal sign-out in which they were involved; and (3) suggestions to improve sign-out. All data were analyzed and categorized using the constant comparative method with independent review by three researchers. Twenty six interns caring for 82 patients were interviewed after receiving sign-out from another intern. Twenty five discrete incidents, all the result of communication failures during the preceding patient sign-out, and 21 worst events were described. Inter-rater agreement for categorization was high (kappa 0.78-1.00). Omitted content (such as medications, active problems, pending tests) or failure-prone communication processes (such as lack of face-to-face discussion) emerged as major categories of failed communication. In nearly all cases these failures led to uncertainty during decisions on patient care. Uncertainty may result in inefficient or suboptimal care such as repeat or unnecessary tests. Interns desired thorough but relevant face-to-face verbal sign-outs that reviewed anticipated issues. They preferred legible, accurate, updated, written sign-out sheets that included standard patient content such as code status or active and anticipated medical problems. Communication failures during sign-out often lead to uncertainty in decisions on patient care. These may result in inefficient or suboptimal care leading to patient harm.

Spatial and Facial Processing in the Signed Discourse of Two Groups of Deaf Signers with Clinical Language Impairment

ERIC Educational Resources Information Center

Penn, Claire; Commerford, Ann; Ogilvy, Dale

2007-01-01

The linguistic and cognitive profiles of five deaf adults with a sign language disorder were compared with those of matched deaf controls. The test involved a battery of sign language tests, a signed narrative discourse task and a neuropsychological test protocol administered in sign language. Spatial syntax and facial processing were examined in…

Sildenafil improves clinical signs and radiographic features in dogs with congenital idiopathic megaoesophagus: a randomised controlled trial.

PubMed

Quintavalla, F; Menozzi, A; Pozzoli, C; Poli, E; Donati, P; Wyler, D K; Serventi, P; Bertini, S

2017-04-22

We evaluated the efficacy of oral sildenafil citrate in dogs with congenital idiopathic megaoesophagus (CIM). Twenty-one puppies were randomly assigned to two groups (treatment and control). The dogs were given sildenafil oral suspension 1 mg/kg every 12 hours for 14 days or placebo in a masked fashion. Clinical signs (frequency of regurgitation and weight gain) and oesophagrams (relative oesophageal diameter, ROD) were evaluated in order to assess the efficacy of drug treatment, by examiners who were unaware of the study protocol. In addition, a set of in vitro experiments on isolated samples of canine lower oesophageal sphincter (LOS) was performed, and the effects of increasing concentrations of sildenafil on basal tone and electrically-stimulated motility were assessed. Sildenafil administration significantly reduced the number of regurgitation episodes (0.88±1.40 v 2.65±1.56, P<0.0001) and significantly increased weight gain in the treated dogs compared to controls (79.76±28.30 per cent v 53.40±19.30 per cent, P=0.034). ROD values, at the end of the treatment period, were significantly decreased in the sildenafil group, compared to pre-treatment values (0.97±0.19 v 0.24±0.14, P<0.0001), in contrast to control subjects (0.98±0.17 v 1.10±0.25, P=0.480). In accordance with the in vivo findings, sildenafil dose-dependently reduced basal tone and increased electrically-induced relaxation of dog LOS samples. These results suggest that sildenafil citrate helps ameliorate clinical and radiographic signs in dogs with CIM by reducing LOS tone, and could represent a novel therapeutic tool for the treatment of this disease. British Veterinary Association.

Pulvinar sign in a case of anti-HU paraneoplastic encephalitis

PubMed Central

Gagnon, Maude-Marie; Savard, Martin; Émond, François

2016-01-01

This article reports the case of a 68-year-old patient with anti-HU antibodies paraneoplastic encephalitis. The clinical manifestations were atypical and the paraclinical work-up, notably the magnetic resonance imaging (MRI) showing bilateral posterior thalamic hyperintensities (pulvinar sign), misleadingly pointed towards a variant Creutzfeld–Jakob disease. After presenting the case, the differential diagnosis of the pulvinar sign is discussed along with other important diagnostic considerations. PMID:27558994

The rope sign: a case of interstitial granulomatous dermatitis with arthritis.

PubMed

Savoia, Francesco; Stinchi, Caterina; Gaddoni, Giuseppe; Patrizi, Annalisa; Odorici, Giulia; Tengattini, Vera; Cataleta, Pierluigi; Zago, Silvia

2016-02-01

Interstitial granulomatous dermatitis with arthritis (IGDA), also known as Ackerman's syndrome, is a rare cutaneous disease classically characterized by the triad of cutaneous cords, a typical histologic infiltrate mainly constituted by histiocytes and arthritis/connective tissue disease. Here we report the case of IGDA with the typical clinical and histological features in a patient affected by lupus erythematosus. In this article we underline that IGDA may have a variety of different clinical and histological features. The rope sign is typical but infrequent, while histology is usually characteristic and shows a dermal inflammatory infiltrate, with a predominance of histiocytes, localized interstitially and in a palisaded array between collagen fibres, that show signs of degeneration. Clinical and histological differential diagnoses are discussed.

Extravasation of contrast (Spot Sign) predicts in-hospital mortality in ruptured arteriovenous malformation.

PubMed

Ye, Zengpanpan; Ai, Xiaolin; Zheng, Jun; Hu, Xin; You, Chao; Andrew M, Faramand; Fang, Fang

2017-10-09

The spot sign is a highly specific and sensitive predictor of hematoma expansion in following primary intracerebral hemorrhage (ICH). Rare cases of the spot sign have been documented in patients with intracranial hemorrhage secondary to arteriovenous malformation (AVM). The purpose of this retrospective study is to assess the accuracy of spot sign in predicting clinical outcomes in patients with ruptured AVM. A retrospective analysis of a prospectively maintained database was performed for patients who presented to West China Hospital with ICH secondary to AVM in the period between January 2009 and September 2016. Two radiologists blinded to the clinical data independently assessed the imaging data, including the presence of spot sign. Statistical analysis using univariate testing, multivariate logistic regression testing, and receiver operating characteristic curve (AUC) analysis was performed. A total of 116 patients were included. Overall, 18.9% (22/116) of subjects had at least 1 spot sign detected by CT angiography, 7% (8/116) died in hospital, and 27% (31/116) of the patients had a poor outcome after 90 days. The spot sign had a sensitivity of 62.5% and specificity of 84.3% for predicting in-hospital mortality (p = .02, AUC 0.734). No correlation detected between the spot sign and 90-day outcomes under multiple logistic regression (p = .19). The spot sign is an independent predictor for in-hospital mortality. The presence of spot sign did not correlate with the 90 day outcomes in this patient cohort. The results of this report suggest that patients with ruptured AVM with demonstrated the spot sign on imaging must receive aggressive treatment early on due to the high risk of mortality.

Adverse-event profile of Crataegus spp.: a systematic review.

PubMed

Daniele, Claudia; Mazzanti, Gabriela; Pittler, Max H; Ernst, Edzard

2006-01-01

Crataegus spp. (hawthorn) monopreparations are predominantly used for treating congestive heart failure. The effectiveness of hawthorn preparations (flowers with leaves; berries) is documented in a number of clinical studies, reviews and meta-analyses. The aim of this article is to assess the safety data of all available human studies on hawthorn monopreparations. Systematic searches were conducted on MEDLINE, EMBASE, AMED, The Cochrane Library, the UK National Research Register and the US ClinicalTrials.gov (up to January 2005). Data were requested from the spontaneous reporting scheme of the WHO. Hand searches were also conducted in a sample of relevant medical journals, conference proceedings, reference lists of identified articles and our own files. Eight manufacturers of hawthorn-containing preparations were contacted and asked to supply any information on adverse events or drug interactions. Data from all clinical studies and reports were assessed. Only human studies on monopreparations were included. Data from hawthorn-containing combination preparations and homeopathic preparations were excluded. All studies were read and evaluated by one reviewer and independently verified by at least one additional reviewer.Twenty-nine clinical studies were identified, of which 24 met our inclusion criteria. A total of 7311 patients were enrolled, and data from 5,577 patients were available for analysis. The daily dose and duration of treatment with hawthorn monopreparations ranged from 160 to 1,800 mg and from 3 to 24 weeks, respectively. The extracts most used in the clinical trials were WS 1,442 (extract of hawthorn standardised to 18.75% oligomeric procyanidins) and LI 132 (extract of hawthorn standardised to 2.25% flavonoids). Overall, 166 adverse events were reported. Most of these adverse events were, in general, mild to moderate; eight severe adverse events have been reported with the LI 132 extract. The most frequent adverse events were dizziness/vertigo (n = 15

Use of Warning Signs for Dengue by Pediatric Health Care Staff in Brazil.

PubMed

Sicuro Correa, Luana; Hökerberg, Yara Hahr Marques; Oliveira, Raquel de Vasconcellos Carvalhaes de; Barros, Danielle Martins de Souza; Alexandria, Helenara Abadia Ferreira; Daumas, Regina Paiva; Andrade, Carlos Augusto Ferreira de; Passos, Sonia Regina Lambert; Brasil, Patrícia

2016-01-01

The aim of this study was to describe the use of dengue warning signs by pediatric healthcare staff in the Brazilian public health care system. Cross-sectional study (2012) with physicians, nurses, and nurse technicians assisting children in five health care facilities. Participants reported the use and importance of dengue warning signs in pediatrics clinical practice through a structured questionnaire. Differences in the use of signs (chi-square test) and in the ranking assigned to each of them (Kruskal-Wallis) were assessed according to health care occupation and level of care (p<0.05). The final sample comprised 474 participants (97%), mean age of 37 years (standard deviation = 10.3), mainly females (83.8%), physicians (40.1%) and from tertiary care (75.1%). The majority (91%) reported using warning signs for dengue in pediatrics clinical practice. The most widely used and highly valued signs were major hemorrhages (gastrointestinal, urinary), abdominal pain, and increase in hematocrit concurrent or not with rapid decrease in platelet count. Persistent vomiting as well as other signs of plasma leakage such as respiratory distress and lethargy/restlessness were not identified as having the same degree of importance, especially by nurse technicians and in primary or secondary care. Although most health care staff reported using dengue warning signs, it would be useful to extend the training for identifying easily recognizable signs of plasma leakage that occur regardless of bleeding.

Use of Warning Signs for Dengue by Pediatric Health Care Staff in Brazil

PubMed Central

Hökerberg, Yara Hahr Marques; de Oliveira, Raquel de Vasconcellos Carvalhaes; Barros, Danielle Martins de Souza; Alexandria, Helenara Abadia Ferreira; Daumas, Regina Paiva; de Andrade, Carlos Augusto Ferreira; Passos, Sonia Regina Lambert; Brasil, Patrícia

2016-01-01

Objective The aim of this study was to describe the use of dengue warning signs by pediatric healthcare staff in the Brazilian public health care system. Methods Cross-sectional study (2012) with physicians, nurses, and nurse technicians assisting children in five health care facilities. Participants reported the use and importance of dengue warning signs in pediatrics clinical practice through a structured questionnaire. Differences in the use of signs (chi-square test) and in the ranking assigned to each of them (Kruskal-Wallis) were assessed according to health care occupation and level of care (p<0.05). Results The final sample comprised 474 participants (97%), mean age of 37 years (standard deviation = 10.3), mainly females (83.8%), physicians (40.1%) and from tertiary care (75.1%). The majority (91%) reported using warning signs for dengue in pediatrics clinical practice. The most widely used and highly valued signs were major hemorrhages (gastrointestinal, urinary), abdominal pain, and increase in hematocrit concurrent or not with rapid decrease in platelet count. Persistent vomiting as well as other signs of plasma leakage such as respiratory distress and lethargy/restlessness were not identified as having the same degree of importance, especially by nurse technicians and in primary or secondary care. Discussion Although most health care staff reported using dengue warning signs, it would be useful to extend the training for identifying easily recognizable signs of plasma leakage that occur regardless of bleeding. PMID:27716812

LSE-Sign: A lexical database for Spanish Sign Language.

PubMed

Gutierrez-Sigut, Eva; Costello, Brendan; Baus, Cristina; Carreiras, Manuel

2016-03-01

The LSE-Sign database is a free online tool for selecting Spanish Sign Language stimulus materials to be used in experiments. It contains 2,400 individual signs taken from a recent standardized LSE dictionary, and a further 2,700 related nonsigns. Each entry is coded for a wide range of grammatical, phonological, and articulatory information, including handshape, location, movement, and non-manual elements. The database is accessible via a graphically based search facility which is highly flexible both in terms of the search options available and the way the results are displayed. LSE-Sign is available at the following website: http://www.bcbl.eu/databases/lse/.

Study of adverse events following immunisation with universal and newer vaccines in the Serampore IMA Child Clinic over a period of 7 years.

PubMed

Das, Pradip Kumar

2013-04-01

Immunisation is an important part of childcare practice. It is one of the most beneficial and cost effective measures for the prevention of diseases. From the previous retrospective studies, it was evident that smallpox has been completely eradicated throughout now-a-days with the wholehearted and sincere efforts of healthcare providers by applying efficient and safe vaccine against smallpox, same is true also to polio which is now close to worldwide eradication and measles and rubella are no longer endemic in certain parts of the world. Not only has that with the introduction of safer and more efficient newer vaccines, the incidence of most other vaccine preventable disease of childhood also reduced considerably. The aim of the present study is to estimate the incidence and clinical presentation of adverse events following immunisation with universal and newer vaccines for a period of seven years using prospective active surveillance. Children under the age of 7 years were taken for universal and newer scheduled vaccinations given in the Serampore IMA Child Clinic under the supervision of the clinicians maintaining strictly the guidelines of Expanded Programme of Immunisation (Government of India). This study of adverse events following immunisation in the Serampore IMA Child Clinic confirms that the adverse events such as fever (0.37%), pain and swelling at the site of injection (0.32%0, urticarial rash (0.02%), anaphylactic shock (0.003%) are negligible. There were only two reports of anaphylaxis following preschool and infant schedule vaccines, including measles, mumps and rubella (MMR), Haemophilus influenzae type B vaccines and typhoid vaccines in approximately 52,000 infants received over a period of 7 years starting from 1st April, 2005 to 31st March, 2012 and there were no deaths or longterm effects reported during the post follow-up period in the Serampore IMA Child Clinic.

Emergency nurses' decisions regarding frequency and nature of vital sign assessment.

PubMed

Lambe, Katherine; Currey, Judy; Considine, Julie

2017-07-01

To explore the factors emergency nurses use to inform their decisions regarding frequency and nature of vital sign assessment. Research related to clinical deterioration and vital sign assessment in the emergency department is in its infancy. Studies to date have explored the frequency of vital sign assessment in the emergency department; however, there are no published studies that have examined factors that emergency nurses use to inform their decisions regarding frequency and nature of ongoing vital sign assessment. A prospective exploratory design was used. Data were collected using a survey consisting of eight patient vignettes. The study was conducted in one emergency department in metropolitan Melbourne. Participants were emergency nurses permanently employed at the study site. A 96% response rate was achieved (n = 47/49). The most common frequency of patient reassessment nominated by participants was 15 or 30 minutely, with an equal number of participants choosing these frequency intervals. Abnormality in initial vital sign parameters was the most common factor identified for choosing either a 15- or 30-minute assessment interval. Frequency of assessment decisions was influenced by years of emergency nursing experience in one vignette and level of postgraduate qualification in three vignettes. Heart rate, respiratory rate and blood pressure were all nominated by over 80% of participants as vital signs that participants considered important for reassessment. The frequency and nature of vital signs selected varied according to vignette content. There were significant negative correlations between assessment of conscious state and years of nursing experience and assessment of respiratory rate and years of emergency nursing experience. Level of postgraduate qualification did not influence selection of parameters for reassessment. Emergency nurses are tailoring vital sign assessment to patients' clinical status, and nurses are integrating known vital sign data

Added value of delayed computed tomography angiography in primary intracranial hemorrhage and hematoma size for predicting spot sign.

PubMed

Wu, Te Chang; Chen, Tai Yuan; Shiue, Yow Ling; Chen, Jeon Hor; Hsieh, Tsyh-Jyi; Ko, Ching Chung; Lin, Ching Po

2018-04-01

Background The computed tomography angiography (CTA) spot sign represents active contrast extravasation within acute primary intracerebral hemorrhage (ICH) and is an independent predictor of hematoma expansion (HE) and poor clinical outcomes. The spot sign could be detected on first-pass CTA (fpCTA) or delayed CTA (dCTA). Purpose To investigate the additional benefits of dCTA spot sign in primary ICH and hematoma size for predicting spot sign. Material and Methods This is a retrospective study of 100 patients who underwent non-contrast CT (NCCT) and CTA within 24 h of onset of primary ICH. The presence of spot sign on fpCTA or dCTA, and hematoma size on NCCT were recorded. The spot sign on fpCTA or dCTA for predicting significant HE, in-hospital mortality, and poor clinical outcomes (mRS ≥ 4) are calculated. The hematoma size for prediction of CTA spot sign was also analyzed. Results Only the spot sign on dCTA could predict high risk of significant HE and poor clinical outcomes as on fpCTA ( P < 0.05). With dCTA, there is increased sensitivity and negative predictive value (NPV) for predicting significant HE, in-hospital mortality, and poor clinical outcomes. The XY value (product of the two maximum perpendicular axial dimensions) is the best predictor (area under the curve [AUC] = 0.82) for predicting spot sign on fpCTA or dCTA in the absence of intraventricular and subarachnoid hemorrhage. Conclusion This study clarifies that dCTA imaging could improve predictive performance of CTA in primary ICH. Furthermore, the XY value is the best predictor for CTA spot sign.

Persistence of clinical signs associated with rotavirus following an outbreak of porcine epidemic diarrhea (PED) on a farrow-to-grow swine operation in southwestern Ontario.

PubMed

Tenbergen, Ryan; O'Sullivan, Terri; Poljak, Zvonimir; DeLay, Josepha; Charbonneau, George

2016-06-01

Clinical signs attributed to porcine epidemic diarrhea (PED) persisted for several months in a southwestern Ontario farm following an outbreak of PED. Extensive testing revealed rotavirus infection and absence of PED in nursing and nursery pigs, highlighting the importance of repeated diagnostic testing following a disease outbreak.

'BeAWARE': supporting non-clinical staff within general practice to promptly identify patients presenting with warning signs of heart attack or stroke.

PubMed

Poulter, Christopher; Stewart, Michelle; Fitzpatrick, Cliona; Keech, Wendy; Stavreski, Bill; Grenfell, Robert

2014-06-01

General practice requires systems to deal with patients presenting with urgent needs. BeAWARE was developed to support non-clinical staff to promptly identify patients with symptoms of heart attack or stroke. Data were collected from May 2012 to December 2012 on participants completing the BeAWARE learning module, including pre- and post-assessments on knowledge, confidence and intended action. From May 2012 to December 2012, 1865 participants completed the module. There were significant increases in recall of heart attack and stroke symptoms among non-clinical participants, including chest tightness (23.4-48.7%, P DISCUSSION: BeAWARE fulfils a practice gap in patient safety by improving non-clinical staff's knowledge, confidence and intended action in response to patients presenting with heart attack or stroke warning signs.

A comparative study of the blend sign and the black hole sign on CT as a predictor of hematoma expansion in spontaneous intracerebral hemorrhage.

PubMed

Li, Ruili; Yang, Mingfei

2017-01-01

Hematoma expansion (HE) is a major determinant of a poor outcome in patients with a spontaneous intracerebral hemorrhage (sICH). The blend sign and the black hole sign are distinguished from non-contrast CT (NCCT) in patients with sICH, and both are independent neuroimaging predictors of HE. The purpose of the current study was to compare the value of the two signs in the prediction of HE. We retrospectively analyzed clinical and neuroimaging data from 228 patients with sICH who were treated at our hospital between August 2015 and September 2017. NCCT of the brain was performed upon admission (within 6 h of the onset of symptoms) to identify the blend sign and the black hole sign. HE was determined based on CT during a follow-up 24 h later. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with which the blend sign and the black hole sign predicted HE were calculated. Receiver operating characteristic (ROC) curve analysis was performed in order to compare the accuracy of the two signs in predicting HE. The blend sign was identified in 46 patients (20.2%) and the black hole sign was identified in 38 (16.7%) based on NCCT of the brain upon admission. Of the 65 patients with HE, the blend sign was noted in 28 and the black hole sign was noted in 22. The blend sign had a sensitivity of predicting HE of 43.1%, a specificity of 89.0%, a PPV of 60.9%, and an NPV of 79.7%. In contrast, the black hole sign had a sensitivity of predicting HE of 33.9%, a specificity of 90.2%, a PPV of 57.9%, and an NPV of 77.4%. The area under the ROC curve was 0.660 for the blend sign and 0.620 for the black hole sign (p = 0.516). In conclusion, the blend sign and the black hole sign on CT are both good predictors of HE in patients with sICH, though the blend sign seems to have a higher level of accuracy.

Clopidogrel-Proton Pump Inhibitor Drug-Drug Interaction and Risk of Adverse Clinical Outcomes Among PCI-Treated ACS Patients: A Meta-analysis.

PubMed

Serbin, Michael A; Guzauskas, Gregory F; Veenstra, David L

2016-08-01

Uncertainty regarding clopidogrel effectiveness attenuation because of a drug-drug interaction with proton pump inhibitors (PPI) has led to conflicting guidelines on concomitant therapy. In particular, the effect of this interaction in patients who undergo a percutaneous coronary intervention (PCI), a population known to have increased risk of adverse cardiovascular events, has not been systematically evaluated. To synthesize the evidence of the effect of clopidogrel-PPI drug interaction on adverse cardiovascular outcomes in a PCI patient population. We conducted a systematic literature review for studies reporting clinical outcomes in patients who underwent a PCI and were initiated on clopidogrel with or without a PPI. Studies were included in the analysis if they reported at least 1 of the clinical outcomes of interest (major adverse cardiovascular event [MACE], cardiovascular death, all-cause death, myocardial infarction, stroke, stent thrombosis, and bleed events). We excluded studies that were not exclusive to PCI patients or had no PCI subgroup analysis and/or did not report at least a 6-month follow-up. Statistical and clinical heterogeneity were evaluated and HRs and 95% CIs for adverse clinical events were pooled using the DerSimonian and Laird random-effects meta-analysis method. We identified 12 studies comprising 50,277 PCI patients that met our inclusion and exclusion criteria. Our analysis included retrospective analyses of randomized controlled trials (2), health registries (3), claims databases (2), and institutional records (5); no prospective studies of PCI patients were identified. On average, patients were in their mid-60s, male, and had an array of comorbidities, including hyperlipidemia, diabetes, hypertension, and smoking history. Concomitant therapy following PCI resulted in statistically significant increases in composite MACE (HR = 1.28; 95% CI = 1.24-1.32), myocardial infarction (HR = 1.51; 95% CI = 1.40-1.62), and stroke (HR = 1.46; 95

[Perception of clinical practice derived risks compared to adverse effects detected in an internal medicine service].

PubMed

Jiménez Muñoz, A B; Muiño Miguez, A; Quintás Viqueira, A; Pinilla Llorente, B; Durán García, M E; Rodríguez Pérez, M P

2008-01-01

To know how the health care workers perceive the risks derived from the care practice. To estimate the most frequent adverse effects (AE) and establish differences and similarities between the perception of risks and the AE produced. A self-administered questionnaire was applied to all the workers of an Internal Medicine Department of a General University Hospital on perception of risks and safety of the patient. After, and by using the screening guide of the IDEA project, edition 1, the clinical histories of the patients selected were analyzed by medical residents of preventive Medicine and Internal Medicine. Questionnaire. Fifty questionnaires we sent with a 42% response rate. Risks prioritized by obtaining a lower mean score: there is not action plan against catastrophes (2.79/10) and lack of spaces to report (3/10); those having greater percentage of open questions: long maintenance of urinary probes (47.61%) and inadequate prescription of antibiotics (33.33%). Study of AE. Incidence of patients with AE: 25% (95% CI 11.06-38.9). Incidence of AE: 26.6% (95% CI 12.6-40.6). 41.6% of AE was related to medication, 25% to nosocomial infection, 16.66% to technical problems in procedures and 16.66% were related to nursing cares. The perception of the health care workers on health care practice derived risks is different from the adverse events that really appear. The professionals are concerned about the information to patients than about scientific and technical quality. The most frequent adverse events produced are those related with medication. The only common point is concern for nosocomial infection.

Clinical Risk Factors for In-Hospital Adverse Cardiovascular Events After Acute Drug Overdose

PubMed Central

Manini, Alex F.; Hoffman, Robert S.; Stimmel, Barry; Vlahov, David

2015-01-01

Objectives It was recently demonstrated that adverse cardiovascular events (ACVE) complicate a high proportion of hospitalizations for patients with acute drug overdoses. The aim of this study was to derive independent clinical risk factors for ACVE in patients with acute drug overdoses. Methods This prospective cohort study was conducted over 3 years at two urban university hospitals. Patients were adults with acute drug overdoses enrolled from the ED. In-hospital ACVE was defined as any of myocardial injury, shock, ventricular dysrhythmia, or cardiac arrest. Results There were 1,562 patients meeting inclusion/exclusion criteria (mean age, 41.8 years; female, 46%; suicidal, 38%). ACVE occurred in 82 (5.7%) patients (myocardial injury, 61; shock, 37; dysrhythmia, 23; cardiac arrests, 22) and there were 18 (1.2%) deaths. On univariate analysis, ACVE risk increased with age, lower serum bicarbonate, prolonged QTc interval, prior cardiac disease, and altered mental status. In a multivariable model adjusting for these factors as well as patient sex and hospital site, independent predictors were: QTc > 500 msec (3.8% prevalence, odds ratio [OR] 27.6), bicarbonate < 20 mEql/L (5.4% prevalence, OR 4.4), and prior cardiac disease (7.1% prevalence, OR 9.5). The derived prediction rule had 51.6% sensitivity, 93.7% specificity, and 97.1% negative predictive value; while presence of two or more risk factors had 90.9% positive predictive value. Conclusions The authors derived independent clinical risk factors for ACVE in patients with acute drug overdose, which should be validated in future studies as a prediction rule in distinct patient populations and clinical settings. PMID:25903997

Intrauterine hematomas in the second and third trimesters associated with adverse pregnancy outcomes: a retrospective study.

PubMed

Ji, Wanqing; Li, Weidong; Mei, Shanshan; He, Ping

2017-09-01

To carry out a retrospective study of the clinical features of patients with intrauterine hematoma in the second and third trimesters, and discuss the risk factors for poor pregnancy outcomes. A total of 398 patients who underwent routine examination in our hospital from January 2011 to December 2015 were classified into normal pregnancy (NP) group (N = 265) and adverse pregnancy (AP) group (N = 133), according to their pregnancy outcomes. Maternal clinical demographics, gestational age, location of hematoma, volume of hematoma, and accompanying contraction and vaginal bleeding were recorded. The average age of pregnant women in the NP and AP groups was 28.25 ± 4.06 and 29.5 ± 5.06 years, respectively (p = 0.007). Gestational age at first detection of hematoma was 15.11 ± 5.13 weeks in the NP group compared with 21.22 ± 8.25 weeks in the AP group (p < 0.001). In the AP group, the incidence of retroplacental hematoma (54.1%) and palpable contractions (62.8%) was significantly higher than in the NP group (25.7% and 12.1%, respectively; p < 0.01). However, similar maternal parity or history of delivery, volume of hematoma and incidence of vaginal bleeding were found. Intrauterine hematoma in the second and third trimesters is a sign of pathological pregnancy, resulting in adverse outcomes. Maternal age, gestational age at first diagnosis, location of hematoma and accompanying contraction are risk factors for poor pregnancy outcomes.

Using clinical symptoms to predict adverse maternal and perinatal outcomes in women with preeclampsia: data from the PIERS (Pre-eclampsia Integrated Estimate of RiSk) study.

PubMed

Yen, Tin-Wing; Payne, Beth; Qu, Ziguang; Hutcheon, Jennifer A; Lee, Tang; Magee, Laura A; Walters, Barry N; von Dadelszen, Peter

2011-08-01

Preeclampsia is a leading cause of maternal morbidity. The clinical challenge lies in predicting which women with preeclampsia will suffer adverse outcomes and would benefit from treatment, while minimizing potentially harmful interventions. Our aim was to determine the ability of maternal symptoms (i.e., severe nausea or vomiting, headache, visual disturbance, right upper quadrant pain or epigastric pain, abdominal pain or vaginal bleeding, and chest pain or dyspnea) to predict adverse maternal or perinatal outcomes. We used data from the PIERS (Pre-eclampsia Integrated Estimate of RiSk) study, a multicentre, prospective cohort study designed to investigate the maternal risks associated with preeclampsia. Relative risks and receiver operating characteristic (ROC) curves were assessed for each preeclampsia symptom and outcome pair. Of 2023 women who underwent assessment, 52% experienced at least one preeclampsia symptom, with 5.2% and 5.3% respectively experiencing an adverse maternal or perinatal outcome. No symptom and outcome pair, in either of the maternal or perinatal groups, achieved an area under the ROC curve value > 0.7, which would be necessary to demonstrate a discriminatory predictive value. Maternal symptoms of preeclampsia are not independently valid predictors of maternal adverse outcome. Caution should be used when making clinical decisions on the basis of symptoms alone in the preeclamptic patient.

High Phosphohistone H3 Expression Correlates with Adverse Clinical, Biological, and Pathological Factors in Neuroblastomas

PubMed Central

Ramani, Pramila; Taylor, Scott; Miller, Elizabeth; Sowa-Avugrah, Emile; May, Margaret T.

2015-01-01

Phosphohistone H3 (pHH3), a biomarker of the late G2- and M-phase of the cell cycle, provides a powerful indication of the proliferative state of many cancers. We investigated the prognostic significance of pHH3 by immunostaining 80 neuroblastomas and counting the average number of strongly stained nuclei and mitotic figures. The median and 75th percentile pHH3 proliferation indices (PIs) were 0.54% and 1.06% (range, 0.01% to 2.23%) respectively. pHH3 expression was significantly higher in neuroblastomas from patients with adverse clinical characteristics, all unfavorable pathological factors including high mitosis karyorrhexis index (MKI), and adverse biological factors including MYCN oncogene amplification. High pHH3-PIs, at 1% threshold, were significantly associated with a shorter overall survival (OS) and event-free survival (EFS) in the univariable Cox regression analyses. In the multivariable models, high pHH3 counts were significantly associated with worse OS after adjustment for age but were not independent of either high MKI or MYCN amplification. In children less than 18 months of age, high MKIs and high PHH3-PIs were associated with significantly worse OS and EFS. In conclusion, high pHH3 expression correlates strongly with high MKI and MYCN amplification and indicates poor prognosis in neuroblastomas. PMID:25711230

Infectious Adverse Events Following Acupuncture: Clinical Progress and Microbiological Etiology.

PubMed

Kim, Youn-Jung; Kim, Sung-Han; Lee, Hak Jin; Kim, Won Young

2018-06-11

We investigated the clinical progress and bacteriological characteristics of infectious adverse events (AEs) following acupuncture and compared patient characteristics between serious and non-serious outcome groups. A retrospective observational study was conducted in 1,174 patients with infectious complications associated with acupuncture at the emergency department (ED) in a tertiary hospital in Korea between 2010 and 2014. Serious outcome was defined as development of septic shock, admission to intensive care unit (ICU) or attaining permanent morbidity. Forty-eight patients had certain causality and cellulitis, necrotizing fasciitis and osteomyelitis were common in order. Among them, 9 patients (18.8%) were categorized into serious outcome group, and they showed devastating outcomes such as septic shock (n = 2), ICU admission (n = 4), and permanent sequelae (n = 5). The serious group had delayed admission to the ED after acupuncture (30.0 [4.0-55.0] vs. 3.0 [1.0-10.0] days, P = 0.023). Methicillin-sensitive Staphylococcus aureus was the most frequently identified microorganism. The patients in the serious group required longer treatment duration (139.0 [49.0-183.5] vs. 14.0 [7.0-34.0] days, P < 0.001) as well as more operation with local (44.4% vs. 10.3%, P = 0.031) or general anaesthesia (33.3% vs. 2.6%, P = 0.017). The infectious AEs after acupuncture may cause serious outcomes. Patients and primary physicians should be aware of the risk of infectious complications and make efforts to prevent them.

Critically appraised topic on adverse food reactions of companion animals (2): common food allergen sources in dogs and cats.

PubMed

Mueller, Ralf S; Olivry, Thierry; Prélaud, Pascal

2016-01-12

To diagnose cutaneous adverse food reactions (CAFRs) in dogs and cats, dietary restriction-provocation trials are performed. Knowing the most common offending food allergens for these species would help determining the order of food challenges to optimize the time to diagnosis. The search for, and review and analysis of the best evidence available as of January 16, 2015 suggests that the most likely food allergens contributing to canine CAFRs are beef, dairy products, chicken, and wheat. The most common food allergens in cats are beef, fish and chicken. In dogs and cats, after a period of dietary restriction leading to the complete remission of clinical signs, food challenges to diagnose CAFR should begin with beef and dairy products, the most commonly recognized food allergens in these two species.

Automatic road sign detecion and classification based on support vector machines and HOG descriptos

NASA Astrophysics Data System (ADS)

Adam, A.; Ioannidis, C.

2014-05-01

This paper examines the detection and classification of road signs in color-images acquired by a low cost camera mounted on a moving vehicle. A new method for the detection and classification of road signs is proposed based on color based detection, in order to locate regions of interest. Then, a circular Hough transform is applied to complete detection taking advantage of the shape properties of the road signs. The regions of interest are finally represented using HOG descriptors and are fed into trained Support Vector Machines (SVMs) in order to be recognized. For the training procedure, a database with several training examples depicting Greek road sings has been developed. Many experiments have been conducted and are presented, to measure the efficiency of the proposed methodology especially under adverse weather conditions and poor illumination. For the experiments training datasets consisting of different number of examples were used and the results are presented, along with some possible extensions of this work.

Correlates of adverse childhood events among adults with schizophrenia spectrum disorders.

PubMed

Rosenberg, Stanley D; Lu, Weili; Mueser, Kim T; Jankowski, Mary Kay; Cournos, Francine

2007-02-01

Multiple studies have found that childhood adversity is related to a range of poor mental health, substance abuse, poor physical health, and poor social functioning outcomes in the general population of adults. However, despite the high rates of childhood adversity in schizophrenia, the clinical correlates of these events have not been systematically evaluated. This study evaluated the relationship between adverse experiences in childhood and functional, clinical, and health outcomes among adults with schizophrenia. The authors surveyed 569 adults with schizophrenia regarding adverse childhood events (including physical abuse, sexual abuse, parental mental illnesses, loss of a parent, parental separation or divorce, witnessing domestic violence, and foster or kinship care). The relationships between cumulative exposure to these events and psychiatric, physical, and functional outcomes were evaluated. Increased exposure to adverse childhood events was strongly related to psychiatric problems (suicidal thinking, hospitalizations, distress, and posttraumatic stress disorder), substance abuse, physical health problems (HIV infection), medical service utilization (physician visits), and poor social functioning (homelessness or criminal justice involvement). The findings extend the results of research in the general population by suggesting that childhood adversity contributes to worse mental health, substance abuse, worse physical health, and poor functional outcomes in schizophrenia.

Minimum retroreflectivity levels for overhead guide signs and street-name signs

DOT National Transportation Integrated Search

2003-12-01

In 1993, the Federal Highway Administration (FHWA) published research recommendations for minimum retroreflectivity (MR) levels for traffic signs. The recommendations included overhead signs, but not street-name signs. In revisions to the recommended...

Persistence of clinical signs associated with rotavirus following an outbreak of porcine epidemic diarrhea (PED) on a farrow-to-grow swine operation in southwestern Ontario

PubMed Central

Tenbergen, Ryan; O’Sullivan, Terri; Poljak, Zvonimir; DeLay, Josepha; Charbonneau, George

2016-01-01

Clinical signs attributed to porcine epidemic diarrhea (PED) persisted for several months in a southwestern Ontario farm following an outbreak of PED. Extensive testing revealed rotavirus infection and absence of PED in nursing and nursery pigs, highlighting the importance of repeated diagnostic testing following a disease outbreak. PMID:27247460

Automated Detection of Surgical Adverse Events from Retrospective Clinical Data

ERIC Educational Resources Information Center

Hu, Zhen

2017-01-01

The Detection of surgical adverse events has become increasingly important with the growing demand for quality improvement and public health surveillance with surgery. Event reporting is one of the key steps in determining the impact of postoperative complications from a variety of perspectives and is an integral component of improving…

Identifying patterns in signs and symptoms preceding the clinical diagnosis of Alzheimer's disease: Retrospective medical record review study and a nested case -control design.

PubMed

Bature, Fidelia; Pang, Dong; Robinson, Anthea; Polson, Norma; Pappas, Yannis; Guinn, Barbara

2018-04-04

Evidence suggests that individuals with Alzheimer's disease (AD) are often diagnosed in the later stages of their disease with a poor prognosis. This study aimed to identify patterns in signs and symptoms preceding the clinical diagnosis of AD to suggest a predictive model for earlier diagnosis of the disease in the primary care. A retrospective medical record review; nested case control design. Participants included one hundred and nine patients from three general practice (GP) surgeries in Milton Keynes and Luton Clinical Commissioning groups (CCG) (37 cases with AD and 72 controls without AD). A retrospective analysis using the logistic regression of the presence of signs and symptoms before the diagnosis of AD was attained. Identification of the timing and sequence of appearance of these presentations as first reported before the clinical diagnosis was measured. Episodic memory with an odds ratio of 1.85 was the most frequent presentation, documented in 1.38% of the controls and 75.6% in cases. Auditory disturbance with an odds ratio of 3.03, which has not previously been noted except in the form of auditory hallucination, could have a diagnostic value. Auditory disturbance, which occurred mostly in the Caucasian females, could discriminate individuals with AD from those without. The symptom, which presented up to 14.5 (mean time) years prior to clinical diagnosis, was identified in Caucasians and mixed race individuals only. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Adverse effects of anticancer agents that target the VEGF pathway.

PubMed

Chen, Helen X; Cleck, Jessica N

2009-08-01

Antiangiogenesis agents that target the VEGF/VEGF receptor pathway have become an important part of standard therapy in multiple cancer indications. With expanded clinical experience with this class of agents has come the increasing recognition of the diverse adverse effects related to disturbance of VEGF-dependent physiological functions and homeostasis in the cardiovascular and renal systems, as well as wound healing and tissue repair. Although most adverse effects of VEGF inhibitors are modest and manageable, some are associated with serious and life-threatening consequences, particularly in high-risk patients and in certain clinical settings. This Review examines the toxicity profiles of anti-VEGF antibodies and small-molecule inhibitors. The potential mechanisms of the adverse effects, risk factors, and the implications for selection of patients and management are discussed.

Neurological Soft Signs in Indian Children with Specific Developmental Disorders of Scholastic Skills

ERIC Educational Resources Information Center

Sadhu, Raja; Mehta, Manju; Kalra, Veena; Sagar, Rajesh; Mongia, Monica

2008-01-01

Aim: To compare the occurrence of neurological soft signs (NSS) in children with specific developmental disorders of scholastic skills (SDDSS) and normal children. Methods: 36 cases of SDDSS were compared with 30 control children regarding sociodemographic and clinical variables and neurological soft signs. Results: Children with SDDSS had…

[Lymphogranuloma venereum: new serovariant L2b and old "groove sign"].

PubMed

de Lavaissière, M; Nougué, J

2013-08-01

An ongoing lymphogranuloma venereum (LGV) outbreak has been reported in several European countries since 2003, related to a new variant L2b. This serovar appears to affect men who have sex with men (MSM), most of them being co-infected with the Human Immunodeficiency Virus (HIV). The secondary stage of LGV may involve lymph nodes and the inguinal form has sometimes been described on each side of the inguinal ligament thus named the "groove sign". We report the case of LGV serovariant L2b acquired by an heterosexual intercourse in an HIV seronegative patient who presented with an inguinal lymph node and a "groove sign". This is an uncommon but suggestive sign of LGV and we suggest that the clinical presentation of L2b LGV might not be so different than other variants and than the 20th century authors' description. Such a new Chlamydia trachomatis variant may circulate in other populations than MSM in Europe and clinical awareness must prevail.