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Sample records for observational study patients

  1. Pain in neurosurgically treated patients: A prospective observational study

    NARCIS (Netherlands)

    M. Klimek (Markus); J.F. Ubben (Johannes); J. Ammann (Jan); K. Borner (Katy); J. Klein (Jan); S.J.C. Verbrugge (Serge)

    2006-01-01

    textabstractObject. This is the first observational study to compare perioperative pain character and intensity in patients undergoing different types of elective neurosurgical procedures. Methods. A structured questionnaire was used to inquire about pain intensity, character, and management during

  2. Nursing diagnoses in patients with chronic venous ulcer: observational study

    Directory of Open Access Journals (Sweden)

    Glycia de Almeida Nogueira

    2015-06-01

    Full Text Available This study aimed to analyze nursing diagnoses in people with chronic venous ulcer. An observational, descriptive, quantitative research conducted in an ambulatory specialized in wound treatment, with a non-probabilistic sample of 20 patients.  Data collection was performed in an institutional form denominated Assessment Protocol for Clients with Tissue Lesions. Diagnoses were established by consensus among four researchers with experience in nursing diagnoses and wound treatments. From data analysis, 16 diagnoses were identified, with 100% of participants presenting: Impaired tissue integrity, Ineffective peripheral tissue perfusion, Risk of infection, Impaired physical mobility and Ineffective health self-control. These diagnoses are found in Safety/Protection, Activity/Rest and Health promotion domains, which from the clinical practice stand point should be priority focuses in nursing intervention and assessment.

  3. Temporomandibular disorders in burning mouth syndrome patients: an observational study.

    Science.gov (United States)

    Corsalini, Massimo; Di Venere, Daniela; Pettini, Francesco; Lauritano, Dorina; Petruzzi, Massimo

    2013-01-01

    Burning Mouth Syndrome (BMS) is a chronic disease characterized by absence of any lesions and burning of the oral mucosa associated to a sensation of dry mouth and/or taste alterations. The purpose of our study is to estimate signs and symptoms of Temporomandibular Disorders (TMD) in patients with BMS and to investigate for the existence of an association between BMS and TMD. Forty-four BMS patients were enrolled; BMS subtype was established according to the classification of Lamey. After a gnathological evaluation, according to the protocol of the European Academy of Craniomandibular Disorders, patients were classified by RDC/TMD criteria. The data were compared and analyzed using a chi-square test to describe the existence of an association between BMS and TMD. 65.9% the BMS patients showed disorders classified as primary signs and symptoms of TMD according to RDC / TMD criteria, and 72.7% showed parafunctional habits. The chi-square test revealed a statistically significant association (p = 0.035) between BMS and TMD. The data suggest that there is a possible relationship not yet well understood between BMS and TMD, may be for neurophatic alterations assumed for BMS that could be also engaged in TMD pathogenesis.

  4. Seeing beyond monitors-Critical care nurses' multiple skills in patient observation: Descriptive qualitative study.

    Science.gov (United States)

    Alastalo, Mika; Salminen, Leena; Lakanmaa, Riitta-Liisa; Leino-Kilpi, Helena

    2017-10-01

    The aim of this study was to provide a comprehensive description of multiple skills in patient observation in critical care nursing. Data from semi-structured interviews were analysed using thematic analysis. Experienced critical care nurses (n=20) from three intensive care units in two university hospitals in Finland. Patient observation skills consist of: information gaining skills, information processing skills, decision-making skills and co-operation skills. The first three skills are integrated in the patient observation process, in which gaining information is a prerequisite for processing information that precedes making decisions. Co-operation has a special role as it occurs throughout the process. This study provided a comprehensive description of patient observation skills related to the three-phased patient observation process. The findings contribute to clarifying this part of the competence. The description of patient observation skills may be applied in both clinical practice and education as it may serve as a framework for orientation, ensuring clinical skills and designing learning environments. Based on this study, patient observation skills can be recommended to be included in critical care nursing education, orientation and as a part of critical care nurses' competence evaluation. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. Measuring disabilities in stroke patients with apraxia: a validation study of an observational method.

    OpenAIRE

    Heugten, C.M. van; Dekker, J.; Deelman, B.G.; Dijk, A.J. van; Stehmann-Saris, F.C.; Kinebanian, A.

    2000-01-01

    The objective of the present study was to determine the clinical and construct validity of the assessment of disabilities in stroke patients with apraxia. Disabilities were assessed by means of observation of activities of daily living (ADL), such as washing the face and upper body and putting on a blouse or shirt. The study was carried out at occupational therapy departments in general hospitals, rehabilitation centres, and nursing homes. Patients diagnosed to have had a stroke in the left h...

  6. Medical student use of communication elements and association with patient satisfaction: a prospective observational pilot study.

    Science.gov (United States)

    Turner, Joseph S; Pettit, Katie E; Buente, Bryce B; Humbert, Aloysius J; Perkins, Anthony J; Kline, Jeffrey A

    2016-05-21

    Effective communication with patients impacts clinical outcome and patient satisfaction. We measure the rate at which medical students use six targeted communication elements with patients and association of element use with patient satisfaction. Participants included fourth year medical students enrolled in an emergency medicine clerkship. A trained observer measured use of six communication elements: acknowledging the patient by name, introducing themselves by name, identifying their role, explaining the care plan, explaining that multiple providers would see the patient, and providing an estimated duration of time in the emergency department. The observer then conducted a survey of patient satisfaction with the medical student encounter. A total of 246 encounters were documented among forty medical student participants. For the six communication elements evaluated, in 61% of encounters medical students acknowledged the patient, in 91% they introduced themselves, in 58 % they identified their role as a student, in 64% they explained the care plan, in 80% they explained that another provider would see the patient, and in only 6% they provided an estimated duration of care. Only 1 encounter (0.4%) contained all six elements. Patients' likelihood to refer a loved one to that ED was increased when students acknowledged the patient and described that other providers would be involved in patient care (P = 0.016 and 0.015 respectively, Chi Square). Likewise, patients' likelihood to return to the ED was increased when students described their role in patient care (P = 0.035, Chi Square). This pilot study demonstrates that medical students infrequently use all targeted communication elements. When they did use certain elements, patient satisfaction increased. These data imply potential benefit to additional training for students in patient communication.

  7. Reliability of patient-reported outcomes in rheumatoid arthritis patients: an observational prospective study.

    Science.gov (United States)

    Studenic, Paul; Stamm, Tanja; Smolen, Josef S; Aletaha, Daniel

    2016-01-01

    Patient-reported outcomes (PROs) such as pain, patient global assessment (PGA) and fatigue are regularly assessed in RA patients. In the present study, we aimed to explore the reliability and smallest detectable differences (SDDs) of these PROs, and whether the time between assessments has an impact on reliability. Forty RA patients on stable treatment reported the three PROs daily over two subsequent months. We assessed the reliability of these measures by calculating intraclass correlation coefficients (ICCs) and the SDDs for 1-, 7-, 14- and 28-day test-retest intervals. Overall, SDD and ICC were 25 mm and 0.67 for pain, 25 mm and 0.71 for PGA and 30 mm and 0.66 for fatigue, respectively. SDD was higher with longer time period between assessments, ranging from 19 mm (1-day intervals) to 30 mm (28-day intervals) for pain, 19 to 33 mm for PGA, and 26 to 34 mm for fatigue; correspondingly, ICC was smaller with longer intervals, and ranged between the 1- and the 28-day interval from 0.80 to 0.50 for pain, 0.83 to 0.57 for PGA and 0.76 to 0.58 for fatigue. The baseline simplified disease activity index did not have any influence on reliability. Lower baseline PRO scores led to smaller SDDs. Reliability of pain, PGA and fatigue measurements is dependent on the tested time interval and the baseline levels. The relatively high SDDs, even for patients in the lowest tertiles of their PROs, indicate potential issues for assessment of the presence of remission. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  8. Coagulation Profile Dynamics in Pediatric Patients with Cushing Syndrome: A Prospective, Observational Comparative Study

    NARCIS (Netherlands)

    Birdwell, L. (Leah); M.B. Lodish (Maya Beth); Tirosh, A. (Amit); P. Chittiboina (Prashant); M. Keil (Mark); Lyssikatos, C. (Charlampos); Belyavskaya, E. (Elena); R.A. Feelders (Richard); C.A. Stratakis (Constantine)

    2016-01-01

    textabstractObjective To evaluate the association between Cushing syndrome and hypercoagulability in children. Study design A prospective, observational study was performed of 54 patients with Cushing syndrome, 15.1 ± 3.9 years, treated at the National Institutes of Health Clinical Center.

  9. Decannulation and Functional Outcome After Tracheostomy in Patients with Severe Stroke (DECAST): A Prospective Observational Study.

    Science.gov (United States)

    Schneider, Hauke; Hertel, Franziska; Kuhn, Matthias; Ragaller, Maximilian; Gottschlich, Birgit; Trabitzsch, Anne; Dengl, Markus; Neudert, Marcus; Reichmann, Heinz; Wöpking, Sigrid

    2017-08-01

    Tracheostomy is performed in ventilated stroke patients affected by persisting severe dysphagia, reduced level of consciousness, or prolonged mechanical ventilation. The study aim was to determine the frequency and predictors of successful decannulation and long-term functional outcome in tracheotomized stroke patients. A prospective single-center observational study recruited ventilated patients with ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage. Follow-up visits were performed at hospital discharge, 3, and 12 months. Competing risk analyses were performed to identify predictors of decannulation. We included 53 ventilated stroke patients who had tracheostomy. One year after tracheostomy, 19 patients were decannulated (median [IQR] time to decannulation 74 [58-117] days), 13 patients were permanently cannulated, and 21 patients died without prior removal of the cannula. Independent predictors for decannulation in our cohort were patient age (HR 0.95 [95% CI: 0.92-0.99] per one year increase, p = 0.003) and absence of sepsis (HR 4.44 [95% CI: 1.33-14.80], p = 0.008). Compared to surviving patients without cannula removal, decannulated patients had an improved functional outcome after one year (median modified Rankin Scale score 4 vs. 5 [p tracheostomy and was associated with better functional outcome compared to patients without decannulation. Further prospective studies with larger sample sizes are needed to confirm our results.

  10. PERICARDIAL FEATURES OF IN-HOSPITAL RHEUMATOLOGY PATIENTS: AN OBSERVATIONAL STUDY.

    Science.gov (United States)

    Bakalli, Aurora; Rexhepi, Mjellma; Rexhepi, Blerta; Koçinaj, Dardan

    Rheumatic disorders can be associated with pericarditis, but severe forms of pericarditis are rare. The aim of this observational study was to evaluate pericardial features in patients with different rheumatic diseases. Thirty-five patients hospitalized at the Clinic of Rheumatology, University Clinical Center of Kosovo, from October 1 to October 21, 2014 were included in the study. Demographic data, history, laboratory, ECG, and echocardiography data, with special emphasis on the analysis of the pericardium, were obtained from each patient. Echocardiography was especially focused on the amount of pericardial fluid and pericardial thickness in the posterior wall of the heart. Mean patient age was 51.5 ± 13.8 years. 65.7% of the patients were women. Out of the patients that we analyzed, 88.6% had an inflammatory rheumatologic disease. 11.3% of the patients had mild symptoms, in 68.7% the symptoms were moderate, and in 20% severe. In all patients, pericardial hyperechogenicity was marked, with a mean pericardial thickness of 4.68 ± 1.66 mm. Pericardial effusion in a small amount was present in 57.1% of patients, with a mean pericardial fluid amount of 3.3 ± 1.9 mm. The severity of rheumatic disease had a positive and significant correlation with the presence of pericardial effusion (r= 0.29, p=0.04) and its amount (r= 0.28, p=0.05). The patients had not been aware of the pericardial involvement and did not have any clinical symptoms. In conclusion, in this short-term small observational study pericardial changes were a frequent finding in the rheumatology patients. In general, the pericarditis was subclinical and with small amounts of effusion. The disease activity of rheumatic disorders can be associated with pericarditis. Further studies with larger samples of patients and of longer duration are needed to further explore this issue.

  11. Prevention of pressure ulcers in patients undergoing subacute rehabilitation after severe brain injury: An observational study.

    Science.gov (United States)

    Sachs, Marianne Brostrup; Wolffbrandt, Mia Moth; Poulsen, Ingrid

    2018-01-09

    To uncover efforts made by healthcare professionals to prevent pressure ulcers in patients with severe brain injury undergoing treatment at a subacute rehabilitation department. Pressure ulcers are a major burden for patients and also generate considerable healthcare costs. Pressure ulcers are, nevertheless, prevalent in both secondary care and primary care. In this qualitative study, we performed 24-hour observation on four patients undergoing rehabilitation for severe brain injury. An observation guide was developed inspired by the Braden Scale and Spradley's theory and methods. Observations were analysed using content analysis. Patricia Benner's aspects of clinical grasp were employed in the interpretation of the observations. One overarching theme was identified: "Professionalism expressed by preventing intervention, involving the patient, employing clinical grasp and professional pride." Seven subcategories were summed up into the following three categories: organisation of clinical practice, professional assessment and interactions with the patient. The healthcare professionals' actions to prevent pressure ulcers consisted of attaining the necessary knowledge about pressure ulcer care and performing the activities. However, our observations revealed one important additional aspect: a very distinct impression that the healthcare professionals were committed to learning about the patients' former life and actively used this knowledge in their planning and provision of daily patient care. We believe this commitment has a very positive effect on prevention of pressure ulcers. Professional knowledge about prevention of pressure ulcer is a necessary requisite, but is not sufficient to ensure effective treatment. To transfer knowledge into practice, we recommend that patients' rehabilitation days be planned in such a manner that activities, mobilisation and training are conducted throughout the day and evening. We also recommend that professional staff are

  12. Variability of linezolid concentrations after standard dosing in critically ill patients: a prospective observational study

    Science.gov (United States)

    2014-01-01

    Introduction Severe infections in intensive care patients show high morbidity and mortality rates. Linezolid is an antimicrobial drug frequently used in critically ill patients. Recent data indicates that there might be high variability of linezolid serum concentrations in intensive care patients receiving standard doses. This study was aimed to evaluate whether standard dosing of linezolid leads to therapeutic serum concentrations in critically ill patients. Methods In this prospective observational study, 30 critically ill adult patients with suspected infections received standard dosing of 600 mg linezolid intravenously twice a day. Over 4 days, multiple serum samples were obtained from each patient, in order to determine the linezolid concentrations by liquid chromatography tandem mass spectrometry. Results A high variability of serum linezolid concentrations was observed (range of area under the linezolid concentration time curve over 24 hours (AUC24) 50.1 to 453.9 mg/L, median 143.3 mg*h/L; range of trough concentrations (Cmin) linezolid concentrations over 24 hours and at single time points (defined according to the literature as AUC24  400 mg*h/L and Cmin > 10 mg/L) were observed for 7 of the patients. Conclusions A high variability of linezolid serum concentrations with a substantial percentage of potentially subtherapeutic levels was observed in intensive care patients. The findings suggest that therapeutic drug monitoring of linezolid might be helpful for adequate dosing of linezolid in critically ill patients. Trial registration Clinicaltrials.gov NCT01793012. Registered 24 January 2013. PMID:25011656

  13. An observational study of cognitive function in patients with irritable bowel syndrome and inflammatory bowel disease.

    Science.gov (United States)

    Berrill, J W; Gallacher, J; Hood, K; Green, J T; Matthews, S B; Campbell, A K; Smith, A

    2013-11-01

    Irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) are associated with several risk factors for developing cognitive impairment. These include altered cytokine levels, concurrent mood disorders, and the presence of chronic pain. This observational study aimed to explore the cognitive profile of patients with these conditions. Participants completed the Cardiff Cognitive Battery, a series of computerized neuropsychological performance tests that examine a range of cognitive function including psychomotor speed, memory, and intelligence. A progressive analysis of covariance model was used with demographic details, anxiety and depression scores entered as covariates. Fecal calprotectin levels were measured in IBD patients to determine disease activity. In total 231 participants were recruited (150 IBD patients, 40 IBS patients, and 41 healthy controls). IBD patients had significantly lower scores on fluid (p = 0.01) and crystalline intelligence tests (p = 0.028) compared to healthy volunteers, however, this reflected differences in concurrent mood disorder and level of education. When these factors were added as covariates, there was no significant difference between the groups. Duration and activity of disease did not affect cognitive function in IBD patients. Severity of symptoms had no impact on cognition in patients with IBS. The results of this observational study do not support the hypothesis that IBS or IBD have an intrinsic disease process that is associated with cognitive dysfunction. It is possible that concurrent mood disorders, in particular depression, may affect the cognitive performance of patients with IBD in specific tasks. © 2013 John Wiley & Sons Ltd.

  14. Efficacy and safety of dexmedetomidine infusion for patients undergoing awake craniotomy: An observational study.

    Science.gov (United States)

    Mahajan, Charu; Rath, Girija Prasad; Singh, Gyaninder Pal; Mishra, Nitasha; Sokhal, Suman; Bithal, Parmod Kumar

    2018-01-01

    The goal of awake craniotomy is to maintain adequate sedation, analgesia, respiratory, and hemodynamic stability and also to provide a cooperative patient for neurologic testing. An observational study carried out to evaluate the efficacy of dexmedetomidine sedation for awake craniotomy. Adult patients with age >18 year who underwent awake craniotomy for intracranial tumor surgery were enrolled. Those who were uncooperative and had difficult airway were excluded from the study. In the operating room, the patients received a bolus dose of dexmedetomidine 1 μg/kg followed by an infusion of 0.2-0.7 μg/kg/h (bispectral index target 60-80). Once the patients were sedated, scalp block was given with bupivacaine 0.25%. The data on hemodynamics at various stages of the procedure, intraoperative complications, total amount of fentanyl used, intravenous fluids required, blood loss and transfusion, duration of surgery, Intensive Care Unit (ICU), and hospital stay were collected. The patients were assessed for Glasgow outcome scale (GOS) score and patient satisfaction score (PSS). A total of 27 patients underwent awake craniotomy during a period of 2 years. Most common intraoperative complication was seizures; observed in five patients (18.5%). None of these patients experienced any episode of desaturation. Two patients had tight brain for which propofol boluses were administered. The average fentanyl consumption was 161.5 ± 85.0 μg. The duration of surgery, ICU, and hospital stays were 231.5 ± 90.5 min, 14.5 ± 3.5 h, and 4.7 ± 1.5 days, respectively. The overall PSS was 8 and GOS was good in all the patients. The use of dexmedetomidine infusion with regional scalp block in patients undergoing awake craniotomy is safe and efficacious. The absence of major complications and higher PSS makes it close to an ideal agent for craniotomy in awake state.

  15. The impact of documentation on communication during patient-physiotherapist interactions: A qualitative observational study.

    Science.gov (United States)

    Schoeb, Veronika; Hiller, Amy

    2018-01-31

    Documentation is an essential component of physiotherapy practice for clinical, legal, and ethical reasons. Research in other healthcare contexts suggests that documentation impacts upon communication in patient-practitioner interactions. Thus, the objective of this qualitative study was to examine how physiotherapists and their patients communicate during episodes of documentation. The research was informed by ethnomethodology and ethnography. In total, 113 patient-physiotherapist interactions were observed in Switzerland and Australia with video-recordings, audio-recordings, and field notes collected as data. Episodes of documentation within these interactions were transcribed, and both verbal and non-verbal communication were analyzed inductively. Analysis identified that communication during documentation was characterized by: pauses in conversation, pre-established order of questioning, minimal eye contact, use of direct communication, and an emphasis on objectivity. The use of documentation was observed to alter the wording of questioning as well as the sequence and flow of conversation between patient and physiotherapist. In addition, the observed communicative features seemed to restrict patient participation, and may hinder the achievement of a patient-centered approach. Recognizing the importance of documentation, we address the challenges that our research highlighted by proposing strategies to assist educators and clinicians to optimize communication with patients when incorporating documentation into practice.

  16. Measuring disabilities in stroke patients with apraxia : A validation study of an observational method

    NARCIS (Netherlands)

    van Heugten, CM; Dekker, J; Deelman, BG; van Dijk, AJ; Stehmann-Saris, FC; Kinebanian, A

    The objective of the present study was to determine the clinical and construct validity of the assessment of disabilities in stroke patients with apraxia. Disabilities were assessed by means of observation of activities of daily living (ADL), such as washing the face and upper body and putting on a

  17. Measuring disabilities in stroke patients with apraxia: a validation study of an observational method.

    NARCIS (Netherlands)

    Heugten, C.M. van; Dekker, J.; Deelman, B.G.; Dijk, A.J. van; Stehmann-Saris, F.C.; Kinebanian, A.

    2000-01-01

    The objective of the present study was to determine the clinical and construct validity of the assessment of disabilities in stroke patients with apraxia. Disabilities were assessed by means of observation of activities of daily living (ADL), such as washing the face and upper body and putting on a

  18. Comorbidities of patients in tiotropium clinical trials: comparison with observational studies of patients with chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Miravitlles M

    2015-03-01

    Full Text Available Marc Miravitlles,1 David Price,2 Klaus F Rabe,3,7 Hendrik Schmidt,4 Norbert Metzdorf,5 Bartolome Celli6 1Pneumology Department, Hospital Universitari Vall d’Hebron, Ciber de Enfermedades Respiratorias (CIBERES, Barcelona, Spain; 2Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 3Department of Medicine, Christian-Albrechts-Universität zu Kiel (CAU, Großhansdorf, Germany; 4Global Biometrics and Clinical Applications, Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim am Rhein, Germany; 5TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim am Rhein, Germany; 6Pulmonary Division, Brigham and Women’s Hospital, Boston, MA, USA; 7LungenClinic Grosshansdorf, Großhansdorf, Germany Background: There is an ongoing debate on whether patients with chronic obstructive pulmonary disease (COPD seen in real-life clinical settings are represented in randomized controlled trials (RCTs of COPD. It is thought that the stringent inclusion and exclusion criteria of RCTs may prevent the participation of patients with specific characteristics or risk factors.Methods: We surveyed a database of patients recruited into 35 placebo-controlled tiotropium RCTs and also conducted a systematic literature review of large-scale observational studies conducted in patients with a documented diagnosis of COPD between 1990 and 2013. Patient demographics and comorbidities with a high prevalence in patients with COPD were compared between the two patient populations at baseline. Using the Medical Dictionary for Regulatory Activities (MedDRA; v 14.0, patient comorbidities in the pooled tiotropium RCTs were classified according to system organ class, pharmacovigilance (PV endpoints, and Standardised MedDRA Queries to enable comparison with the observational studies.Results: We identified 24,555 patients in the pooled tiotropium RCTs and 61,361 patients among the 13 observational studies that met our

  19. [Observation of critically ill patients

    DEFF Research Database (Denmark)

    Fuhrmann, L.; Hesselfeldt, R.; Lippert, A.

    2009-01-01

    . MATERIAL AND METHODS: Prospective observational study at Herlev Hospital, Copenhagen, Denmark. Study personnel measured vital signs on all patients present on five wards during the evening and night and interviewed nursing staff about patients with abnormal vital signs. Subsequently, patient records were...

  20. Primary and secondary patient data in contrast: the use of observational studies like RABBIT.

    Science.gov (United States)

    Richter, Adrian; Meißner, Yvette; Strangfeld, Anja; Zink, Angela

    2016-01-01

    The study of secondary patient data, particularly represented by claims data, has increased in recent years. The strength of this approach involves easy access to data that have been generated for administrative purposes. By contrast, collection of primary data for research is time-consuming and may therefore appear outdated. Both administrative data and data collected prospectively in clinical care can address similar research questions concerning effectiveness and safety of treatments. Therefore, why should we invest the precious time of rheumatologists to generate primary patient data? This article will outline some features of primary patient data collection illustrated by the German biologics register RABBIT (Rheumatoid arthritis: observation of biologic therapy). RABBIT is a long-term observational cohort study that was initiated more than 15 years ago. We will discuss as quality indicators: (i) study design, (ii) type of documentation, standardisation of (iii) clinical and (iv) safety data, (v) monitoring of the longitudinal follow-up, (vi) losses to follow-up as well as (vii) the possibilities to link the data base. The impact of these features on interpretation and validity of results is illustrated using recent publications. We conclude that high quality and completeness of data prospectively-collected offers many advantages over large quantities of non-standardised data collected in an unsupervised manner. We expect the enthusiasm about the use of secondary patient data to decline with more awareness of their methodological limitations while studies with primary patient data like RABBIT will maintain and broaden their impact on daily clinical practice.

  1. Respiratory Viruses in Invasively Ventilated Critically Ill Patients-A Prospective Multicenter Observational Study.

    Science.gov (United States)

    van Someren Gréve, Frank; Juffermans, Nicole P; Bos, Lieuwe D J; Binnekade, Jan M; Braber, Annemarije; Cremer, Olaf L; de Jonge, Evert; Molenkamp, Richard; Ong, David S Y; Rebers, Sjoerd P H; Spoelstra-de Man, Angelique M E; van der Sluijs, Koenraad F; Spronk, Peter E; Verheul, Kirsten D; de Waard, Monique C; de Wilde, Rob B P; Winters, Tineke; de Jong, Menno D; Schultz, Marcus J

    2018-01-01

    The presence of respiratory viruses and the association with outcomes were assessed in invasively ventilated ICU patients, stratified by admission diagnosis. Prospective observational study. Five ICUs in the Netherlands. Between September 1, 2013, and April 30, 2014, 1,407 acutely admitted and invasively ventilated patients were included. None. Nasopharyngeal swabs and tracheobronchial aspirates were collected upon intubation and tested for 14 respiratory viruses. Out of 1,407 patients, 156 were admitted because of a severe acute respiratory infection and 1,251 for other reasons (non-severe acute respiratory infection). Respiratory viruses were detected in 28.8% of severe acute respiratory infection patients and 17.0% in non-severe acute respiratory infection (p < 0.001). In one third, viruses were exclusively detected in tracheobronchial aspirates. Rhinovirus and human metapneumovirus were more prevalent in severe acute respiratory infection patients (9.6% and 2.6% vs 4.5 and 0.2%; p = 0.006 and p < 0.001). In both groups, there were no associations between the presence of viruses and the number of ICU-free days at day 28, crude mortality, and mortality in multivariate regression analyses. Respiratory viruses are frequently detected in acutely admitted and invasively ventilated patients. Rhinovirus and human metapneumovirus are more frequently found in severe acute respiratory infection patients. Detection of respiratory viruses is not associated with worse clinically relevant outcomes in the studied cohort of patients.

  2. Incidence and risk factors for delirium development in ICU patients - a prospective observational study.

    Science.gov (United States)

    Kanova, Marcela; Sklienka, Peter; Roman, Kula; Burda, Michal; Janoutova, Jana

    2017-06-01

    Delirium is an acute brain dysfunction and a frequent complication in critically ill patients. When present it significantly worsens the prognosis of patients. The aim of this study was to evaluate the incidence of delirium and risk factors for delirium in a mixed group of trauma, medical and surgical ICU patients. A prospective observational study was conducted in one of the six-bed Intensive Care Units of the University Hospital Ostrava in the Czech Republic during a 12-month period. We evaluated the incidence of delirium and its predisposing and precipitating risk factors. All patients were assessed daily using the Confusion Assessment Method for the ICU (CAM-ICU). Of the total of 332 patients with a median APACHE II (the Acute Physiology and Chronic Health Evaluation) score of 12, who were evaluated for delirium, 48 could not be assessed using CAM-ICU (47 due to prolonged coma, 1 due to language barriers). The incidence of delirium was 26.1%, with trauma and medical patients being more likely to develop delirium than surgical patients. Risk of delirium was significantly associated with age ≥ 65 years, and alcohol abuse in their anamnesis, with APACHE II score on admission, and with the use of sedatives and/or vasopressors. Delirious patients who remained in the ICU for a prolonged period showed a greater need for ventilator support and had a greater ICU-mortality.

  3. Accumulation of advanced glycation end (AGEs products in intensive care patients: an observational, prospective study

    Directory of Open Access Journals (Sweden)

    Rommes Johannes H

    2010-05-01

    Full Text Available Abstract Background Oxidative stress plays an important role in the course and eventual outcome in a majority of patients admitted to the intensive care unit (ICU. Markers to estimate oxidative stress are not readily available in a clinical setting. AGEs accumulation has been merely described in chronic conditions, but can also occur acutely due to oxidative stress. Since AGEs have emerged to be stable end products, these can be a marker of oxidative stress. Skin autofluorescence (AF is a validated marker of tissue content of AGEs. We hypothesized that AGEs accumulate acutely in ICU patients. Methods We performed an observational prospective study in a medical surgical ICU in a university affiliated teaching hospital. All consecutively admitted ICU patients in a 2 month period were included. Skin AF was measured using an AGE reader in 35 consecutive ICU patients > 18 yrs. As a comparison, historical data of a control group (n = 231 were used. These were also used to calculate age-adjusted AF-levels (AFadj. Values are expressed as median and interquartile range [P25-P75]. Differences between groups were tested by non parametric tests. P Results AFadj values were higher in ICU patients (0.33 [0.00 - 0.68] than in controls (-0.07 [-0.29 - 0.24]; P adj were observed between acute or planned admissions, or presence of sepsis, nor was skin AFadj related to severity of disease as estimated by APACHE-II score, length of ICU, hospital stay or mortality. Conclusion Acute AGE accumulation in ICU patients was shown in this study, although group size was small. This can possibly reflect oxidative stress in ICU patients. Further studies should reveal whether AGE-accumulation will be a useful parameter in ICU patients and whether skin AF has a predictive value for outcome, which was not shown in this small study.

  4. Distress in suspected lung cancer patients following rapid and standard diagnostic programs: a prospective observational study.

    Science.gov (United States)

    Brocken, Pepijn; van der Heijden, Erik H F M; Oud, Karen T M; Bootsma, Gerben; Groen, Harry J M; Donders, A Rogier T; Dekhuijzen, P N Richard; Prins, Judith B

    2015-04-01

    Timeliness may influence emotional distress during the diagnostic phase of suspected lung cancer patients. We performed a prospective observational study to compare distress and quality of life (QoL) in two medical centres with a Rapid Outpatient Diagnostic Program (RODP) and two using conventional Stepwise Diagnostic Approach (SDA) on the basis of trained nurse-led care. Outpatients with radiological suspicion of lung cancer completed the Hospital Anxiety and Depression Scale (HADS), European Organization for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (QLQ-C30) and its 13-item Lung Cancer specific module (QLQ-LC13) upon first visit, 2 days later, thereafter weekly for 5 weeks and after 3 months. The 72 SDA patients and 121 RODP patients had a mean pre-diagnostic HADS-total score of 13.5 (SD 7.6); 63.4% had a score ≥10. Baseline QLQ-C30 global QoL was 61.6 (SD 22.7) exceeding reference values for lung cancer patients. Generalized least square models showed a significant centre by time interaction effect: during the first 6 weeks, HADS-total scores decreased in RODP patients (13.8-11.9) but sustained in SDA patients (13.1-13.6), whereas QoL showed no relevant changes. Times to diagnosis and discussion of therapy plan for RODP patients were 7 and 11 days shorter, respectively. Suspected lung cancer patients had high baseline distress levels. A decrease over time was found in RODP compared with SDA patients. QoL did not change relevantly. Albeit observational, these data indicate that patients experience less distress in rapid diagnostic programs than in stepwise diagnostic evaluation. Copyright © 2014 John Wiley & Sons, Ltd.

  5. Lower Bispectral index values in psychiatric patients: A prospective, observational study

    Directory of Open Access Journals (Sweden)

    Venkatapura J Ramesh

    2014-01-01

    Full Text Available Background : Bispectral index score (BIS is a processed electroencephalographic parameter used to measure level of sedation in anaesthetised patients. In few studies of psychiatric patients undergoing electroconvulsive therapy (ECT, it was observed that the BIS values were lower at baseline. It is not clear from those studies whether the BIS values are really low. Also, it is not clear whether the lower values are related to the primary psychiatric illness or the due to the effect of ECT. Therefore, we studied the BIS values in psychiatric illnesses and compared them with the normal controls. Materials and Methods : BIS index was recorded in 237 patients with various psychiatric illness (Group P and 40 control patients without any psychiatric illness undergoing spinal surgery (Group C. BIS values were recorded in supine position before breakfast and before the morning doses of antipsychotic/benzodiazepine medications. It was recorded during resting state in all the subjects. Results : BIS values were lower in group P compared to control group (a mean of 89.8 ± 7.8 vs 95.7 ± 2.4, P < 0.0001. In the group P, the patients with psychosis and bipolar disorder had significantly lower BIS values than the patients with depression (P = 0.04. Conclusions : BIS values in psychiatric patients are lower than those in the control group. Psychotic and bipolar disorders are associated with significantly lower BIS values than the depression.

  6. Fingolimod Treatment in Relapsing-Remitting Multiple Sclerosis Patients: A Prospective Observational Multicenter Postmarketing Study

    Directory of Open Access Journals (Sweden)

    Rocco Totaro

    2015-01-01

    Full Text Available Objective. The aim of this prospective observational multicenter postmarketing study was to evaluate fingolimod efficacy in a real world clinical setting. Methods. One hundred forty-two subjects with relapsing-remitting multiple sclerosis (RRMS were enrolled in three multiple sclerosis centers throughout Central and Southern Italy between January 2011 and September 2013. After enrollment, regular visits and EDSS assessment were scheduled every 3 months, and MRI scan was obtained every 12 months. Patients were followed up from 1 to 33 months (mean 14.95 ± 9.15 months. The main efficacy endpoints included the proportion of patients free from clinical relapses, from disability progression, from magnetic resonance imaging activity, and from any disease activity. Results. Out of 142 patients enrolled in the study, 88.1% were free from clinical relapse and 69.0% were free from disability progression; 68.5% of patients remained free from new or newly enlarging T2 lesions and 81.7% of patients were free from gadolinium enhancing lesions. Overall the proportion of patients free from any disease activity was 41.9%. Conclusions. Our data in a real world cohort are consistent with previous findings that yield convincing evidence for the efficacy of fingolimod in patients with RRMS.

  7. Observational study on markers of cardiovascular risk in renal patient: conventional hemodialysis vs. haemofiltration online.

    Science.gov (United States)

    Melero-Rubio, Esperanza; Párraga-Díaz, Mateo; Gómez-Sánchez, M Paz; Pellicer-Villaescusa, Silvia; Merchán-Mayado, Esteban

    2009-12-01

    Homocysteine is considered as independent predictor of cardiovascular risk. Patients treated with haemodialysis (HD) exhibit elevated homocysteine levels, even four times higher than the general population does. This study focuses on the determination of the vascular risk in patients treated with conventional HD and haemodiafiltration on-line (HDF). It was also considered important to determine whether there was a relationship between homocysteine and the variables given to the patient such as dialysis dose, obesity and treatment with folic acid, vitamin B6 and vitamin B12. A one-year cross-sectional observational study was conducted on patients initially treated with renal replacement therapy such as HDF on-line and conventional HD. Data collected included patient's age, sex, aetiology, duration of dialysis treatment and association with dialysis session, including data on body mass index, waist circumference, treatment with vitamin B6, B12 and folic acid. The results obtained conclusively indicate that patients treated with renal replacement therapy such as HDF on-line exhibit lower homocysteine levels than those treated with conventional HD. Therefore we can conclude that: homocysteine markers indicate that patients treated with HDF on-line are exposed to lower average vascular risk.

  8. Recovery in patients with major depressive disorder (MDD): results of a 6-month, multinational, observational study.

    Science.gov (United States)

    Novick, Diego; Montgomery, William; Vorstenbosch, Ellen; Moneta, Maria Victoria; Dueñas, Héctor; Haro, Josep Maria

    2017-01-01

    Not all individuals treated for major depressive disorder (MDD) achieve recovery. This observational study examined the recovery rates in MDD patients and the patient characteristics associated with achieving recovery in a naturalistic clinical setting. Recovery was defined as having both clinical and functional remission. Data for this post hoc analysis were taken from a 24-week prospective, observational study that involved 1,549 MDD patients. Clinical remission was assessed using the 16-item Quick Inventory of Depressive Symptomatology Self-Report and functional remission through the Sheehan Disability Scale and no days of reduced productivity in the previous week. Generalized estimating equation regression models were used to examine the baseline factors associated with recovery during follow-up. Clinical and functional remission was achieved in 70.6% and 56.1% of the MDD patients, respectively. MDD patients who achieved recovery (52.1%) were significantly less likely to have impaired levels of functioning, concurrent medical or psychiatric conditions, low levels of education, or nonadherence to therapy at follow-up. The level of functioning during the index episode seems to be a better predictor of recovery than symptom severity. Therefore, the level of functioning should be considered while determining recovery from depression.

  9. Critical Outcomes in Longitudinal Observational Studies and Registries in Patients with Rheumatoid Arthritis

    DEFF Research Database (Denmark)

    Zamora, Natalia V; Christensen, Robin; Goel, Niti

    2017-01-01

    OBJECTIVE: Outcomes important to patients are those that are relevant to their well-being, including quality of life, morbid endpoints, and death. These outcomes often occur over the longterm and can be identified in prospective longitudinal observational studies (PLOS). There are no standards...... for which outcome domains should be considered. Our overarching goal is to identify critical longterm outcome domains for patients with rheumatic diseases, and to develop a conceptual framework to measure and classify them within the scope of OMERACT Filter 2.0. METHODS: The steps of this initiative...

  10. Risk factors associated with early reintubation in trauma patients: a prospective observational study.

    Science.gov (United States)

    Brown, Carlos V R; Daigle, Jacob B; Foulkrod, Kelli H; Brouillette, Brandee; Clark, Adam; Czysz, Clea; Martinez, Marnie; Cooper, Hassie

    2011-07-01

    After mechanical ventilation, extubation failure is associated with poor outcomes and prolonged hospital and intensive care unit (ICU) stays. We hypothesize that specific and unique risk factors exist for failed extubation in trauma patients. The purpose of this study was to identify the risk factors in trauma patients. We performed an 18-month (January 2008-June 2009) prospective, cohort study of all adult (8 years or older) trauma patients admitted to the ICU who required mechanical ventilation. Failure of extubation was defined as reintubation within 24 hours of extubation. Patients who failed extubation (failed group) were compared with those who were successfully extubated (successful group) to identify independent risk factors for failed extubation. A total of 276 patients were 38 years old, 76% male, 84% sustained blunt trauma, with an mean Injury Severity Score = 21, Glasgow Coma Scale (GCS) score = 7, and systolic blood pressure = 125 mm Hg. Indications for initial intubation included airway (4%), breathing (13%), circulation (2%), and neurologic disability (81%). A total of 17 patients (6%) failed extubation and failures occurred a mean of 15 hours after extubation. Independent risk factors to fail extubation included spine fracture, airway intubation, GCS at extubation, and delirium tremens. Patients who failed extubation spent more days in the ICU (11 vs. 6, p = 0.006) and hospital (19 vs. 11, p = 0.002). Mortality was 6% (n = 1) in the failed group and 0.4% (n = 1) in the successful extubation group. Independent risk factors for trauma patients to fail extubation include spine fracture, initial intubation for airway, GCS at extubation, and delirium tremens. Trauma patients with these four risk factors should be observed for 24 hours after extubation, because the mean time to failure was 15 hours. In addition, increased complications, extended need for mechanical ventilation, and prolonged ICU and hospital stays should be expected for trauma patients

  11. An observation tool for studying patient-oriented workflow in hospital emergency departments.

    Science.gov (United States)

    Ozkaynak, M; Brennan, P

    2013-01-01

    Studying workflow is a critical step in designing, implementing and evaluating informatics interventions in complex sociotechnical settings, such as hospital emergency departments (EDs). Known approaches to studying workflow in clinical settings attend to the activities of individual clinicians, thus being inadequate to characterize patient care as a cooperative work. The purpose of this paper is twofold. First, we introduce a novel, theory-driven patient-oriented workflow methodology, which better addresses the complex, multiple-provider nature of patient care. Second, we report the development of an observational tool and protocol for use in studies of this type, and the results of an evaluation study. We created a tablet computer implementation of an instrument to efficiently capture patient-oriented workflow, and evaluated it through a field study in three EDs. We focused on activities occurring over time during a single patient care episode as well as the roles of the ED staff members who conducted the activities. The evidence generated supports the validity, viability, and reliability of the tool. The coverage of the tool in terms of activities and roles was satisfactory. The tool was able to capture the sequence of activity-role pairs for 108 patient care episodes. The inter-rater reliability assessment yielded a high kappa value (0.79). The patient-oriented workflow methodology has the potential to facilitate modeling patient care in EDs by characterizing both roles and activities in sequence. The methodology also provides researchers and practitioners a more realistic and comprehensive workflow perspective that can inform the design, implementation and evaluation of health information technology interventions.

  12. [Preliminary study on detox in outpatient care units with 18 alcoholic patients in Directly Observed Treatment].

    Science.gov (United States)

    Lloréns Martínez, Ramón; Calatayud Francés, María; Morales Gallús, Esperanza; Añó Cervera, Consol; Adriá Caballero, Librada

    2008-01-01

    Directly Observed Treatment (TOD-DOT) has been tested in different conditions. The objective of this work is to check whether a UCA-CAB (Centre for Addictive Behaviour) can achieve detox and reduce the risk of early relapse (up to 12 weeks) in alcoholic patients. All patients had an established organic addiction and serious withdrawal syndrome, and had undergone multiple previous treatments. Furthermore, they had not managed to abstain for a 3-month consecutive period over the previous 2 years. The aim of the Directly Observed Treatment was to attain detox and reduce relapse by following a multi-method approach: medical, psychological and personal care, based on a brief daily consultation and pharmacological supervision. The results were as follows: Of the 18 patients included in the study, after 12 weeks, 13 (72 %) were still abstinent and 4 (22 %) had relapsed. Thus, 17 (94 %) were still following the treatment, with just one drop-out. We analysed the profiles of the patients abstaining, of those who relapsed (4) and of the one who dropped out. The average CIWA-Ar was 27.05 (21-36). Any value over 20 is considered to indicate serious withdrawal syndrome, though there were no negative events leading to hospitalization. Level of adherence to the treatment (94 %) meant that the most seriously affected patients and those with fewest financial resources could benefit, not only from any auxiliary social schemes, but also from basic health services, permitting them to improve the quality of their everyday life.

  13. Prevalence and Characteristics of Work Anxiety in Medical Rehabilitation Patients: A Cross-Sectional Observation Study.

    Science.gov (United States)

    Muschalla, Beate; Jöbges, Michael

    2018-01-01

    To investigate frequency, type, and characteristics of work anxieties in patients with somatic illness. Cross-sectional observation study. Neurology, orthopedic, and cardiology rehabilitation clinics. Patients (N=1610; age, 18-65y) with work anxieties. Not applicable. Patients who scored high on at least 2 of 9 items in the work-anxiety screening questionnaire and who reported impairment were investigated with a differential diagnostic interview on work anxieties and with the Mini-International Neuropsychiatric Interview on non-work-related common mental disorders. Patients also filled out a self-rating questionnaire on their subjective symptom load and sociodemographic data. Approximately 20% to 27% of the investigated inpatients in somatic rehabilitation (altogether n=393) received a work-anxiety diagnosis. Patients with orthopedic illness report highest work anxiety and have previous longest sick leave (20.6wk in the past 12mo). Patients with orthopedic illness suffer from work-related adjustment disorder with anxiety, social anxieties, and workplace phobias, whereas patients with cardiac illness are more often affected by hypochondriac anxieties. Anxieties of insufficiency and worrying occur equally in all indications. About a quarter of patients in somatic rehabilitation are in need of additional diagnostic attention owing to work anxieties. Differential diagnostic of work anxiety is needed for initiating adequate therapeutic action. Somatic rehabilitation physicians should be aware of work anxieties in their patients, especially in patients with orthopedic illness with previous long-term sick leave. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  14. Clinical characteristics of pneumonia in bedridden patients receiving home care: a 3-year prospective observational study.

    Science.gov (United States)

    Ishida, Tadashi; Tachibana, Hiromasa; Ito, Akihiro; Ikeda, Satoshi; Furuta, Kenjiro; Nishiyama, Akihiro; Noyama, Maki; Tokioka, Fumiaki; Yoshioka, Hiroshige; Arita, Machiko

    2015-08-01

    The aim of the study was to describe the epidemiology, clinical features, antimicrobial treatment, and outcomes of bedridden pneumonia patients receiving home healthcare. A 3-year prospective observational study of poor performance status (PS) 3-4 patients receiving long-term home healthcare and hospitalized at a single center with pneumonia between October 2010 and September 2013 was conducted, and their clinical characteristics were compared with non-bedridden community-acquired pneumonia (CAP) patients. A total of 131 CAP patients with PS 3-4, and 400 CAP patients with PS 0-2 were evaluated. The PS 3-4 patients were older, and exhibited a higher frequency of underlying diseases. Aspiration was thought to be associated with pneumonia in 77.1% of the PS 3-4 patients. Streptococcus pneumoniae was the leading pathogen in both groups, whereas the frequency of streptococci and polymicrobial infections was higher in the PS 3-4 group. The incidence of multidrug-resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa was lower than in previous healthcare-associated pneumonia reports. The in-hospital mortality and recurrence rates were significantly higher in the PS 3-4 group than in the good PS group (17.6% vs. 6.0%, p < 0.001 and 15.3% vs. 7.5%, p = 0.008, respectively). The clinical characteristics of pneumonia in poor PS patients were similar to healthcare-associated pneumonia (HCAP), except for the frequency of drug-resistant pathogens. Hence, it might be beneficial to categorize pneumonia in home residents with poor PS separately from pneumonia in CAP patients who were previously healthy or experienced mild comorbidities. Copyright © 2015 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  15. Observational study to analyze patterns of treatment of breakthrough dyspnea in cancer patients in clinical practice.

    Science.gov (United States)

    Cabezón-Gutiérrez, Luis; Delgado-Mingorance, Ignacio; Nabal-Vicuña, María; Jiménez-López, Antonio Javier; Cabezón-Álvarez, Ana; Soler-López, Begoña

    2018-06-12

    Although breakthrough dyspnea is very frequent in cancer patients, there are no precise recommendations for treating it. The main objective of this study was to analyze what treatments are used in clinical practice for the management of breakthrough dyspnea in cancer patients in Spain and the secondary objectives were to describe the characteristics of cancer patients with breakthrough dyspnea and the attributes of the disorder. Cancer patients over 18 years of age, with breakthrough dyspnea and a Karnofsky performance score of ≥30, who were treated at departments of oncology in institutes across Spain were included in this cross-sectional observational study. The characteristics of breakthrough dyspnea, history of treatment, anthropometric variables, Mahler dyspnea index, Borg scale, Edmonton Symptoms Assessment Scale, and patient satisfaction with current breakthrough dyspnea treatment were assessed. The mean age of the 149 included patients was 66 years (95% confidence interval: 64.3 to 67.9), and 53 were females (35.6%). The mean breakthrough dyspnea intensity was 5.85 (95% confidence interval 5.48 to 6.22, Borg scale). A total of 55.1% of the first-choice treatments consisted of opioids, followed by oxygen (17.3%). A total of 119 patients (79.9%) received monotherapy for breakthrough dyspnea. Patients presenting with basal dyspnea received oxygen in a greater proportion of cases (21.1% vs 7.4%; p = 0.07). Patients with predictable dyspnea received a greater proportion of opioids (70.9% vs 44.4%; p = 0.01). Opioids constitute first-line therapy for breakthrough dyspnea in routine clinical practice, though the scientific evidence supporting their use is scarce. Further information derived from controlled clinical trials is needed regarding the comparative efficacy of the different treatments in order to justify their use.

  16. [Therapeutic characteristance and tolerance of topical comfrey preparations. Results of an observational study of patients].

    Science.gov (United States)

    Koll, R; Klingenburg, S

    2002-01-01

    To analyze the anti-inflammatory and analgetic properties of the topical comfrey, preparations Kytta-Salbe f, Kytta-Plasma f and Kytta-Balsam f applied to bruises, sprains and distortions and painful conditions of the muscles and joints. A prospective open multicentric observational study complying with paragraph 67(6) of the AMG and involving 162 general practitioners. During the two-week period of observation, the patients received an average of one to three applications of the comfrey preparation per day. All 492 questionnaires were evaluated. Efficacy and tolerability were assessed by both physician and patient. Pain at rest and on movement, as also tenderness, improved in the overall observation group by an average of 45-47%. The duration of morning joint stiffness decreased from 20 minutes initially to 3 minutes. During the course of treatment with comfrey, more than two-thirds of the patients were able to reduce or even discontinue their intake of non-steroidal anti-inflammatory drugs and other specific concomitant medication. In most of the cases, both effectiveness and tolerability were assessed to be excellent or good. The results of the study confirm the effectiveness and tolerability of the topical comfrey preparation investigated in the treatment of bruises, sprains and distortions as well as painful conditions affecting muscles and joints.

  17. Pharmacotherapy of elderly patients in everyday anthroposophic medical practice: a prospective, multicenter observational study

    Directory of Open Access Journals (Sweden)

    Bockelbrink Angelina

    2010-07-01

    Full Text Available Abstract Background Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care. Methods Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. Results In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female were included. The most frequent diagnoses were hypertension (11.1%, breast cancer (3.5%, and heart failure (3.0%. In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic. The adjusted odds ratio (AOR for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79, treatment by an internist (AOR = 1.49; CI: 1.40-1.58, female patients (AOR = 1.35; CI: 1.27-1.43, cancer (AOR = 4.54; CI: 4.12-4.99, arthropathies (AOR = 1.36; CI: 1.19-1.55, or dorsopathies (AOR = 1.34; CI: 1.16-1.55 and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98. The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39, diabetes mellitus (AOR = 0.17; CI: 0

  18. An observational study based on the interaction between the paediatric patient and radiographer

    International Nuclear Information System (INIS)

    Harding, J.; Davis, M.

    2015-01-01

    Background: The practice of paediatric radiography requires a completely different skill set to that of adult radiography. Often, obtaining a paediatric patient's cooperation is the most difficult aspect of the role. Ensuring that a child cooperates for the examination can make positioning easier, thereby potentially providing a more diagnostic image. Aim: The aim of this study was to observe the interaction between the paediatric patient and the radiographer and to uncover techniques used by the radiographer to help alleviate any fear or stress that the child might have had. Method: A direct observational method was conducted, after both the radiographer and the child's guardians provided full written consent. The actions of the radiographer and resultant reactions from the child were recorded on an observational checklist designed for paediatric examinations. Results: Seventy-nine patients aged between three months to fifteen years and thirteen radiographers with no specific paediatric training other than experience were observed. Examinations observed included lower limb, upper limb, pelvis, abdomen and chest projections. The data gathered were the result of radiographer actions when interacting with both happy and sad children. Conclusions: Successful methods of alleviating a child's fear and anxiety whilst in the X-ray room included the use of child friendly equipment such as colourful lead protection and posters on the wall, a simple explanation of what the equipment is before moving it, offering rewards such as stickers and praise and showing the child their image after the examination. When time was short and the workload was high, it was observed that radiographers were less likely to spend time calming the child down and instead were more focused on completing the examination as quickly as possible. - Highlights: • Seventy-nine patients and thirteen radiographers were observed in this study. • The use of child-friendly equipment and

  19. Coagulation Profile in Patients with Different Etiologies for Cushing Syndrome: A Prospective Observational Study.

    Science.gov (United States)

    Tirosh, Amit; Lodish, Maya; Lyssikatos, Charalampos; Belyavskaya, Elena; Feelders, Richard A; Stratakis, Constantine A

    2017-05-01

    Previous studies reported a higher prevalence of venous-thromboembolic events among patients with Cushing disease (CD) compared to those with ACTH-independent Cushing syndrome (CS) from adrenal sources. The objective of the current study was to evaluate the coagulation profile of patients with CS from different etiologies. A prospective observational study was conducted at a clinical research center. The study included adult patients admitted for evaluation of suspected CS (n=85), that were divided into 3 groups: CD (n=22), ACTH-independent CS from an adrenal tumor/hyperplasia (adrenal CS, n=21), and a control group consisting of subjects with negative screening for CS (rule-out CS, n=42). Coagulation profiles were drawn before and 8.5±4.3 months after surgery (trans-sphenoidal or adrenalectomy, n=18), and included fibrinogen, Factor VIII (FVIII), von Willebrand factor antigen (vWF:Ag), plasminogen activator inhibitor-1 (PAI-1), antithrombin III (ATIII), Protein C (PC), Protein S (PS), α2-antiplasmin (α2AP), and aPTT measurements. Patients with CD had higher baseline mean cortisol levels, ATIII activity and vWF:Ag levels compared with adrenal CS. Differences in ATIII activity and vWF:Ag levels remained even after controlling for BMI, and ATIII after also controlling for 24-h urinary free cortisol collections. Our study showed for the first time the differences in coagulation profiles between various etiologies of CS. We assume that the higher cortisol burden among CD patients may explain the differences found in the coagulation profile as well as the higher risk for VTE compared with primary adrenal CS patients. © Georg Thieme Verlag KG Stuttgart · New York.

  20. Conifer Green Needle Complex in Patients with Precancerous Gastric Lesions: An Observational Pilot Study

    Directory of Open Access Journals (Sweden)

    Vladimir Bespalov

    2016-01-01

    Full Text Available Objectives. Helicobacter pylori infection is common and can lead to precancerous gastric lesions. Standard antibiotic therapy has a failure rate of more than 25% from antibiotic resistance. The primary aim of this observational pilot study was to test the feasibility of a large-scale clinical trial of Conifer Green Needle Complex (CGNC to treat precancerous gastric lesions. Secondary aims were to investigate H. pylori infection, stomach function, and histopathology of the gastric mucosa. Methods. A tablet form of CGNC (extracted from Pinus sylvestris and Picea abies (L Karst was prescribed to 26 patients with precancerous gastric lesions (two tablets, 100 mg CGNC/tablet, three times per day for six months. Another 24 patients received no treatment. Results. Compared with control patients, CGNC-treated patients showed total or partial regression (using the quantitative Rome III diagnostic criteria of dyspeptic symptoms (92.3%, p<0.0001, eradication of H. pylori infection (57.1%, p<0.03, a reduction in endoscopic signs of gastritis (92.3%, p<0.001, an increase of pepsinogen-pepsin in the gastric juice (57.7%, p<0.05, and total regression or reduction in the degree of intestinal metaplasia (46.2%, p<0.05 and lymphoplasmacytic infiltration (53.8%, p<0.05. Conclusions. This study justifies a randomised-controlled trial with CGNC in patients with atrophic gastritis.

  1. Physician-patient communication about overactive bladder: Results of an observational sociolinguistic study.

    Directory of Open Access Journals (Sweden)

    Steven R Hahn

    Full Text Available Overactive bladder (OAB and urinary incontinence are common problems that have significant impact on quality of life (QOL. Less than half of sufferers seek help from their physicians; many who do are dissatisfied with treatment and their physicians' understanding of their problems. Little is known about the sociolinguistic characteristics of physician-patient communication about OAB in community practice.An IRB-approved observational sociolinguistic study of dialogues between patients with OAB and treating physicians was conducted. Study design included semi-structured post-visit interviews, post-visit questionnaires, and follow-up phone calls. Conversations were analyzed using techniques from interactional sociolinguistics.Communication was physician- rather than patient-centered. Physicians spoke the majority of words and 83% of questions were closed-ended. The impact of OAB on QOL and concerns about and adherence to treatment were infrequently addressed by physicians, who were poorly aligned with patients in their understanding. These topics were addressed more frequently when open-ended questions successfully eliciting elaborated responses were used in ask-tell-ask or ask-tell sequences.Clinical dialogue around OAB is physician-centered; topics critical to managing OAB are infrequently and inadequately addressed. The use of patient-centered communication is correlated with more discussion of critical topics, and thus, more effective management of OAB.

  2. Physician-patient communication about overactive bladder: Results of an observational sociolinguistic study.

    Science.gov (United States)

    Hahn, Steven R; Bradt, Pamela; Hewett, Kathleen A; Ng, Daniel B

    2017-01-01

    Overactive bladder (OAB) and urinary incontinence are common problems that have significant impact on quality of life (QOL). Less than half of sufferers seek help from their physicians; many who do are dissatisfied with treatment and their physicians' understanding of their problems. Little is known about the sociolinguistic characteristics of physician-patient communication about OAB in community practice. An IRB-approved observational sociolinguistic study of dialogues between patients with OAB and treating physicians was conducted. Study design included semi-structured post-visit interviews, post-visit questionnaires, and follow-up phone calls. Conversations were analyzed using techniques from interactional sociolinguistics. Communication was physician- rather than patient-centered. Physicians spoke the majority of words and 83% of questions were closed-ended. The impact of OAB on QOL and concerns about and adherence to treatment were infrequently addressed by physicians, who were poorly aligned with patients in their understanding. These topics were addressed more frequently when open-ended questions successfully eliciting elaborated responses were used in ask-tell-ask or ask-tell sequences. Clinical dialogue around OAB is physician-centered; topics critical to managing OAB are infrequently and inadequately addressed. The use of patient-centered communication is correlated with more discussion of critical topics, and thus, more effective management of OAB.

  3. Physician-patient communication about overactive bladder: Results of an observational sociolinguistic study

    Science.gov (United States)

    Hahn, Steven R.; Bradt, Pamela; Hewett, Kathleen A.; Ng, Daniel B.

    2017-01-01

    Introduction Overactive bladder (OAB) and urinary incontinence are common problems that have significant impact on quality of life (QOL). Less than half of sufferers seek help from their physicians; many who do are dissatisfied with treatment and their physicians’ understanding of their problems. Little is known about the sociolinguistic characteristics of physician-patient communication about OAB in community practice. Methods An IRB-approved observational sociolinguistic study of dialogues between patients with OAB and treating physicians was conducted. Study design included semi-structured post-visit interviews, post-visit questionnaires, and follow-up phone calls. Conversations were analyzed using techniques from interactional sociolinguistics. Results Communication was physician- rather than patient-centered. Physicians spoke the majority of words and 83% of questions were closed-ended. The impact of OAB on QOL and concerns about and adherence to treatment were infrequently addressed by physicians, who were poorly aligned with patients in their understanding. These topics were addressed more frequently when open-ended questions successfully eliciting elaborated responses were used in ask-tell-ask or ask-tell sequences. Discussion Clinical dialogue around OAB is physician-centered; topics critical to managing OAB are infrequently and inadequately addressed. The use of patient-centered communication is correlated with more discussion of critical topics, and thus, more effective management of OAB. PMID:29140974

  4. Response of Treatment in Patients with Primary Headaches and Hypertension: A Prospective Observational Pilot Study

    Directory of Open Access Journals (Sweden)

    Abdullah Cüneyt Hocagil

    2018-03-01

    Full Text Available Objective: To determine the priority in the treatment of patients with primary headaches accompanied by high blood pressure. In our study, we investigated whether there was a relationship between the decline in headache after treatment and the change in the average arterial pressure. Materials and Methods: This prospective observational study was performed with 101 patients who were admitted to the hospital emergency department with primary headache accompanied by high blood pressure. After treatment, the decrease in the severity of headaches, mean arterial pressure, and percentage value for the drop of mean arterial pressure were calculated for all patients. Results: In the study, 25 (24.8% patients’ headache decreased 3 levels, 43 (42.6% patients’ headache decreased 2 levels, and 23 (22.8% patients’ headache decreased one level. The mean arterial pressure value at admission was 118.58±12.65 mmHg, and after treatment at the 30th minute decreased to 98.41±13.43 mmHg. Although there was a statistically significant (p0.05 drop in the mean arterial pressure value of the patients with one level decrease in headache severity after treatment. Conclusion: This study showed that when a primary headache, which is often associated with high blood pressure, was treated instead of treating high blood pressure as a secondary cause of headache, blood pressure decreased spontaneously

  5. A prospective observational study of pigmented naevi changes in psoriasis patients on biologic therapy.

    Science.gov (United States)

    Choi, Seohee Deanne; D'Souza, Mario I; Menzies, Scott W; Weninger, Wolfgang

    2018-05-23

    Patients on biologic therapy are thought to be at increased risk of developing non-melanoma skin cancers and melanomas. It is unknown whether biologic therapy alters the natural history of melanocytic naevi. Therefore, a prospective observational study was conducted to determine whether psoriasis patients on biologic therapy develop changes in naevi. Clinical and dermoscopic assessment of all melanocytic naevi was performed in 45 psoriasis patients on biologic therapy versus a control cohort of 43 subjects, using sequential digital dermoscopic imaging and total body photography. The mean follow-up period was 1.5 years. The study and control patients had comparable age, gender, previous and family history of non-melanoma skin cancers and melanomas, as well as previous sun exposure and total number of naevi. The number of naevi with major dermoscopic changes was 3% in the study and 1.9% in the control group, with an adjusted incidence rate ratio of 1.45 (95% confidence interval 0.90-2.33; P = 0.125). The rate of minor changes was 15.9% in the study group versus 19.4% in the control (adjusted incidence rate ratio 0.77, 95% confidence interval 0.57-1.08; P = 0.14). There were six new dysplastic naevi in 4/45 biologic patients and four in 4/43 controls; however, the difference was not significant (relative risk 0.96, 95% confidence interval -0.12 to 0.12; P = 0.95). There were no melanomas in either group. Over a mean follow-up period of 1.5 years there was no evidence of significantly different changes in naevi or development of new dysplastic naevi in psoriasis patients on biologic treatment compared to controls. © 2018 The Australasian College of Dermatologists.

  6. Mortality in patients with diabetes mellitus and Addison's disease: a nationwide, matched, observational cohort study.

    Science.gov (United States)

    Chantzichristos, Dimitrios; Persson, Anders; Eliasson, Björn; Miftaraj, Mervete; Franzén, Stefan; Bergthorsdottir, Ragnhildur; Gudbjörnsdottir, Soffia; Svensson, Ann-Marie; Johannsson, Gudmundur

    2017-01-01

    Our hypothesis was that patients with diabetes mellitus obtain an additional risk of death if they develop Addison's disease (AD). Nationwide, matched, observational cohort study cross-referencing the Swedish National Diabetes Register with Inpatient, Cancer and Cause of Death Registers in patients with diabetes (type 1 and 2) and AD and matched controls with diabetes. Clinical characteristics at baseline, overall, and cause-specific mortality were assessed. The relative risk of death was assessed using a Cox proportional hazards regression model. Between January 1996 and December 2012, 226 patients with diabetes and AD were identified and matched with 1129 controls with diabetes. Median (interquartile range) follow-up was 5.9 (2.7-8.6) years. When patients with diabetes were diagnosed with AD, they had an increased frequency of diabetes complications, but both medical history of cancer and coronary heart disease did not differ compared with controls. Sixty-four of the 226 patients with diabetes and AD (28%) died, while 112 of the 1129 controls (10%) died. The estimated relative risk increase (hazard ratio) in overall mortality in the diabetes and AD group was 3.89 (95% confidence interval 2.84-5.32) compared with controls with diabetes. The most common cause of death was cardiovascular in both groups, but patients with diabetes and AD showed an increased death rate from diabetes complications, infectious diseases and unknown causes. Patients with the rare combination of diabetes and AD showed a markedly increased mortality and died more frequently from infections and unknown causes than patients with diabetes alone. Improved strategy for the management of this combination of metabolic disorders is needed. © 2017 European Society of Endocrinology.

  7. Reticulocyte Hemoglobin Content Helps Avoid Iron Overload in Hemodialysis Patients: A Retrospective Observational Study.

    Science.gov (United States)

    Capone, Domenico; Cataldi, Mauro; Vinciguerra, Mauro; Mosca, Teresa; Barretta, Salvatore; Ragosta, Annalisa; Sorrentino, Aniello; Vecchione, Alessandra; Barretta, Luca; Tarantino, Giovanni

    2017-01-01

    Anemia in patients suffering from end-stage renal failure is currently treated with Erythropoiesis-Stimulating Agents (ESA). This treatment needs sufficient iron supplementation to avoid an inadequate dosage of ESA. Nowadays modern analytical instruments allow to accurately calculate the content of Hemoglobin (Hb) in reticulocytes (CHr), that can be used as a guide for prescribing patients with the appropriate amount of iron. Patients, undergoing hemodialysis, were retrospectively selected from the database and were divided in two groups: group A received intravenous (IV) iron and subcutaneously ESA, and their dosages were adjusted on the basis of the following parameters: Hb, Mean corpuscular haemoglobin (MCH), CHr with consequent MCH/CHr ratio and reticulocyte count determined by the ADVIA 120 Hematology System of Siemens; group B patients were administered IV iron and ESA monitoring iron storage, Hb and ferritin. The aforementioned parameters and the administered amount of iron and ESA were monitored at baseline, four and eight months from the begining of the study. For ESA supplementation, no difference was observed between the groups at the various observed times. Despite similar Hb levels, the patients of group A needed significant lower doses of IV iron (-57.8%) avoiding risks of organ toxicity and obtaining consequent cost saving of nearly 1 €/patient/month. The use of CHr and its related parameters allows the avoidance of overdosage of IV iron, which can potentially damage organs, and the reduction of health care direct and indirect costs. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

  8. Patient characteristics associated with measurement of routine diabetes care: an observational study.

    Directory of Open Access Journals (Sweden)

    Arna L Van Doorn-Klomberg

    Full Text Available Non-modifiable patient characteristics, including age, gender, ethnicity as well as the occurrence of multi-morbidities, are associated with processes and outcomes of diabetes care. Information on these factors can be used in case mix adjustment of performance measures. However, the practical relevance of such adjustment is not clear. The aim of this study was to assess the strength of associations between patient factors and diabetes care processes and outcomes.We performed an observational study based on routinely collected data of 12,498 diabetes patients in 59 Dutch primary care practices. Data were collected on patient age, gender, whether the patient lived in a deprived area, body mass index and the co-occurrence of cardiovascular disease, chronic obstructive pulmonary disease, depression or anxiety. Outcomes included 6 dichotomous measures (3 process and 3 outcome related regarding glycosylated hemoglobin, systolic blood pressure and low density lipoprotein-cholesterol. We performed separate hierarchical logistic mixed model regression models for each of the outcome measures.Each of the process measure models showed moderate effect sizes, with pooled areas under the curve that varied between 0.66 and 0.76. The frequency of diabetes related consultations as a measure of patient compliance to treatment showed the strongest association with all process measures (odds ratios between 5.6 and 14.5. The effect sizes of the outcome measure models were considerably smaller than the process measure models, with pooled areas under the curve varying from 0.57 to 0.61.Several non-modifiable patient factors could be associated with processes and outcomes of diabetes care. However, associations were small. These results suggest that case-mix correction or stratification in assessing diabetes care has limited practical relevance.

  9. Recovery in patients with major depressive disorder (MDD: results of a 6-month, multinational, observational study

    Directory of Open Access Journals (Sweden)

    Novick D

    2017-10-01

    Full Text Available Diego Novick,1 William Montgomery,2 Ellen Vorstenbosch,3 Maria Victoria Moneta,3 Héctor Dueñas,4 Josep Maria Haro3 1Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 3Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 4Eli Lilly de Mexico, Mexico City, Mexico Abstract: Not all individuals treated for major depressive disorder (MDD achieve recovery. This observational study examined the recovery rates in MDD patients and the patient characteristics associated with achieving recovery in a naturalistic clinical setting. Recovery was defined as having both clinical and functional remission. Data for this post hoc analysis were taken from a 24-week prospective, observational study that involved 1,549 MDD patients. Clinical remission was assessed using the 16-item Quick Inventory of Depressive Symptomatology Self-Report and functional remission through the Sheehan Disability Scale and no days of reduced productivity in the previous week. Generalized estimating equation regression models were used to examine the baseline factors associated with recovery during follow-up. Clinical and functional remission was achieved in 70.6% and 56.1% of the MDD patients, respectively. MDD patients who achieved recovery (52.1% were significantly less likely to have impaired levels of functioning, concurrent medical or psychiatric conditions, low levels of education, or nonadherence to therapy at follow-up. The level of functioning during the index episode seems to be a better predictor of recovery than symptom severity. Therefore, the level of functioning should be considered while determining recovery from depression. Keywords: remission, functional impairment, clinical remission, course of illness, disability, predictors

  10. Usefulness of Positron Emission Tomography in Patients with Syphilis: A Systematic Review of Observational Studies.

    Science.gov (United States)

    Chen, Jian-Hua; Zheng, Xin; Liu, Xiu-Qin

    2017-05-05

    Diagnosis of syphilis is difficult. Follow-up and therapy evaluation of syphilitic patients are poor. Little is known about positron emission tomography (PET) in syphilis. This review was to systematically review usefulness of PET for diagnosis, disease extent evaluation, follow-up, and treatment response assessment in patients with syphilis. We searched PubMed, EMBASE, SCOPUS, Cochrane Library, Web of Science, ClinicalTrials.gov, and three Chinese databases (SinoMed, Wanfang, and CNKI) for English and Chinese language articles from inception to September 2016. We also collected potentially relevant studies and reviews using a manual search. The search keywords included the combined text and MeSH terms "syphilis" and "positron emission tomography". We included studies that reporting syphilis with a PET scan before and/or after antibiotic treatment. The diagnosis of syphilis was based on serological criteria or dark field microscopy. Outcomes include pre- and post-treatment PET scan, pre- and post-treatment computed tomography, and pre- and post-treatment magnetic resonance imaging. We excluded the articles not published in English or Chinese or not involving humans. Of 258 identified articles, 34 observational studies were included. Thirty-three studies were single-patient case reports and one study was a small case series. All patients were adults. The mean age of patients was 48.3 ± 12.1 years. In primary syphilis, increased fluorodeoxyglucose (FDG) accumulation could be seen at the site of inoculation or in the regional lymph nodes. In secondary syphilis with lung, bone, gastrointestinal involvement, or generalized lymphadenopathy, increased FDG uptake was the most commonly detected changes. In tertiary syphilis, increased glucose metabolic activity, hypometabolic lesions, or normal glucose uptake might be seen on PET. There were five types of PET scans in neurosyphilis. A repeated PET scan after treatment revealed apparent or complete resolution of the

  11. Carboxyhemoglobin levels in medical intensive care patients: a retrospective, observational study.

    Science.gov (United States)

    Fazekas, Andreas S; Wewalka, Marlene; Zauner, Christian; Funk, Georg-Christian

    2012-01-11

    Critical illness leads to increased endogenous production of carbon monoxide (CO) due to the induction of the stress-response enzyme, heme oxygenase-1 (HO-1). There is evidence for the cytoprotective and anti-inflammatory effects of CO based on animal studies. In critically ill patients after cardiothoracic surgery, low minimum and high maximum carboxyhemoglobin (COHb) levels were shown to be associated with increased mortality, which suggests that there is an 'optimal range' for HO-1 activity. Our study aimed to test whether this relationship between COHb and outcome exists in non-surgical ICU patients. We conducted a retrospective, observational study in a medical ICU at a university hospital in Vienna, Austria involving 868 critically ill patients. No interventions were undertaken. Arterial COHb was measured on admission and during the course of treatment in the ICU. The association between arterial COHb levels and ICU mortality was evaluated using bivariate tests and a logistic regression model. Minimum COHb levels were slightly lower in non-survivors compared to survivors (0.9%, 0.7% to 1.2% versus 1.2%, 0.9% to 1.5%; P=0.0001), and the average COHb levels were marginally lower in non-survivors compared to survivors (1.5%, 1.2% to 1.8% versus 1.6%, 1.4% to 1.9%, P=0.003). The multivariate logistic regression analysis revealed that the association between a low minimum COHb level and increased mortality was independent of the severity of illness and the type of organ failure. Critically ill patients surviving the admission to a medical ICU had slightly higher minimum and marginally higher average COHb levels when compared to non-survivors. Even though the observed differences are statistically significant, the minute margins would not qualify COHb as a predictive marker for ICU mortality.

  12. Work impairment in bipolar disorder patients--results from a two-year observational study (EMBLEM).

    Science.gov (United States)

    Reed, C; Goetz, I; Vieta, E; Bassi, M; Haro, J M

    2010-10-01

    To explore factors associated with work impairment at 2 years following an acute episode. European Mania in Bipolar disorder Longitudinal Evaluation of Medication (EMBLEM) is a prospective, observational study on the outcomes of patients with a manic/mixed episode. Work impairment was measured using a Longitudinal Interval Follow-up Evaluation (slice of LIFE) item and patients were categorised with either low or high work impairment at each observation. Baseline factors associated with work impairment at 2 years were assessed using multivariate modelling. At baseline (n=2289), 69% of patients had high work impairment. At 2 years (n=1393), high impairment reduced to 41%. Modelling identified rapid cycling as the strongest disease-related factor associated with high work impairment at 2 years, although high work impairment at baseline had the strongest association overall. Lower levels of education, recent admissions, CGI-BP overall severity in the 12 months prior to baseline and CGI-BP mania at baseline all predicted higher work impairment. Living together in a relationship and independent housing were both significantly associated with having low work impairment at 2 years. Work impairment in bipolar disorder is maintained over long periods, and is strongly associated with relationship status, living conditions and various disease-related factors. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

  13. A Retrospective Observational Study of Anesthetic Induction Dosing Practices in Female Elderly Surgical Patients: Are We Overdosing Older Patients?

    Science.gov (United States)

    Akhtar, Shamsuddin; Heng, Joseph; Dai, Feng; Schonberger, Robert B; Burg, Mathew M

    2016-10-01

    Despite guidelines suggesting a 25-50 % reduction in induction doses of intravenous anesthetic agents in the elderly (≥65 years), we hypothesized that practitioners were not sufficiently correcting drug administration for age, contributing to an increased incidence of hypotension in older patients undergoing general anesthesia. We conducted a retrospective, observational study in a tertiary-care academic hospital. The study included 768 female patients undergoing gynecologic surgeries who received propofol-based induction of general anesthesia. Weight-adjusted anesthetic induction dosing, age-associated differences in dosing by ASA-PS (American Society of Anesthesiology-Physical Status), and hemodynamic outcomes between younger (18-64 years, n = 537) and older (≥65 years, n = 231) female patients were analyzed. Older patients received lower doses of propofol and midazolam than younger patients (propofol: 2.037 ± 0.783 vs 2.322 ± 0.834 mg/kg, p < 0.001; midazolam: 0.013 ± 0.014 vs 0.023 ± 0.042 mg/kg, p < 0.001). However, practitioners still consistently exceeded the FDA recommended dose (1-1.5 mg/kg) of propofol for elderly patients. There was no significant difference in the doses of fentanyl administered between the two age groups (1.343 ± 0.744 vs 1.363 ± 0.763 μg/kg, p = 0.744), and doses of fentanyl in older patients exceeded the recommended dose (0.5-1.0 μg/kg). Corresponding to observed overdosing of induction agents, older patients experienced larger decreases in post-induction blood pressure and were more likely to receive vasopressor therapy. Anesthetic induction doses of fentanyl and propofol were not sufficiently corrected in older patients in accordance with recommendations. Significantly greater frequency of post-induction hypotension occurred amongst older patients. Quality improvement efforts may lead to improved outcomes in this vulnerable population.

  14. Comparing nutritional requirements, provision and intakes among patients prescribed therapeutic diets in hospital: An observational study.

    Science.gov (United States)

    Rattray, Megan; Desbrow, Ben; Roberts, Shelley

    Nutrition is an important part of recovery for hospitalized patients. The aim of this study was to assess the nutritional adequacy of meals provided to and consumed by patients prescribed a therapeutic diet. Patients (N = 110) prescribed a therapeutic diet (texture-modified, low-fiber, oral fluid, or food allergy or intolerance diets) for medical or nutritional reasons were recruited from six wards of a tertiary hospital. Complete (24-h) dietary provisions and intakes were directly observed and analyzed for energy (kJ) and protein (g) content. A chart audit gathered demographic, clinical, and nutrition-related information to calculate each patient's disease-specific estimated energy and protein requirements. Provisions and intake were considered adequate if they met ≥75% of the patient's estimated requirements. Mean energy and protein provided to patients (5844 ± 2319 kJ, 53 ± 30 g) were significantly lower than their mean estimated requirements (8786 ± 1641 kJ, 86 ± 18 g). Consequently, mean nutrition intake (4088 ± 2423 kJ, 37 ± 28 g) were significantly lower than estimated requirements. Only 37% (41) of patients were provided with and 18% (20) consumed adequate nutrition to meet their estimated requirements. No therapeutic diet provided adequate food to meet the energy and protein requirements of all recipients. Patients on oral fluid diets had the highest estimated requirements (9497 ± 1455 kJ, 93 ± 16 g) and the lowest nutrient provision (3497 ± 1388 kJ, 25 ± 19 g) and intake (2156 ± 1394 kJ, 14 ± 14 g). Hospitalized patients prescribed therapeutic diets (particularly fluid-only diets) are at risk for malnutrition. Further research is required to determine the most effective strategies to improve nutritional provision and intake among patients prescribed therapeutic diets. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Assessing the Use of Mobile Health Technology by Patients: An Observational Study in Primary Care Clinics.

    Science.gov (United States)

    Ramirez, Veronica; Johnson, Emily; Gonzalez, Cesar; Ramirez, Vanessa; Rubino, Barbara; Rossetti, Gina

    2016-04-19

    There is significant potential for mobile health technology to improve health outcomes for patients with chronic diseases. However, there is a need for further development of mobile health technology that would help to improve the health of lower-income communities. The study objective was to assess mobile phone and app usage among a culturally diverse patient population, and to determine whether patients would be interested in using mobile health technology to help manage their chronic diseases. An observational study was conducted with patients of the Internal Medicine resident primary care clinics of Los Angeles County and University of Southern California (LAC+USC) Medical Center. Self-reported information regarding demographics, current mobile phone usage, current mobile health app and social media usage, barriers to using mobile phones or mobile health apps, and interest in using a mobile health app was collected. Ninety-one percent of patients owned a mobile phone, with 76% (169/223) of these reporting having a mobile phone with Internet capability. Fifty-seven percent of subjects used mobile apps on their mobile phones, and 32% (41/130) of these used mobile apps related to their health. Eighty-six percent (207/241) of respondents voiced interest in using a mobile app to improve their health, and 40% (88/221) stated they would use such an app daily. Patients stated they would find the mobile health app most useful for nutrition, exercise, and obtaining general information on medical conditions. Despite the fact that the majority of our primary care patients were of lower socioeconomic status, they utilized mobile phones with Internet and mobile app capabilities to a great extent. There was substantial interest among our patients in using mobile health technology to both manage chronic disease and improve overall health. Given that cultural, educational, and socioeconomic disparities strongly correlate with higher rates of chronic diseases such as obesity

  16. An observational study in psychiatric acute patients admitted to General Hospital Psychiatric Wards in Italy

    Directory of Open Access Journals (Sweden)

    Margari Francesco

    2007-01-01

    Full Text Available Abstract Objectives this Italian observational study was aimed at collecting data of psychiatric patients with acute episodes entering General Hospital Psychiatric Wards (GHPWs. Information was focused on diagnosis (DSM-IV, reasons of hospitalisation, prescribed treatment, outcome of aggressive episodes, evolution of the acute episode. Methods assessments were performed at admission and discharge. Used psychometric scales were the Brief Psychiatric Rating Scale (BPRS, the Modified Overt Aggression Scale (MOAS and the Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30. Results 864 adult patients were enrolled in 15 GHPWs: 728 (320 M; mean age 43.6 yrs completed both admission and discharge visits. A severe psychotic episode with (19.1% or without (47.7% aggressive behaviour was the main reason of admission. Schizophrenia (42.8% at admission and 40.1% at discharge and depression (12.9% at admission and 14.7% at discharge were the predominant diagnoses. The mean hospital stay was 12 days. The mean (± SD total score of MOAS at admission, day 7 and discharge was, respectively, 2.53 ± 5.1, 0.38 ± 2.2, and 0.21 ± 1.5. Forty-four (6.0% patients had episodes of aggressiveness at admission and 8 (1.7% at day 7. A progressive improvement in each domain/item vs. admission was observed for MOAS and BPRS, while NOSIE-30 did not change from day 4 onwards. The number of patients with al least one psychotic drug taken at admission, in the first 7 days of hospitalisation, and prescribed at discharge, was, respectively: 472 (64.8%, 686 (94.2% and 676 (92.9%. The respective most frequently psychotic drugs were: BDZs (60.6%, 85.7%, 69.5%, typical anti-psychotics (48.3%, 57.0%, 49.6%, atypical anti-psychotics (35.6%, 41.8%, 39.8% and antidepressants (40.9%, 48.8%, 43.2%. Rates of patients with one, two or > 2 psychotic drugs taken at admission and day 7, and prescribed at discharge, were, respectively: 24.8%, 8.2% and 13.5% in mono-therapy; 22.0%, 20

  17. Learning from positively deviant wards to improve patient safety: an observational study protocol.

    Science.gov (United States)

    Baxter, Ruth; Taylor, Natalie; Kellar, Ian; Lawton, Rebecca

    2015-12-11

    Positive deviance is an asset-based approach to improvement which has recently been adopted to improve quality and safety within healthcare. The approach assumes that solutions to problems already exist within communities. Certain groups or individuals identify these solutions and succeed despite having the same resources as others. Within healthcare, positive deviance has previously been applied at individual or organisational levels to improve specific clinical outcomes or processes of care. This study explores whether the positive deviance approach can be applied to multidisciplinary ward teams to address the broad issue of patient safety among elderly patients. Preliminary work analysed National Health Service (NHS) Safety Thermometer data from 34 elderly medical wards to identify 5 'positively deviant' and 5 matched 'comparison' wards. Researchers are blinded to ward status. This protocol describes a multimethod, observational study which will (1) assess the concurrent validity of identifying positively deviant elderly medical wards using NHS Safety Thermometer data and (2) generate hypotheses about how positively deviant wards succeed. Patient and staff perceptions of safety will be assessed on each ward using validated surveys. Correlation and ranking analyses will explore whether this survey data aligns with the routinely collected NHS Safety Thermometer data. Staff focus groups and researcher fieldwork diaries will be completed and qualitative thematic content analysis will be used to generate hypotheses about the strategies, behaviours, team cultures and dynamics that facilitate the delivery of safe patient care. The acceptability and sustainability of strategies identified will also be explored. The South East Scotland Research Ethics Committee 01 approved this study (reference: 14/SS/1085) and NHS Permissions were granted from all trusts. Findings will be published in peer-reviewed, scientific journals, and presented at academic conferences. This study

  18. Symptom clusters predict mortality among dialysis patients in Norway: a prospective observational cohort study.

    Science.gov (United States)

    Amro, Amin; Waldum, Bård; von der Lippe, Nanna; Brekke, Fredrik Barth; Dammen, Toril; Miaskowski, Christine; Os, Ingrid

    2015-01-01

    Patients with end-stage renal disease on dialysis have reduced survival rates compared with the general population. Symptoms are frequent in dialysis patients, and a symptom cluster is defined as two or more related co-occurring symptoms. The aim of this study was to explore the associations between symptom clusters and mortality in dialysis patients. In a prospective observational cohort study of dialysis patients (n = 301), Kidney Disease and Quality of Life Short Form and Beck Depression Inventory questionnaires were administered. To generate symptom clusters, principal component analysis with varimax rotation was used on 11 kidney-specific self-reported physical symptoms. A Beck Depression Inventory score of 16 or greater was defined as clinically significant depressive symptoms. Physical and mental component summary scores were generated from Short Form-36. Multivariate Cox regression analysis was used for the survival analysis, Kaplan-Meier curves and log-rank statistics were applied to compare survival rates between the groups. Three different symptom clusters were identified; one included loading of several uremic symptoms. In multivariate analyses and after adjustment for health-related quality of life and depressive symptoms, the worst perceived quartile of the "uremic" symptom cluster independently predicted all-cause mortality (hazard ratio 2.47, 95% CI 1.44-4.22, P = 0.001) compared with the other quartiles during a follow-up period that ranged from four to 52 months. The two other symptom clusters ("neuromuscular" and "skin") or the individual symptoms did not predict mortality. Clustering of uremic symptoms predicted mortality. Assessing co-occurring symptoms rather than single symptoms may help to identify dialysis patients at high risk for mortality. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  19. Screening and managing obstructive sleep apnoea in nocturnal heart block patients: an observational study.

    Science.gov (United States)

    Wu, Xu; Liu, Zilong; Chang, Su Chi; Fu, Cuiping; Li, Wenjing; Jiang, Hong; Jiang, Liyan; Li, Shanqun

    2016-02-16

    Nocturnal heart block often occurs in patients with obstructive sleep apnoea (OSA). It is more likely to be undiagnosed in heart block patients who are ignorant of the symptoms of sleep disorder. Berlin Questionnaire (BQ) is a highly reliable way to discover the risk factors of OSA, whereas the validity in sleep-related heart block patients is uncertain. We performed an observational study to address these issues and confirmed the potential protective effect of continuous positive airway pressure (CPAP). Patients who were previously diagnosed with nocturnal heart block with R-R pauses exceeding 2 seconds were retrospective screened from the ECG centre of Zhongshan hospital. These recruited participants completed Berlin Questionnaire and underwent polysomnography synchronously with 24-hour Holter monitoring. A cross-sectional analysis was performed to confirm the association between nocturnal arrhythmia and OSA, as well as to assess the diagnostic accuracy of the BQ. Subsequently, subjects diagnosed with OSA (apnoea-hypopnoea index > 5) underwent 3 consecutive days of CPAP therapy. On the third day, patients repeated 24-hour Holter monitoring within the institution of CPAP. The symptoms of disruptive snoring and hypersomnolence in 72 enrolled patients were more related to the occurrence of nocturnal heart block (r = 0.306, 0.226, respectively, p = 0.015, 0.019) than syncope (r = 0.134, p = 0.282) and palpitations (r = 0.106, p = 0.119), which were prominent trait of our study population. The sensitivity, specificity, positive and negative predictive value of the BQ at a cut-off point of 5 of AHI for detecting OSA in heart block patients was 81.0 %, 44.4 %, 91.07 % and 25 %. Nocturnal heart block does not appear to occur exclusively in severe sleep apnoea. The frequent occurrence of arrhythmias in prominent oxygen desaturation supports the correlation between them. CPAP therapy resulted in significant decrease in the average number of

  20. [Utilization of carbamazepine and oxcarbazepine in pediatric patients with partial epilepsy in Spain. An observational study].

    Science.gov (United States)

    Rufo Campos, M; Carreño, M

    2009-01-01

    It is important to conduct studies on the utilization of new antiepileptic drugs in order to improve their use. Our objective is to describe the use patterns of carbamazepine and oxcarbazepine. Observational, cross-sectional, national study with 58 investigators that included 185 pediatric patients with partial epilepsy. We recorded prescription patterns, quality of life (QoL) using the QoL scale in childhood epilepsy (CAVE) and use of resources. 134 patients were under treatment with oxcarbazepine (72.4 %), with a mean dose of 22.3 mg/kg/day; standard deviation (SD): 8.04; 95 % confidence interval (CI): 20.9 to 23.7, and 51 (27.6%) with carbamazepine, mean dose of 14 mg/kg/day; SD: 6.2; 95 % CI: 12.3 to 15.8. A total of 19.4% and 21.6 %, respectively, followed multiple drug treatment. The mean scores on functional dimensions of CAVE were (out of 5): school attendance: 4.5; SD: 0.7; social relationships: 4.1; SD: 0.9, and autonomy: 3.9; SD: 1.9. Patients receiving multiple drug therapy had worse results in quality of life (p used in lower doses than recommended and the dosing is not adjusted for weight. Underdosing may lead to regimes of multiple drug therapy that should be reviewed individually.

  1. Incidence, predictors and outcomes of postoperative coma: an observational study of 858,606 patients.

    Science.gov (United States)

    Newman, Jessica; Blake, Kathryn; Fennema, Jordan; Harris, David; Shanks, Amy; Avidan, Michael S; Kelz, Max B; Mashour, George A

    2013-08-01

    Coma is a state of profound unresponsiveness that can occur as a serious perioperative complication. The study of risk factors for, and sequelae of, postoperative coma has been limited due to the rarity of the event. To determine the incidence, risk factors and impact of postoperative coma in a large patient population. Observational study using a prospectively gathered national dataset. Data from 858 606 patients were analysed. The incidence of postoperative coma of more than 24-h duration was identified. Logistic regression was used to identify independent predictors and develop a risk model of postoperative coma in derivation and validation cohorts; 30-day mortality was also analysed. The incidence of postoperative coma was 0.06%. Multivariate analysis revealed the following independent predictors: liver disease, systemic sepsis, age at least 63 years, renal disease, emergency operation, cardiac disease, hypertension, prior neurological disease, diabetes mellitus and BMI 25 to 29.99 kg m (protective). These predictors were incorporated into a risk index classification; odds ratios for postoperative coma increased from 2.5 with one risk factor to 18.4 with three. Coma was associated with 74.2% all-cause mortality; coma associated with cardiac arrest had a 1.9-fold higher mortality. This is the largest study of postoperative coma ever reported and will be useful for determining risk of coma of more than 24 h duration when evaluating an unresponsive patient following surgery. Data on prognosis will aid medical and ethical decision-making for the comatose surgical patient.

  2. The host response in critically ill sepsis patients on statin therapy: a prospective observational study.

    Science.gov (United States)

    Wiewel, Maryse A; Scicluna, Brendon P; van Vught, Lonneke A; Hoogendijk, Arie J; Zwinderman, Aeilko H; Lutter, René; Horn, Janneke; Cremer, Olaf L; Bonten, Marc J; Schultz, Marcus J; van der Poll, Tom

    2018-01-18

    Statins can exert pleiotropic anti-inflammatory, vascular protective and anticoagulant effects, which in theory could improve the dysregulated host response during sepsis. We aimed to determine the association between prior statin use and host response characteristics in critically ill patients with sepsis. We performed a prospective observational study in 1060 patients admitted with sepsis to the mixed intensive care units (ICUs) of two hospitals in the Netherlands between January 2011 and July 2013. Of these, 351 patients (33%) were on statin therapy before admission. The host response was evaluated by measuring 23 biomarkers providing insight into key pathways implicated in sepsis pathogenesis and by analyzing whole-blood leukocyte transcriptomes in samples obtained within 24 h after ICU admission. To account for indication bias, a propensity score-matched cohort was created (N = 194 in both groups for protein biomarkers and N = 95 in both groups for gene expression analysis). Prior statin use was not associated with an altered mortality up to 90 days after admission (38.0 vs. 39.7% in the non-statin users in the propensity-matched analysis). Statin use did not modify systemic inflammatory responses, activation of the vascular endothelium or the coagulation system. The blood leukocyte genomic response, characterized by over-expression of genes involved in inflammatory and innate immune signaling pathways as well as under-expression of genes associated to T cell function, was not different between patients with and without prior statin use. Statin therapy is not associated with a modified host response in sepsis patients on admission to the ICU.

  3. Patient-Related Benefits for Adults with Cochlear Implantation: A Multicultural Longitudinal Observational Study

    Science.gov (United States)

    Lenarz, Thomas; Muller, Lida; Czerniejewska-Wolska, Hanna; Vallés Varela, Hector; Orús Dotú, César; Durko, Marcin; Huarte Irujo, Alicia; Piszczatowski, Bartosz; Zadrożniak, Marek; Irwin, Colin; Graham, Petra L.; Wyss, Josie

    2017-01-01

    Objectives To assess subjectively perceived, real-world benefits longitudinally for unilateral cochlear implant (CI) recipients in a multinational population treated routinely. To identify possible predictors of self-reported benefits. Design This was a prospective, multicenter, repeated-measures study. Self-assessment of performance at preimplantation and postimplantation at 1, 2, and 3 years using standardized, validated, local language versions of the Speech, Spatial, and Qualities of Hearing Scale (SSQ), and the Health Utilities Index Mark 3 (HUI3) was performed. Outcomes were analyzed using a longitudinal mixed-effects model incorporating country effect. Patient demographics were explored for associations with change over time. Subjects Two hundred ninety-one routinely treated, unilateral CI recipients, aged 137–81 years, from 9 clinics across 4 countries. Results Highly significant improvements were observed for all outcome measures (p < 0.0001). Postimplantation, mean outcome scores remained stable beyond 1 year, with notable individual variability. A significant association for one or more outcomes with preimplantation contralateral hearing aid use, telephone use, age at implantation, implantation side, preimplantation comorbidities, dizziness, and tinnitus was observed (p < 0.004). Conclusions Longitudinal benefits of CI treatment can be measured using clinically standardized self-assessment tools to provide a holistic view of patient-related benefits in routine clinical practice for aggregated data from multinational populations. Self-reported outcomes can provide medical-based evidence regarding CI treatment to support decision-making by health service providers. PMID:28719901

  4. Improving patient safety during insertion of peripheral venous catheters: an observational intervention study

    Directory of Open Access Journals (Sweden)

    Kampf, Günter

    2013-11-01

    Full Text Available [english] Background: Peripheral venous catheters are frequently used in hospitalized patients but increase the risk of nosocomial bloodstream infection. Evidence-based guidelines describe specific steps that are known to reduce infection risk. However, the degree of guideline implementation in clinical practice is not known. The aim of this study was to determine the use of specific steps for insertion of peripheral venous catheters in clinical practice and to implement a multimodal intervention aimed at improving both compliance and the optimum order of the steps.Methods: The study was conducted at University Hospital Hamburg. An optimum procedure for inserting a peripheral venous catheter was defined based on three evidence-based guidelines (WHO, CDC, RKI including five steps with 1A or 1B level of evidence: hand disinfection before patient contact, skin antisepsis of the puncture site, no palpation of treated puncture site, hand disinfection before aseptic procedure, and sterile dressing on the puncture site. A research nurse observed and recorded procedures for peripheral venous catheter insertion for healthcare workers in four different departments (endoscopy, central emergency admissions, pediatrics, and dermatology. A multimodal intervention with 5 elements was established (teaching session, dummy training, e-learning tool, tablet and poster, and direct feedback, followed by a second observation period. During the last observation week, participants evaluated the intervention.Results: In the control period, 207 insertions were observed, and 202 in the intervention period. Compliance improved significantly for four of five steps (e.g., from 11.6% to 57.9% for hand disinfection before patient contact; p<0.001, chi-square test. Compliance with skin antisepsis of the puncture site was high before and after intervention (99.5% before and 99.0% after. Performance of specific steps in the correct order also improved (e.g., from 7.7% to 68

  5. Daily pilates exercise or inactivity for patients with low back pain: a clinical prospective observational study.

    Science.gov (United States)

    Notarnicola, A; Fischetti, F; Maccagnano, G; Comes, R; Tafuri, S; Moretti, B

    2014-02-01

    Studies have shown the effectiveness of a few weekly pilates sessions as helping to reduce lower back pain (LBP). However many patients fear that physical activity can actually make the pain and disability worse. We carried out this observational prospective clinical study to look at the effects that taking part in daily pilates has one on side and on the other the effects of LBP management without physical exercise. The volunteers who participated in this study were recruited from among some local cultural associations. Patients affected by LBP were evaluated. The subjects were 60 volunteers (27 males and 33 females) with a mean age of 51.2 years who had chronic low back pain (CLBP). They were allocated to pilates group (N.=30) or inactivity control group (N.=30). The pilates group performed one-hour lesson of pilates exercise, 5 lessons per week during the following 6 months. The inactivity group continued with their normal daily activities. The Roland-Morris Disability, the Oswestry, the SF-36 and the Spinal Functional Sort Questionaries of all subjects were measured at the baseline (T1) and at 6 months (T2). At T2 improvements were observed in the pilates group with increases in physical and social functioning, general health and vitality (Ppilates. Some authors underlined the possible risk of a lack of adherence to an exercise program at home. This study suggests that a daily pilates program is effective for the management of CLBP. On the other hand, the inactivity contributes to further worsening, inducing a vicious cycle in which pain and physical activity intolerance follow each other.

  6. Plasma proteome analysis in patients with pulmonary arterial hypertension: an observational cohort study.

    Science.gov (United States)

    Rhodes, Christopher J; Wharton, John; Ghataorhe, Pavandeep; Watson, Geoffrey; Girerd, Barbara; Howard, Luke S; Gibbs, J Simon R; Condliffe, Robin; Elliot, Charles A; Kiely, David G; Simonneau, Gerald; Montani, David; Sitbon, Olivier; Gall, Henning; Schermuly, Ralph T; Ghofrani, H Ardeschir; Lawrie, Allan; Humbert, Marc; Wilkins, Martin R

    2017-09-01

    Idiopathic and heritable pulmonary arterial hypertension form a rare but molecularly heterogeneous disease group. We aimed to measure and validate differences in plasma concentrations of proteins that are associated with survival in patients with idiopathic or heritable pulmonary arterial hypertension to improve risk stratification. In this observational cohort study, we enrolled patients with idiopathic or heritable pulmonary arterial hypertension from London (UK; cohorts 1 and 2), Giessen (Germany; cohort 3), and Paris (France; cohort 4). Blood samples were collected at routine clinical appointment visits, clinical data were collected within 30 days of blood sampling, and biochemical data were collected within 7 days of blood sampling. We used an aptamer-based assay of 1129 plasma proteins, and patient clinical details were concealed to the technicians. We identified a panel of prognostic proteins, confirmed with alternative targeted assays, which we evaluated against the established prognostic risk equation for pulmonary arterial hypertension derived from the REVEAL registry. All-cause mortality was the primary endpoint. 20 proteins differentiated survivors and non-survivors in 143 consecutive patients with idiopathic or heritable pulmonary arterial hypertension with 2 years' follow-up (cohort 1) and in a further 75 patients with 2·5 years' follow-up (cohort 2). Nine proteins were both prognostic independent of plasma NT-proBNP concentrations and confirmed by targeted assays. The functions of these proteins relate to myocardial stress, inflammation, pulmonary vascular cellular dysfunction and structural dysregulation, iron status, and coagulation. A cutoff-based score using the panel of nine proteins provided prognostic information independent of the REVEAL equation, improving the C statistic from area under the curve 0·83 (for REVEAL risk score, 95% CI 0·77-0·89; parterial hypertension in cohort 3 (p=0·0133). The protein panel was validated in 93 patients

  7. Rasagiline for sleep disorders in patients with Parkinson’s disease: a prospective observational study

    Directory of Open Access Journals (Sweden)

    Schettino C

    2016-09-01

    Full Text Available Carla Schettino,1,2,* Clemente Dato,1,2,* Guglielmo Capaldo,1,2 Simone Sampaolo,1,2 Giuseppe Di Iorio,1,2 Mariarosa AB Melone1,2 1Department of Medical, Surgical, Neurological, Metabolic Sciences, and Aging, 2Division of Neurology and InterUniversity Center for Research in Neurosciences, Second University of Naples, Naples, Italy *These authors contributed equally to this work Introduction: Rasagiline is a selective, irreversible monoamine oxidase B inhibitor that ameliorates the symptoms of Parkinson’s disease (PD by inhibiting striatal dopamine metabolism. There is also evidence that monoamine oxidase B inhibitors increase melatonin levels in the pineal gland and may have a beneficial effect on sleep disorders, which are a common feature in patients with PD.Methods: This single-center, prospective, observational, 12-week study compared the effect of combination therapy with levodopa 200–300 mg/d + rasagiline 1 mg/d (n=19 with levodopa 200–300 mg/d alone (n=19 in the treatment of sleep disorders in patients with idiopathic PD.Results: After 12 weeks’ treatment, mean sleep latency was significantly (P<0.001 lower and the improvement in sleep latency from baseline was significantly (P=0.001 greater in patients receiving levodopa + rasagiline than in patients receiving levodopa alone. Similarly, at the end of the study, the mean total sleep time was significantly (P=0.002 longer and the improvement from baseline in mean total sleep time was significantly (P=0.026 greater in patients receiving levodopa + rasagiline than levodopa alone. There were no significant differences between treatment groups for the mean number of awakenings reported at week 12 nor the change from baseline to week 12 in mean number of awakenings.Conclusion: Adding rasagiline to levodopa improved sleep outcomes and may be an appropriate option for patients with PD experiencing sleep disorders. Keywords: Parkinson’s disease, rasagiline, sleep disorders, Parkinson

  8. Barriers towards insulin therapy in type 2 diabetic patients: results of an observational longitudinal study

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    Kulzer Bernd

    2010-10-01

    Full Text Available Abstract Background The course of barriers towards insulin therapy was analysed in three different groups of type 2 diabetic patients. This observational longitudinal study surveyed a three-month follow-up. Methods Participants in this study totalled 130 type 2 diabetic patients. The first subgroup was on insulin therapy at baseline (group 1: n = 57, age 55.6 ± 8.7 yrs, disease duration 12.7 ± 7.2 yrs, HbA1c 8.5 ± 1.6% and remained on insulin at follow-up. Of an initial 73 insulin-naïve patients, 44 were switched to insulin therapy (group 2: age 58.1 ± 6.8 yrs, disease duration 7.7 ± 5.0 yrs, HbA1c 9.1 ± 1.7% and 29 patients remained on an oral regimen (group 3: age 52.7 ± 10.7 yrs, disease duration 5.3 ± 4.6 yrs, HbA1c 8.3 ± 1.4%. Barriers towards insulin therapy were measured using the Insulin Treatment Appraisal Scale (ITAS. As generic instruments of health related quality of life patients completed also the Problem Areas of Diabetes Questionnaire (PAID, the WHO-5 Well-Being Scale (WHO-5, the Centre for Epidemiologic Studies Depression Scale (CES-D and the Trait Version of the State Trait Anxiety Inventory (STAI at baseline and at three-month follow-up. Results At the three-month follow-up, HbA1c had improved in all three groups (7.7 ± 1.2% vs. 7.1 ± 1.1% vs. 6.7 ± 0.8%. The course of negative appraisal of insulin therapy was significantly different in the three groups (p > .003: the ITAS score increased in patients remained on oral antidiabetic drugs (51.2 ± 12.2 to 53.6 ± 12.3, whereas it decreased in patients switched to insulin therapy (49.2 ± 9.8 to 46.2 ± 9.9 or remained on insulin treatment (45.8 ± 8.3 to 44.5 ± 8.0. Diabetes-related distress, trait anxiety, and well-being, showed a similar course in all three groups. The depression score improved significantly in patients switched to insulin treatment compared with patients remaining on insulin therapy. Conclusions In summary, this study suggests that a negative

  9. An Observational Study on 100 Patients with Polycystic Ovarian Syndrome (PCOS

    Directory of Open Access Journals (Sweden)

    Khaleda Khanam

    2014-09-01

    Full Text Available Background: Women with polycystic ovarian syndrome (PCOS have chronic anovulation and androgen excess not attributable to another cause. The fundamental pathophysiologic defect is unknown. Defects in LH secretion, LH/FSH ratio, amplitude of LH pulsations have been described; but the prevalence of these defects is not still clearly determined. Objective: To review the variable clinical presentations of polycystic ovarian syndrome. Materials and Methods: This observational study was carried out in Combined Military Hospitals of Jessore, Rangpur and Ghatail during November 2008 to June 2013. One hundred patients attending Gynaecology Outpatient Department (GOPD having at least two of the following criteria ––hyperandrogenism, chronic oligo- or anovulation and ultrasonographic findings were selected. In all selected women LH and FSH serum levels were determined and LH/FSH ratios were calculated. Body mass index (BMI was measured and was scored to classify their state of obesity. The collected data were compiled and arranged in tables and were subjected to analysis. Results: Most of the patients (92% were 20–30 years old. Chief complaint of the patients was infertility, either primary (72% or secondary (28%. Eighty percent women had menstrual irregularities, 30% were hirsute, 71% cases were overweight and 17% were obese. On pelvic ultrasonogram polycystic ovaries were found in 20% cases and 80% had normal ovaries. Thirty percent patients had LH/FSH ratio between 2.1–2.9, 32% had >3 and it was found normal in 38% of cases. Conclusion: PCOS cannot be diagnosed by a single clinical or laboratory finding. The diagnostic approach should be based largely on history and physical examination.

  10. Hospitalization and survival in patients using epoprostenol for injection in the PROSPECT observational study.

    Science.gov (United States)

    Frantz, Robert P; Schilz, Robert J; Chakinala, Murali M; Badesch, David B; Frost, Adaani E; McLaughlin, Vallerie V; Barst, Robyn J; Rosenberg, Daniel M; Miller, Dave P; Hartline, Brian K; Benton, Wade W; Farber, Harrison W

    2015-02-01

    Few studies have prospectively reported outcomes in patients with pulmonary arterial hypertension (PAH) treated with epoprostenol in the modern-day era of oral therapy and combination treatments. The Registry to Prospectively Describe Use of Epoprostenol for Injection (Veletri, prolonged room temperature stable-epoprostenol [RTS-Epo]) in Patients with Pulmonary Arterial Hypertension (PROSPECT) was established to prospectively describe the course of PAH in patients prescribed RTS-Epo. PROSPECT is a multicenter, US-based drug registry of primarily group 1 patients with PAH treated with RTS-Epo who were parenteral-naive or parenteral-transitioned at enrollment. Patients were followed until discontinuation of RTS-Epo, withdrawal, loss to follow-up, death, or end of study (maximum 1 year). One-year freedom from hospitalization (FH) and survival estimates were summarized by prostacyclin history (parenteral-naive or parenteral-transitioned), sex, and chronic renal insufficiency (CRI). A total of 336 patients were included. The overall 1-year FH estimate was 51.0% ± 2.8% and was lower in parenteral-naive patients than parenteral-transitioned patients (42.8% ± 4.3% vs 57.1% ± 3.7%, respectively; P = .002). FH estimates were lower in male patients than female patients (38.3% ± 5.9% vs 54.6% ± 3.2%, respectively; P < .015) and in patients with CRI than patients without CRI (17.0% ± 8.4% vs 53.7% ± 2.9%, respectively; P < .001). The overall 1-year survival estimate was 84.0% ± 2.1%. Survival was poorer in parenteral-naive patients, male patients, and patients with CRI. Risk of hospitalization and mortality remain high in patients with PAH. In particular, patients who are parenteral-naive at initiation of RTS-Epo therapy, male patients, and patients with CRI require close monitoring and aggressive clinical management.

  11. Altered cortical activation during action observation in amyotrophic lateral sclerosis patients: a parametric functional MRI study

    International Nuclear Information System (INIS)

    Li, Haiqing; Li, Yuxin; Yin, Bo; Tang, Weijun; Yu, Xiangrong; Geng, Daoying; Chen, Yan; Huang, Weiyuan; Zhang, Biyun

    2015-01-01

    To investigate functional cerebral abnormalities in patients with amyotrophic lateral sclerosis (ALS) using functional magnetic resonance imaging (fMRI) during action observation. Thirty patients with ALS and 30 matched healthy controls underwent fMRI with an experimental paradigm while observing a video of repetitive flexion-extension of the fingers at three frequency levels or three complexity levels, alternated with periods of a static hand. A parametric analysis was applied to determine the effects of each of the two factors. Action observation activated similar neural networks as the research on execution of action in the ALS patients and healthy subjects in several brain regions related to the mirror-neuron system (MNS). In the ALS patients, in particular, the dorsal lateral premotor cortex (dPMC), inferior parietal gyrus (IPG), and SMA, were more activated compared with the activation in the controls. Increased activation within the primary motor cortex (M1), dPMC, inferior frontal gyrus (IFG), and superior parietal gyrus (SPG) mainly correlated with hand movement frequency/complexity in the videos in the patients compared with controls. The findings indicated an ongoing compensatory process occurring within the higher order motor-processing system of ALS patients, likely to overcome the loss of function. (orig.)

  12. Altered cortical activation during action observation in amyotrophic lateral sclerosis patients: a parametric functional MRI study

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    Li, Haiqing; Li, Yuxin; Yin, Bo; Tang, Weijun; Yu, Xiangrong; Geng, Daoying [Huashan Hospital, Department of Radiology, Fudan University, Shanghai (China); Chen, Yan [Fudan University, Department of Neurology, Huashan Hospital, Shanghai (China); Huang, Weiyuan [People' s Hospital of Hainan Province, Department of Radiology, Haikou, Hainan Province (China); Zhang, Biyun [Nanjing University of Traditional Chinese Medicine, Department of radiotherapy, Affiliated Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing (China)

    2015-09-15

    To investigate functional cerebral abnormalities in patients with amyotrophic lateral sclerosis (ALS) using functional magnetic resonance imaging (fMRI) during action observation. Thirty patients with ALS and 30 matched healthy controls underwent fMRI with an experimental paradigm while observing a video of repetitive flexion-extension of the fingers at three frequency levels or three complexity levels, alternated with periods of a static hand. A parametric analysis was applied to determine the effects of each of the two factors. Action observation activated similar neural networks as the research on execution of action in the ALS patients and healthy subjects in several brain regions related to the mirror-neuron system (MNS). In the ALS patients, in particular, the dorsal lateral premotor cortex (dPMC), inferior parietal gyrus (IPG), and SMA, were more activated compared with the activation in the controls. Increased activation within the primary motor cortex (M1), dPMC, inferior frontal gyrus (IFG), and superior parietal gyrus (SPG) mainly correlated with hand movement frequency/complexity in the videos in the patients compared with controls. The findings indicated an ongoing compensatory process occurring within the higher order motor-processing system of ALS patients, likely to overcome the loss of function. (orig.)

  13. Low Triiodothyronine Syndrome in Patients With Radiation Enteritis: Risk Factors and Clinical Outcomes an Observational Study.

    Science.gov (United States)

    Fan, Shengxian; Ni, Xiaodong; Wang, Jian; Zhang, Yongliang; Tao, Shen; Chen, Mimi; Li, Yousheng; Li, Jieshou

    2016-02-01

    The implications of low triiodothyronine syndrome (LT3S) in patients with radiation enteritis (RE) have not been properly investigated. As such, we conducted this cohort study to investigate the association between LT3S and RE, to explore the etiology of LT3S in RE, to evaluate the clinical features and clinical outcomes of LT3S patients, and to inspect the correlation of clinical variables and LT3S in RE.This prospective study included 39 RE patients. Medical records and various laboratory parameters (including thyroidal, tumorous, nutritional, and radiotherapy variables) were collected in all participants.Our results showed that the incidence of LT3S was 84.6% in patients with RE. Total protein (71.7 ± 5.7 vs 63.2 ± 9.6 g/L, P = 0.04) and albumin (ALB, 46.0 ± 4.6 vs 38.7 ± 5.3 g/L, P = 0.01) were significantly lower in LT3S group compared with those in euthyroid group. Standard thyroid-stimulating hormone index (-0.89 ± 2.11 vs -2.39 ± 1.33, P = 0.03) and sum activity of deiodinases (19.74 ± 4.19 vs 12.55 ± 4.32 nmol/L, P = 0.01) were significantly lower in LT3S group. Patients with LT3S suffered longer duration of hospitalization (48.25 ± 23.29 days in LT3S vs 26.75 ± 10.56 days in euthyroid, P = 0.036). Low serum ALB (β = 0.694, 95% CI = 0.007-0.190, P = 0.037) was the only significant predictor of LT3S.LT3S was common in RE patients. A hypodeiodination condition and a potential pituitary-thyrotroph dysfunction might play a role in the pathophysiology of LT3S in RE. Worse nutritional status and clinical outcomes were confirmed in RE patients with LT3S. Furthermore, total protein and ALB were observed as protective and differentiating parameters of LT3S in RE. In summary, this was the 1st investigation to evaluate the clinical correlation between RE and LT3S, investigate the prevalence of LT3S in RE, and explore the pathogenesis of LT3S, despite the limitation of a

  14. Current clinical nutrition practices in critically ill patients in Latin America: a multinational observational study.

    Science.gov (United States)

    Vallejo, Karin Papapietro; Martínez, Carolina Méndez; Matos Adames, Alfredo A; Fuchs-Tarlovsky, Vanessa; Nogales, Guillermo Carlos Contreras; Paz, Roger Enrique Riofrio; Perman, Mario Ignacio; Correia, Maria Isabel Toulson Davisson; Waitzberg, Dan Linetzky

    2017-08-25

    Malnutrition in critically ill adults in the intensive care unit (ICU) is associated with a significantly elevated risk of mortality. Adequate nutrition therapy is crucial to optimise outcomes. Currently, there is a paucity of such data in Latin America. Our aims were to characterise current clinical nutrition practices in the ICU setting in Latin America and evaluate whether current practices meet caloric and protein requirements in critically ill patients receiving nutrition therapy. We conducted a cross-sectional, retrospective, observational study in eight Latin American countries (Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Panama, and Peru). Eligible patients were critically ill adults hospitalised in the ICU and receiving enteral nutrition (EN) and/or parenteral nutrition (PN) on the Screening Day and the previous day (day -1). Caloric and protein balance on day -1, nutritional status, and prescribed nutrition therapy were recorded. Multivariable logistic regression analysis was performed to identify independent predictors of reaching daily caloric and protein targets. The analysis included 1053 patients from 116 hospitals. Evaluation of nutritional status showed that 74.1% of patients had suspected/moderate or severe malnutrition according to the Subjective Global Assessment. Prescribed nutrition therapy included EN alone (79.9%), PN alone (9.4%), and EN + PN (10.7%). Caloric intake met >90% of the daily target in 59.7% of patients on day -1; a caloric deficit was present in 40.3%, with a mean (±SD) daily caloric deficit of -688.8 ± 455.2 kcal. Multivariable logistic regression analysis showed that combined administration of EN + PN was associated with a statistically significant increase in the probability of meeting >90% of daily caloric and protein targets compared with EN alone (odds ratio, 1.56; 95% confidence interval, 1.02-2.39; p = 0.038). In the ICU setting in Latin America, malnutrition was highly prevalent and caloric

  15. A Prospective Observational Study

    African Journals Online (AJOL)

    Methods: This was a prospective, questionnaire-based observational study. Printed questionnaires were distributed to the visitors of medical, surgical and neurosurgical ICU patients to determine awareness of basic infection control practices among visitors to an ICU. All the ICU staff, including nurses, doctors, consultant ...

  16. Effect of Immunotherapy on Seizure Outcome in Patients with Autoimmune Encephalitis: A Prospective Observational Registry Study

    Science.gov (United States)

    Jung, Keun-Hwa; Sunwoo, Jun-Sang; Moon, Jangsup; Lim, Jung-Ah; Lee, Doo Young; Shin, Yong-Won; Kim, Tae-Joon; Lee, Keon-Joo; Lee, Woo-Jin; Lee, Han-Sang; Jun, Jinsun; Kim, Dong-Yub; Kim, Man-Young; Kim, Hyunjin; Kim, Hyeon Jin; Suh, Hong Il; Lee, Yoojin; Kim, Dong Wook; Jeong, Jin Ho; Choi, Woo Chan; Bae, Dae Woong; Shin, Jung-Won; Jeon, Daejong; Park, Kyung-Il; Jung, Ki-Young; Chu, Kon; Lee, Sang Kun

    2016-01-01

    Objective To evaluate the seizure characteristics and outcome after immunotherapy in adult patients with autoimmune encephalitis (AE) and new-onset seizure. Methods Adult (age ≥18 years) patients with AE and new-onset seizure who underwent immunotherapy and were followed-up for at least 6 months were included. Seizure frequency was evaluated at 2–4 weeks and 6 months after the onset of the initial immunotherapy and was categorized as “seizure remission”, “> 50% seizure reduction”, or “no change” based on the degree of its decrease. Results Forty-one AE patients who presented with new-onset seizure were analysed. At 2–4 weeks after the initial immunotherapy, 51.2% of the patients were seizure free, and 24.4% had significant seizure reduction. At 6 months, seizure remission was observed in 73.2% of the patients, although four patients died during hospitalization. Rituximab was used as a second-line immunotherapy in 12 patients who continued to have seizures despite the initial immunotherapy, and additional seizure remission was achieved in 66.6% of them. In particular, those who exhibited partial response to the initial immunotherapy had a better seizure outcome after rituximab, with low adverse events. Conclusion AE frequently presented as seizure, but only 18.9% of the living patients suffered from seizure at 6 months after immunotherapy. Aggressive immunotherapy can improve seizure outcome in patients with AE. PMID:26771547

  17. Effect of Immunotherapy on Seizure Outcome in Patients with Autoimmune Encephalitis: A Prospective Observational Registry Study.

    Directory of Open Access Journals (Sweden)

    Jung-Ick Byun

    Full Text Available To evaluate the seizure characteristics and outcome after immunotherapy in adult patients with autoimmune encephalitis (AE and new-onset seizure.Adult (age ≥18 years patients with AE and new-onset seizure who underwent immunotherapy and were followed-up for at least 6 months were included. Seizure frequency was evaluated at 2-4 weeks and 6 months after the onset of the initial immunotherapy and was categorized as "seizure remission", "> 50% seizure reduction", or "no change" based on the degree of its decrease.Forty-one AE patients who presented with new-onset seizure were analysed. At 2-4 weeks after the initial immunotherapy, 51.2% of the patients were seizure free, and 24.4% had significant seizure reduction. At 6 months, seizure remission was observed in 73.2% of the patients, although four patients died during hospitalization. Rituximab was used as a second-line immunotherapy in 12 patients who continued to have seizures despite the initial immunotherapy, and additional seizure remission was achieved in 66.6% of them. In particular, those who exhibited partial response to the initial immunotherapy had a better seizure outcome after rituximab, with low adverse events.AE frequently presented as seizure, but only 18.9% of the living patients suffered from seizure at 6 months after immunotherapy. Aggressive immunotherapy can improve seizure outcome in patients with AE.

  18. The NIMO Scandinavian Study: A Prospective Observational Study of Iron Isomaltoside Treatment in Patients with Iron Deficiency

    Directory of Open Access Journals (Sweden)

    Svein Oskar Frigstad

    2017-01-01

    Full Text Available Background. Intravenous iron allows for efficient and well-tolerated treatment in iron deficiency and is routinely used in diseases of the gastrointestinal tract. Objective. The aims of this study were to determine the probability of relapse of iron deficiency over time and to investigate treatment routine, effectiveness, and safety of iron isomaltoside. Methods. A total of 282 patients treated with iron isomaltoside were observed for two treatments or a minimum of one year. Results. Out of 282 patients, 82 had Crohn’s disease and 67 had ulcerative colitis. Another 133 patients had chronic blood loss, malabsorption, or malignancy. Patients who received an iron isomaltoside dose above 1000 mg had a 65% lower probability of needing retreatment compared with those given 1000 mg. A clinically significant treatment response was shown, but in 71/191 (37% of patients, anaemia was not corrected. The mean dose given was 1100 mg, lower than the calculated total iron need of 1481 mg. Adverse drug reactions were reported in 4% of patients. Conclusion. Iron isomaltoside is effective with a good safety profile, and high doses reduce the need for retreatment over time. Several patients were anaemic after treatment, indicating that doses were inadequate for full iron correction. This trial is registered with NCT01900197.

  19. How do GPs in Switzerland perceive their patients' satisfaction and expectations? An observational study.

    Science.gov (United States)

    Sebo, Paul; Herrmann, François R; Haller, Dagmar M

    2015-06-10

    To assess doctors' perceptions of their patients' satisfaction and expectations in primary care. Cross-sectional study using questionnaires completed by general practitioners (GPs) and their patients. Primary care practices in Geneva, Switzerland. 23 GPs from a random list of 75 GPs practising in the canton of Geneva (participation rate 31%), who each recruited between 50 and 100 consecutive patients coming to the practice for a scheduled medical consultation, leading to a total of 1637 patients (participation rate: 97%, women: 63%, mean age: 54 years). Patient exclusion criteria were: new patients, those consulting in an emergency situation or suffering from disorders affecting their ability to consent, and those who did not speak French. Patients satisfaction with and expectations from the care they received in this practice; GPs perceptions of their patient's satisfaction and expectations. GPs underestimated all patient satisfaction items (p<0.001 for all items) whereas they overestimated their expectations, except for equipment (laboratory and X-ray) and some accessibility items. In a multivariate analysis to assess which GP factors were associated with correct assessment of their patients' views, only GPs' certification status was a significant factor. GPs tend to underestimate patients' satisfaction but overestimate their expectations in primary care. These findings may help GPs to understand patients' views in order to adequately meet their expectations and concerns. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  20. Use of an electronic patient portal among the chronically ill: an observational study.

    Science.gov (United States)

    Riippa, Iiris; Linna, Miika; Rönkkö, Ilona; Kröger, Virpi

    2014-12-08

    Electronic patient portals may enhance effective interaction between the patient and the health care provider. To grasp the full potential of patient portals, health care providers need more knowledge on which patient groups prefer electronic services and how patients should be served through this channel. The objective of this study was to assess how chronically ill patients' state of health, comorbidities, and previous care are associated with their adoption and use of a patient portal. A total of 222 chronically ill patients, who were offered access to a patient portal with their health records and secure messaging with care professionals, were included in the study. Differences in the characteristics of non-users, viewers, and interactive users of the patient portal were analyzed before access to the portal. Patients' age, gender, diagnoses, levels of the relevant physiological measurements, health care contacts, and received physiological measurements were collected from the care provider's electronic health record. In addition, patient-reported health and patient activation were assessed by a survey. Despite the broad range of measures used to indicate the patients' state of health, the portal user groups differed only in their recorded diagnosis for hypertension, which was most common in the non-user group. However, there were significant differences in the amount of care received during the year before access to the portal. The non-user group had more nurse visits and more measurements of relevant physiological outcomes than viewers and interactive users. They also had fewer referrals to specialized care during the year before access to the portal than the two other groups. The viewers and the interactive users differed from each other significantly in the number of nurse calls received, the interactive users having more calls than the viewers. No significant differences in age, gender, or patient activation were detected between the user groups. Previous

  1. A prospective observational study of ICU patient position and frequency of turning.

    Science.gov (United States)

    Goldhill, D R; Badacsonyi, A; Goldhill, A A; Waldmann, C

    2008-05-01

    Positioning and turning critically ill patients may be beneficial but there are little data on current practice. We prospectively recorded patient position every hour over two separate days in 40 British intensive care units and analysed 393 sets of observation. Five patients were prone at any time and 3.8% (day 1) and 5% (day 2) were on rotating beds. Patients were on their back for 46.1% of observations, turned left for 28.4% and right for 25.5%, and head up for 97.4%. A turn was defined as a change between on back, turned left or turned right. The average time (SD) between turns was 4.85 (3.3) h. There was no significant association between the average time between turns and age, weight, height, gender, respiratory diagnosis, intubated and ventilated, sedation score, day of week or nurse:patient ratio. There was a significant difference between hospitals in the frequency with which patients were turned.

  2. Neuropsychiatric and cardiometabolic comorbidities in patients with previously diagnosed Cushing's disease: a longitudinal observational study

    OpenAIRE

    Dimopoulou, C; Geraedts, V; Stalla, G K; Sievers, C

    2015-01-01

    INTRODUCTION: Only few studies have systematically investigated neuropsychiatric aspects in patients with Cushing's disease (CD). Pain syndromes have been described in patients with pituitary adenomas, but so far no systematical investigation has been conducted in patients with CD. Additionally, CD has an association with cardiometabolic comorbidities which ultimately leads to increased morbidity and mortality. Long-term treatment of the hypercortisolic state cannot prevent the persistence of...

  3. Patient satisfaction and side effects in primary care: An observational study comparing homeopathy and conventional medicine

    Directory of Open Access Journals (Sweden)

    Thurneysen André

    2008-09-01

    Full Text Available Abstract Background This study is part of a nationwide evaluation of complementary medicine in Switzerland (Programme Evaluation of Complementary Medicine PEK and was funded by the Swiss Federal Office of Public Health. The main objective of this study is to investigate patient satisfaction and perception of side effects in homeopathy compared with conventional care in a primary care setting. Methods We examined data from two cross-sectional studies conducted in 2002–2003. The first study was a physician questionnaire assessing structural characteristics of practices. The second study was conducted on four given days during a 12-month period in 2002/2003 using a physician and patient questionnaire at consultation and a patient questionnaire mailed to the patient one month later (including Europep questionnaire. The participating physicians were all trained and licensed in conventional medicine. An additional qualification was required for medical doctors providing homeopathy (membership in the Swiss association of homeopathic physicians SVHA. Results A total of 6778 adult patients received the questionnaire and 3126 responded (46.1%. Statistically significant differences were found with respect to health status (higher percentage of chronic and severe conditions in the homeopathic group, perception of side effects (higher percentage of reported side effects in the conventional group and patient satisfaction (higher percentage of satisfied patients in the homeopathic group. Conclusion Overall patient satisfaction was significantly higher in homeopathic than in conventional care. Homeopathic treatments were perceived as a low-risk therapy with two to three times fewer side effects than conventional care

  4. Podiatric care for diabetic patients with foot problems: an observational study.

    NARCIS (Netherlands)

    Rijken, P.M.; Dekker, J.; Lankhorst, G.J.; Dekker, E.; Bakker, K.; Dooren, J.; Rauwerda, J.A.

    1999-01-01

    The aims of this study were to describe podiatric care for diabetic patients with foot problems and to explore the changes in knowledge, self-care behaviour and physical functioning after podiatric care. the treatment characteristics of 26 diabetic patients referred to podiatry were assessed. Prior

  5. What components of chronic care organisation relate to better primary care for coronary heart disease patients? An observational study.

    NARCIS (Netherlands)

    Lieshout, J. van; Frigola Capell, E.; Ludt, S.; Grol, R.P.T.M.; Wensing, M.J.P.

    2012-01-01

    OBJECTIVES: Cardiovascular risk management (CVRM) received by patients shows large variation across countries. In this study we explored the aspects of primary care organisation associated with key components of CVRM in coronary heart disease (CHD) patients. DESIGN: Observational study. SETTING: 273

  6. Thiamine in septic shock patients with alcohol use disorders: An observational pilot study.

    Science.gov (United States)

    Holmberg, Mathias Johan; Moskowitz, Ari; Patel, Parth Vijay; Grossestreuer, Anne Victoria; Uber, Amy; Stankovic, Nikola; Andersen, Lars Wiuff; Donnino, Michael William

    2018-02-01

    Alcohol-use disorders (AUDs) have been associated with increased sepsis-related mortality. As patients with AUDs are often thiamine deficient, we investigated practice patterns relating to thiamine administration in patients with AUDs presenting with septic shock and explored the association between receipt of thiamine and mortality. We performed a retrospective cohort study of patients presenting with septic shock between 2008 and 2014 at a single tertiary care center. We identified patients with an AUD diagnosis, orders for microbial cultures and use of antibiotics, vasopressor dependency, and lactate levels≥4mmol/L. We excluded those who received thiamine later than 48h of sepsis onset. We included 53 patients. Thirty-four (64%) patients received thiamine. Five patients (15%) received their first thiamine dose in the emergency department. The median time to thiamine administration was 9 (quartiles: 4, 18) hours. The first thiamine dose was most often given parenterally (68%) and for 100mg (88%). In those receiving thiamine, 15/34 (44%) died, compared to 15/19 (79%) of those not receiving thiamine, p=0.02. A considerable proportion of patients with AUDs admitted for septic shock do not receive thiamine. Thiamine administration in this patient population was associated with decreased mortality. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Hand hygiene compliance in transplant and other special patient groups: an observational study.

    Science.gov (United States)

    Graf, Karolin; Ott, Ella; Wolny, Michael; Tramp, Nadine; Vonberg, Ralf-Peter; Haverich, Axel; Chaberny, Iris Freya

    2013-06-01

    This study evaluates hand hygiene behavior of health care workers in a German university hospital stratified for treatment of special patient groups (eg, transplant patients). From 2008 to 2010, comprehensive education and training of all health care workers was implemented to improve hand hygiene compliance. Consumption rates of alcohol-based hand rub and gloves were collected and evaluated. Of the 5,647 opportunities of hand disinfection evaluated, 1,607 occurred during care for transplant patients. To our knowledge, this is the largest survey of hand hygiene compliance in special patient groups on intensive care units in a university hospital in Germany. Health care workers on surgical intensive care units showed lower hand hygiene compliance compared with health care workers on other types of intensive care units. Compliance toward hand hygiene was significantly higher on hemato-oncologic and pediatric wards. In general, hand disinfection was performed significantly more frequently after an intervention than before (P hand hygiene compliance when caring for transplant patients or other patients (odds ratio, 1.16; 95% confidence interval: 0.95-1.42). Nurse's and physician's hand hygiene compliance improved because of education. Hand hygiene compliance is not increased in the care for transplant patients (despite their predisposition for nosocomial infections) compared with other patients. Additional studies will be necessary to further investigate these findings. Copyright © 2013 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

  8. What components of chronic care organisation relate to better primary care for coronary heart disease patients? An observational study.

    OpenAIRE

    Lieshout, J. van; Frigola Capell, E.; Ludt, S.; Grol, R.P.T.M.; Wensing, M.J.P.

    2012-01-01

    OBJECTIVES: Cardiovascular risk management (CVRM) received by patients shows large variation across countries. In this study we explored the aspects of primary care organisation associated with key components of CVRM in coronary heart disease (CHD) patients. DESIGN: Observational study. SETTING: 273 primary care practices in Austria, Belgium, England, Finland, France, Germany, The Netherlands, Slovenia, Switzerland and Spain. PARTICIPANTS: A random sample of 4563 CHD patients identified by co...

  9. Effects of nurse staffing, work environments, and education on patient mortality: an observational study.

    Science.gov (United States)

    Cho, Eunhee; Sloane, Douglas M; Kim, Eun-Young; Kim, Sera; Choi, Miyoung; Yoo, Il Young; Lee, Hye Sun; Aiken, Linda H

    2015-02-01

    While considerable evidence has been produced showing a link between nursing characteristics and patient outcomes in the U.S. and Europe, little is known about whether similar associations are present in South Korea. To examine the effects of nurse staffing, work environment, and education on patient mortality. This study linked hospital facility data with staff nurse survey data (N=1024) and surgical patient discharge data (N=76,036) from 14 high-technology teaching hospitals with 700 or more beds in South Korea, collected between January 1, 2008 and December 31, 2008. Logistic regression models that corrected for the clustering of patients in hospitals were used to estimate the effects of the three nursing characteristics on risk-adjusted patient mortality within 30 days of admission. Risk-adjusted models reveal that nurse staffing, nurse work environments, and nurse education were significantly associated with patient mortality (OR 1.05, 95% CI 1.00-1.10; OR 0.52, 95% CI 0.31-0.88; and OR 0.91, CI 0.83-0.99; respectively). These odds ratios imply that each additional patient per nurse is associated with an 5% increase in the odds of patient death within 30 days of admission, that the odds of patient mortality are nearly 50% lower in the hospitals with better nurse work environments than in hospitals with mixed or poor nurse work environments, and that each 10% increase in nurses having Bachelor of Science in Nursing Degree is associated with a 9% decrease in patient deaths. Nurse staffing, nurse work environments, and percentages of nurses having Bachelor of Science in Nursing Degree in South Korea are associated with patient mortality. Improving hospital nurse staffing and work environments and increasing the percentages of nurses having Bachelor of Science in Nursing Degree would help reduce the number of preventable in-hospital deaths. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. Prevention of NSAID gastropathy in elderly patients. An observational study in general practice and nursing homes.

    Science.gov (United States)

    van Leen, M W F; van der Eijk, I; Schols, J M G A

    2007-07-01

    The objectives of this study were to (i) survey the risk factors for NSAID gastropathy in outpatients (elderly patients in the community), compared to those living in old people's homes or nursing homes, (ii) study the prescription of medication prophylaxis during use of NSAIDs conform the current national guidelines and (iii) survey the influence on gastrointestinal symptoms and safety of pantoprazole 20 mg as prophylaxis for NSAID gastropathy. Patients over 65 years of age, using an NSAID without prophylaxis or newly starting NSAID treatment were included in the study. Pantoprazole 20 mg was prescribed as prophylaxis. Patients using an NSAID with prophylaxis being a proton pump inhibitor at the first visit were registered for epidemiological reasons. Demographic data, risk factors, gastrointestinal complaints, and adverse events were collected at t = 0, t = 2 weeks, t = 3 months and t = 6 months. Differences between groups were analysed with Chi-square tests and Mann-Whitney U tests; changes in time in GI symptoms were tested using Wilcoxon signed ranks tests and McNemar tests. One hundred eighty one general practitioners (treating outpatients and patients in old people's homes)and five nursing home physicians participated in the study and a total of 615 patients were included (522 patients treated by general practitioners (GP) and 93 patients in nursing homes). Four hundred thirty two patients were using NSAIDs without prophylaxis or started using an NSAID at the first visit; 269 (62.1%) and 163 (37.9%) patients respectively. 65.3% of the outpatients (224 out of 343) did not receive indicated prophylaxis, versus 76.2% (16 out of 21) in old people's homes and 42.6% in nursing homes (29 out of 69) (P NSAID prior to the study complained of gastrointestinal symptoms compared to new users (P NSAIDs caused these symptoms. After 2 weeks of treatment with pantoprazole, there was no statistical difference between the two groups. Moreover, both groups showed improvement

  11. Patients with cardiac arrest are ventilated two times faster than guidelines recommend : An observational prehospital study using tracheal pressure measurement

    NARCIS (Netherlands)

    Maertens, Vicky L.; De Smedt, Lieven E. G.; Lemoyne, Sabine; Huybrechts, Sofie A. M.; Wouters, Kristien; Kalmar, Alain F.; Monsieurs, Koenraad G.

    Aim: To measure ventilation rate using tracheal airway pressures in prehospitally intubated patients with and without cardiac arrest. Methods: Prospective observational study. In 98 patients (57 with and 41 without cardiac arrest) an air-filled catheter was inserted into the endotracheal tube and

  12. Does the Internet provide patients or clinicians with useful information regarding faecal incontinence? An observational study.

    Science.gov (United States)

    Leo, C A; Murphy, J; Hodgkinson, J D; Vaizey, C J; Maeda, Y

    2018-01-01

    The Internet has become an important platform for information communication. This study aim to investigate the utility of social media and search engines to disseminate faecal incontinence information. We looked into Social media platforms and search engines. There was not a direct patient recruitment and any available information from patients was already on public domain at the time of search. A quantitative analysis of types and volumes of information regarding faecal incontinence was made. Twelve valid pages were identified on Facebook: 5 (41%) pages were advertising commercial incontinence products, 4 (33%) pages were dedicated to patients support groups and 3 (25%) pages provided healthcare information. Also we found 192 Facebook posts. On Twitter, 2890 tweets were found of which 51% tweets provided healthcare information; 675 (45%) were sent by healthcare professionals to patients, 530 tweets (35.3%) were between healthcare professionals, 201 tweets (13.4%) were from medical journals or scientific books and 103 tweets (7%) were from hospitals or clinics with information about events and meetings. The second commonest type of tweets was advertising commercial incontinence products 27%. Patients tweeted to exchange information and advice between themselves (20.5%). In contrast, search engines as Google/Yahoo/Bing had a higher proportion of healthcare information (over 70%). Internet appears to have potential to be a useful platform for patients to learn about faecal incontinence and share information; however, given one lack of focus of available data, patients may struggle to identify valid and useful information.

  13. The effectiveness of Korean medicine treatment in male patients with infertility: a study protocol for a prospective observational pilot study.

    Science.gov (United States)

    Kim, Kwan-Ii; Jo, Junyoung

    2018-01-01

    Male factor subfertility has increasingly been considered the cause of infertility in couples. Many men with male infertility have sperm problems such as oligozoospermia, asthenozoospermia, or teratozoospermia. Because abnormal semen parameters are idiopathic to some extent, no standard therapy has been established to date. Herbal medicine has been reported to have beneficial properties in the treatment of subfertility, especially in improving semen quality both in vivo and in human studies. Therefore, we intend to investigate the effectiveness and safety of treatment using Korean medicine (KM) for infertile male patients with poor semen quality.This will be a single-center, prospective, case-only observational pilot study. About 20 male patients with infertility who visit Conmaul Hospital of Korean Medicine will be recruited. We will follow the standard treatment protocol, which has shown good results in the treatment of male infertility. The protocol is composed mainly of a 10-week herbal decoction treatment; acupuncture and/or pharmacopuncture are added when needed. Semen samples, quality of life, and the scrotal temperatures of infertile men will be observed before and after the 10-week treatment with KM.The study has received ethical approval from the Public Institutional Review Board (approval number: P01-201708-21-008). The findings will be disseminated to appropriate audiences via peer-reviewed publication and conference presentations. Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002611.

  14. Home parenteral nutrition improves quality of life and nutritional status in patients with cancer: a French observational multicentre study.

    Science.gov (United States)

    Culine, S; Chambrier, C; Tadmouri, A; Senesse, P; Seys, P; Radji, A; Rotarski, M; Balian, A; Dufour, P

    2014-07-01

    Malnutrition is a predictor of poor outcomes in patients with cancer. Little is known about the benefit of nutritional support in these patients. The purpose of this study was to assess the impact of home parenteral nutrition (HPN) on quality of life (Qol) in cancer patients. We performed an observational prospective study to determine the impact of HPN on Qol in a population of patients with heterogeneous cancer. Physicians, patients and family members had to complete a questionnaire before HPN administration and 28 days after the course of HPN. Qol was evaluated using the self-administered questionnaire FACT-G. We included 767 patients with cancer of whom 437 ended the study. Mean patient age was 63±11.4 years and 60.5% were men. Primary gastrointestinal cancer was reported in 50% of patients and 65.3% were presenting metastases. Malnutrition was reported in 98.3%. After 28 days of HPN intake, significant improvement was observed in the Qol (49.95±5.82 vs. 48.35±5.01 at baseline, pnutrition risk index had also improved significantly. Most patients (78%) had perceived a positive impact of the HPN. A significant improvement in patient's well-being was perceived also by family members and physicians. Our data suggest that preventing and correcting malnutrition using HPN in patients with cancer might have a significant benefit on their well-being. Randomized controlled studies are required to confirm this finding.

  15. Refeeding syndrome influences outcome of anorexia nervosa patients in intensive care unit: an observational study.

    Science.gov (United States)

    Vignaud, Marie; Constantin, Jean-Michel; Ruivard, Marc; Villemeyre-Plane, Michele; Futier, Emmanuel; Bazin, Jean-Etienne; Annane, Djillali

    2010-01-01

    Data on the epidemiology and management of anorexia nervosa (AN) in the intensive care unit (ICU) are scarce. The aim of this study was to evaluate the prevalence and associated morbidity and mortality of AN in French ICUs. We randomly selected 30 ICUs throughout France. Thereafter, we retrospectively analyzed all patients with AN admitted to any of these 30 ICUs between May 2006 and May 2008. We considered demographic data, diagnosis at admission and complications occurring during the stay, focusing on refeeding syndrome and management of refeeding. Eleven of the 30 ICUs participated in the retrospective study, featuring 68 patients, including 62 women. Average body mass index at the admission was 12 ± 3 kg/m2. Twenty one were mechanically ventilated, mainly for neurological reasons. The reported average calorie intake was 22.3 ± 13 kcal/kg/24 h. Major diagnoses at admission were metabolic problems, refeeding survey and voluntary drug intoxication and infection. The most common complications were metabolic, hematological, hepatic, and infectious events, of which 10% occurred during refeeding. Seven patients developed refeeding syndrome. At day one, the average calorie intake was higher for patients who developed refeeding syndrome (23.2 ± 5 Kcal/kg/j; n = 7) versus patients without refeeding syndrome (14.1 ± 3 Kcal/kg/j; n = 61) P = 0.02. Seven patients died, two from acute respiratory distress syndrome and five from multiorgan-failure associated with major hydroelectrolytic problems. The frequency of AN in ICU patients is very low and the crude mortality in this group is about 10%. Prevention and early-detection of refeeding syndrome is the key point.

  16. Improving response rates using a monetary incentive for patient completion of questionnaires: an observational study

    Directory of Open Access Journals (Sweden)

    Orchard Jo

    2007-02-01

    Full Text Available Abstract Background Poor response rates to postal questionnaires can introduce bias and reduce the statistical power of a study. To improve response rates in our trial in primary care we tested the effect of introducing an unconditional direct payment of £5 for the completion of postal questionnaires. Methods We recruited patients in general practice with knee problems from sites across the United Kingdom. An evidence-based strategy was used to follow-up patients at twelve months with postal questionnaires. This included an unconditional direct payment of £5 to patients for the completion and return of questionnaires. The first 105 patients did not receive the £5 incentive, but the subsequent 442 patients did. We used logistic regression to analyse the effect of introducing a monetary incentive to increase the response to postal questionnaires. Results The response rate following reminders for the historical controls was 78.1% (82 of 105 compared with 88.0% (389 of 442 for those patients who received the £5 payment (diff = 9.9%, 95% CI 2.3% to 19.1%. Direct payments significantly increased the odds of response (adjusted odds ratio = 2.2, 95% CI 1.2 to 4.0, P = 0.009 with only 12 of 442 patients declining the payment. The incentive did not save costs to the trial – the extra cost per additional respondent was almost £50. Conclusion The direct payment of £5 significantly increased the completion of postal questionnaires at negligible increase in cost for an adequately powered study.

  17. Improving response rates using a monetary incentive for patient completion of questionnaires: an observational study

    Science.gov (United States)

    Brealey, Stephen D; Atwell, Christine; Bryan, Stirling; Coulton, Simon; Cox, Helen; Cross, Ben; Fylan, Fiona; Garratt, Andrew; Gilbert, Fiona J; Gillan, Maureen GC; Hendry, Maggie; Hood, Kerenza; Houston, Helen; King, David; Morton, Veronica; Orchard, Jo; Robling, Michael; Russell, Ian T; Torgerson, David; Wadsworth, Valerie; Wilkinson, Clare

    2007-01-01

    Background Poor response rates to postal questionnaires can introduce bias and reduce the statistical power of a study. To improve response rates in our trial in primary care we tested the effect of introducing an unconditional direct payment of £5 for the completion of postal questionnaires. Methods We recruited patients in general practice with knee problems from sites across the United Kingdom. An evidence-based strategy was used to follow-up patients at twelve months with postal questionnaires. This included an unconditional direct payment of £5 to patients for the completion and return of questionnaires. The first 105 patients did not receive the £5 incentive, but the subsequent 442 patients did. We used logistic regression to analyse the effect of introducing a monetary incentive to increase the response to postal questionnaires. Results The response rate following reminders for the historical controls was 78.1% (82 of 105) compared with 88.0% (389 of 442) for those patients who received the £5 payment (diff = 9.9%, 95% CI 2.3% to 19.1%). Direct payments significantly increased the odds of response (adjusted odds ratio = 2.2, 95% CI 1.2 to 4.0, P = 0.009) with only 12 of 442 patients declining the payment. The incentive did not save costs to the trial – the extra cost per additional respondent was almost £50. Conclusion The direct payment of £5 significantly increased the completion of postal questionnaires at negligible increase in cost for an adequately powered study. PMID:17326837

  18. Long-term cardiovascular mortality in patients with differentiated thyroid carcinoma : An observational study

    NARCIS (Netherlands)

    Klein Hesselink, Esther; Klein Hesselink, Mariëlle; de Bock, Truuske; Gansevoort, Ronald; Bakker, Stephan; Vredeveld, Eline; van der Horst-Schrivers, Anouk N. A.; van der Horst, Iwan; Kamphuisen, Pieter Willem; Plukker, John; Links, Thera P.; Lefrandt, Johan

    2013-01-01

    Purpose The primary aim was to study the risk of cardiovascular mortality in patients with differentiated thyroid carcinoma (DTC). Secondary aims were to evaluate all-cause mortality and explore the relation between thyroid-stimulating hormone (TSH; also known as thyrotropin) level and these outcome

  19. Pneumoperitoneum deteriorates intratidal respiratory system mechanics: an observational study in lung-healthy patients.

    Science.gov (United States)

    Wirth, Steffen; Biesemann, Andreas; Spaeth, Johannes; Schumann, Stefan

    2017-02-01

    Pneumoperitoneum during laparoscopic surgery leads to atelectasis and impairment of oxygenation. Positive end-expiratory pressure (PEEP) is supposed to counteract atelectasis. We hypothesized that the derecruiting effects of pneumoperitoneum would deteriorate the intratidal compliance profile in patients undergoing laparoscopic surgery. In 30 adult patients scheduled for surgery with pneumoperitoneum, respiratory variables were measured during mechanical ventilation. We calculated the dynamic compliance of the respiratory system (C RS ) and the intratidal volume-dependent C RS curve using the gliding-SLICE method. The C RS curve was then classified in terms of indicating intratidal recruitment/derecruitment (increasing profile) and overdistension (decreasing profile). During the surgical interventions, the PEEP level was maintained nearly constant at 7 cm H 2 O. Data are expressed as mean [confidence interval]. Baseline C RS was 60 [54-67] mL cm H 2 O -1 . Application of pneumoperitoneum decreased C RS to 40 [37-43] mL cm H 2 O -1 which partially recovered to 54 [50-59] mL cm H 2 O -1 (P < 0.001) after removal but remained below the value measured before pneumoperitoneum (P < 0.001). Baseline compliance profiles indicated intratidal recruitment/derecruitment in 48 % patients. After induction of pneumoperitoneum, intratidal recruitment/derecruitment was indicated in 93 % patients (P < 0.01), and after removal intratidal recruitment/derecruitment was indicated in 59 % patients. Compliance profiles showing overdistension were not observed. Analyses of the intratidal compliance profiles reveal that pneumoperitoneum during laparoscopic surgery causes intratidal recruitment/derecruitment which partly persists after its removal. The analysis of the intratidal volume-dependent C RS profiles could be used to guide intraoperative PEEP adjustments during elevated intraabdominal pressure.

  20. Dose Titration of Pregabalin in Patients with Painful Diabetic Peripheral Neuropathy: Simulation Based on Observational Study Patients Enriched with Data from Randomized Studies.

    Science.gov (United States)

    Alexander, Joe; Edwards, Roger A; Manca, Luigi; Grugni, Roberto; Bonfanti, Gianluca; Emir, Birol; Whalen, Edward; Watt, Stephen; Parsons, Bruce

    2018-03-01

    Achieving a therapeutic response to pregabalin in patients with painful diabetic peripheral neuropathy (pDPN) requires adequate upward dose titration. Our goal was to identify relationships between titration and response to pregabalin in patients with pDPN. Data were integrated from nine randomized, placebo-controlled clinical trials as well as one 6-week open-label observational study conducted by 5808 physicians (2642 patients with pDPN) in standard outpatient settings in Germany. These studies evaluated pregabalin for treatment of pDPN. Using these data, we examined "what if" scenarios using a microsimulation platform that integrates data from randomized and observational sources as well as autoregressive-moving-average with exogenous inputs models that predict pain outcomes, taking into account weekly changes in pain, sleep interference, dose, and other patient characteristics that were unchanging. Final pain levels were significantly different depending on dose changes (P titration regardless of baseline pain severity. Altogether, 78.5% of patients with pDPN had 0-1 dose change, and 15.2% had ≥ 2 dose changes. Simulation demonstrated that the 4.8% of inadequately titrated patients who did not improve/very much improve their pain levels would have benefited from ≥ 2 dose changes. Patient satisfaction with tolerability (range 90.3-96.2%) was similar, regardless of baseline pain severity, number of titrations, or extent of improvement, suggesting that tolerability did not influence treatment response patterns. Upward dose titration reduced pain in patients with pDPN who actually received it. Simulation also predicted pain reduction in an inadequately titrated nonresponder subgroup of patients had they actually received adequate titration. The decision not to uptitrate must have been driven by factors other than tolerability. Pfizer, Inc.

  1. Psychiatric morbidity in patients of pulmonary tuberculosis-an observational study

    Directory of Open Access Journals (Sweden)

    Lalit Singh

    2015-01-01

    Full Text Available Background: A lot of stigma and misconceptions about pulmonary tuberculosis still persist, in spite of the advances in treatment. Thus, a mere diagnosis of pulmonary tuberculosis can be a psychological trauma to an individual. The situation has aggravated with the association of tuberculosis with HIV infection. Aim: To study the psychiatric morbidity due to the various psychological stresses faced by a patient of pulmonary tuberculosis. Materials and Methods: The study group consisted of 100 inpatients admitted to pulmonary ward with diagnosis of pulmonary tuberculosis. The control group consisted of 100 inpatients admitted to pulmonary ward with nontuberculous pulmonary diseases. Psychiatric history and mental status were recorded on a specially designed proforma and diagnosis of any psychiatric illness, if present, arrived at as per International Classification of Diseases (ICD-10. The psychiatric tests applied were beck's depression inventory (BDI and Taylor's Manifest Anxiety Scale (TMAS. Results: Of the patients of pulmonary tuberculosis, 24% could be given a diagnostic category, as per ICD-10, as compared to only 8% of the controls (P < 0.005. On BDI, 44% of patients of pulmonary tuberculosis showed depression as compared to 27% of the controls (P < 0.02. On TMAS, 38% of patients of pulmonary tuberculosis showed anxiety as compared to 24% of controls (P < 0.05. A greater incidence of depression (on BDI and anxiety (on TMAS was seen in those with longer duration of illness (P < 0.02 and in those with greater severity of illness (P < 0.02. Conclusion: In view of the high psychiatric morbidity associated with pulmonary tuberculosis, there is enough scope for psychiatric services to be made available to these patients. In addition, personnel involved in the treatment of these patients should be trained for early detection of psychiatric symptoms.

  2. Efficacy of Epley’s Maneuver in Treating BPPV Patients: A Prospective Observational Study

    Directory of Open Access Journals (Sweden)

    Sushil Gaur

    2015-01-01

    Full Text Available Vertigo and balance disorders are among the most common symptoms encountered in patients who visit ENT outpatient department. This is associated with risk of falling and is compounded in elderly persons with other neurologic deficits and chronic medical problems. BPPV is the most common cause of peripheral vertigo. BPPV is a common vestibular disorder leading to significant morbidity, psychosocial impact, and medical costs. The objective of Epley’s maneuver, which is noninvasive, inexpensive, and easily administered, is to move the canaliths out of the canal to the utricle where they no longer affect the canal dynamics. Our study aims to analyze the response to Epley’s maneuver in a series of patients with posterior canal BPPV and compares the results with those treated exclusively by medical management alone. Even though many studies have been conducted to prove the efficacy of this maneuver, this study reinforces the validity of Epley’s maneuver by comparison with the medical management.

  3. Quality of Life analysis of patients in chronic use of oral anticoagulant: an observational study

    Directory of Open Access Journals (Sweden)

    Almeida Geisa

    2011-10-01

    Full Text Available Abstract Background Treatment with oral anticoagulant may influence the quality of life perception as it promotes changes in the patient's life, not offering an evident symptomatic relief and presenting well defined risks, such as bleeding. In this trial, the influence of chronic use of anticoagulants on the quality of life perception has been analyzed in patients assisted at the anticoagulation outpatient unit. Methods The health related quality of life was evaluated through a cross-section study with a sample composed of 72 patients seen from July 23, 2009 to September 2, 2010 at the Anticoagulation Outpatient Unit of the Federal University of Bahia's University Hospital. The study's population was composed by patients with atrial fibrillation and mechanical heart valve. The patients were submitted to two quality of life evaluation questionnaires: a generic questionnaire - the Medical Outcomes Study SF-36 Health Survey (SF36 - and a specific questionnaire - the Duke Anticoagulation Satisfaction Scale (DASS. Results The quality of life perception of the patients studied, based on both the DASS and the SF36, was positive regarding the treatment with oral anticoagulant. The SF36 presented an average score of 62.2 (± 20.0. Among the SF36 evaluated domains, the physical-emotional aspect was the most compromised one regarding life quality perception. The DASS presented an average score of 67.1 (± 18.2 and the domain presenting a greater compromise was the one related to the treatment inconveniences (annoyances, burdens and obligations. Previous hemorrhagic event, comorbidities, drug interactions with medicines that increase the anticoagulant effect, lower education level in the SF36 and younger age group influence a more negative perception of the quality of life, whereas lower education level in the DASS and the duration of treatment for more than 1 year offer a more positive perception. Conclusion Patients seen at the anticoagulation outpatient

  4. Refeeding syndrome influences outcome of anorexia nervosa patients in intensive care unit: an observational study

    OpenAIRE

    Vignaud, Marie; Constantin, Jean-Michel; Ruivard, Marc; Villemeyre-Plane, Michele; Futier, Emmanuel; Bazin, Jean-Etienne; Annane, Djillali

    2010-01-01

    Introduction Data on the epidemiology and management of anorexia nervosa (AN) in the intensive care unit (ICU) are scarce. The aim of this study was to evaluate the prevalence and associated morbidity and mortality of AN in French ICUs. Methods We randomly selected 30 ICUs throughout France. Thereafter, we retrospectively analyzed all patients with AN admitted to any of these 30 ICUs between May 2006 and May 2008. We considered demographic data, diagnosis at admission and complications occurr...

  5. A single-center, cross-sectional, observational study of heart failure patients

    Directory of Open Access Journals (Sweden)

    U M Nagamalesh

    2017-01-01

    Conclusion: This study showed that a significant proportion of inpatients belonged to elderly age group. Octogenarians also formed a sizeable proportion of patients. Hypertension, CAD, DM, overweight, and anemia were identified as the commonly associated comorbidities and understanding the complex interplay of these factors to plan optimal treatment strategy is of great challenge to the physician, especially when dealing with the elderly and very elderly group.

  6. Acute and long-term survival in chronically critically ill surgical patients: a retrospective observational study.

    Science.gov (United States)

    Hartl, Wolfgang H; Wolf, Hilde; Schneider, Christian P; Küchenhoff, Helmut; Jauch, Karl-Walter

    2007-01-01

    Various cohort studies have shown that acute (short-term) mortality rates in unselected critically ill patients may have improved during the past 15 years. Whether these benefits also affect acute and long-term prognosis in chronically critically ill patients is unclear, as are determinants relevant to prognosis. We conducted a retrospective analysis of data collected from March 1993 to February 2005. A cohort of 390 consecutive surgical patients requiring intensive care therapy for more than 28 days was analyzed. The intensive care unit (ICU) survival rate was 53.6%. Survival rates at one, three and five years were 61.8%, 44.7% and 37.0% among ICU survivors. After adjustment for relevant covariates, acute and long-term survival rates did not differ significantly between 1993 to 1999 and 1999 to 2005 intervals. Acute prognosis was determined by disease severity during ICU stay and by primary diagnosis. However, only the latter was independently associated with long-term prognosis. Advanced age was an independent prognostic determinant of poor short-term and long-term survival. Acute and long-term prognosis in chronically critically ill surgical patients has remained unchanged throughout the past 12 years. After successful surgical intervention and intensive care, long-term outcome is reasonably good and is mainly determined by age and underlying disease.

  7. Impact of anxiety symptoms on outcomes of depression: an observational study in Asian patients

    Directory of Open Access Journals (Sweden)

    Novick D

    2016-04-01

    Full Text Available Diego Novick,1 William Montgomery,2 Jaume Aguado,3 Xiaomei Peng,4 Josep Maria Haro3 1Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 3Parc Sanitari Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 4Eli Lilly and Company, Indianapolis, IN, USA Objective: To investigate the impact of anxiety symptoms on depression outcomes in Asian patients with major depressive disorder (MDD (n=714. Methods: The 17-item Hamilton Depression Scale (HAMD-17, overall severity, somatic symptoms, and quality of life (QOL (EuroQOL Questionnaire-5 Dimensions [EQ-5D] were assessed at baseline and 3 months. Anxiety was measured using items 10 and 11 from the HAMD-17. Linear, tobit, and logistic multiple regression models analyzed the impact of anxiety symptoms on outcomes. Baseline anxiety was related to age and the presence of pain symptoms at baseline. Results: Regression models showed that a higher level of anxiety was associated with a lower frequency of remission and lower QOL at 3 months. Patients with lower baseline anxiety symptoms had higher remission rates (odds ratio for each point of anxiety symptoms, 0.829 [95% confidence interval [CI]: 0.723–0.951]. Patients with higher levels of baseline anxiety had a lower QOL at 3 months (a decrease in EQ-5D tariff score for each point of anxiety symptoms, 0.023 [95% CI: 0.045–0.001]. Conclusion: In conclusion, the presence of anxiety symptoms negatively impacts the outcomes of depression. Keywords: depression, anxiety, Asia, observational, outcomes

  8. A prospective international observational prevalence study on prone positioning of ARDS patients: the APRONET (ARDS Prone Position Network) study

    NARCIS (Netherlands)

    Guérin, C.; Beuret, P.; Constantin, J. M.; Bellani, G.; Garcia-Olivares, P.; Roca, O.; Meertens, J. H.; Maia, P. Azevedo; Becher, T.; Peterson, J.; Larsson, A.; Gurjar, M.; Hajjej, Z.; Kovari, F.; Assiri, A. H.; Mainas, E.; Hasan, M. S.; Morocho-Tutillo, D. R.; Baboi, L.; Chrétien, J. M.; François, G.; Ayzac, L.; Chen, L.; Brochard, L.; Mercat, A.; Hajjej, Zied; Sellami, Walid; Ferjani, M.; Gurjar, Mohan; Assiri, Amer; Al Bshabshe, Ali; Almekhlafi, Ghaleb; Mandourah, Yasser; Hasan, Mohd Shahnaz; Rai, Vineya; Marzida, M.; Corcoles Gonzalez, Virgilio; Sanchez Iniesta, Rafael; Garcia, Pablo; Garcia-Montesinos de La Peña, Manuel; Garcia Herrera, Adriana; Roca, Oriol; Garcia-de-Acilu, Marina; Masclans Enviz, Joan Ramon; Mancebo, Jordi; Heili, Sarah; Artigas Raventos, Antonio; Blanch Torra, Lluís; Roche-Campo, Ferran; Schultz, Marcus

    2018-01-01

    While prone positioning (PP) has been shown to improve patient survival in moderate to severe acute respiratory distress syndrome (ARDS) patients, the rate of application of PP in clinical practice still appears low. This study aimed to determine the prevalence of use of PP in ARDS patients (primary

  9. Patients' and observers' perceptions of involvement differ. Validation study on inter-relating measures for shared decision making.

    Science.gov (United States)

    Kasper, Jürgen; Heesen, Christoph; Köpke, Sascha; Fulcher, Gary; Geiger, Friedemann

    2011-01-01

    Patient involvement into medical decisions as conceived in the shared decision making method (SDM) is essential in evidence based medicine. However, it is not conclusively evident how best to define, realize and evaluate involvement to enable patients making informed choices. We aimed at investigating the ability of four measures to indicate patient involvement. While use and reporting of these instruments might imply wide overlap regarding the addressed constructs this assumption seems questionable with respect to the diversity of the perspectives from which the assessments are administered. The study investigated a nested cohort (N = 79) of a randomized trial evaluating a patient decision aid on immunotherapy for multiple sclerosis. Convergent validities were calculated between observer ratings of videotaped physician-patient consultations (OPTION) and patients' perceptions of the communication (Shared Decision Making Questionnaire, Control Preference Scale & Decisional Conflict Scale). OPTION reliability was high to excellent. Communication performance was low according to OPTION and high according to the three patient administered measures. No correlations were found between observer and patient judges, neither for means nor for single items. Patient report measures showed some moderate correlations. Existing SDM measures do not refer to a single construct. A gold standard is missing to decide whether any of these measures has the potential to indicate patient involvement. Pronounced heterogeneity of the underpinning constructs implies difficulties regarding the interpretation of existing evidence on the efficacy of SDM. Consideration of communication theory and basic definitions of SDM would recommend an inter-subjective focus of measurement. Controlled-Trials.com ISRCTN25267500.

  10. Organ donation in cardiac arrest patients treated with extracorporeal CPR: A single centre observational study.

    Science.gov (United States)

    Casadio, Maria Chiara; Coppo, Anna; Vargiolu, Alessia; Villa, Jacopo; Rota, Matteo; Avalli, Leonello; Citerio, Giuseppe

    2017-09-01

    In a consecutive cohort of cardiac arrest (CA) treated with extracorporeal cardiopulmonary resuscitation (eCPR), we describe the incidence of brain death (BD), the eligibility for organ donation and the short-term follow-up of the transplanted organs. All refractory in- and out-of-hospital CA admitted to our Cardiac Intensive Care Unit between January 2011 and September 2016 treated with eCPR were enrolled in the study. 112 CA patients received eCPR. 82 (73.2%) died in hospital, 25 BD (22.3%) and 57 for other causes (50.9%). At the time of first neurological evaluation after rewarming, variables related to evolution to BD were a lower GCS (3 [3-3] vs. 8 [3-11], pdonation in BD patients was 56%, with 39 donated organs: 23 kidneys, 12 livers, and 4 lungs. 89.74% of the transplanted organs reached an early good functional recovery. In refractory CA patients treated with eCPR, the prevalence of BD is high. This population has a high potential for considering organ donation. Donated organs have a good outcome. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. RISK OF INFERTILITY IN PATIENTS WITH CELIAC DISEASE: a meta-analysis of observational studies

    Directory of Open Access Journals (Sweden)

    Juan Sebastian LASA

    2014-04-01

    Full Text Available Context Celiac disease is an autoimmune disorder of the small intestine associated with several extra-intestinal features, such as reproductive disorders. The relationship between celiac disease and infertility has been previously assessed, with conflicting results. Objectives We seek to determine the relationship between celiac disease and infertility. Methods Data was extracted from case-control or cohort design studies from 1966 to December 2013 using the MEDLINE-Pubmed, EMBASE, LILACS and Cochrane Library databases. We analyzed two kinds of trials: those assessing the risk of infertility in subjects with already diagnosed celiac disease, and those evaluating the prevalence of undiagnosed celiac disease in subjects with a diagnosis of infertility. Results The search yielded 413 potentially relevant studies for revision, 12 of which were finally included for analysis. A significant association was found between women with a diagnosis of infertility and undiagnosed celiac disease [OR 3.09 (95% CI 1.74-5.49]. When considering those studies assessing the occurrence of infertility in subjects with already-diagnosed celiac disease, no difference was found between celiac disease patients and control subjects [OR 0.99 (0.86-1.13]. Conclusions Undiagnosed celiac disease is a risk factor for infertility. Women seeking medical advice for this particular condition should be screened for celiac disease. Adoption of a gluten-free diet could have a positive impact on fertility in this group of patients.

  12. A prospective observational study assessing home parenteral nutrition in patients with gastrointestinal cancer: benefits for quality of life.

    Science.gov (United States)

    Senesse, Pierre; Tadmouri, Abir; Culine, Stéphane; Dufour, Patrick R; Seys, Patrick; Radji, Abderraouf; Rotarski, Maciej; Balian, Axel; Chambrier, Cecile

    2015-02-01

    Patients with gastrointestinal cancer are at high risk for deterioration of nutrition. Home parenteral nutrition (HPN) could improve nutritional status and quality of life (QoL). The purpose of this study was 1) to evaluate the impact of HPN on QoL, 2) to assess changes in nutritional status, and 3) to assess proxy perception of patient well-being. We conducted a prospective, observational, and a multicenter study. Inclusion criteria were adult patients with gastrointestinal cancer, for whom HPN was indicated and prescribed for at least 14 days. The physician, the patient, and a family member completed questionnaires at inclusion and 28 days later. The QoL was assessed by the patients using the Functional Assessment of Cancer Therapy-General questionnaire, at inclusion and 28 days later. The study included 370 patients with gastrointestinal cancer. The HPN was indicated for cancer-related undernutrition in 89% of the patients and was used as a complement to oral intake in 84%. After 28 days of parenteral intake, global QoL was significantly increased (48.9 at inclusion vs. 50.3, P=0.007). The patients' weight improved significantly by 2.7% (Pnutrition risk screening also decreased significantly (3.2±1.1 vs. 2.8±1.3, P=0.003). HPN could provide benefit for malnourished patients with gastrointestinal cancer. However, randomized controlled studies are required to confirm this benefit and the safety profile. Copyright © 2015. Published by Elsevier Inc.

  13. Long-term treatment of ADHD with stimulants: A large observational study of real-life patients

    DEFF Research Database (Denmark)

    Powell, Shelagh G.; Thomsen, Per Hove; Frydenberg, Morten

    2011-01-01

    : The diversity of ADHD patients was evident from the comorbidity, age at start, comedication, and treatment needs over time. Dosages corresponded to guidelines in most patients, but some needed higher dosages or got along on lower dosages for long periods. Age at start and comorbidity influenced dosage......, and dosage was associated to differential outcome groups. Conclusion: The study findings underscored the diversity of ADHD patients and that individual factors should be taken into account when tailoring individual treatment schedules. Findings further showed that stimulant dosages are dynamic over time......Objective: To evaluate 410 real-life patients treated with stimulants and assessed systematically over several years. Method: Naturalistic observational study. A database was compiled on the basis of a review of the medical charts of patients attending a specialized ADHD clinic. Results...

  14. A clinical observational study on patient-reported outcomes, hip functional performance and return to sports activities in hip arthroscopy patients

    NARCIS (Netherlands)

    Tijssen, M.P.W.; Cingel, R.E. van; Visser, E de; Nijhuis-Van der Sanden, M.W.G.

    2016-01-01

    OBJECTIVES: To describe data of short- and midterm results of hip arthroscopy patients based on patient-reported hip function, hip functional performance and return to sports activities. DESIGN: Observational cohort study. SETTING: Sports medical center. PARTICIPANTS: 37 recreational athletes (21

  15. Tuberculosis patients hospitalized in the Albert Schweitzer Hospital, Lambaréné, Gabon-a retrospective observational study

    NARCIS (Netherlands)

    Stolp, S. M.; Huson, M. A. M.; Janssen, S.; Beyeme, J. O.; Grobusch, M. P.

    2013-01-01

    Epidemiological data on tuberculosis in Central Africa are limited. We performed a retrospective observational study on clinical characteristics of 719 hospitalized tuberculosis patients in Lambaréné, Gabon. Human immunodeficiency virus (HIV) co-infection rate was high (34%) and in-hospital

  16. Radiation-induced acute dysphagia. Prospective observational study on 42 head and neck cancer patients

    International Nuclear Information System (INIS)

    Alterio, D.; Gerardi, M.A.; Fodor, C.; Ciardo, D.; Ferrari, A.; Colangione, S.; Cella, L.; D'Avino, V.; Conson, M.; Palma, G.; Spoto, R.; Dicuonzo, S.; Jereczek-Fossa, B.A.; Zurlo, V.; Bruschini, R.; Sabbatini, A.; Valoriani, F.; Pacelli, R.; Maisonneuve, P.; Preda, L.; Cossu Rocca, M.; Rondi, E.; Orecchia, R.; Sanguineti, G.

    2017-01-01

    Acute toxicity in head and neck (H and N) cancer patients treated with definitive radiotherapy (RT) has a crucial role in compliance to treatments. The aim of this study was to correlate doses to swallowing-associated structures and acute dysphagia. We prospectively analyzed 42 H and N cancer patients treated with RT. Dysphagia (grade ≥ 3) and indication for percutaneous endoscopic gastrostomy (PEG) insertion were classified as acute toxicity. Ten swallowing-related structures were considered for the dosimetric analysis. The correlation between clinical information and the dose absorbed by the contoured structures was analyzed. Multivariate logistic regression method using resampling methods (bootstrapping) was applied to select model order and parameters for normal tissue complication probability (NTCP) modelling. A strong multiple correlation between dosimetric parameters was found. A two-variable model was suggested as the optimal order by bootstrap method. The optimal model (Rs = 0.452, p < 0.001) includes V 45 of the cervical esophagus (odds ratio [OR] = 1.016) and D mean of the cricopharyngeal muscle (OR = 1.057). The model area under the curve was 0.82 (95% confidence interval 0.69-0.95). Our results suggested that the absorbed dose to the cricopharyngeal muscle and cervical esophagus might play a relevant role in the development of acute RT-related dysphagia. (orig.) [de

  17. Discontinuation of tofacitinib after achieving low disease activity in patients with rheumatoid arthritis: a multicentre, observational study.

    Science.gov (United States)

    Kubo, Satoshi; Yamaoka, Kunihiro; Amano, Koichi; Nagano, Shuji; Tohma, Shigeto; Suematsu, Eiichi; Nagasawa, Hayato; Iwata, Kanako; Tanaka, Yoshiya

    2017-08-01

    To determine whether tofacitinib can be discontinued in patients with RA who achieve low disease activity (LDA). RA patients with LDA after tofacitinib treatment in a phase III and long-term extension study were enrolled in this multicentre, non-randomized, open, prospective, observational study. The decision of discontinuation or continuation of tofacitinib was determined based on patient-physician decision making with informed consent. The primary endpoint was the proportion of patients who remained tofacitinib-free at post-treatment week 52. Clinical outcome was compared between those who continued and those who discontinued tofacitinib. The last observation carried forward method was used for patients who could not discontinue tofacitinib before week 52. Of 64 patients, 54 discontinued and 10 continued tofacitinib therapy. At post-treatment week 52, 20 of the 54 patients (37%) of the discontinuation group remained tofacitinib-free without disease flare. Disease activity at post-treatment week 52 was higher in the discontinuation group than the continuation group. Among the discontinuation group, the RF titre at baseline was significantly lower in patients who remained tofacitinib-free than those who did not (40 vs 113 U/ml). In fact, a higher proportion of patients with lower RF remained tofacitinib-free at week 52 compared with those with higher RF at baseline. In patients who could not achieve tofacitinib-free status, re-initiation of tofacitinib or other biologics improved disease activity. It is possible to discontinue tofacitinib without flare in about a third of patients with RA. A low RF predicts maintenance of LDA after discontinuation of tofacitinib. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  18. A work observation study of nuclear medicine technologists: interruptions, resilience and implications for patient safety.

    Science.gov (United States)

    Larcos, George; Prgomet, Mirela; Georgiou, Andrew; Westbrook, Johanna

    2017-06-01

    Errors by nuclear medicine technologists during the preparation of radiopharmaceuticals or at other times can cause patient harm and may reflect the impact of interruptions, busy work environments and deficient systems or processes. We aimed to: (a) characterise the rate and nature of interruptions technologists experience and (b) identify strategies that support safety. We performed 100 hours of observation of 11 technologists at a major public hospital and measured the proportions of time spent in eight categories of work tasks, location of task, interruption rate and type and multitasking (tasks conducted in parallel). We catalogued specific safety-oriented strategies used by technologists. Technologists completed 5227 tasks and experienced 569 interruptions (mean, 4.5 times per hour; 95% CI 4.1 to 4.9). The highest interruption rate occurred when technologists were in transit between rooms (10.3 per hour (95% CI 8.3 to 12.5)). Interruptions during radiopharmaceutical preparation occurred a mean of 4.4 times per hour (95% CI 3.3 to 5.6). Most (n=426) tasks were interrupted once only and all tasks were resumed after interruption. Multitasking occurred 16.6% of the time. At least some interruptions were initiated by other technologists to convey important information and/or to render assistance. Technologists employed a variety of verbal and non-verbal strategies in all work areas (notably in the hot-lab) to minimise the impact of interruptions and optimise the safe conduct of procedures. Although most were due to individual choices, some strategies reflected overt or subliminal departmental policy. Some interruptions appear beneficial. Technologists' self-initiated strategies to support safe work practices appear to be an important element in supporting a resilient work environment in nuclear medicine. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  19. Patient-Reported Treatment Satisfaction with Rivaroxaban for Stroke Prevention in Atrial Fibrillation. A French Observational Study, the SAFARI Study.

    Science.gov (United States)

    Hanon, Olivier; Chaussade, Edouard; Gueranger, Pierre; Gruson, Elise; Bonan, Sabrina; Gay, Alain

    2016-01-01

    For antithrombotic treatments, Patient Reported Outcomes (PRO) and patient satisfaction with treatment are essential data for physicians because of the strong relationship between patient satisfaction and adherence to treatment. The impact of rivaroxaban on patient satisfaction and quality of life was not sufficiently documented in phase III studies. There is a need for further data in this field especially in real life conditions. The SAFARI study is composed of patients with non-valvular atrial fibrillation (AF), previously treated with vitamin K antagonist (VKA) and switched to rivaroxaban. Patient satisfaction with anticoagulant therapy was measured by the Anti-Clot Treatment Scale (ACTS), a validated 15-item patient-reported scale including a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. Satisfaction of medication was compared between baseline and 1, 3 and 6 months. Study population was composed of 405 patients. Mean age was 74.8 (standard deviation = 9.0) years and 63.0% were male. Mean CHA2DS2-VASc score was 3.4 (1.5) and mean HAS-BLED score was 2.9 (1.0). After 3 months of treatment with rivaroxaban, patient satisfaction improved compared with VKA: mean ACTS burdens scores significantly increased by 8.3 (8.9) points (pSAFARI data support a good risk-benefit balance for rivaroxaban, with a good safety profile and encourage PRO design studies. The switch from VKA to rivaroxaban improved patient satisfaction at 1, 3 and 6 months after rivaroxaban initiation among patients with AF, particularly in reducing patient-reported anticoagulation burden.

  20. Severe infection in patients with rheumatoid arthritis taking anakinra, rituximab, or abatacept: a systematic review of observational studies.

    Science.gov (United States)

    Cabral, Vanderlea Poeys; Andrade, Carlos Augusto Ferreira de; Passos, Sonia Regina Lambert; Martins, Maria de Fátima Moreira; Hökerberg, Yara Hahr Marques

    A question is raised about an increased risk of severe infection from the use of biological drugs in patients with rheumatoid arthritis. This systematic review of observational studies aimed at assessing the risk of severe infection associated with the use of anakinra, rituximab, and abatacept in patients with rheumatoid arthritis. The following databases were searched: PubMed, Science Direct, Scopus, Web of Knowledge, Scirus, Cochrane, Exerpta Medica Database, Scielo, and Lilacs up to July 2010. Severe infections were defined as those life-threatening ones in need of the use of parenteral antibiotics or of hospitalization. Longitudinal observational studies were selected without language restriction, involving adult patients diagnosed with rheumatoid arthritis and who used anakinra, rituximab, or abatacept. In four studies related to anakinra, 129 (5.1%) severe infections were related in 2896 patients, of which three died. With respect to rituximab, two studies reported 72 (5.9%) severe infections in 1224 patients, of which two died. Abatacept was evaluated in only one study in which 25 (2.4%) severe infections were reported in 1046 patients. The main site of infection for these three drugs was the respiratory tract. One possible explanation for the high frequency of severe infections associated with anakinra may be the longer follow-up time in the selected studies. The high frequency of severe infections associated with rituximab could be credited to the less strict inclusion criteria for the patients studied. Therefore, infection monitoring should be cautious in patients with rheumatoid arthritis in use of these three drugs. Copyright © 2016. Published by Elsevier Editora Ltda.

  1. How do patients with a Turkish background evaluate their medical care in Germany? An observational study in primary care

    Directory of Open Access Journals (Sweden)

    Goetz K

    2015-11-01

    Full Text Available Katja Goetz,1 Jessica Bungartz,2 Joachim Szecsenyi,1 Jost Steinhaeuser3 1Department of General Practice and Health Services Research, University of Heidelberg, Heidelberg, Germany; 2Praxis Medizin im Zentrum, München, Germany; 3Institute of Family Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany Background: Patients’ evaluation of medical care is an essential dimension of quality of care and an important aspect of the feedback cycle for health care providers. The aim of this study was to document how patients with a Turkish background evaluate primary care in Germany and determine which aspects of care are associated with language abilities.Methods: The study was based on an observational design. Patients with a Turkish background from German primary care practices completed the EUROPEP (European Project on Patient Evaluation of General Practice Care questionnaire consisting of 23 items. Seventeen primary care practices were involved with either German (n=8 or Turkish (n=9 general practitioners (GPs.Results: A convenience sample of 472 patients with a Turkish background from 17 practices participated in the study (response rate 39.9%. Practices with a German GP had a lower response rate (19.6% than those with a Turkish GP (57.5%. Items evaluated the highest were “keeping data confidential” (73.4% and “quick services for urgent health problems” (69.9%. Subgroup analysis showed lower evaluation scores from patients with good or excellent German language abilities. Patients who consulted a Turkish GP had higher evaluation scores.Conclusion: The evaluation from patients with a Turkish background living in Germany with either Turkish or German GPs showed lower scores than patients in other studies in Europe using EUROPEP. However, our results had higher evaluation scores than those of Turkish patients evaluating GPs in Turkey. Therefore, different explanation models for these findings should be explored in future studies

  2. Understanding how adherence goals promote adherence behaviours: a repeated measure observational study with HIV seropositive patients

    Directory of Open Access Journals (Sweden)

    Jones Gareth

    2012-08-01

    behaviours over and above the effects of the behaviour-specific thinking and ii the relationship between adherence to exercise and to medical treatment is stronger among those with more favourable views about the goal. Results from this study should identify the key contributing factors to inform subsequent adherence research and afford a more streamlined assessment matrix. The project also aims to inform patient care practices. UK Clinical Research Network registration number UKCRN 7842.

  3. Constipation is more frequent than diarrhea in patients fed exclusively by enteral nutrition: results of an observational study.

    Science.gov (United States)

    Bittencourt, Amanda F; Martins, Juliana R; Logullo, Luciana; Shiroma, Glaucia; Horie, Lilian; Ortolani, Maria Claudia; Silva, Maria de Lourdes T; Waitzberg, Dan L

    2012-08-01

    Digestive complications in enteral nutrition (EN) can negatively affect the nutrition clinical outcome of hospitalized patients. Diarrhea and constipation are intestinal motility disorders associated with pharmacotherapy, hydration, nutrition status, and age. The aim of this study was to analyze the frequency of these intestinal motility disorders in patients receiving EN and assess risk factors associated with diarrhea and constipation in hospitalized patients receiving exclusive EN therapy in a general hospital. The authors performed a sequential and observational study of 110 hospitalized adult patients fed exclusively by EN through a feeding tube. Patients were categorized according to the type of intestinal transit disorder as follows: group D (diarrhea, 3 or more watery evacuations in 24 hours), group C (constipation, less than 1 evacuation during 3 days), and group N (absence of diarrhea or constipation). All prescription drugs were recorded, and patients were analyzed according to the type and amount of medication received. The authors also investigated the presence of fiber in the enteral formula. Patients classified in group C represented 70% of the study population; group D comprised 13%, and group N represented 17%. There was an association between group C and orotracheal intubation as the indication for EN (P constipation (logistic regression analysis: P Constipation is more frequent than diarrhea in patients fed exclusively by EN. Enteral diet with fiber may protect against medication-associated intestinal motility disorders. The addition of prokinetic drugs seems to be useful in preventing constipation.

  4. Management of minor head injury in patients receiving oral anticoagulant therapy: a prospective study of a 24-hour observation protocol.

    Science.gov (United States)

    Menditto, Vincenzo G; Lucci, Moira; Polonara, Stefano; Pomponio, Giovanni; Gabrielli, Armando

    2012-06-01

    Patients receiving warfarin who experience minor head injury are at risk of intracranial hemorrhage, and optimal management after a single head computed tomography (CT) scan is unclear. We evaluate a protocol of 24-hour observation followed by a second head CT scan. In this prospective case series, we enrolled consecutive patients receiving warfarin and showing no intracranial lesions on a first CT scan after minor head injury treated at a Level II trauma center. We implemented a structured clinical pathway, including 24-hour observation and a CT scan performed before discharge. We then evaluated the frequency of death, admission, neurosurgery, and delayed intracranial hemorrhage. We enrolled and observed 97 consecutive patients. Ten refused the second CT scan and were well during 30-day follow-up. Repeated CT scanning in the remaining 87 patients revealed a new hemorrhage lesion in 5 (6%), with 3 subsequently hospitalized and 1 receiving craniotomy. Two patients discharged after completing the study protocol with 2 negative CT scan results were admitted 2 and 8 days later with symptomatic subdural hematomas; neither received surgery. Two of the 5 patients with delayed bleeding at 24 hours had an initial international normalized ratio greater than 3.0, as did both patients with delayed bleeding beyond 24 hours. The relative risk of delayed hemorrhage with an initial international normalized ratio greater than 3.0 was 14 (95% confidence interval 4 to 49). For patients receiving warfarin who experience minor head injury and have a negative initial head CT scan result, a protocol of 24-hour observation followed by a second CT scan will identify most occurrences of delayed bleeding. An initial international normalized ratio greater than 3 suggests higher risk. Copyright © 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

  5. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study.

    Science.gov (United States)

    Mosadeghi, Sasan; Reid, Mark William; Martinez, Bibiana; Rosen, Bradley Todd; Spiegel, Brennan Mason Ross

    2016-06-27

    Virtual reality (VR) offers immersive, realistic, three-dimensional experiences that "transport" users to novel environments. Because VR is effective for acute pain and anxiety, it may have benefits for hospitalized patients; however, there are few reports using VR in this setting. The aim was to evaluate the acceptability and feasibility of VR in a diverse cohort of hospitalized patients. We assessed the acceptability and feasibility of VR in a cohort of patients admitted to an inpatient hospitalist service over a 4-month period. We excluded patients with motion sickness, stroke, seizure, dementia, nausea, and in isolation. Eligible patients viewed VR experiences (eg, ocean exploration; Cirque du Soleil; tour of Iceland) with Samsung Gear VR goggles. We then conducted semistructured patient interview and performed statistical testing to compare patients willing versus unwilling to use VR. We evaluated 510 patients; 423 were excluded and 57 refused to participate, leaving 30 participants. Patients willing versus unwilling to use VR were younger (mean 49.1, SD 17.4 years vs mean 60.2, SD 17.7 years; P=.01); there were no differences by sex, race, or ethnicity. Among users, most reported a positive experience and indicated that VR could improve pain and anxiety, although many felt the goggles were uncomfortable. Most inpatient users of VR described the experience as pleasant and capable of reducing pain and anxiety. However, few hospitalized patients in this "real-world" series were both eligible and willing to use VR. Consistent with the "digital divide" for emerging technologies, younger patients were more willing to participate. Future research should evaluate the impact of VR on clinical and resource outcomes. Clinicaltrials.gov NCT02456987; https://clinicaltrials.gov/ct2/show/NCT02456987 (Archived by WebCite at http://www.webcitation.org/6iFIMRNh3).

  6. Heart rate awareness in patients with chronic stable heart failure. A multi-center observational study.

    LENUS (Irish Health Repository)

    Moran, D

    2014-08-23

    We assessed adherence to European Society of Cardiology heart rate guidelines (i.e. heart rates less than 70bpm) in patients with chronic stable heart failure. We also investigated the percent of patients on target doses of rate controlling drugs.

  7. Rapid eye movement-sleep is reduced in patients with acute uncomplicated diverticulitis—an observational study

    DEFF Research Database (Denmark)

    Huang, Chenxi; Alamili, Mahdi; Nielsen, Claus Henrik

    2015-01-01

    responses are believed to cause postoperative sleep disturbances, as inflammatory responses can alter sleep architecture through cytokine-brain interactions. Our aim was to investigate alteration of sleep architecture during acute infection and its relationships to inflammation and clinical symptoms......Introduction. Sleep disturbances are commonly found in patients in the postoperative period. Sleep disturbances may give rise to several complications including cardiopulmonary instability, transient cognitive dysfunction and prolonged convalescence. Many factors including host inflammatory....... Materials & Methods. In this observational study, we included patients with acute uncomplicated diverticulitis as a model to investigate the isolated effects of inflammatory responses on sleep. Eleven patients completed the study. Patients were admitted and treated with antibiotics for two nights, during...

  8. Baseline Lower Urinary Tract Symptoms in Patients Enrolled in LURN: A Prospective, Observational Cohort Study.

    Science.gov (United States)

    Cameron, Anne P; Lewicky-Gaupp, Christina; Smith, Abigail R; Helfand, Brian T; Gore, John L; Clemens, J Quentin; Yang, Claire C; Siddiqui, Nazema Y; Lai, H Henry; Griffith, James W; Andreev, Victor P; Liu, Gang; Weinfurt, Kevin; Amundsen, Cindy L; Bradley, Catherine S; Kusek, John W; Kirkali, Ziya

    2018-04-01

    We described and compared the frequency and type of lower urinary tract symptoms reported by men and women at the time that they were recruited from urology and urogynecology clinics into the Symptoms of Lower Urinary Tract Dysfunction Research Network multicenter, prospective, observational cohort study. At 6 research sites treatment seeking men and women were enrolled who reported any lower urinary tract symptoms at a frequency more than rarely during the last month on the LUTS (Lower Urinary Tract Symptoms) Tool. At baseline the study participants underwent a standardized clinical evaluation and completed validated questionnaires. Urological tests were performed, including pelvic/rectal examination, post-void residual urine measurement and urinalysis. A total of 545 women and 519 men were enrolled in the study. Mean ± SD age was 58.8 ± 14.1 years. At baseline nocturia, frequency and a sensation of incomplete emptying were similar in men and women but men experienced more voiding symptoms (90% vs 85%, p = 0.007) and women reported more urgency (85% vs 66%, p urinary incontinence than men (82% vs 51% p urinary incontinence, including post-void dribbling in 44% and urgency incontinence in 46%. Older participants had higher odds of reporting symptoms of nocturia and urgency. In this large, treatment seeking cohort of men and women lower urinary tract symptoms varied widely by gender and age. Men reported more voiding symptoms and nonstress or urgency urinary incontinence while women reported more incontinence overall and urgency. Older participants had greater odds of urgency and nocturia. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  9. Patients' and observers' perceptions of involvement differ. Validation study on inter-relating measures for shared decision making.

    Directory of Open Access Journals (Sweden)

    Jürgen Kasper

    Full Text Available OBJECTIVE: Patient involvement into medical decisions as conceived in the shared decision making method (SDM is essential in evidence based medicine. However, it is not conclusively evident how best to define, realize and evaluate involvement to enable patients making informed choices. We aimed at investigating the ability of four measures to indicate patient involvement. While use and reporting of these instruments might imply wide overlap regarding the addressed constructs this assumption seems questionable with respect to the diversity of the perspectives from which the assessments are administered. METHODS: The study investigated a nested cohort (N = 79 of a randomized trial evaluating a patient decision aid on immunotherapy for multiple sclerosis. Convergent validities were calculated between observer ratings of videotaped physician-patient consultations (OPTION and patients' perceptions of the communication (Shared Decision Making Questionnaire, Control Preference Scale & Decisional Conflict Scale. RESULTS: OPTION reliability was high to excellent. Communication performance was low according to OPTION and high according to the three patient administered measures. No correlations were found between observer and patient judges, neither for means nor for single items. Patient report measures showed some moderate correlations. CONCLUSION: Existing SDM measures do not refer to a single construct. A gold standard is missing to decide whether any of these measures has the potential to indicate patient involvement. PRACTICE IMPLICATIONS: Pronounced heterogeneity of the underpinning constructs implies difficulties regarding the interpretation of existing evidence on the efficacy of SDM. Consideration of communication theory and basic definitions of SDM would recommend an inter-subjective focus of measurement. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN25267500.

  10. Radiation-induced acute dysphagia. Prospective observational study on 42 head and neck cancer patients

    Energy Technology Data Exchange (ETDEWEB)

    Alterio, D.; Gerardi, M.A.; Fodor, C.; Ciardo, D.; Ferrari, A.; Colangione, S. [European Institute of Oncology, Department of Radiotherapy, Milan (Italy); Cella, L.; D' Avino, V.; Conson, M.; Palma, G. [National Research Council (CNR), Institute of Biostructures and Bioimaging, Naples (Italy); Spoto, R.; Dicuonzo, S.; Jereczek-Fossa, B.A. [European Institute of Oncology, Department of Radiotherapy, Milan (Italy); University of Milan, Department of Oncology and Hemato-oncology, Milan (Italy); Zurlo, V.; Bruschini, R. [European Institute of Oncology, Division of Head and Neck Surgery, Milan (Italy); Sabbatini, A.; Valoriani, F. [European Institute of Oncology, Dietetic and Clinical Nutrition Unit, Milan (Italy); Pacelli, R. [National Research Council (CNR), Institute of Biostructures and Bioimaging, Naples (Italy); Federico II University School of Medicine, Department of Advanced Biomedical Sciences, Naples (Italy); Maisonneuve, P. [European Institute of Oncology, Department of Epidemiology and Statistics, Milan (Italy); Preda, L. [European Institute of Oncology, Department of Radiology, Milan (Italy); Cossu Rocca, M. [European Institute of Oncology, Division of Urogenital and Head and Neck Tumors, Department of Medical Oncology, Milan (Italy); Rondi, E. [European Institute of Oncology, Unit of Medical Physics, Milan (Italy); Orecchia, R. [European Institute of Oncology, Scientific Directorate, Milan (Italy); Sanguineti, G. [Istituto Tumori Regina Elena, Rome (Italy)

    2017-11-15

    Acute toxicity in head and neck (H and N) cancer patients treated with definitive radiotherapy (RT) has a crucial role in compliance to treatments. The aim of this study was to correlate doses to swallowing-associated structures and acute dysphagia. We prospectively analyzed 42 H and N cancer patients treated with RT. Dysphagia (grade ≥ 3) and indication for percutaneous endoscopic gastrostomy (PEG) insertion were classified as acute toxicity. Ten swallowing-related structures were considered for the dosimetric analysis. The correlation between clinical information and the dose absorbed by the contoured structures was analyzed. Multivariate logistic regression method using resampling methods (bootstrapping) was applied to select model order and parameters for normal tissue complication probability (NTCP) modelling. A strong multiple correlation between dosimetric parameters was found. A two-variable model was suggested as the optimal order by bootstrap method. The optimal model (Rs = 0.452, p < 0.001) includes V{sub 45} of the cervical esophagus (odds ratio [OR] = 1.016) and D{sub mean} of the cricopharyngeal muscle (OR = 1.057). The model area under the curve was 0.82 (95% confidence interval 0.69-0.95). Our results suggested that the absorbed dose to the cricopharyngeal muscle and cervical esophagus might play a relevant role in the development of acute RT-related dysphagia. (orig.) [German] Bei Kopf-Hals-Tumorpatienten, die mit einer kurativen Strahlentherapie (''radiation therapy'', RT) behandelt werden, spielt die Akuttoxizitaet eine entscheidende Rolle fuer die Patientencompliance bei der Behandlung. Ziel dieser Studie war es, die Dosen im Bereich des Schluckapparates mit der akuten Dysphagie zu korrelieren. Prospektiv analysiert wurden 42 mit einer RT behandelten Patienten. Eine Dysphagie III und/oder die Indikation fuer eine PEG(perkutane endoskopische Gastrostomie)-Anlage wurden als Akuttoxizitaet klassifiziert. Fuer die dosimetrische

  11. Does delay in diagnosing colorectal cancer in symptomatic patients affect tumor stage and survival? A population-based observational study

    Directory of Open Access Journals (Sweden)

    Visser Otto

    2010-06-01

    Full Text Available Abstract Background Diagnosing colorectal cancer (CRC at an early stage improves survival. To what extent any delay affects outcome once patients are symptomatic is still unclear. Our objectives were to evaluate the association between diagnostic delay and survival in symptomatic patients with early stage CRC and late stage CRC. Methods Prospective population-based observational study evaluating daily clinical practice in Northern Holland. Diagnostic delay was determined through questionnaire-interviews. Dukes' stage was classified into two groups: early stage (Dukes A or B and late stage (Dukes C or D cancer. Patients were followed up for 3.5 years after diagnosis. Results In total, 272 patients were available for analysis. Early stage CRC was present in 136 patients while 136 patients had late stage CRC. The mean total diagnostic delay (SE was 31 (1.5 weeks in all CRC patients. No significant difference was observed in the mean total diagnostic delay in early versus late stage CRC (p = 0.27. In early stage CRC, no difference in survival was observed between patients with total diagnostic delay shorter and longer than the median (Kaplan-Meier, log-rank p = 0.93. In late stage CRC, patients with a diagnostic delay shorter than the median had a shorter survival than patients with a diagnostic delay longer than the median (log-rank p = 0.01. In the multivariate Cox regression model with survival as dependent variable and median delay, age, open access endoscopy, number and type of symptoms as independent variables, the odd's ratio for survival in patients with long delay (>median versus short delay (≤median was 1.8 (95% confidence interval (CI 1.1 to 3.0; p = 0.01. Tumor-site was not associated with patient survival. When separating late stage CRC in Dukes C and Dukes D tumors, a shorter delay was associated with a shorter survival in Dukes D tumors only and not in Dukes C tumors. Conclusion In symptomatic CRC patients, a longer diagnostic and

  12. Observational Study of a French and Belgian Multicenter Cohort of 23 Patients Diagnosed in Adulthood With Mevalonate Kinase Deficiency.

    Science.gov (United States)

    Durel, Cécile-Audrey; Aouba, Achille; Bienvenu, Boris; Deshayes, Samuel; Coppéré, Brigitte; Gombert, Bruno; Acquaviva-Bourdain, Cécile; Hachulla, Eric; Lecomte, Frédéric; Touitou, Isabelle; Ninet, Jacques; Philit, Jean-Baptiste; Messer, Laurent; Brouillard, Marc; Girard-Madoux, Marie-Hélène; Moutschen, Michel; Raison-Peyron, Nadia; Hutin, Pascal; Duffau, Pierre; Trolliet, Pierre; Hatron, Pierre-Yves; Heudier, Philippe; Cevallos, Ramiro; Lequerré, Thierry; Brousse, Valentine; Lesire, Vincent; Audia, Sylvain; Maucort-Boulch, Delphine; Cuisset, Laurence; Hot, Arnaud

    2016-03-01

    The aim of this study was to describe the clinical and biological features of Mevalonate kinase deficiency (MKD) in patients diagnosed in adulthood. This is a French and Belgian observational retrospective study from 2000 to 2014. To constitute the cohort, we cross-check the genetic and biochemical databases. The clinical, enzymatic, and genetic data were gathered from medical records. Twenty-three patients were analyzed. The mean age at diagnosis was 40 years, with a mean age at onset of symptoms of 3 years. All symptomatic patients had fever. Febrile attacks were mostly associated with arthralgia (90.9%); lymphadenopathy, abdominal pain, and skin lesions (86.4%); pharyngitis (63.6%); cough (59.1%); diarrhea, and hepatosplenomegaly (50.0%). Seven patients had psychiatric symptoms (31.8%). One patient developed recurrent seizures. Three patients experienced renal involvement (13.6%). Two patients had angiomyolipoma (9.1%). All but one tested patients had elevated serum immunoglobulin (Ig) D level. Twenty-one patients had genetic diagnosis; most of them were compound heterozygote (76.2%). p.Val377Ile was the most prevalent mutation. Structural articular damages and systemic AA amyloidosis were the 2 most serious complications. More than 65% of patients displayed decrease in severity and frequency of attacks with increasing age, but only 35% achieved remission. MKD diagnosed in adulthood shared clinical and genetic features with classical pediatric disease. An elevated IgD concentration is a good marker for MKD in adults. Despite a decrease of severity and frequency of attacks with age, only one-third of patients achieved spontaneous remission.

  13. Implementing the Keele stratified care model for patients with low back pain: an observational impact study.

    Science.gov (United States)

    Bamford, Adrian; Nation, Andy; Durrell, Susie; Andronis, Lazaros; Rule, Ellen; McLeod, Hugh

    2017-02-03

    The Keele stratified care model for management of low back pain comprises use of the prognostic STarT Back Screening Tool to allocate patients into one of three risk-defined categories leading to associated risk-specific treatment pathways, such that high-risk patients receive enhanced treatment and more sessions than medium- and low-risk patients. The Keele model is associated with economic benefits and is being widely implemented. The objective was to assess the use of the stratified model following its introduction in an acute hospital physiotherapy department setting in Gloucestershire, England. Physiotherapists recorded data on 201 patients treated using the Keele model in two audits in 2013 and 2014. To assess whether implementation of the stratified model was associated with the anticipated range of treatment sessions, regression analysis of the audit data was used to determine whether high- or medium-risk patients received significantly more treatment sessions than low-risk patients. The analysis controlled for patient characteristics, year, physiotherapists' seniority and physiotherapist. To assess the physiotherapists' views on the usefulness of the stratified model, audit data on this were analysed using framework methods. To assess the potential economic consequences of introducing the stratified care model in Gloucestershire, published economic evaluation findings on back-related National Health Service (NHS) costs, quality-adjusted life years (QALYs) and societal productivity losses were applied to audit data on the proportion of patients by risk classification and estimates of local incidence. When the Keele model was implemented, patients received significantly more treatment sessions as the risk-rating increased, in line with the anticipated impact of targeted treatment pathways. Physiotherapists were largely positive about using the model. The potential annual impact of rolling out the model across Gloucestershire is a gain in approximately 30

  14. [Self-hypnosis training for in-hospital chronic pain patients : A retrolective observational study].

    Science.gov (United States)

    Keil, Peter C; Lindenberg, Nicole; Lassen, Christoph L; Graf, Bernhard M; Meier, Jens; Wiese, Christoph H

    2018-04-16

    Hypnosis is probably one of the oldest therapies known to man. In the last decades modern hypnosis has mainly been used by psychotherapists; however, hypnosis is becoming increasingly more important as a therapeutic method in medicine. Hypnosis can be used for a variety of medical indications. In the literature there is much evidence for the effectiveness of hypnosis. The aim of the present investigation was to demonstrate the effectiveness of hypnosis in inpatient treatment of chronic pain patients and to present a self-hypnosis program, which can be easily integrated into pain therapy. From October 2012 to April 2013 all inpatient chronic pain patients were included (group 1: non-hypnosis group, group 2: hypnosis group). Concerning group 2 a standardized protocol for hypnotherapy was integrated in addition to the standardized pain management program. The main goal of hypnotherapy was to integrate a self-hypnosis training so that further implementation in a domestic setting could be guaranteed. By means of standardized test procedures, e. g. Patient Health Questionnaire (PHQ-9), Pain Disability Index (PDI), Generalized Anxiety Disorder (GAD-7) and Numerical Rating Scales (NRS) for pain and general well-being, data were evaluated before and after the pain therapy. The prestandardized and poststandardized test procedures of 30 chronic pain patients were evaluated (17 patients without hypnosis, 13 patients with hypnosis). The main diagnosis according to ICD-10 was "chronic pain disorder" (F45.41) with a MPSS stage III in all patients. The PDI was significantly improved in the hypnosis group (p = 0.019). The other items all showed a trend towards improvement in the hypnosis group (exception GAD-7) but without statistical significance (p > 0.05). In a small patient collective, the present investigation was able to show that the integration of modern hypnotherapy into the treatment of chronic pain patients in an inpatient setting can be another

  15. Computed Tomography Profile and its Utilization in Head Injury Patients in Emergency Department: A Prospective Observational Study

    Directory of Open Access Journals (Sweden)

    Archana Waganekar

    2018-01-01

    Full Text Available Context: Based on Glasgow Coma Scale (GCS, head injury can be classified as minor (GCS 13–15, moderate (GCS 9–12, and severe (GCS 3–8. There is a lot of controversy in the use of computed tomography (CT in head injury patients. Aims: This study was intended to estimate the rate of CT positivity in head injury patients and to define the criteria for doing CT in head injury patients. Settings and Design: This was a prospective observational study in the emergency department (ED over a 12-month period. Subjects and Methods: Study involved all head injury patients attending ED. Risk factors studied were a loss of consciousness (LOC, vomiting, seizures, ear bleed, nosebleed, external injuries, and alcohol intoxication. Statistical Analysis Used: Comparison of CT positivity with the patient's demographics and clinical characteristics was carried out using Chi-square. Results: A total of 1782 patients were included in this study. Overall CT positivity was 50.9%. In minor head injury (MHI, CT positivity rate was 38%. The study showed significant association of CT positivity with five variables: LOC >5 min, vomiting, seizures, ear bleed, and nosebleed. Conclusions: From the study, we recommend following: CT is indicated in all patients with moderate and severe head injury (GCS ≤12. Low threshold for taking CT is advisable in elderly and alcohol-intoxicated patients. In MHI, CT is indicated if any one of the following risk factors are present: LOC >5 min, history of vomiting, history of seizures, history of ear bleed, and history of nosebleed.

  16. Incidence of dizziness and vertigo in Japanese primary care clinic patients with lifestyle-related diseases: an observational study.

    Science.gov (United States)

    Wada, Masaoki; Takeshima, Taro; Nakamura, Yosikazu; Nagasaka, Shoichiro; Kamesaki, Toyomi; Oki, Hiroshi; Kajii, Eiji

    2015-01-01

    Dizziness and vertigo are highly prevalent symptoms among patients presenting at primary care clinics, and peripheral vestibular disorder (PVD) is their most frequent cause. However, the incidence of PVD has not been well documented. This study aimed to investigate the incidence of dizziness, vertigo, and PVD among patients presenting at a primary care clinic. This was an observational study. Between November 2011 and March 2013, we observed 393 patients, all at least 20 years old, who had been treated for chronic diseases such as hypertension, dyslipidemia, and diabetes mellitus for at least 6 months at a primary clinic (Oki Clinic) in Japan. The main outcome of interest was new incidence of dizziness, vertigo, and PVD events. During the 1-year follow-up period, the otorhinolaryngologist diagnosed and reported new PVD events. The mean age of the 393 participants at entry was 65.5 years. Of the study participants, 12.7%, 82.4%, and 92.6% had diabetes mellitus, hypertension, and dyslipidemia, respectively. We followed up all the participants (100%). During the 662.5 person-years of follow-up, 121 cases of dizziness or vertigo (dizziness/vertigo) and 76 cases of PVD were observed. The incidence of dizziness/vertigo and PVD was 194.7 (95% confidence interval: 161.6-232.6) per 1,000 person-years and 115.7 (95% confidence interval: 92.2-142.6) per 1,000 person-years, respectively. There were 61 cases of acute peripheral vestibulopathy, 12 of benign paroxysmal positional vertigo, and three of Meniere's disease among the 76 PVD patients. We reported the incidence of dizziness/vertigo among Japanese primary care clinic patients, which was higher than that usually observed in the general population. Furthermore, we described the incidence of PVD and found that it was a major cause of dizziness/vertigo.

  17. Incidence of dizziness and vertigo in Japanese primary care clinic patients with lifestyle-related diseases: an observational study

    Science.gov (United States)

    Wada, Masaoki; Takeshima, Taro; Nakamura, Yosikazu; Nagasaka, Shoichiro; Kamesaki, Toyomi; Oki, Hiroshi; Kajii, Eiji

    2015-01-01

    Objective Dizziness and vertigo are highly prevalent symptoms among patients presenting at primary care clinics, and peripheral vestibular disorder (PVD) is their most frequent cause. However, the incidence of PVD has not been well documented. This study aimed to investigate the incidence of dizziness, vertigo, and PVD among patients presenting at a primary care clinic. Design This was an observational study. Setting and participants Between November 2011 and March 2013, we observed 393 patients, all at least 20 years old, who had been treated for chronic diseases such as hypertension, dyslipidemia, and diabetes mellitus for at least 6 months at a primary clinic (Oki Clinic) in Japan. Outcome The main outcome of interest was new incidence of dizziness, vertigo, and PVD events. During the 1-year follow-up period, the otorhinolaryngologist diagnosed and reported new PVD events. Results The mean age of the 393 participants at entry was 65.5 years. Of the study participants, 12.7%, 82.4%, and 92.6% had diabetes mellitus, hypertension, and dyslipidemia, respectively. We followed up all the participants (100%). During the 662.5 person-years of follow-up, 121 cases of dizziness or vertigo (dizziness/vertigo) and 76 cases of PVD were observed. The incidence of dizziness/vertigo and PVD was 194.7 (95% confidence interval: 161.6–232.6) per 1,000 person-years and 115.7 (95% confidence interval: 92.2–142.6) per 1,000 person-years, respectively. There were 61 cases of acute peripheral vestibulopathy, 12 of benign paroxysmal positional vertigo, and three of Meniere’s disease among the 76 PVD patients. Conclusion We reported the incidence of dizziness/vertigo among Japanese primary care clinic patients, which was higher than that usually observed in the general population. Furthermore, we described the incidence of PVD and found that it was a major cause of dizziness/vertigo. PMID:25931828

  18. Course, risk factors, and prognostic factors in elderly primary care patients with mild depression: a two-year observational study.

    Science.gov (United States)

    Magnil, Maria; Janmarker, Lena; Gunnarsson, Ronny; Björkelund, Cecilia

    2013-03-01

    The aim of this study was to observe course, risk factors, and prognostic factors in a primary care cohort aged > 60 with mild to moderate depression during two-year follow-up. Observational study. Primary care. During an 11-month period all (n = 302) consecutive patients aged 60 and above attending a primary care centre in Gothenburg, Sweden were screened by a nurse for depressive symptoms with the Primary Care Evaluation of Mental Disorders, Patient Questionnaire (PRIME-MD PQ) and the Montgomery-Åsberg Depression Rating Scale, self-rated version (MADRS-S) and by a GP with a patient-centred consultation model. In the second step, the GPs diagnosed depression in screen-positives by use of the PRIME-MD Clinical Evaluation Guide (PRIME-MD CEG). All patients with mild to moderate depression were followed up for two years to assess course with several MADRS-S score assessments. Main outcome measures. Risk factors, prognostic factors, and symptoms at baseline and after two years were tested with logistic regression, using the DSM-IV and MADRS-S (cut-off > 13) respectively. Course patterns were observed and described. A total of 54 patients were diagnosed with depression. Follow-up revealed declining median MADRS-S scores and three course patterns: remitting, stable, and fluctuating. History of depression, significant life events, lacking leisure activities, and use of sedatives were risk factors for depression, all previously known. An important finding was that lacking leisure activities also increased the risk of depressive symptoms after two years (odds ratio 12, confidence interval 1.1-136). It is desirable to identify elderly individuals with less severe depression. Three course patterns were observed; this finding requires further study of the clinical characteristics related to the different patterns. Awareness of risk factors may facilitate identification of those at highest risk of poor prognosis.

  19. Hemostatic function to regulate perioperative bleeding in patients undergoing spinal surgery: A prospective observational study.

    Directory of Open Access Journals (Sweden)

    Atsushi Kimura

    Full Text Available Although bleeding is a common complication of surgery, routine laboratory tests have been demonstrated to have a low ability to predict perioperative bleeding. Better understanding of hemostatic function during surgery would lead to identification of high-risk patients for bleeding. Here, we aimed to elucidate hemostatic mechanisms to determine perioperative bleeding. We prospectively enrolled 104 patients undergoing cervical spinal surgery without bleeding diathesis. Blood sampling was performed just before the operation. Volumes of perioperative blood loss were compared with the results of detailed laboratory tests assessing primary hemostasis, secondary hemostasis, and fibrinolysis. Platelet aggregations induced by several agonists correlated with each other, and only two latent factors determined inter-individual difference. Platelet aggregability independently determined perioperative bleeding. We also identified low levels of plasminogen-activator inhibitor-1 (PAI-1 and α2-plasmin inhibitor to be independent risk factors for intraoperative and postoperative bleeding, respectively. Most important independent factor to determine postoperative bleeding was body weight. Of note, obese patients with low levels of PAI-1 became high-risk patients for bleeding during surgery. Our data suggest that bleeding after surgical procedure may be influenced by inter-individual differences of hemostatic function including platelet function and fibrinolysis, even in the patients without bleeding diathesis.

  20. Black cohosh (Cimicifuga racemosa) in tamoxifen-treated breast cancer patients with climacteric complaints - a prospective observational study.

    Science.gov (United States)

    Rostock, Matthias; Fischer, Julia; Mumm, Andreas; Stammwitz, Ute; Saller, Reinhard; Bartsch, Hans Helge

    2011-10-01

    The antihormonal therapy of breast cancer patients with the antiestrogen tamoxifen often induces or aggravates menopausal complaints. As estrogen substitution is contraindicated, herbal alternatives, e.g. extracts of black cohosh are often used. A prospective observational study was carried out in 50 breast cancer patients with tamoxifen treatment. All patients had had surgery, most of them had undergone radiation therapy (87%) and approximately 50% had received chemotherapy. Every patient was treated with an isopropanolic extract of black cohosh (1-4 tablets, 2.5 mg) for 6 months. Patients recorded their complaints before therapy and after 1, 3, and 6 months of therapy using the menopause rating scale (MRS II). The reduction of the total MRS II score under black cohosh treatment from 17.6 to 13.6 was statistically significant. Hot flashes, sweating, sleep problems, and anxiety improved, whereas urogenital and musculoskeletal complaints did not change. In all, 22 patients reported adverse events, none of which were linked with the study medication; 90% reported the tolerability of the black cohosh extract as very good or good. Black cohosh extract seems to be a reasonable treatment approach in tamoxifen treated breast cancer patients with predominantly psychovegetative symptoms.

  1. What components of chronic care organisation relate to better primary care for coronary heart disease patients? An observational study.

    Science.gov (United States)

    van Lieshout, Jan; Frigola Capell, Eva; Ludt, Sabine; Grol, Richard; Wensing, Michel

    2012-01-01

    Cardiovascular risk management (CVRM) received by patients shows large variation across countries. In this study we explored the aspects of primary care organisation associated with key components of CVRM in coronary heart disease (CHD) patients. Observational study. 273 primary care practices in Austria, Belgium, England, Finland, France, Germany, The Netherlands, Slovenia, Switzerland and Spain. A random sample of 4563 CHD patients identified by coded diagnoses in eight countries, based on prescription lists and while visiting the practice in one country each. We performed an audit in primary care practices in 10 European countries. We used six indicators to measure key components of CVRM: risk factor recording, antiplatelet therapy, influenza vaccination, blood pressure levels (systolic organisation based on 39 items. Using multilevel regression analyses we explored the effects of practice organisation on CVRM, controlling for patient characteristics. Better overall organisation of a primary care practice was associated with higher scores on three indicators: risk factor registration (B=0.0307, porganisation was not found to be related with recorded blood pressure or cholesterol levels. Only the organisational domains 'self-management support' and 'use of clinical information systems' were linked to three CVRM indicators. A better organisation of a primary care practice was associated with better scores on process indicators of CVRM in CHD patients, but not on intermediate patient outcome measures. Direct support for patients and clinicians seemed most influential.

  2. An observational study of vitamin b12 levels and peripheral neuropathy profile in patients of diabetes mellitus on metformin therapy.

    Science.gov (United States)

    Gupta, Kamesh; Jain, Anand; Rohatgi, Anurag

    A descriptive, observational study was completed in a tertiary care hospital between November 2014 and March 2016. Fifty consecutive patients of Type 2-Diabetes Mellitus who had been on metformin therapy for at least three months were included in our study. Several Parameters were compared with vitamin B12 levels and severity of peripheral neuropathy (using Toronto Clinical Scoring System (TCSS) and Nerve Conduction Velocity). These included the duration of diabetes, duration of metformin usage, dietary history, and HbA1c levels. Definite B12 deficiency was defined as B12peripheral neuropathy (r=0.40). The mean TCSS score was 6.8. The percentage of patients with mild neuropathy was 28%, with moderate neuropathy was 20% and severe neuropathy in 12% of the patients. The average duration of metformin use in patients without peripheral neuropathy was 5.5yrs whereas the average length of metformin use in patients with peripheral neuropathy was 10.4 yrs. Patients on long-term metformin therapy are at a high risk for Vitamin B12 deficiency and peripheral neuropathy. Interval Screening for peripheral neuropathy is recommended for patients on metformin even if Vitamin B12 levels appear to be normal. Copyright © 2017 Diabetes India. Published by Elsevier Ltd. All rights reserved.

  3. EFFECTIVENESS OF PROSTAGLANDIN E1 IN THE PAIN MANAGEMENT OF PATIENTS WITH CRITICAL LIMB ISCHAEMIA- A PROSPECTIVE OBSERVATIONAL STUDY

    Directory of Open Access Journals (Sweden)

    John Sajan Kurien

    2017-08-01

    Full Text Available BACKGROUND Critical Limb Ischaemia (CLI was defined for the first time in 1982 by P. R. F. Bell as a manifestation of peripheral artery disease, which describes patient with typical chronic ischaemic rest pain or ischaemic skin ulcers or gangrene.1 This term of CLI should only be used in patients with chronic ischaemic disease defined as presence of recurring rest pain that persists for more than two weeks requiring regular analgesics and with ulceration or gangrene of the foot or toes. These criteria correspond to stage 3 and 4 of Fontaine’s classification of POVD. Observational studies have shown that one year after diagnosis of CLI, 25% of patients experience a major amputation, 25% had died and only 50% survived without requiring a major amputation, though some have rest pain, ulcer or gangrene persisting. The primary goals in treating CLI are to relieve claudication pain and rest pain, to heal the ulcer, to prevent amputation of limbs, to improve quality of life and to prolong survival. The aim of the study is to study the improvement of claudication pain, rest pain and improvement of the level of amputation in patients with diffuse peripheral arterial disease (CLI after administration of PGE1. MATERIALS AND METHODS From June 2013 to November 2014, a total of 45 patients having advanced CLI (Fontaine’s grade III and IV not suitable for angioplasty and stenting or bypass procedures received different courses of PGE1. 20 patients (44.44% received 6 full courses of PGE1,3 patients (6.66% received 5 courses, 5 patients (11.11% received 4 courses, 4 patients (8.8% received 3 courses, 4 patients (8.8% received 2 courses and 9 patients (20% received one course. PGE1 was administered through intravenous infusion (alprostadil 100mcg over 10 hours a day for 5 days in one month (1course. The reduction in claudication and rest pain, improvement in level of amputation and complications were assessed. RESULTS In all cases, there was reduction in pain

  4. Reduction of perception of chronic fatigue in an observational study of patients receiving 12 weeks of Kampo therapy.

    Science.gov (United States)

    Sekiya, Nobuyasu; Shimada, Yutaka; Shintani, Takahiro; Tahara, Eiichi; Kouta, Kazufumi; Shibahara, Naotoshi; Terasawa, Katsutoshi

    2005-10-01

    The aim of this study was to observe the influence of Kampo therapy on latent chronic fatigue of patients with chronic diseases. One hundred and seventy-three (173) consecutive patients with chronic diseases came to our department for the first time. This was a prospective study. Patients were divided into two groups: a chronic fatigue group (CFG) and a nonchronic fatigue group (NCFG). Based on Kampo diagnosis, both groups were prescribed Kampo formulae as an extract or decoction for 12 weeks. By using questionnaires, patients were assessed concerning their physical and mental types of fatigue, their sleep situation, and their attitude toward work or housekeeping, both before and after 12 weeks of treatment, according to Kampo diagnosis. The mental fatigue, physical fatigue, and sleep scores of both groups, and the work score of CFG, were decreased. The rate of reduction of the fatigue score was significantly greater in CFG than in NCFG. The factor responsible for this difference in fatigue score was physical fatigue. A reduction of the perception of chronic fatigue was observed in patients receiving 12 weeks of Kampo therapy.

  5. Oncological outcome and patient satisfaction with skin-sparing mastectomy and immediate breast reconstruction: a prospective observational study

    International Nuclear Information System (INIS)

    Reefy, Sara; Patani, Neill; Anderson, Anne; Burgoyne, Gwyne; Osman, Hisham; Mokbel, Kefah

    2010-01-01

    The management of early breast cancer (BC) with skin-sparing mastectomy (SSM) and immediate breast reconstruction (IBR) is not based on level-1 evidence. In this study, the oncological outcome, post-operative morbidity and patients' satisfaction with SSM and IBR using the latissimus dorsi (LD) myocutaneous flap and/or breast prosthesis is evaluated. 137 SSMs with IBR (10 bilateral) were undertaken in 127 consecutive women, using the LD flap plus implant (n = 85), LD flap alone (n = 1) or implant alone (n = 51), for early BC (n = 130) or prophylaxis (n = 7). Nipple reconstruction was performed in 69 patients, using the trefoil local flap technique (n = 61), nipple sharing (n = 6), skin graft (n = 1) and Monocryl mesh (n = 1). Thirty patients underwent contra-lateral procedures to enhance symmetry, including 19 augmentations and 11 mastopexy/reduction mammoplasties. A linear visual analogue scale was used to assess patient satisfaction with surgical outcome, ranging from 0 (not satisfied) to 10 (most satisfied). After a median follow-up of 36 months (range = 6-101 months) there were no local recurrences. Overall breast cancer specific survival was 99.2%, 8 patients developed distant disease and 1 died of metastatic BC. There were no cases of partial or total LD flap loss. Morbidities included infection, requiring implant removal in 2 patients and 1 patient developed marginal ischaemia of the skin envelope. Chemotherapy was delayed in 1 patient due to infection. Significant capsule formation, requiring capsulotomy, was observed in 85% of patients who had either post-mastectomy radiotherapy (PMR) or prior radiotherapy (RT) compared with 13% for those who had not received RT. The outcome questionnaire was completed by 82 (64.6%) of 127 patients with a median satisfaction score of 9 (range = 5-10). SSM with IBR is associated with low morbidity, high levels of patient satisfaction and is oncologically safe for T(is), T1 and T2 tumours without extensive skin

  6. Relationship between Resilience, Psychological Distress and Physical Activity in Cancer Patients: A Cross-Sectional Observation Study.

    Directory of Open Access Journals (Sweden)

    Martin Matzka

    Full Text Available Psychological distress remains a major challenge in cancer care. The complexity of psychological symptoms in cancer patients requires multifaceted symptom management tailored to individual patient characteristics and active patient involvement. We assessed the relationship between resilience, psychological distress and physical activity in cancer patients to elucidate potential moderators of the identified relationships.A cross-sectional observational study to assess the prevalence of symptoms and supportive care needs of oncology patients undergoing chemotherapy, radiotherapy or chemo-radiation therapy in a tertiary oncology service. Resilience was assessed using the 10-item Connor-Davidson Resilience Scale (CD-RISC 10, social support was evaluated using the 12-item Multidimensional Scale of Perceived Social Support (MSPSS and both psychological distress and activity level were measured using corresponding subscales of the Rotterdam Symptom Checklist (RSCL. Socio-demographic and medical data were extracted from patient medical records. Correlation analyses were performed and structural equation modeling was employed to assess the associations between resilience, psychological distress and activity level as well as selected socio-demographic variables.Data from 343 patients were included in the analysis. Our revised model demonstrated an acceptable fit to the data (χ2(163 = 313.76, p = .000, comparative fit index (CFI = .942, Tucker-Lewis index (TLI = .923, root mean square error of approximation (RMSEA = .053, 90% CI [.044.062]. Resilience was negatively associated with psychological distress (β = -.59, and positively associated with activity level (β = .20. The relationship between resilience and psychological distress was moderated by age (β = -0.33 but not social support (β = .10, p = .12.Cancer patients with higher resilience, particularly older patients, experience lower psychological distress. Patients with higher resilience are

  7. Amino Acids in Cerebrospinal Fluid of Patients with Aneurysmal Subarachnoid Haemorrhage: An Observational Study

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    Bartosz Sokół

    2017-08-01

    Full Text Available BackgroundThe authors are aware of only one article investigating amino acid concentrations in cerebrospinal fluid (CSF in patients with ruptured intracranial aneurysms, and this was published 31 years ago. Since then, both management of subarachnoid haemorrhage (SAH and amino acid assay techniques have seen radical alterations, yet the pathophysiology of SAH remains unclear.ObjectiveTo analyse the pattern of concentrations of amino acids and related compounds in patients with different outcomes following aneurysmal SAH.Methods49 CSF samples were collected from 23 patients on days 0–3, 5, and 10 post-SAH. Concentrations of 33 amino acids and related compounds were assayed by liquid chromatography tandem mass spectrometry in patients with good [Glasgow Outcome Scale (GOS 1–3] and poor (GOS 4–5 outcome.ResultsOf the 33 compounds assayed, only hydroxyproline and 3-aminoisobutyric acid appeared not to increase significantly following SAH. In poor outcome patients, we found significantly higher concentrations of aspartic acid (p = 0.038, glutamic acid (p = 0.038, and seven other compounds on days 0–3 post-SAH; glutamic acid (p = 0.041 on day 5 post-SAH, and 2-aminoadipic acid (p = 0.033 on day 10 post-SAH. The most significant correlation with GOS at 3 months was found for aminoadipic acid on day 10 post-SAH (cc = −0.81.ConclusionAneurysmal rupture leads to a generalised increase of amino acids and related compounds in CSF. The patterns differ between good and poor outcome cases. Increased excitatory amino acids are strongly indicative of poor outcome.

  8. Coinfection and Mortality in Pneumonia-Related Acute Respiratory Distress Syndrome Patients with Bronchoalveolar Lavage: A Prospective Observational Study.

    Science.gov (United States)

    Kao, Kuo-Chin; Chiu, Li-Chung; Hung, Chen-Yiu; Chang, Chih-Hao; Yang, Cheng-Ta; Huang, Chung-Chi; Hu, Han-Chung

    2017-05-01

    Pneumonia is the leading risk factor of acute respiratory distress syndrome (ARDS). It is increasing studies in patients with pneumonia to reveal that coinfection with viral and bacterial infection can lead to poorer outcomes than no coinfection. This study evaluated the role of coinfection identified through bronchoalveolar lavage (BAL) examination on the outcomes of pneumonia-related ARDS. We performed a prospective observational study at Chang Gung Memorial Hospital from October 2012 to May 2015. Adult patients were included if they met the Berlin definition of ARDS. The indications for BAL were clinically suspected pneumonia-related ARDS and no definite microbial sample identified from tracheal aspirate or sputum. The presence of microbial pathogens and clinical outcomes were analyzed. Of the 19,936 patients screened, 902 (4.5%) fulfilled the Berlin definition of ARDS. Of these patients, 255 (22.7%) had pneumonia-related ARDS and were included for analysis. A total of 142 (55.7%) patients were identified to have a microbial pathogen through BAL and were classified into three groups: a virus-only group (n = 41 [28.9%]), no virus group (n = 60 [42.2%]), and coinfection group (n = 41 [28.9%]). ARDS severity did not differ significantly between the groups (P = 0.43). The hospital mortality rates were 53.7% in virus-only identified group, 63.3% in no virus identified group, and 80.5% in coinfection identified group. The coinfection group had significantly higher mortality than virus-only group (80.5% vs. 53.7%; P = 0.01). In patients with pneumonia-related ARDS, the BAL pathogen-positive patients had a trend of higher mortality rate than pathogen-negative patients. Coinfection with a virus and another pathogen was associated with increased hospital mortality in pneumonia-related ARDS patients.

  9. Physical Trauma Patients with Symptoms of an Acute and Posttraumatic Stress Disorder: Protocol for an Observational Prospective Cohort Study.

    Science.gov (United States)

    Visser, Eva; Gosens, Taco; Den Oudsten, Brenda; De Vries, Jolanda

    2018-03-29

    Injury, medical treatment, and rehabilitation can have major impacts on patients' wellbeing. About 25-33% of the patients experience an acute stress disorder (ASD) or a posttraumatic stress disorder (PTSD) after injury. ASD is a relatively new diagnosis. Therefore, knowledge about patients' experiences, the course of ASD and PTSD, and who is at risk for developing ASD or PTSD is lacking. The aims of this multi-method study are to explore patients' experiences with injury (and their care) using a focus group study. Then, in the observational study, different courses of ASD, PTSD, and quality of life will be examined. In addition, this study will examine if these courses could be characterized by socio-demographic, clinical, and psychological variables. Consequently, a risk profile will be developed to determine which patients are at risk for developing ASD or PTSD during the 12 months after injury. Trauma patients treated in the shock room (in 2015) of the Elisabeth-TweeSteden Hospital will share their experiences with injury in the focus group study. Open, axial, and selective coding will be used to analyze the data. Concerning the observational study, patients treated in the shock room (during 2016 and 2017, Elisabeth-TweeSteden Hospital and Erasmus Medical Centre) will be asked to participate. The inclusion period is 12 months. Participants will complete the Impact of Event Scale-Revised, MINI-plus, the Hospital Anxiety and Depression Scale, and the World Health Organization Quality of Life-BREF after inclusion and at 3, 6, 9, and 12 months after injury. The NEO-Five Factor Inventory and the State-Trait Anxiety Inventory-Trait are completed after inclusion only. Repeated measures of latent class analysis and linear mixed models will be used to examine the research aims. This project was funded in August 2015 by ZonMw. The results of the focus group study are expected in the first trimester of 2018. With regard to the observational study, recruitment is currently

  10. An international observational study suggests that artificial intelligence for clinical decision support optimizes anemia management in hemodialysis patients.

    Science.gov (United States)

    Barbieri, Carlo; Molina, Manuel; Ponce, Pedro; Tothova, Monika; Cattinelli, Isabella; Ion Titapiccolo, Jasmine; Mari, Flavio; Amato, Claudia; Leipold, Frank; Wehmeyer, Wolfgang; Stuard, Stefano; Stopper, Andrea; Canaud, Bernard

    2016-08-01

    Managing anemia in hemodialysis patients can be challenging because of competing therapeutic targets and individual variability. Because therapy recommendations provided by a decision support system can benefit both patients and doctors, we evaluated the impact of an artificial intelligence decision support system, the Anemia Control Model (ACM), on anemia outcomes. Based on patient profiles, the ACM was built to recommend suitable erythropoietic-stimulating agent doses. Our retrospective study consisted of a 12-month control phase (standard anemia care), followed by a 12-month observation phase (ACM-guided care) encompassing 752 patients undergoing hemodialysis therapy in 3 NephroCare clinics located in separate countries. The percentage of hemoglobin values on target, the median darbepoetin dose, and individual hemoglobin fluctuation (estimated from the intrapatient hemoglobin standard deviation) were deemed primary outcomes. In the observation phase, median darbepoetin consumption significantly decreased from 0.63 to 0.46 μg/kg/month, whereas on-target hemoglobin values significantly increased from 70.6% to 76.6%, reaching 83.2% when the ACM suggestions were implemented. Moreover, ACM introduction led to a significant decrease in hemoglobin fluctuation (intrapatient standard deviation decreased from 0.95 g/dl to 0.83 g/dl). Thus, ACM support helped improve anemia outcomes of hemodialysis patients, minimizing erythropoietic-stimulating agent use with the potential to reduce the cost of treatment. Copyright © 2016 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

  11. Contemporary Trends in the Management and Outcomes of Patients With Familial Hypercholesterolemia in Canada: A Prospective Observational Study.

    Science.gov (United States)

    Brunham, Liam R; Cermakova, Lubomira; Lee, Terry; Priecelova, Ida; Alloul, Karine; de Chantal, Marilyn; Francis, Gordon A; Frohlich, Jiri

    2017-03-01

    Heterozygous familial hypercholesterolemia (HeFH) is one of the most common genetic diseases in the world and an important cause of premature cardiovascular (CV) disease. The purpose of this study was to characterize the clinical features, current treatment patterns, and CV outcomes of patients with HeFH in British Columbia, Canada. We conducted a longitudinal observational study of patients with HeFH attending a specialized lipid clinic. We collected data on lipid levels, medication use, and CV events at baseline and last follow-up. We recruited 339 patients with clinically diagnosed HeFH, with a total of 3700 person-years of follow-up. The mean low-density lipoprotein cholesterol (LDL-C) level was 5.9 mmol/L at baseline and 3.7 mmol/L at last follow-up. Use of lipid-lowering therapy (LLT) increased from 35.7% at baseline to 84.7% at last follow-up. A ≥ 50% reduction in LDL-C level was achieved in 34.5% of patients, and an LDL-C level ≤ 2 mmol/L was seen in 8.3%. The overall CV event rate in this cohort was 33.5/1000 person-years. Among patients who had a CV event during follow-up, 59% experienced a recurrent event within 5 years. These data contribute to our understanding of contemporary trends in the management of patients with HeFH in Canada. Despite a majority of patients receiving LLT, few patients reached high-risk lipid targets. These data highlight important opportunities to improve the care of patients with HeFH. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  12. A prospective observational study comparing a physiological scoring system with time-based discharge criteria in pediatric ambulatory surgical patients.

    Science.gov (United States)

    Armstrong, James; Forrest, Helen; Crawford, Mark W

    2015-10-01

    Discharge criteria based on physiological scoring systems can be used in the postanesthesia care unit (PACU) to fast-track patients after ambulatory surgery; however, studies comparing physiological scoring systems with traditional time-based discharge criteria are lacking. The purpose of this study was to compare PACU discharge readiness times using physiological vs time-based discharge criteria in pediatric ambulatory surgical patients. We recorded physiological observations from consecutive American Society of Anesthesiologists physical status I-III patients aged 1-18 yr who were admitted to the PACU after undergoing ambulatory surgery in a tertiary academic pediatric hospital. The physiological score was a combination of the Aldrete and Chung systems. Scores were recorded every 15 min starting upon arrival in the PACU. Patients were considered fit for discharge once they attained a score ≥12 (maximum score, 14), provided no score was zero, with the time to achieve a score ≥12 defining the criteria-based discharge (CBD) time. Patients were discharged from the PACU when both the CBD and the existing time-based discharge (TBD) criteria were met. The CBD and TBD data were compared using Kaplan-Meier and log-rank analysis. Observations from 506 children are presented. Median (interquartile range [IQR]) age was 5.5 [2.8-9.9] yr. Median [IQR] CBD and TBD PACU discharge readiness times were 30 [15-45] min and 60 [45-60] min, respectively. Analysis of Kaplan-Meier curves indicated a significant difference in discharge times using the different criteria (hazard ratio, 5.43; 95% confidence interval, 4.51 to 6.53; P < 0.001). All patients were discharged home without incident. This prospective study suggests that discharge decisions based on physiological criteria have the potential for significantly speeding the transit of children through the PACU, thereby enhancing PACU efficiency and resource utilization.

  13. Rapid eye movement-sleep is reduced in patients with acute uncomplicated diverticulitis—an observational study

    Directory of Open Access Journals (Sweden)

    Chenxi Huang

    2015-08-01

    Full Text Available Introduction. Sleep disturbances are commonly found in patients in the postoperative period. Sleep disturbances may give rise to several complications including cardiopulmonary instability, transient cognitive dysfunction and prolonged convalescence. Many factors including host inflammatory responses are believed to cause postoperative sleep disturbances, as inflammatory responses can alter sleep architecture through cytokine-brain interactions. Our aim was to investigate alteration of sleep architecture during acute infection and its relationships to inflammation and clinical symptoms.Materials & Methods. In this observational study, we included patients with acute uncomplicated diverticulitis as a model to investigate the isolated effects of inflammatory responses on sleep. Eleven patients completed the study. Patients were admitted and treated with antibiotics for two nights, during which study endpoints were measured by polysomnography recordings, self-reported discomfort scores and blood samples of cytokines. One month later, the patients, who now were in complete remission, were readmitted and the endpoints were re-measured (the baseline values.Results. Total sleep time was reduced 4% and 7% the first (p = 0.006 and second (p = 0.014 nights of diverticulitis, compared to baseline, respectively. The rapid eye movement sleep was reduced 33% the first night (p = 0.016, compared to baseline. Moreover, plasma IL-6 levels were correlated to non-rapid eye movement sleep, rapid eye movement sleep and fatigue.Conclusion. Total sleep time and rapid eye movement sleep were reduced during nights with active diverticulitis and correlated with markers of inflammation.

  14. Persistence and concomitant medication in patients with overactive bladder treated with antimuscarinic agents in primary care. An observational baseline study.

    Science.gov (United States)

    Sicras-Mainar, A; Navarro-Artieda, R; Ruiz-Torrejón, A; Sáez-Zafra, M; Coll-de Tuero, G

    2016-03-01

    To assess therapeutic persistence and its relationship with concomitant medication in patients treated with fesoterodine versus tolterodine and solifenacin for overactive bladder (OAB) in standard clinical practice conditions. An observational, multicentre retrospective study was performed based on medical registries of patients followed-up in primary care (PC). Three study groups were analysed. Persistence was defined as the time (in months) without withdrawing from the initial therapy or without changing to another medication for at least 30 days after the initial prescription. The concomitant medications were antidepressants, anxiolytic/hypnotic agents, antibiotics, antiseptic agents, laxatives and skin products. We employed the SPSSWIN program version 17 (statistical significance, P<.05). We selected 3094 patients for the study. The median age was 54.0 years and 62.2% were women. The patients treated with fesoterodine shown greater treatment persistence (12 months) when compared with those who took solifenacin and tolterodine (40.2% vs. 34.7% and 33.6%, respectively; P=.008). They also showed a lower use of concomitant medication (1.1 vs. 1.2 and 1.2 drugs, respectively; percentages: 61.6% vs. 67.1% and 70.1%, respectively; P<.03). The patients undergoing OAB treatment with fesoterodine, when compared with those taking solifenacin and tolterodine, were associated with greater treatment persistence and a reduced use of concomitant medication. Copyright © 2015 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  15. Long-term Follow-up Assessing Renal Angiomyolipoma Treatment Patterns, Morbidity, and Mortality : An Observational Study in Tuberous Sclerosis Complex Patients in the Netherlands

    NARCIS (Netherlands)

    Eijkemans, Marinus J C; van der Wal, Willem; Reijnders, Leida J; Roes, Kit C B; van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh; Pelletier, Corey; Magestro, Matthew; Zonnenberg, Bernard

    2015-01-01

    BACKGROUND: Long-term data from patients with tuberous sclerosis complex (TSC)-associated renal angiomyolipoma (angiomyolipoma) are limited. STUDY DESIGN: Retrospective observational study. SETTING & PARTICIPANTS: Adult patients with TSC treated at the University Medical Center Utrecht (the

  16. Tuberculosis patients hospitalized in the Albert Schweitzer Hospital, Lambaréné, Gabon-a retrospective observational study.

    Science.gov (United States)

    Stolp, S M; Huson, M A M; Janssen, S; Beyeme, J O; Grobusch, M P

    2013-11-01

    Epidemiological data on tuberculosis in Central Africa are limited. We performed a retrospective observational study on clinical characteristics of 719 hospitalized tuberculosis patients in Lambaréné, Gabon. Human immunodeficiency virus (HIV) co-infection rate was high (34%) and in-hospital mortality was significantly higher in HIV-positive patients (10% versus 2%). Long-term information on patient outcome was limited; however, from 2008 to 2011, loss to follow up was noted in 28% of cases. Our data illustrate the high burden of TB in Gabon, where loss to follow up and emerging drug resistance are important problems for which comprehensive data are still lacking. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

  17. Incidence of dizziness and vertigo in Japanese primary care clinic patients with lifestyle-related diseases: an observational study

    Directory of Open Access Journals (Sweden)

    Wada M

    2015-04-01

    Full Text Available Masaoki Wada,1,2 Taro Takeshima,1 Yosikazu Nakamura,3 Shoichiro Nagasaka,4 Toyomi Kamesaki,1 Hiroshi Oki,2 Eiji Kajii1 1Division of Community and Family Medicine, Center for Community Medicine, Jichi Medical University, Tochigi, Japan; 2Oki Clinic, Ibaraki, Japan; 3Department of Public Health, Jichi Medical University, Tochigi, Japan; 4Department of Internal Medicine, Division of Endocrinology and Metabolism, Jichi Medical University, Tochigi, Japan Objective: Dizziness and vertigo are highly prevalent symptoms among patients presenting at primary care clinics, and peripheral vestibular disorder (PVD is their most frequent cause. However, the incidence of PVD has not been well documented. This study aimed to investigate the incidence of dizziness, vertigo, and PVD among patients presenting at a primary care clinic. Design: This was an observational study. Setting and participants: Between November 2011 and March 2013, we observed 393 patients, all at least 20 years old, who had been treated for chronic diseases such as hypertension, dyslipidemia, and diabetes mellitus for at least 6 months at a primary clinic (Oki Clinic in Japan. Outcome: The main outcome of interest was new incidence of dizziness, vertigo, and PVD events. During the 1-year follow-up period, the otorhinolaryngologist diagnosed and reported new PVD events. Results: The mean age of the 393 participants at entry was 65.5 years. Of the study participants, 12.7%, 82.4%, and 92.6% had diabetes mellitus, hypertension, and dyslipidemia, respectively. We followed up all the participants (100%. During the 662.5 person-years of follow-up, 121 cases of dizziness or vertigo (dizziness/vertigo and 76 cases of PVD were observed. The incidence of dizziness/vertigo and PVD was 194.7 (95% confidence interval: 161.6–232.6 per 1,000 person-years and 115.7 (95% confidence interval: 92.2–142.6 per 1,000 person-years, respectively. There were 61 cases of acute peripheral vestibulopathy, 12 of

  18. Characterization and utilization of an international neurofibromatosis web-based, patient-entered registry: An observational study.

    Science.gov (United States)

    Seidlin, Mindell; Holzman, Robert; Knight, Pamela; Korf, Bruce; Rangel Miller, Vanessa; Viskochil, David; Bakker, Annette

    2017-01-01

    The neurofibromatoses (neurofibromatosis type 1, neurofibromatosis type 2 and schwannomatosis) are rare disorders having clinical manifestations that vary greatly from patient to patient. The rarity and variability of these disorders has made it challenging for investigators to identify sufficient numbers of patients with particular clinical characteristics or specific germline mutations for participation in interventional studies. Similarly, because the natural history of all types of neurofibromatosis (NF) is variable and unique for each individual, it is difficult to identify meaningful clinical outcome measures for potential therapeutic interventions. In 2012, the Children's Tumor Foundation created a web-based patient-entered database, the NF Registry, to inform patients of research opportunities for which they fit general eligibility criteria and enable patients to contact investigators who are seeking to enroll patients in approved trials. Registrants were recruited through CTF-affiliated NF clinics and conferences, through its website, and by word-of-mouth and social media. Following online consent, demographic information and details regarding manifestations of NF were solicited on the Registry website. Statistical analyses were performed on data from a cohort of 4680 registrants (the number of registrants as of October 9, 2015) who met diagnostic criteria for one of the 3 NF conditions. The analyses support our hypothesis that patient-reported symptom incidences in the NF Registry are congruent with published clinician-sourced data. Between April 26, 2013 and July 8, 2016, the registry has been useful to investigators in recruitment, particularly for observational trials, especially those for development of patient-reported outcomes.

  19. Characterization and utilization of an international neurofibromatosis web-based, patient-entered registry: An observational study.

    Directory of Open Access Journals (Sweden)

    Mindell Seidlin

    Full Text Available The neurofibromatoses (neurofibromatosis type 1, neurofibromatosis type 2 and schwannomatosis are rare disorders having clinical manifestations that vary greatly from patient to patient. The rarity and variability of these disorders has made it challenging for investigators to identify sufficient numbers of patients with particular clinical characteristics or specific germline mutations for participation in interventional studies. Similarly, because the natural history of all types of neurofibromatosis (NF is variable and unique for each individual, it is difficult to identify meaningful clinical outcome measures for potential therapeutic interventions. In 2012, the Children's Tumor Foundation created a web-based patient-entered database, the NF Registry, to inform patients of research opportunities for which they fit general eligibility criteria and enable patients to contact investigators who are seeking to enroll patients in approved trials. Registrants were recruited through CTF-affiliated NF clinics and conferences, through its website, and by word-of-mouth and social media. Following online consent, demographic information and details regarding manifestations of NF were solicited on the Registry website. Statistical analyses were performed on data from a cohort of 4680 registrants (the number of registrants as of October 9, 2015 who met diagnostic criteria for one of the 3 NF conditions. The analyses support our hypothesis that patient-reported symptom incidences in the NF Registry are congruent with published clinician-sourced data. Between April 26, 2013 and July 8, 2016, the registry has been useful to investigators in recruitment, particularly for observational trials, especially those for development of patient-reported outcomes.

  20. Patient-centered and clinical outcomes of mandibular overdentures retained with the locator system: A prospective observational study.

    Science.gov (United States)

    Fernandez-Estevan, Lucia; Montero, Javier; Selva Otaolaurruchi, Eduardo J; Sola Ruiz, Fernanda

    2017-03-01

    Whether clinical or demographic variables affect the perception of treatment in terms of quality of life and satisfaction is unknown. The purpose of this prospective study was to make an evidence-based assessment of the treatment outcomes (patient- and clinically based) of locator-retained mandibular overdentures. This prospective observational study assessed patients with edentulism who had worn mandibular overdentures supported by 2 implants and retained by the locator system for at least 1 year of functional life (N=80). Medical histories were reviewed, and patients underwent oral examinations. Prosthetic clinical outcomes and patient well-being were registered using the Oral Health Impact Profile 20 (OHIP-20) and Oral Satisfaction Scale (OSS). Patient well-being scored an overall OHIP-20 score of 19.0 ±14.0 of 80 (the higher the score, the greater the impact and the worse the oral health-related quality of life); overall oral satisfaction was 8.3 ±1.7 of 10. Women suffered greater social impact (0.8 ±1.0) and disability (0.4 ±0.8) than men (0.4 ±0.7 versus 0.2 ±0.4, respectively). Impact on well-being was inversely proportional to both patient age and the age of the prosthesis (r=-0.25; Poverdentures had been functioning for over 60 months. Relining (46.3%), readjustments (82.5%), and changes of nylon retention (1.5 ±1.8 per patient over 60 months of use) devices negatively influenced well-being. Mandibular overdentures produced good results with regard to quality of life and oral satisfaction, but attention should be paid to factors affecting clinical outcomes and patient well-being. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  1. Physicians' responses to patients' expressions of negative emotions in hospital consultations: a video-based observational study.

    Science.gov (United States)

    Mjaaland, Trond A; Finset, Arnstein; Jensen, Bård Fossli; Gulbrandsen, Pål

    2011-09-01

    Patients express their negative emotions in medical consultations either implicitly as cue to an underlying unpleasant emotion or explicitly as a clear, unambiguous concern. The health provider's response to such cues and concerns is important for the outcome of consultations. Yet, physicians often neglect patient's negative emotions. Most studies of this subject are from primary health care. We aimed to describe how physicians in a hospital respond to negative emotions in an outpatient setting. Ninety six consultations were videotaped in a general teaching hospital. The Verona Coding Definitions of Emotional Sequences was used to identify patients' expression of negative emotions in terms of cue and concern and to code physicians' subsequent responses. Cohen's kappa was used as interrater reliability measure. Acceptable kappa level was set to .60. We observed 163 expressions of negative emotions. In general, the physician responses to patients' cues and concerns did not include follow up or exploration. Concerns more often than cues led to lack of emotional exploration. When patients expressed negative emotions or cues to such, hospital physicians tended to move away from emotional communication, particularly if the emotion was expressed as an explicit concern. Medical training should enable physicians' to explore the patients' emotions in situations where it will improve the medical treatment. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  2. A prospective study of ocular toxicity in patients receiving ethambutol as a part of directly observed treatment strategy therapy

    Directory of Open Access Journals (Sweden)

    Pragati Garg

    2015-01-01

    Full Text Available Background and Objectives: India is among the largest countries to implement the revised National Tuberculosis Control Program (RNTCP. This program provides intermittent regimens to the patients, where the doses of isoniazid and ethambutol are more as compared to the daily regimen, which is a cause of concern, particularly with regard to the ocular toxicity of ethambutol. The present study was undertaken to explore the ocular toxicity in the patients registered under the program. Materials and Methods: This was a prospective single center cohort study of 64 patients of categories I and II, coming to the RNTCP-Directly Observed Treatment Strategy (DOTS center at a tertiary care referral hospital. The detailed history, best corrected visual acuity, fundus examination, and color vision test were carried out in all patients at the start of treatment and then at the first and second month of treatment. Results: Loss in visual acuity from the baseline was noted at the second month follow up in 12 (9.4% eyes (P = 0.001, visual field defects were seen in eight (6.3% eyes (P = 0.0412, and optic disc abnormalities were observed in six (4.7% (P = 0.013 eyes. Color vision abnormalities were noted in 16 (12.6% eyes (P = 0.003, four eyes showed impairment in red-green color perception, and the others showed impairment in blue-yellow color perception as well. Patients with ocular symptoms were advised to stop ethambutol and they showed improvement in visual acuity after follow up of one to two months. The overall outcome of treatment was not affected by discontinuation of ethambutol in these patients. Conclusion: Ethambutol when taken according to program could cause ocular toxicity. The early recognition of ocular symptoms is important to prevent unnecessary delay in diagnosis and probable irreversible visual loss.

  3. The rapid suicide protection of mood stabilizers on patients with bipolar disorder: A nationwide observational cohort study in Taiwan.

    Science.gov (United States)

    Tsai, Chia-Jui; Cheng, Chin; Chou, Po-Han; Lin, Ching-Heng; McInnis, Melvin G; Chang, Chia-Li; Lan, Tsuo-Hung

    2016-05-15

    The suicide rate is high among bipolar disorder (BD) patients. Previous studies have focused on the anti-suicidal effect of long-term treatment with mood stabilizers but less on the immediate preventive effects of interventions. The aim of the study was to evaluate the short-term and immediate anti-suicidal effects of mood stabilizers on recent-onset BD patients. The National Health Insurance Database (NHID) of Taiwan was used to perform a nationwide cohort observation study of suicide behaviors in bipolar disorder. All the recent-onset BD patients (ICD-9-CM code 296 except 296.2 and 296.3) diagnosed between 2000-2005 were collected (n=5091) and followed through 2009. The primary endpoint was the presence of a suicide code or the end of observation; exposure to mood stabilizers in the final month of observation was the independent variable. The hazard ratios (HRs) of suicide-related events, completed suicide, and all-cause mortality were significantly lower for those treated with lithium, divalproex, or carbamazepine compared with no use in the last month (HRs of suicide-related events were 0.10, 0.14 and 0.10, respectively, and all-cause mortality HRs were 0.03; Pmood stabilizers. The NIHD does not provide information on the severity, mood status, or treatment adherence of BD patients. Neither substance-related disorder nor personality disorder were included in the analysis. We focused on the effect of the final prescription time period, not the long-term protective effect. The immediate recent use of any mood stabilizer significantly lowers the rate of death, suicide, or suicidal behavior in BD. Copyright © 2016 Elsevier B.V. All rights reserved.

  4. Observation-based assessment of functional ability in patients with chronic widespread pain: A cross-sectional study

    DEFF Research Database (Denmark)

    Amris, Kirstine; Wæhrens, Eva Elisabet Ejlersen; Jespersen, Anders

    2011-01-01

    Knowledge about functional ability, including activities of daily living (ADL), in patients with chronic widespread pain (CWP) and fibromyalgia (FMS) is largely based on self-report. The purpose of this study was to assess functional ability by using standardised, observation-based assessment...... of ADL performance and to examine the relationship between self-reported and observation-based measures of disability. A total of 257 women with CWP, 199 (77%) fulfilling the American College of Rheumatology tender point criteria for FMS, were evaluated with the Assessment of Motor and Process Skills...... (AMPS), an observation-based assessment providing linear measures of ADL motor and ADL process skill ability (unit: logits). A cutoff for effortless and independent ADL task performance is set at 2.0 for the motor scale and 1.0 for the process scale. A total of 248 (96.5%) had ability measures below...

  5. Social Support and Health in Diabetes Patients: An Observational Study in Six European Countries in an Era of Austerity.

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    Jan Koetsenruijter

    Full Text Available Support from individual social networks, community organizations and neighborhoods is associated with better self-management and health outcomes. This international study examined the relative impact of different types of support on health and health-related behaviors in patients with type 2 diabetes.Observational study (using interviews and questionnaires in a sample of 1,692 type 2 diabetes patients with 5,433 connections from Bulgaria, Greece, Netherlands, Norway, Spain, and the United Kingdom. Outcomes were patient-reported health status (SF-12, physical exercise (RAPA, diet and smoking (SDCSCA. Random coefficient regression models were used to examine linkages with individual networks, community organizations, and neighborhood type (deprived rural, deprived urban, or affluent urban.Patients had a median of 3 support connections and 34.6% participated in community organizations. Controlled for patients' age, sex, education, income and comorbidities, large emotional support networks were associated with decrease of non-smoking (OR = 0.87. Large practical support networks were associated with worse physical and mental health (B = -0.46 and -0.27 respectively and less physical activity (OR = 0.90. Participation in community organizations was associated with better physical and mental health (B = 1.39 and 1.22, respectively and, in patients with low income, with more physical activity (OR = 1.53.Participation in community organizations was most consistently related to better health status. Many diabetes patients have individual support networks, but this study did not provide evidence to increase their size as a public health strategy. The consistent association between participation in community organizations and health status provides a clear target for interventions and policies.

  6. Evaluation of a polymerase chain reaction assay for pathogen detection in septic patients under routine condition: an observational study.

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    Frank Bloos

    Full Text Available BACKGROUND: Treatment of septic shock relies on appropriate antimicrobial therapy. Current culture based methods deliver final results after days, which may delay potentially lifesaving adjustments in antimicrobial therapy. This study was undertaken to compare PCR with blood culture results under routine conditions regarding 1. impact on antimicrobial therapy, and 2. time to result, in patients with presumed sepsis. METHODOLOGY/PRINCIPAL FINDINGS: This was an observational study in a 50 beds ICU of a university hospital. In 245 patients with suspected sepsis, 311 concomitant blood cultures and blood for multiplex PCR (VYOO(® were obtained. 45 of 311 blood cultures (14.5% and 94 of 311 PCRs (30.1% were positive. However, blood culture or microbiological sampling from the presumed site of infection rarely confirmed PCR results and vice versa. Median time to positivity and interquartile range were 24.2 (18.0, 27.5 hours for the PCR and 68 (52.2, 88.5 hours for BC (p<0.01. PCR median time to result was dependent on technician availability (53.5 hours on Saturdays, 7.2 hours under optimal logistic conditions. PCR results showed good correlation with procalcitonin (p<0.001. In 34% of patients with positive PCRs antimicrobial therapy was considered inadequate according to assessment of clinical arbitrators including 5 patients with vancomycin-resistant enterococci (VRE, 3 cases with multiresistant staphylococci, and 4 patients with fungi. CONCLUSIONS: The results of this observational study support the hypothesis that PCR results are available faster, are more frequently positive, and may result in earlier adjustment of antimicrobial therapy. However, shorter time to result can only be fully exploited when the laboratory is adequately staffed for a 24 hour/7 day service, or when point of care/automated assay systems become available.

  7. Four minutes for a patient, twenty seconds for a relative - an observational study at a university hospital

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    Xander Carola J

    2010-04-01

    Full Text Available Abstract Background In the modern hospital environment, increasing possibilities in medical examination techniques and increasing documentation tasks claim the physicians' energy and encroach on their time spent with patients. This study aimed to investigate how much time physicians at hospital wards spend on communication with patients and their families and how much time they spend on other specific work tasks. Methods A non-participatory, observational study was conducted in thirty-six wards at the University Medical Center Freiburg, a 1700-bed academic hospital in Germany. All wards belonging to the clinics of internal medicine, surgery, radiology, neurology, and to the clinic for gynaecology took part in the study. Thirty-four ward doctors from fifteen different medical departments were observed during a randomly chosen complete work day. The Physicians' time for communication with patients and relatives and time spent on different working tasks during one day of work were assessed. Results 374 working hours were analysed. On average, a physician's workday on a university hospital ward added up to 658.91 minutes (10 hrs 58 min; range 490 - 848 min. Looking at single items of time consumption on the evaluation sheet, discussions with colleagues ranked first with 150 minutes on average. Documentation and administrative requirements took an average time of 148 minutes per day and ranked second. Total time for communication with patients and their relatives was 85 minutes per physician and day. Consequently, the available time for communication was 4 minutes and 17 seconds for each patient on the ward and 20 seconds for his or her relatives. Physicians assessed themselves to communicate twice as long with patients and sevenfold with relatives than they did according to this study. Conclusions Workload and time pressure for physicians working on hospital wards are high. To offer excellent medical treatment combined with patient centred care and

  8. Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study

    OpenAIRE

    García-Gutierrez, Susana; Orive, Miren; Sarasqueta, Cristina; Legarreta, Maria Jose; Gonzalez, Nerea; Redondo, Maximino; Rivero, Amado; Serrano-Aguilar, Pedro; Castells, Xavier; Quintana, Jose Maria; Sala, Maria

    2018-01-01

    Background Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Methods Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to...

  9. Safety of telmisartan in patients with arterial hypertension - An open-label observational study

    NARCIS (Netherlands)

    Michel, Martin C.; Bohner, Herbert; Köster, Jürgen; Schäfers, Rafael; Heemann, Uwe

    2004-01-01

    Objective: To determine whether age, gender, concomitant disease and/or previous or present antihypertensive medication affect the safety or antihypertensive efficacy of telmisartan in the treatment of arterial hypertension. Study Design and Methods: In this large-scale, open-label postmarketing

  10. An observational study of acarbose treatment in patients with type 2 diabetes from the Middle East and Morocco

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    Shihabi AR

    2013-04-01

    Full Text Available Abdul R Shihabi,1 Essam M Moussa,2 Hania Sobierajska,3 Birgit Schmidt4 1Al Ain Centre, Dubai, United Arab Emirates; 2New Jeddah Hospital, Jeddah, Saudi Arabia; 3Etihad Airways Medical Centre, Abu Dhabi, United Arab Emirates; 4Bayer Schering Pharma AG, Leverkusen, Germany Background: The prevalence of type 2 diabetes is increasing dramatically in the Middle East and North Africa region. However, there are few trials that have determined the effect of antidiabetic treatment in an observational setting in these countries. Methods: This was a noninterventional study performed in Morocco in 2006–2007 and in the Middle East in 2005–2006 to observe the efficacy and safety of acarbose in patients with pretreated or untreated type 2 diabetes. Glycemic parameters (fasting blood glucose, one-hour postprandial blood glucose, and HbA1c were recorded within a 3-month period. The observation period included an initial visit at the start of acarbose therapy and up to three follow-ups. Results: Acarbose was effective in reducing glycemic parameters in patients from Morocco (n = 1082 and the Middle East (n = 1737. The mean one-hour postprandial blood glucose decreased by 35.5% to 165.4 ± 47.9 mg/dL in the Middle East and by 35.5% to 179.0 ± 49.9 mg/dL in Morocco. Mean fasting blood glucose decreased by 30.8% to 126.6 ± 34.2 mg/dL (Middle East and by 34.5% to 150.6 ± 47.1 mg/dL (Morocco. The absolute reduction in HbA1c was 1.3% in the Middle East (final value 7.4% and 1.0% in Morocco (final value 7.5%. Overall, 107 patients (Middle East and 26 patients (Morocco experienced minor drug-related adverse events, which were mainly gastrointestinal. The tolerability of acarbose was rated as very good/good by 80.8% in the Middle East and by 68.6% in Morocco. Conclusion: This study illustrates the efficacy and safety of acarbose in the treatment of type 2 diabetic patients in an observational setting. Keywords: type 2 diabetes, acarbose, Glucobay®, Glucor

  11. Patients presenting with acute poisoning to an outpatient emergency clinic: a one-year observational study in Oslo, Norway.

    Science.gov (United States)

    Vallersnes, Odd Martin; Jacobsen, Dag; Ekeberg, Øivind; Brekke, Mette

    2015-08-13

    In Oslo, the majority of patients with acute poisoning are treated in primary care, at an emergency outpatient clinic with limited diagnostic and treatment resources. We describe the poisonings currently seen in this setting. We compare our findings with previous studies, with special concern for the appearance of new toxic agents, and changes in overall numbers and patterns of poisoning. Observational study. Patients above the age of 12 years presenting at Oslo Accident and Emergency Outpatient Clinic (Oslo Legevakt) with acute poisoning were included consecutively from October 2011 through September 2012. Physicians and nurses registered data on preset forms. Main outcome measures were toxic agents, age, sex, intention, referral and time of presentation. There were 2923 episodes of acute poisoning in 2261 patients. Median age of the patients was 32 years, and 1430 (63%) were males. The most frequent toxic agents were ethanol in 1684 (58%) episodes, heroin in 542 (19 %), benzodiazepines in 521 (18%), amphetamine in 275 (9%), fire smoke in 192 (7%), gamma-hydroxybutyrate (GHB) in 144 (5%), and cannabis in 143 (5%). In 904 (31%) poisonings there were more than one toxic agent. In 493 episodes (17%), the patient was hospitalised, and in 60 episodes (2%) admitted to a psychiatric ward. Most poisonings, 2328 (80%), were accidental overdoses with substances of abuse, 276 (9%) were suicide attempts, and 312 (11%) were accidents. Among ethanol poisonings in patients above the age of 26 years, 685/934 (73%) were in males, and 339/934 (36%) presented during weekends. However, among ethanol poisonings in patients under the age of 26 years, 221/451 (49 ) were in females, and 297/451 (66%) presented during weekends. The poisonings treated in this primary care setting were mostly due to accidental overdoses with ethanol or other substances of abuse. There is a disconcerting weekend drinking pattern among adolescents and young adults, with young females presenting as often as

  12. Are patients' preferences regarding the place of treatment heard and addressed at the point of referral: an exploratory study based on observations of GP-patient consultations.

    Science.gov (United States)

    Victoor, Aafke; Noordman, Janneke; Sonderkamp, Johan A; Delnoij, Diana M J; Friele, Roland D; van Dulmen, Sandra; Rademakers, Jany J D J M

    2013-12-10

    Today, in several north-western European countries, patients are encouraged to choose, actively, a healthcare provider. However, patients often visit the provider that is recommended by their general practitioner (GP). The introduction of patient choice requires GPs to support patients to be involved, actively, in the choice of a healthcare provider. We aim to investigate whether policy on patient choice is reflected in practice, i.e. what the role of the patient is in their choices of healthcare providers at the point of referral and to what extent GPs' and patients' healthcare paths influence the role that patients play in the referral decision. In 2007-2008, we videotaped Dutch GP-patient consultations. For this study, we selected, at random, 72 videotaped consultations between 72 patients and 39 GPs in which the patient was referred to a healthcare provider. These were analysed using an observation protocol developed by the researchers. The majority of the patients had little or no input into the choice of a healthcare provider at the point of referral by their GP. Their GPs did not support them in actively choosing a provider and the patients often agreed with the provider that the GP proposed. Patients who were referred for diagnostic purposes seem to have had even less input into their choice of a provider than patients who were referred for treatment. We found that the GP chooses a healthcare provider on behalf of the patient in most consultations, even though policy on patient choice expects from patients that they choose, actively, a provider. On the one hand, this could indicate that the policy needs adjustments. On the other hand, adjustments may be needed to practice. For instance, GPs could help patients to make an active choice of provider. However, certain patients prefer to let their GP decide as their agent. Even then, GPs need to know patients' preferences, because in a principal-agent relationship, it is necessary that the agent is fully

  13. Polypharmacy as a risk factor for depressive symptoms in geriatric patients: an observational, cross-sectional study

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    Spandel Leszek

    Full Text Available Aim: The aim of this study was to investigate the correlation between polypharmacy and depressive symptoms in hospitalized adults aged over 65 years. Patients and methods: We obtained medical history and current treatment data from clinical records. We used the Abbreviated Mental Test Score (AMTS to exclude patients with dementia. The Geriatric Depression Scale (GDS was used assess depressive symptoms. Pearson and Spearman coefficients were used to determine the relationship between variables. Results: A total of 206 individuals were included. The average number of medications taken by the individuals was 6.9 ± 2.7 and the average GDS score was 4.9 ± 3.4 points. Depressive symptoms (GDS score >5 points were observed in 68 (33.0% individuals. GDS score positively correlated with the number of medications used (R = 0.74; P = 0.0001, the number of chronic conditions (R = 0.78; P = 0.001, and pain complaints (Z = 7.94; P = 0.0001. A significant association between GDS score and the use of the following medications was observed: statins, cytostatic agents, corticosteroids, benzodiazepines, cardiac glycosides, non-steroidal anti-inflammatory drugs, muscle relaxants, non-psychotropic drugs with anticholinergic properties, and centrally acting analgesics (all P < 0.05. Conclusions: Our study indicates that polypharmacy is positively correlated with the presence of depressive symptoms in geriatric patients. We identified a number of medications associated with a higher prevalence of depressive symptoms, however these relationships require further examination.

  14. The relationship between serum ammonia level and neurologic complications in patients with acute glufosinate ammonium poisoning: A prospective observational study.

    Science.gov (United States)

    Cha, Y S; Kim, H; Lee, Y; Choi, E H; Kim, H I; Kim, O H; Cha, K-C; Lee, K H; Hwang, S O

    2018-06-01

    Glufosinate ammonium poisoning can cause neurological complications even after a symptom-free period. We prospectively investigated the predictors of neurologic complications in acute glufosinate ammonium poisoning and the change of serum ammonia level as a predictor of patient's presence and recovery of neurologic complication. This prospective observational study collected data from consecutive patients diagnosed with acute glufosinate ammonium poisoning between September 2014 and June 2016. Serum ammonia was serially measured. The patients were divided into two groups: the neurologic complication group and the nonneurologic complication group. We also defined 25 other insecticide- or herbicide-poisoned patients as controls. The neurologic complication group included 18 patients (72.0%). The latency period for neurologic complications was within 48-h postingestion. The peak ammonia level was statistically higher in the neurologic complication group than in the control group ( p glufosinate ammonium poisoning, serial serum ammonia level measurements are needed and a serum peak ammonia level greater than 90 μg/dL is a predictor of neurologic complications. Also, it is important to treat the hyperammonemia in acute glufosinate ammonium poisoning.

  15. Understanding why cancer patients accept or turn down psycho-oncological support: a prospective observational study including patients' and clinicians' perspectives on communication about distress.

    Science.gov (United States)

    Zwahlen, Diana; Tondorf, Theresa; Rothschild, Sacha; Koller, Michael T; Rochlitz, Christoph; Kiss, Alexander

    2017-05-30

    International standards prioritize introducing routine emotional distress screening in cancer care to accurately identify patients who most need psycho-oncological treatment, and ensure that patients can access appropriate supportive care. However, only a moderate proportion of distressed patients accepts referrals to or uses psycho-oncological support services. Predictors and barriers to psycho-oncological support service utilization are under-studied. We know little about how patients and oncologists perceive the discussions when oncologists assess psychosocial distress with a screening instrument. We aim to 1) assess the barriers and predictors of uptake of in-house psycho-oncological support along the distress screening pathway in cancer patients treated at a University Oncology Outpatient Clinic and, 2) determine how patients and clinicians perceive communication about psychosocial distress after screening with the Distress Thermometer. This is a quantitative prospective observational study with qualitative aspects. We will examine medical and demographic variables, cancer patient self-reports of various psychological measures, and aspects of the patient-clinician communication as variables that potentially predict uptake of psycho-oncological support service. We will also assess the patients' reasons for accepting or refusing psycho-oncological support services. We assess at three points in time, based on paper-and-pencil questionnaires and two patient interviews during the study period. We will monitor outcomes (psycho-oncology service uptake) four months after study entry. The study will improve our understanding of characteristics of patients who accept or refuse psycho-oncological support, and help us understand how patients' and oncologists perceive communication about psychosocial distress, and referral to a psycho-oncologist. We believe this is the first study to focus on factors that affect uptake or rejection of psycho-oncological support services

  16. Baseline characteristics of patients with chronic kidney disease stage 3 and stage 4 in spain: the MERENA observational cohort study

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    Montes Rafael

    2011-10-01

    Full Text Available Abstract Background To obtain information on cardiovascular morbidity, hypertension control, anemia and mineral metabolism based on the analysis of the baseline characteristics of a large cohort of Spanish patients enrolled in an ongoing prospective, observational, multicenter study of patients with stages 3 and 4 chronic kidney diseases (CKD. Methods Multicenter study from Spanish government hospital-based Nephrology outpatient clinics involving 1129 patients with CKD stages 3 (n = 434 and 4 (n = 695 defined by GFR calculated by the MDRD formula. Additional analysis was performed with GFR calculated using the CKD-EPI and Cockcroft-Gault formula. Results In the cohort as a whole, median age 70.9 years, morbidity from all cardiovascular disease (CVD was very high (39.1%. In CKD stage 4, CVD prevalence was higher than in stage 3 (42.2 vs 35.6% p 300 mg/day was present in more than 60% of patients and there was no significant differences between stages 3 and 4 CKD (1.2 ± 1.8 and 1.3 ± 1.8 g/day, respectively. A majority of the patients had hemoglobin levels greater than 11 g/dL (91.1 and 85.5% in stages 3 and 4 CKD respectively p Conclusion This study provides an overview of key clinical parameters in patients with CKD Stages 3 and 4 where delivery or care was largely by nephrologists working in a network of hospital-based clinics of the Spanish National Healthcare System.

  17. Itopride in the treatment of functional dyspepsia in Chinese patients: a prospective, multicentre, post-marketing observational study.

    Science.gov (United States)

    Sun, Jing; Yuan, Yao-Zong; Holtmann, Gerald

    2011-12-01

    Prokinetic agents are commonly used in the symptomatic treatment of functional dyspepsia (FD). Safety or efficacy issues associated with the use of available prokinetics, such as metoclopramide, domperidone, cisapride and mosapride, mean there is a need for an effective and well tolerated prokinetic agent. Itopride is a novel prokinetic agent with a dual mode of action, good safety profile and documented efficacy in placebo-controlled trials. The objective of this study was to assess the effectiveness and safety of itopride in the management of FD. This was a prospective, multicentre, post-marketing observational study carried out in private outpatient clinics throughout China. The study included patients with symptomatic FD aged ≥18 years. Patients were prescribed itopride 50 mg three times daily before meals for 4 weeks, after which there was a 2-week follow-up period during which they did not take itopride. Effectiveness and tolerability data obtained from patients who completed 4 weeks of therapy were analysed. The treatment response rate after 4 weeks was measured by patient global assessment; scores at the end of treatment were compared with baseline scores. Response rate based on symptom scoring was also measured after 4 weeks, with an effective treatment being defined as a symptom improvement of ≥50%. In total, 587 patients with FD were enrolled. The mean ± SD difference in the total symptom score before and after the 4-week treatment period was -5.62 ± 3.27, corresponding to a 69.23 ± 26.53% reduction from baseline (p Itopride was an effective and well tolerated drug in the management of FD in this patient population.

  18. Time spent in primary care for hip osteoarthritis patients once the diagnosis is set: a prospective observational study

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    van den Akker-Scheek Inge

    2011-06-01

    Full Text Available Abstract Background Previous research on time to referral to orthopaedic surgery has predominantly used hip complaints as starting point instead of the moment the diagnosis of osteoarthritis (OA of the hip is established, therefore little is known about the length of time a patient diagnosed with hip OA stays under the care of a general practitioner (GP. No knowledge on factors of influence on this time period is available either. Aim of this study was thus to determine the time an incident hip OA patient stays in the care of a GP until referral to an orthopaedic department. Influencing factors were also analyzed. Methods A prospective observational study was conducted based on data over a 10-year period from a general practice-based registration network (17 GPs, > 30,000 patients registered yearly. Patients with the diagnosis of hip OA were included. A survival analysis was used to determine time until referral to an orthopaedic department, and to determine factors of influence on this time. Results Of 391 patients diagnosed with hip OA, 121 (31% were referred; average survival time until referral was 82.0 months (95% CI 76.6-87.5. Less contact with the GP for hip complaints before the diagnosis of hip OA was established resulted in a decreased time to referral. Conclusions The results of this study show that patients with hip OA were under the care of a general practitioner, and thus in primary care, for a considerable amount of time once the diagnosis of hip OA was established.

  19. How are patients with type 2 diabetes and renal disease monitored and managed? Insights from the observational OREDIA study

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    Penfornis A

    2014-06-01

    Full Text Available Alfred Penfornis,1 Jean Frédéric Blicklé,2 Béatrice Fiquet,3 Stéphane Quéré,4 Sylvie Dejager3 1Department of Endocrinology-Metabolism and Diabetology-Nutrition, Jean Minjoz Hospital, University of Franche-Comté, Besançon, France; 2Department of Internal Medicine and Diabetology, Strasbourg University Hospital, Strasbourg, France; 3Clinical Affairs, Novartis Pharma SAS, Rueil-Malmaison, France; 4BioStatistics, Novartis Pharma SAS, Rueil-Malmaison, France Background and aim: Chronic kidney disease (CKD is frequent in type 2 diabetes mellitus (T2DM, and therapeutic management of diabetes is more challenging in patients with renal impairment (RI. The place of metformin is of particular interest since most scientific societies now recommend using half the dosage in moderate RI and abstaining from use in severe RI, while the classic contraindication with RI has not been removed from the label. This study aimed to assess the therapeutic management, in particular the use of metformin, of T2DM patients with CKD in real life. Methods: This was a French cross-sectional observational study: 3,704 patients with T2DM diagnosed for over 1 year and pharmacologically treated were recruited in two cohorts (two-thirds were considered to have renal disease [CKD patients] and one-third were not [non-CKD patients] by 968 physicians (81% general practitioners in 2012. Results: CKD versus non-CKD patients were significantly older with longer diabetes history, more diabetic complications, and less strict glycemic control (mean glycated hemoglobin [HbA1c] 7.5% versus 7.1%; 25% of CKD patients had HbA1c ≥8% versus 15% of non-CKD patients. Fifteen percent of CKD patients had severe RI, and 66% moderate RI. Therapeutic management of T2DM was clearly distinct in CKD, with less use of metformin (62% versus 86% but at similar mean daily doses (~2 g/d. Of patients with severe RI, 33% were still treated with metformin, at similar doses. For other oral anti

  20. Evaluation of fixed dose combination of glimepiride and metformin in patients with type 2 diabetes. Results of Russian observational study

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    Natalya Vladislavovna Zaytseva

    2015-04-01

    Full Text Available Aim. To investigate the efficacy and safety of combined glimepiride and metformin therapy in patients with type 2 diabetes mellitus (T2DM. Materials and methods. A multi-centre, open-label, prospective, observational study was conducted. A total of 1200 patients with T2DM inadequately controlled with metformin, glimepiride or combination of metformin + glimepiride were enrolled. Change in serum glycated haemoglobin (HbA1c, fasting plasma glucose (FPG, and postprandial blood glucose (PPG levels; weight; waist circumference and hypoglycemic episodes were evaluated. Results. Baseline HbA1c levels (8.24% ? 0.42% were significantly reduced after 12 weeks of treatment (7.48% ? 0.48% and at the end of the study. (6.88% ? 0.56%. Target HbA1c levels (?7% were achieved in 65.1% of patients at the final visit at 24 weeks. FPG and PPG levels decreased by 1.45 ? 1.14 mmol/l and 2.17 ? 1.27 mmol/l respectively (p < 0.001. No severe hypoglycemic events were reported. Body mass index reduced by 0.85 ? 1.28 kg/m2 (p < 0.001. Conclusion. . Combined glimepiride and metformin therapy significantly improved long-term glycemic control in patients with T2DM during the period of 24 weeks. without additional risk of hypoglycemic events or weight gain.

  1. Effect of natalizumab treatment on circulating plasmacytoid dendritic cells: a cross-sectional observational study in patients with multiple sclerosis.

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    Pia Kivisäkk

    Full Text Available Dendritic cells (DCs serve a critical role both in promoting and inhibiting adaptive immunity. The goal of this study was to investigate the effect of natalizumab (NTZ treatment on DC numbers, phenotype, and function in patients with multiple sclerosis (MS.Frequency and phenotype of myeloid and plasmacytoid DCs (MDCs and PDCs, respectively were analyzed in blood from two separate cohorts of untreated, interferon-treated, or NTZ-treated MS patients. In addition, PDCs were stimulated with CpG-containing oligonucleotides or co-cultured with homologous T cells in the presence or absence of NTZ in vitro to determine functional effects of NTZ treatment.We observed that NTZ treatment was associated with a 25-50% reduction in PDC frequency in peripheral blood as compared to untreated MS patients, while the frequency of MDCs was unchanged. PDCs in NTZ-treated patients displayed a mature, activated phenotype with increased expression of HLA-DR, TLR9, CCR7, IL-6 and IL-12. In contrast, in vitro treatment with NTZ did not increase markers of PDC activation or their ability to induce T cell differentiation.Our study shows that NTZ treatment is associated with a reduced frequency of PDCs in the peripheral circulation, but that PDCs in NTZ-treated individuals display an activated phenotype. Taken together the data suggests that transmigration of activated PDCs is preferentially affected by blockade of integrin α4 leading to an increased frequency of activated PDCs in blood.

  2. Blood transfusion in patients having caesarean section: a prospective multicentre observational study of practice in three Pakistan hospitals.

    Science.gov (United States)

    Ismail, S; Siddiqui, S; Shafiq, F; Ishaq, M; Khan, S

    2014-08-01

    Increasing awareness of the risks of blood transfusion has prompted examination of red cell transfusion practice in obstetrics. A six-month prospective observational study was performed to examine blood transfusion practices in patients undergoing caesarean delivery at three hospitals in Pakistan. In the three hospitals (two private, one public) 3438 caesarean deliveries were performed in the study period. Data were collected on patient demographics, indications for transfusion, ordering physicians, consent, associations with obstetric factors, estimated allowable blood loss, calculated blood loss, pre- and post-transfusion haemoglobin and discharge haemoglobin. A total number of 397 (11.5%) patients who underwent caesarean section received a blood transfusion. The highest transfusion rate of 16% was recorded in the public tertiary care hospital compared to 5% in the two private hospitals. Emergency caesarean delivery and multiparity were associated with blood transfusion (Ptransfusion in 98% of cases. In 343 (86%) patients, blood transfusion was given even when the haemoglobin was >7g/dL. The method for documenting the indication or consent for transfusion was not found in any of the three hospitals. Blood transfusion was prescribed more readily in the public hospital. Identification of a transfusion trigger and the development of institutional guidelines to reduce unnecessary transfusion are required. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. Implementation fidelity of self-administered transcutaneous electrical nerve stimulation (TENS) in patients with chronic back pain: an observational study.

    Science.gov (United States)

    Pallett, Edward J; Rentowl, Patricia; Johnson, Mark I; Watson, Paul J

    2014-03-01

    The efficacy of transcutaneous electrical nerve stimulation (TENS) for pain relief has not been reliably established. Inconclusive findings could be due to inadequate TENS delivery and inappropriate outcome assessment. Electronic monitoring devices were used to determine patient compliance with a TENS intervention and outcome assessment protocol, to record pain scores before, during, and after TENS, and measure electrical output settings. Patients with chronic back pain consented to use TENS daily for 2 weeks and to report pain scores before, during, and after 1-hour treatments. A ≥ 30% reduction in pain scores was used to classify participants as TENS responders. Electronic monitoring devices "TLOG" and "TSCORE" recorded time and duration of TENS use, electrical settings, and pain scores. Forty-two patients consented to participate. One of 35 (3%) patients adhered completely to the TENS use and pain score reporting protocol. Fourteen of 33 (42%) were TENS responders according to electronic pain score data. Analgesia onset occurred within 30 to 60 minutes for 13/14 (93%) responders. It was not possible to correlate TENS amplitude, frequency, or pulse width measurements with therapeutic response. Findings from TENS research studies depend on the timing of outcome assessment; pain should be recorded during stimulation. TENS device sophistication might be an issue and parameter restriction should be considered. Careful protocol design is required to improve adherence and monitoring is necessary to evaluate the validity of findings. This observational study provides objective evidence to support concerns about poor implementation fidelity in TENS research.

  4. Evaluation of fixed dose combination of glimepiride and metformin in patients with type 2 diabetes. Results of Russian observational study

    Directory of Open Access Journals (Sweden)

    Natalya Vladislavovna Zaytseva

    2015-04-01

    Full Text Available Aim.To investigate the efficacy and safety of combined glimepiride and metformin therapy in patients with type 2 diabetes mellitus (T2DM.Materials and methods.A multi-centre, open-label, prospective, observational study was conducted. A total of 1200 patients with T2DM inadequately controlled with metformin, glimepiride or combination of metformin + glimepiride were enrolled. Change in serum glycated haemoglobin (HbA1c, fasting plasma glucose (FPG, and postprandial blood glucose (PPG levels; weight; waist circumference and hypoglycemic episodes were evaluated.Results.Baseline HbA1c levels (8.24% ± 0.42% were significantly reduced after 12 weeks of treatment (7.48% ± 0.48% and at the end of the study(6.88% ± 0.56%. Target HbA1c levels (≤7% were achieved in 65.1% of patients at the final visit at 24 weeks. FPG and PPG levels decreased by 1.45 ± 1.14 mmol/l and 2.17 ± 1.27 mmol/l respectively (p < 0.001. No severe hypoglycemic events were reported. Body mass index reduced by 0.85 ± 1.28 kg/m2 (p < 0.001.Conclusion. Combined glimepiride and metformin therapy significantly improved long-term glycemic control in patients with T2DM during the period of 24 weeks without additional risk of hypoglycemic events or weight gain.

  5. The effectiveness of the telehomecare for self-care behaviors of patients with diabetes in Taiwan: A consecutive observational study

    Directory of Open Access Journals (Sweden)

    Szu-Han Chiu

    2017-01-01

    Full Text Available Background: Poor glycemic control in patients with diabetes mellitus can increase associated complications and mortality. We use the telehomecare system in patients with diabetes and investigate the associated impact in clinical practice. Materials and Methods: The purpose of the study is to examine the effectiveness of the telehomecare system on diabetic self-care. The telehomecare system incorporated into the daily care program in the experimental group. A cloud health-care platform designed for information storage and exchange be constructed and monitored by case managers. Comprehensive care instructions and in-time consultation in case of abnormalities were provided. The patients in the control group adopted conventional care program. Self-care questionnaires were completed by both groups before and after the study. All participants measured before the experiment and at 4 months after. Results: The participants were 117 patients (including 56 at the experimental and 61 at the control group, which recruited from a community hospital in New Taipei city, Taiwan. In two-way mixed design ANCOVA, in self-care behaviors, there are significant differences between two groups. The outcome of experimental group is superior to the control group both in posttest. However, there is no significant difference between two groups in subscales of foot care and athletics care. Moreover, there is no delayed effect in self-care behaviors of drug adjustment and blood sugar surveillance. Conclusions: This observational study revealed early intervention model to the health education strategy, the telehomecare might strengthen self-care behaviors of the participants. To the future study, we can put emphasis on the diabetes mellitus patient's foot care and exercise behaviors. The telehomecare model could also become the important health-care policy for the government in the future.

  6. Mental health self-assessment in patients with moderate to severe psoriasis: an observational, multicenter study of 1164 patients in Spain (the VACAP Study).

    Science.gov (United States)

    Pujol, R M; Puig, L; Daudén, E; Sánchez-Carazo, J L; Toribio, J; Vanaclocha, F; Yébenes, M; Sabater, E; Casado, M A; Caloto, M T; Aragón, B

    2013-12-01

    Poor self-assessed mental health appears to be related to the severity of psoriasis. To evaluate the impact of psoriasis severity on mood and anxiety disorders. A prospective, observational, multicenter study was conducted by 123 dermatologists in Spain. Patients (n=164; mean [SD] age, 45.11 [13.92] years; 60.8% males) with moderate to severe psoriasis were evaluated at baseline and 4 months later. Psoriasis severity was measured using the Psoriasis Area and Severity Index (PASI), with a score range of 0 (mild) to 72 (severe); body surface area involvement (BSA); and physician global assessment (PGA) scores, with a range of 1 (mild) to 7 (severe). Mental health was assessed using the Hospital Anxiety and Depression Scale (HADS), with a total possible score of 0-42 (higher scores representing worse mental health). Mean first and second visit scores were compared. Mean (SD) scores improved between the first and second visit as follows: 13.24 (9.50) to 5.07 (6.03) for PASI, 12.52 (7.92) to 10.78 (7.32) for overall HADS, 7.83 (4.55) to 6.85 (4.21) for the HADS anxiety subscale, and 4.72 (4.12) to 3.95 (3.76) for the HADS depression subscale (P<.001 in all cases). Multivariate analyses showed that the main factors related to anxiety were psoriasis severity, sex, and completion of graduate studies. The independent variables included in the model for depression were psoriasis severity, sex, and psoriasis located on the head. Reductions in disease severity improve self-assessed mood and anxiety disorders in patients with moderate to severe psoriasis. Copyright © 2012 Elsevier España, S.L. and AEDV. All rights reserved.

  7. Implementation of patient blood management remains extremely variable in Europe and Canada: the NATA benchmark project: An observational study.

    Science.gov (United States)

    Van der Linden, Philippe; Hardy, Jean-François

    2016-12-01

    Preoperative anaemia is associated with increased postoperative morbidity and mortality. Patient blood management (PBM) is advocated to improve patient outcomes. NATA, the 'Network for the advancement of patient blood management, haemostasis and thrombosis', initiated a benchmark project with the aim of providing the basis for educational strategies to implement optimal PBM in participating centres. Prospective, observational study with online data collection in 11 secondary and tertiary care institutions interested in developing PBM. Ten European centres (Austria, Spain, England, Denmark, Belgium, Netherlands, Romania, Greece, France, and Germany) and one Canadian centre participated between January 2010 and June 2011. A total of 2470 patients undergoing total hip (THR) or knee replacement, or coronary artery bypass grafting (CABG), were registered in the study. Data from 2431 records were included in the final analysis. Primary outcome measures were the incidence and volume of red blood cells (RBC) transfused. Logistic regression analysis identified variables independently associated with RBC transfusions. The incidence of transfusion was significantly different between centres for THR (range 7 to 95%), total knee replacement (range 3 to 100%) and CABG (range 20 to 95%). The volume of RBC transfused was significantly different between centres for THR and CABG. The incidence of preoperative anaemia ranged between 3 and 40% and its treatment between 0 and 40%, the latter not being related to the former. Patient characteristics, evolution of haemoglobin concentrations and blood losses were also different between centres. Variables independently associated with RBC transfusion were preoperative haemoglobin concentration, lost volume of RBC and female sex. Implementation of PBM remains extremely variable across centres. The relative importance of factors explaining RBC transfusion differs across institutions, some being patient related whereas others are related to

  8. Perception of co-speech gestures in aphasic patients: a visual exploration study during the observation of dyadic conversations.

    Science.gov (United States)

    Preisig, Basil C; Eggenberger, Noëmi; Zito, Giuseppe; Vanbellingen, Tim; Schumacher, Rahel; Hopfner, Simone; Nyffeler, Thomas; Gutbrod, Klemens; Annoni, Jean-Marie; Bohlhalter, Stephan; Müri, René M

    2015-03-01

    Co-speech gestures are part of nonverbal communication during conversations. They either support the verbal message or provide the interlocutor with additional information. Furthermore, they prompt as nonverbal cues the cooperative process of turn taking. In the present study, we investigated the influence of co-speech gestures on the perception of dyadic dialogue in aphasic patients. In particular, we analysed the impact of co-speech gestures on gaze direction (towards speaker or listener) and fixation of body parts. We hypothesized that aphasic patients, who are restricted in verbal comprehension, adapt their visual exploration strategies. Sixteen aphasic patients and 23 healthy control subjects participated in the study. Visual exploration behaviour was measured by means of a contact-free infrared eye-tracker while subjects were watching videos depicting spontaneous dialogues between two individuals. Cumulative fixation duration and mean fixation duration were calculated for the factors co-speech gesture (present and absent), gaze direction (to the speaker or to the listener), and region of interest (ROI), including hands, face, and body. Both aphasic patients and healthy controls mainly fixated the speaker's face. We found a significant co-speech gesture × ROI interaction, indicating that the presence of a co-speech gesture encouraged subjects to look at the speaker. Further, there was a significant gaze direction × ROI × group interaction revealing that aphasic patients showed reduced cumulative fixation duration on the speaker's face compared to healthy controls. Co-speech gestures guide the observer's attention towards the speaker, the source of semantic input. It is discussed whether an underlying semantic processing deficit or a deficit to integrate audio-visual information may cause aphasic patients to explore less the speaker's face. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. Skeletal involvement in Gaucher disease: An observational multicenter study of prognostic factors in the Argentine Gaucher disease patients.

    Science.gov (United States)

    Drelichman, Guillermo; Fernández Escobar, Nicolás; Basack, Nora; Aversa, Luis; Larroude, María Silvia; Aguilar, Gabriela; Szlago, Marina; Schenone, Andrea; Fynn, Alcyra; Cuello, María Fernanda; Aznar, Marcela; Fernández, Ramiro; Ruiz, Alba; Reichel, Paola; Guelbert, Norberto; Robledo, Hugo; Watman, Nora; Bolesina, Moira; Elena, Graciela; Veber, S Ernesto; Pujal, Graciela; Galván, Graciela; Chain, Juan José; Arizo, Adriana; Bietti, Julieta; Bar, Daniel; Dragosky, Marta; Marquez, Marisa; Feldman, Leonardo; Muller, Katja; Zirone, Sandra; Buchovsky, Greogorio; Lanza, Victoria; Sanabria, Alba; Fernández, Ignacio; Jaureguiberry, Rossana; Contte, Marcelo; Barbieri María, Angie; Maro, Alejandra; Zárate, Graciela; Fernández, Gabriel; Rapetti, María Cristina; Donato, Hugo; Degano, Adriana; Kantor, Gustavo; Albina, Roberto; Á Lvarez Bollea, María; Brun, María; Bacciedoni, Viviana; Del Río, Francis; Soberón, Bárbara; Boido, Nazario; Schweri, Maya; Borchichi, Sandra; Welsh, Victoria; Corrales, Marcela; Cedola, Alejandra; Carvani, Analía; Diez, Blanca; Richard, Lucía; Baduel, Ccecilia; Nuñez, Gabriela; Colimodio, Rubén; Barazzutti, Lucía; Medici, Hugo; Meschengieser, Susana; Damiani, Germán; Nucifora, María; Girardi, Beatriz; Gómez, Sergio; Papucci, Maura; Verón, David; Quiroga, Luis; Carro, Gustavo; De Ambrosio, Patricia; Ferro, José; Pujol, Marcelo; Castella, Cristina Cabral; Franco, Liliana; Nisnovich, Gisela; Veloso, María; Pacheco, Isabel; Savarino, Mario; Marino, Andrés; Saavedra, José Luis

    2016-10-01

    Patients with Gaucher type 1 (GD1) throughout Argentina were enrolled in the Argentine bone project to evaluate bone disease and its determinants. We focused on presence and predictors of bone lesions (BL) and their relationship to therapeutic goals (TG) with timing and dose of enzyme replacement therapy (ERT). A total of 124 patients on ERT were enrolled in a multi-center study. All six TG were achieved by 82% of patients: 70.1% for bone pain and 91.1% for bone crisis. However, despite the fact that bone TGs were achieved, residual bone disease was present in 108 patients on ERT (87%) at time 0. 16% of patients showed new irreversible BL (bone infarcts and avascular osteonecrosis) despite ERT, suggesting that they appeared during ERT or were not detected at the moment of diagnosis. We observed 5 prognostic factors that predicted a higher probability of being free of bone disease: optimal ERT compliance; early diagnosis; timely initiation of therapy; ERT initiation dose ≥45 UI/kg/EOW; and the absence of history of splenectomy. Skeletal involvement was classified into 4 major phenotypic groups according to BL: group 1 (12.9%) without BL; group 2 (28.2%) with reversible BL; group 3 (41.9%) with reversible BL and irreversible chronic BL; and group 4 (16.9%) with acute irreversible BL. Our study identifies prognostic factors for achieving best therapeutic outcomes, introduces new risk stratification for patients and suggests the need for a redefinition of bone TG. Am. J. Hematol. 91:E448-E453, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  10. Correlation Between Serum Concentrations of N-Desmethylclozapine and Granulocyte Levels in Patients with Schizophrenia: A Retrospective Observational Study.

    Science.gov (United States)

    Smith, Robert L; Haslemo, Tore; Andreassen, Ole A; Eliasson, Erik; Dahl, Marja-Liisa; Spigset, Olav; Molden, Espen

    2017-11-01

    Clozapine is restricted to use in patients with treatment-refractory schizophrenia due to the risk of a serious drop in absolute neutrophil granulocyte count (ANC). The formation of reactive, unstable metabolites (adducts) has been suggested as a mechanism of clozapine-induced granulocyte decline. These adducts are not detectable in vivo, but stable clozapine metabolites could potentially be indirect pharmacokinetic measures of adduct formation. The present retrospective observational study investigated the correlation between concentrations of N-desmethylclozapine, the major stable clozapine metabolite, and ANC in a real-life population of clozapine-treated patients. Patients were included from a therapeutic drug monitoring service at the Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway, between March 2005 and December 2015. Information about clozapine and N-desmethylclozapine steady-state trough concentrations, as well as accompanying measurements of ANC, were collected from the laboratory database. Correlations of serum concentrations of N-desmethylclozapine and clozapine (and their respective ratios) with ANC were investigated by linear mixed-model analysis. Overall, 129 patients with 855 measurements of clozapine/N-desmethylclozapine concentrations and ANC (range 0.9-19 × 10 9 cells/L, median 4.6) were included. Concentrations of N-desmethylclozapine, but not clozapine, correlated significantly and positively with ANC (estimated model slope 0.0011 × 10 9 cells/L/nM; p = 0.002), and the N-desmethylclozapine/clozapine ratio also positively correlated with ANC (p = 0.040). N-Desmethylclozapine level and ANC significantly correlated in this real-life population of schizophrenia patients. The positive correlation, which was also present for the metabolic ratio, might reflect reduced clozapine availability for the formation of reactive metabolites potentially affecting granulocyte level. However, as our findings were based on ANC mainly

  11. Functional changes during hospital stay in older patients admitted to an acute care ward: a multicenter observational study.

    Directory of Open Access Journals (Sweden)

    Stefanie L De Buyser

    Full Text Available Changes in physical performance during hospital stay have rarely been evaluated. In this study, we examined functional changes during hospital stay by assessing both physical performance and activities of daily living. Additionally, we investigated characteristics of older patients associated with meaningful in-hospital improvement in physical performance.The CRiteria to assess appropriate Medication use among Elderly complex patients project recruited 1123 patients aged ≥65 years, consecutively admitted to geriatric or internal medicine acute care wards of seven Italian hospitals. We analyzed data from 639 participating participants with a Mini Mental State Examination score ≥18/30. Physical performance was assessed by walking speed and grip strength, and functional status by activities of daily living at hospital admission and at discharge. Meaningful improvement was defined as a measured change of at least 1 standard deviation. Multivariable logistic regression models predicting meaningful improvement, included age, gender, type of admission (through emergency room or elective, and physical performance at admission.Mean age of the study participants was 79 years (range 65-98, 52% were female. Overall, mean walking speed and grip strength performance improved during hospital stay (walking speed improvement: 0.04±0.20 m/s, p<0.001; grip strength improvement: 0.43±5.66 kg, p = 0.001, no significant change was observed in activities of daily living. Patients with poor physical performance at admission had higher odds for in-hospital improvement.Overall, physical performance measurements show an improvement during hospital stay. The margin for meaningful functional improvement is larger in patients with poor physical function at admission. Nevertheless, most of these patients continue to have poor performance at discharge.

  12. [Therapeutic effects of venlafaxine extended release for patients with depressive and anxiety disorders in the German outpatient setting - results of 2 observational studies including 8500 patients].

    Science.gov (United States)

    Anghelescu, I-G; Dierkes, W; Volz, H-P; Loeschmann, P-A; Schmitt, A B

    2009-11-01

    The therapeutic effects of venlafaxine extended release have been investigated by two prospective observational studies including 8506 patients in the outpatient setting of office based general practitioners and specialists. The efficacy has been documented by the Clinical Global Impression (CGI) scale and by the Hamilton depression (HAMD-21) scale. The tolerability has been assessed by the documentation of adverse events. About (2/3) of the patients were treated because of depression and about (1/3) mainly because of anxiety disorder. The patients of specialists did receive higher dosages and were more severely affected. The response rate on the CGI scale was 87.4 for the patients of general practitioners and 74.2 % for the patients of specialists. The results of the HAMD-21 scale, which has been used by specialists, showed a response rate of 71.8 and a remission rate of 56.3 %. These positive effects could be demonstrated even for the more severely and chronically affected patients. The incidence of adverse events was low in both studies and comparable to the tolerability profile of randomized studies. Importantly, the good tolerability profile was similar even for patients with concomitant cardiovascular disease. In conclusion, these results confirm the efficacy and good tolerability of venlafaxine extended release in the outpatient setting in Germany. Georg Thieme Verlag KG Stuttgart, New York.

  13. A two year observational study of nicotinamide and intensive insulin therapy in patients with recent onset type 1 diabetes mellitus.

    Science.gov (United States)

    Crinó, A; Schiaffini, R; Ciampalini, P; Suraci, M C; Manfrini, S; Visalli, N; Matteoli, M C; Patera, P; Buzzetti, R; Guglielmi, C; Spera, S; Costanza, F; Fioriti, E; Pitocco, D; Pozzilli, P

    2005-08-01

    A number of trials have evaluated residual beta-cell function in patients with recent onset type 1 diabetes mellitus (DM1) treated with nicotinamide in addition to intensive insulin therapy (IIT). In most studies, only a slight decline of C-peptide secretion was observed 12 months after diagnosis; however, no data is available on C-peptide secretion and metabolic control in patients continuing nicotinamide and IIT for up to 2 years after diagnosis. We retrospectively analysed data from 25 patients (mean age 14.7 years +/- 5 SD) with DM1 in whom nicotinamide at a dose of 25 mg/kg b. wt. was added from diagnosis (< 4 weeks) to IIT (three injections of regular insulin at meals + one NPH at bed time) and continued for up to 2 years after diagnosis. Data were also analysed from patients (n = 27) in whom IIT was introduced at diagnosis and who were similarly followed for 2 years. Baseline C-peptide as well as insulin dose and HbA1c levels were evaluated at 12 and 24 months after diagnosis. In the course of the follow-up, patients on nicotinamide + IIT or IIT alone did not significantly differ in terms of C-peptide secretion (values at 24 months in the two groups were 0.19 +/- 0.24 nM vs 0.19 +/- 0.13 nM, respectively). Insulin requirement (0.6 +/- 0.3 U/kg/day vs 0.7 +/- 0.2 U/kg/day at 24 months, respectively) did not differ between the two groups. However, HbA1c was significantly lower 2 years after diagnosis in patients treated with nicotinamide + IIT (6.09 +/- 0.9% vs 6.98 +/- 0.9%, respectively, p < 0.01). No adverse effects were observed in patients receiving nicotinamide for 2 years. Implementation of IIT with the addition of nicotinamide at diagnosis continued for 2 years improves metabolic control as assessed by HbA1c. In both nicotinamide and control patients, no decline in C-peptide was detected 2 years after diagnosis, indicating that IIT preserves C-peptide secretion. We conclude that nicotinamide + IIT at diagnosis of DM1 prolonged for up to 2 years can be

  14. Verbal and non-verbal behaviour and patient perception of communication in primary care: an observational study.

    Science.gov (United States)

    Little, Paul; White, Peter; Kelly, Joanne; Everitt, Hazel; Gashi, Shkelzen; Bikker, Annemieke; Mercer, Stewart

    2015-06-01

    Few studies have assessed the importance of a broad range of verbal and non-verbal consultation behaviours. To explore the relationship of observer ratings of behaviours of videotaped consultations with patients' perceptions. Observational study in general practices close to Southampton, Southern England. Verbal and non-verbal behaviour was rated by independent observers blind to outcome. Patients competed the Medical Interview Satisfaction Scale (MISS; primary outcome) and questionnaires addressing other communication domains. In total, 275/360 consultations from 25 GPs had useable videotapes. Higher MISS scores were associated with slight forward lean (an 0.02 increase for each degree of lean, 95% confidence interval [CI] = 0.002 to 0.03), the number of gestures (0.08, 95% CI = 0.01 to 0.15), 'back-channelling' (for example, saying 'mmm') (0.11, 95% CI = 0.02 to 0.2), and social talk (0.29, 95% CI = 0.4 to 0.54). Starting the consultation with professional coolness ('aloof') was helpful and optimism unhelpful. Finishing with non-verbal 'cut-offs' (for example, looking away), being professionally cool ('aloof'), or patronising, ('infantilising') resulted in poorer ratings. Physical contact was also important, but not traditional verbal communication. These exploratory results require confirmation, but suggest that patients may be responding to several non-verbal behaviours and non-specific verbal behaviours, such as social talk and back-channelling, more than traditional verbal behaviours. A changing consultation dynamic may also help, from professional 'coolness' at the beginning of the consultation to becoming warmer and avoiding non-verbal cut-offs at the end. © British Journal of General Practice 2015.

  15. The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis.

    Science.gov (United States)

    Abbott, T E F; Ahmad, T; Phull, M K; Fowler, A J; Hewson, R; Biccard, B M; Chew, M S; Gillies, M; Pearse, R M

    2018-01-01

    The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of elective in-patient surgery, accompanied by a systematic review and meta-analysis of published literature. The exposure was surgical safety checklist use. The primary outcome was in-hospital mortality and the secondary outcome was postoperative complications. In the ISOS cohort, a multivariable multi-level generalized linear model was used to test associations. To further contextualise these findings, we included the results from the ISOS cohort in a meta-analysis. Results are reported as odds ratios (OR) with 95% confidence intervals. We included 44 814 patients from 497 hospitals in 27 countries in the ISOS analysis. There were 40 245 (89.8%) patients exposed to the checklist, whilst 7508 (16.8%) sustained ≥1 postoperative complications and 207 (0.5%) died before hospital discharge. Checklist exposure was associated with reduced mortality [odds ratio (OR) 0.49 (0.32-0.77); P<0.01], but no difference in complication rates [OR 1.02 (0.88-1.19); P=0.75]. In a systematic review, we screened 3732 records and identified 11 eligible studies of 453 292 patients including the ISOS cohort. Checklist exposure was associated with both reduced postoperative mortality [OR 0.75 (0.62-0.92); P<0.01; I 2 =87%] and reduced complication rates [OR 0.73 (0.61-0.88); P<0.01; I 2 =89%). Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine. Copyright © 2017 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

  16. Molecular profiling in Italian patients with advanced non-small-cell lung cancer: An observational prospective study.

    Science.gov (United States)

    Gobbini, Elisa; Galetta, Domenico; Tiseo, Marcello; Graziano, Paolo; Rossi, Antonio; Bria, Emilio; Di Maio, Massimo; Rossi, Giulio; Gregorc, Vanesa; Riccardi, Ferdinando; Scotti, Vieri; Ceribelli, Anna; Buffoni, Lucio; Delmonte, Angelo; Franchina, Tindara; Migliorino, Maria Rita; Cortinovis, Diego; Pisconti, Salvatore; Bordi, Paola; Catino, Annamaria; Maiello, Evaristo; Arizio, Francesca; Novello, Silvia

    2017-09-01

    Molecular profiling of advanced non-small-cell lung cancer (NSCLC) is recommended according to European and Italian guidelines. However, molecular routine assessment remains still heterogeneous. This observational study aimed to take a picture of the real clinical practice in molecular testing and therapeutic choices in advanced Italian NSCLCs. This study prospectively enrolled newly diagnosed advanced or recurrent NSCLCs referred to 38 Italian centres, from November 2014 to November 2015. Information regarding molecular profiling and treatment choices were collected. Description of patients' outcome included overall survival (OS), progression-free survival in first (PFS1) and second-line (PFS2). Among 1787 patients enrolled, 1388 (78%) performed at least one molecular analysis during the history of disease: 76% were tested for EGFR, 53% for ALK, 27% for KRAS, 16% for ROS1, 14% for BRAF, 5% for HER2, 4% for MET and 1% for FGFR. The remaining 399 patients (22.3%) did not receive any molecular test. Among patients receiving at least one molecular analysis, 583 (42%) presented a molecular alteration. Considering EGFR mutated and/or ALK rearranged patients (402), for which target agents were routinely reimbursed at time of study in Italy, the 86% received a personalized treatment as first and/or second line: the 90% (286) of EGFR mutants received an EGFR tyrosine kinase inhibitor, mostly gefitinib (41.1%) or afatinib (36.4%) while 74% (62) of ALK translocated patients received an ALK inhibitor, mostly crizotinib (64%). Median OS was 9.34 months (95% CI 8.62-10.0), median PFS1 was 4.61 months (95%CI 4.31-4.84) and median PFS2 was 2.76 months (95%CI 2.57-3.19). In the Italian clinical practice, routine molecular assessment was largely applied in NSCLC patients, according to national guidelines, but a low level of ALK test was reached. Most of EGFR mutants an ALK rearranged patients received a personalized treatment as first and/or second line. Copyright © 2017 Elsevier

  17. The association between insulin resistance and hepatic fibrosis in patients with chronic hepatitis C: an observational, multicenter study in Turkey.

    Science.gov (United States)

    Dökmeci, Abdulkadir; Ustündağ, Yücel; Hulagu, Saadettin; Tuncer, Ilyas; Akdoğan, Meral; Demirsoy, Hüseyin; Köklü, Seyfettin; Güzelbulut, Fatih; Doğan, Ibrahim; Demir, Ali; Akarsu, Mesut; Yüceyar, Hakan; Ozdoğan, Osman Cavit; Ozdener, Fatih; Erdoğan, Seda

    2014-10-01

    To evaluate the association between insulin resistance and hepatic fibrosis in patients with chronic hepatitis C. A total of 104 chronic hepatitis C patients were included in this non-interventional, open-label, observational, multicenter, cross-sectional study conducted at 20 gastroenterology clinics in Turkey. The primary end point was the correlation between stage of hepatic fibrosis and insulin resistance evaluated via the homeostasis model of assessment-insulin resistance index. Confounders of hepatic fibrosis and insulin resistance were the secondary end points. The mean age of patients was 52.8 years; 65.4% were female. Type 2 diabetes was present in 6.8% and insulin resistance noted in 38.0% of patients. Further, 45.7% of the patients had mild (A0/A1) and the remaining had moderate/severe (A2/A3) hepatic necroinflammatory activity. Patient distribution according to Metavir fibrosis stage was as follows: F0/F1 (57.0%); F2 (6.5%); F3 (23.7%); and F4 (12.9%). A univariate analysis revealed significant positive correlations between Metavir fibrosis stage and insulin resistance (r=0.297; p=0.007). Logistic regression analysis showed that significant predictors of insulin resistance were high alanine transaminase levels (odds ratio, 0.97; 95% confidence interval, 0.944-0.997) and liver fibrosis stage (odds ratio, 0.114; 95% confidence interval, 0.021-0.607). Our findings revealed significant associations between insulin resistance and hepatic fibrosis.

  18. Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes : results from the ASSESS study

    NARCIS (Netherlands)

    Miravitlles, Marc; Worth, Heinrich; Soler Cataluna, Juan Jose; Price, David; De Benedetto, Fernando; Roche, Nicolas; Godtfredsen, Nina Skavlan; van der Molen, Thys; Lofdahl, Claes-Goran; Padulles, Laura; Ribera, Anna

    2014-01-01

    Background: Few studies have investigated the 24-hour symptom profile in patients with COPD or how symptoms during the 24-hour day are inter-related. This observational study assessed the prevalence, severity and relationship between night-time, early morning and daytime COPD symptoms and explored

  19. Severity of gentamicin's nephrotoxic effect on patients with infective endocarditis: a prospective observational cohort study of 373 patients

    DEFF Research Database (Denmark)

    Buchholtz, Kristine; Larsen, Carsten T; Hassager, Christian

    2009-01-01

    BACKGROUND: Gentamicin is often used to treat infective endocarditis (IE). Gentamicin is highly effective, but its applicability is reduced by its nephrotoxic effect. The aim of this study was to quantify the nephrotoxic effect of gentamicin and the association between the nephrotoxic effect...

  20. Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study.

    Science.gov (United States)

    García-Gutierrez, Susana; Orive, Miren; Sarasqueta, Cristina; Legarreta, Maria Jose; Gonzalez, Nerea; Redondo, Maximino; Rivero, Amado; Serrano-Aguilar, Pedro; Castells, Xavier; Quintana, Jose Maria; Sala, Maria

    2018-01-08

    Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study. Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment. Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system. The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for

  1. Association between oxidative stress index and post-CPR early mortality in cardiac arrest patients: A prospective observational study.

    Science.gov (United States)

    Yücel, Hasan; Türkdoğan, Kenan Ahmet; Zorlu, Ali; Aydın, Hüseyin; Kurt, Recep; Yılmaz, Mehmet Birhan

    2015-09-01

    Cardiopulmonary resuscitation (CPR) is a series of lifesaving actions that improve the chance of survival following cardiac arrest (CA). Many clinical and laboratory parameters, such as the presence of asystole, out-of-hospital CPR, and duration of cardiac arrest, are associated with failed CPR in patients with CA. Asystole is a state of no cardiac electrical activity, along with the absence of contractions of the myocardium and absence of cardiac output. Oxidative stress index (OSI), which is the ratio of total oxidative status to total antioxidant status, increases by ischemia-reperfusion injury. We investigated whether OSI levels in patients with CA could predict early mortality after CPR. This study has a prospective observational cohort design. Five patients with a history of cancer, four patients who developed hemolysis in their blood, six patients who were transferred to our hospital from other hospitals, and six patients in whom blood samples for OSI could not be stored properly were excluded. Finally, a total of 90 in-hospital or out-of-hospital CA patients and 40 age- and sex-matched healthy volunteers as the control group were evaluated prospectively. The patients were classified according to the CPR response into a successful group (n=46) and a failed group (n=44). Comparisons between groups were performed using one-way ANOVA with post hoc analysis by Tukey's HSD or independent samples t-test and the Kruskal-Wallis tests or Mann- Whitney U test for normally and abnormally distributed data, respectively. Also, we used chi-square test, Spearman's correlation test, univariate and multible logistic regression analyses, and receiver operator characteristic curve analysis. OSI was 3.0±4.0, 5.6±4.3, and 8.7±3.8 in the control group, the successful CPR group, and the failed CPR group, respectively (pOSI on admission, ischemia-modified albumin, presence of asystole, mean duration of cardiac arrest, out-of-hospital CPR, pH, and potassium and sodium levels were

  2. Characteristics and outcomes of older HIV-infected patients receiving antiretroviral therapy in Malawi: A retrospective observation cohort study.

    Directory of Open Access Journals (Sweden)

    Hannock Tweya

    Full Text Available To estimate patients enrolling on antiretroviral therapy (ART over time; describe trends in baseline characteristics; and compare immunological response, loss to follow-up (LTFU, and mortality by three age groups (25-39, 40-49 and ≥50 years.A retrospective observation cohort study.This study used routine ART data from two public clinics in Lilongwe, Malawi. All HIV-infected individuals, except pregnant or breastfeeding women, aged ≥ 25 years at ART initiation between 2006 and 2015 were included. Poisson regression models estimated risk of mortality, stratified by age groups.Of 37,378 ART patients, 3,406 were ≥ 50 years old. Patients aged ≥ 50 years initiated ART with more advanced WHO clinical stage and lower CD4 cell count than their younger counterparts. Older patients had a significantly slower immunological response to ART in the first 18 months on ART compared to patients aged 25-39 years (p = 0.04. Overall mortality rates were 2.3 (95% confidence Interval (CI 2.2-2.4, 2.9 (95% CI 2.7-3.2 and 4.6 (95% CI 4.2-5.1 per 100 person-years in patients aged 25-39 years, 40-49 years and 50 years and older, respectively. Overall LTFU rates were 6.3 (95% CI 6.1-6.5, 4.5 (95% CI 4.2-4.7, and 5.6 (95% CI 5.1-6.1 per 100 person years among increasing age cohorts. The proportion of patients aged ≥ 50 years and newly enrolling into ART care remained stable at 9% while the proportion of active ART patients aged ≥50 years increased from 10% in 2006 to 15% in 2015.Older people had slower immunological response and higher mortality. Malawi appears to be undergoing a demographic shift in people living with HIV. Increased consideration of long-term ART-related problems, drug-drug interactions and age-related non-communicable diseases is warranted.

  3. Efficacy of a Moderately Low Carbohydrate Diet in a 36-Month Observational Study of Japanese Patients with Type 2 Diabetes.

    Science.gov (United States)

    Sanada, Mariko; Kabe, Chinatsu; Hata, Hisa; Uchida, Junichi; Inoue, Gaku; Tsukamoto, Yoko; Yamada, Yoshifumi; Irie, Junichiro; Tabata, Shogo; Tabata, Mitsuhisa; Yamada, Satoru

    2018-04-24

    We previously showed that a non-calorie-restricted, moderately low-carbohydrate diet (mLCD) is more effective than caloric restriction for glycemic and lipid profile control in patients with type 2 diabetes. To determine whether mLCD intervention is sustainable, effective, and safe over a long period, we performed a 36-month observational study. We sequentially enrolled 200 patients with type 2 diabetes and taught them how to follow the mLCD. We compared the following parameters pre- and post-dietary intervention in an outpatient setting: glycated hemoglobin (HbA1c), body weight, lipid profile (total cholesterol, low and high-density lipoprotein cholesterol, triglycerides), systolic and diastolic blood pressure, liver enzymes (aspartate aminotransferase, alanine aminotransferase), and renal function (urea nitrogen, creatinine, estimated glomerular filtration rate). Data from 157 participants were analyzed (43 were lost to follow-up). The following parameters decreased over the period of study: HbA1c (from 8.0 ± 1.5% to 7.5 ± 1.3%, p 36 months, the mLCD intervention showed sustained effectiveness (without safety concerns) in improving HbA1c, lipid profile, and liver enzymes in Japanese patients with type 2 diabetes.

  4. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study

    DEFF Research Database (Denmark)

    Connolly, S. J.; Wallentin, L.; Ezekowitz, M. D.

    2013-01-01

    . There is a need for longer-term follow-up of patients on dabigatran and for further data comparing the 2 dabigatran doses. Methods and Results Patients randomly assigned to dabigatran in RE-LY were eligible for the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY...

  5. Clinical predictors for severe sepsis in patients with necrotizing fasciitis: an observational cohort study in northern Thailand

    Directory of Open Access Journals (Sweden)

    Khamnuan P

    2015-07-01

    Full Text Available Patcharin Khamnuan,1,2 Wilaiwan Chongruksut,3 Kijja Jearwattanakanok,4 Jayanton Patumanond,5 Apichat Tantraworasin,3 1Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; 2Department of Nursing, Phayao Hospital, Phayao, Thailand; 3Department of Surgery, Faculty of Medicine, Chiang Mai University, 4Department of Surgery, Nakornping Hospital, Chiang Mai, Thailand; 5Clinical Epidemiology Unit, Clinical Research Center, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand Background: Necrotizing fasciitis (NF is a life-threatening infection of skin and fascia. Its progress is extremely fast, with extensive necrosis. Delay in treatment, with subsequent huge soft tissue loss and associated severe sepsis, remains a major cause of death in the management of NF. Objective: The aim of this study was to explore clinical characteristics that may be used to predict severe sepsis in patients with NF, in the context of routine clinical practice in northern Thailand. Methods: A retrospective observational cohort study was conducted. The patient cohort in this study consisted of all patients who were diagnosed with NF by surgical or pathological confirmation. The follow-up period started with the admission date and ended with the discharge date. The clinical variables were collected from patients registered at three provincial hospitals in northern Thailand from 2009 to 2012. The clinical predictors for severe sepsis were analyzed using multivariable risk regression. Results: A total of 1,452 patients were diagnosed with NF, either with severe sepsis (n=237 [16.3%] or without severe sepsis (n=1,215 [83.7%]. From the multivariable analysis, female sex (relative risk [RR] =1.51; 95% confidence interval [CI] =1.04–2.20, diabetes mellitus (RR =1.40; 95% CI =1.25–1.58, chronic heart disease (RR =1.31; 95% CI =1.15–1.49, hemorrhagic bleb (RR =1.47; 95% CI =1.32–1.63, skin necrosis (RR =1.45; 95% CI =1

  6. Quality of prescribing in community-dwelling elderly patients in France: an observational study in community pharmacies.

    Science.gov (United States)

    Bourcier, E; Mille, F; Brunie, V; Korb-Savoldelli, V; Lafortune, C; Buyse, M; Fernandez, C; Hindlet, P

    2017-12-01

    Background In order to ensure safer prescriptions in the elderly, lists of potentially inappropriate medications (PIMs) and guidelines have been introduced. Whereas the effectiveness of these measures has been well studied in hospitals, data are sparse for the community-dwelling patients. Objective To assess the quality of prescriptions among community-dwelling elderly patients, and potential associations between prescription patterns, patient characteristics and medication adherence. Setting Community pharmacies in France. Method We conducted a prospective observational study between January and June 2013. Patients aged 75 and over coming to the community pharmacy with a prescription from a general practitioner were invited to participate to the study. The compliance of the prescription was assessed with regards to Beers Criteria and French Health Authority guidelines (FHA) for prescription in the elderly, the degree of adherence was assessed with the Girerd score. Main outcome measure Percentage of prescriptions compliant with Beers Criteria and FHA guidelines. Results Among the 1206 prescriptions analysed, 67.49% (n = 814) contained a PIM. Only 12.77% (n = 154) complied with mandatory requirements of the FHA. Prescriptions were ordered by therapeutic field in 51.24% (n = 618) of cases. Dosing regimen was incomplete in 57.21% (n = 690) of prescriptions. Only 29.19% (n = 352) of patients reported no difficulty with regard to adherence (Girerd score = 0). The use of International Non-proprietary Name was associated with an increased risk of nonadherence (adjusted OR = 1.59 [95% CI = 1.13-2.23] and 1.68 [95% CI = 1.12-2.49] respectively). Patient satisfaction with formulation was associated with a lower risk of non-adherence (adjusted OR = 0.63 [95% CI = 0.45-0.90]). Conclusion A substantial proportion of patients are exposed to PIMs and prescriptions that do not comply with the FHA Guidelines. This issue, as well as identified risk factors for

  7. Red blood cell transfusion and mortality in trauma patients: risk-stratified analysis of an observational study.

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    Pablo Perel

    2014-06-01

    Full Text Available Haemorrhage is a common cause of death in trauma patients. Although transfusions are extensively used in the care of bleeding trauma patients, there is uncertainty about the balance of risks and benefits and how this balance depends on the baseline risk of death. Our objective was to evaluate the association of red blood cell (RBC transfusion with mortality according to the predicted risk of death.A secondary analysis of the CRASH-2 trial (which originally evaluated the effect of tranexamic acid on mortality in trauma patients was conducted. The trial included 20,127 trauma patients with significant bleeding from 274 hospitals in 40 countries. We evaluated the association of RBC transfusion with mortality in four strata of predicted risk of death: 50%. For this analysis the exposure considered was RBC transfusion, and the main outcome was death from all causes at 28 days. A total of 10,227 patients (50.8% received at least one transfusion. We found strong evidence that the association of transfusion with all-cause mortality varied according to the predicted risk of death (p-value for interaction 50% predicted risk of death (OR 0.59, 95% CI 0.47-0.74, p<0.0001. Transfusion was associated with an increase in fatal and non-fatal vascular events (OR 2.58, 95% CI 2.05-3.24, p<0.0001. The risk associated with RBC transfusion was significantly increased for all the predicted risk of death categories, but the relative increase was higher for those with the lowest (<6% predicted risk of death (p-value for interaction <0.0001. As this was an observational study, the results could have been affected by different types of confounding. In addition, we could not consider haemoglobin in our analysis. In sensitivity analyses, excluding patients who died early; conducting propensity score analysis adjusting by use of platelets, fresh frozen plasma, and cryoprecipitate; and adjusting for country produced results that were similar.The association of transfusion

  8. A multicomponent approach to identify predictors of hospital outcomes in older in-patients: a multicentre, observational study.

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    Stefanie L De Buyser

    Full Text Available BACKGROUND: The identification of older patients at risk of poor hospital outcomes (e.g. longer hospital stay, in-hospital mortality, and institutionalisation is important to provide an effective healthcare service. OBJECTIVE: To identify factors related to older patients' clinical, nutritional, functional and socio-demographic profiles at admission to an acute care ward that can predict poor hospital outcomes. DESIGN AND SETTING: The CRiteria to assess appropriate Medication use among Elderly complex patients project was a multicentre, observational study performed in geriatric and internal medicine acute care wards of seven Italian hospitals. SUBJECTS: One thousand one hundred twenty-three consecutively admitted patients aged 65 years or older. METHODS: Hospital outcomes were length of stay, in-hospital mortality, and institutionalisation. RESULTS: Mean age of participants was 81 years, 56% were women. Median length of stay was 10 (7-14 days, 41 patients died during hospital stay and 37 were newly institutionalised. Number of drugs before admission, metastasized cancer, renal failure or dialysis, infection, falls at home during the last year, pain, and walking speed were independent predictors of LoS. Total dependency in activities of daily living and inability to perform grip strength test were independent predictors of in-hospital mortality. Malnutrition and total dependency in activities of daily living were independent predictors of institutionalisation. CONCLUSIONS: Our results confirm that not only diseases, but also multifaceted aspects of ageing such as physical function and malnutrition are strong predictors of hospital outcomes and suggest that these variables should be systematically recorded.

  9. Quality of life improvement in HIV-1 patients treated with raltegravir in a real-life observational study: RACING.

    Science.gov (United States)

    Spire, Bruno; Nait-Ighil, Lella; Pugliese, Pascal; Poizot-Martin, Isabelle; Jullien, Vincent; Marcelin, Anne-Geneviève; Billaud, Eric

    2017-01-01

    Good efficacy and safety of raltegravir in person living with HIV was demonstrated in clinical trials over five years, but real-life data, particularly about quality of life (QoL), are lacking. QoL was evaluated over time in adult patients first treated or switched to regimens containing raltegravir in an observational cohort study. Patient QoL was evaluated using the Fatigue Impact Scale (FIS) and the HIV Symptom Index (HSI). Data were collected at baseline and at 1, 3, 6, 12, 18, and 24 months. Baseline FIS and HSI subscores were compared with the scores at each visit using the paired Wilcoxon test. The impact of time, sociodemographic and medical variables upon patient-perceived fatigue and symptoms was also assessed using mixed multivariate models. From baseline, all FIS and HSI subscores improved significantly after one month of treatment. In addition, psychosocial FIS subscores and both the frequency of bothersome symptoms and HSI subscores improved significantly at each visit. Physical FIS subscores also improved significantly, except at month 18, whereas both cognitive and total FIS subscores improved only after 6 months and 24 months, respectively. In multivariate analysis, employment was independently associated over time with improved improvement in both FIS and HSI subscores. Patient QoL improved significantly over a 24-month period of treatment with a raltegravir-containing regimen. FIS and HSI are sensitive tools to measure the impact of new antiretroviral combinations on a patient's perception of QoL.

  10. Telephone Encounters Predict Future High Financial Expenditures in Inflammatory Bowel Disease Patients: A 3-Year Prospective Observational Study.

    Science.gov (United States)

    Click, Benjamin; Anderson, Alyce M; Ramos Rivers, Claudia; Koutroubakis, Ioannis E; Hashash, Jana G; Dunn, Michael A; Schwartz, Marc; Swoger, Jason; Barrie, Arthur; Szigethy, Eva; Regueiro, Miguel; Schoen, Robert E; Binion, David G

    2018-04-01

    Telephone activity is essential in management of complex chronic diseases including inflammatory bowel disease (IBD). Telephone encounters logged in the electronic medical record have recently been proposed as a surrogate marker of disease activity and impending health care utilization; however, the association between telephone calls and financial expenditures has not been evaluated. We performed a 3-year prospective observational study of telephone encounters logged at a tertiary referral IBD center. We analyzed patient demographics, disease characteristics, comorbidities, clinical activity, and health care financial charges by telephone encounter frequency. Eight hundred one patients met inclusion criteria (52.3% female; mean age, 44.1 y), accounted for 12,669 telephone encounters, and accrued $70,513,449 in charges over 3 years. High telephone encounter frequency was associated with female gender (P=0.003), anxiety/depression (Pfinancial charges the following year after controlling for demographic, utilization, and medication covariates. Increased telephone encounters are associated with significantly higher health care utilization and financial expenditures. Increased call frequency is predictive of future health care spending. Telephone encounters are a useful tool to identify patients at risk of clinical deterioration and large financial expense.

  11. Analysis of home-based rehabilitation in patients with motor impairment in primary care: a prospective observational study.

    Science.gov (United States)

    Vega-Ramírez, Francisco Antonio; López-Liria, Remedios; Granados-Gámez, Genoveva; Aguilar-Parra, Jose Manuel; Padilla-Góngora, David

    2017-07-14

    The purpose of health and social policies is to encourage older people more longevity, remain free of disability and experience quality of life while living in their homes. The aim of this study was to describe the characteristics of 473 patients diagnosed with motor impairment in primary care, the objectives of home-based rehabilitation and its functional impact. This prospective observational study was conducted in the Almería Health District. The analysed variables included age, gender, secondary diagnosis, Barthel Index (BI), physiotherapeutic objectives and techniques, and number of sessions. The sample had a mean age of 83 years, and 59% were women. The assessed conditions with a high prevalence included osteoarticular pathology (55%), Alzheimer's disease (15.1%), cardiovascular disease (13.7%) and stroke (6.5%). The techniques applied mainly consisted of functional exercises (57.1%), caregiver education (13.8%), and technical assistance (5.7%). There were statistically significant differences (t = -15.79; p physiotherapy. Lower patient age was correlated with higher initial and final functional capacities in primary care. This study aimed to present a useful starting point for decision making among management and health administration regarding this population group by approaching the process from the reality of practice and in relation to the rehabilitation provided. ClinicalTrials.gov identifier: NCT02715245 ; Date of registration: 18 January 2016.

  12. The impact of airway management on quality of cardiopulmonary resuscitation: an observational study in patients during cardiac arrest.

    Science.gov (United States)

    Yeung, Joyce; Chilwan, Mehboob; Field, Richard; Davies, Robin; Gao, Fang; Perkins, Gavin D

    2014-07-01

    Minimising interruptions in chest compressions is associated with improved survival from cardiac arrest. Current in-hospital guidelines recommend continuous chest compressions after the airway is secured on the premise that this will reduce no flow time. The aim of this study was to determine the effect of advanced airway use on the no flow ratio and other measures of CPR quality. Consecutive adult patients who sustained an in-hospital cardiac arrest were enrolled in this prospective observational study. The quality of CPR was measured using the Q-CPR device (Phillips, UK) before and after an advanced airway device (endotracheal tube [ET] or laryngeal mask airway [LMA]) was inserted. Patients receiving only bag-mask ventilation were used as the control cohort. The primary outcome was no flow ratio (NFR). Secondary outcomes were chest compression rate, depth, compressions too shallow, compressions with leaning, ventilation rate, inflation time, change in impedance and time required to successfully insert airway device. One hundred patients were enrolled in the study (2008-2011). Endotracheal tube and LMA placement took similar durations (median 15.8 s (IQR 6.8-19.4) vs. LMA median 8.0s (IQR 5.5-15.9), p=0.1). The use of an advanced airway was associated with improved no flow ratios (endotracheal tube placement (n=50) improved NFR from baseline median 0.24 IQR 0.17-0.40) to 0.15 to (IQR 0.09-0.28), p=0.012; LMA (n=25) from median 0.28 (IQR 0.23-0.40) to 0.13 (IQR 0.11- 0.19), p=0.0001). There was no change in NFR in patients managed solely with bag valve mask (BVM) (n=25) (median 0.29 (IQR 0.18-0.59) vs. median 0.26 (IQR 0.12-0.37), p=0.888). There was no significant difference in time taken to successfully insert the airway device between the two groups. The use of an advanced airway (ETT or LMA) during in-hospital cardiac arrest was associated with improved no flow ratio. Further studies are required to determine the effect of airway devices on overall patient

  13. Development and Validation of a Multidisciplinary Mobile Care System for Patients With Advanced Gastrointestinal Cancer: Interventional Observation Study.

    Science.gov (United States)

    Soh, Ji Yeong; Cha, Won Chul; Chang, Dong Kyung; Hwang, Ji Hye; Kim, Kihyung; Rha, Miyong; Kwon, Hee

    2018-05-07

    Mobile health apps have emerged as supportive tools in the management of advanced cancers. However, only a few apps have self-monitoring features, and they are not standardized and validated. This study aimed to develop and validate a multidisciplinary mobile care system with self-monitoring features that can be useful for patients with advanced gastrointestinal cancer. The development of the multidisciplinary mobile health management system was divided into 3 steps. First, the service scope was set up, and the measurement tools were standardized. Second, the service flow of the mobile care system was organized. Third, the mobile app (Life Manager) was developed. The app was developed to achieve 3 major clinical goals: support for quality of life, nutrition, and rehabilitation. Three main functional themes were developed to achieve clinical goals: a to-do list, health education, and in-app chat. Thirteen clinically oriented measures were included: the modified Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events questionnaire, Scored Patient-Generated Subjective Global Assessment (PG-SGA), distress, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, International Physical Activity Questionnaire-Short Form, Low anterior resection syndrome score, satisfaction rate, etc. To validate the system, a prospective observational study was conducted. Patients with gastric cancer or colon cancer undergoing chemotherapy were recruited. We followed the subjects for 12 weeks, and selected clinical measures were taken online and offline. After the development process, a multidisciplinary app, the Life Manager, was launched. For evaluation, 203 patients were recruited for the study, of whom 101 (49.8%) had gastric cancer, and 102 (50.2%) were receiving palliative care. Most patients were in their fifties (35.5%), and 128 (63.1%) were male. Overall, 176 subjects (86.7%) completed the study. Among subjects who

  14. An observational study of patient care outcomes sensitive to handover quality in the Post-Anaesthetic Care Unit.

    Science.gov (United States)

    Lillibridge, Nichole; Botti, Mari; Wood, Beverley; Redley, Bernice

    2017-12-01

    To identify patient care outcome indicators sensitive to the quality of interprofessional handover between the anaesthetist and the Post-Anaesthetic Care Unit nurse. The relationship between interprofessional clinical handover when patients are transferred from the operating theatre to the Post-Anaesthetic Care Unit and patient outcomes of subsequent patient care delivery is not well understood. Naturalistic, exploratory descriptive design using observation. Observations of 31 patient journeys through Post-Anaesthetic Care Units across three public and private hospitals. Characteristics of interprofessional handover on arrival in the Post-Anaesthetic Care Unit, the trajectory of patient care activities in Post-Anaesthetic Care Unit and patient outcomes were observed. Of the 821 care activities observed across 31 "patient journeys" in the Post-Anaesthetic Care Unit, observations (assessments and vital signs) (52.5 %), communication (15.8 %) and pain management (assessment of pain and analgesic administration) (10.3%) were most common. Examination of patterns in handover communications and subsequent trajectories of patient care activities revealed three patient trajectory typologies and two patient outcome indicators expected to be sensitive to the quality of interprofessional handover communication in the Post-Anaesthetic Care Unit: pain on discharge from the Post-Anaesthetic Care Unit and timely response to clinical deterioration. An additional process indicator, seeking missing information, was also identified. Patient's pain on discharge from Post-Anaesthetic Care Unit, escalation of care in response to early signs of deterioration and the need for nurses to seek out missing information to deliver care are indicators expected to be sensitive to the quality of interprofessional handover communication in the Post-Anaesthetic Care Unit. Future research should test these indicators. Patient outcomes sensitive to the quality of interprofessional handover on patient

  15. Soluble Suppression of Tumorigenicity-2 Predicts Hospital Mortality in Burn Patients: An Observational Prospective Cohort Pilot Study.

    Science.gov (United States)

    Ruiz-Castilla, Mireia; Bosacoma, Pau; Dos Santos, Bruce; Baena, Jacinto; Guilabert, Patricia; Marin-Corral, Judith; Masclans, Joan R; Roca, Oriol; Barret, Juan P

    2018-04-10

    The IL33/ST2 pathway has been implicated in the pathogenesis of different inflammatory diseases. Our aim was to analyze whether plasma levels of biomarkers involved in the IL33/ST2 axis might help to predict mortality in burn patients. Single-center prospective observational cohort pilot study performed at the Burns Unit of the Plastic and Reconstructive Surgery Department of the Vall d'Hebron University Hospital (Barcelona). All patients aged ≥18 years old with second or third-degree burns requiring admission to the Burns Unit were considered for inclusion. Blood samples were taken to measure levels of interleukins (IL)6, IL8, IL33, and soluble suppression of tumorigenicity-2 (sST2) within 24 h of admission to the Burns Unit and at day 3. Results are expressed as medians and interquartile ranges or as frequencies and percentages. Sixty-nine patients (58 [84.1%] male, mean age 52 [35-63] years, total body surface area burned 21% [13%-30%], Abbreviated Burn Severity Index 6 [4-8]) were included. Thirteen (18.8%) finally died in the Burns Unit. Plasma levels of sST2 measured at day 3 after admission demonstrated the best prediction accuracy for survival (area under the ROC curve 0.85 [0.71-0.99]; P < 0.001). The best cutoff point for the AUROC index was estimated to be 2,561. In the Cox proportional hazards model, after adjusting for potential confounding, a plasma sST2 level ≥2,561 measured at day 3 was significantly associated with mortality (HR 6.94 [1.73-27.74]; P = 0.006). Plasma sST2 at day 3 predicts hospital mortality in burn patients.

  16. Patient information materials in general practices and promotion of health literacy: an observational study of their effectiveness.

    Science.gov (United States)

    Protheroe, Joanne; Estacio, Emee Vida; Saidy-Khan, Sirandou

    2015-03-01

    Government policy in the UK emphasises providing patients with good health information to encourage participation in their health care. Patient information leaflets (PILs) form part of this policy and have been shown to affect patient health outcomes; however, many are poorly written. To describe the PILs in general practice surgeries in Stoke-on-Trent in terms of readability and variety of content. An observational study of randomly selected GP practices (n = 17) across Stoke-on-Trent. PILs were assessed for readability (Flesch Reading Ease and Flesch-Kincaid Grade Level) and compared with national skills level data and with the recommended level for medical information. The PILs were also categorised for content using the Rudd (2007) health material classification framework. A total of 345 PILs were collected and assessed. Only 24.3% meet recommended reading-level criteria. Compared with national skills levels, over 75% of the PILs collected were too complex for at least 15% of the English population. Of the PILs, 47.8% were classified as 'systems navigation' (information regarding services); 22.9% were disease prevention (screening and immunisations); 14.2% personal and public safety; and less than 10% were for managing illness or health promotion. Current PILs in general practices do not all promote health literacy. Information only accessible to a proportion of higher skilled patients may increase inequalities in health. Less than 10% of PILs promote managing illness or healthy lifestyles. Processes must be put in place to improve the readability and variety of content of PILs in GP practices. © British Journal of General Practice 2015.

  17. An observational study investigating the impact of simulated patients in teaching communication skills in preclinical dietetic students.

    Science.gov (United States)

    Gibson, S J; Davidson, Z E

    2016-08-01

    Simulated patients (SPs) are often used in dietetics for the teaching and assessment of communication skills. The present study aimed to determine the impact of a SP encounter on communication skills in undergraduate preclinical dietetic students in the context of the resources required for delivering this educational strategy. This observational study collected assessment data from four cohorts of third-year dietetic students to examine the effect of participation in SP-embedded Objective Structured Clinical Exams. Students completed two SP interviews, 2 weeks apart, and communication skills were measured on both occasions. A subgroup of students received a video of their SP encounter. Differences between the two SP interview scores were compared to assess the impact of the SP encounter on communication skills. The required staff and resources were described. Data were collected involving 215 students. Out of 30 marks, there was a modest mean (SD) improvement in communication skills from the first to the second SP interview of 2.5 (4.2) (P skills, with failing students demonstrating the greatest improvement between SP encounters. There were no observed benefits for the subset of students who received videos. Providing repeat SP interview opportunities results in only modest improvement in communication skills for most students. The use of SPs needs to be considered in context of the substantial costs and resources involved and tailored to student ability. © 2015 The British Dietetic Association Ltd.

  18. Association between illness severity and timing of initial enteral feeding in critically ill patients: a retrospective observational study

    Directory of Open Access Journals (Sweden)

    Huang Hsiu-Hua

    2012-05-01

    Full Text Available Abstract Background Early enteral nutrition is recommended in cases of critical illness. It is unclear whether this recommendation is of most benefit to extremely ill patients. We aim to determine the association between illness severity and commencement of enteral feeding. Methods One hundred and eight critically ill patients were grouped as “less severe” and “more severe” for this cross-sectional, retrospective observational study. The cut off value was based on Acute Physiology and Chronic Health Evaluation II score 20. Patients who received enteral feeding within 48 h of medical intensive care unit (ICU admission were considered early feeding cases otherwise they were assessed as late feeding cases. Feeding complications (gastric retention/vomiting/diarrhea/gastrointestinal bleeding, length of ICU stay, length of hospital stay, ventilator-associated pneumonia, hospital mortality, nutritional intake, serum albumin, serum prealbumin, nitrogen balance (NB, and 24-h urinary urea nitrogen data were collected over 21 days. Results There were no differences in measured outcomes between early and late feedings for less severely ill patients. Among more severely ill patients, however, the early feeding group showed improved serum albumin (p = 0.036 and prealbumin (p = 0.014 but worsened NB (p = 0.01, more feeding complications (p = 0.005, and prolonged ICU stays (p = 0.005 compared to their late feeding counterparts. Conclusions There is a significant association between severity of illness and timing of enteral feeding initiation. In more severe illness, early feeding was associated with improved nutritional outcomes, while late feeding was associated with reduced feeding complications and length of ICU stay. However, the feeding complications of more severely ill early feeders can be handled without significantly affecting nutritional intake and there is no eventual difference in length of hospital stay or mortality

  19. Duration of the action of rocuronium in patients with BMI of less than 25: An observational study.

    Science.gov (United States)

    Takahata, Osamu; Takahoko, Ken-Ichi; Sasakawa, Tomoki; Inagaki, Yasuyoshi; Takahoko, Hiroyuki; Kunisawa, Takayuki

    2018-05-02

    The duration of rocuronium in patients with BMI more than 30 kg m is prolonged. Whether the reverse is true when BMI is less than 18.5 kg m is unclear. The objective of this study was to investigate whether a BMI less than 25 kg m affects the duration of rocuronium in doses adjusted for actual body weight. A prospective, observational, single-centre study. The operating room of a teaching hospital from 1 June 2008 to 30 June 2015. Thirty patients with American Society of Anesthesiologists physical status I or II who were scheduled to undergo elective surgery (BMI rocuronium (D1) was defined as the time from injection of rocuronium 0.6 mg kg to return of first twitch height to 25% of the control. Duration of additional doses (D2) was the time from a supplement of 0.15 mg kg rocuronium to return of first twitch height to 25% of the control. The relationship between D1 or D2 and BMI was examined using linear regression analysis. Linear regression analysis revealed a significant correlation between duration of initial dose and BMI (R = 0.246; P = 0.00531). A significant correlation between the duration of the additional dose and BMI was also found (R = 0.316; P = 0.00122). The lower the BMI, the shorter the duration of rocuronium at initial and additional doses determined by the actual body weight in adult patients with a BMI less than 25 kg m. www.umin.ac.jp/ctr/index/htm with registry number UMIN 00009337 and UMIN 000015407.

  20. Serum Cystatin C Predicts AKI and the Prognosis of Patients in Coronary Care Unit: a Prospective, Observational Study

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    Yugang Hu

    2017-11-01

    Full Text Available Background/Aims: Acute Kidney Injury (AKI is a serious clinical state associated with high morbidity and mortality, particularly in critical ill patients. We investigated the hypothesis that serum Cystatin C (sCysC is a good predictor for AKI and may affect the short-term prognosis of coronary care unit (CCU patients. Methods: In this prospective, observational study, we screened 412 adults admitted to the CCU from January 1, 2014 to June 1, 2015 at Zhongnan Hospital of Wuhan University. Serum samples were obtained at the time of admission, and sCysC was quantified through nephelometry. AKI was defined based on KDIGO-AKI criteria. After the patients’ hospital discharge, the survivors in this study were followed up for up to 2 years. The primary endpoint was the incidence of AKI stratified by severity stage, while the second endpoints included 2-year mortality, rehospitalization and failure in renal recovery rates, as well as the progression of AKI to CKD. Results: According to the KDIGO-AKI criteria, AKI occurred in 130 (31.6% patients. After multivariate adjustments, the highest quartile of sCysC was associated with a 9-fold increased risk of incident AKI compared with the lowest quartile. For predicting AKI, sCysC [area under the receiver operating characteristic curve (AUC=0.842] outperformed β2-micro globulin (AUC=0.813 and the clinical model (AUC=0.777, and a cutoff of 1.255 mg/L yielded good sensitivity and specificity. After a median 19.8-month follow-up, 112 (27.2% patients died within 2 years after admission. The sCysC independently predicted the risk of 2-year mortality [adjusted odds ratio (OR, 4.955; 95% confidence interval (95% CI, 2.853 to 8.603] and rehospitalization (OR, 3.128; 95% CI, 2.011 to 4.867, as well as renal recovery failure (OR, 3.618, 95% CI, 1.753 to 7.463. Conclusions: Serum CysC is a strong predictor of AKI and the short-term prognosis of CCU patients.

  1. Influence of socioeconomic status on community-acquired pneumonia outcomes in elderly patients requiring hospitalization: a multicenter observational study

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    Carratalà Jordi

    2010-07-01

    Full Text Available Abstract Background The associations between socioeconomic status and community-acquired pneumonia outcomes in adults have been studied although studies did not always document a relationship. The aim of this multicenter observational study was to determine the association between socioeconomic status and community-acquired pneumonia outcomes in the elderly, in the context of a public health system providing universal free care to the whole population. Methods A total of 651 patients aged ≥65 years hospitalized due to community-acquired pneumonia through the emergency departments of five Spanish public hospitals were recruited and followed up between May 2005 and January 2007. The primary outcomes studied were: length of stay, intensive care unit admission, overall mortality and readmission. Socioeconomic status was measured using both individual and community data: occupation [categorized in six social groups (I, II, III, IVa, IVb and V], educational level (≤ primary level or ≥ secondary level and disposable family income of the municipality or district of residence [>12,500 € (high municipality family income and ≤12,500 € (low municipality family income]. The six social groups were further categorized as upper/middle social class (groups I-IVb and lower class (group V. Bivariate and multivariate analyses were performed. OR and their 95% confidence intervals were calculated. All statistical tests were two tailed and statistical significance was established as p Results 17.7% of patients lived in a municipality or district with a high municipality family income and 63.6% were upper/middle social class (I-IVb. Only 15.7% of patients had a secondary education. The adjusted analysis showed no association between pneumonia outcomes and social class, educational level or municipality family income. However, length of stay increased significantly in patients in whom the factors, living alone and being a smoker or ex-smoker coincided (p

  2. NutriCancer: A French observational multicentre cross-sectional study of malnutrition in elderly patients with cancer.

    Science.gov (United States)

    Lacau St Guily, Jean; Bouvard, Éric; Raynard, Bruno; Goldwasser, François; Maget, Brigitte; Prevost, Alain; Seguy, David; Romano, Olivier; Narciso, Bérengère; Couet, Charles; Balon, Jean-Michel; Vansteene, Damien; Salas, Sébastien; Grandval, Philippe; Gyan, Emmanuel; Hebuterne, Xavier

    2018-01-01

    To compare the prevalence of malnutrition and nutritional management between elderly (≥70years old) and younger patients (malnutrition in adult patients with cancer in France. Patients diagnosed with cancer at the study date in both inpatient and outpatient settings were included. Data collection was performed by means of questionnaires completed by the physician, the patient and the caregiver. This post-hoc analysis compared 578 elderly patients (27.6%) vs. 1517 younger patients (72.4%). There were significant differences in cancer localization between the groups particularly in gastrointestinal cancer (27% in younger patients vs. 42% in elderly), breast cancer (17% vs 8% in elderly) and oropharyngeal (15% vs. 9% in elderly). Weight loss was significantly more reported in the elderly than in younger patients (73.6% vs. 67.6%, p=0.009). Elderly patients were more frequently malnourished than younger patients (44.9% vs. 36.7%, p=0.0006). Food intake was comparable between the groups; however, physicians overestimated the food intake, particularly in the elderly. The malnutrition management was more frequently proposed in elderly, as dietary advice and oral nutritional supplements, than in younger patients; however, enteral nutrition was significantly less undertaken in the elderly. Malnutrition is prevalent in elderly patients with cancer, and more frequent than in younger patients. There is a need for an early integration of the nutritional counselling in patients with cancer, and particularly in the elderly. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. A PROSPECTIVE OBSERVATIONAL STUDY REGARDING PREVALENCE OF DRY EYE DISEASE IN POST-OPERATIVE CATARACT SURGERY PATIENTS OF 140 CASES.

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    S. Srinivasan

    2017-02-01

    Full Text Available BACKGROUND Dry eye disease is one of the most common ocular surface disorder with large number of studies carried out in various countries estimate the prevalence of dry eye disease to be between 5-34%. The prevalence of dry eye increases with age. As per Breaver Dam study regarding dry eye the prevalence of DED 13.3%. Dry eye was apparently higher in women than men. Studies have shown that cataract surgery worsen dry eye symptoms in patients with preexisting dry eye symptoms as well as without preexisting DES, mostly dry eye symptoms last for two months of post cataract surgery period. MATERIALS AND METHODS The prospective observational study was conducted in Department of Ophthalmology, Government Vellore Medical College and Hospital, Vellore. The total number of cataract surgery performed cases were 140 in number. The study period was four months, conducted in tertiary eye center. The Cataract patients were preoperatively at normal tear secretions. Post cataract surgery period from first POD, one week POD, four weeks, six weeks, two months and three months POD examined by slit lamp, Schirmer's test I, TBUT and corneal sensitivity test were performed. RESULTS Our study revealed that increased prevalence in female sex with increased age group range from 51-70 years showed post cataract surgery period dryness of eye. The ratio of Post cataract surgery DED in male and female is 13:29. This shows increased female sex prevalence of postoperative DED. In our study, the prevalence of post cataract surgery dry eye disease was 30%. CONCLUSION 73% cataract surgeries is now clear corneal cataract surgery and this procedure cuts a large part of corneal nerves. The nerve essential for tear production gets disturbed leading to dryness and hence decreased visual function. The corneal nerves are important in self-regulation of tears since they provide the sensation in the feedback loop that signals tear production. When the functions of the nerves get blocked

  4. Effect of the TNF-α inhibitor adalimumab in patients with recalcitrant sarcoidosis: a prospective observational study using FDG-PET

    DEFF Research Database (Denmark)

    Milman, Nils; Graudal, Niels; Loft, Annika

    2012-01-01

    -PET) in patients with recalcitrant sarcoidosis treated with adalimumab. Methods: Prospective 24-week observational study. Patients continued medication with steroids and antimetabolites and received adalimumab 40 mg subcutaneously every other week. Ten patients with biopsy-proven sarcoidosis (two men) were...

  5. Impact of alprazolam in allostatic load and neurocognition of patients with anxiety disorders and chronic stress (GEMA): observational study protocol

    Science.gov (United States)

    Soria, Carlos A; Remedi, Carolina; Núñez, Daniel A; D'Alessio, Luciana; Roldán, Emilio J A

    2015-01-01

    Introduction The allostatic load model explains the additive effects of multiple biological processes that accelerate pathophysiology related to stress, particularly in the central nervous system. Stress-related mental conditions such as anxiety disorders and neuroticism (a well-known stress vulnerability factor), have been linked to disturbances of hypothalamo–pituitary–adrenal with cognitive implications. Nevertheless, there are controversial results in the literature and there is a need to determine the impact of the psychopharmacological treatment on allostatic load parameters and in cognitive functions. Gador study of Estres Modulation by Alprazolam, aims to determine the impact of medication on neurobiochemical variables related to chronic stress, metabolic syndrome, neurocognition and quality of life in patients with anxiety, allostatic load and neuroticism. Methods/analysis In this observational prospective phase IV study, highly sympthomatic patients with anxiety disorders (six or more points in the Hamilton-A scale), neuroticism (more than 18 points in the Neo five personality factor inventory (NEO-FFI) scale), an allostatic load (three positive clinical or biochemical items at Crimmins and Seeman criteria) will be included. Clinical variables of anxiety, neuroticism, allostatic load, neurobiochemical studies, neurocognition and quality of life will be determined prior and periodically (1, 2, 4, 8, and 12 weeks) after treatment (on demand of alprazolam from 0.75 mg/day to 3.0 mg/day). A sample of n=55/182 patients will be considered enough to detect variables higher than 25% (pretreatment vs post-treatment or significant correlations) with a 1-ß power of 0–80. t Test and/or non-parametric test, and Pearson's test for correlation analysis will be determined. Ethics and dissemination This study protocol was approved by an Independent Ethics Committee of FEFyM (Foundation for Pharmacological Studies and Drugs, Buenos Aires) and by regulatory

  6. Comparative effect of olmesartan and candesartan on lipid metabolism and renal function in patients with hypertension: a retrospective observational study

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    Nakayama Tomohiro

    2011-08-01

    Full Text Available Abstract Background Angiotensin II receptor blockers (ARBs, including olmesartan and candesartan, are widely used antihypertensive agents. Many clinical studies have demonstrated that ARBs have organ-protecting effects, e.g., cardioprotection, vasculoprotection and renoprotection. However, the effect of prolonged olmesartan monotherapy on lipid metabolism in patients with hypertension is less well studied. We performed a retrospective observational study to compare the effects of olmesartan with those of candesartan, focusing on lipid metabolism and renal function. Methods We used data from the Clinical Data Warehouse of Nihon University School of Medicine obtained between Nov 1, 2004 and Feb 28, 2011, to identify cohorts of new olmesartan users (n = 168 and candesartan users (n = 266. We used propensity-score weighting to adjust for differences in all covariates (age, sex, comorbid diseases, previous drugs between olmesartan and candesartan users, and compared serum chemical data including serum triglyceride (TG, LDL-cholesterol (LDL-C, total cholesterol (TC, potassium, creatinine and urea nitrogen. The mean exposure of olmesartan and candesartan users was 126.1 and 122.8 days, respectively. Results After adjustment, there were no statistically significant differences in all covariates between olmesartan and candesartan users. The mean age was 60.7 and 61.0 years, and 33.4% and 33.7% of olmesartan and candesartan users were women, respectively. There were no statistically significant differences in mean values for all laboratory tests between baseline and during the exposure period in both olmesartan and candesartan users. In olmesartan users, the reduction of serum TG level was significant in comparison with that in candesartan users. Other parameters of lipid profile and renal function showed no statistically significant difference in the change from baseline to during the exposure period between olmesartan and candesartan users. Conclusions

  7. Squamous Cell Carcinoma: Clinical and Pathological Features and Associated Risk Factors in an Observational Study of 118 Patients.

    Science.gov (United States)

    Díaz-Corpas, T; Morales-Suárez-Varela, M; Rausell Fontestad, N; Fuertes Prósper, A; Marquina-Vila, A; Jordá-Cuevas, E

    2015-12-01

    In the latest edition of its cancer staging manual, the American Joint Committee on Cancer (AJCC) revised the criteria for staging squamous cell carcinoma (SCC) by introducing high-risk tumor features to define tumor stage (T) and help to identify tumors with a higher risk of metastasis. The aim of this study was to investigate the characteristics associated with SCC meeting the high-risk criteria defined by the AJCC for T2 lesions. We performed a case-case observational study in which patients with SCC were included over a period of 18 months. We collected clinical, anthropometric, and tumor data, and analyzed these using PASW Statistics (SPSS) version 18. One-hundred eighteen patients, the majority of whom were men, were included. Mean age was 77 years. Over 70% of the tumors were located in the head region and a majority of tumors measured 2 cm or less. The prevalence of SCC T2 was 61.9%. The risk factors significantly associated with SCC T2 were an age of over 85 years (odds ratio [OR], 4.48), location in the head and neck region (OR, 3.38), presence of solar elastosis in the peritumoral tissue (OR, 2.08), a higher tumor growth rate (>1.5 mm·wk(-1); OR, 5.73), and higher cumulative exposure to smoking (>20 pack-years, OR, 3.63). Advanced age, location in the head and neck region, presence of solar elastosis, high tumor growth rate, and high cumulative smoking exposure were all significantly associated with the presence of SCC T2. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

  8. Iron deficiency and preoperative anaemia in patients scheduled for elective hip- and knee arthroplasty - an observational study

    DEFF Research Database (Denmark)

    Jans, Ø; Nielsen, C S; Khan, N

    2018-01-01

    BACKGROUND AND OBJECTIVES: Preoperative anaemia is prevalent in elderly patients scheduled for major orthopaedic surgery and is associated with increased transfusion risk and postoperative morbidity. New guidelines recommend preoperative correction of anaemia and iron deficiency in all patients......-five (10·8%) and 243 (27·6%) of the study population were WHO anaemic or had a Hb Transfusion was more common in anaemic vs. non-anaemic patients 43 vs. 13%; (P 13 g/dl 28 vs. 11% (P

  9. The Medical Necessity for Medicinal Cannabis: Prospective, Observational Study Evaluating the Treatment in Cancer Patients on Supportive or Palliative Care

    OpenAIRE

    Bar-Sela, Gil; Vorobeichik, Marina; Drawsheh, Saher; Omer, Anat; Goldberg, Victoria; Muller, Ella

    2013-01-01

    Background. Cancer patients using cannabis report better influence from the plant extract than from synthetic products. However, almost all the research conducted to date has been performed with synthetic products. We followed patients with a medicinal cannabis license to evaluate the advantages and side effects of using cannabis by cancer patients. Methods. The study included two interviews based on questionnaires regarding symptoms and side effects, the first held on the day the license was...

  10. The MS@Work study: a 3-year prospective observational study on factors involved with work participation in patients with relapsing-remitting Multiple Sclerosis.

    Science.gov (United States)

    van der Hiele, Karin; van Gorp, Dennis A M; Heerings, Marco A P; van Lieshout, Irma; Jongen, Peter J; Reneman, Michiel F; van der Klink, Jac J L; Vosman, Frans; Middelkoop, Huub A M; Visser, Leo H

    2015-08-12

    Multiple Sclerosis (MS) is the most common cause of neurological disability in young and middle-aged adults. At this stage in life most people are in the midst of their working career. The majority of MS patients are unable to retain employment within 10 years from disease onset. Leading up to unemployment, many may experience a reduction in hours or work responsibilities and increased time missed from work. The MS@Work study examines various factors that may influence work participation in relapsing-remitting MS patients, including disease-related factors, the working environment and personal factors. The MS@Work study is a multicenter, 3-year prospective observational study on work participation in patients with relapsing-remitting MS. We aim to include 350 patients through 15-18 MS outpatient clinics in the Netherlands. Eligible participants are 18 years and older, and either currently employed or within three years since their last employment. At baseline and after 1, 2 and 3 years, the participants are asked to complete online questionnaires (including questions on work participation, work problems and accommodations, cognitive and physical ability, anxiety, depression, psychosocial stress, quality of life, fatigue, empathy, personality traits and coping strategies) and undergo cognitive and neurological examinations. After six months, patients are requested to only complete online questionnaires. Patient perspectives on maintaining and improving work participation and reasons to stop working are gathered through semi-structured interviews in a sub-group of patients. Prospective studies with long-term follow-up on work participation in MS are rare, or take into account a limited number of factors. The MS@Work study provides a 3-year follow-up on various factors that may influence work participation in patients with relapsing-remitting MS. We aim to identify factors that relate to job loss and to provide information about preventative measures for physicians

  11. Integrating data from randomized controlled trials and observational studies to predict the response to pregabalin in patients with painful diabetic peripheral neuropathy

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    Joe Alexander

    2017-07-01

    Full Text Available Abstract Background More patient-specific medical care is expected as more is learned about variations in patient responses to medical treatments. Analytical tools enable insights by linking treatment responses from different types of studies, such as randomized controlled trials (RCTs and observational studies. Given the importance of evidence from both types of studies, our goal was to integrate these types of data into a single predictive platform to help predict response to pregabalin in individual patients with painful diabetic peripheral neuropathy (pDPN. Methods We utilized three pivotal RCTs of pregabalin (398 North American patients and the largest observational study of pregabalin (3159 German patients. We implemented a hierarchical cluster analysis to identify patient clusters in the Observational Study to which RCT patients could be matched using the coarsened exact matching (CEM technique, thereby creating a matched dataset. We then developed autoregressive moving average models (ARMAXs to estimate weekly pain scores for pregabalin-treated patients in each cluster in the matched dataset using the maximum likelihood method. Finally, we validated ARMAX models using Observational Study patients who had not matched with RCT patients, using t tests between observed and predicted pain scores. Results Cluster analysis yielded six clusters (287–777 patients each with the following clustering variables: gender, age, pDPN duration, body mass index, depression history, pregabalin monotherapy, prior gabapentin use, baseline pain score, and baseline sleep interference. CEM yielded 1528 unique patients in the matched dataset. The reduction in global imbalance scores for the clusters after adding the RCT patients (ranging from 6 to 63% depending on the cluster demonstrated that the process reduced the bias of covariates in five of the six clusters. ARMAX models of pain score performed well (R 2 : 0.85–0.91; root mean square errors: 0.53–0

  12. Ethnographic Observational Study of the Biologic Initiation Conversation Between Rheumatologists and Biologic-Naive Rheumatoid Arthritis Patients.

    Science.gov (United States)

    Kottak, Nicholas; Tesser, John; Leibowitz, Evan; Rosenberg, Melissa; Parenti, Dennis; DeHoratius, Raphael

    2018-01-30

    This ethnographic market research study investigated the biologic initiation conversation between rheumatologists and biologic-naive patients with rheumatoid arthritis to assess how therapy options, particularly mode of administration, were discussed. Consenting rheumatologists (n = 16) and patients (n = 48) were videotaped during medical visits and interviewed by a trained ethnographer. The content, structure, and timing of conversations regarding biologic initiation were analyzed. The mean duration of physician-patient visits was approximately 15 minutes; biologic therapies were discussed for a mean of 5.6 minutes. Subcutaneous (SC) and intravenous (IV) therapy options were mentioned in 45 and 35 visits, respectively, out of a total of 48 visits. All patients had some familiarity with SC administration, but nearly half of patients (22 of 48) were unfamiliar with IV therapy going into the visit. IV administration was not defined or described by rheumatologists in 77% of visits (27 of 35) mentioning IV therapy. Thus, 19 of 22 patients who were initially unfamiliar with IV therapy remained unfamiliar after the visit. Disparities in physician-patient perceptions were revealed, as all rheumatologists (16 of 16) believed IV therapy would be less convenient than SC therapy for patients, while 46% of patients (22 of 48) felt this way. In post-visit interviews, some patients seemed confused and overwhelmed, particularly when presented with many treatment choices in a visit. Some patients stated they would benefit from visual aids or summary sheets of key points. This study revealed significant educational opportunities to improve the biologic initiation conversation and indicated a disparity between patients' and rheumatologists' perception of IV therapy. © 2018 The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

  13. Long-term Efficacy of Trabeculectomy on Chinese Patients with Pigmentary Glaucoma: A Prospective Case Series Observational Study

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    Guo-Ping Qing

    2016-01-01

    Conclusions: All surgical PG eyes in this study had satisfactory IOP control 8 years after the surgery with well-preserved visual function. The long-term efficacy and safety of trabeculectomy are promising in PG patients.

  14. Phenotypic ASCO Characterisation of Young Patients with Ischemic Stroke in the Prospective Multicentre Observational sifap1 Study.

    Science.gov (United States)

    Wolf, Marc E; Grittner, Ulrike; Böttcher, Tobias; Norrving, Bo; Rolfs, Arndt; Hennerici, Michael G

    2015-01-01

    The prospective, multinational European 'Stroke in Young Fabry Patients' (sifap1) study collected 4,467 patients with acute ischemic cerebrovascular events aged 18-55 years. Initially, aetiologic subtyping was performed using the TOAST classification; however, recently the phenotypic ASCO classification was presented and might be more useful to identify stroke aetiologies in young patients with a wide set of different causes. ASCO is a classification system divided in four etiologic categories (Atherosclerosis, Small vessel disease (SVD), Cardiac embolism, Other cause) with different grades of severity (1-3) and aims to characterise patients in a more comprehensive way. We determined the ASCO score for each patient, according to prospectively collected data using the study protocol. The distribution of aetiologies was analysed with regard to concomitant causes, cryptogenic stroke and different age groups. A potentially causal aetiology (grade 1) was detected in 29.3% of 4,467 patients. Merging grades 1 and 2, a suspected aetiology was found in 54.1%. In 8.6% of patients concomitant aetiologies were identified. Most common causes were cervical arterial dissection and persistent foramen ovale, but there was also a high prevalence of large artery atherosclerosis and SVD especially in older patients of this collective. About 50% of patients had more than one finding with a lower grade of evidence (grade 3). In 14% final classification of strictly cryptogenic stroke was made. This is the largest study to date, using the ASCO characterisation of ischemic stroke aetiologies. ASCO classification provides first evidence that many young patients presenting with acute stroke have concomitant stroke aetiologies associated with a substantial atherosclerosis risk profile. ASCO could be integrated in clinical routine and registry data banks, as well as large clinical trials to improve stroke documentation. © 2015 S. Karger AG, Basel.

  15. Influence of patient symptoms and physical findings on general practitioners' treatment of respiratory tract infections: a direct observation study

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    Kochen Michael M

    2005-02-01

    Full Text Available Abstract Background The high rate of antibiotic prescriptions general practitioners (GPs make for respiratory tract infections (RTI are often explained by non-medical reasons e.g. an effort to meet patient expectations. Additionally, it is known that GPs to some extent believe in the necessity of antibiotic treatment in patients with assumed bacterial infections and therefore attempt to distinguish between viral and bacterial infections by history taking and physical examination. The influence of patient complaints and physical examination findings on GPs' prescribing behaviour was mostly investigated by indirect methods such as questionnaires. Methods Direct, structured observation during a winter "cough an cold period" in 30 (single handed general practices. All 273 patients with symptoms of RTI (age above 14, median 37 years, 51% female were included. Results The most frequent diagnoses were 'uncomplicated upper RTI/common cold' (43% followed by 'bronchitis' (26%. On average, 1.8 (95%-confidence interval (CI: 1.7–2.0 medicines per patient were prescribed (cough-and-cold preparations in 88% of the patients, antibiotics in 49%. Medical predictors of antibiotic prescribing were pathological findings in physical examination such as coated tonsils (odds ratio (OR 15.4, 95%-CI: 3.6–66.2 and unspecific symptoms like fatigue (OR 3.1, 95%-CI 1.4–6.7, fever (OR 2.2, 95%-CI: 1.1–4.5 and yellow sputum (OR 2.1, 95%-CI: 1.1–4.1. Analysed predictors explained 70% of the variance of antibiotic prescribing (R2 = 0,696. Efforts to reduce antibiotic prescribing, e.g. recommendations for self-medication, counselling on home remedies or delayed antibiotic prescribing were rare. Conclusions Patient complaints and pathological results in physical examination were strong predictors of antibiotic prescribing. Efforts to reduce antibiotic prescribing should account for GPs' beliefs in those (non evidence based predictors. The method of direct observation was

  16. Medical Complications Predict Cognitive Decline in Nondemented Hip Fracture Patients-Results of a Prospective Observational Study.

    Science.gov (United States)

    Hack, Juliana; Eschbach, Daphne; Aigner, Rene; Oberkircher, Ludwig; Ruchholtz, Steffen; Bliemel, Christopher; Buecking, Benjamin

    2018-03-01

    The aim of this study was to identify factors that are associated with cognitive decline in the long-term follow-up after hip fractures in previously nondemented patients. A consecutive series of 402 patients with hip fractures admitted to our university hospital were analyzed. After exclusion of all patients with preexisting dementia, 266 patients were included, of which 188 could be examined 6 months after surgery. Additional to several demographic data, cognitive ability was assessed using the Mini-Mental State Examination (MMSE). Patients with 19 or less points on the MMSE were considered demented. Furthermore, geriatric scores were recorded, as well as perioperative medical complications. Mini-Mental State Examination was performed again 6 months after surgery. Of 188 previously nondemented patients, 12 (6.4%) patients showed a cognitive decline during the 6 months of follow-up. Multivariate regression analysis showed that age ( P = .040) and medical complications ( P = .048) were the only significant independent influencing factors for cognitive decline. In our patient population, the incidence of dementia exceeded the average age-appropriate cognitive decline. Significant independent influencing factors for cognitive decline were age and medical complications.

  17. Evaluation of Aryoseven Safety (Recombinant Activated Factor VII) in Patients with Bleeding Disorders (An Observational Post-Marketing Surveillance Study).

    Science.gov (United States)

    Toogeh, Gholamreza; Abolghasemi, Hassan; Eshghi, Peyman; Managhchi, Mohammadreza; Shaverdi-Niasari, Mohammadreza; Karimi, Katayoon; Roostaei, Samin; Emran, Neda; Abdollahi, Alireza

    2016-01-01

    Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. This single-center, descriptive, cross sectional study was carried out in Thrombus and Homeostasis Research Center ValiAsr Hospital during 2013-2014. Fifty one patients with bleeding disorders who received at least one dose of Aryoseven were enrolled. Patients' demographic data and adverse effect of drug and reaction related to Aryoseven or previous usage of Recombinant activated FVII were recorded in questionnaires. Finally data were analyzed to compare side effects of Aryoseven and other Recombinant activated FVII brands. Aryoseven was prescribed for 51 Patients. Of all participants with mean age 57.18+21.38 yr, 31 cases were male and 26 subjects had past history of recombinant activated FVII usage. Glanzman was the most frequent disorder followed by congenital FVII deficiency, hemophilia with inhibitors, factor 5 deficiency, acquired hemophilia, hemophilia A with inhibitor, and hemophilia A or B with inhibitor. The majority of bleeding episodes had occurred in joints. Three patients (5.9%) complained about adverse effects of Aryoseven vs. 11.5 % about adverse effects of other brands. However this difference was not significant, statistically. Based on monitor patients closely for any adverse events, we concluded that Aryoseven administration under careful weighing of benefit versus potential harm may comparable with other counterpart drugs.

  18. Effect of Tracheostomy on Weaning Parameters in Difficult-to-Wean Mechanically Ventilated Patients: A Prospective Observational Study

    Science.gov (United States)

    Lim, Chor-Kuan; Ruan, Sheng-Yuan; Lin, Feng-Ching; Wu, Chao-Ling; Chang, Hou-Tai; Jerng, Jih-Shuin; Wu, Huey-Dong; Yu, Chong-Jen

    2015-01-01

    Background and Objective Weaning parameters are commonly measured through an endotracheal tube in mechanically ventilated patients recovering from acute respiratory failure, however this practice has rarely been evaluated in tracheostomized patients. This study aimed to investigate changes in weaning parameters measured before and after tracheostomy, and to explore whether the data measured after tracheostomy were associated with weaning outcomes in difficult-to-wean patients. Methods In a two-year study period, we enrolled orotracheally intubated patients who were prepared for tracheostomy due to difficult weaning. Weaning parameters were measured before and after the conversion to tracheostomy and compared, and the post-tracheostomy data were tested for associations with weaning outcomes. Results A total of 86 patients were included. After tracheostomy, maximum inspiratory pressure (mean difference (Δ) = 4.4, 95% CI, 2.7 to 6.1, Ptracheostomy than those who were unsuccessfully weaned. Conclusions In conclusion, the conversion from endotracheal tube to tracheostomy significantly improved the measured values of weaning parameters in difficult-to-wean patients who subsequently weaned successfully from the mechanical ventilator. The change was significant only for airway resistance in patients who failed weaning. Trial Registration ClinicalTrials.gov NCT01312142 PMID:26379127

  19. Association between Low-density lipoprotein cholesterol and occipital periventricular hyperintensities in a group of Chinese patients: an observational study.

    Science.gov (United States)

    Duan, Dazhi; Shen, Lin; Cui, Chun; Shu, Tongsheng; Zheng, Jian

    2017-02-27

    While occipital periventricular hyperintensities (OPVHs) are among the most common mild white matter hyperintensities, the clinical factors associated with OPVHs remain unclear. In this study, we investigated the role of clinical factors in development of pure OPVHs. This study included 97 patients with OPVHs and 73 healthy controls. Univariate analysis of clinical factors in OPVH patients and controls was followed by binomial logistic regression analysis to identify clinical factors significantly associated with OPVHs. Univariate analysis indicated that age, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein-B (Apo-B) levels differed significantly between the OPVH patients and controls (p correlated with OPVH scores (p anti-correlated with OPVHs scores (p correlated with OPVHs (p correlated with OPVHs (p < 0.001). In summary, LDL-C was negatively and age was positively associated with OPVHs among Chinese patients in a hospital.

  20. Longitudinal observation of treatment patterns and outcomes for patients with fibromyalgia: 12-month findings from the reflections study.

    Science.gov (United States)

    Robinson, Rebecca L; Kroenke, Kurt; Williams, David A; Mease, Philip; Chen, Yi; Faries, Douglas; Peng, Xiaomei; Hann, Danette; Wohlreich, Madelaine; McCarberg, Bill

    2013-09-01

    To describe 12-month treatment patterns and outcomes for patients starting a new medication for fibromyalgia in routine clinical practice. Data from 1,700 patients were collected at baseline and 1, 3, 6, and 12 months. Repeated measures and Poisson regression models controlling for demographic, clinical, and baseline outcomes were used to assess changes in health outcomes (Brief Pain Inventory severity and interference, Sheehan Disability Scale, Fibromyalgia Impact Questionnaire), satisfaction, and economic factors for patients who initiated on pregabalin (214, 12.6%), duloxetine (264, 15.5%), milnacipran (134, 7.9%), or tricyclic antidepressants (66, 3.9%). Sensitivity analyses were run using propensity-matched cohorts. Patients started on 145 unique drugs for fibromyalgia, and over 75% of patients took two or more medications concurrently for fibromyalgia at each time point assessed. Overall, patients showed improvement on the four health outcomes, with few differences across medication cohorts. At baseline, patients reported annual averages of 20.3 visits for outpatient care, 27.7 missed days of work, and 32.6 days of care by an unpaid caregiver. The duloxetine and milnacipran (vs pregabalin or tricyclic antidepressant) cohorts had fewer outpatient visits during the 12-month study. Patients reported satisfaction with overall treatment and their fibromyalgia medication (46.0% and 42.8%, respectively). In this real-world setting, patients with fibromyalgia reported modest improvements, high resource, and medication use, and were satisfied with the care they received. Cohort differences were difficult to discern because of the high rates of drug discontinuation and concomitant medication use over the 12-month study period. Wiley Periodicals, Inc.

  1. The Medical Necessity for Medicinal Cannabis: Prospective, Observational Study Evaluating the Treatment in Cancer Patients on Supportive or Palliative Care

    Directory of Open Access Journals (Sweden)

    Gil Bar-Sela

    2013-01-01

    Full Text Available Background. Cancer patients using cannabis report better influence from the plant extract than from synthetic products. However, almost all the research conducted to date has been performed with synthetic products. We followed patients with a medicinal cannabis license to evaluate the advantages and side effects of using cannabis by cancer patients. Methods. The study included two interviews based on questionnaires regarding symptoms and side effects, the first held on the day the license was issued and the second 6–8 weeks later. Cancer symptoms and cannabis side effects were documented on scales from 0 to 4 following the CTCAE. The distress thermometer was used also. Results. Of the 211 patients who had a first interview, only 131 had the second interview, 25 of whom stopped treatment after less than a week. All cancer or anticancer treatment-related symptoms showed significant improvement (P<0.001. No significant side effects except for memory lessening in patients with prolonged cannabis use (P=0.002 were noted. Conclusion. The positive effects of cannabis on various cancer-related symptoms are tempered by reliance on self-reporting for many of the variables. Although studies with a control group are missing, the improvement in symptoms should push the use of cannabis in palliative treatment of oncology patients.

  2. Psychiatric comorbidity as predictor of costs in back pain patients undergoing disc surgery: a longitudinal observational study

    Directory of Open Access Journals (Sweden)

    Konnopka Alexander

    2012-09-01

    Full Text Available Abstract Background Psychiatric comorbidity is common in back pain patients undergoing disc surgery and increases economic costs in many areas of health. The objective of this study was to analyse psychiatric comorbidity as predictor of direct and indirect costs in back pain patients undergoing disc surgery in a longitudinal study design. Methods A sample of 531 back pain patients was interviewed after an initial disc surgery (T0, 3 months (T1 and 15 months (T2 using the Composite International Diagnostic Interview to assess psychiatric comorbidity and a modified version of the Client Sociodemographic and Service Receipt Inventory to assess resource utilization and lost productivity for a 3-month period prior interview. Health care utilization was monetarily valued by unit costs and productivity by labour costs. Costs were analysed using random coefficient models and bootstrap techniques. Results Psychiatric comorbidity was associated with significantly (p  Conclusion Psychiatric comorbidity presents an important predictor of direct and indirect costs in back pain patients undergoing disc surgery, even if patients do not utilize mental health care. This effect seems to be stable over time. More attention should be given to psychiatric comorbidity and cost-effective treatments should be applied to treat psychiatric comorbidity in back pain patients undergoing disc surgery to reduce health care utilization and costs associated with psychiatric comorbidity.

  3. The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis

    NARCIS (Netherlands)

    Abbott, T. E. F.; Ahmad, T.; Phull, M. K.; Fowler, A. J.; Hewson, R.; Biccard, B. M.; Chew, M. S.; Gillies, M.; Pearse, R. M.; Pearse, Rupert M.; Beattie, Scott; Clavien, Pierre-Alain; Demartines, Nicolas; Fleisher, Lee A.; Grocott, Mike; Haddow, James; Hoeft, Andreas; Holt, Peter; Moreno, Rui; Pritchard, Naomi; Rhodes, Andrew; Wijeysundera, Duminda; Wilson, Matt; Ahmed, Tahania; Everingham, Kirsty; Hewson, Russell; Januszewska, Marta; Phull, Mandeep-Kaur; Halliwell, Richard; Shulman, Mark; Myles, Paul; Schmid, Werner; Hiesmayr, Michael; Wouters, Patrick; de Hert, Stefan; Lobo, Suzana; Fang, Xiangming; Rasmussen, Lars; Futier, Emmanuel; Biais, Matthieu; Venara, Aurélien; Slim, Karem; Sander, Michael; Koulenti, Despoina; Arvaniti, Kostoula; Chan, Mathew; Kulkarni, Atul; Chandra, Susilo; Tantri, Aida; Geddoa, Emad; Abbas, Muntadhar; Della Rocca, Giorgio; Sivasakthi, Datin; Mansor, Marzida; Luna, Pastor; Bouwman, Arthur; Buhre, Wolfgang; Beavis, Vanessa; Campbell, Douglas; Short, Tim; Osinaike, Tunde; Matos, Ricardo; Grigoras, Ioana; Kirov, Mikhail; Protsenko, Denis; Biccard, Bruce; Aldecoa, Cesar; Chew, Michelle; Hofer, Christoph; Hubner, Martin; Ditai, James; Szakmany, Tamas; Fleisher, Lee; Ferguson, Marissa; MacMahon, Michael; Cherian, Ritchie; Currow, Helen; Kanathiban, Kathirgamanathan; Gillespie, David; Pathmanathan, Edward; Phillips, Katherine; Reynolds, Jenifer; Rowley, Joanne; Douglas, Jeanene; Kerridge, Ross; Garg, Sameer; Bennett, Michael; Jain, Megha; Alcock, David; Terblanche, Nico; Cotter, Rochelle; Leslie, Kate; Stewart, Marcelle; Zingerle, Nicolette; Clyde, Antony; Hambidge, Oliver; Rehak, Adam; Cotterell, Sharon; Huynh, Wilson Binh Quan; McCulloch, Timothy; Ben-Menachem, Erez; Egan, Thomas; Cope, Jennifer; Fellinger, Paul; Haisjackl, Markus; Haselberger, Simone; Holaubek, Caroline; Lichtenegger, Paul; Scherz, Florian; Hoffer, Franz; Cakova, Veronika; Eichwalder, Andreas; Fischbach, Norbert; Klug, Reinhold; Schneider, Elisabeth; Vesely, Martin; Wickenhauser, Reinhart; Grubmueller, Karl Gernot; Leitgeb, Marion; Lang, Friedrich; Toro, Nancy; Bauer, Marlene; Laengle, Friedrich; Haberl, Claudia; Mayrhofer, Thomas; Trybus, Christoph; Buerkle, Christian; Forstner, Karin; Germann, Reinhard; Rinoesl, Harald; Schindler, Elke; Trampitsch, Ernst; Bogner, Gerhard; Dankl, Daniel; Duenser, Martin; Fritsch, Gerhard; Gradwohl-Matis, Ilse; Hartmann, Andreas; Hoelzenbein, Thomas; Jaeger, Tarkan; Landauer, Franz; Lindl, Gregor; Lux, Michael; Steindl, Johannes; Stundner, Ottokar; Szabo, Christian; Bidgoli, Jawad; Verdoodt, Hans; Forget, Patrice; Kahn, David; Lois, Fernande; Momeni, Mona; Prégardien, Caroline; Pospiech, Audrey; Steyaert, Arnaud; Veevaete, Laurent; de Kegel, Dirk; de Jongh, Karen; Foubert, Luc; Smitz, Carine; Vercauteren, Marcel; Poelaert, Jan; van Mossevelde, Veerle; Abeloos, Jacques; Bouchez, Stefaan; Coppens, Marc; de Baerdemaeker, Luc; Deblaere, Isabel; de Bruyne, Ann; Fonck, Kristine; Heyse, Bjorn; Jacobs, Tom; Lapage, Koen; Moerman, Anneliese; Neckebroek, Martine; Parashchanka, Aliaksandra; Roels, Nathalie; van den Eynde, Nancy; Vandenheuvel, Michael; Limmen, JurgenVan; Vanluchene, Ann; Vanpeteghem, Caroline; Wyffels, Piet; Huygens, Christel; Vandenbempt, Punitha; van de Velde, Marc; Dylst, Dimitri; Janssen, Bruno; Schreurs, Evelien; Aleixo, Fábia Berganton; Candido, Keulle; Batista, Hugo Dias; Guimarães, Mario; Guizeline, Jaqueline; Hoffmann, João; Lobo, Francisco Ricardo Marques; Nascimento, Vinícius; Nishiyama, Katia; Pazetto, Lucas; Souza, Daniela; Rodrigues, Rodrigo Souza; Vilela Dos Santos, Ana Maria; Jardim, Jaquelline; Sá Malbouisson, Luiz Marcelo; Silva, Joao; Nascimento Junior, Paulo do; Baio, Thalissa Hermínia; Pereira de Castro, Gabriel Isaac; Watanabe Oliveira, Henri Roger; Amendola, Cristina Prata; Cardoso, Gutemberg; Ortega, Daniela; Brotto, Ana Flavia; de Oliveira, Mirella Cristine; Réa-Neto, Álvaro; Dias, Fernando; Travi, Maria Eduarda; Zerman, Luiza; Azambuja, Pedro; Knibel, Marcos Freitas; Martins, Antonio; Almeida, William; Neto, Calim Neder; Tardelli, Maria Angela; Caser, Eliana; Machado, Marcio; Aguzzoli, Crisitiano; Baldisserotto, Sérgio; Tabajara, Fernanda Beck; Bettega, Fernanda; Rodrigues Júnior, La Hore Correa; de Gasperi, Julia; Faina, Lais; Nolasco, Marcos Farias; Ferreira da Costa Fischer, Bruna; Fosch de Campos Ferreira, Mariana; Hartmann, Cristina; Kliemann, Marta; Hubert Ribeiro, Gustavo Luis; Fraga, Julia Merladete; Netto, Thiago Motta; Pozza, Laura Valduga; Wendling, Paulo Rafael; Azevedo, Caroline; Garcia, Juliana; Lopes, Marcel; Maia, Bernardo; Maselli, Paula; Melo, Ralph; Mendes, Weslley; Neves, Matheus; Ney, Jacqueline; Piras, Claudio; Applewhaite, Christopher; Carr, Adrienne; Chow, Lorraine; Duttchen, Kaylene; Foglia, Julena; Greene, Michael; Hinther, Ashley; Houston, Kendra; McCormick, Thomas Jared; Mikhayel, Jennifer; Montasser, Sam; Ragan, Alex; Suen, Andrew; Woolsey, Adrianna; Yu, Hai Chuan; Funk, Duane; Kowalski, Stephen; Legaspi, Regina; McDonald, Heather; Siddiqui, Faisal; Pridham, Jeremy; Rowe, Bernadette; Sampson, Sonia; Thiessen, Barton; Zbitnew, Geoff; Bernard, Andre; George, Ronald; Jones, Philip; Moor, Rita; Siddiqui, Naveed; Wolfer, Alexandra; Tran, Diem; Winch, Denyse; Dobson, Gary; McCormick, Thomas; Montasser, Osama; Hall, Richard; Baghirzada, Leyla; Curley, Gerard; Dai, Si Yuan; Hare, Gregory; Lee, Esther; Shastri, Uma; Tsui, Albert; Yagnik, Anmol; Alvares, Danielle; Choi, Stephen; Dwyer, Heather; Flores, Kathrina; McCartney, Colin; Somascanthan, Priya; Carroll, Jo; Pazmino-Canizares, Janneth; Ami, Noam; Chan, Vincent; Perlas, Anahi; Argue, Ruth; Huang, Yang; Lavis, Katie; Mayson, Kelly; Cao, Ying; Gao, Hong; Hu, Tingju; Lv, Jie; Yang, Jian; Yang, Yang; Zhong, Yi; Zhou, Jing; Zou, Xiaohua; He, Miao; Li, Xiaoying; Luo, Dihuan; Wang, Haiying; Yu, Tian; Chen, Liyong; Wang, Lijun; Cai, Yunfei; Cao, Zhongming; Li, Yanling; Lian, Jiaxin; Sun, Haiyun; Wang, Sheng; Wang, Zhipeng; Wang, Kenru; Zhu, Yi; Du, Xindan; Fan, Hao; Fu, Yunbin; Huang, Lixia; Huang, Yanming; Hwan, Haifang; Luo, Hong; Qu, Pi-Sheng; Tao, Fan; Wang, Zhen; Wang, Guoxiang; Wang, Shun; Zhang, Yan; Zhang, Xiaolin; Chen, Chao; Wang, Weixing; Liu, Zhengyuan; Fan, Lihua; Tang, Jing; Chen, Yijun; Chen, Yongjie; Han, Yangyang; Huang, Changshun; Liang, Guojin; Shen, Jing; Wang, Jun; Yang, Qiuhong; Zhen, Jungang; Zhou, Haidong; Chen, Junping; Chen, Zhang; Li, Xiaoyu; Meng, Bo; Ye, Haiwang; Zhang, Xiaoyan; Bi, Yanbing; Cao, Jianqiao; Guo, Fengying; Lin, Hong; Liu, Yang; Lv, Meng; Shi, Pengcai; Song, Xiumei; Sun, Chuanyu; Sun, Yongtao; Wang, Yuelan; Wang, Shenhui; Zhang, Min; Chen, Rong; Hou, Jiabao; Leng, Yan; Meng, Qing-Tao; Qian, Li; Shen, Zi-Ying; Xia, Zhong-Yuan; Xue, Rui; Zhang, Yuan; Zhao, Bo; Zhou, Xian-Jin; Chen, Qiang; Guo, Huinan; Guo, Yongqing; Qi, Yuehong; Wang, Zhi; Wei, Jianfeng; Zhang, Weiwei; Zheng, Lina; Bao, Qi; Chen, Yaqiu; Chen, Yijiao; Fei, Yue; Hu, Nianqiang; Hu, Xuming; Lei, Min; Li, Xiaoqin; Lv, Xiaocui; Miao, Fangfang; Ouyang, Lingling; Qian, Lu; Shen, Conyu; Sun, Yu; Wang, Yuting; Wang, Dong; Wu, Chao; Xu, Liyuan; Yuan, Jiaqi; Zhang, Lina; Zhang, Huan; Zhang, Yapping; Zhao, Jinning; Zhao, Chong; Zhao, Lei; Zheng, Tianzhao; Zhou, Dachun; Zhou, Haiyan; Zhou, Ce; Lu, Kaizhi; Zhao, Ting; He, Changlin; Chen, Hong; Chen, Shasha; Cheng, Baoli; He, Jie; Jin, Lin; Li, Caixia; Li, Hui; Pan, Yuanming; Shi, Yugang; Wen, Xiao Hong; Wu, Shuijing; Xie, Guohao; Zhang, Kai; Zhao, Bing; Lu, Xianfu; Chen, Feifei; Liang, Qisheng; Lin, Xuewu; Ling, Yunzhi; Liu, Gang; Tao, Jing; Yang, Lu; Zhou, Jialong; Chen, Fumei; Cheng, Zhonggui; Dai, Hanying; Feng, Yunlin; Hou, Benchao; Gong, Haixia; Hu, Chun Hua; Huang, Haijin; Huang, Jian; Jiang, Zhangjie; Li, Mengyuan; Lin, Jiamei; Liu, Mei; Liu, Weicheng; Liu, Zhen; Liu, Zhiyi; Luo, Foquan; Ma, Longxian; Min, Jia; Shi, Xiaoyun; Song, Zhiping; Wan, Xianwen; Xiong, Yingfen; Xu, Lin; Yang, Shuangjia; Zhang, Qin; Zhang, Hongyan; Zhang, Huaigen; Zhang, Xuekang; Zhao, Lili; Zhao, Weihong; Zhao, Weilu; Zhu, Xiaoping; Bai, Yun; Chen, Linbi; Chen, Sijia; Dai, Qinxue; Geng, Wujun; Han, Kunyuan; He, Xin; Huang, Luping; Ji, Binbin; Jia, Danyun; Jin, Shenhui; Li, Qianjun; Liang, Dongdong; Luo, Shan; Lwang, Lulu; Mo, Yunchang; Pan, Yuanyuan; Qi, Xinyu; Qian, Meizi; Qin, Jinling; Ren, Yelong; Shi, Yiyi; Wang, Junlu; Wang, Junkai; Wang, Leilei; Xie, Junjie; Yan, Yixiu; Yao, Yurui; Zhang, Mingxiao; Zhao, Jiashi; Zhuang, Xiuxiu; Ai, Yanqiu; Du, Fang; He, Long; Huang, Ledan; Li, Zhisong; Li, Huijuan; Li, Yetong; Li, Liwei; Meng, Su; Yuan, Yazhuo; Zhang, Enman; Zhang, Jie; Zhao, Shuna; Ji, Zhenrong; Pei, Ling; Wang, Li; Chen, Chen; Dong, Beibei; Li, Jing; Miao, Ziqiang; Mu, Hongying; Qin, Chao; Su, Lin; Wen, Zhiting; Xie, Keliang; Yu, Yonghao; Yuan, Fang; Hu, Xianwen; Zhang, Ye; Xiao, Wangpin; Zhu, Zhipeng; Dai, Qingqing; Fu, Kaiwen; Hu, Rong; Hu, Xiaolan; Huang, Song; Li, Yaqi; Liang, Yingping; Yu, Shuchun; Guo, Zheng; Jing, Yan; Tang, Na; Wu, Jie; Yuan, Dajiang; Zhang, Ruilin; Zhao, Xiaoying; Li, Yuhong; Bai, Hui-Ping; Liu, Chun-Xiao; Liu, Fei-Fei; Ren, Wei; Wang, Xiu-Li; Xu, Guan-Jie; Hu, Na; Li, Bo; Ou, Yangwen; Tang, Yongzhong; Yao, Shanglong; Zhang, Shihai; Kong, Cui-Cui; Liu, Bei; Wang, Tianlong; Xiao, Wei; Lu, Bo; Xia, Yanfei; Zhou, Jiali; Cai, Fang; Chen, Pushan; Hu, Shuangfei; Wang, Hongfa; Xu, Qiong; Hu, Liu; Jing, Liang; Li, Bin; Liu, Qiang; Liu, Yuejiang; Lu, Xinjian; Peng, Zhen Dan; Qiu, Xiaodong; Ren, Quan; Tong, Youliang; Wang, Jin; Wen, Yazhou; Wu, Qiong; Xia, Jiangyan; Xie, Jue; Xiong, Xiapei; Xu, Shixia; Yang, Tianqin; Ye, Hui; Yin, Ning; Yuan, Jing; Zeng, Qiuting; Zhang, Baoling; Zheng, Kang; Cang, Jing; Chen, Shiyu; Fan, Yu; Fu, Shuying; Ge, Xiaodong; Guo, Baolei; Huang, Wenhui; Jiang, Linghui; Jiang, Xinmei; Liu, Yi; Pan, Yan; Ren, Yun; Shan, Qi; Wang, Jiaxing; Wang, Fei; Wu, Chi; Zhang, Xiaoguang; Christiansen, Ida Cecilie; Granum, Simon Nørgaard; Rasmussen, Bodil Steen; Daugaard, Morten; Gambhir, Rajiv; Brandsborg, Birgitte; Steingrímsdóttir, Guðný Erla; Jensen-Gadegaard, Peter; Olsen, Karsten Skovgaard; Siegel, Hanna; Eskildsen, Katrine Zwicky; Gätke, Mona Ring; Wibrandt, Ida; Heintzelmann, Simon Bisgaard; Wiborg Lange, Kai Henrik; Lundsgaard, Rune Sarauw; Amstrup-Hansen, Louise; Hovendal, Claus; Larsen, Michael; Lenstrup, Mette; Kobborg, Tina; Larsen, Jens Rolighed; Pedersen, Anette Barbre; Smith, Søren Hübertz; Oestervig, Rebecca Monett; Afshari, Arash; Andersen, Cheme; Ekelund, Kim; Secher, Erik Lilja; Beloeil, Helene; Lasocki, Sigismond; Ouattara, Alexandre; Sineus, Marlene; Molliex, Serge; Legouge, Marie Lim; Wallet, Florent; Tesniere, Antoine; Gaudin, Christophe; Lehur, Paul; Forsans, Emma; de Rudnicki, Stéphane; Maudet, Valerie Serra; Mutter, Didier; Sojod, Ghassan; Ouaissi, Mehdi; Regimbeau, Jean-Marc; Desbordes, Jacques; Comptaer, Nicolas; Manser, Diae El; Ethgen, Sabine; Lebuffe, Gilles; Auer, Patrick; Härtl, Christine; Deja, Maria; Legashov, Kirill; Sonnemann, Susanne; Wiegand-Loehnert, Carola; Falk, Elke; Habicher, Marit; Angermair, Stefan; Laetsch, Beatrix; Schmidt, Katrin; von Heymann, Christian; Ramminger, Axel; Jelschen, Florian; Pabel, Svenja; Weyland, Andreas; Czeslick, Elke; Gille, Jochen; Malcharek, Michael; Sablotzki, Armin; Lueke, Katharina; Wetzel, Peter; Weimann, Joerg; Lenhart, Franz-Peter; Reichle, Florian; Schirmer, Frederike; Hüppe, Michael; Klotz, Karl; Nau, Carla; Schön, Julika; Mencke, Thomas; Wasmund, Christina; Bankewitz, Carla; Baumgarten, Georg; Fleischer, Andreas; Guttenthaler, Vera; Hack, Yvonne; Kirchgaessner, Katharina; Männer, Olja; Schurig-Urbaniak, Marlen; Struck, Rafael; van Zyl, Rebekka; Wittmann, Maria; Goebel, Ulrich; Harris, Sarah; Veit, Siegfried; Andreadaki, Evangelia; Souri, Flora; Katsiadramis, Ioannis; Skoufi, Anthi; Vasileiou, Maria; Aimoniotou-Georgiou, Eleni; Katsourakis, Anastasios; Veroniki, Fotini; Vlachogianni, Glyceria; Petra, Konstantina; Chlorou, Dimitra; Oloktsidou, Eirini; Ourailoglou, Vasileios; Papapostolou, Konstantinos; Tsaousi, Georgia; Daikou, Panagoula; Dedemadi, Georgia; Kalaitzopoulos, Ioannis; Loumpias, Christos; Bristogiannis, Sotirios; Dafnios, Nikolaos; Gkiokas, Georgios; Kontis, Elissaios; Kozompoli, Dimitra; Papailia, Aspasia; Theodosopoulos, Theodosios; Bizios, Christol; Koutsikou, Anastasia; Moustaka, Aleaxandra; Plaitakis, Ioannis; Armaganidis, Apostolos; Christodoulopoulou, Theodora; Lignos, Mihail; Theodorakopoulou, Maria; Asimakos, Andreas; Ischaki, Eleni; Tsagkaraki, Angeliki; Zakynthinos, Spyros; Antoniadou, Eleni; Koutelidakis, Ioannis; Lathyris, Dimitrios; Pozidou, Irene; Voloudakis, Nikolaos; Dalamagka, Maria; Elena, Gkonezou; Chronis, Christos; Manolakaki, Dimitra; Mosxogiannidis, Dimitris; Slepova, Tatiana; Tsakiridou, Isaia-Sissy; Lampiri, Claire; Vachlioti, Anastasia; Panagiotakis, Christos; Sfyras, Dimitrios; Tsimpoukas, Fotios; Tsirogianni, Athanasia; Axioti, Elena; Filippopoulos, Andreas; Kalliafa, Elli; Kassavetis, George; Katralis, Petros; Komnos, Ioannis; Pilichos, Georgios; Ravani, Ifigenia; Totis, Antonis; Apagaki, Eymorfia; Efthymiadi, Andromachi; Kampagiannis, Nikolaos; Paraforou, Theoniki; Tsioka, Agoritsa; Georgiou, Georgios; Vakalos, Aristeidis; Bairaktari, Aggeliki; Charitos, Efthimios; Markou, George; Niforopoulou, Panagiota; Papakonstantinou, Nikolaos; Tsigou, Evdoxia; Xifara, Archontoula; Zoulamoglou, Menelaos; Gkioni, Panagiota; Karatzas, Stylianos; Kyparissi, Aikaterini; Mainas, Efstratios; Papapanagiotou, Ioannis; Papavasilopoulou, Theonymfi; Fragandreas, George; Georgopoulou, Eleni; Katsika, Eleni; Psarras, Kyriakos; Synekidou, Eirini; Verroiotou, Maria; Vetsiou, Evangelia; Zaimi, Donika; Anagnou, Athina; Apostolou, Konstantinos; Melissopoulou, Theodora; Rozenberg, Theophilos; Tsigris, Christos; Boutsikos, Georgios; Kalles, Vasileios; Kotsalas, Nikolaos; Lavdaiou, Christina; Paikou, Fotini; Panagou, Georgia-Laura; Spring, Anna; Botis, Ioannis; Drimala, Maria; Georgakakis, Georgios; Kiourtzieva, Ellada; Ntouma, Panagiota; Prionas, Apostolos; Xouplidis, Kyriakos; Dalampini, Eleftheria; Giannaki, Chrysavgi; Iasonidou, Christina; Ioannidis, Orestis; Lavrentieva, Athina; Lavrentieva, Athena; Papageorgiou, George; Kokkinoy, Maria; Stafylaraki, Maria; Gaitanakis, Stylianos; Karydakis, Periclis; Paltoglou, Josef; Ponireas, Panagiotis; Chaloulis, Panagiotis; Provatidis, Athanasios; Sousana, Anisoglou; Gardikou, Varvara Vanessa; Konstantivelli, Maria; Lataniotou, Olga; Lisari, Elisavet; Margaroni, Maria; Stamatiou, Konstantinos; Nikolaidis, Edouardos; Pnevmatikos, Ioannis; Sertaridou, Eleni; Andreou, Alexandros; Arkalaki, Eleni; Athanasakis, Elias; Chaniotaki, Fotini; Chatzimichali, Chatzimichali Aikaterini; Christofaki, Maria; Dermitzaki, Despina; Fiorentza, Klara; Frantzeskos, Georgios; Geromarkaki, Elisavet; Kafkalaki, Kalliopi; Kalogridaki, Marina; Karydi, Konstyllia; Kokkini, Sofia; Kougentakis, Georgios; Lefaki, Tatiana; Lilitsis, Emmanouhl; Makatounaki, Aikaterini; Malliotakis, Polychronis; Michelakis, Dimosthenis; Neonaki, Maria; Nyktari, Vasileia; Palikyra, Iliana; Papadakis, Eleftherios; Papaioannou, Alexandra; Sfakianakis, Konstantinos; Sgouraki, Maria; Souvatzis, Xenia; Spartinou, Anastasia; Stefanidou, Nefeli; Syrogianni, Paulina; Tsagkaraki, Georgia; Arnaoutoglou, Elena; Arnaoutoglou, Christina; Bali, Christina; Bouris, Vasilios; Doumos, Rodamanthos; Gkini, Konstantia-Paraskevi; Kapaktsi, Clio; Koulouras, Vasilios; Lena, Arian; Lepida, Dimitra; Michos, Evangelos; Papadopoulos, Dimitrios; Paschopoulos, Minas; Rompou, Vaia Aliki; Siouti, Ioanna; Tsampalas, Stavros; Ververidou, Ourania; Zilis, Georgios; Charlalampidoy, Alexandra; Christodoulidis, Gregory; Flossos, Andreas; Stamoulis, Konstantinos; Chan, Matthew; Tsang, Man Shing Caleb; Tsang, Man Shing; Lai, Man Ling; Yip, Chi Pang; Heymans Chan, Hey Man; Law, Bassanio; Li, Wing Sze; Chu, Hiu Man; Koo, Emily Gar Yee; Lam, Chi Cheong Joe; Cheng, Ka Ho; Lam, Tracy; Chu, Susanna; Lam, Wing Yan; Wong, Kin Wai Kevin; Kwok, Dilys; Hung, Ching Yue Janice; Chan, Wai Kit Jacky; Wong, Wing Lam; Chung, Chun Kwong Eric; Ma, Shu Kai; Kaushik, Shuchi; Shah, Bhagyesh; Shah, Dhiren; Shah, Sanjay; Ar, Praburaj; Muthuchellappan, Radhakrishnan; Agarwal, Vandana; Divatia, Jigeeshu; Mishra, Sanghamitra; Nimje, Ganesh; Pande, Swati; Savarkar, Sukhada; Shrivastava, Aditi; Thomas, Martin; Yegnaram, Shashikant; Hidayatullah, Rahmat; Puar, Nasman; Niman, Sumara; Indra, Imai; Hamzah, Zulkarnain; Yuliana, Annika; Abidin, Ucu Nurhadiat; Dursin, Ade Nurkacan; Kurnia, Andri; Susanti, Ade; Handayani, Dini; Alit, Mahaalit Aribawa; Arya, Aryabiantara; Senapathi, Tjokorda Gde Agung; Utara, Utara Hartawan; Wid, Widnyana Made; Wima, Semarawima; Wir, Wiryana Made; Jehosua, Brillyan; Kaunang, Jonathan; Lantang, Eka Yudha; Najoan, Rini; Waworuntu, Neil; Awad, Hadi; Fuad, Akram; Geddoa, Burair; Khalaf, Abdel Razzaq; Al Hussaini, Sabah; Albaj, Safauldeensalem; Kenber, Maithem; Bettinelli, Alessandra; Spadaro, Savino; AlbertoVolta, Carlo; Giancarlo, Luigi; Sottosanti, Vicari; Copetti, Elisa; Spagnesi, Lorenzo; Toretti, Ilaria; Alloj, Chiara; Cardellino, Silvano; Carmino, Livio; Costanzo, Eleonora; Fanfani, Lucia Caterina; Novelli, Maria Teresa; Roasio, Agostino; Bellandi, Mattia; Beretta, Luigi; Bignami, Elena; Bocchino, Speranza; Cabrini, Luca; Corti, Daniele; Landoni, Giovanni; Meroni, Roberta; Moizo, Elena; Monti, Giacomo; Pintaudi, Margherita; Plumari, Valentina Paola; Taddeo, Daiana; Testa, Valentina; Winterton, Dario; Zangrillo, Alberto; Cloro, Luigi Maria; Colangelo, Chiara; Colangelo, Antonio; Rotunno, Giuseppe; Paludi, Miguel Angel; Maria, Cloro Paolo; Pata, Antonio; Parrini, Vieri; Gatta, Alessandro; Nastasi, Mauro; Tinti, Carla; Baroselli, Antonio; Arrigo, Mario; Benevento, Angelo; Bottini, Corrado; Cannavo', Maurizio; Gastaldi, Christian; Marchesi, Alessandro; Pascazio, Angelantonio; Pata, Francesco; Pozzi, Emilio; Premoli, Alberto; Tessera, Gaetano; Boschi, Luca; D'Andrea, Rocco; Ghignone, Federico; Poggioli, Gilberto; Sibilio, Andrea; Taffurelli, Mario; Ugolini, Giampaolo; Ab Majid, Mohd Azuan; Ab Rahman, Rusnah; Joseph, James; Pathan, Furquan; Sybil Shah, Mohammad Hafizshah; Yap, Huey Ling; Cheah, Seleen; Chin, Im Im; Looi, Ji Keon; Tan, Siew Ching; Visvalingam, Sheshendrasurian; Kwok, Fan Yin; Lee, Chew Kiok; Tan, Tse Siang; Wong, Sze Meng; Abdullah, Noor Hairiza; Liew, Chiat Fong; Luxuman, Lovenia; Mohd Zin, Nor Hafizah; Norddin, Muhamad Faiz; Raja Alias, Raja Liza; Wong, Juan Yong; Yong, Johnny; Bin Mustapha, Mohd Tarmimi; Chan, Weng Ken; Dzulkipli, Norizawati; Kuan, Pei Xuan; Lee, Yew Ching; Alias, Anita; Guok, Eng Ching; Jee, Chiun Chen; Ramon, Brian Rhadamantyne; Wong, Cheng Weng; Abd Ghafar, Fara Nur Idayu; Aziz, Faizal Zuhri; Hussain, Nabilah; Lee, Hooi Sean; Sukawi, Ismawaty; Woon, Yuan Liang; Abd Hadi, Husni Zaeem; Ahmad Azam, Ummi Azmira; Alias, Abdul Hafiz; Kesut, Saiful Aizar; Lee, Jun May; Ooi, Dar Vin; Sulaiman, Hetty Ayuni; Lih, Tengku Alini Tengku; Veerakumaran, Jeyaganesh; Rojas, Eder; Resendiz, Gerardo Esteban Alvarez; Zapata, Darcy Danitza Mari; López, Julio Cesar Jesús Aguilar; Flores, Armando Adolfo Alvarez; Amador, Juan Carlos Bravo; Avila, Erendira Jocelin Dominguez; Aquino, Laura Patricia González; Rodriguez, Ricardo Lopez; Landa, Mariana Torres; Urias, Emma; Hollmann, Markus; Hulst, Abraham; Preckel, Benedikt; Koopman-van Gemert, Ankie; Buise, Marc; Tolenaar, Noortje; Weber, Eric; de Fretes, Jennifer; Houweling, Peter; Ormskerk, Patricia; van Bommel, Jasper; Lance, Marcus; Smit-Fun, Valerie; van Zundert, Tom; Baas, Peter; Donald de Boer, Hans; Sprakel, Joost; Elferink-Vonk, Renske; Noordzij, Peter; van Zeggeren, Laura; Brand, Bastiaan; Spanjersberg, Rob; ten Bokkel-Andela, Janneke; Numan, Sandra; van Klei, Wilton; van Zaane, Bas; Boer, Christa; van Duivenvoorde, Yoni; Hering, Jens Peter; van Rossum, Sylvia; Zonneveldt, Harry; Campbell, Doug; Hoare, Siobhan; Santa, Sahayam; Ali, Marlynn; Allen, Sara Jane; Bell, Rachel; Choi, Hyun-Min David; Drake, Matthew; Farrell, Helen; Hayes, Katia; Higgie, Kushlin; Holmes, Kerry; Jenkins, Nicole; Kim, Chang Joon; Kim, Steven; Law, Kiew Chai; McAllister, Davina; Park, Karen; Pedersen, Karen; Pfeifer, Leesa; Pozaroszczyk, Anna; Salmond, Timothy; Steynor, Martin; Tan, Michael; Waymouth, Ellen; Ab Rahman, Ahmad Sufian; Armstrong, John; Dudson, Rosie; Jenkins, Nia; Nilakant, Jayashree; Richard, Seigne; Virdi, Pardeep; Dixon, Liane; Donohue, Roana; Farrow, Mehreen; Kennedy, Ross; Marissa, Henderson; McKellow, Margie; Nicola, Delany; Pascoe, Rebecca; Roberts, Stephen John; Rowell, George; Sumner, Matthew; Templer, Paul; Chandrasekharan, Shardha; Fulton, Graham; Jammer, Ib; More, Richard; Wilson, Leona; Chang, Yuan Hsuan; Foley, Julia; Fowler, Carolyn; Panckhurst, Jonathan; Sara, Rachel; Stapelberg, Francois; Cherrett, Veronica; Ganter, Donna Louise; McCann, Lloyd; Gilmour, Fiona; Lumsden, Rachelle; Moores, Mark; Olliff, Sue; Sardareva, Elitza; Tai, Joyce; Wikner, Matthew; Wong, Christopher; Chaddock, Mark; Czepanski, Carolyn; McKendry, Patrick; Polakovic, Daniel; Polakovich, Daniel; Robert, Axe; Belda, Margarita Tormo; Norton, Tracy; Alherz, Fadhel; Barneto, Lisa; Ramirez, Alberto; Sayeed, Ahmed; Smith, Nicola; Bennett, Cambell; McQuoid, Shane; Jansen, Tracy-Lee; Nico, Zin; Scott, John; Freschini, David; Freschini, Angela; Hopkins, Brian; Manson, Lara; Stoltz, Deon; Bates, Alexander; Davis, Simon; Freeman, Victoria; McGaughran, Lynette; Williams, Maya; Sharma, Swarna Baskar; Burrows, Tom; Byrne, Kelly; English, Duane; Johnson, Robert; Manikkam, Brendon; Naidoo, Shaun; Rumball, Margot; Whittle, Nicola; Franks, Romilla; Gibson-Lapsley, Hannah; Salter, Ryan; Walsh, Dean; Cooper, Richard; Perry, Katherine; Obobolo, Amos; Sule, Umar Musa; Ahmad, Abdurrahman; Atiku, Mamuda; Mohammed, Alhassan Datti; Sarki, Adamu Muhammad; Adekola, Oyebola; Akanmu, Olanrewaju; Durodola, Adekunle; Olukoju, Olusegun; Raji, Victor; Olajumoke, Tokunbo; Oyebamiji, Emmanuel; Adenekan, Anthony; Adetoye, Adedapo; Faponle, Folayemi; Olateju, Simeon; Owojuyigbe, Afolabi; Talabi, Ademola; Adenike, Odewabi; Adewale, Badru; Collins, Nwokoro; Ezekiel, Emmanuel; Fatungase, Oluwabunmi Motunrayo; Grace, Anuforo; Sola, Sotannde; Stella, Ogunmuyiwa; Ademola, Adeyinka; Adeolu, Augustine A.; Adigun, Tinuola; Akinwale, Mukaila; Fasina, Oluyemi; Gbolahan, Olalere; Idowu, Olusola; Olonisakin, Rotimi Peter; Osinaike, Babatunde Babasola; Asudo, Felicia; Mshelia, Danladi; Abdur-Rahman, Lukman; Agodirin, Olayide; Bello, Jibril; Bolaji, Benjamin; Oyedepo, Olanrewaju Olubukola; Ezike, Humphrey; Iloabachie, Ikechukwu; Okonkwo, Ikemefuna; Onuora, Elias; Onyeka, Tonia; Ugwu, Innocent; Umeh, Friday; Alagbe-Briggs, Olubusola; Dodiyi-Manuel, Amabra; Echem, Richard; Obasuyi, Bright; Onajin-Obembe, Bisola; Bandeira, Maria Expedito; Martins, Alda; Tomé, Miguel; Costa, Ana Cristina Miranda Martins; Krystopchuk, Andriy; Branco, Teresa; Esteves, Simao; Melo, Marco António; Monte, Júlia; Rua, Fernando; Martins, Isabel; Pinho-Oliveira, Vítor Miguel; Rodrigues, Carla Maria; Cabral, Raquel; Marques, Sofia; Rêgo, Sara; Jesus, Joana Sofia Teixeira; Marques, Maria Conceição; Romao, Cristina; Dias, Sandra; Santos, Ana Margarida; Alves, Maria Joao; Salta, Cristina; Cruz, Salome; Duarte, Célia; Paiva, António Armando Furtado; Cabral, Tiago do Nascimento; Faria E Maia, Dionisio; Correia da Silva, Rui Freitas Mendonça; Langner, Anuschka; Resendes, Hernâni Oliveira; Soares, Maria da Conceição; Abrunhosa, Alexandra; Faria, Filomena; Miranda, Lina; Pereira, Helena; Serra, Sofia; Ionescu, Daniela; Margarit, Simona; Mitre, Calin; Vasian, Horatiu; Manga, Gratiela; Stefan, Andreea; Tomescu, Dana; Filipescu, Daniela; Paunescu, Marilena-Alina; Stefan, Mihai; Stoica, Radu; Gavril, Laura; Pătrășcanu, Emilia; Ristescu, Irina; Rusu, Daniel; Diaconescu, Ciresica; Iosep, Gabriel Florin; Pulbere, Dorin; Ursu, Irina; Balanescu, Andreea; Grintescu, Ioana; Mirea, Liliana; Rentea, Irina; Vartic, Mihaela; Lupu, Mary-Nicoleta; Stanescu, Dorin; Streanga, Lavinea; Antal, Oana; Hagau, Natalia; Patras, Dumitru; Petrisor, Cristina; Tosa, Flaviu; Tranca, Sebastian; Copotoiu, Sanda Maria; Ungureanu, Liviu Lucian; Harsan, Cristian Remus; Papurica, Marius; Cernea, Daniela Denisa; Dragoescu, Nicoleta Alice; CarmenVaida, Laura Aflori; Ciobotaru, Oana Roxana; Aignatoaie, Mariana; Carp, Cristina Paula; Cobzaru, Isabelle; Mardare, Oana; Purcarin, Bianca; Tutunaru, Valentin; Ionita, Victor; Arustei, Mirela; Codita, Anisoara; Busuioc, Mihai; Chilinciuc, Ion; Ciobanu, Cristina; Belciu, Ioana; Tincu, Eugen; Blaj, Mihaela; Grosu, Ramona-Mihaela; Sandu, Gigel; Bruma, Dana; Corneci, Dan; Dutu, Madalina; Krepil, Adriana; Copaciu, Elena; Dumitrascu, Clementina Oana; Jemna, Ramona; Mihaescu, Florentina; Petre, Raluca; Tudor, Cristina; Ursache, Elena; Kulikov, Alexander; Lubnin, Andrey; Grigoryev, Evgeny; Pugachev, Stanislav; Tolmasov, Alexander; Hussain, Ayyaz; Ilyina, Yana; Roshchina, Anna; Iurin, Aleksandr; Chazova, Elena; Dunay, Artem; Karelov, Alexey; Khvedelidze, Irina; Voldaeva, Olga; Belskiy, Vladislav; Dzhamullaev, Parvin; Grishkowez, Elena; Kretov, Vladimir; Levin, Valeriy; Molkov, Aleksandr; Puzanov, Sergey; Samoilenko, Aleksandr; Tchekulaev, Aleksandr; Tulupova, Valentina; Utkin, Ivan; Allorto, Nikki Leigh; Bishop, David Gray; Builu, Pierre Monji; Cairns, Carel; Dasrath, Ashish; de Wet, Jacques; Hoedt, Marielle den; Grey, Ben; Hayes, Morgan Philip; Küsel, Belinda Senta; Shangase, Nomcebo; Wise, Robert; Cacala, Sharon; Farina, Zane; Govindasamy, Vishendran; Kruse, Carl-Heinz; Lee, Carolyn; Marais, Leonard; Naidoo, Thinagrin Dhasarthun; Rajah, Chantal; Rodseth, Reitze Nils; Ryan, Lisa; von Rhaden, Richard; Adam, Suwayba; Alphonsus, Christella; Ameer, Yusuf; Anderson, Frank; Basanth, Sujith; Bechan, Sudha; Bhula, Chettan; Biccard, Bruce M.; Biyase, Thuli; Buccimazza, Ines; Cardosa, Jorge; Chen, James; Daya, Bhavika; Drummond, Leanne; Elabib, Ali; Abdel Goad, Ehab Helmy; Goga, Ismail E.; Goga, Riaz; Harrichandparsad, R.; Hodgson, Richard E.; Jordaan, J.; Kalafatis, Nicky; Kampik, Christian; Landers, A. T.; Loots, Emil; Madansein, Rajhmum; Madaree, Anil; Madiba, Thandinkosi E.; Manzini, Vukani T.; Mbuyisa, Mbali; Moodley, Rajan; Msomi, Mduduzi; Mukama, Innocent; Naidoo, Desigan; Naidoo, Rubeshan; Naidu, Tesuven K.; Ntloko, Sindiswa; Padayachee, Eneshia; Padayachee, Lucelle; Phaff, Martijn; Pillay, Bala; Pillay, Desigan; Pillay, Lutchmee; Ramnarain, Anupa; Ramphal, Suren R.; Ryan, Paul; Saloojee, Ahmed; Sebitloane, Motshedisi; Sigcu, Noluyolo; Taylor, Jenna L.; Torborg, Alexandra; Visser, Linda; Anderson, Philip; Conradie, Alae; de Swardt, Mathew; de Villiers, Martin; Eikman, Johan; Liebenberg, Riaan; Mouton, Johan; Paton, Abbey; van der Merwe, Louwrence; Wilscott-Davids, Candice; Barrett, Wendy Joan; Bester, Marlet; de Beer, Johan; Geldenhuys, Jacques; Gouws, Hanni; Potgieter, Jan-Hendrik; Strydom, Magdel; WilberforceTurton, Edwin; Chetty, Rubendraj R.; Chirkut, Subash; Cronje, Larissa; de Vasconcellos, Kim; Dube, Nokukhanya Z.; Gama, N. Sibusiso; Green, Garyth M.; Green-Thompson, Randolph; Kinoo, Suman Mewa; Kistnasami, Prenolin; Maharaj, Kapil; Moodley, Manogaran S.; Mothae, Sibongile J.; Naidoo, Ruvashni; Aslam F Noorbhai, M.; Rughubar, Vivesh; Reddy, Jenendhiran; Singh, Avesh; Skinner, David L.; Smith, Murray J.; Singh, Bhagwan; Misra, Ravi; Naidoo, Maheshwar; Ramdharee, Pireshin; Selibea, Yvonne; Sewpersad, Selina; Sham, Shailendra; Wessels, Joseph D.; Africander, Cucu; Bejia, Tarek; Blakemore, Stephen P.; Botes, Marisa; Bunwarie, Bimalshakth; Hernandez, Carlos B.; Jeeraz, Mohammud A.; Legutko, Dagmara A.; Lopez, Acela G.; de Meyer, Jenine N.; Muzenda, Tanaka; Naidoo, Noel; Patel, Maryam; Pentela, Rao; Junge, Marina; Mansoor, Naj; Rademan, Lana; Scislowski, Pawel; Seedat, Ismail; van den Berg, Bianca; van der Merwe, Doreen; van Wyk, Steyn; Govender, Komalan; Naicker, Darshan; Ramjee, Rajesh; Saley, Mueen; Kuhn, Warren Paul; Matos-Puig, Roel; Alberto Lisi, Zaheer Moolla; Perez, Gisela; Beltran, Anna Valle; Lozano, Angels; Navarro, Carlos Delgado; Duca, Alejandro; Ernesto, Ernesto Pastor Martinez; Ferrando, Carlos; Fuentes, Isabel; García-Pérez, Maria Luisa; Gracia, Estefania; Palomares, Ana Izquierdo; Katime, Antonio; Miñana, Amanda; Incertis, Raul Raul; Romero, Esther; Romero Garcia, Carolina Soledad; Rubio, Concepcion; Artiles, Tania Socorro; Soro, Marina; Valls, Paola; Laguarda, Gisela Alaman; Benavent, Pau; Cuenca, Vicente Chisbert; Cueva, Andreu; Lafuente, Matilde; Parra, Asuncion Marques; Rodrigo, Alejandra Romero; Sanchez-Morcillo, Silvia; Tormo, Sergi; Redondo, Francisco Javier; de Andrés Ibanez, José Antonio; Diago, Lorena Gómez; José Hernández Cádiz, Maria; Manuel, Granell Gil; Peris, Raquel; Saiz, Cristina; Vivo, Jose Tatay; Soto, Maria Teresa Tebar; Brunete, Tamara; Cancho, David; Delgado García, David R.; Zamudio, Diana; del Valle, Santiago Garcia; Serrano, M. Luz; Alonso, Eduardo; Anillo, Victor; Maseda, Emilio; Salgado, Patricia; Suarez, Luis; Suarez-de-la-Rica, Alejandro; Villagrán, María José; Alonso, José Ignacio; Cabezuelo, Estefania; Garcia-Saiz, Irene; Lopez del Moral, Olga; Martín, Silvia; Gonzalez, Alba Perez; Doncel, Ma Sherezade Tovar; Vera, Martin Agüero; José Ávila Sánchez, Francisco; Castaño, Beatriz; Moreira, Beatriz Castaño; Risco, Sahely Flores; Martín, Daniel Paz; Martín, Fernando Pérez; Poza, Paloma; Ruiz, Adela; Serna Martínez, Wilson Fabio; Vicente, Bárbara Vázquez; Dominguez, Saul Velaz; Fernández, Salvador; Munoz-López, Alfonso; Bernat, Maria Jose; Mas, Arantxa; Planas, Kenneth; Jawad, Monir; Saeed, Yousif; Hedin, Annika; Levander, Helena; Holmström, Sandra; Lönn, David; Zoerner, Frank; Åkring, Irene; Widmark, Carl; Zettergren, Jan; Liljequist, Victor Aspelund; Nystrom, Lena; Odeberg-Wernerman, Suzanne; Oldner, Anders; Fagerlund, Malin Jonsson; Reje, Patrik; Lyckner, Sara; Sperber, Jesper; Adolfsson, Anne; Klarin, Bengt; Ögren, Katrin; Barras, Jean-Pierre; Bührer, Thomas; Despotidis, Vasileios; Helmy, Naeder; Holliger, Stephan; Raptis, Dimitri Aristotle; Schmid, Roger; Meyer, Antoine; Jaquet, Yves; Kessler, Ulf; Muradbegovic, Mirza; Nahum, Solange R.; Rotunno, Teresa; Schiltz, Boris; Voruz, François; Worreth, Marc; Christoforidis, Dimitri; Popeskou, Sotirios Georgios; Furrer, Markus; Prevost, Gian Andrea; Stocker, Andrea; Lang, Klaus; Breitenstein, Stefan; Ganter, Michael T.; Geisen, Martin; Soll, Christopher; Korkmaz, Michelle; Lubach, Iris; Schmitz, Michael; Meyer Zu Schwabedissen, Moritz; Moritz, Meyer Zu Schwabedissen; Zingg, Urs; Hillermann, Thomas; Wildi, Stefan; Pinto, Bernardo Bollen; Walder, Bernhard; Mariotti, Giustina; Slankamenac, Ksenija; Namuyuga, Mirioce; Kyomugisha, Edward; Kituuka, Olivia; Shikanda, Anne Wesonga; Kakembo, Nasser; Tom, Charles Otim; Antonina, Webombesa; Bua, Emmanuel; Ssettabi, Eden Michael; Epodoi, Joseph; Kabagenyi, Fiona; Kirya, Fred; Dempsey, Ged; Seasman, Colette; Nawaz Khan, Raja Basit; Kurasz, Claire; Macgregor, Mark; Shawki, Burhan; Francis, Daren; Hariharan, Vimal; Chau, Simon; Ellis, Kate; Butt, Georgina; Chicken, Dennis-Wayne; Christmas, Natasha; Allen, Samantha; Daniel, Gayatri Daniel; Dempster, Angie; Kemp, Juliette; Matthews, Lewis; Mcglone, Philip; Tambellini, Joanne; Trodd, Dawn; Freitas, Katie; Garg, Atul; Gupta, Janesh Kumar; Karpate, Shilpaja; Kulkarni, Aditi; O'Hara, Chloe; Troko, Jtroko; Angus, Kirsty; Bradley, Jacqueline; Brennan, Emma; Brooks, Carolyn; Brown, Janette; Brown, Gemma; Finch, Amanda; Gratrix, Karen; Hesketh, Sue; Hill, Gillian; Jeffs, Carol; Morgan, Maureen; Pemberton, Chris; Slawson, Nicola; Spickett, Helen; Swarbrick, Gemma; Thomas, Megan; van Duyvenvoorde, Greta; Brennan, Andrew; Briscoe, Richard; Cooper, Sarah; Lawton, Tom; Northey, Martin; Senaratne, Rashmi; Stanworth, Helen; Burrows, Lorna; Cain, Helen; Craven, Rachael; Davies, Keith; Jonas, Attila; Pachucki, Marcin; Walkden, Graham; Davies, Helen; Gudaca, Mariethel; Hobrok, Maria; Arawwawala, Dilshan; Fergey, Lauren; Gardiner, Matthew; Gunn, Jacqueline; Johnson, Lyndsay; Lofting, Amanda; Lyle, Amanda; Neela, Fiona Mc; Smolen, Susan; Topliffe, Joanne; Williams, Sarah; Bland, Martin; Balaji, Packianathaswamy; Kaura, Vikas; Lanka, Prasad; Smith, Neil; Ahmed, Ahmed; Myatt, John; Shenoy, Ravikiran; Soon, Wai Cheong; Tan, Jessica; Karadia, Sunny; Self, James; Durant, Emma; Tripathi, Shiva; Bullock, Clare; Campbell, Debbie; Ghosh, Alison; Hughes, Thomas; Zsisku, Lajos; Bengeri, Sheshagiri; Cowton, Amanda; Khalid, Mohammed Shazad; Limb, James; McAdam, Colin; Porritt, Mandy; Rafi, M. Amir; Shekar, Priya; Adams, David; Harden, Catherine; Hollands, Heidi; King, Angela; March, Linda; Minto, Gary; Patrick, Abigail; Squire, Rosalyn; Waugh, Darren; Kumara, Paramesh; Simeson, Karen; Yarwood, Jamie; Browning, Julie; Hatton, Jonathan; Julian, Howes; Mitra, Atideb; Newton, Maria; Pernu, Pawan Kootelu; Wilson, Alison; Commey, Thelma; Foot, Helen; Glover, Lyn; Gupta, Ajay; Lancaster, Nicola; Levin, Jill; Mackenzie, Felicity; Mestanza, Claire; Nofal, Emma; Pout, Lauren; Varden, Rosanna; Wild, Jonathan; Jones, Stephanie; Moreton, Sarah; Pulletz, Mark; Davies, Charlotte; Martin, Matthew; Thomas, Sian; Burns, Karen; McArthur, Carol; Patel, Panna; Lau, Gary; Rich, Natalie; Davis, Fiona; Lyons, Rachel; Port, Beth; Prout, Rachel; Smith, Christopher; Adelaja, Yemi; Bennett, Victoria; Bidd, Heena; Dumitrescu, Alexandra; Murphy, Jacqui Fox; Keen, Abigail; Mguni, Nhlanhla; Ong, Cheng; Adams, George; Boshier, Piers; Brown, Richard; Butryn, Izabella; Chatterjee, Jayanta; Freethy, Alexander; Lockwood, Geoffrey; Tsakok, Maria; Tsiligiannis, Sophia; Peat, William; Stephenson, Lorraine; Bradburn, Mike; Pick, Sara; Cunha, Pedro; Olagbaiye, Olufemi; Tayeh, Salim; Packianathaswamy, Balaji; Abernethy, Caroline; Balasubramaniam, Madhu; Bennett, Rachael; Bolton, David; Martinson, Victoria; Naylor, Charde; Bell, Stephanie; Heather, Blaylock; Kushakovsky, Vlad; Alcock, Liam; Alexander, Hazel; Anderson, Colette; Baker, Paul; Brookes, Morag; Cawthorn, Louise; Cirstea, Emanuel; Clarkson, Rachel; Colling, Kerry; Coulter, Ian; Das, Suparna; Haigh, Kathryn; Hamdan, Alhafidz; Hugill, Keith; Kottam, Lucksy; Lisseter, Emily; Mawdsley, Matthew; McGivern, Julie; Padala, Krishnaveni; Phelps, Victoria; Ramesh Kumar, Vineshykaa; Stewart, Kirsten; Towse, Kayley; Tregonning, Julie; Vahedi, Ali; Walker, Alycon; Baines, Duncan; Bilolikar, Anjali; Chande, Shiv; Copley, Edward; Dunk, Nigel; Kulkarni, Raghavendra; Kumar, Pawan; Metodiev, Yavor; Ncomanzi, Dumisani; Raithatha, Bhavesh; Raymode, Parizade; Szafranski, Jan; Twohey, Linda; Watt, Philip; Weatherall, Lucie; Weatherill, J.; Whitman, Zoe; Wighton, Elinor; Abayasinghe, Chamika; Chan, Alexander; Darwish, Sharif; Gill, James; Glasgow, Emma; Hadfield, Daniel; Harris, Clair; Hopkins, Phil; Kochhar, Arun; Kunst, Gudrun; Mellis, Clare; Pool, Andrew; Riozzi, Paul; Selman, Andrew; Smith, Emma-Jane; Vele, Liana; Gercek, Yuksel; Guy, Kramer; Holden, Douglas; Watson, Nicholas; Whysall, Karen; Andreou, Prematie; Hales, Dawn; Thompson, Jonathan; Bowrey, Sarah; McDonald, Shara; Gilmore, Jemma; Hills, Vicky; Kelly, Chan; Kelly, Sinead; Lloyd, Geraint; Abbott, Tom; Gall, Lewis; Torrance, Hew; Vivian, Mark; Berntsen, Emer; Nolan, Tracey; Turner, Angus; Vohra, Akbar; Brown, Andrew; Clark, Richard; Coughlan, Elaine; Daniel, Conway; Patvardhan, Chinmay; Pearson, Rachel; Predeep, Sheba; Saad, Hesham; Shanmugam, Mohanakrishnan; Varley, Simon; Wylie, Katharine; Cooper, Lucy; Makowski, Arystarch; Misztal, Beata; Moldovan, Eliza; Pegg, Claire; Donovan, Andrew; Foot, Jayne; Large, Simon; Claxton, Andrew; Netke, Bhagyashree; Armstrong, Richard; Calderwood, Claire; Kwok, Andy; Mohr, Otto; Oyeniyi, Peter; Patnaik, Lisa; Post, Benjamin; Ali, Sarah; Arshad, Homa; Baker, Gerard; Brenner, Laura; Brincat, Maximilian; Brunswicker, Annemarie; Cox, Hannah; Cozar, Octavian Ionut; Cheong, Edward; Durst, Alexander; Fengas, Lior; Flatt, Jim; Glister, Georgina; Narwani, Vishal; Photi, Evangelos; Rankin, Adeline; Rosbergen, Melissa; Tan, Mark; Beaton, Ceri; Horn, Rachel; Hunt, Jane; Rousseau, Guy; Stancombe, Lucia; Absar, Mohammed; Allsop, Joanne; Drinkwater, Zoe; Hodgkiss, Tracey; Smith, Kirsty; Brown, Jamie; Alexander-Sefre, Farhad; Campey, Lorraine; Dudgeon, Lucy; Hall, Kathryn; Hitchcock, Rachael; James, Lynne; Smith, Kate; Winstone, Ulrika; Ahmad, Norfaizan; Bauchmuller, Kris; Harrison, Jonathan; Jeffery, Holly; Miller, Duncan; Pinder, Angela; Pothuneedi, Sailaja; Rosser, Jonathan; Sanghera, Sumayer; Swift, Diane; Walker, Rachel; Bester, Delia; Cavanagh, Sarah; Cripps, Heather; Daniel, Harvey; Lynch, Julie; Paton, Alison; Pyke, Shirley; Scholefield, John; Whitworth, Helen; Bottrill, Fiona; Ramalingam, Ganesh; Webb, Stephen; Akerman, Nik; Antill, Philip; Bourner, Lynsey; Buckley, Sarah; Castle, Gail; Charles, Rob; Eggleston, Christopher; Foster, Rebecca; Gill, Satwant; Lindley, Kate; Lklouk, Mohamed; Lowery, Tracey; Martin, Oliver; Milne, David; O'Connor, Patrick; Ratcliffe, Andrew; Rose, Alastair; Smith, Annie; Varma, Sandeep; Ward, Jackie; Barcraft-Barnes, Helena; Camsooksai, Julie; Colvin, Carolyn; Reschreiter, Henrik; Tbaily, Lee; Venner, Nicola; Hamilton, Caroline; Kelly, Lewis; Toth-Tarsoly, Piroska; Dodsworth, Kerry; Foord, Denise; Gordon, Paul; Hawes, Elizabeth; Lamb, Nikki; Mouland, Johanna; Nightingale, Jeremy; Rose, Steve; Schrieber, Joe; Al'Amri, Khalid; Aladin, Hafiz; Arshad, Mohammed Asif; Barraclough, James; Bentley, Conor; Bergin, Colin; Carrera, Ronald; Clarkson, Aisling; Collins, Michelle; Cooper, Lauren; Denham, Samuel; Griffiths, Ewen; Ip, Peter; Jeyanthan, Somasundaram; Joory, Kavita; Kaur, Satwant; Marriott, Paul; Mitchell, Natalie; Nagaiah, Sukumar; Nilsson, Annette; Parekh, Nilesh; Pope, Martin; Seager, Joseph; Serag, Hosam; Tameem, Alifia; Thomas, Anna; Thunder, Joanne; Torrance, Andrew; Vohra, Ravinder; Whitehouse, Arlo; Wong, Tony; Blunt, Mark; Wong, Kate; Giles, Julian; Reed, Isabelle; Weller, Debbie; Bell, Gillian; Birch, Julie; Damant, Rose; Maiden, Jane; Mewies, Clare; Prince, Claire; Radford, Jane; Reynolds, Tim; Balain, Birender; Banerjee, Robin; Barnett, Andrew; Burston, Ben; Davies, Kirsty; Edwards, Jayne; Evans, Chris; Ford, David; Gallacher, Pete; Hill, Simon; Jaffray, David; Karlakki, Sudheer; Kelly, Cormac; Kennedy, Julia; Kiely, Nigel; Lewthwaite, Simon; Marquis, Chris; Ockendon, Matthew; Phillips, Stephen; Pickard, Simon; Richardson, James; Roach, Richard; Smith, Tony; Spencer-Jones, Richard; Steele, Niall; Steen, Julie; van Liefland, Marck; White, Steve; Faulds, Matthew; Harris, Meredyth; Kelly, Carrie; Nicol, Scott; Pearson, Sally Anne; Chukkambotla, Srikanth; Andrew, Alyson; Attrill, Elizabeth; Campbell, Graham; Datson, Amanda; Fouracres, Anna; Graterol, Juan; Graves, Lynne; Hong, Bosun; Ishimaru, Alexander; Karthikeyan, Arvind; King, Helen; Lawson, Tom; Lee, Gregory; Lyons, Saoirse; Hall, Andrew Macalister; Mathoulin, Sophie; Mcintyre, Eilidh; Mclaughlin, Danny; Mulcahy, Kathleen; Paddle, Jonathan; Ratcliffe, Anna; Robbins, James; Sung, Weilin; Tayo, Adeoluwa; Trembath, Lisa; Venugopal, Suneetha; Walker, Robert; Wigmore, Geoffrey; Boereboom, Catherine; Downes, Charlotte; Humphries, Ryan; Melbourne, Susan; Smith, Coral; Tou, Samson; Ullah, Shafa; Batchelor, Nick; Boxall, Leigh; Broomby, Rupert; Deen, Tariq; Hellewell, Alistair; Helliwell, Laurence; Hutchings, Melanie; Hutchins, David; Keenan, Samantha; Mackie, Donna; Potter, Alison; Smith, Frances; Stone, Lucy; Thorpe, Kevin; Wassall, Richard; Woodgate, Andrew; Baillie, Shelley; Campbell, Tara; James, Sarah; King, Chris; Marques de Araujo, Daniela; Martin, Daniel; Morkane, Clare; Neely, Julia; Rajendram, Rajkumar; Burton, Megan; James, Kathryn; Keevil, Edward; Minik, Orsolya; Morgan, Jenna; Musgrave, Anna; Rajanna, Harish; Roberts, Tracey; Adamson, Michael; Jumbe, Sandra; Kendall, Jennie; Muthuswamy, Mohan Babu; Anderson, Charlotte; Cruikshanks, Andrew; Wrench, Ian; Zeidan, Lisa; Ardern, Diane; Harris, Benjamin; Hellstrom, Johanna; Martin, Jane; Thomas, Richard; Varsani, Nimu; Brown, Caroline Wrey; Docherty, Philip; Gillies, Michael; McGregor, Euan; Usher, Helen; Craig, Jayne; Smith, Andrew; Ahmad, Tahania; Bodger, Phoebe; Creary, Thais; Fowler, Alexander; Hewson, Russ; Ijuo, Eke; Jones, Timothy; Kantsedikas, Ilya; Lahiri, Sumitra; McLean, Aaron Lawson; Niebrzegowska, Edyta; Phull, Mandeep; Wang, Difei; Wickboldt, Nadine; Baldwin, Jacqueline; Doyle, Donna; Mcmullan, Sean; Oladapo, Michelle; Owen, Thomas; Williams, Alexandra; Daniel, Hull; Gregory, Peter; Husain, Tauqeer; Kirk-Bayley, Justin; Mathers, Edward; Montague, Laura; Harper, Mark; White, Stuart; Jack, James; Ridley, Carrie; Avis, Joanne; Cook, Tim; Dali-Kemmery, Lola; Kerslake, Ian; Lambourne, Victoria; Pearson, Annabel; Boyd, Christine; Callaghan, Mark; Lawson, Cathy; McCrossan, Roopa; Nesbitt, Vanessa; O'connor, Laura; Scott, Julia; Sinclair, Rhona; Farid, Nahla; Morgese, Ciro; Bhatia, Kailash; Karmarkar, Swati; Ahmed, Jamil; Branagan, Graham; Hutton, Monica; Swain, Andrew; Brookes, Jamie; Cornell, Jonathan; Dolan, Rachael; Hulme, Jonathan; Jansen van Vuuren, Amanda; Jowitt, Tom; Kalashetty, Gunasheela; Lloyd, Fran; Patel, Kiran; Sherwood, Nicholas; Brown, Lynne; Chandler, Ben; Deighton, Kerry; Emma, Temlett; Haunch, Kirsty; Cheeseman, Michelle; Dent, Kathy; Garg, Sanjeev; Gray, Carol; Hood, Marion; Jones, Dawn; Juj, Joanne; Rao, Roshan; Walker, Tara; Al Anizi, Mashel; Cheah, Clarissa; Cheing, Yushio; Coutinho, Francisco; Gondo, Prisca; Hadebe, Bernard; Hove, Mazvangu Onie; Khader, Ahamed; Krishnachetty, Bobby; Rhodes, Karen; Sokhi, Jagdish; Baker, Katie-Anne; Bertram, Wendy; Looseley, Alex; Mouton, Ronelle; Hanna, George; Arnold, Glenn; Arya, Shobhit; Balfoussia, Danai; Baxter, Linden; Harris, James; Jones, Craig; Knaggs, Alison; Markar, Sheraz; Perera, Anisha; Scott, Alasdair; Shida, Asako; Sirha, Ravneet; Wright, Sally; Frost, Victoria; Gray, Catherine; Andrews, Emma; Arrandale, Lindsay; Barrett, Stephen; Cifra, Elna; Cooper, Mariese; Dragnea, Dragos; Elna, Cifra; Maclean, Jennifer; Meier, Sonja; Milliken, Donald; Munns, Christopher; Ratanshi, Nadir; Ramessur, Suneil; Salvana, Abegail; Watson, Anthony; Ali, Hani; Campbell, Gill; Critchley, Rebecca; Endersby, Simon; Hicks, Catherine; Liddle, Alison; Pass, Marc; Ritchie, Charlotte; Thomas, Charlotte; Too, Lingxi; Welsh, Sarah; Gill, Talvinder; Johnson, Joanne; Reed, Joanne; Davis, Edward; Papadopoullos, Sam; Attwood, Clare; Biffen, Andrew; Boulton, Kerenza; Gray, Sophie; Hay, David; Mills, Sarah; Montgomery, Jane; Riddell, Rory; Simpson, James; Bhardwaj, Neeraj; Paul, Elaine; Uwubamwen, Nosakhare; Alexander, Maini; Arrich, James; Arumugam, Swarna; Blackwood, Douglas; Boggiano, Victoria; Brown, Robyn; Chan, Yik Lam; Chatterjee, Devnandan; Chhabra, Ashok; Christian, Rachel; Costelloe, Hannah; Matthewman, Madeline Coxwell; Dalton, Emma; Darko, Julia; Davari, Maria; Dave, Tejal; Deacon, Matthew; Deepak, Shantal; Edmond, Holly; Ellis, Jessica; El-Sayed, Ahmed; Eneje, Philip; English, Rose; Ewe, Renee; Foers, William; Franklin, John; Gallego, Laura; Garrett, Emily; Goldberg, Olivia; Goss, Harry; Greaves, Rosanna; Harris, Rudy; Hennings, Charles; Jones, Eleanor; Kamali, Nelson; Kokkinos, Naomi; Lewis, Carys; Lignos, Leda; Malgapo, Evaleen Victoria; Malik, Rizwana; Milne, Andrew; Mulligan, John-Patrick; Nicklin, Philippa; Palipane, Natasha; Parsons, Thomas; Piper, Rebecca; Prakash, Rohan; Ramesh, Byron; Rasip, Sarah; Reading, Jacob; Rela, Mariam; Reyes, Anna; Stephens, Robert; Rooms, Martin; Shah, Karishma; Simons, Henry; Solanki, Shalil; Spowart, Emma; Stevens, Amy; Thomas, Christopher; Waggett, Helena; Yassaee, Arrash; Kennedy, Anthony; Scott, Sara; Somanath, Sameer; Berg, Andrew; Hernandez, Miguel; Nanda, Rajesh; Tank, Ghanshyambhai; Wilson, Natalie; Wilson, Debbie; Al-Soudaine, Yassr; Baldwin, Matthew; Cornish, Julie; Davies, Zoe; Davies, Leigh; Edwards, Marc; Frewer, Natasha; Gallard, Sian; Glasbey, James; Harries, Rhiannon; Hopkins, Luke; Kim, Taeyang; Koompirochana, Vilavan; Lawson, Simon; Lewis, Megan; Makzal, Zaid; Scourfield, Sarah; Ahmad, Yousra; Bates, Sarah; Blackwell, Clare; Bryant, Helen; Collins, Hannah; Coulter, Suzanne; Cruickshank, Ross; Daniel, Sonya; Daubeny, Thomas; Edwards, Mark; Golder, Kim; Hawkins, Lesley; Helen, Bryant; Hinxman, Honor; Levett, Denny; Salmon, Karen; Seaward, Leanne; Skinner, Ben; Tyrell, Bryony; Wadams, Beverley; Walsgrove, Joseph; Dickson, Jane; Constantin, Kathryn; Karen, Markwell; O'Brien, Peter; O'Donohoe, Lynn; Payne, Hannah; Sundayi, Saul; Walker, Elaine; Brooke, Jenny; Cardy, Jon; Humphreys, Sally; Kessack, Laura; Kubitzek, Christiane; Kumar, Suhas; Cotterill, Donna; Hodzovic, Emil; Hosdurga, Gurunath; Miles, Edward; Saunders, Glenn; Campbell, Marta; Chan, Peter; Jemmett, Kim; Raj, Ashok; Naik, Aditi; Oshowo, Ayo; Ramamoorthy, Rajarajan; Shah, Nimesh; Sylvan, Axel; Blyth, Katharine; Burtenshaw, Andrew; Freeman, David; Johnson, Emily; Lo, Philip; Martin, Terry; Plunkett, Emma; Wollaston, Julie; Allison, Joanna; Carroll, Christine; Craw, Nicholas; Craw, Sarah; Pitt-Kerby, Tressy; Rowland-Axe, Rebecca; Spurdle, Katie; McDonald, Andrew; Simon, Davies; Sinha, Vivek; Smith, Thomas; Banner-Goodspeed, Valerie; Boone, Myles; Campbell, Kathleen; Lu, Fengxin; Scannell, Joseph; Sobol, Julia; Balajonda, Naraida; Clemmons, Karen; Conde, Carlos; Elgasim, Magdi; Funk, Bonita; Hall, Roger; Hopkins, Thomas; Olaleye, Omowunmi; Omer, Omer; Pender, Michelle; Porto, Angelo; Stevens, Alice; Waweru, Peter; Yeh, Erlinda; Bodansky, Daniella; Evans, Adam; Kleopoulos, Steven; Maril, Robert; Mathney, Edward; Sanchez, Angela; Tinuoye, Elizabeth; Bateman, Brian; Eng, Kristen; Jiang, Ning; Ladha, Karim; Needleman, Joseph; Chen, Lee-Lynn; Lane, Rondall; Robinowitz, David; Ghushe, Neil; Irshad, Mariam; O'Connor, John; Patel, Samir; Takemoto, Steven; Wallace, Art; Mazzeffi, Michael; Rock, Peter; Wallace, Karin; Zhu, Xiaomao; Chua, Pandora; Mattera, Matthew; Sharar, Rebecca; Thilen, Stephan; Treggiari, Miriam; Morgan, Angela; Sofjan, Iwan; Subramaniam, Kathirvel; Avidan, Michael; Maybrier, Hannah; Muench, Maxwell; Wildes, Troy

    2018-01-01

    The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of

  4. Care of cancer patients at the end of life in a German university hospital: A retrospective observational study from 2014.

    Directory of Open Access Journals (Sweden)

    Burkhard Dasch

    Full Text Available Cancer care including aggressive treatment procedures during the last phase of life in patients with incurable cancer has increasingly come under scrutiny, while integrating specialist palliative care at an early stage is regarded as indication for high quality end-of-life patient care.To describe the demographic and clinical characteristics and the medical care provided at the end of life of cancer patients who died in a German university hospital.Retrospective cross-sectional study on the basis of anonymized hospital data for cancer patients who died in the Munich University Hospital in 2014. Descriptive analysis and multivariate logistic regression analyses for factors influencing the administration of aggressive treatment procedures at the end of life.Overall, 532 cancer patients died. Mean age was 66.8 years, 58.5% were men. 110/532 (20.7% decedents had hematologic malignancies and 422/532 (79.3% a solid tumor. Patients underwent the following medical interventions in the last 7/30 days: chemotherapy (7.7%/38.3%, radiotherapy (2.6%/6.4%, resuscitation (8.5%/10.5%, surgery (15.2%/31.0%, renal replacement therapy (12.0%/16.9%, blood transfusions (21.2%/39.5%, CT scan (33.8%/60.9%. In comparison to patients with solid tumors, patients with hematologic malignancies were more likely to die in intensive care (25.4% vs. 49.1%; p = 0.001, and were also more likely to receive blood transfusions (OR 2.21; 95% CI, 1.36 to 3.58; p = 0.001 and renal replacement therapy (OR 2.65; 95% CI, 1.49 to 4.70; p = 0.001 in the last 7 days of life. Contact with the hospital palliative care team had been initiated in 161/532 patients (30.3%. In 87/161 cases (54.0%, the contact was initiated within the last week of the patient's life.Overambitious treatments are still reality at the end of life in cancer patients in hospital but patients with solid tumors and hematologic malignancies have to be differentiated. More efforts are necessary for the timely inclusion of

  5. Airway management by physician-staffed Helicopter Emergency Medical Services - a prospective, multicentre, observational study of 2,327 patients.

    Science.gov (United States)

    Sunde, Geir Arne; Heltne, Jon-Kenneth; Lockey, David; Burns, Brian; Sandberg, Mårten; Fredriksen, Knut; Hufthammer, Karl Ove; Soti, Akos; Lyon, Richard; Jäntti, Helena; Kämäräinen, Antti; Reid, Bjørn Ole; Silfvast, Tom; Harm, Falko; Sollid, Stephen J M

    2015-08-07

    Despite numerous studies on prehospital airway management, results are difficult to compare due to inconsistent or heterogeneous data. The objective of this study was to assess advanced airway management from international physician-staffed helicopter emergency medical services. We collected airway data from 21 helicopter emergency medical services in Australia, England, Finland, Hungary, Norway and Switzerland over a 12-month period. A uniform Utstein-style airway template was used for collecting data. The participating services attended 14,703 patients on primary missions during the study period, and 2,327 (16 %) required advanced prehospital airway interventions. Of these, tracheal intubation was attempted in 92 % of the cases. The rest were managed with supraglottic airway devices (5 %), bag-valve-mask ventilation (2 %) or continuous positive airway pressure (0.2 %). Intubation failure rates were 14.5 % (first-attempt) and 1.2 % (overall). Cardiac arrest patients showed significantly higher first-attempt intubation failure rates (odds ratio: 2.0; 95 % CI: 1.5-2.6; p < 0.001) compared to non-cardiac arrest patients. Complications were recorded in 13 %, with recognised oesophageal intubation being the most frequent (25 % of all patients with complications). For non-cardiac arrest patients, important risk predictors for first-attempt failure were patient age (a non-linear association) and administration of sedatives (reduced failure risk). The patient's sex, provider's intubation experience, trauma type (patient category), indication for airway intervention and use of neuromuscular blocking agents were not risk factors for first-attempt intubation failure. Advanced airway management in physician-staffed prehospital services was performed frequently, with high intubation success rates and low complication rates overall. However, cardiac arrest patients showed significantly higher first-attempt failure rates compared to non-cardiac arrest patients. All

  6. Colchicum autumnale in Patients with Goitre with Euthyroidism or Mild Hyperthyroidism: Indications for a Therapeutic Regulative Effect?Results of an Observational Study

    OpenAIRE

    Scheffer, Christian; Debus, Marion; Heckmann, Christian; Cysarz, Dirk; Girke, Matthias

    2016-01-01

    Introduction. Goitre with euthyroid function or with subclinical or mild hyperthyroidism due to thyroid autonomy is common. In anthroposophic medicine various thyroid disorders are treated with Colchicum autumnale (CAU). We examined the effects of CAU in patients with goitre of both functional states. Patients and methods. In an observational study, 24 patients with goitre having suppressed thyroid stimulating hormone (TSH) levels with normal or slightly elevated free thyroxine (fT4) and free...

  7. Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study.

    Science.gov (United States)

    Miravitlles, Marc; Worth, Heinrich; Soler Cataluña, Juan José; Price, David; De Benedetto, Fernando; Roche, Nicolas; Godtfredsen, Nina Skavlan; van der Molen, Thys; Löfdahl, Claes-Göran; Padullés, Laura; Ribera, Anna

    2014-10-21

    Few studies have investigated the 24-hour symptom profile in patients with COPD or how symptoms during the 24-hour day are inter-related. This observational study assessed the prevalence, severity and relationship between night-time, early morning and daytime COPD symptoms and explored the relationship between 24-hour symptoms and other patient-reported outcomes. The study enrolled patients with stable COPD in clinical practice. Baseline night-time, early morning and daytime symptoms (symptom questionnaire), severity of airflow obstruction (FEV1), dyspnoea (modified Medical Research Council Dyspnoea Scale), health status (COPD Assessment Test), anxiety and depression levels (Hospital Anxiety and Depression Scale), sleep quality (COPD and Asthma Sleep Impact Scale) and physical activity level (sedentary, moderately active or active) were recorded. The full analysis set included 727 patients: 65.8% male, mean ± standard deviation age 67.2 ± 8.8 years, % predicted FEV1 52.8 ± 20.5%. In each part of the 24-hour day, >60% of patients reported experiencing ≥1 symptom in the week before baseline. Symptoms were more common in the early morning and daytime versus night-time (81.4%, 82.7% and 63.0%, respectively). Symptom severity was comparable for each period assessed. Overall, in the week before baseline, 56.7% of patients had symptoms throughout the whole 24-hour day (3 parts of the day); 79.9% had symptoms in ≥2 parts of the 24-hour day. Symptoms during each part of the day were inter-related, irrespective of disease severity (all p < 0.001). Early morning and daytime symptoms were associated with the severity of airflow obstruction (p < 0.05 for both). Night-time, early morning and daytime symptoms were all associated with worse dyspnoea, health status and sleep quality, and higher anxiety and depression levels (all p < 0.001 versus patients without symptoms in each corresponding period). In each part of the 24-hour day, there was also an association between

  8. Incidence and Risk Factors of Refeeding Syndrome in Head and Neck Cancer Patients-An Observational Study.

    Science.gov (United States)

    Rasmussen, Stine Ostenfeldt; Kristensen, Marianne Boll; Wessel, Irene; Andersen, Jens Rikardt

    2016-01-01

    This study aimed to determine the incidence rates of refeeding phenomena (defined as a decline in p-phosphate) and refeeding syndrome (RFS; defined as development of clinical symptoms in addition to a decline in p-phosphate) in head and neck cancer patients, and to identify risk factors. Fifty-four head and neck cancer patients referred for surgery were included. Forty-six potential risk factors were registered at the baseline, and p-phosphate was measured at Days 2, 4, and 7. Eleven patients (20%) developed RFS, and twenty-eight (52%) developed refeeding phenomena. At baseline, these patients presented a higher prevalence of head and neck pain, eating difficulties, higher p-phosphate levels, lower p-transferrin levels, and, in men, lower b-hemoglobin levels. Patients who developed symptoms had a decline in p-phosphate ≥0.22 mmol/l. At baseline, these patients had higher p-phosphate levels, higher alcohol consumption, and lower p-transferrin and p-sodium levels, as well as a higher prevalence of eating difficulties, low handgrip strength (HGS), and a history of radiation therapy. The risk factors most strongly associated with the development of refeeding phenomena and RFS were pain, eating difficulties, low HGS, high alcohol intake, and previous radiation therapy.

  9. Methotrexate intolerance in oral and subcutaneous administration in patients with juvenile idiopathic arthritis: a cross-sectional, observational study.

    Science.gov (United States)

    van Dijkhuizen, E H Pieter; Pouw, Juliëtte N; Scheuern, Andrea; Hügle, Boris; Hardt, Sven; Ganser, Gerd; Kümmerle-Deschner, Jasmin Beate; Horneff, Gerd; Holzinger, Dirk; Bulatović Ćalasan, Maja; Wulffraat, Nico M

    2016-01-01

    Methotrexate (MTX) is the cornerstone disease-modifying anti-rheumatic drug (DMARD) in juvenile idiopathic arthritis (JIA). In Dutch patients, MTX intolerance occurred frequently and was associated with subcutaneous (SC) administration. The aim of this study was to assess the prevalence of MTX intolerance and its association with the route of administration in a German cohort of JIA patients. A cross-sectional study of JIA patients on MTX was performed. Primary outcome was MTX intolerance, which was determined using the validated Methotrexate Intolerance Severity Score (MISS) questionnaire. The prevalence of gastrointestinal adverse effects and MTX intolerance was compared between patients on MTX SC and MTX administered orally (PO). Of 179 JIA patients on MTX, 73 (40.8%) were intolerant. The odds of MTX intolerance were higher in patients using MTX exclusively SC compared to exclusively PO (adjusted odds ratio 3.37 [95% confidence interval 1.19-10.0]). There was strong evidence that the former experienced more behavioural complaints (76.1% vs. 47.4%, p=0.001) and weak evidence that they experienced more abdominal pain after MTX intake (43.5% vs. 27.4%, p=0.056). The prevalence of MTX intolerance was high and exclusively SC administration of MTX was associated with MTX intolerance and behavioural adverse effects. The prevalence of gastrointestinal adverse effects was at least as high as in patients on MTX PO. The frequently held assumption that SC causes fewer side effects than PO seems unwarranted. Definite answers about the differences between SC and PO administration with respect to safety and efficacy should be obtained by randomised trials.

  10. The medical necessity for medicinal cannabis: prospective, observational study evaluating the treatment in cancer patients on supportive or palliative care.

    Science.gov (United States)

    Bar-Sela, Gil; Vorobeichik, Marina; Drawsheh, Saher; Omer, Anat; Goldberg, Victoria; Muller, Ella

    2013-01-01

    Background. Cancer patients using cannabis report better influence from the plant extract than from synthetic products. However, almost all the research conducted to date has been performed with synthetic products. We followed patients with a medicinal cannabis license to evaluate the advantages and side effects of using cannabis by cancer patients. Methods. The study included two interviews based on questionnaires regarding symptoms and side effects, the first held on the day the license was issued and the second 6-8 weeks later. Cancer symptoms and cannabis side effects were documented on scales from 0 to 4 following the CTCAE. The distress thermometer was used also. Results. Of the 211 patients who had a first interview, only 131 had the second interview, 25 of whom stopped treatment after less than a week. All cancer or anticancer treatment-related symptoms showed significant improvement (P cannabis use (P = 0.002) were noted. Conclusion. The positive effects of cannabis on various cancer-related symptoms are tempered by reliance on self-reporting for many of the variables. Although studies with a control group are missing, the improvement in symptoms should push the use of cannabis in palliative treatment of oncology patients.

  11. Gentamicin serum concentrations in patients with gentamicin-PMMA beads for infected hip joints : A prospective observational cohort study

    NARCIS (Netherlands)

    De Klaver, Paul A.G.; Hendriks, Johannes G.E.; Van Onzenoort, Hein A.W.; Schreurs, Berend W.; Touw, Daan J.; Derijks, Luc J.J.

    Background: Gentamicin-polymethylmethacrylate (PMMA) beads release gentamicin gradually, and high concentrations develop only locally. It is unclear how frequent and in which patients gentamicin serum concentrations are measurable and possibly lead to toxicity. The aim of this study was to

  12. The influence of body composition on therapeutic hypothermia: a prospective observational study of patients after cardiac arrest

    NARCIS (Netherlands)

    Jimmink, Joost J.; Binnekade, Jan M.; Paulus, Frederique; Mathus-Vliegen, Lisbeth M. H.; Schultz, Marcus J.; Vroom, Margreeth B.

    2008-01-01

    Introduction Patients after out-of-hospital cardiac arrest (OHCA) benefit from therapeutic hypothermia for 24 hours. The time needed to reach hypothermia (target temperature of 32 degrees C to 34 degrees C) varies widely. In this study, we explore the relation between measures of body composition

  13. Frequency of GP communication addressing the patient's resources and coping strategies in medical interviews: a video-based observational study

    Directory of Open Access Journals (Sweden)

    Finset Arnstein

    2009-07-01

    Full Text Available Abstract Background There is increasing focus on patient-centred communicative approaches in medical consultations, but few studies have shown the extent to which patients' positive coping strategies and psychological assets are addressed by general practitioners (GPs on a regular day at the office. This study measures the frequency of GPs' use of questions and comments addressing their patients' coping strategies or resources. Methods Twenty-four GPs were video-recorded in 145 consultations. The consultations were coded using a modified version of the Roter Interaction Analysis System. In this study, we also developed four additional coding categories based on cognitive therapy and solution-focused therapy: attribution, resources, coping, and solution-focused techniques. The reliability between coders was established, a factor analysis was applied to test the relationship between the communication categories, and a tentative validating exercise was performed by reversed coding. Results Cohen's kappa was 0.52 between coders. Only 2% of the utterances could be categorized as resource or coping oriented. Six GPs contributed 59% of these utterances. The factor analysis identified two factors, one task oriented and one patient oriented. Conclusion The frequency of communication about coping and resources was very low. Communication skills training for GPs in this field is required. Further validating studies of this kind of measurement tool are warranted.

  14. The degree of local inflammatory response after colonic resection depends on the surgical approach: an observational study in 61 patients.

    Science.gov (United States)

    Glatz, Torben; Lederer, Ann-Kathrin; Kulemann, Birte; Seifert, Gabriel; Holzner, Philipp Anton; Hopt, Ulrich Theodor; Hoeppner, Jens; Marjanovic, Goran

    2015-10-06

    Clinical data indicate that laparoscopic surgery reduces postoperative inflammatory response and benefits patient recovery. Little is known about the mechanisms involved in reduced systemic and local inflammation and the contribution of reduced trauma to the abdominal wall and the parietal peritoneum. Included were 61 patients, who underwent elective colorectal resection without intraabdominal complications; 17 received a completely laparoscopic, 13 a laparoscopically- assisted procedure and 31 open surgery. Local inflammatory response was quantified by measurement of intraperitoneal leukocytes and IL-6 levels during the first 4 days after surgery. There was no statistical difference between the groups in systemic inflammatory parameters and intraperitoneal leukocytes. Intraperitoneal interleukin-6 was significantly lower in the laparoscopic group than in the laparoscopically-assisted and open group on postoperative day 1 (26.16 versus 43.25 versus 40.83 ng/ml; p = 0.001). No difference between the groups was recorded on POD 2-4. Intraperitoneal interleukin-6 showed a correlation with duration of hospital stay on POD 1 (0.233, p = 0.036), but not on POD 2-4. Patients who developed a surgical wound infection showed higher levels of intraperitoneal interleukin-6 on postoperative day 2-4 (POD 2: 42.56 versus 30.02 ng/ml, p = 0.03), POD 3: 36.52 versus 23.62 ng/ml, p = 0.06 and POD 4: 34.43 versus 19.99 ng/ml, p = 0.046). Extraabdominal infections had no impact. The analysis shows an attenuated intraperitoneal inflammatory response on POD 1 in completely laparoscopically-operated patients, associated with a quicker recovery. This effect cannot be observed in patients, who underwent a laparoscopically-assisted or open procedure. Factors inflicting additional trauma to the abdominal wall and parietal peritoneum promote the intraperitoneal inflammation process.

  15. The prognosis of incurable cachectic cancer patients on home parenteral nutrition: a multi-centre observational study with prospective follow-up of 414 patients

    NARCIS (Netherlands)

    Bozzetti, F.; Santarpia, L.; Pironi, L.; Thul, P.; Klek, S.; Gavazzi, C.; Tinivella, M.; Joly, F.; Jonkers, C.; Baxter, J.; Gramlich, L.; Chicharro, L.; Staun, M.; van Gossum, A.; Lo Vullo, S.; Mariani, L.

    2014-01-01

    The role of home parenteral nutrition (HPN) in incurable cachectic cancer patients unable to eat is extremely controversial. The aim of this study is to analyse which factors can influence the outcome. We studied prospectively 414 incurable cachectic (sub)obstructed cancer patients receiving HPN and

  16. Lung cancer development in patients with connective tissue disease-related interstitial lung disease: A retrospective observational study.

    Science.gov (United States)

    Enomoto, Yasunori; Inui, Naoki; Yoshimura, Katsuhiro; Nishimoto, Koji; Mori, Kazutaka; Kono, Masato; Fujisawa, Tomoyuki; Enomoto, Noriyuki; Nakamura, Yutaro; Iwashita, Toshihide; Suda, Takafumi

    2016-12-01

    Previous studies have reported that patients with idiopathic pulmonary fibrosis occasionally develop lung cancer (LC). However, in connective tissue disease (CTD)-related interstitial lung disease (ILD), there are few data regarding the LC development. The aim of the present study was to evaluate the clinical significance of LC development in patients with CTD-ILD. A retrospective review of our database of 562 patients with ILD between 2000 and 2014 identified 127 patients diagnosed with CTD-ILD. The overall and cumulative incidences of LC were calculated. In addition, the risk factors and prognostic impact of LC development were evaluated. The median age at the ILD diagnosis was 63 years (range 37-84 years), and 73 patients (57.5%) were female. The median follow-up period from the ILD diagnosis was 67.4 months (range 10.4-322.1 months). During the period, 7 out of the 127 patients developed LC (overall incidence 5.5%). The cumulative incidences at 1, 3, and 5 years were 0.0%, 1.8%, and 2.9%, respectively. The risk of LC development was significantly higher in patients with higher smoking pack-year (odds ratio [OR] 1.028; 95% confidence interval [CI] 1.008-1.049; P = 0.007) and emphysema on chest high-resolution computed tomography (OR 14.667; 95% CI 2.871-74.926; P = 0.001). The median overall survival time after developing LC was 7.0 months (95% CI 4.9-9.1 months), and the most common cause of death was LC, not ILD. According to the Cox proportional hazard model analysis with time-dependent covariates, patients who developed LC showed significantly poorer prognosis than those who did not (hazard ratio 87.86; 95% CI 19.56-394.67; P < 0.001). In CTD-ILD, clinicians should be careful with the risk of LC development in patients with a heavy smoking history and subsequent emphysema. Although not so frequent, the complication could be a poor prognostic determinant.

  17. CLINICAL AND HEMATOLOGICAL PROFILE OF PATIENTS WITH DENGUE FEVER AT A TERTIARY CARE HOSPITAL – AN OBSERVATIONAL STUDY

    Directory of Open Access Journals (Sweden)

    Vishal Vishnu Tewari

    2018-03-01

    Full Text Available Abstract Background: Dengue is a major health issue with seasonal rise in dengue fever cases imposing an additional burden on hospitals, necessitating bolstering of services in the emergency department, laboratory with creation of additional dengue fever wards. Objectives: To study the clinical and hematological profile of dengue fever cases presenting to a hospital. Methods: Patients with fever and other signs of dengue with either positive NS1 antigen test or IgM or IgG antibody were included. Age, gender, clinical presentation, platelet count and hematocrit were noted and patients classified as dengue fever (DF, dengue hemorrhagic fever (DHF or dengue shock syndrome (DSS. Duration of hospitalization, bleeding manifestations, requirement for platelet component support and mortality were recorded. Results: There were 443 adults and 57 children between 6 months to 77 year age. NS1 was positive in 115 patients (23%. Fever (99.8% and severe bodyache (97.4% were the commonest presentation. DF was seen in 484 (96.8 %, DHF in 10 (2% and DSS in 6 cases (1.2%. OPD treatment was needed in 412 (82% and hospitalization in 88 (18%. Intravenous fluid resuscitation was needed in 16 (3.2% patients. Thrombocytopenia was seen in 335 (67% patients at presentation. Platelet transfusion was needed in 46 (9.2%. PRC transfusion was given in 3 patients with DF and 10 of DHF. Death occurred in 03 DSS and 2 DHF patients. Conclusions: Majority of DF cases can be managed on OPD basis. DHF and DSS carry high mortality. Hospitals can analyze annual data for resource allocation for capacity expansion.

  18. The association of infrared imaging findings of the breast with prognosis in breast cancer patients: an observational cohort study

    International Nuclear Information System (INIS)

    Wu, Li-An; Kuo, Wen-Hung; Chen, Chin-Yu; Tsai, Yuh-Show; Wang, Jane

    2016-01-01

    To evaluate whether infrared (IR) imaging findings are associated with prognosis in patients with invasive breast carcinomas. This study was approved by the institutional review board of the research ethics committee of our hospital, and all participants gave written informed consent. From March 2005 to June 2007, we enrolled 143 patients with invasive breast cancer that underwent preoperative IR imaging. We used five IR signs to interpret breast IR imaging. Cox proportional hazards model was used to evaluate the effect of IR signs on long-term mortality. During a median follow-up of 2451 days (6.7 years), 31 patients died. Based on the Cox Proportional Hazards Model, IR1 sign (the temperature of cancer site minus that of the contralateral mirror imaging site) was positively associated with mortality in the univariate analysis (overall mortality hazard ratio [HR], 2.29; p = 0.03; disease-specific mortality HR, 2.57; p = 0.04) as well as the multivariate analysis after controlling for clinicopathological factors (overall mortality HR, 3.85; p = 0.01; disease-specific mortality HR, 3.91, p = 0.02). In patients with clinical stage I and II disease, IR1 was also positively associated with mortality (overall mortality HR, 3.76; p = 0.03; disease-specific mortality HR, 4.59; p = 0.03). Among patients with node-negative disease, IR1 and IR5 (asymmetrical thermographic pattern) were associated with mortality (p = 0.04 for both IR1 and IR5, chi-squared test). Breast IR findings are associated with mortality in patients with invasive breast carcinomas. The association remained in patients with node-negative disease. ClinicalTrials.gov: NCT00166998

  19. Hypothyrodism in male patients: a descriptive, observational and cross-sectional study in a series of 260 men.

    Science.gov (United States)

    Iglesias, Pedro; Díez, Juan J

    2008-10-01

    Several aspects of thyroid dysfunction have not been fully characterized in large series of male patients. Our aim was to investigate the etiology and clinical features of hypothyroidism and assess the adequacy of replacement therapy in men attending an endocrinology clinic. We studied a group of 260 men (mean (+/-standard deviation) age 58.3 +/- 16.1 years) periodically seen because of thyroid hypofunction. We evaluated the etiology of hypothyroidism, presence or absence of goiter, time of evolution from diagnosis, current thyroid autoimmunity and thyroid functional status, and adequacy of disease control. Overt hypothyroidism was found in 182 (70.0%) and subclinical hypothyroidism in 78 (30.0%) patients. Autoimmune thyroiditis was the most frequent etiology (n = 107, 41.2%). Of these, 96 (89.7%) showed no goiter. Thyroid peroxidase antibodies were measured in 238 patients, being positive in 129 (54.2%) and negative in 109 (45.8%) patients. After excluding patients with thyroid carcinoma and those with recently diagnosed hypothyroidism, we found an adequate control of thyroid function, ie, normal thyrotropin and free thyroxine levels, in 95 patients (64.2%). Adequacy of treatment did not show any relationship with age, age at diagnosis, etiology, and autoimmune status. However, adequacy was significantly related to the degree of thyroid hypofunction (P < 0.001) and to the duration of disease (P < 0.01). We conclude that autoimmune thyroiditis, mainly the nongoitrous form, and postoperative hypothyroidism are the foremost causes of thyroid hypofunction in male patients. Adequacy of replacement treatment seems to be mainly related to the degree of thyroid hypofunction and the time from starting therapy.

  20. Incidence and Risk Factors for Delirium among Mechanically Ventilated Patients in an African Intensive Care Setting: An Observational Multicenter Study

    Directory of Open Access Journals (Sweden)

    Arthur Kwizera

    2015-01-01

    Full Text Available Aim. Delirium is common among mechanically ventilated patients in the intensive care unit (ICU. There are little data regarding delirium among mechanically ventilated patients in Africa. We sought to determine the burden of delirium and associated factors in Uganda. Methods. We conducted a multicenter prospective study among mechanically ventilated patients in Uganda. Eligible patients were screened daily for delirium using the confusional assessment method (CAM-ICU. Comparisons were made using t-test, chi-squares, and Fisher’s exact test. Predictors were assessed using logistic regression. The level of statistical significance was set at P<0.05. Results. Of 160 patients, 81 (51% had delirium. Median time to onset of delirium was 3.7 days. At bivariate analysis, history of mental illness, sedation, multiorgan dysfunction, neurosurgery, tachypnea, low mean arterial pressure, oliguria, fevers, metabolic acidosis, respiratory acidosis, anaemia, physical restraints, marital status, and endotracheal tube use were significant predictors. At multivariable analysis, having a history of mental illness, sedation, respiratory acidosis, higher PEEP, endotracheal tubes, and anaemia predicted delirium. Conclusion. The prevalence of delirium in a young African population is lower than expected considering the high mortality. A history of mental illness, anaemia, sedation, endotracheal tube use, and respiratory acidosis were factors associated with delirium.

  1. Postural and Balance Disorders in Patients with Parkinson's Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment

    Science.gov (United States)

    Santamato, Andrea; Ranieri, Maurizio; Cinone, Nicoletta; Stuppiello, Lucia Anna; Valeno, Giovanni; De Sanctis, Jula Laura; Fortunato, Francesca; Solfrizzi, Vincenzo; Greco, Antonio; Seripa, Davide; Panza, Francesco

    2015-01-01

    Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson's disease (PD) to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy) for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients. PMID:26798551

  2. Postural and Balance Disorders in Patients with Parkinson’s Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment

    Directory of Open Access Journals (Sweden)

    Andrea Santamato

    2015-01-01

    Full Text Available Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson’s disease (PD to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients.

  3. [Prospective observational study of insulin detemir in patients with poorly controlled type 2 diabetes mellitus initiating insulin therapy for the first time (SOLVE Study)].

    Science.gov (United States)

    Orozco-Beltrán, Domingo; Artola-Menéndez, Sara

    2016-02-01

    Describe the experience in the primary care setting with insulin detemir in patients with poorly controlled type2 diabetes mellitus that need to add-on insulin to their oral antidiabetic drug therapy. Prospective observational study of 6 months of follow up, performed in 10 countries. In Spain, participating sites were only from the primary care setting. Eligible patients were those with poorly controlled type2 diabetes mellitus adding-on once-daily insulin detemir to their existing oral antidiabetic therapy in the month prior to their enrollment. The change of Hb1Ac and of weight at the end of the study and the incidence of hypoglycemia and adverse reactions, were analyzed. We report the results obtained in the Spanish cohort. Overall 17,374 patients were included, 973 in Spain [mean age 64.8 years (SE 12); duration of diabetes 9.4 years (SE 6.2); Hb1Ac 8.9% (DE 1.4)]. In the sample analyzed for efficacy (n=474) the mean change of Hb1Ac was -1.6% (95%CI: -1.75 to -1.42; P<.001), mean change of weight was -2.9 kg (95%CI: -3.72 to -2.08; P<.001). Only one episode of severe hypoglycemia was reported, which was also the only serious adverse reaction reported in the study. The incidence rate of non-severe hypoglycemia was 2.44 events/patient-year. In this cohort of patients with type 2 diabetes mellitus receiving newly initiated insulin therapy, once-daily detemir improved the glycemic control, with low incidence of hypoglycemia and a significant reduction of the weight. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

  4. Quality of life, treatment satisfaction and efficacy of non-biological systemic therapies in patients with plaque psoriasis: study protocol for a prospective observational study.

    Science.gov (United States)

    Fink, Christine; Schank, Timo E; Trenkler, Nina; Uhlmann, Lorenz; Schäkel, Knut

    2017-06-30

    Psoriasis vulgaris often leads to a significant impaired quality of life and dissatisfaction with the existing therapeutic approaches. However, patients' quality of life and treatment satisfaction are of utmost importance, since it is positively related to therapy adherence and encourages patient's compliance. The study described herein evaluates the quality of life, treatment satisfaction and efficacy during the initial 6 months of treatment with a non-biological systemic agent in a real-life clinical setting. This observational study compares quality of life, treatment satisfaction and the efficacy of non-biological systemic therapy between 60 patients suffering from plaque psoriasis receiving the non-biological systemic therapies with apremilast, methotrexate and fumaric acid esters. Ethics approval was provided by the ethics committee of the medical faculty of the University of Heidelberg. Ethics approval number is S-298/2015. The design and the final results of the study will be published and made available to the public. German Clinical Trial Register (DRKS): DRKS00008721 (https://www.germanctr.de/). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  5. Acute and long-term dysphagia in critically ill patients with severe sepsis: results of a prospective controlled observational study.

    Science.gov (United States)

    Zielske, Joerg; Bohne, Silvia; Brunkhorst, Frank M; Axer, Hubertus; Guntinas-Lichius, Orlando

    2014-11-01

    Dysphagia is a major risk factor for morbidity and mortality in critically ill patients treated in intensive care units (ICUs). Structured otorhinolaryngological data on dysphagia in ICU survivors with severe sepsis are missing. In a prospective study, 30 ICU patients with severe sepsis and thirty without sepsis as control group were examined using bedside fiberoptic endoscopic evaluation of swallowing after 14 days in the ICU (T1) and 4 months after onset of critical illness (T2). Swallowing dysfunction was assessed using the Penetration-Aspiration Scale (PAS). The Functional Oral Intake Scale was applied to evaluate the diet needed. Primary endpoint was the burden of dysphagia defined as PAS score >5. At T1, 19 of 30 severe sepsis patients showed aspiration with a PAS score >5, compared to 7 of 30 in critically ill patients without severe sepsis (p = 0.002). Severe sepsis and tracheostomy were independent risk factors for severe dysphagia with aspiration (PAS > 5) at T1 (p = 0.042 and 0.006, respectively). 4-month mortality (T2) was 57 % in severe sepsis patients compared to 20 % in patients without severe sepsis (p = 0.006). At T2, more severe sepsis survivors were tracheostomy-dependent and needed more often tube or parenteral feeding (p = 0.014 and p = 0.040, respectively). Multivariate analysis revealed tracheostomy at T1 as independent risk factor for severe dysphagia at T2 (p = 0.030). Severe sepsis appears to be a relevant risk factor for long-term dysphagia. An otorhinolaryngological evaluation of dysphagia at ICU discharge is mandatory for survivors of severe critical illness to plan specific swallowing rehabilitation programs.

  6. Association between painful physical symptoms and clinical outcomes in East Asian patients with major depressive disorder: a 3-month prospective observational study.

    Science.gov (United States)

    Ang, Q Q; Wing, Y K; He, Y; Sulaiman, A H; Chiu, N-Y; Shen, Y-C; Wang, G; Zhang, C; Lee, K-H; Singh, P; Granger, R E; Raskin, J; Dossenbach, M

    2009-07-01

    Reports from non-Asian populations indicate that painful physical symptoms (PPS) are associated with poorer clinical and functional outcomes in major depressive disorder (MDD). The purpose of this study is to report comparative changes in disease severity, treatment patterns and quality of life observed in East Asian patients with MDD, with and without PPS, as assessed prospectively over a 3-month observation period. This observational study enrolled 909 patients with MDD in psychiatric care settings in China, Hong Kong, Korea, Malaysia, Singapore and Taiwan. Patients were classified as PPS positive (PPS+) or negative (PPS-) based on mean modified Somatic Symptom Inventory scores of >or= 2 or Depression Rating Scale (HAMD(17)) determined depression severity; a visual analogue scale (VAS) determined pain severity; and the EuroQoL (EQ-5D) assessed well-being after 3 months observation. Of the 909 enrollees, 355/471 (75.4%) of PPS+ patients and 363/438 (82.9%) of PPS- patients completed the study (p = 0.006). PPS+ patients improved less than PPS- patients on depression, pain and quality of life measures during the study (HAMD(17) p < 0.001, CGI-S p < 0.001, VAS p = 0.008 and EQ-5D p = 0.004). Fewer PPS+ patients (46.5%) achieved remission compared with PPS- patients (69.4%, p < 0.001). As the presence of PPS is associated with poorer outcomes in East Asian MDD patients, clinical management should aim to address both the mental and PPS associated with MDD.

  7. Paradigm-shift: radiological changes in the asymptomatic iNPH-patient to be: an observational study.

    Science.gov (United States)

    Engel, D C; Adib, S D; Schuhmann, M U; Brendle, C

    2018-02-09

    Many radiological signs are known for the diagnosis of idiopathic normal pressure hydrocephalus (iNPH). However, there is little information about these signs in the pre-symptomatic phase. For pathophysiological investigative purposes we conducted a descriptive image analysis study on pre-symptomatic patients. Patients that had contact with either the neurological or neurosurgical department of the university hospital Tuebingen from 2010 through 2016 with magnetic resonance images > 3 years before onset of symptoms, were included. The date of onset and severity of symptoms, date of first imaging and birth date were recorded. Evan's index (EI), width of the third ventricle (3VW), tight high convexity (THC), Sylvian fissure, extent of white matter hyperintensities and aqueductal flow were assessed in images before and around symptom onset. Ten patients were included. In all ten patients the first symptom was gait disturbance. Nine of ten pre-symptomatic images showed classic signs for iNPH. EI showed a significant increase between the pre-symptomatic and symptomatic phase. 3VW showed a trend for increase without significance. THC changed back and forth over time within some patients. In accordance with the scarce literature available, radiological changes are present at least 3 years before onset of iNPH-symptoms. EI seems to be a robust measure for pre-symptomatic radiological changes. Extrapolating the data, the development of iNPH typical changes might be an insidious process and the development of THC might be a variable and non-linear process. Further studies with larger sample sizes are necessary to put these findings into the pathophysiological perspective for the development of iNPH.

  8. Evaluation of nonmemory cognitive parameters in psychiatric patients? pre- and post-electroconvulsive therapy: An observational study

    OpenAIRE

    Prakash, Jyoti; Srivastava, Kalpana; Manandhar, Pradeep; Saha, Amitabh

    2015-01-01

    Introduction: Possibility of cognitive side effects has made electroconvulsive therapy (ECT) questionable. Variable deficits have been debated in memory cognition. Pattern of changes in nonmemory cognition pre- and post-ECT is not clear. Methodology: Forty patients undergoing ECT were studied on nonmemory cognitive parameters before ECT, after a course of ECT, and after 4 weeks of last. ECT. Results: Nonmemory cognition improved during the course of ECT and over 4 weeks of ECT. Co...

  9. Japanese study of tofogliflozin with type 2 diabetes mellitus patients in an observational study of the elderly (J-STEP/EL): A 12-week interim analysis.

    Science.gov (United States)

    Utsunomiya, Kazunori; Shimmoto, Naoki; Senda, Masayuki; Kurihara, Yuji; Gunji, Ryoji; Kameda, Hiroyuki; Tamura, Masahiro; Mihara, Hanako; Kaku, Kohei

    2016-09-01

    Sodium-glucose co-transporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, but are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing surveillance of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus and here report the results of a 12-week interim analysis, focusing on adverse drug reactions of special interest. The present prospective observational study included all type 2 diabetes mellitus patients aged ≥65 years who started tofogliflozin during the first 3 months after its launch. Data on demographic and baseline characteristics, clinical course and adverse events were collected. Of 1,535 patients registered, 1,506 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis at 12 weeks. A total of 178 of 1,506 patients (11.82%) had at least one adverse drug reaction to tofogliflozin. The incidence of adverse drug reactions of special interest (polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, skin disorders and hypoglycemia) was 2.19, 2.32, 1.33, 1.13, 1.46 and 0.73%, respectively. No new safety concerns were identified. Among those evaluable for clinical effectiveness, the mean (standard deviation) glycated hemoglobin decreased from 7.65% (1.35%) at baseline to 7.25% (1.16%) at 12 weeks by 0.39% (0.94%; P type 2 diabetes mellitus during the early post-marketing period. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  10. Person-centred interactions between nurses and patients during medication activities in an acute hospital setting: qualitative observation and interview study.

    Science.gov (United States)

    Bolster, Danielle; Manias, Elizabeth

    2010-02-01

    There is increasing emphasis on person-centred care within the literature and the health care context. It is suggested that a person-centred approach to medication activities has the potential to improve patient experiences and outcomes. This study set out to examine how nurses and patients interact with each other during medication activities in an acute care environment with an underlying philosophy of person-centred care. A qualitative approach was used comprising naturalistic observation and semi-structured interviews. The study setting was an acute care ward with a collaboratively developed philosophy of person-centre care, in an Australian metropolitan hospital. Eleven nurses of varying levels of experience were recruited to participate in observations and interviews. Nurses were eligible to participate if they were employed on the study ward in a role that incorporated direct patient care, including medication activities. A stratified sampling technique ensured that nurses with a range of years of clinical experience were represented. Patients who were being cared for by participating nurses during the observation period were recruited to participate unless they met the following exclusion criteria: those less than 18 years of age, non-English speaking patients, and those who were unable to give informed consent. Twenty-five patients were observed and 16 of those agreed to be interviewed. The results of the study generated insights into the nature of interactions between nurses and patients where person-centred care is the underlying philosophy of care. Three major themes emerged from the findings: provision of individualised care, patient participation and contextual barriers to providing person-centred care. While the participating nurses valued a person-centred approach and perceived that they were conducting medication activities in a person-centred way, some nurse-patient interactions during medication activities were centred on routines rather than

  11. The ICTUS Study: A Prospective longitudinal observational study of 1,380 AD patients in Europe. Study design and baseline characteristics of the cohort.

    NARCIS (Netherlands)

    Reynish, E.; Cortes, F.; Andrieu, S.; Cantet, C.; Olde Rikkert, M.G.M.; Melis, R.J.F.; Froelich, L.; Frisoni, G.B.; Jonsson, L.; Visser, P.J.; Ousset, P.J.; Vellas, B.

    2007-01-01

    The long-term objective of the ICTUS study is to identify milestones in Alzheimer's disease (AD) progression and to develop a model to predict disease course in individual AD patients in Europe. The secondary objectives are to describe the patterns of prescribing, and the socioeconomic impact of AD

  12. [Comparison between Endoscopic Therapy and Medical Therapy in Peptic Ulcer Patients with Adherent Clot: A Multicenter Prospective Observational Cohort Study].

    Science.gov (United States)

    Kim, Si Hye; Jung, Jin Tae; Kwon, Joong Goo; Kim, Eun Young; Lee, Dong Wook; Jeon, Seong Woo; Park, Kyung Sik; Lee, Si Hyung; Park, Jeong Bae; Ha, Chang Yoon; Park, Youn Sun

    2015-08-01

    The optimal management of bleeding peptic ulcer with adherent clot remains controversial. The purpose of this study was to compare clinical outcome between endoscopic therapy and medical therapy. We also evaluated the risk factors of rebleeding in Forrest type IIB peptic ulcer. Upper gastrointestinal (UGI) bleeding registry data from 8 hospitals in Korea between February 2011 and December 2013 were reviewed and categorized according to the Forrest classification. Patients with acute UGI bleeding from peptic ulcer with adherent clots were enrolled. Among a total of 1,101 patients diagnosed with peptic ulcer bleeding, 126 bleedings (11.4%) were classified as Forrest type IIB. Of the 126 patients with adherent clots, 84 (66.7%) received endoscopic therapy and 42 (33.3%) were managed with medical therapy alone. The baseline characteristics of patients in two groups were similar except for higher Glasgow Blatchford Score and pre-endoscopic Rockall score in medical therapy group. Bleeding related mortality (1.2% vs.10%; p=0.018) and all cause mortality (3.7% vs. 20.0%; p=0.005) were significantly lower in the endoscopic therapy group. However, there was no difference between endoscopic therapy and medical therapy regarding rebleeding (7.1% vs. 9.5%; p=0.641). In multivariate analysis, independent risk factors of rebleeding were previous medication with aspirin and/or NSAID (OR, 13.1; p=0.025). In patients with Forrest type IIB peptic ulcer bleeding, endoscopic therapy was associated with a significant reduction in bleeding related mortality and all cause mortality compared with medical therapy alone. Important risk factor of rebleeding was use of aspirin and/or NSAID.

  13. Changes in albuminuria and renal outcome in patients with type 2 diabetes and hypertension: a real-life observational study.

    Science.gov (United States)

    Viazzi, Francesca; Ceriello, Antonio; Fioretto, Paola; Giorda, Carlo; Guida, Pietro; Russo, Giuseppina; Greco, Eulalia; De Cosmo, Salvatore; Pontremoli, Roberto

    2018-04-19

    To assess the predictive role of changes in albuminuria on the loss of renal function under antihypertensive treatment in patients with type 2 diabetes (T2D). Clinical records from a total of 12 611 patients with hypertension and T2D, attending 100 antidiabetic centers in Italy, with normal estimated glomerular filtration rate (eGFR) at baseline and regular visits during a 4-year period were retrieved and analyzed. We assessed the association between changes in albuminuria status during a 1-year baseline period and time updated blood pressure (BP) and eGFR loss over the subsequent 4-year follow-up. Mean age at baseline was 65 ± 9 years, known duration of diabetes11 ± 8 years, eGFR 85 ± 13 ml/min and BP 142 ± 17/81 ± 9 mmHg. Patients with persistent albuminuria showed the highest 4-year risk of eGFR loss more than 30% from baseline or onset of stage 3 chronic kidney disease (eGFR < 60 ml/min) as compared with those with persistent normal albuminuria (odds ratio 2.00, confidence interval 1.71-2.34; P < 0.001). Female sex, age, disease duration, BMI, low baseline eGFR, lipid profile, the number of antihypertensive drugs and variations in albuminuria status were associated with renal risk in the whole study population. Furthermore, lower time updated BP values and the use of renin-angiotensin-aldosterone-system-inhibitors were related to the occurrence of renal endpoints only in the subgroup of patients without albuminuria. In patients with hypertension and T2D under real-life clinical conditions, changes in albuminuria parallel changes of renal risk. Albuminuria status could be a guide to optimize therapeutic strategy.

  14. A multicentre observational study for early diagnosis of Gaucher disease in patients with Splenomegaly and/or Thrombocytopenia.

    Science.gov (United States)

    Motta, Irene; Filocamo, Mirella; Poggiali, Erika; Stroppiano, Marina; Dragani, Alfredo; Consonni, Dario; Barcellini, Wilma; Gaidano, Gianluca; Facchini, Luca; Specchia, Giorgina; Cappellini, Maria Domenica

    2016-04-01

    Gaucher disease (GD) is the most common lysosomal disorder resulting from deficient activity of the β-glucosidase enzyme that causes accumulation of glucosylceramide in the macrophage-monocyte system. Notably, because of non-specific symptoms and a lack of awareness, patients with GD experience long diagnostic delays. The aim of this study was to apply a diagnostic algorithm to identify GD type 1 among adults subjects referred to Italian haematology outpatient units because of splenomegaly and/or thrombocytopenia and, eventually, to estimate the prevalence of GD in this selected population. One hundred and ninety-six subjects (61 females, 135 males; mean age 47.8 ± 18.2 years) have been enrolled in the study and tested for β-glucosidase enzyme activity on dried blood spot (DBS). Seven of 196 patients have been diagnosed with GD, (5 females and 2 males) with mean age 31.8 ± 8.2 years, with a prevalence of 3.6% (with a prevalence of 3.6% (I95% CI 1.4-7.2; 1/28 patients) in this population. These results show that the use of an appropriate diagnostic algorithm and a simple diagnostic method, such as DBS, are important tools to facilitate the diagnosis of a rare disease even for not disease-expert physicians. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. Neuron-Specific Enolase Is Correlated to Compromised Cerebral Metabolism in Patients Suffering from Acute Bacterial Meningitis; An Observational Cohort Study

    DEFF Research Database (Denmark)

    Bartek, Jiri; Thelin, Eric Peter; Ghatan, Per Hamid

    2016-01-01

    between day 1 (0-24 h) and day 3 (48-72 h) after admission to the NICU (p = 0.0001). No correlation between MD parameters or biomarkers and outcome was found. CONCLUSION: In this observational cohort study, we were able to show that cerebral metabolism is frequently affected in patients with ABM...... in combination with serum samples of biomarkers indicating brain tissue injury, S100B and Neuron Specific Enolase (NSE), additional information might be provided. The aim of this study was to evaluate biomarkers in serum and MD parameters in patients with ABM. METHODS: From a prior study on patients (n = 52......) with a confirmed ABM and impaired consciousness (GCS ≤ 9, or GCS = 10 combined with lumbar spinal opening pressure > 400 mmH2O), a subgroup of patients (n = 21) monitored with intracerebral MD and biomarkers was included in the present study. All patients were treated in the NICU with intracranial pressure (ICP...

  16. Prehospital triage of patients diagnosed with perforated peptic ulcer or peptic ulcer bleeding: an observational study of patients calling 1-1-2.

    Science.gov (United States)

    Bonnesen, Kasper; Friesgaard, Kristian D; Boetker, Morten T; Nikolajsen, Lone

    2018-04-05

    Triage systems are used in emergency medical services to systematically prioritize prehospital resources according to individual patient conditions. Previous studies have shown cases of preventable deaths in emergency medical services even when triage systems are used, indicating a potential undertriage among some conditions. The aim of this study was to investigate the triage level among patients diagnosed with perforated peptic ulcer (PPU) or peptic ulcer bleeding (PUB). In a three-year period in Central Denmark Region, all patients hospitalized within 24 h after a 1-1-2 emergency call and who subsequently received either a PPU or a PUB (hereinafter combined and referred to as PPU/PUB) or a First Hour Quintet (FHQ: respiratory failure, stroke, trauma, cardiac chest pain, and cardiac arrest) diagnosis were investigated. A modified Poisson regression was used to estimate the relative risk of receiving the highest and lowest prehospital response level. Also, a linear regression analysis was used to estimate the relative risk of 30-day mortality. Of 8658 evaluated patients, 263 were diagnosed with PPU/PUB. After adjusting for relevant confounding variables, patients diagnosed with PPU/PUB were less likely to receive ambulance transportation compared to patients diagnosed with stroke, RR = 1.41 (CI: 1.28-1.56); trauma, RR = 1.28 (CI: 1.15-1.42); cardiac chest pain, RR = 1.47 (CI: 1.33-1.62); and cardiac arrest, RR = 1.44 (CI: 1.31-1.42). Among patients diagnosed with PPU/PUB, 6.5% (CI: 3.3-9.7) did not receive ambulance transportation. The proportion of patients not receiving ambulance transportation was higher among patients diagnosed with PPU/PUB compared to patients diagnosed with an FHQ diagnosis. The 30-day mortality rate among patients diagnosed with PPU/PUB was 7.8% (CI: 4.2-11.1). This was lower than the 30-day mortality rate among patients diagnosed with respiratory failure (P = 0.010), stroke (P = 0.001), and cardiac arrest (P

  17. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study.

    Science.gov (United States)

    Carroccio, Antonio; Soresi, Maurizio; D'Alcamo, Alberto; Sciumè, Carmelo; Iacono, Giuseppe; Geraci, Girolamo; Brusca, Ignazio; Seidita, Aurelio; Adragna, Floriana; Carta, Miriam; Mansueto, Pasquale

    2014-11-28

    Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the spectrum of gluten-related disorders. No data are available on the prevalence of low bone mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS patients and search for correlations with other clinical characteristics. This prospective observation study included 75 NCWS patients (63 women; median age 36 years) with irritable bowel syndrome (IBS)-like symptoms, 65 IBS and 50 celiac controls. Patients were recruited at two Internal Medicine Departments. Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent BMD assessment by Dual Energy X-Ray Absorptiometry (DXA), duodenal histology, HLA DQ typing, body mass index (BMI) evaluation and assessment for daily calcium intake. DBPC cow's milk proteins challenge showed that 30 of the 75 NCWS patients suffered from multiple food sensitivity. Osteopenia and osteoporosis frequency increased from IBS to NCWS and to celiac disease (CD) (P <0.0001). Thirty-five NCWS patients (46.6%) showed osteopenia or osteoporosis. Low BMD was related to low BMI and multiple food sensitivity. Values of daily dietary calcium intake in NCWS patients were significantly lower than in IBS controls. An elevated frequency of bone mass loss in NCWS patients was found; this was related to low BMI and was more frequent in patients with NCWS associated with other food sensitivity. A low daily intake of dietary calcium was observed in patients with NCWS.

  18. The prevalence of injection-site reactions with disease-modifying therapies and their effect on adherence in patients with multiple sclerosis: an observational study

    Directory of Open Access Journals (Sweden)

    Beer Karsten

    2011-11-01

    Full Text Available Abstract Background Interferon beta (IFNβ and glatiramer acetate (GA are administered by subcutaneous (SC or intramuscular (IM injection. Patients with multiple sclerosis (MS often report injection-site reactions (ISRs as a reason for noncompliance or switching therapies. The aim of this study was to compare the proportion of patients on different formulations of IFNβ or GA who experienced ISRs and who switched or discontinued therapy because of ISRs. Methods The Swiss MS Skin Project was an observational multicenter study. Patients with MS or clinically isolated syndrome who were on the same therapy for at least 2 years were enrolled. A skin examination was conducted at the first study visit and 1 year later. Results The 412 patients enrolled were on 1 of 4 disease-modifying therapies for at least 2 years: IM IFNβ-1a (n = 82, SC IFNβ-1b (n = 123, SC IFNβ-1a (n = 184, or SC GA (n = 23. At first evaluation, ISRs were reported by fewer patients on IM IFNβ-1a (13.4% than on SC IFNβ-1b (57.7%; P P P = not significant [NS]. No patient on IM IFNβ-1a missed a dose in the previous 4 weeks because of ISRs, compared with 5.7% of patients on SC IFNβ-1b (P = 0.044, 7.1% of patients on SC IFNβ-1a (P = 0.011, and 4.3% of patients on SC GA (P = NS. Primary reasons for discontinuing or switching therapy were ISRs or lack of efficacy. Similar patterns were observed at 1 year. Conclusions Patients on IM IFNβ-1a had fewer ISRs and were less likely to switch therapies than patients on other therapies. This study may have implications in selecting initial therapy or, for patients considering switching or discontinuing therapy because of ISRs, selecting an alternative option.

  19. Electroacupuncture Modulates Reproductive Hormone Levels in Patients with Primary Ovarian Insufficiency: Results from a Prospective Observational Study

    Directory of Open Access Journals (Sweden)

    Kehua Zhou

    2013-01-01

    Full Text Available To investigate the effects of electroacupuncture (EA on serum FSH, E2, and LH levels, women with primary ovarian insufficiency (POI were treated with EA once a day, five times a week for the first four weeks and once every other day, three times a week, for the following two months, and then were followed up for three months. Serum E2, FSH, and LH levels were measured at baseline, at the end of treatment, and during followup. A total of 11 women with POI were included in this prospective consecutive case series study. Compared with baseline, patients’ serum E2 increased, FSH decreased, and LH decreased (P=0.002, 0.001, and 0.002, resp. after EA treatment, and these effects persisted during followup. With treatment, 10 patients resumed menstruation (10/11, 90.91%, whereas one patient remained amenorrhea. During followup, two patients, including the one with amenorrhea during treatment, reported absence of menstruation. Temporary pain occurred occasionally, and no other adverse events were found during treatment. The results suggest that EA could decrease serum FSH and LH levels and increase serum E2 level in women with POI with little or no side effects; however, further randomized control trials are needed.

  20. Observational Study of Infective Endocarditis at a Community-based Hospital: Dominance of Elderly Patients with Comorbidity.

    Science.gov (United States)

    Nagai, Tomoo; Takase, Yoshiyuki; Hamabe, Akira; Tabata, Hirotsugu

    2018-02-01

    Objective The purpose of this study was to present the recent clinical profiles and the real-world management of infective endocarditis (IE). Methods All medical records of patients with IE were reviewed retrospectively for their clinical data, including clinical presentation, laboratory results, blood cultures, echocardiographic findings, treatments and complications. Using the clinical data collected, we calculated the EuroSCORE II, the European risk score for adult cardiac surgery, the Charlson Comorbidity Index as a surrogate of comordibity, and the Katz Index as a surrogate of frailty. Results Thirty-eight patients were identified as having IE (24 men, age: 71.8±13.1 years). Congestive heart failure occurred in 16 patients (42%), stroke in 14 (50%), and systemic embolism in 5 (13%). The EuroSCORE II and Charlson Comorbidity Index were high (7.7±5.8% and 5.5±2.8%, respectively). The Katz Index was fair (5.5±1.4) before the onset but deteriorated to 2.8±2.7 at the time of establishing the diagnosis of IE (p<0.001). Early surgery was performed in 22 cases (61%). In-hospital death occurred in 10 cases (26%). A EuroSCORE II ≥9%, Staphylococcus aureus etiology, and a Charlson Comorbidity Index were suggested as determinants of in-hospital death (hazard ratios: 173.60, 9.31, 1.57, respectively). In contrast, early surgery was suggested as a determinant of the survival (hazard ratio: 0.04). The Charlson Comorbidity Index was also suggested as a determinant for selecting conservative management (odds ratio: 1.40). Conclusion Comorbidity may influence the treatment selection and outcome of elderly patients with IE.

  1. Evaluation of nonmemory cognitive parameters in psychiatric patients' pre- and post-electroconvulsive therapy: An observational study

    Directory of Open Access Journals (Sweden)

    Jyoti Prakash

    2015-01-01

    Full Text Available Introduction: Possibility of cognitive side effects has made electroconvulsive therapy (ECT questionable. Variable deficits have been debated in memory cognition. Pattern of changes in nonmemory cognition pre- and post-ECT is not clear. Methodology: Forty patients undergoing ECT were studied on nonmemory cognitive parameters before ECT, after a course of ECT, and after 4 weeks of last. ECT. Results: Nonmemory cognition improved during the course of ECT and over 4 weeks of ECT. Conclusions: ECT does not affect the nonmemory cognition adversely.

  2. No Negative Impact of Palliative Sedation on Relatives' Experience of the Dying Phase and Their Wellbeing after the Patient's Death: An Observational Study.

    Directory of Open Access Journals (Sweden)

    S M Bruinsma

    Full Text Available Palliative sedation is the widely-used intervention of administering sedating agents to induce a state of unconsciousness to take away a dying patient's perception of otherwise irrelievable symptoms. However, it remains questionable whether this ethically complex intervention is beneficial for patients and whether the associated lack of communication in the last phase of life has a negative impact on relatives' wellbeing.An observational questionnaire study was conducted among relatives of a consecutive sample of patients who died a non-sudden death in the Erasmus MC Cancer Institute or in the hospice 'Laurens Cadenza' (both in Rotterdam between 2010 and 2013.Relatives filled in questionnaires regarding 151 patients who had been sedated and 90 patients who had not been sedated. The median time since all patients had passed away was 21 (IQR 14-32 months. No significant differences were found in relatives´ assessments of the quality of end-of-life care, patients´ quality of life in the last week before death and their quality of dying, between patients who did and did not receive sedation, or in relatives' satisfaction with their own life, their general health and their mental wellbeing after the patient's death.The use of sedation in these patients appears to have no negative effect on bereaved relatives' evaluation of the patient's dying phase, or on their own wellbeing after the patient's death.

  3. No Negative Impact of Palliative Sedation on Relatives' Experience of the Dying Phase and Their Wellbeing after the Patient's Death: An Observational Study.

    Science.gov (United States)

    Bruinsma, S M; van der Heide, A; van der Lee, M L; Vergouwe, Y; Rietjens, J A C

    2016-01-01

    Palliative sedation is the widely-used intervention of administering sedating agents to induce a state of unconsciousness to take away a dying patient's perception of otherwise irrelievable symptoms. However, it remains questionable whether this ethically complex intervention is beneficial for patients and whether the associated lack of communication in the last phase of life has a negative impact on relatives' wellbeing. An observational questionnaire study was conducted among relatives of a consecutive sample of patients who died a non-sudden death in the Erasmus MC Cancer Institute or in the hospice 'Laurens Cadenza' (both in Rotterdam) between 2010 and 2013. Relatives filled in questionnaires regarding 151 patients who had been sedated and 90 patients who had not been sedated. The median time since all patients had passed away was 21 (IQR 14-32) months. No significant differences were found in relatives´ assessments of the quality of end-of-life care, patients´ quality of life in the last week before death and their quality of dying, between patients who did and did not receive sedation, or in relatives' satisfaction with their own life, their general health and their mental wellbeing after the patient's death. The use of sedation in these patients appears to have no negative effect on bereaved relatives' evaluation of the patient's dying phase, or on their own wellbeing after the patient's death.

  4. Resource utilisation, costs and clinical outcomes in non-institutionalised patients with Alzheimer’s disease: 18-month UK results from the GERAS observational study

    OpenAIRE

    Alan Lenox-Smith; Catherine Reed; Jeremie Lebrec; Mark Belger; Roy W. Jones

    2016-01-01

    Abstract Background Alzheimer’s disease (AD), the commonest cause of dementia, represents a significant cost to UK society. This analysis describes resource utilisation, costs and clinical outcomes in non-institutionalised patients with AD in the UK. Methods The GERAS prospective observational study assessed societal costs associated with AD for patients and caregivers over 18 months, stratified according to baseline disease severity (mild, moderate, or moderately severe/severe [MS/S]). All p...

  5. Prognosis of patients excluded by the definition of septic shock based on their lactate levels after initial fluid resuscitation: a prospective multi-center observational study.

    Science.gov (United States)

    Ko, Byuk Sung; Kim, Kyuseok; Choi, Sung-Hyuk; Kang, Gu Hyun; Shin, Tae Gun; Jo, You Hwan; Ryoo, Seung Mok; Beom, Jin Ho; Kwon, Woon Yong; Han, Kap Su; Choi, Han Sung; Chung, Sung Phil; Suh, Gil Joon; Lim, Tae Ho; Kim, Won Young

    2018-02-24

    Septic shock can be defined both by the presence of hyperlactatemia and need of vasopressors. Lactate levels should be measured after volume resuscitation (as per the Sepsis-3 definition). However, currently, no studies have evaluated patients who have been excluded by the new criteria for septic shock. The aim of this study was to determine the clinical characteristics and prognosis of these patients, based on their lactate levels after initial fluid resuscitation. This observational study was performed using a prospective, multi-center registry of septic shock, with the participation of 10 hospitals in the Korean Shock Society, between October 2015 and February 2017. We compared the 28-day mortality between patients who were excluded from the new definition (defined as lactate level definition of septic shock. These patients, in whom perfusion was restored, demonstrated significantly lower age, platelet count, and initial and subsequent lactate levels (all p < 0.01). Similarly, significantly lower 28-day mortality was observed in these patients than in those who had not been excluded (8.2% vs 25.5%, p = 0.02). In-hospital mortality and the maximum SOFA score were also significantly lower in the excluded patients group (p = 0.03, both). It seems reasonable for septic shock to be defined by the lactate levels after volume resuscitation. However, owing to the small number of patients in whom lactate levels were improved, further study is warranted.

  6. Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting

    DEFF Research Database (Denmark)

    Rajzbaum, Gerald; Jakob, Franz; Karras, Dimitrios

    2007-01-01

    OBJECTIVE: The European Forsteo Observational Study (EFOS) study was primarily designed to assess fracture incidence, degree of pain, health-related quality of life (HRQoL) and compliance in women prescribed teriparatide in a community setting. This report describes the design of the study...... deformities and 91.7% were pre-treated with bisphosphonates. HRQoL, evaluated by the health state value (HSV) (median: 0.59, Q1; Q3: 0.08; 0.71) and visual analogue scale (VAS) (median 50.0, Q1; Q3: 35.0; 69.0) status of the European quality of life questionnaire (EQ-5D) was poor. Extreme problems were...

  7. Dysplastic vs. Common Naevus-associated vs. De novo Melanomas: An Observational Retrospective Study of 1,021 Patients

    Directory of Open Access Journals (Sweden)

    Alejandro Martin-Gorgojo

    2018-03-01

    Full Text Available The aim of this case-case study was to determine the differences between dysplastic and common naevus-associated melanomas (NAM and de novo melanomas. A total of 1,021 prospectively collected patients with invasive cutaneous melanoma from an oncology referral centre were included in the study. Of these, 75.51% had de novo melanomas, 12.93% dysplastic NAM, and 11.56% common NAM. Dysplastic NAM, compared with de novo melanomas, were associated with intermittently photo-exposed sites, atypical melanocytic naevi, decreased tumour thickness, and presence of MC1R non-synonymous variants. Common NAM were more frequent on the trunk and of superficial spreading type. Comparison of dysplastic with common NAM showed significant difference only with regard to mitoses. Both subtypes of NAM shared less aggressive traits than de novo melanomas, albeit with no significant differences in survival after multivariate adjustment. In conclusion, NAM present with less aggressive traits, mostly due to a greater awareness among patients of changing moles than due to their intrinsic biological characteristics.

  8. Using a didactic model to improve patient observation skills in neonatal intensive care nurse trainees - a pilot study.

    Science.gov (United States)

    Solberg, Marianne Trygg; Tandberg, Bente Silnes; Lerdal, Anners

    2012-08-01

    To implement a didactic model for students specialising in intensive care nursing (n=12) and nurses working in neonatal intensive care units (NICU) (n=17). To evaluate nurse self-assessments following observation of children with congenital heart disease (CHD), before and after participation in the programme, as well as the usefulness of the programme. A pilot study with a pre- and post-test design, using self-administered questionnaires. The didactic model increased the number of clinical observations and assessments of physiological factors made by both students and NICU nurses during evaluation of children with suspected CHD. The majority of nurses reported that both participation in the programme and the didactic model were useful and they demonstrated high-level knowledge, according to Bloom's taxonomy for cognitive learning. In particular, subjects found that the literature provided and structured bedside guidance in the clinical setting assisted learning. Intensive care students and NICU nurses performed clinical observations and physical factor assessments more frequently after completing the programme, compared with baseline. We speculate that this didactic model may also be useful in other clinical settings. Copyright © 2011 Elsevier Ltd. All rights reserved.

  9. Characteristics and outcomes of patients admitted to Spanish ICU: A prospective observational study from the ENVIN-HELICS registry (2006-2011).

    Science.gov (United States)

    Olaechea, P M; Álvarez-Lerma, F; Palomar, M; Gimeno, R; Gracia, M P; Mas, N; Rivas, R; Seijas, I; Nuvials, X; Catalán, M

    2016-05-01

    To describe the case-mix of patients admitted to intensive care units (ICUs) in Spain during the period 2006-2011 and to assess changes in ICU mortality according to severity level. Secondary analysis of data obtained from the ENVN-HELICS registry. Observational prospective study. Spanish ICU. Patients admitted for over 24h. None. Data for each of the participating hospitals and ICUs were recorded, as well as data that allowed to knowing the case-mix and the individual outcome of each patient. The study period was divided into two intervals, from 2006 to 2008 (period 1) and from 2009 to 2011 (period 2). Multilevel and multivariate models were used for the analysis of mortality and were performed in each stratum of severity level. The study population included 142,859 patients admitted to 188 adult ICUs. There was an increase in the mean age of the patients and in the percentage of patients >79 years (11.2% vs. 12.7%, P<0.001). Also, the mean APACHE II score increased from 14.35±8.29 to 14.72±8.43 (P<0.001). The crude overall intra-UCI mortality remained unchanged (11.4%) but adjusted mortality rate in patients with APACHE II score between 11 and 25 decreased modestly in recent years (12.3% vs. 11.6%, odds ratio=0.931, 95% CI 0.883-0.982; P=0.008). This study provides observational longitudinal data on case-mix of patients admitted to Spanish ICUs. A slight reduction in ICU mortality rate was observed among patients with intermediate severity level. Copyright © 2015 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

  10. The real world effect of omalizumab add on therapy for patients with moderate to severe allergic asthma: The ASTERIX Observational study.

    Science.gov (United States)

    Bhutani, Mohit; Yang, William H; Hébert, Jacques; de Takacsy, Frederica; Stril, Jean-Louis

    2017-01-01

    Omalizumab is a non-steroidal medication indicated for the treatment of poorly controlled moderate-to-severe allergic asthmatics. This observational study examines the "real world" effectiveness of omalizumab in this population. This is a one year open-label observational study that compared clinical outcomes including total oral corticosteroid use, exacerbation history, measures of quality of life and inflammation in patients with moderate-to-severe allergic asthma, who were prescribed omalizumab as part of their treatment with the year prior to therapy. A total of 99 patients were enrolled at 25 sites in Canada. During the study period, the mean total annual OCS dose was reduced from 2301.5 mg (prednisone equivalents) in the year prior to omalizumab to 1130.0 mg (pomalizumab remained exacerbation free when compared to the year prior to study entry. Associated with this was reduced health care utilization. There were significant improvements in the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life questionnaire (AQLQ) Patients with an elevated FeNO at baseline showed a better response to treatment. No new safety issues were identified during the study period. Our study demonstrates that in "real world" clinical practice, after initiating omalizumab, there is a reduction in total OCS use and exacerbation frequency in patients with moderate-to-severe allergic asthma. Patients on treatment reported improved asthma control and quality of life. FeNO may be a useful biomarker to identify patients who may benefit with omalizumab treatment.

  11. Effect of Diabetes Mellitus on Tuberculosis Treatment Outcome and Adverse Reactions in Patients Receiving Directly Observed Treatment Strategy in India: A Prospective Study

    Directory of Open Access Journals (Sweden)

    Ali Nasir Siddiqui

    2016-01-01

    Full Text Available Despite successful implementation of directly observed treatment, short course (DOTS in India, the growing number of diabetes mellitus (DM patients appears to be a cause in the increasing tuberculosis (TB incidence, affecting their management. In this regard, a prospective study was conducted on DOTS patients in three primary health care centers in urban slum region of South Delhi, India, to evaluate the effect of DM on sputum conversion, treatment outcome, and adverse drug reactions (ADR due to anti-TB treatment. Eligible TB patients underwent blood glucose screening at treatment initiation. Disease presentation, clinical outcome, and ADRs were compared between patients of TB with and without DM. Out of 316 patients, the prevalence of DM was found to be 15.8%, in which 19.4% and 9.6% were PTB and EPTB patients, respectively. DM patients have observed higher sputum positivity (OR 1.247 95% CI; 0.539–2.886 at the end of 2-month treatment and poor outcome (OR 1.176 95% CI; 0.310–4.457 at the completion of treatment compared with non DM patients. Presence of DM was significantly associated (OR 3.578 95% CI; 1.114–11.494, p=0.032 with the development of ADRs. DM influences the treatment outcome of PTB patients in our setting and also on the ADR incidence.

  12. Effect of donepezil in patients with Alzheimer's disease previously untreated or treated with memantine or nootropic agents in Germany: an observational study.

    Science.gov (United States)

    Klinger, Tatjana; Ibach, Bernd; Schoenknecht, Peter; Kamleiter, Martin; Silver, Gabrielle; Schroeder, Johannes; Mielke, Ruediger

    2005-05-01

    This open-label, prospective, observational, Post-Marketing Surveillance (PMS) study assessed the efficacy and safety of donepezil in patients who had been switched from therapies currently used in Germany to treat Alzheimer's disease (AD), such as memantine and nootropics, due to insufficient efficacy or poor tolerability. A treatment-naive population was included as a comparator. Patients with AD were treated with donepezil and observed for a period of approximately 3 months. A cognitive assessment was made using the Mini-Mental State Examination (MMSE). Quality of life (QoL) was assessed by the investigators who answered the question 'How did therapy with donepezil influence the QoL of the patient and/or his family over the observation period?' and was graded using three ratings: improved/unchanged/worsened. Adverse events (AEs) were also monitored. A total of 913 patients entered the study (mean +/- SD MMSE score 18.03 +/- 5.34). Efficacy assessments were analyzed for three groups: an overall group of patients who had received any form of prior AD drug therapy (N+ group; n = 709); a subgroup of patients from the N+ group who had received prior memantine therapy only (M+ group; n = 111) and patients who were drug treatment naive (N- group; n = 204). In the evaluable population donepezil improved MMSE scores by 2.21 +/- 3.47 points on average, with similar improvements observed in all three groups. QoL was judged to be improved in at least 70% of patients, again with similar results obtained for all three groups. Donepezil was well tolerated, with 85 of 913 (9.3%) patients reporting AEs. The most common AEs were those typically seen with cholinergic therapies (i.e., diarrhoea, vomiting and nausea). In this observational PMS study, donepezil was shown to be efficacious and well tolerated in patients who were being insufficiently treated with memantine or nootropic therapy. The magnitude of response was similar to that observed in patients who were previously

  13. The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese male patients with osteoporosis.

    Science.gov (United States)

    Kondo, Satoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Furuno, Yuko; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

    2018-03-12

    We conducted a post-marketing observational study to investigate the safety and effectiveness of eldecalcitol for the treatment of osteoporosis in a Japanese clinical setting. The observation period was 12 months for women and 36 months for men. The final results for the female patients have already been published. In this article, the final results for the male patients are reported. A total of 470 male osteoporosis patients were enrolled. The safety analysis set included 431 patients (mean age, 76.8 years; mean ± SD follow-up period, 631.0 ± 450.3 days), and 175 patients continued treatment throughout the 3-year observational period. Adverse drug reactions (ADRs) were reported in 28 patients (6.49%); the most common ADRs were hypercalcemia (1.16%) and renal impairment (1.16%). Serious ADRs were reported in 5 patients (1.16%). Mean serum calcium was within the normal range throughout the observation period. The cumulative incidence of new vertebral and nonvertebral fractures at 36 months, estimated by Kaplan-Meier analysis, was 10.23 and 4.06%, respectively. At the last observation, mean lumbar spine bone mineral density was 3.49% higher (P effectiveness of eldecalcitol for the treatment of Japanese male osteoporosis patients was confirmed in clinical practice. Careful monitoring of serum calcium and estimated glomerular filtration rate, both before and during treatment, is necessary to minimize the risk of hypercalcemia and renal impairment while maximizing the effectiveness of eldecalcitol.

  14. In infectious endocarditis patients mortality is highly related to kidney function at time of diagnosis: a prospective observational cohort study of 231 cases

    DEFF Research Database (Denmark)

    Buchholtz, Kristine; Larsen, Carsten T; Hassager, Christian

    2009-01-01

    function at the time of admittance. METHODS: In a prospective observational cohort study data from 235 consecutive IE patients were collected at 2 tertiary heart centres in Copenhagen. Kidney function was evaluated as Estimated Endogenous Creatinine Clearance (EECC) calculated at the time of admission...

  15. Memories of paternal relations are associated with coping and defense mechanisms in breast cancer patients: an observational study

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    Chiara Renzi

    2017-11-01

    Full Text Available Abstract Background Breast cancer diagnosis and treatment represent stressful events that demand emotional adjustment, thus recruiting coping strategies and defense mechanisms. As parental relations were shown to influence emotion regulation patterns and adaptive processes in adulthood, the present study investigated whether they are specifically associated to coping and defense mechanisms in patients with breast cancer. Methods One hundred and ten women hospitalized for breast cancer surgery were administered questionnaires assessing coping with cancer, defense mechanisms, and memories of parental bonding in childhood. Results High levels of paternal overprotection were associated with less mature defenses, withdrawal and fantasy and less adaptive coping mechanisms, such as hopelessness/helplessness. Low levels of paternal care were associated with a greater use of repression. No association was found between maternal care, overprotection, coping and defense mechanisms. Immature defenses correlated positively with less adaptive coping styles, while mature defenses were positively associated to a fighting spirit and to fatalism, and inversely related to less adaptive coping styles. Conclusions These data suggest that paternal relations in childhood are associated with emotional, cognitive, and behavioral regulation in adjusting to cancer immediately after surgery. Early experiences of bonding may constitute a relevant index for adaptation to cancer, indicating which patients are at risk and should be considered for psychological interventions.

  16. Periprosthetic joint infections in modular endoprostheses of the lower extremities: a retrospective observational study in 101 patients.

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    Zajonz, Dirk; Zieme, Almut; Prietzel, Torsten; Moche, Michael; Tiepoldt, Solveig; Roth, Andreas; Josten, Christoph; von Salis-Soglio, Georg Freiherr; Heyde, Christoph-E; Ghanem, Mohamed

    2016-01-01

    Modular mega-endoprosthesis systems are used to bridge very large bone defects and have become a widespread method in orthopaedic surgery for the treatment of tumours and revision arthroplasty. However, the indications for the use of modular mega-endoprostheses must be carefully considered. Implanting modular endoprostheses requires major, complication-prone surgery in which the limited salvage procedures should always be borne in mind. The management of periprosthetic infection is particularly difficult and beset with problems. Given this, the present study was designed to gauge the significance of periprosthetic infections in connection with modular mega-implants in the lower extremities among our own patients. Patients who had been fitted with modular endoprosthesis on a lower extremity at our department between September 1994 and December 2011 were examined retrospectively. A total of 101 patients with 114 modular prostheses were identified. Comprising 30 men (29.7 %) and 71 women (70.3 %), their average age at the time of surgery was 67 years (18-92 years). The average follow-up period was 27 months (5 months and 2 weeks to 14 years and 11 months) and the drop-out rate was about 8.8 %. Altogether, there were 19 (17.7 %) endoprosthesis infections: 3 early infections and 16 late or delayed infections. The pathogen spectrum was dominated by coagulase-negative staphylococci (36 %) and Staphylococcus aureus (16 %), including 26 % multi-resistant pathogens. Reinfection occurred in 37 % of cases of infection. Tumours were followed by significantly fewer infections than the other indications. Infections were twice as likely to occur after previous surgery. In our findings modular endoprostheses (18 %) are much more susceptible to infection than primary endoprostheses (0.5-2,5 %). Infection is the most common complication alongside the dislocation of proximal femur endoprostheses. Consistent, radical surgery is essential - although even with an adequate

  17. Skin hydration of the heel with fissure in patients with diabetes: a cross-sectional observational study

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    Oe M

    2018-06-01

    Full Text Available Makoto Oe,1 Kimie Takehara,2 Hiroshi Noguchi,3 Yumiko Ohashi,4 Mayu Fukuda,1 Takashi Kadowaki,5 Hiromi Sanada1,6 1Global Nursing Research Center, 2Department of Advanced Nursing Technology, 3Department of Life Support Technology (Molten, Graduate School of Medicine, The University of Tokyo, 4Department of Nursing, The University of Tokyo Hospital, 5Department of Diabetes and Metabolic Diseases, 6Department of Gerontological Nursing/Wound Care Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan Purpose: Foot fissure should be prevented in patients with diabetes due to the likelihood of subsequent diabetic ulcer. The purpose of this study was to investigate a cutoff point for skin hydration with fissure and the factors associated with low skin hydration in patients with diabetes. Subjects and methods: Subjects were patients with diabetes who visited the diabetic foot clinic and were evaluated for skin hydration on the heel between April 2008 and March 2015. Information about fissure, skin hydration, age, sex, autonomic neuropathy, angiopathy, and tinea pedis were collected from the medical charts. Skin hydration on the heel was measured using a moisture checker. Skin hydration was compared between heels with and without fissure, and a cutoff for skin hydration with fissure was determined using receiver operating characteristic analysis. Based on the determined cutoff, factors associated with lower skin hydration were analyzed using logistic regression analysis. Results: Participants comprised 693 patients. Mean±SD age was 66.8±10.8 years, and 57.0% of subjects were male. The frequency of fissures on the heels was 10.4%. Area under the receiver operating characteristic curve for skin hydration in the presence of fissure was 0.717. Twenty percent was selected as the cutoff point, offering sensitivity of 0.478 and specificity of 0.819. Logistic regression analysis showed correlations between three factors (male sex, tinea

  18. Comparison of three scoring systems in predicting clinical outcomes in patients with acute upper gastrointestinal bleeding: a prospective observational study.

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    Zhong, Min; Chen, Wan Jun; Lu, Xiao Ye; Qian, Jie; Zhu, Chang Qing

    2016-12-01

    To compare the performances of the Glasgow-Blatchford score (GBS), modified GBS (mGBS) and AIMS65 in predicting clinical outcomes in patients with acute upper gastrointestinal bleeding (AUGIB). This study enrolled 320 consecutive patients with AUGIB. Patients at high and low risks of developing adverse clinical outcomes (rebleeding, the need of clinical intervention and death) were categorized according to the GBS, mGBS and AIMS65 scoring systems. The outcome of the patients were the occurrences of adverse clinical outcomes. The areas under the receiver operating characteristics curve (AUROC) of three scoring systems were compared. Irrespective of the systems used, the high-risk groups showed higher rates of rebleeding, intervention and death compared with the low-risk groups (P < 0.05). For the prediction of rebleeding, AIMS65 (AUROC 0.735, 95% CI 0.667-0.802) performed significantly better than GBS (AUROC 0.672, 95% CI 0.597-0.747; P < 0.01) and mGBS (AUROC 0.677, 95% CI 0.602-0.753; P < 0.01). For the prediction of interventions, there was no significant difference among the three systems (GBS: AUROC 0.769, 95% CI 0.668-0.870; mGBS: AUROC 0.745, 95% CI 0.643-0.847; AIMS65: AUROC 0.746, 95% CI 0.640-0.851). For the prediction of in-hospital mortality, there was no significant difference among the three systems (GBS: AUROC 0.796, 95% CI 0.694-0.898; mGBS: AUROC 0.803, 95% CI 0.703-0.904; AIMS65: AUROC 0.786, 95% CI 0.670-0.903). The three scoring systems are reliable and accurate in predicting the rates of rebleeding, surgery and mortality in AUGIB. However, AIMS65 outperforms GBS and mGBS in predicting rebleeding. © 2016 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

  19. Use of cumulative mortality data in patients with acute myocardial infarction for early detection of variation in clinical practice: observational study.

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    Lawrance, R A; Dorsch, M F; Sapsford, R J; Mackintosh, A F; Greenwood, D C; Jackson, B M; Morrell, C; Robinson, M B; Hall, A S

    2001-08-11

    Use of cumulative mortality adjusted for case mix in patients with acute myocardial infarction for early detection of variation in clinical practice. Observational study. 20 hospitals across the former Yorkshire region. All 2153 consecutive patients with confirmed acute myocardial infarction identified during three months. Variable life-adjusted displays showing cumulative differences between observed and expected mortality of patients; expected mortality calculated from risk model based on admission characteristics of age, heart rate, and systolic blood pressure. The performance of two individual hospitals over three months was examined as an example. One, the smallest district hospital in the region, had a series of 30 consecutive patients but had five more deaths than predicted. The variable life-adjusted display showed minimal variation from that predicted for the first 15 patients followed by a run of unexpectedly high mortality. The second example was the main tertiary referral centre for the region, which admitted 188 consecutive patients. The display showed a period of apparently poor performance followed by substantial improvement, where the plot rose steadily from a cumulative net lives saved of -4 to 7. These variations in patient outcome are unlikely to have been revealed during conventional audit practice. Variable life-adjusted display has been integrated into surgical care as a graphical display of risk-adjusted survival for individual surgeons or centres. In combination with a simple risk model, it may have a role in monitoring performance and outcome in patients with acute myocardial infarction.

  20. Safety and feasibility audit of a home-based drug-transitioning approach for patients with pulmonary arterial hypertension: an observational study.

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    Dawson, A; Reddecliffe, S; Coghlan, C; Schreiber, B E; Coghlan, J G

    2018-04-01

    Newer endothelin receptor antagonists (ERAs) used to treat patients with pulmonary arterial hypertension (PAH) are associated with fewer drug-drug interactions than bosentan and require less monitoring. This, combined with a pharmacokinetic basis for improved efficacy, means there may be a clinical rationale for changing therapies. However, this can be challenging and few data on its safety in patients with PAH are available. At the Royal Free Hospital in London, UK, home-based medication transitioning has been standard practice since 2009 to avoid unnecessary hospital visits for patients, unless there is a clinical imperative. In this audit of standard practice we evaluated the consequences of adopting such a strategy when transitioning PAH patients between ERA therapies. Using a Clinical Nurse Specialist-led, home-based transitioning strategy, 92 patients with PAH were transitioned from bosentan to macitentan or ambrisentan. Observational data were analysed retrospectively. The majority of patients were female with PAH associated with connective tissue disease and their ERA was changed in the hope of improving efficacy. The process was well tolerated with no adverse events associated with the process. Seventeen patients died during the study (macitentan, n = 5; ambrisentan, n = 12). None of the deaths was considered related to ERA treatment. The majority of patients remained clinically stable, based on WHO functional class and exercise capacity. An established home-based transitioning strategy can be adopted safely for patients with PAH changing ERA therapies. Most patients remained stable and the therapy change was well tolerated.

  1. Procoagulant, tissue factor-bearing microparticles in bronchoalveolar lavage of interstitial lung disease patients: an observational study.

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    Federica Novelli

    Full Text Available Coagulation factor Xa appears involved in the pathogenesis of pulmonary fibrosis. Through its interaction with protease activated receptor-1, this protease signals myofibroblast differentiation in lung fibroblasts. Although fibrogenic stimuli induce factor X synthesis by alveolar cells, the mechanisms of local posttranslational factor X activation are not fully understood. Cell-derived microparticles are submicron vesicles involved in different physiological processes, including blood coagulation; they potentially activate factor X due to the exposure on their outer membrane of both phosphatidylserine and tissue factor. We postulated a role for procoagulant microparticles in the pathogenesis of interstitial lung diseases. Nineteen patients with interstitial lung diseases and 11 controls were studied. All subjects underwent bronchoalveolar lavage; interstitial lung disease patients also underwent pulmonary function tests and high resolution CT scan. Microparticles were enumerated in the bronchoalveolar lavage fluid with a solid-phase assay based on thrombin generation. Microparticles were also tested for tissue factor activity. In vitro shedding of microparticles upon incubation with H₂O₂ was assessed in the human alveolar cell line, A549 and in normal bronchial epithelial cells. Tissue factor synthesis was quantitated by real-time PCR. Total microparticle number and microparticle-associated tissue factor activity were increased in interstitial lung disease patients compared to controls (84±8 vs. 39±3 nM phosphatidylserine; 293±37 vs. 105±21 arbitrary units of tissue factor activity; mean±SEM; p<.05 for both comparisons. Microparticle-bound tissue factor activity was inversely correlated with lung function as assessed by both diffusion capacity and forced vital capacity (r² = .27 and .31, respectively; p<.05 for both correlations. Exposure of lung epithelial cells to H₂O₂ caused an increase in microparticle-bound tissue factor

  2. Risk factors associated with the development of overt nephropathy in type 2 diabetes patients: A 12 years observational study

    Science.gov (United States)

    Viswanathan, Vijay; Tilak, Priyanka; Kumpatla, Satyavani

    2012-01-01

    Background & objectives: Diabetic nephropathy (DN) is the leading cause of chronic kidney disease and end-stage renal disease in developing countries. Early detection and risk reduction measures can prevent DN. The aim of the study was to determine the risk factors for the development of proteinuria over a period of 12 years of follow up in normoalbuminuric type 2 diabetes patients attending a specialized centre. Methods: Of the 2630 type 2 diabetes subjects newly registered in 1996, 152 (M:F;92:60) normoalbuminuric subjects had baseline and subsequent measurements of anthropometric, haemodynamic and biochemical details spanning 12 years. The subjects were divided into 2 groups based on the renal status during follow up visits. Group 1 (non-progressors) had persistent normoalbuminuria and group 2 (progressors) had persistent proteinuria. Presence of other diabetic complications during follow up and details on antidiabetic and antihypertensive agents were noted. Results: During median follow up of 11 years in subjects with normal renal function at baseline, 44.1 per cent developed proteinuria at follow up. Glucose levels, HbA1c, systolic blood pressure (SBP), triglycerides, and urea levels were significantly higher at baseline among progressors than non-progressors. Progressors had a longer duration of diabetes and significant fall in estimated glomerular filtration rate (eGFR) levels at follow up. In Cox's regression analysis, baseline age, duration of diabetes, baseline HbA1c and mean values of HbA1c, triglycerides, SBP and presence of retinopathy showed significant association with the development of macroalbuminuria. Interpretation & conclusions: Type 2 diabetes patients with uncontrolled diabetes and increase in blood pressure are at high risk of developing nephropathy. Age, long duration of diabetes, elevated BP, poor glycaemic control and presence of retinopathy were significantly associated with the progression of diabetic nephropathy. PMID:22885263

  3. Predictors for half-year outcome of impairment in daily life for back pain patients referred for physiotherapy: a prospective observational study.

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    Sven Karstens

    Full Text Available BACKGROUND AND OBJECTIVE: From observational studies, there is only sparse information available on the predictors of development of impairment in daily life for patients receiving physiotherapy. Therefore, our aim was to identify factors which predict impairment in daily life for patients with back pain 6 months after receiving physiotherapy. METHODS: We conducted a prospective cohort study with 6-month follow-up. Patients were enrolled for treatment in private physiotherapy practices. Patients with a first physiotherapy referral because of thoracic or low back pain, aged 18 to 65 years were included. Primary outcome impairment was measured utilising the 16-item version of the Musculoskeletal Function Assessment Questionnaire. Therapy was documented on a standardized form. Baseline scores for impairment in daily life, symptom characteristics, sociodemographic and psychosocial factors, physical activity, nicotine consumption, intake of analgesics, comorbidity and delivered primary therapy approach were investigated as possible predictors. Univariate and multiple linear regression analyses were performed. RESULTS: A total of 792 patients participated in the study (59% female, mean age 44.4 (SD 11.4, with 6-month follow-up results available from 391 patients. In univariate analysis 17 variables reached significance. In multiple linear regression identified predictors were: impairment in daily life before therapy, mental disorders, duration of the complaints, self-prognosis on work ability, rheumatoid arthritis, age, form of stress at work and physical activity. The variables explain 34% of variance (adjusted R(2, p<0.001. CONCLUSIONS: With minimal information available from observational studies on the predictors of development of back problems for physiotherapy patients, this study adds new knowledge for forming appropriate referral guidelines. Impairment in daily life before therapy, mental disorder as comorbidity and the duration of the

  4. Estimating the adjuvant chemotherapy effect in elderly stage II and III colon cancer patients in an observational study.

    Science.gov (United States)

    Kim, Ki-Yeol; Cha, In-Ho; Ahn, Joong Bae; Kim, Nam Kyu; Rha, Sun Young; Chung, Hyun Cheol; Roh, Jae Kyung; Shin, Sang Joon

    2013-05-01

    Adjuvant chemotherapy has been known as a standard treatment for patients with resected colon cancer. However, in elderly colon cancer patients, the characteristics of patients are heterogeneous with regard to life expectancy and comorbidities. Thus, with regard to the effectiveness of adjuvant chemotherapy for colon cancer, it is difficult to extrapolate data of clinical trials from the younger into the older general population. Data for 382 elderly colon cancer patients were analyzed: 217 in Stage II and 165 in Stage III. The efficacy of adjuvant chemotherapy was evaluated in elderly colon cancer patients after a match by the propensity score method. For matched patients with Stage II colon cancer, there was no significant efficacy of adjuvant chemotherapy in the risk of death during all follow-up periods (P-value, 0.06-0.37). Though there was a tendency that the adjuvant chemotherapy reduces the death rate during the follow-up periods, it was not statistically significant. In the case of Stage III, the adjuvant chemotherapy was significantly effective in matched patients for 5-year (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.30-0.90) and overall survival (HR, 0.56; 95% CI, 0.34-0.94). Adjuvant chemotherapy for elderly patients with Stage II colon cancer is not effective, whereas elderly patients with Stage III with adjuvant chemotherapy appear to have a better survival rate in the general population. Copyright © 2012 Wiley Periodicals, Inc.

  5. Neuron-Specific Enolase Is Correlated to Compromised Cerebral Metabolism in Patients Suffering from Acute Bacterial Meningitis; An Observational Cohort Study.

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    Jiri Bartek

    Full Text Available Patients suffering from acute bacterial meningitis (ABM with a decreased level of consciousness have been shown to have an improved clinical outcome if treated with an intracranial pressure (ICP guided therapy. By using intracranial microdialysis (MD to monitor cerebral metabolism in combination with serum samples of biomarkers indicating brain tissue injury, S100B and Neuron Specific Enolase (NSE, additional information might be provided. The aim of this study was to evaluate biomarkers in serum and MD parameters in patients with ABM.From a prior study on patients (n = 52 with a confirmed ABM and impaired consciousness (GCS ≤ 9, or GCS = 10 combined with lumbar spinal opening pressure > 400 mmH2O, a subgroup of patients (n = 21 monitored with intracerebral MD and biomarkers was included in the present study. All patients were treated in the NICU with intracranial pressure (ICP guided therapy. Serum biomarkers were obtained at admission and every 12 hours. The MD parameters glucose, lactate, pyruvate and glycerol were analyzed. Outcome was assessed at 12-55 months after discharge from hospital. Mann-Whitney U-Test and Wilcoxon matched-pairs signed rank test were applied.The included patients had a mean GCS of 8 (range, 3-10 on admission and increased ICP (>20 mmHg was observed in 62% (n = 13/21 of the patients. Patients with a lactate:pyruvate ratio (LPR >40 (n = 9/21, 43% had significantly higher peak levels of serum NSE (p = 0.03, with similar, although non-significant observations made in patients with high levels of glycerol (>500 μmol/L, p = 0.11 and those with a metabolic crisis (Glucose 25, p = 0.09. No associations between serum S100B and MD parameters were found. Furthermore, median MD glucose levels decreased significantly between day 1 (0-24 h and day 3 (48-72 h after admission to the NICU (p = 0.0001. No correlation between MD parameters or biomarkers and outcome was found.In this observational cohort study, we were able to show

  6. Statin treatment and mortality in community-dwelling frail older patients with diabetes mellitus : A retrospective observational study

    NARCIS (Netherlands)

    A. Pilotto (Alberto); F. Panza (Francesco); Copetti, M. (Massimiliano); Simonato, M. (Matteo); D. Sancarlo; P. Gallina (Pietro); T.E. Strandberg (Timo); A.J. Cruz-Jentoft (A.); Daragjati, J. (Julia); L. Ferrucci (Luigi); A. Fontana (Andrea); S. Maggi; F.U.S. Mattace Raso (Francesco); M. Paccalin; Polidori, M.C. (Maria Cristina); Schulz, R.-J. (Ralf-Joachim); E. Topinkova; G. Trifirò (Gianluca); A.-K. Welmer

    2015-01-01

    textabstractBackground: Older adults are often excluded from clinical trials. Decision making for administration of statins to older patients with diabetes mellitus (DM) is under debate, particularly in frail older patients with comorbidity and high mortality risk. We tested the hypothesis that

  7. Effectiveness of the Medtep Hemophilia online platform for adherence to prophylactic treatment in haemophilia patients: Results from a 1-year observational study.

    Science.gov (United States)

    Cuesta-Barriuso, R; López-Pina, J A; Nieto-Munuera, J; Sagarra-Valls, G; Panisello-Royo, J M; Torres-Ortuño, A

    2018-03-01

    Medtep Hemophilia platform is an online tool that allows patients with congenital coagulopathies to keep track of their daily condition-related events with the objective of ensuring successful adherence to therapy. To assess the effectiveness of Medtep Hemophilia in improving adherence to prophylactic treatment in haemophilia A and B patients in a 1-year prospective observational study, as well as its impact on the patient's disease status. Patients (>13 years old) received support material to familiarize themselves with Medtep Hemophilia. Adherence to treatment, quality of life (QoL) and illness perception were assessed. Values at baseline, 1, 6 and 12 months, and changes from baseline value were analysed. The Hemophilia Joint Health Score (HJHS) test was applied at baseline and study completion. Forty-six patients were enrolled (43 evaluable). After 1 year, 56.4% patients showed continued use of the platform (100% compliance) whereas 25.6% were inactive. Treatment adherence increased both significantly (P 80% of platform use) tended to score better than noncompliant. The HJHS test values remained similar during the study. The Medtep Hemophilia online platform helped the studied patients with haemophilia to improve their adherence to prophylactic treatment, while increasing their QoL and illness perception, as well as joint arthropathies stabilization. © 2018 John Wiley & Sons Ltd.

  8. Thrombolysis and clinical outcome in patients with stroke after implementation of the Tyrol Stroke Pathway: a retrospective observational study.

    Science.gov (United States)

    Willeit, Johann; Geley, Theresa; Schöch, Johannes; Rinner, Heinrich; Tür, Andreas; Kreuzer, Hans; Thiemann, Norbert; Knoflach, Michael; Toell, Thomas; Pechlaner, Raimund; Willeit, Karin; Klingler, Natalie; Praxmarer, Silvia; Baubin, Michael; Beck, Gertrud; Berek, Klaus; Dengg, Christian; Engelhardt, Klaus; Erlacher, Thomas; Fluckinger, Thomas; Grander, Wilhelm; Grossmann, Josef; Kathrein, Hermann; Kaiser, Norbert; Matosevic, Benjamin; Matzak, Heinrich; Mayr, Markus; Perfler, Robert; Poewe, Werner; Rauter, Alexandra; Schoenherr, Gudrun; Schoenherr, Hans-Robert; Schinnerl, Adolf; Spiss, Heinrich; Thurner, Theresa; Vergeiner, Gernot; Werner, Philipp; Wöll, Ewald; Willeit, Peter; Kiechl, Stefan

    2015-01-01

    Intravenous thrombolysis for ischaemic stroke remains underused worldwide. We aimed to assess whether our statewide comprehensive stroke management programme would improve thrombolysis use and clinical outcome in patients. In 2008-09, we designed the Tyrol Stroke Pathway, which provided information campaigns for the public and standardised the entire treatment pathway from stroke onset to outpatient rehabilitation. It was commenced in Tyrol, Austria, as a long-term routine-care programme and aimed to include all patients with stroke in the survey area. We focused on thrombolysis use and outcome in the first full 4 years of implementation (2010-13). We enrolled 4947 (99%) of 4992 patients with ischaemic stroke who were admitted to hospitals in Tyrol; 675 (14%) of the enrollees were treated with alteplase. Thrombolysis administration in Tyrol increased after programme implementation, from 160 of 1238 patients (12·9%, 95% CI 11·1-14·9) in 2010 to 213 of 1266 patients (16·8%, 14·8-19·0) in 2013 (ptrend 2010-13stroke programmes, thrombolysis administration remained stable or declined between 2010 and 2013 (mean reduction 14·4%, 95% CI 10·9-17·9). Although the 3-month mortality was not affected by our programme (137 [13%] of 1060 patients in 2010 vs 143 [13%] of 1069 patients in 2013), 3-month functional outcome significantly improved (modified Rankin Scale score 0-1 in 375 [40%] of 944 patients in 2010 vs 493 [53%] of 939 in 2013; score 0-2 in 531 [56%] patients in 2010 and 615 [65%] in 2013; ptrend 2010-13stroke management programme, thrombolysis administration increased and clinical outcome significantly improved, although mortality did not change. We hope that these results will guide health authorities and stroke physicians elsewhere when implementing similar programmes for patients with stroke. Reformpool of the Tyrolean Health Care Fund. Copyright © 2015 Elsevier Ltd. All rights reserved.

  9. Patient satisfaction and non-UK educated nurses: a cross-sectional observational study of English National Health Service Hospitals.

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    Germack, Hayley D; Griffiths, Peter; Sloane, Douglas M; Rafferty, Anne Marie; Ball, Jane E; Aiken, Linda H

    2015-12-02

    To examine whether patient satisfaction with nursing care in National Health Service (NHS) hospitals in England is associated with the proportion of non-UK educated nurses providing care. Cross-sectional analysis using data from the 2010 NHS Adult Inpatient Survey merged with data from nurse and hospital administrator surveys. Logistic regression models with corrections for clustering were used to determine whether the proportions of non-UK educated nurses were significantly related to patient satisfaction before and after taking account of other hospital, nursing and patient characteristics. 31 English NHS trusts. 12,506 patients 16 years of age and older with at least one overnight stay that completed a satisfaction survey; 2962 bedside care nurses who completed a nurse survey; and 31 NHS trusts. Patient satisfaction. The percentage of non-UK educated nurses providing bedside hospital care, which ranged from 1% to 52% of nurses, was significantly associated with patient satisfaction. After controlling for potential confounding factors, each 10-point increase in the percentage of non-UK educated nurses diminished the odds of patients reporting good or excellent care by 12% (OR=0.88), and decreased the odds of patients agreeing that they always had confidence and trust in nurses by 13% (OR=0.87). Other indicators of patient satisfaction also revealed lower satisfaction in hospitals with higher percentages of non-UK educated nurses. Use of non-UK educated nurses in English NHS hospitals is associated with lower patient satisfaction. Importing nurses from abroad to substitute for domestically educated nurses may negatively impact quality of care. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  10. Risk of postoperative hypoxemia in ambulatory orthopedic surgery patients with diagnosis of obstructive sleep apnea: a retrospective observational study

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    Ma Yan

    2010-06-01

    Full Text Available Abstract Background It is unclear when it is safe to discharge patients with a diagnosis of Obstructive Sleep Apnea (OSA after ambulatory surgical procedures due to concern for postoperative respiratory compromise and hypoxemia. Our OSA patients undergoing ambulatory-type orthopedic procedures are monitored overnight in the PACU, thus we reviewed patient records to determine incidence of complications. Methods Two hundred and six charts of patients with preoperative diagnosis of OSA based on ICD-9 codes were reviewed for outcomes including episodes of hypoxemia. Univariate analysis followed by logistic regression and propensity analysis was performed to determine independent risk factors for hypoxemia and association with adverse outcomes. Results The majority of patients had regional anesthesia (95%. Thirty four percent of patients had hypoxemia in the PACU. Initial risk factors for hypoxemia identified by univariate analysis were BMI ≥ 35, increased age, history of COPD, upper extremity procedure, and use of peripheral nerve block. Independent risk factors identified by logistic regression were history of COPD (OR 3.64 with 95% CI 1.03-12.88 and upper extremity procedure (2.53, 1.36-4.68. After adjustment with propensity scores, adverse events were rare, and unplanned hospital admission after PACU stay was not increased with hypoxemia (11% vs 16% Conclusions Episodes of postoperative hypoxemia in OSA patients undergoing ambulatory surgery with regional anesthesia are not associated with increased adverse outcomes or unplanned hospital admission.

  11. The real world effect of omalizumab add on therapy for patients with moderate to severe allergic asthma: The ASTERIX Observational study.

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    Mohit Bhutani

    Full Text Available Omalizumab is a non-steroidal medication indicated for the treatment of poorly controlled moderate-to-severe allergic asthmatics. This observational study examines the "real world" effectiveness of omalizumab in this population.This is a one year open-label observational study that compared clinical outcomes including total oral corticosteroid use, exacerbation history, measures of quality of life and inflammation in patients with moderate-to-severe allergic asthma, who were prescribed omalizumab as part of their treatment with the year prior to therapy.A total of 99 patients were enrolled at 25 sites in Canada. During the study period, the mean total annual OCS dose was reduced from 2301.5 mg (prednisone equivalents in the year prior to omalizumab to 1130.0 mg (p<0.0001. There was a 71% reduction in asthma exacerbations and 56% of patients on omalizumab remained exacerbation free when compared to the year prior to study entry. Associated with this was reduced health care utilization. There were significant improvements in the Asthma Control Questionnaire (ACQ and Asthma Quality of Life questionnaire (AQLQ Patients with an elevated FeNO at baseline showed a better response to treatment. No new safety issues were identified during the study period.Our study demonstrates that in "real world" clinical practice, after initiating omalizumab, there is a reduction in total OCS use and exacerbation frequency in patients with moderate-to-severe allergic asthma. Patients on treatment reported improved asthma control and quality of life. FeNO may be a useful biomarker to identify patients who may benefit with omalizumab treatment.

  12. HFE gene mutation and oxidative damage biomarkers in patients with myelodysplastic syndromes and its relation to transfusional iron overload: an observational cross-sectional study.

    Science.gov (United States)

    De Souza, Geane Felix; Ribeiro, Howard Lopes; De Sousa, Juliana Cordeiro; Heredia, Fabíola Fernandes; De Freitas, Rivelilson Mendes; Martins, Manoel Ricardo Alves; Gonçalves, Romélia Pinheiro; Pinheiro, Ronald Feitosa; Magalhães, Silvia Maria Meira

    2015-04-03

    A relation between transfusional IOL (iron overload), HFE status and oxidative damage was evaluated. An observational cross-sectional study involving 87 healthy individuals and 78 patients with myelodysplastic syndromes (MDS) with and without IOL, seen at University Hospital of the Federal University of Ceará, Brazil, between May 2010 and September 2011. IOL was defined using repeated measures of serum ferritin ≥1000 ng/mL. Variations in the HFE gene were investigated using PCR/restriction fragment length polymorphism (RFLP). The biomarkers of oxidative stress (plasmatic malonaldehyde (MDA), glutathione peroxidase (GPx) and superoxide dismutase (SOD)) were determined by spectrophotometry. The HFE gene variations were identified in 24 patients (30.77%) and 5 volunteers (5.74%). The H63D variant was observed in 35% and the C282Y variant as heterozygous in 5% of patients with MDS with IOL. One patient showed double heterozygous variant (C282Y/H63D) and serum ferritin of 11,649 ng/mL. In patients without IOL, the H63D variant was detected in 29.34%. Serum MDA levels were highest in patients with MDS with IOL, with a significant difference when compared with patients without IOL and healthy volunteers, pointing to the relationship between IOL and oxidative stress. The GPx and SOD were also significantly higher in these patients, indicating that lipid peroxidation increase was followed by an increase in antioxidant capacity. Higher ferritin levels were observed in patients with HFE gene variation. 95.7% of patients with MDS with the presence of HFE gene variations had received more of 20 transfusions. We observed a significant increase in MDA levels in patients with MDS and IOL, suggesting an increased lipid peroxidation in these patients. The accumulation of MDA alters the organisation of membrane phospholipids, contributing to the process of cellular degeneration. Results show that excess iron intensifies the process of cell damage through oxidative stress

  13. Psychosocial and nonclinical factors predicting hospital utilization in patients of a chronic disease management program: a prospective observational study.

    Science.gov (United States)

    Tran, Mark W; Weiland, Tracey J; Phillips, Georgina A

    2015-01-01

    Psychosocial factors such as marital status (odds ratio, 3.52; 95% confidence interval, 1.43-8.69; P = .006) and nonclinical factors such as outpatient nonattendances (odds ratio, 2.52; 95% confidence interval, 1.22-5.23; P = .013) and referrals made (odds ratio, 1.20; 95% confidence interval, 1.06-1.35; P = .003) predict hospital utilization for patients in a chronic disease management program. Along with optimizing patients' clinical condition by prescribed medical guidelines and supporting patient self-management, addressing psychosocial and nonclinical issues are important in attempting to avoid hospital utilization for people with chronic illnesses.

  14. Are patients’ preferences regarding the place of treatment heard and addressed at the point of referral: an exploratory study based on observations of GP-patient consultations

    Science.gov (United States)

    2013-01-01

    Background Today, in several north-western European countries, patients are encouraged to choose, actively, a healthcare provider. However, patients often visit the provider that is recommended by their general practitioner (GP). The introduction of patient choice requires GPs to support patients to be involved, actively, in the choice of a healthcare provider. We aim to investigate whether policy on patient choice is reflected in practice, i.e. what the role of the patient is in their choices of healthcare providers at the point of referral and to what extent GPs’ and patients’ healthcare paths influence the role that patients play in the referral decision. Methods In 2007–2008, we videotaped Dutch GP-patient consultations. For this study, we selected, at random, 72 videotaped consultations between 72 patients and 39 GPs in which the patient was referred to a healthcare provider. These were analysed using an observation protocol developed by the researchers. Results The majority of the patients had little or no input into the choice of a healthcare provider at the point of referral by their GP. Their GPs did not support them in actively choosing a provider and the patients often agreed with the provider that the GP proposed. Patients who were referred for diagnostic purposes seem to have had even less input into their choice of a provider than patients who were referred for treatment. Conclusions We found that the GP chooses a healthcare provider on behalf of the patient in most consultations, even though policy on patient choice expects from patients that they choose, actively, a provider. On the one hand, this could indicate that the policy needs adjustments. On the other hand, adjustments may be needed to practice. For instance, GPs could help patients to make an active choice of provider. However, certain patients prefer to let their GP decide as their agent. Even then, GPs need to know patients’ preferences, because in a principal-agent relationship

  15. Effects of Speech Therapy in Hospitalized Patients with Post-Stroke Dysphagia: A Systematic Review of Observational Studies

    Directory of Open Access Journals (Sweden)

    Joice Santos Andrade

    2017-12-01

    Conclusion: Speech therapy in hospital bed in post-stroke hospitalized patients with dysphagia seems to bring satisfactory results in the short-term, revealing the importance of diagnosis and early intervention in these cases.

  16. Bleeding Risk Related to Upper Gastrointestinal Endoscopic Biopsy in Patients Receiving Antithrombotic Therapy: A Multicenter Prospective Observational Study

    Directory of Open Access Journals (Sweden)

    Takafumi Yuki, MD, PhD

    2017-01-01

    Conclusions: We found no significant increase in upper-GI bleeding risk following an EGD biopsy in patients taking antithrombotic agents, suggesting its safety without the need for antithrombotic treatment interruption.

  17. Evaluation of coagulation activation after rhinovirus infection in patients with asthma and healthy control subjects: an observational study

    NARCIS (Netherlands)

    Majoor, Christof J.; van de Pol, Marianne A.; Kamphuisen, Pieter Willem; Meijers, Joost C. M.; Molenkamp, Richard; Wolthers, Katja C.; van der Poll, Tom; Nieuwland, Rienk; Johnston, Sebastian L.; Sterk, Peter J.; Bel, Elisabeth H. D.; Lutter, Rene; van der Sluijs, Koenraad F.

    2014-01-01

    Asthma exacerbations are frequently triggered by rhinovirus infections. Both asthma and respiratory tract infection can activate haemostasis. Therefore we hypothesized that experimental rhinovirus-16 infection and asthmatic airway inflammation act in synergy on the haemostatic balance. 28 patients

  18. Reliability of Ultrasound Diameter Measurements in Patients with a Small Asymptomatic Popliteal Artery Aneurysm: An Intra- and Inter-observer Agreement Study.

    Science.gov (United States)

    Zwiers, I; Hoogland, C M T; Mackaay, A J C

    2016-03-01

    In this study the intra- and inter-observer variability of ultrasound measurements of the diameter of the popliteal artery were tested in a group of patients under surveillance for a small (diameter 10-20 mm), asymptomatic popliteal artery aneurysm (PAA). From a group of patients under ultrasound surveillance for bilateral, asymptomatic PAAs, 13 consecutive patients agreed to participate in the study and provided informed consent. The maximum diameter of the popliteal arteries was assessed by a vascular technologist. The same assessment was repeated by a second vascular technologist, unaware of the results of the first measurement. After a week, this protocol was repeated. The intra- and inter-observer reliability of this measurement was calculated using intra-class correlation coefficients (ICCs) and Bland and Altman plots. Of the 10 patients with bilateral and three patients with unilateral PAA, 12 completed the 2 week protocol. A total of 86 measurements were analyzed. The mean diameter of the popliteal arteries was 13.5 ± 3.4 mm. The ICC for the intra-observer reliability of observer 1 was 0.96 (95% CI 0.92-0.99), p .47. The absolute magnitude of the systematic error of both observers was less than 0.135 mm (median 0.00). Ultrasound measurement of the maximum diameter of the popliteal artery is reproducible; hence, it is suitable for making a clinical treatment decision. Its use for surveillance of small, asymptomatic PAAs is justified. Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

  19. A national, multicenter, non-interventional, observational study on treatment patterns in patients with metastatic renal cell carcinoma in Turkey – NOTES study

    Directory of Open Access Journals (Sweden)

    Yalcin Ş

    2018-03-01

    Full Text Available Şuayib Yalçın,1 Ramazan Yildiz,2 Faysal Dane,3 Aziz Karaoğlu,4 Berna Öksüzoğlu,5 Özgür Özyılkan,6 Alper Sevinç,7 Feyyaz Özdemir,8 Hande Turna,9 Rüçhan Uslu,10 Esat Ulay11 1Hacettepe University, Department of Medical Oncology, Ankara, Turkey; 2Gazi University, Department of Medical Oncology, Ankara, Turkey; 3Marmara University, Department of Medical Oncology, İstanbul, Turkey; 4Dokuz Eylül University, Department of Medical Oncology, İzmir, Turkey; 5Ankara Oncology Hospital, Clinic of Medical Oncology, Ankara, Turkey; 6Başkent University, Department of Medical Oncology, Ankara, Turkey; 7Medical Park Gaziantep Hospital, Medical Oncology Unit, Gaziantep, Turkey; 8Karadeniz Technical University, Department of Medical Oncology, Trabzon, Turkey; 9İstanbul University, Department of Medical Oncology, İstanbul, Turkey; 10Ege University, Department of Medical Oncology, İzmir, Turkey; 11Novartis Oncology, İstanbul, Turkey Introduction: The introduction of targeted therapies in renal cell carcinoma has significantly improved its prognosis and treatment outcomes in recent years. Such treatment options are targeted therapies of the vascular endothelial growth factor (VEGF pathway and the mammalian target of the rapamycin pathway. With the use of tyrosine kinase inhibitors (TKIs and mammalian target of the rapamycin inhibitors, overall survival has increased up to 2 years. In Turkey, due to applicable reimbursement conditions for patients with metastatic renal cell carcinoma (mRCC, interferon use is mandated as a first-line treatment, thus providing information on the use of everolimus only after initial interferon and second-line VEGF-targeted treatments such as VEGF-TKI. Patients and methods: To provide a first real-life data set in Turkey, we conducted a prospective, non-interventional, observational study and assessed the efficacy and safety of everolimus after two lines of treatment including interferon. A total of 100 patients with

  20. What does built-in software of home ventilators tell us? An observational study of 150 patients on home ventilation.

    Science.gov (United States)

    Pasquina, Patrick; Adler, Dan; Farr, Pamela; Bourqui, Pascale; Bridevaux, Pierre Olivier; Janssens, Jean-Paul

    2012-01-01

    Recent home ventilators are equipped with built-in software which provides data such as compliance, estimations of leaks, tidal volume, minute ventilation, respiratory rate, apnea and apnea-hypopnea indexes, and percentage of inspirations triggered by the patient (or ventilator). However, for many of these variables, there is neither consensus nor documentation as to what is to be expected in a population of stable patients under noninvasive ventilation (NIV). To document the values and distribution of specific items downloaded from ventilator monitoring software, by diagnostic category. Analysis of data downloaded from home ventilators in clinically stable patients under long-term NIV, during elective home visits by specialized nurses. Data were collected from home ventilators of 150 patients with chronic obstructive pulmonary disease (n = 32), overlap syndrome (n = 29), obesity-hypoventilation (n = 38), neuromuscular disorders (n = 19), restrictive disorders (n = 21), and central sleep apnea syndrome (n = 11). On average, leaks were low, being lowest in patients with facial masks (vs. nasal masks), and increased with older age. Compliance was excellent in all groups. Patients with neuromuscular diseases triggered their ventilators less and tended to be 'captured', while other groups triggered at least half of inspiratory cycles. Most patients had a respiratory rate just slightly above the back-up rate. Residual apneas and hypopneas were highest in patients with central apneas. Built-in software of home ventilators provides the clinician with new parameters, some of which are a useful adjunct to recommended tools for monitoring NIV and may contribute to a better understanding of residual hypoventilation and/or desaturations. However, an independent validation of the accuracy of this information is mandatory. Copyright © 2011 S. Karger AG, Basel.

  1. Related factors to semi-recumbent position compliance and pressure ulcers in patients with invasive mechanical ventilation: An observational study (CAPCRI study).

    Science.gov (United States)

    Llaurado-Serra, Mireia; Ulldemolins, Marta; Fernandez-Ballart, Joan; Guell-Baro, Rosa; Valentí-Trulls, Teresa; Calpe-Damians, Neus; Piñol-Tena, Angels; Pi-Guerrero, Mercedes; Paños-Espinosa, Cristina; Sandiumenge, Alberto; Jimenez-Herrera, María F

    2016-09-01

    Semi-recumbent position is recommended to prevent ventilator-associated pneumonia. Its implementation, however, is below optimal. We aimed to assess real semi-recumbent position compliance and the degree of head-of-bed elevation in Spanish intensive care units, along with factors determining compliance and head-of-bed elevation and their relationship with the development of pressure ulcers. Finally, we investigated the impact that might have the diagnosis of pressure ulcers in the attitude toward head-of-bed elevation. We performed a prospective, multicenter, observational study in 6 intensive care units. Inclusion criteria were patients ≥18 years old and expected to remain under mechanical ventilator for ≥48h. Exclusion criteria were patients with contraindications for semi-recumbent position from admission, mechanical ventilation during the previous 7 days and prehospital intubation. Head-of-bed elevation was measured 3 times/day for a maximum of 28 days using the BOSCH GLM80(®) device. The variables collected related to patient admission, risk of pressure ulcers and the measurements themselves. Bivariate and multivariate analyses were carried out using multiple binary logistic regression and linear regression as appropriate. Statistical significance was set at preplacement therapy, nursing shift, open abdomen, abdominal vacuum therapy and agitation. Twenty-five patients (9.1%) developed a total of 34 pressure ulcers. The diagnosis of pressure ulcers did not affect the head-of-bed elevation. In the multivariate analysis, head-of-bed elevation was not identified as an independent risk factor for pressure ulcers. Semi-recumbent position compliance is below optimal despite the fact that it seems achievable most of the time. Factors that affect semi-recumbent position include the particular intensive care unit, abdominal conditions, renal replacement therapy, agitation and bed type. Head-of-bed elevation was not related to the risk of pressure ulcers. Efforts

  2. Portuguese Observational Study of Ischaemic Stroke in Patients Medicated with Non-Vitamin K Antagonist Oral Anticoagulants.

    Science.gov (United States)

    Beato-Coelho, José; Marto, João Pedro; Alves, José Nuno; Marques-Matos, Cláudia; Calado, Sofia; Araújo, José; Cunha, Luís; Pinho, João; Azevedo, Elsa; Viana-Baptista, Miguel; Sargento-Freitas, João

    2018-01-01

    Clinical trials and subsequent meta-analyses showed advantages of non-vitamin K antagonists oral anticoagulants (NOACs) over vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation. The impact of preadmission anticoagulation in acute ischaemic stroke (AIS) has not been established. To compare functional outcome of patients with AIS with preadmission NOACs vs. VKAs. A retrospective analysis was conducted on consecutive AIS patients under oral anticoagulation (VKAs or NOACs) admitted in 4 Portuguese hospitals within a period of 30 months. Two primary outcomes were defined and compared between VKA and NOAC groups: symptomatic intracerebral hemorrhage transformation (sICH) and modified Rankin Scale (mRS) at 3 months. Four hundred sixty-nine patients were included, of whom 332 (70.8%) were treated with VKA and 137 (29.2%) with NOAC. Patients' median age was 78.0 and 234 (49.9%) were male. NOAC-treated patients had a higher median CHA2DS2-VASc score than those under VKA (5.0 vs. 4.0, p = 0.023). The two primary outcomes showed no statistical differences between the VKAs' group and the NOACs' group (sICH: 5.4 vs. 5.4% [p = 0.911]; mRS at 3 months: 3.0 vs. 3.0 [p = 0.646], respectively). Preadmission anticoagulation with NOACs in AIS has a functional impact similar to that of VKAs. © 2018 S. Karger AG, Basel.

  3. Transoral laser resection or radiotherapy? Patient choice in the treatment of early laryngeal cancer: a prospective observational cohort study.

    Science.gov (United States)

    Zahoor, T; Dawson, R; Sen, M; Makura, Z

    2017-06-01

    The choices made by patients offered treatment for early laryngeal cancer with radiotherapy or transoral laser resection were reviewed. A prospective review was conducted of all patients diagnosed and treated for early laryngeal carcinoma from December 2002 to September 2009 at the Leeds Teaching Hospitals NHS Trust. A total of 209 patients with tumour stage T1 or T2 laryngeal cancer were treated; each new patient suitable for radiotherapy or transoral laser resection was seen jointly by the clinical (radiation) oncologist and head and neck surgeon, and offered the choice of treatment. Of the patients, 47.4 per cent were given a choice between radiotherapy and transoral laser resection; 51.2 per cent were advised to have radiotherapy, and there were no records for the remaining 1.4 per cent. From those given the choice, 59.6 per cent chose transoral laser resection (p < 0.02 (t-test)) and 35.4 per cent chose radiotherapy. When given the choice, a statistically significant majority of patients choose transoral laser resection rather than radiotherapy.

  4. Preeruptive intracoronal resorption observed in 13 patients

    DEFF Research Database (Denmark)

    Kjær, Inger; Steiniche, Kirsten; Kortegaard, Ulla

    2012-01-01

    The literature on preeruptive intracoronal resorption is sparse, comprising mainly reports of single patients. This study includes 13 patients with preeruptive intracoronal resorption, forwarded for consultation regarding diagnostics and etiology. The purposes were to determine which teeth...

  5. Association of body temperature and antipyretic treatments with mortality of critically ill patients with and without sepsis: multi-centered prospective observational study

    Science.gov (United States)

    2012-01-01

    Introduction Fever is frequently observed in critically ill patients. An independent association of fever with increased mortality has been observed in non-neurological critically ill patients with mixed febrile etiology. The association of fever and antipyretics with mortality, however, may be different between infective and non-infective illness. Methods We designed a prospective observational study to investigate the independent association of fever and the use of antipyretic treatments with mortality in critically ill patients with and without sepsis. We included 1,425 consecutive adult critically ill patients (without neurological injury) requiring > 48 hours intensive care admitted in 25 ICUs. We recorded four-hourly body temperature and all antipyretic treatments until ICU discharge or 28 days after ICU admission, whichever occurred first. For septic and non-septic patients, we separately assessed the association of maximum body temperature during ICU stay (MAXICU) and the use of antipyretic treatments with 28-day mortality. Results We recorded body temperature 63,441 times. Antipyretic treatment was given 4,863 times to 737 patients (51.7%). We found that treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen independently increased 28-day mortality for septic patients (adjusted odds ratio: NSAIDs: 2.61, P = 0.028, acetaminophen: 2.05, P = 0.01), but not for non-septic patients (adjusted odds ratio: NSAIDs: 0.22, P = 0.15, acetaminophen: 0.58, P = 0.63). Application of physical cooling did not associate with mortality in either group. Relative to the reference range (MAXICU 36.5°C to 37.4°C), MAXICU ≥ 39.5°C increased risk of 28-day mortality in septic patients (adjusted odds ratio 8.14, P = 0.01), but not in non-septic patients (adjusted odds ratio 0.47, P = 0.11). Conclusions In non-septic patients, high fever (≥ 39.5°C) independently associated with mortality, without association of administration of NSAIDs or

  6. Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report

    Science.gov (United States)

    Terao, Takeshi; Ishida, Atsuko; Kimura, Toshifumi; Yoshida, Mitsuhiro; Hara, Terufumi

    2017-01-01

    Background A post-marketing surveillance (PMS) study was conducted with a 1-year observation period to assess the safety and efficacy of lamotrigine in routine clinical practice in patients with bipolar disorder (BD). Patients and methods Central enrollment method was used to recruit patients diagnosed with BD who were being treated for the first time with lamotrigine to prevent the recurrence/relapse of BD mood episodes. Adverse drug reactions (ADRs) and recurrence/relapse were assessed. Improvement of mania and depression was also assessed using the Hamilton’s Rating Scale for Depression (HAM-D) and the Young Mania Rating Scale (YMRS) at treatment initiation, 4–6 months post treatment initiation, and 10–12 months post treatment initiation. Results A total of 237/989 patients (24.0%) reported ADRs, most commonly rash (9.1%), and the incidence of serious ADRs was 3.3% (33/989 patients). Skin disorders occurred in 130 patients (13.1%), mostly within 8 weeks post treatment. A total of 237/703 patients (33.7%) experienced recurrence/relapse of mood episodes. The 25th percentile of the time to recurrence/relapse of mood episodes was 105 days. Remission of depression symptoms (HAM-D ≤7) occurred in 147/697 patients (21.1%) at treatment initiation, rising to 361 patients (67.4%) at 10–12 months post treatment. Remission of manic symptoms (YMRS ≤13) occurred in 615/676 patients (91.0%) at treatment initiation, rising to 500 patients (97.3%) at 10–12 months post treatment. Conclusion The results of this PMS study suggest that lamotrigine is a well-tolerated and effective drug for preventing recurrence/relapse of BD in clinical practice. PMID:28652744

  7. Increased Severe Trauma Patient Volume is Associated With Survival Benefit and Reduced Total Health Care Costs: A Retrospective Observational Study Using a Japanese Nationwide Administrative Database.

    Science.gov (United States)

    Endo, Akira; Shiraishi, Atsushi; Fushimi, Kiyohide; Murata, Kiyoshi; Otomo, Yasuhiro

    2017-06-07

    The aim of this study was to evaluate the associations of severe trauma patient volume with survival benefit and health care costs. The effect of trauma patient volume on survival benefit is inconclusive, and reports on its effects on health care costs are scarce. We conducted a retrospective observational study, including trauma patients who were transferred to government-approved tertiary emergency hospitals, or hospitals with an intensive care unit that provided an equivalent quality of care, using a Japanese nationwide administrative database. We categorized hospitals according to their annual severe trauma patient volumes [1 to 50 (reference), 51 to 100, 101 to 150, 151 to 200, and ≥201]. We evaluated the associations of volume categories with in-hospital survival and total cost per admission using a mixed-effects model adjusting for patient severity and hospital characteristics. A total of 116,329 patients from 559 hospitals were analyzed. Significantly increased in-hospital survival rates were observed in the second, third, fourth, and highest volume categories compared with the reference category [94.2% in the highest volume category vs 88.8% in the reference category, adjusted odds ratio (95% confidence interval, 95% CI) = 1.75 (1.49-2.07)]. Furthermore, significantly lower costs (in US dollars) were observed in the second and fourth categories [mean (standard deviation) for fourth vs reference = $17,800 ($17,378) vs $20,540 ($32,412), adjusted difference (95% CI) = -$2559 (-$3896 to -$1221)]. Hospitals with high volumes of severe trauma patients were significantly associated with a survival benefit and lower total cost per admission.

  8. Thrombopoietin receptor agonists for preparing adult patients with immune thrombocytopenia to splenectomy: results of a retrospective, observational GIMEMA study.

    Science.gov (United States)

    Zaja, Francesco; Barcellini, Wilma; Cantoni, Silvia; Carpenedo, Monica; Caparrotti, Giuseppe; Carrai, Valentina; Di Renzo, Nicola; Santoro, Cristina; Di Nicola, Massimo; Veneri, Dino; Simonetti, Federico; Liberati, Anna M; Ferla, Valeria; Paoloni, Francesca; Crea, Enrico; Volpetti, Stefano; Tuniz, Enrica; Fanin, Renato

    2016-05-01

    In patients with immune thrombocytopenia (ITP) refractory to corticosteroids and intravenous immunoglobulins (IVIG), splenectomy may result at higher risk of peri-operative complications and, for this reason, potentially contraindicated. The thrombopoietin receptor agonists (TPO-RAs) romiplostim and eltrombopag have shown high therapeutic activity in primary ITP, but data of efficacy and safety regarding their use in preparation for splenectomy are missing. Thirty-one adult patients, median age 50 years, with corticosteroids and/or IVIG refractory persistent and chronic ITP who were treated with TPO-RAs (romiplostim= 24; eltrombopag= 7) with the aim to increase platelet count and allow a safer execution of splenectomy were retrospectively evaluated. Twenty-four patients (77%) responded to the use of TPO-RAs with a median platelet count that increased from 11 × 10(9) /L before starting TPO-RAs to 114 × 10(9) /L pre-splenectomy, but a concomitant treatment with corticosteroids and/or IVIG was required in 19 patients. Twenty-nine patients underwent splenectomy while two patients who responded to TPO-RAs subsequently refused surgery. Post-splenectomy complications were characterized by two Grade 3 thrombotic events (1 portal vein thrombosis in the patient with previous history of HCV hepatitis and 1 pulmonary embolism), with a platelet count at the time of thrombosis of 260 and 167 × 10(9) /L, respectively and one Grade 3 infectious event. TPO-RAs may represent a therapeutic option to improve platelet count and reduce the risk of peri-operative complications in ITP candidates to splenectomy. An increased risk of post-splenectomy thromboembolic events cannot be ruled out and thromboprophylaxis with low-molecular weight heparin is generally recommended. © 2016 Wiley Periodicals, Inc.

  9. Burden and outcomes of pressure ulcers in cancer patients receiving the Kerala model of home based palliative care in India: Results from a prospective observational study

    Directory of Open Access Journals (Sweden)

    Biji M Sankaran

    2015-01-01

    Full Text Available Aim: To report the prevalence and outcomes of pressure ulcers (PU seen in a cohort of cancer patients requiring home-based palliative care. Materials and Methods: All patients referred for home care were eligible for this prospective observational study, provided they were living within a distance of 35 km from the institute and gave informed consent. During each visit, caregivers were trained and educated for providing nursing care for the patient. Dressing material for PU care was provided to all patients free of cost and care methods were demonstrated. Factors influencing the occurrence and healing of PUs were analyzed using logistic regression. Duration for healing of PU was calculated using the Kaplan Meier method. P < 0.05 are taken as significant. Results: Twenty-one of 108 (19.4% enrolled patients had PU at the start of homecare services. None of the patients developed new PU during the course of home care. Complete healing of PU was seen in 9 (42.9% patients. The median duration for healing of PU was found to be 56 days. Median expenditure incurred in patients with PU was Rs. 2323.40 with a median daily expenditure of Rs. 77.56. Conclusions: The present model of homecare service delivery was found to be effective in the prevention and management of PUs. The high prevalence of PU in this cohort indicates a need for greater awareness for this complication. Clinical Trial Registry Number: CTRI/2014/03/004477

  10. Low, rather than High, Body Mass Index Is a Risk Factor for Acute Kidney Injury in Multiethnic Asian Patients: A Retrospective Observational Study

    Directory of Open Access Journals (Sweden)

    Allen Yan Lun Liu

    2018-01-01

    Full Text Available Background. Acute kidney injury (AKI is common in hospitalised patients. The relationship between body mass index (BMI and the risk of having AKI for patients in the acute hospital setting is not known, particularly in the Asian population. Methods. This was a retrospective, single-centre, observational study conducted in Singapore, a multiethnic population. All patients aged ≥21 years and hospitalised from January to December 2013 were recruited. Results. A total of 12,555 patients were eligible for the analysis. A BMI of <18.5 kg/m2 was independently associated with the development of AKI in hospitalised patients (odds ratio (OR: 1.23 [95% confidence interval [CI]: 1.04–1.44, P=0.01] but not for overweight and obesity. Subgroup analysis further revealed that underweight patients aged ≥75 and repeated hospitalisation posed a higher risk of AKI (OR: 1.25 [CI: 1.01–1.56], P=0.04; OR: 1.23 [CI: 1.04–1.44], P=0.01, resp.. Analyses by interactions between different age groups and BMI using continuous or categorised variables did not affect the overall probability of developing AKI. Conclusions. Underweight Asian patients are susceptible to AKI in acute hospital settings. Identification of this novel risk factor for AKI allows us to optimise patient care by prevention, early detection, and timely intervention.

  11. Evaluating the impact of spirituality on the quality of life, anxiety, and depression among patients with cancer: an observational transversal study.

    Science.gov (United States)

    Chaar, Emile Abou; Hallit, Souheil; Hajj, Aline; Aaraj, Racha; Kattan, Joseph; Jabbour, Hicham; Khabbaz, Lydia Rabbaa

    2018-02-16

    Spiritual well-being was found to have some protective effect against end-of life despair in cancer patients. We aimed at assessing the impact of spirituality on the quality of life, depression, and anxiety of Lebanese cancer patients. Our observational transversal monocentric study was conducted between January and April 2016 among a convenient sample of 115 Lebanese cancer patients admitted to Hôtel-Dieu de France Hospital (HDF), Beirut-Lebanon. In addition to socio-demographic and clinical data, three questionnaires were used: EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, 3rd version), FACIT-Sp-12 (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being; The 12-item Spiritual Well-Being Scale, 4th version), and HADS (Hospital Anxiety and Depression Scale). Eighteen patients taking anxiolytic and/or antidepressants were not included in the analysis. The remaining 97 patients were analyzed. Better emotional and cognitive functioning was seen in patients with higher meaning, peace, faith, and total FACIT scores. Meaning, peace, and total FACIT scores were also higher among patients with better global health status and quality of life. Anxiety as well as depression was significantly associated to all spiritual well-being factors. Spirituality can improve quality of life and decrease the incidence of anxiety and depression in cancer patients. Our results highlight the need to incorporate spiritual care in healthcare systems.

  12. Quality of life, compliance, safety and effectiveness in fit older metastatic colorectal patients with cancer treated in first-line with chemotherapy plus cetuximab: A restrospective analysis from the ObservEr study.

    Science.gov (United States)

    Rosati, Gerardo; Pinto, Carmine; Di Fabio, Francesca; Chiara, Silvana; Lolli, Ivan R; Ruggeri, Enzo M; Ciuffreda, Libero; Ferrara, Raimondo; Antonuzzo, Lorenzo; Adua, Daniela; Racca, Patrizia; Bilancia, Domenico; Benincasa, Elena; Stroppolo, Maria Elena; Di Costanzo, Francesco

    2018-05-01

    The influence of age (<70 years and ≥70 years) was retrospectively studied on the quality of life (QoL), incidence of side effects (including skin reactions) and efficacy of chemotherapy plus cetuximab in patients with KRAS wild type (WT) metastatic colorectal cancer (mCRC). 225 patients of the Observed study (PS 0-1) were retrieved based on age (< 70 and ≥70 years) and evaluated through EORTC QLQ-C30 and DLQI questionnaires. The two patient groups (141 < 70 and 84 ≥ 70 years, respectively) were balanced with no differences in any of the clinical and pathological characteristics considered. Both groups underwent similar type of first-line chemotherapy plus cetuximab, treatment duration and compliance. Cetuximab therapy caused similar incidence of side effects and impact on QoL in older and younger patients. No difference was observed in progression free survival (PFS) and in disease control rates between the two patient populations. Median overall survival (OS) was higher in patients <70 (27 months, 95% CI: 22.7-31.27) than in patients ≥70 (19 months, 95% CI: 14.65-23.35) (p = 0.002), which is likely due to higher proportions of metastatic resection (27.0% vs 8.3%; p = 0.001) and utilization of second-line therapy in younger group (58.9% vs 42.9%; p = 0.028). The current data suggest that fit older patients with mCRC can be safely treated with a cetuximab-based therapy, as QoL and safety profile do not seem to be affected by age. In addition, age did not impact the choice of chemotherapy to be associated to cetuximab and treatment compliance. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Major bleeding complications in patients treated with direct oral anticoagulants: One-year observational study in a Paris Hospital.

    Science.gov (United States)

    Deville, L; Konan, M; Hij, A; Goldwirt, L; Peyrony, O; Fieux, F; Faure, P; Madelaine, I; Villiers, S; Farge-Bancel, D; Frère, C

    Direct oral anticoagulants (DAOC) are indicated for the treatment of venous thromboembolism and the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation. Given their advantages and friendly use for patient, the prescription of long term DOAC therapy has rapidly increased both as first line treatment while initiating anticoagulation and as a substitute to vitamins K antagonist (VKA) in poorly controlled patients. However, DOAC therapy can also be associated with significant bleeding complications, and in the absence of specific antidote at disposal, treatment of serious hemorrhagic complications under DOAC remains complex. We report and discuss herein five cases of major hemorrhagic complications under DOAC, which were reported to the pharmacological surveillance department over one year at Saint-Louis University Hospital (Paris, France). We further discuss the need for careful assessment of the risk/benefit ratio at time of starting DOAC therapy in daily clinical practice. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  14. A cross-sectional observational study to assess inhaler technique in Saudi hospitalized patients with asthma and chronic obstructive pulmonary disease

    Science.gov (United States)

    Ammari, Maha Al; Sultana, Khizra; Yunus, Faisal; Ghobain, Mohammed Al; Halwan, Shatha M. Al

    2016-01-01

    Objectives: To assess the proportion of critical errors committed while demonstrating the inhaler technique in hospitalized patients diagnosed with asthma and chronic obstructive pulmonary disease (COPD). Methods: This cross-sectional observational study was conducted in 47 asthmatic and COPD patients using inhaler devices. The study took place at King Abdulaziz Medical City, Riyadh, Saudi Arabia between September and December 2013. Two pharmacists independently assessed inhaler technique with a validated checklist. Results: Seventy percent of patients made at least one critical error while demonstrating their inhaler technique, and the mean number of critical errors per patient was 1.6. Most patients used metered dose inhaler (MDI), and 73% of MDI users and 92% of dry powder inhaler users committed at least one critical error. Conclusion: Inhaler technique in hospitalized Saudi patients was inadequate. Health care professionals should understand the importance of reassessing and educating patients on a regular basis for inhaler technique, recommend the use of a spacer when needed, and regularly assess and update their own inhaler technique skills. PMID:27146622

  15. A randomized controlled study comparing community based with health facility based direct observation of treatment models on patients' satisfaction and TB treatment outcome in Nigeria.

    Science.gov (United States)

    Adewole, Olanisun O; Oladele, T; Osunkoya, Arinola H; Erhabor, Greg E; Adewole, Temitayo O; Adeola, Oluwaseun; Obembe, Olufemi; Ota, Martin O C

    2015-12-01

    Directly observed treatment short-course (DOTS) strategy is an effective mode of treating TB. We aimed to study the cost effectiveness and patients' satisfaction with home based direct observation of treatment (DOT), an innovative approach to community-based DOT (CBDOT) and hospital based DOT (HBDOT). A randomized controlled trial involving 150 newly diagnosed pulmonary TB patients in four TB clinics in Ile Ife , Nigeria, was done. They were randomly assigned to receive treatment with anti TB drugs for the intensive phase administered at home by a TB worker (CBDOT) or at the hospital (HBDOT). Outcome measures were treatment completion/default rates, cost effectiveness and patients' satisfaction with care using a 13 item patients satisfaction questionnaire (PS-13) at 2 months. This trial was registered with pactr.org: number PACTR 201503001058381. At the end of intensive phase, 15/75 (20%) and 2/75 (3%) of patients in the HBDOT and CBDOT, respectively had defaulted from treatment, p= 0.01. Of those with pretreatment positive sputum smear, 97% (68/70) on CBDOT and 54/67 (81%) on HBDOT were sputum negative for AFB at the end of 2 months of treatment, p=0.01. The CBDOT method was associated with a higher patient satisfaction score compared with HBDOT (OR 3.1; 95% CI 1.25-7.70), p=0.001.The total cost for patients was higher in HBDOT (US$159.38) compared with the CBDOT (US$89.52). The incremental cost effectiveness ratio was US$410 per patient who completed the intensive phase treatment with CBDOT. CBDOT is a cost effective approach associated with better compliance to treatment and better patient satisfaction compared to HBDOT. © The Author 2015. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  16. An observational cohort study of patients with newly diagnosed digital ulcer disease secondary to systemic sclerosis registered in the EUSTAR database.

    Science.gov (United States)

    Brand, Monika; Hollaender, Rebecca; Rosenberg, Daniel; Scott, Martin; Hunsche, Elke; Tyndall, Alan; Denaro, Valentina; Carreira, Patricia; Varju, Cecilia; Gabrielli, Barbara; Zingarelli, Stefania; Caramaschi, Paola; Simic-Pasalic, Katarina; Müller-Ladner, Ulf; Vasile, Massimiliano; Mihai, Carina; Rosato, Edoardo; Vacca, Alessandra; Zenone, Thierry; Mohamed, Walid A; Ancuta, Codrina; Zampogna, Giuseppe; Rednic, Simona; Jabaar, Nadia; Belloli, Laura; Pozzi, Maria R; Foti, Rosario; Walker, Ulrich A

    2015-01-01

    This study describes clinical characteristics, prognostic factors, and quality of life in patients with newly diagnosed (incident) digital ulcers (DU). Observational cohort study of 189 consecutive SSc patients with incident DU diagnosis identified from the EUSTAR database (22 centres in 10 countries). Data were collected from medical charts and during one prospective visit between 01/2004 and 09/2010. Median age at DU diagnosis was 51 years, majority of patients were female (88%), and limited cutaneous SSc was the most common subtype (61%). At incident DU diagnosis, 41% of patients had one DU and 59% had ≥2 DU; at the prospective visit 52% had DU. Pulmonary arterial hypertension (PAH) and multiple DU at diagnosis were associated with presence of any DU at the prospective visit (odds ratios: 4.34 and 1.32). During the observation period (median follow-up was 2 years) 127 patients had ≥1 hospitalisation. The event rate of new DU per person-year was 0.66, of DU-associated complications was 0.10, and of surgical or diagnostic procedures was 0.12. At the prospective visit, patients with ≥1 DU reported impairment in daily activities by 57%, those with 0 DU by 37%. The mean difference between patients with or without DU in the SF-36 physical component was 2.2, and in the mental component 1.4. DU patients were not routinely prescribed endothelin receptor antagonists or prostanoids. This real world cohort demonstrates that DU require hospital admission, and impair daily activity. PAH and multiple DU at diagnosis were associated with future occurrence of DU.

  17. An Open-Label, Multicenter Observational Study for Patients with Alzheimer’s Disease Treated with Memantine in the Clinical Practice

    Directory of Open Access Journals (Sweden)

    S.S. Stamouli

    2011-01-01

    Full Text Available Background/Aims: In this post-marketing observational study, the safety and effectiveness of memantine were evaluated in patients with Alzheimer’s disease (AD. Methods: In a 6-month, observational, open-label study at 202 specialist sites in Greece, the effectiveness of memantine was evaluated using the Mini-Mental State Examination (MMSE and the Instrumental Activities of Daily Living (IADL scale at baseline, and after 3 and 6 months. Discontinuation rates and adverse drug reactions (ADRs were also recorded to evaluate the safety profile of memantine. Results: 2,570 patients participated in the study. Three and 6 months after baseline, MMSE and IADL scores were significantly improved compared to baseline. At the end of the study, 67% of the patients had improved their MMSE score; 7.1% of the patients reported ≧1 ADRs, and treatment was discontinued due to ADR in 0.7%. Conclusion: Memantine was well tolerated and had a positive effect on the patient’s cognitive and functional ability in real-life clinical practice, in agreement with randomized, controlled trials.

  18. Time spent in primary care for hip osteoarthritis patients once the diagnosis is set : a prospective observational study

    NARCIS (Netherlands)

    Paans, Nienke; van der Veen, Willem Jan; van der Meer, Klaas; Bulstra, Sjoerd K.; van den Akker-Scheek, Inge; Stevens, Martin

    2011-01-01

    Background: Previous research on time to referral to orthopaedic surgery has predominantly used hip complaints as starting point instead of the moment the diagnosis of osteoarthritis (OA) of the hip is established, therefore little is known about the length of time a patient diagnosed with hip OA

  19. Shared Medical Appointments marginally enhance interaction between patients: an observational study on children and adolescents with type 1 diabetes.

    NARCIS (Netherlands)

    Noordman, J.; Dulmen, S. van

    2013-01-01

    Objective: To examine informational and emotional patient–provider and patient–patient communication sequences (i.e. cues and subsequent responses) during Shared Medical Appointments (SMAs) for children and adolescents with type 1 Diabetes Mellitus (T1DM) and their parents. Methods: 57

  20. Electroacupuncture Improves Bladder and Bowel Function in Patients with Traumatic Spinal Cord Injury: Results from a Prospective Observational Study

    Directory of Open Access Journals (Sweden)

    Zhishun Liu

    2013-01-01

    Full Text Available In order to explore the effect of electroacupuncture (EA for chronic bowel and bladder dysfunction after traumatic spinal cord injury, 14 patients were treated with electroacupuncture once a day, five times a week for the first four weeks, and once every other day, three times a week for the following four weeks. The patients were then followed up for six months. After treatment, four (4/14, 28.57% patients resumed normal voiding; six (6/14, 42.86% resumed normal voiding for no less than half of all micturition behaviors; four (4/14, 28.57% required supplementary urination methods for higher than half of all micturition behaviors. These effects persisted during followup. Mean postvoid RUV decreased by 190.29±101.87 mL (P<0.01 after treatment and by 198.86±112.18 mL (P<0.01 during followup. Patients’ weekly urinary incontinence frequency decreased 7.14±46.34 times/week (P=0.036 after treatment and decreased 49.86±44.38 times/week during followup. After treatment, four (4/14, 28.57% patients resumed normal bowel movements (P=0.025; five (5/14, 35.71% reduced the dependence on supplementary defecation methods; five (5/14, 35.71% had no changes. In patients with chronic bowel and bladder dysfunction after traumatic SCI, EA may provide a valuable alternative tool in improving patients’ self-controlled bowel and bladder functions with minimal side effects.

  1. Predictors for half-year outcome of impairment in daily life for back pain patients referred for physiotherapy: a prospective observational study.

    Science.gov (United States)

    Karstens, Sven; Hermann, Katja; Froböse, Ingo; Weiler, Stephan W

    2013-01-01

    From observational studies, there is only sparse information available on the predictors of development of impairment in daily life for patients receiving physiotherapy. Therefore, our aim was to identify factors which predict impairment in daily life for patients with back pain 6 months after receiving physiotherapy. We conducted a prospective cohort study with 6-month follow-up. Patients were enrolled for treatment in private physiotherapy practices. Patients with a first physiotherapy referral because of thoracic or low back pain, aged 18 to 65 years were included. Primary outcome impairment was measured utilising the 16-item version of the Musculoskeletal Function Assessment Questionnaire. Therapy was documented on a standardized form. Baseline scores for impairment in daily life, symptom characteristics, sociodemographic and psychosocial factors, physical activity, nicotine consumption, intake of analgesics, comorbidity and delivered primary therapy approach were investigated as possible predictors. Univariate and multiple linear regression analyses were performed. A total of 792 patients participated in the study (59% female, mean age 44.4 (SD 11.4), with 6-month follow-up results available from 391 patients. In univariate analysis 17 variables reached significance. In multiple linear regression identified predictors were: impairment in daily life before therapy, mental disorders, duration of the complaints, self-prognosis on work ability, rheumatoid arthritis, age, form of stress at work and physical activity. The variables explain 34% of variance (adjusted R(2), pphysiotherapy patients, this study adds new knowledge for forming appropriate referral guidelines. Impairment in daily life before therapy, mental disorder as comorbidity and the duration of the complaints can be named as outstanding factors. The results of this study can be used to facilitate comparison of patient therapy goals with the prognosis in everyday practice.

  2. Efficacy and tolerability of rasagiline in daily clinical use--a post-marketing observational study in patients with Parkinson's disease.

    Science.gov (United States)

    Reichmann, H; Jost, W H

    2010-09-01

    The MAO-B inhibitor rasagiline is indicated for the treatment of idiopathic Parkinson's disease (PD), and its use is supported by evidence from large-scale, controlled clinical studies. The post-marketing observational study presented here investigated the efficacy and tolerability of rasagiline treatment (monotherapy or combination therapy) in daily clinical practice. The study included patients with idiopathic PD who received rasagiline (recommended dose 1 mg, once daily) as monotherapy or combination therapy. The treatment and observation period was approximately 4 months. Outcome measures included the change from baseline in the Columbia University Rating Scale (CURS), the Unified PD Rating Scale fluctuation subscale, daily OFF time (patient home diaries) and the PD Questionnaire-39. Adverse drug reactions/adverse events (ADRs/AEs) and the physician's global judgement of tolerability and efficacy were also examined. Overall, 754 patients received rasagiline during the study. Patients treated with rasagiline (monotherapy or combination therapy) showed significant improvements from baseline in symptom severity (including classical motor and non-classical motor/non-motor symptoms) and quality of life (QoL). Patients receiving combination therapy also experienced significant reductions in daily OFF time. Tolerability was rated as good/very good in over 90% of patients. In daily clinical practice, monotherapy or combination therapy with rasagiline is able to improve PD symptoms, reduce OFF time, and improve QoL, whilst demonstrating favourable tolerability. In addition, rasagiline has a simple dosing schedule of one tablet, once daily, with no titration. These results are consistent with the pivotal rasagiline clinical studies (TEMPO, LARGO and PRESTO).

  3. A prospective, observational study comparing the PK/PD relationships of generic Meropenem (Mercide®) to the innovator brand in critically ill patients.

    Science.gov (United States)

    Mer, Mervyn; Snyman, Jacques Rene; van Rensburg, Constance Elizabeth Jansen; van Tonder, Jacob John; Laurens, Ilze

    2016-01-01

    Clinicians' skepticism, fueled by evidence of inferiority of some multisource generic antimicrobial products, results in the underutilization of more cost-effective generics, especially in critically ill patients. The aim of this observational study was to demonstrate equivalence between the generic or comparator brand of meropenem (Mercide ® ) and the leading innovator brand (Meronem ® ) by means of an ex vivo technique whereby antimicrobial activity is used to estimate plasma concentration of the active moiety. Patients from different high care and intensive care units were recruited for observation when prescribed either of the meropenem brands under investigation. Blood samples were collected over 6 hours after a 30 minute infusion of the different brands. Meropenem concentration curves were established against United States Pharmacopeia standard meropenem (Sigma-Aldrich) by using standard laboratory techniques for culture of Klebsiella pneumoniae. Patients' plasma samples were tested ex vivo, using a disc diffusion assay, to confirm antimicrobial activity and estimate plasma concentrations of the two brands. Both brands of meropenem demonstrated similar curves in donor plasma when concentrations in vials were confirmed. Patient-specific serum concentrations were determined from zones of inhibition against a standard laboratory Klebsiella strain ex vivo, confirming at least similar in vivo concentrations as the concentration curves (90% confidence interval) overlapped; however, the upper limit of the area under the curve for the ratio comparator/innovator exceeded the 1.25-point estimate, i.e., 4% higher for comparator meropenem. This observational, in-practice study demonstrates similar ex vivo activity and in vivo plasma concentration time curves for the products under observation. Assay sensitivity is also confirmed. Current registration status of generic small molecules is in place. The products are therefore clinically interchangeable based on

  4. Long-term survival in patients hospitalized for chronic obstructive pulmonary disease: a prospective observational study in the Nordic countries

    Directory of Open Access Journals (Sweden)

    Gudmundsson G

    2012-09-01

    Full Text Available Gunnar Gudmundsson,1,2 Charlotte Suppli Ulrik,3 Thorarinn Gislason,1,2 Eva Lindberg,4 Eva Brøndum,3 Per Bakke,5 Christer Janson31Department of Respiratory Medicine, Allergy and Sleep, National University Hospital, Reykjavik, Iceland; 2Faculty of Medicine, University of Iceland, Reykjavik, Iceland; 3Department of Respiratory Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark; 4Department of Medical Sciences: Respiratory Medicine and Allergology, Uppsala University, Uppsala, Sweden; 5Haukeland University Hospital, Bergen, NorwayBackground and aim: Mortality rate is high in patients with chronic obstructive pulmonary disease (COPD. Our aim was to investigate long-term mortality and associated risk factors in COPD patients previously hospitalized for a COPD exacerbation.Methods: A total of 256 patients from the Nordic countries were followed for 8.7 ± 0.4 years after the index hospitalization in 2000–2001. Prior to discharge, the St George’s Respiratory Questionnaire was administered and data on therapy and comorbidities were obtained. Information on long-term mortality was obtained from national registries in each of the Nordic countries.Results: In total, 202 patients (79% died during the follow up period, whereas 54 (21% were still alive. Primary cause of death was respiratory (n = 116, cardiovascular (n = 43, malignancy (n = 28, other (n = 10, or unknown (n = 5. Mortality was related to older age, with a hazard risk ratio (HRR of 1.75 per 10 years, lower forced expiratory volume in 1 second (FEV1 (HRR 0.80, body mass index (BMI <20 kg/m2 (HRR 3.21, and diabetes (HRR 3.02. Older age, lower BMI, and diabetes were related to both respiratory and cardiovascular mortality. An association was also found between lower FEV1 and respiratory mortality, whereas mortality was not significantly associated with therapy, anxiety, or depression.Conclusion: Almost four out of five patients died within 9 years following an admission

  5. Palliative Sedation in Terminal Cancer Patients Admitted to Hospice or Home Care Programs: Does the Setting Matter? Results From a National Multicenter Observational Study.

    Science.gov (United States)

    Caraceni, Augusto; Speranza, Raffaella; Spoldi, Elio; Ambroset, Cristina Sonia; Canestrari, Stefano; Marinari, Mauro; Marzi, Anna Maria; Orsi, Luciano; Piva, Laura; Rocchi, Mirta; Valenti, Danila; Zeppetella, Gianluigi; Zucco, Furio; Raimondi, Alessandra; Matos, Leonor Vasconcelos; Brunelli, Cinzia

    2018-03-13

    Few studies regarding palliative sedation (PS) have been carried out in home care (HC) setting. A comparison of PS rate and practices between hospice (HS) and HC is also lacking. Comparing HC and HS settings for PS rate, patient clinical characteristics before and during PS, decision-making process, and clinical aspects of PS. About 38 HC/HS services in Italy participated in a multicenter observational longitudinal study. Consecutive adult cancer patients followed till death during a four-month period and undergoing PS were eligible. Symptom control and level of consciousness were registered every eight hours to death. About 4276 patients were screened, 2894 followed till death, and 531 (18%) underwent PS. PS rate was 15% in HC and 21% in HS (P Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  6. Use of an Impedance Threshold Device in Spontaneously Breathing Patients with Hypotension Secondary to Trauma: An Observational Cohort Feasibility Study

    Science.gov (United States)

    2014-09-09

    hypotensive patient. Crystalloid infusion is not necessarily benign.1,2 Difficult vascular access, hemodilution, acidosis , decreased oxygen delivery, and...blood pressure, heart rate (HR), respiratory rate, and arterial oxygen saturation (SpO2) were recorded im- mediately before application of the ITD...per minute (p = 0.007). The respiratory rate was constant: 19 (7) breaths before to 18 (4) breaths (p = 0.31) per minute after ITD use. Oxygen

  7. Hypertension control after an initial cardiac event among Medicare patients with diabetes mellitus: A multidisciplinary group practice observational study.

    Science.gov (United States)

    Chaddha, Ashish; Smith, Maureen A; Palta, Mari; Johnson, Heather M

    2018-04-23

    Patients with diabetes mellitus and cardiovascular disease have a high risk of mortality and/or recurrent cardiovascular events. Hypertension control is critical for secondary prevention of cardiovascular events. The objective was to determine rates and predictors of achieving hypertension control among Medicare patients with diabetes and uncontrolled hypertension after hospital discharge for an initial cardiac event. A retrospective analysis of linked electronic health record and Medicare data was performed. The primary outcome was hypertension control within 1 year after hospital discharge for an initial cardiac event. Cox proportional hazard models assessed sociodemographics, medications, utilization, and comorbidities as predictors of control. Medicare patients with diabetes were more likely to achieve hypertension control when prescribed beta-blockers at discharge or with a history of more specialty visits. Adults ≥ 80 were more likely to achieve control with diuretics. These findings demonstrate the importance of implementing guideline-directed multidisciplinary care in this complex and high-risk population. ©2018 Wiley Periodicals, Inc.

  8. An observational study on oesophageal variceal endoscopic ...

    African Journals Online (AJOL)

    An observational study on oesophageal variceal endoscopic injection sclerotherapy in patients with portal hypertension seen at the Centre for Clinical Research, ... The report concludes that variceal injection sclerotherapy is a useful method of treating oesophageal varices and can be performed on an out patient basis.

  9. Effects of a radiation dose reduction strategy for computed tomography in severely injured trauma patients in the emergency department: an observational study.

    Science.gov (United States)

    Kim, Soo Hyun; Jung, Seung Eun; Oh, Sang Hoon; Park, Kyu Nam; Youn, Chun Song

    2011-11-03

    Severely injured trauma patients are exposed to clinically significant radiation doses from computed tomography (CT) imaging in the emergency department. Moreover, this radiation exposure is associated with an increased risk of cancer. The purpose of this study was to determine some effects of a radiation dose reduction strategy for CT in severely injured trauma patients in the emergency department. We implemented the radiation dose reduction strategy in May 2009. A prospective observational study design was used to collect data from patients who met the inclusion criteria during this one year study (intervention group) from May 2009 to April 2010. The prospective data were compared with data collected retrospectively for one year prior to the implementation of the radiation dose reduction strategy (control group). By comparison of the cumulative effective dose and the number of CT examinations in the two groups, we evaluated effects of a radiation dose reduction strategy. All the patients met the institutional adult trauma team activation criteria. The radiation doses calculated by the CT scanner were converted to effective doses by multiplication by a conversion coefficient. A total of 118 patients were included in this study. Among them, 33 were admitted before May 2009 (control group), and 85 were admitted after May 2009 (intervention group). There were no significant differences between the two groups regarding baseline characteristics, such as injury severity and mortality. Additionally, there was no difference between the two groups in the mean number of total CT examinations per patient (4.8 vs. 4.5, respectively; p = 0.227). However, the mean effective dose of the total CT examinations per patient significantly decreased from 78.71 mSv to 29.50 mSv (p trauma patients effectively decreased the cumulative effective dose of the total CT examinations in the emergency department. But not effectively decreased the number of CT examinations.

  10. Effects of a radiation dose reduction strategy for computed tomography in severely injured trauma patients in the emergency department: an observational study

    Directory of Open Access Journals (Sweden)

    Kim Soo Hyun

    2011-11-01

    Full Text Available Abstract Background Severely injured trauma patients are exposed to clinically significant radiation doses from computed tomography (CT imaging in the emergency department. Moreover, this radiation exposure is associated with an increased risk of cancer. The purpose of this study was to determine some effects of a radiation dose reduction strategy for CT in severely injured trauma patients in the emergency department. Methods We implemented the radiation dose reduction strategy in May 2009. A prospective observational study design was used to collect data from patients who met the inclusion criteria during this one year study (intervention group from May 2009 to April 2010. The prospective data were compared with data collected retrospectively for one year prior to the implementation of the radiation dose reduction strategy (control group. By comparison of the cumulative effective dose and the number of CT examinations in the two groups, we evaluated effects of a radiation dose reduction strategy. All the patients met the institutional adult trauma team activation criteria. The radiation doses calculated by the CT scanner were converted to effective doses by multiplication by a conversion coefficient. Results A total of 118 patients were included in this study. Among them, 33 were admitted before May 2009 (control group, and 85 were admitted after May 2009 (intervention group. There were no significant differences between the two groups regarding baseline characteristics, such as injury severity and mortality. Additionally, there was no difference between the two groups in the mean number of total CT examinations per patient (4.8 vs. 4.5, respectively; p = 0.227. However, the mean effective dose of the total CT examinations per patient significantly decreased from 78.71 mSv to 29.50 mSv (p Conclusions The radiation dose reduction strategy for CT in severely injured trauma patients effectively decreased the cumulative effective dose of the total

  11. A prospective, multicenter, observational study of complicated skin and soft tissue infections in hospitalized patients: clinical characteristics, medical treatment, and outcomes

    Directory of Open Access Journals (Sweden)

    Lipsky Benjamin A

    2012-09-01

    Full Text Available Abstract Background Complicated skin and soft tissue infections (cSSTIs occur frequently, but limited data do not allow any consensus on an optimal treatment strategy. We designed this prospective, multicenter, observational study to to explore the current epidemiology, treatment, and resulting clinical outcomes of cSSTIs to help develop strategies to potentially improve outcomes. Methods From June 2008 to December 2009 we enrolled a pre-specified number of adults treated in 56 U.S. hospitals with intravenous antibiotic(s for any of the following cSSTIs: diabetic foot infection (DFI; surgical site infection (SSI; deep soft tissue abscess (DSTA; or, cellulitis. Investigators treated all patients per their usual practice during the study and collected data on a standardized form. Results We enrolled 1,033 patients (DFI 27%; SSI 32%; DSTA 14%; cellulitis 27%; mean age 54 years; 54% male, of which 74% had healthcare-associated risk factors. At presentation, 89% of patients received initial empiric therapy with intravenous antibiotics; ~20% of these patients had this empiric regimen changed or discontinued based on culture and sensitivity results. Vancomycin was the most frequently used initial intravenous antibiotic, ordered in 61% of cases. During their stay 44% of patients underwent a surgical procedure related to the study infection, usually incision and drainage or debridement. The mean length of stay was 7.1 days, ranging from 5.8 (DSTA to 8.1 (SSI. Conclusion Our findings from this large prospective observational study that characterized patients with cSSTIs from diverse US inpatient populations provide useful information on the current epidemiology, clinical management practices and outcomes of this common infection.

  12. A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration.

    Science.gov (United States)

    van Asten, Freekje; Evers-Birkenkamp, Kim U; van Lith-Verhoeven, Janneke J C; de Jong-Hesse, Yvonne; Hoppenreijs, Vincent P T; Hommersom, Richard F; Scholten, Agnes M; Hoyng, Carel B; Klaver, Johannes H J

    2015-03-01

    The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice. The HELIOS study was a 2-year prospective, observational, open-label, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time-points 3, 6, 12, 18 and 24 months after inclusion. Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ-5D questionnaire, which did not significantly change over the study period. The more subjective EQ-VAS questionnaire showed an overall improvement. The VFQ-25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long-term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice. This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  13. Effectiveness and tolerability of fixed-dose combination enalapril plus nitrendipine in hypertensive patients: results of the 3-month observational, post-marketing, multicentre, prospective CENIT study.

    Science.gov (United States)

    Sierra, Alejandro de la; Roca-Cusachs, Alejandro; Redón, Josep; Marín, Rafael; Luque, Manuel; Figuera, Mariano de la; Garcia-Garcia, Margarida; Falkon, Liliana

    2009-01-01

    Monotherapy with any class of antihypertensive drug effectively controls blood pressure (BP) in only about 50% of patients. Consequently, the majority of patients with hypertension require combined therapy with two or more medications. This study aimed to evaluate the effectiveness (systolic BP [SBP]/diastolic BP [DBP] control) and tolerability of the fixed-dose combination enalapril/nitrendipine 10 mg/20 mg administered as a single daily dose in hypertensive patients. This was a post-authorization, multicentre, prospective, observational study conducted in primary care with a 3-month follow-up. Patients throughout Spain with uncontrolled hypertension (> or =140/90 mmHg for patients without diabetes mellitus, or > or =130/85 mmHg for patients with diabetes) on monotherapy or with any combination other than enalapril + nitrendipine, or who were unable to tolerate their previous antihypertensive therapy, were recruited. Change from previous to study treatment was according to usual clinical practice. BP was measured once after 5 minutes of rest in the sitting position. Therapeutic response was defined as follows: 'controlled' meant controlled BP ( or =20 mmHg and in DBP of > or =10 mmHg. The main laboratory test parameters were documented at baseline and after 3 months. Patients aged >65 years, with diabetes, with isolated systolic hypertension (ISH; SBP > or =140 mmHg for patients without diabetes, SBP > or =130 mmHg for patients with diabetes) and who were obese (body mass index [BMI] > or =30 kg/m2) were analysed separately. Of 6537 patients included, 5010 and 6354 patients were assessed in effectiveness and tolerability analyses, respectively. In the tolerability analysis population, there were 3023 men (47.6%) and 3321 women (52.4%). The mean (+/- SD) age of the tolerability analysis group was 62.8 (+/- 10.7) years. A total of 71.1% of the patients presented at least one clinical cardiovascular risk factor other than hypertension, with the most frequent being

  14. Unscheduled-return-visits after an emergency department (ED) attendance and clinical link between both visits in patients aged 75 years and over: a prospective observational study.

    Science.gov (United States)

    Pereira, Laurent; Choquet, Christophe; Perozziello, Anne; Wargon, Mathias; Juillien, Gaelle; Colosi, Luisa; Hellmann, Romain; Ranaivoson, Michel; Casalino, Enrique

    2015-01-01

    Predictors of unscheduled return visits (URV), best time-frame to evaluate URV rate and clinical relationship between both visits have not yet been determined for the elderly following an ED visit. We conducted a prospective-observational study including 11,521 patients aged ≥75-years and discharged from ED (5,368 patients (53.5%)) or hospitalized after ED visit (6,153 patients). Logistic Regression and time-to-failure analyses including Cox proportional model were performed. Mean time to URV was 17 days; 72-hour, 30-day and 90-day URV rates were 1.8%, 6.1% and 10% respectively. Multivariate analysis indicates that care-pathway and final disposition decisions were significantly associated with a 30-day URV. Thus, we evaluated predictors of 30-day URV rates among non-admitted and hospitalized patient groups. By using the Cox model we found that, for non-admitted patients, triage acuity and diagnostic category and, for hospitalized patients, that visit time (day, night) and diagnostic categories were significant predictors (prisk of URV, and that some diagnostic categories are also related for non-admitted and hospitalized subjects alike. Our study also demonstrates that the best time frame to evaluate the URV rate after an ED visit is 30 days, because this is the time period during which most URVs and cases with close clinical relationships between two visits are concentrated. Our results suggest that URV can be used as an indicator or quality.

  15. The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese patients with osteoporosis: interim report.

    Science.gov (United States)

    Saito, Hitoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Yatomi, Sawako; Nihojima, Shigeru; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

    2017-07-01

    This large-scale post-marketing surveillance study was conducted to assess the safety and effectiveness of eldecalcitol treatment in patients with osteoporosis in a Japanese clinical setting. A total of 3567 patients with osteoporosis were enrolled and received eldecalcitol 0.75 μg/day for 12 months. For this interim report, 3285 patients were eligible for analysis. Mean age was 74.9 ± 8.7 years; 86.8 % (2854/3285) were women. There were 142 reported adverse drug reactions (ADRs) in 129 patients (3.92 % of the total 3285 patients): the most common were hypercalcemia and increased blood calcium (0.88 %), renal impairment (0.27 %), abdominal discomfort (0.24 %), constipation (0.24 %), and pruritus (0.24 %). The incidence of ADRs was 5.10 % in men and 3.74 % in women. Although 10 serious ADRs were reported in 9 patients (0.27 %), no clinically significant safety issues were identified. Incidence of hypercalcemia or increased blood calcium was 8.47 % in patients with renal impairment and only 0.74 % in patients without renal impairment. At last observation, the incidence of new vertebral and nonvertebral fractures was 2.44 % and 1.70 %, respectively. There was a significant increase in bone mineral density at the lumbar spine and distal radius. The bone turnover markers BAP, serum NTX, urinary NTX, and TRACP-5b were suppressed by eldecalcitol treatment in both sexes. In conclusion, consistent with the findings of the phase III pivotal clinical trial, eldecalcitol was shown to have a favorable safety profile and effectiveness in Japanese patients with osteoporosis. However, periodic measurements of serum calcium were required to prevent occurrence of hypercalcemia during eldecalcitol treatment, especially in patients with renal impairment.

  16. Clinical Practice in the Use of Adjuvant Chemotherapy for Patients with Colon Cancer in South Korea: a Multi-Center, Prospective, Observational Study.

    Science.gov (United States)

    Kim, Jung Han; Baek, Moo Jun; Ahn, Byung-Kwon; Kim, Dae Dong; Kim, Ik Yong; Kim, Jin Soo; Bae, Byung-Noe; Seo, Bong-Gun; Jung, Sang Hun; Hong, Kwan Hee; Kim, Hungdai; Park, Dong Guk; Lee, Ji Hye

    2016-01-01

    Adjuvant chemotherapy is a crucial part of treatment for patients with locally advanced colon cancer. This study was conducted to investigate the actual practice in the use of adjuvant chemotherapy for patients with high-risk stage II or stage III colon cancer in South Korea. This was a 24-month open-label, prospective, observational study conducted at 12 centers across South Korea. Patients with high-risk stage II and stage III colon cancer receiving adjuvant chemotherapy after curative surgery were included, and data were collected at baseline, third, and sixth month. A total of 246 patients were included in the analyses. Of five available regimens (FOLFOX, CAPOX, 5-FU/LV, capecitabine, and UFT/LV), FOLFOX was most commonly used (82.5%). Investigators indicated the "efficacy" as the major cause for selecting FOLFOX or CAPOX. For 5-FU/LV, capecitabine, or UFT/LV, the "safety" or "patient's characteristics (age, comorbidity, and stage)" was one of the most important selecting factors. Patients receiving 5-FU/LV, capecitabine, or UFT/LV had older age, worse PS and lower disease stage (stage II) than patients receiving FOLFOX or CAPOX. Hematologic toxicities were the most common cause of dose adjustment and treatment delay. In South Korea, FOLFOX was the most commonly used regimen for adjuvant chemotherapy and its efficacy was the main cause for selecting this regimen. Patients receiving 5-FU/LV, capecitabine, or UFT/LV had older age, worse PS and lower disease stage (stage II) than patients receiving FOLFOX or CAPOX.

  17. Treatment Compliance with Fixed-Dose Combination of Vildagliptin/Metformin in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin Monotherapy: A 24-Week Observational Study

    Directory of Open Access Journals (Sweden)

    Grigorios Rombopoulos

    2015-01-01

    Full Text Available Objective. To evaluate the differences in treatment compliance with vildagliptin/metformin fixed-dose versus free-dose combination therapy in patients with type 2 diabetes mellitus (T2DM in Greece. Design. Adult patients with T2DM, inadequately controlled with metformin monotherapy, (850 mg bid, participated in this 24-week, multicenter, observational study. Patients were enrolled in two cohorts: vildagliptin/metformin fixed-dose combination (group A and vildagliptin metformin free-dose combination (group B. Results. 659 patients were enrolled, 360 were male, with mean BMI 30.1, mean T2DM duration 59.6 months, and mean HbA1c at baseline 8%; 366 patients were assigned to group A and 293 to group B; data for 3 patients was missing. In group A, 98.9% of patients were compliant with their treatment compared to 84.6% of group B. The odds ratio for compliance in group A versus B was (OR 18.9 (95% CI: 6.2, 57.7; P<0.001. In group A mean HbA1c decreased from 8.1% at baseline to 6.9% (P<0.001 at the study end and from 7.9% to 6.8% (P<0.001 in group B. Conclusions. Patients in group A were more compliant than patients in group B. These results are in accordance with international literature suggesting that fixed-dose combination therapies lead to increased compliance to treatment.

  18. Are patients' preferences regarding the place of treatment heard and addressed at the point of referral: an exploratory study based on observations of GP-patient consultations

    NARCIS (Netherlands)

    Victoor, A.; Noordman, J.; Sonderkamp, J.A.; Delnoij, D.M.; Friele, R.D.; Dulmen, S. van; Rademakers, J.J.

    2013-01-01

    BACKGROUND: Today, in several north-western European countries, patients are encouraged to choose, actively, a healthcare provider. However, patients often visit the provider that is recommended by their general practitioner (GP). The introduction of patient choice requires GPs to support patients

  19. Plantar pressure in diabetic peripheral neuropathy patients with active foot ulceration, previous ulceration and no history of ulceration: a meta-analysis of observational studies.

    Science.gov (United States)

    Fernando, Malindu Eranga; Crowther, Robert George; Pappas, Elise; Lazzarini, Peter Anthony; Cunningham, Margaret; Sangla, Kunwarjit Singh; Buttner, Petra; Golledge, Jonathan

    2014-01-01

    Elevated dynamic plantar pressures are a consistent finding in diabetes patients with peripheral neuropathy with implications for plantar foot ulceration. This meta-analysis aimed to compare the plantar pressures of diabetes patients that had peripheral neuropathy and those with neuropathy with active or previous foot ulcers. Published articles were identified from Medline via OVID, CINAHL, SCOPUS, INFORMIT, Cochrane Central EMBASE via OVID and Web of Science via ISI Web of Knowledge bibliographic databases. Observational studies reporting barefoot dynamic plantar pressure in adults with diabetic peripheral neuropathy, where at least one group had a history of plantar foot ulcers were included. Interventional studies, shod plantar pressure studies and studies not published in English were excluded. Overall mean peak plantar pressure (MPP) and pressure time integral (PTI) were primary outcomes. The six secondary outcomes were MPP and PTI at the rear foot, mid foot and fore foot. The protocol of the meta-analysis was published with PROPSERO, (registration number CRD42013004310). Eight observational studies were included. Overall MPP and PTI were greater in diabetic peripheral neuropathy patients with foot ulceration compared to those without ulceration (standardised mean difference 0.551, 95% CI 0.290-0.811, pdiabetic peripheral neuropathy with a history of foot ulceration compared to those with diabetic neuropathy without a history of ulceration. More homogenous data is needed to confirm these findings.

  20. The presence of nonthoracic distracting injuries does not affect the initial clinical examination of the cervical spine in evaluable blunt trauma patients: a prospective observational study.

    Science.gov (United States)

    Konstantinidis, Agathoklis; Plurad, David; Barmparas, Galinos; Inaba, Kenji; Lam, Lydia; Bukur, Marko; Branco, Bernardino C; Demetriades, Demetrios

    2011-09-01

    A distracting injury mandates cervical spine (c-spine) imaging in the evaluable blunt trauma patient who demonstrates no pain or tenderness over the c-spine. The purpose of this study was to examine which distracting injuries can negatively affect the sensitivity of the standard clinical examination of the c-spine. This is a prospective observational study conducted at a Level I Trauma Center from January 1, 2008, to December 31, 2009. After institutional review board approval, all evaluable (Glasgow Coma Scale score ≥13) blunt trauma patients older than 16 years sustaining a c-spine injury were enrolled. A distracting injury was defined as any immediately evident bony or soft tissue injury or a complaint of non-c-spine pain whether or not an actual injury was subsequently diagnosed. Information regarding the initial clinical examination and the presence of a distracting injury was collected from the senior resident or attending trauma surgeon involved in the initial management. During the study period, 101 evaluable patients sustained a c-spine injury. Distracting injuries were present in 88 patients (87.1%). The most common was rib fracture (21.6%), followed by lower extremity fracture (20.5%) and upper extremity fracture (12.5%). Only four (4.0%) patients had no pain or tenderness on the initial examination of the c-spine. All four patients had bruising and tenderness to the upper anterior chest. None of these four patients developed neurologic sequelae or required a surgical stabilization or immobilization. C-spine imaging may not be required in the evaluable blunt trauma patient despite distracting injuries in any body regions that do not involve the upper chest. Further definition of distracting injuries is mandated to avoid unnecessary utilization of resources and to reduce the imaging burden associated with the evaluation of the c-spine.

  1. Patient-Related Determinants of the Administration of Continuous Palliative Sedation in Hospices and Palliative Care Units: A Prospective, Multicenter, Observational Study.

    Science.gov (United States)

    van Deijck, Rogier H P D; Hasselaar, Jeroen G J; Verhagen, Stans C A H H V M; Vissers, Kris C P; Koopmans, Raymond T C M

    2016-05-01

    Knowledge of determinants that are associated with the administration of continuous palliative sedation (CPS) helps physicians identify patients who are at risk of developing refractory symptoms, thereby enabling proactive care planning. This study aims to explore which patient-related factors at admission are associated with receiving CPS later in the terminal phase of life. A prospective multicenter observational study was performed in six Dutch hospices and three nursing home-based palliative care units. The association between patient-related variables at admission (age, gender, diagnosis, use of opioids or psycholeptics, number of medications, Karnofsky Performance Status scale score, Edmonton Symptom Assessment System distress score, and Glasgow Coma Scale score) and the administration of CPS at the end of life was analyzed. A total of 467 patients died during the study period, of whom 130 received CPS. In univariate analysis, statistically significant differences were noted between the sedated and nonsedated patients with respect to younger age (P = 0.009), malignancy as a diagnosis (P = 0.05), higher Karnofsky Performance Status score (P = 0.03), the use of opioids (P Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  2. Patient evaluation of the use of follitropin alfa in a prefilled ready-to-use injection pen in assisted reproductive technology: an observational study

    Directory of Open Access Journals (Sweden)

    Welcker J

    2010-09-01

    Full Text Available Abstract Background Self-administration of recombinant human follicle-stimulating hormone (r-hFSH can be performed using injection pen devices by women undergoing assisted reproductive technology procedures. The objective of this study was to explore the use of the prefilled follitropin alfa pen in routine assisted reproductive technology procedures in Germany. Methods This prospective, observational study was conducted across 43 German IVF centres over a period of 1.75 years. Patients who had used the prefilled follitropin alfa pen in the current or a previous cycle of controlled ovarian stimulation completed a questionnaire to assess their opinions of the device. Results A total of 5328 patients were included in the study. Of these, 2888 reported that they had previous experience of daily FSH injections. Significantly more patients reported that less training was required to use the prefilled follitropin alfa pen than a syringe and lyophilized powder (1997/3081 [64.8%]; p Conclusions In this questionnaire-based survey, routine use of the prefilled follitropin alfa pen was well accepted and associated with favourable patient perceptions. Users of the pen found it easier to initially learn how to use, and subsequently use, than other injection methods. In general, the prefilled follitropin alfa pen was the preferred method for self-administration of gonadotrophins. Together with previous findings, the results here indicate a high level of patient satisfaction among users of the prefilled follitropin alfa pen for daily self-administration of r-hFSH.

  3. Effects of switching from NPH insulin to insulin glargine in patients with type 2 diabetes: the retrospective, observational LAUREL study in Italy.

    Science.gov (United States)

    Bellia, Alfonso; Babini, Anna C; Marchetto, Paolo E; Arsenio, Leone; Lauro, Davide; Lauro, Renato

    2014-04-01

    The aim was to observe the effects of switching from neutral protamine Hagedorn (NPH) insulin to insulin glargine on glycaemic control in patients with type 2 diabetes mellitus (T2DM) in everyday clinical practice in Italy. This multicenter, observational, retrospective study included 1,011 patients with T2DM who switched from NPH insulin to glargine or were maintained on NPH insulin. The primary outcome was change in HbA1c over 4-8 months. Secondary outcomes included fasting blood glucose (FBG), insulin dose, and hypoglycaemia. The intention-to-treat population consisted of 996 patients (glargine 496; NPH 500). Prior to switching, HbA1c was higher in the glargine than the NPH group [mean (±SD) 8.8 ± 1.4 vs. 7.9 ± 1.2%; p < 0.001]. HbA1c decreased after 4-8 months with glargine (8.2 ± 1.4%; p < 0.001) but not with NPH (8.0 ± 1.4%; p = 0.20). Similar results were observed for FBG. The daily dose of glargine increased from 0.22 ± 0.10 U/kg at the switch to 0.26 ± 0.11 U/kg at study end, while the NPH dose remained stable (0.19 ± 0.09-0.20 ± 0.09 U/kg). While not statistically significant, the percentage of patients with hypoglycaemic episodes during the last month of treatment tended to be less with glargine. No significant change in body weight occurred in either group. Switching patients from NPH insulin to insulin glargine in a real-life setting was associated with significant improvement in glycaemic control. The increase in glargine dose was not accompanied by increased hypoglycaemia or weight gain.

  4. Cognitive and affective changes in mild to moderate Alzheimer's disease patients undergoing switch of cholinesterase inhibitors: a 6-month observational study.

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    Gianfranco Spalletta

    Full Text Available Patients with Alzheimer's disease after an initial response to cholinesterase inhibitors may complain a later lack of efficacy. This, in association with incident neuropsychiatric symptoms, may worsen patient quality of life. Thus, the switch to another cholinesterase inhibitor could represent a valid therapeutic strategy. The aim of this study was to investigate the effectiveness of the switch from one to another cholinesterase inhibitor on cognitive and affective symptoms in mild to moderate Alzheimer disease patients. Four hundred twenty-three subjects were included from the EVOLUTION study, an observational, longitudinal, multicentre study conducted on Alzheimer disease patients who switched to different cholinesterase inhibitor due either to lack/loss of efficacy or response, reduced tolerability or poor compliance. All patients underwent cognitive and neuropsychiatric assessments, carried out before the switch (baseline, and at 3 and 6-month follow-up. A significant effect of the different switch types was found on Mini-Mental State Examination score during time, with best effectiveness on mild Alzheimer's disease patients switching from oral cholinesterase inhibitors to rivastigmine patch. Depressive symptoms, when measured using continuous Neuropsychiatric Inventory values, decreased significantly, while apathy symptoms remained stable over the 6 months after the switch. However, frequency of both depression and apathy, when measured categorically using Neuropsychiatric Inventory cut-off scores, did not change significantly during time. In mild to moderate Alzheimer disease patients with loss of efficacy and tolerability during cholinesterase inhibitor treatment, the switch to another cholinesterase inhibitor may represent an important option for slowing cognitive deterioration. The evidence of apathy stabilization and the positive tendency of depressive symptom improvement should definitively be confirmed in double-blind controlled

  5. Hospitalisation in an emergency department short-stay unit compared to an internal medicine department is associated with fewer complications in older patients - an observational study

    DEFF Research Database (Denmark)

    Strøm, Camilla; Mollerup, Talie Khadem; Kromberg, Laurits Schou

    2017-01-01

    Medicine Department (IMD). METHODS: Observational study evaluating adverse events during hospitalisation in non-emergent, age-matched, internal medicine patients ≥75 years, acutely admitted to either the SSU or the IMD at Holbaek Hospital, Denmark, from January to August, 2014. Medical records were......, unplanned readmission, and nosocomial infection. CONCLUSIONS: Adverse events of hospitalisation were significantly less common in older patients acutely admitted to an Emergency Department Short-stay Unit as compared to admission to an Internal Medicine Department.......BACKGROUND: Older patients are at particular risk of experiencing adverse events during hospitalisation. OBJECTIVE: To compare the frequencies and types of adverse events during hospitalisation in older persons acutely admitted to either an Emergency Department Short-stay Unit (SSU) or an Internal...

  6. Intramedullary nailing of femoral shaft fractures in polytraumatized patients. a longitudinal, prospective and observational study of the procedure-related impact on cardiopulmonary- and inflammatory responses

    Directory of Open Access Journals (Sweden)

    Husebye Elisabeth E

    2012-01-01

    Full Text Available Abstract Background Early intramedullary nailing (IMN of long bone fractures in severely injured patients has been evaluated as beneficial, but has also been associated with increased inflammation, multi organ failure (MOF and morbidity. This study was initiated to evaluate the impact of primary femoral IMN on coagulation-, fibrinolysis-, inflammatory- and cardiopulmonary responses in polytraumatized patients. Methods Twelve adult polytraumatized patients with femoral shaft fractures were included. Serial blood samples were collected to evaluate coagulation-, fibrinolytic-, and cytokine activation in arterial blood. A flow-directed pulmonary artery (PA catheter was inserted prior to IMN. Cardiopulmonary function parameters were recorded peri- and postoperatively. The clinical course of the patients and complications were monitored and recorded daily. Results Mean Injury Severity Score (ISS was 31 ± 2.6. No procedure-related effect of the primary IMN on coagulation- and fibrinolysis activation was evident. Tumor necrosis factor alpha (TNF-α increased significantly from 6 hours post procedure to peak levels on the third postoperative day. Interleukin-6 (IL-6 increased from the first to the third postoperative day. Interleukin-10 (IL-10 peaked on the first postoperative day. A procedure-related transient hemodynamic response was observed on indexed pulmonary vascular resistance (PVRI two hours post procedure. 11/12 patients developed systemic inflammatory response syndrome (SIRS, 7/12 pneumonia, 3/12 acute lung injury (ALI, 3/12 adult respiratory distress syndrome (ARDS, 3/12 sepsis, 0/12 wound infection. Conclusion In the polytraumatized patients with femoral shaft fractures operated with primary IMN we observed a substantial response related to the initial trauma. We could not demonstrate any major additional IMN-related impact on the inflammatory responses or on the cardiopulmonary function parameters. These results have to be interpreted

  7. Drug utilization of biological drugs in the treatment of chronic Immune-Mediated Inflammatory Diseases (IMIDs: an observational study on Italian patients

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    Paolo Faccendini

    2017-09-01

    Full Text Available Drug utilization of biological drugs in the treatment of chronic Immune-Mediated Inflammatory Diseases (IMIDs: an observational study on Italian patientsObjectives:The aim of this analysis was to provide an estimate of drug utilization indicators (dose escalation and dose tapering related to biologic drugs in the chronic treatment of adult patients with Immune-Mediated Inflammatory Diseases (IMIDs.Methods:We conducted an observational retrospective cohort analysis using the Policlinico di Tor Vergata (PTV database. We considered all biologic drugs dispensed by the PTV hospital pharmacy between January 2010 and December 2015:abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab (originator and biosimilar, tocilizumab, and ustekinumab were included. Drug dose escalation and dose tapering were calculated and compared with their Defined Daily Dose (DDD.Results:A total of 1803 patients with IMID and biologic drug prescription were analyzed (male: 51.2%. The majority of patients were in the class 36-50 years (n = 612. The median follow-up was 33.8 months (IQR 14.43-56.20. Dermatology was the ward with the largest number of patients (n = 882; 48.9%, followed by rheumatology (n = 619; 34.3% and gastroenterology (n = 302; 16.8%. Dose escalation was observed in 406 patients (22.5%. Infliximab biosimilar (n = 51 was the biological drug with the highest dose escalation rate (86.3%, followed by infliximab originator (n = 28; 60.3% and ustekinumab (37.8%. Etanercept was the biological drug with the lowest dose escalation rate (7.4%, followed by golimumab (12.2% and adalimumab (13.8%. In 677 patients (37.5% a dose tapering was observed. Etanercept showed the highest rate of patients with dose tapering (41.6%, followed by adalimumab (33.6%.Conclusions:The results of this analysis show that dose modification is quite common in PTV clinical practice. Considering the strong focus on the pharmaceutical expenditure and the need of cost containment

  8. Utility of Volume Assessment Using Bioelectrical Impedance Analysis in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Prospective Observational Study

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    Ki Hyun Park

    2017-08-01

    Full Text Available Background Fluid overload prior to continuous renal replacement therapy (CRRT is an important prognostic factor. Thus, precise evaluation of fluid status is necessary to treat such patients. In this study, we investigated whether fluid assessment using bioelectrical impedance analysis (BIA can predict outcomes in critically ill patients requiring CRRT. Methods A prospective observational study was performed in patients who were admitted to the intensive care unit and who required CRRT. BIA was conducted before CRRT; then, the ratio of extracellular water to total body water (ECW/TBW was derived to estimate volume status. Results A total of 31 patients treated with CRRT were included. There were 18 men (58.1%, and the median age was 67 years (interquartile range, 51 to 78 years. Fourteen patients (45.2% died within 28 days after CRRT initiation. Patients were divided into 16 with ECW/TBW ≥0.41 and 15 with ECW/TBW <0.41. Survival rate within 28 days was different between the two groups (P = 0.044. Cox regression analysis revealed a relationship between ECW/TBW ≥0.41 and 28-day mortality, but it was not statistically significant (hazard ratio, 3.0; 95% confidence interval, 0.9 to 9.8; P = 0.061. Lastly, the area under the curve of ECW/TBW for 28-day mortality was analyzed. The area under the curve of ECW/TBW was 0.73 (95% confidence interval, 0.54 to 0.92, and this was significant (P = 0.037. Conclusions Fluid status can be assessed using BIA in critically ill patients requiring CRRT, and BIA can predict mortality. Further large trials are needed to confirm the usefulness of BIA in critically ill patients.

  9. Sites, frequencies, and causes of self-reported fractures in 9,720 rheumatoid arthritis patients: a large prospective observational cohort study in Japan.

    Science.gov (United States)

    Ochi, Kensuke; Furuya, Takefumi; Ikari, Katsunori; Taniguchi, Atsuo; Yamanaka, Hisashi; Momohara, Shigeki

    2013-01-01

    Sites, frequencies, and causes of self-reported fractures in Japanese patients with rheumatoid arthritis (RA) were evaluated in a prospective, observational cohort study. The incidence and cause of fracture differ by anatomical site, sex, and age. These differences may be considered in establishing custom strategies for preventing fractures in RA patients in the future. The literature contains limited data describing the details of fractures at different skeletal sites in patients with RA. We evaluated the details of fractures in Japanese RA patients on the basis of our Institute of Rheumatology Rheumatoid Arthritis cohort study in 9,720 RA patients (82 % women; mean age, 56 years) who were enrolled from 2000 to 2010. The details of fractures were obtained through biannual patient self-report questionnaires. Over a mean duration of 5.2 years, 1,317 patients (13.5 %) reported 2,323 incident fractures comprising 563 (24.2 %) clinical vertebral fractures and 1,760 (75.8 %) nonvertebral fractures. Rib fractures were the most common fractures in men, followed by clinical vertebral and hip fractures; the most common fractures in women were clinical vertebral fractures, followed by rib, foot, and hip fractures. There was a significant difference between sexes in the rates of rib, clavicle, shoulder, and ankle fractures. Spontaneous event was the primary cause of clinical vertebral fracture (65.4 %), whereas falls were the primary cause of upper extremity (76.5 %) and lower extremity (57.8 %) fractures. Rates of clinical vertebral and hip fractures increased, while those of rib and foot fractures decreased with increasing age. Incidence of falls, as causes of nonvertebral fractures, also increased in older age groups. Our results suggest that the causes of fractures may differ depending on anatomical site and that prevention of falls may be the most effective way to reduce upper and lower extremity fractures, especially in older patients with RA.

  10. Cross-sectional analysis of adult diabetes type 1 and type 2 patients with diabetic microvascular complications from a German retrospective observational study.

    Science.gov (United States)

    Happich, M; Breitscheidel, L; Meisinger, C; Ulbig, M; Falkenstein, P; Benter, U; Watkins, J

    2007-06-01

    To obtain epidemiological data on the prevalence of predefined stages of diabetic microvascular complications from a representative cross-section of patients with existing microvascular complications of type 1 or type 2 diabetes in Germany. A cross-sectional, retrospective study of medical records of 705 type 1 and 1910 type 2 adult diabetic patients with a diagnosis of retinopathy and/or peripheral neuropathy and/or nephropathy before 2002 and treated in 2002 in Germany. Of 376 patients with type 1 diabetes having retinopathy, 59.3% had mild or moderate non-proliferative retinopathy without macular oedema, 27.1% had macular oedema, and 13.6% had severe retinopathy without macular oedema. In 862 patients with type 2 diabetes, the distribution of retinopathy/maculopathy classes was 56.8%, 35.5%, and 7.7%, respectively. Of 381 type 1 diabetes patients with observed peripheral neuropathy, 81.4% had sensorimotor neuropathy, 8.9% had diabetic foot conditions, and 9.7% had lower extremity amputations because of diabetes. In 1005 patients with type 2 diabetes, the distribution of neuropathy classes was 78.2%, 12.1%, and 9.7%, respectively. The proportions of patients with renal insufficiency in type 1 and type 2 diabetes groups were 15.3% versus 13.5%, respectively. The study suggests that there are considerable proportions of patients with progressive stages of microvascular complications related to type 1 and type 2 diabetes in Germany. This underlines the importance of improvement of optimal quality of care and frequent screening for preventing late diabetic microvascular complications and the necessity of effective intervention strategies to tackle this major public health problem.

  11. Treatment Outcome of Tuberculosis Patients under Directly Observed Treatment Short Course and Factors Affecting Outcome in Southern Ethiopia: A Five-Year Retrospective Study.

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    Gebremedhin Gebrezgabiher

    Full Text Available Tuberculosis (TB is one of the major public health and socio-economic issues in the 21st century globally. Assessment of TB treatment outcomes, and monitoring and evaluation of its risk factors in Directly Observed Treatment Short Course (DOTS are among the major indicators of the performance of a national TB control program. Hence, this institution-based retrospective study was conducted to determine the treatment outcome of TB patients and investigate factors associated with unsuccessful outcome at Dilla University Referral Hospital, southern Ethiopia. Five years (2008 to 2013 TB record of TB clinic of the hospital was reviewed. A total 1537 registered TB patients with complete information were included. Of these, 942 (61.3% were male, 1015 (66% were from rural areas, 544 (35.4% were smear positive pulmonary TB (PTB+, 816 (53.1% were smear negative pulmonary TB (PTB- and 177(11.5% were extra pulmonary TB (EPTB patients. Records of the 1537 TB patients showed that 181 (11.8% were cured, 1129(73.5% completed treatment, 171 (11.1% defaulted, 52 (3.4% died and 4 (0.3% had treatment failure. The overall mean treatment success rate of the TB patients was 85.2%. The treatment success rate of the TB patients increased from 80.5% in September 2008-August 2009 to 84.8% in September 2012-May 2013. Tuberculosis type, age, residence and year of treatment were significantly associated with unsuccessful treatment outcome. The risk of unsuccessful outcome was significantly higher among TB patients from rural areas (AOR = 1.63, 95% CI: 1.21-2.20 compared to their urban counterparts. Unsuccessful treatment outcome was also observed in PTB- patients (AOR = 1.77, 95% CI: 1.26-2.50 and EPTB (AOR = 2.07, 95% CI: 1.28-3.37 compared to the PTB+ patients. In conclusion, it appears that DOTS have improved treatment success in the hospital during five years. Regular follow-up of patients with poor treatment outcome and provision of health information on TB treatment to

  12. Safety of Adding Oats to a Gluten-Free Diet for Patients With Celiac Disease: Systematic Review and Meta-analysis of Clinical and Observational Studies.

    Science.gov (United States)

    Pinto-Sánchez, María Inés; Causada-Calo, Natalia; Bercik, Premysl; Ford, Alexander C; Murray, Joseph A; Armstrong, David; Semrad, Carol; Kupfer, Sonia S; Alaedini, Armin; Moayyedi, Paul; Leffler, Daniel A; Verdú, Elena F; Green, Peter

    2017-08-01

    Patients with celiac disease should maintain a gluten-free diet (GFD), excluding wheat, rye, and barley. Oats might increase the nutritional value of a GFD, but their inclusion is controversial. We performed a systematic review and meta-analysis to evaluate the safety of oats as part of a GFD in patients with celiac disease. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases for clinical trials and observational studies of the effects of including oats in GFD of patients with celiac disease. The studies reported patients' symptoms, results from serology tests, and findings from histologic analyses. We used the GRADE approach to assess the quality of evidence. We identified 433 studies; 28 were eligible for analysis. Of these, 6 were randomized and 2 were not randomized controlled trials comprising a total of 661 patients-the remaining studies were observational. All randomized controlled trials used pure/uncontaminated oats. Oat consumption for 12 months did not affect symptoms (standardized mean difference: reduction in symptom scores in patients who did and did not consume oats, -0.22; 95% CI, -0.56 to 0.13; P = .22), histologic scores (relative risk for histologic findings in patients who consumed oats, 0.24; 95% CI, 0.01-4.8; P = .35), intraepithelial lymphocyte counts (standardized mean difference, 0.21; 95% CI, reduction of 1.44 to increase in 1.86), or results from serologic tests. Subgroup analyses of adults vs children did not reveal differences. The overall quality of evidence was low. In a systematic review and meta-analysis, we found no evidence that addition of oats to a GFD affects symptoms, histology, immunity, or serologic features of patients with celiac disease. However, there were few studies for many endpoints, as well as limited geographic distribution and low quality of evidence. Rigorous double-blind, placebo-controlled, randomized controlled trials, using commonly available oats sourced from

  13. Comparison of markers of oxidative stress, inflammation and arterial stiffness between incident hemodialysis and peritoneal dialysis patients – an observational study

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    Ratanjee Sharad

    2009-03-01

    Full Text Available Abstract Background Patients on peritoneal and hemodialysis have accelerated atherosclerosis associated with an increase in cardiovascular morbidity and mortality. The atherosclerosis is associated with increased arterial stiffness, endothelial dysfunction and elevated oxidative stress and inflammation. The aims of this study are to investigate the effects of peritoneal and hemodialysis on arterial stiffness, vascular function, myocardial structure and function, oxidative stress and inflammation in incident patients with end stage kidney disease. Methods This is an observational study. Eighty stage five CKD patients will be enrolled and followed for one-year. Primary outcome measures will be changes in 1 arterial stiffness measured by aortic pulse wave velocity, 2 oxidative stress assessed by plasma F2 isoprostanes and 3 inflammation measured by plasma pentraxin-3. Secondary outcomes will include additional measures of oxidative stress and inflammation, changes in vascular function assessed using the brachial artery reactivity technique, carotid artery intimal medial thickness, augmentation index and trans thoracic echocardiography to assess left ventricular geometry, and systolic and diastolic function. Patients will undergo these measures at baseline (6–8 weeks prior to starting dialysis therapy, then at six and 12 months after starting dialysis. Discussion The results of this study may guide the choice of dialysis modality in the first year of treatment. It may also lead to a larger study prospectively assessing the effect of dialysis modality on cardiovascular morbidity and mortality. Trial Registration ACTRN12609000049279

  14. Clinical and Biological Predictors of Plasma Levels of Soluble RAGE in Critically Ill Patients: Secondary Analysis of a Prospective Multicenter Observational Study

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    Thibaut Pranal

    2018-01-01

    Full Text Available Rationale. Although soluble forms of the receptor for advanced glycation end products (RAGE have been recently proposed as biomarkers in multiple acute or chronic diseases, few studies evaluated the influence of usual clinical and biological parameters, or of patient characteristics and comorbidities, on circulating levels of soluble RAGE in the intensive care unit (ICU setting. Objectives. To determine, among clinical and biological parameters that are usually recorded upon ICU admission, which variables, if any, could be associated with plasma levels of soluble RAGE. Methods. Data for this ancillary study were prospectively obtained from adult patients with at least one ARDS risk factor upon ICU admission enrolled in a large multicenter observational study. At ICU admission, plasma levels of total soluble RAGE (sRAGE and endogenous secretory (esRAGE were measured by duplicate ELISA and baseline patient characteristics, comorbidities, and usual clinical and biological indices were recorded. After univariate analyses, significant variables were used in multivariate, multidimensional analyses. Measurements and Main Results. 294 patients were included in this ancillary study, among whom 62% were admitted for medical reasons, including septic shock (11%, coma (11%, and pneumonia (6%. Although some variables were associated with plasma levels of RAGE soluble forms in univariate analysis, multidimensional analyses showed no significant association between admission parameters and baseline plasma sRAGE or esRAGE. Conclusions. We found no obvious association between circulating levels of soluble RAGE and clinical and biological indices that are usually recorded upon ICU admission. This trial is registered with NCT02070536.

  15. Long-term effect of galantamine on cognitive function in patients with Alzheimer’s disease versus a simulated disease trajectory: an observational study in the clinical setting

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    Nakagawa R

    2017-04-01

    Full Text Available Ryoko Nakagawa,1 Takashi Ohnishi,1 Hisanori Kobayashi,1 Toshio Yamaoka,2 Tsutomu Yajima,3 Ai Tanimura,4 Toshiya Kato,4 Kazutake Yoshizawa1 1Evidence Generation Department, Medical Affairs Division, 2Clinical Data Management Department, R&D Division, 3Biostatistics Department, Quantitative Science Division, 4Drug Surveillance Department, R&D Division, Janssen Pharmaceutical K.K., Tokyo, Japan Background: Long-term maintenance of cognitive function is an important goal of treatment for Alzheimer’s disease (AD, but evidence about the long-term efficacy of cholinesterase inhibitors is sparse. To evaluate the long-term efficacy and safety of galantamine for AD in routine clinical practice, we conducted a 72-week post-marketing surveillance study. The effect of galantamine on cognitive function was estimated in comparison with a simulated disease trajectory. Patients and methods: Patients with mild-to-moderate AD received flexible dosing of galantamine (16–24 mg/day during this study. Cognitive function was assessed by the mini mental state examination (MMSE and the clinical status was determined by the Clinical Global Impression-Improvement (CGI-I. Changes of the MMSE score without treatment were estimated in each patient using Mendiondo’s model. Generalized linear mixed model analysis was performed to compare the simulated MMSE scores with the actual scores. Results: Of the 661 patients who were enrolled, 642 were evaluable for safety and 554 were assessed for efficacy. The discontinuation rate was 46.73%. Cognitive decline indicated by the mean change of actual MMSE scores was significantly smaller than the simulated decline. Individual analysis demonstrated that >70% of patients had better actual MMSE scores than their simulated scores. Significant improvement of CGI-I was also observed during the observation period. Adverse events occurred in 28.5% of patients and were serious in 8.41%. The reported events generally corresponded with the

  16. Effect of Transcutaneous Electrical Nerve Stimulation on Sensation Thresholds in Patients with Painful Diabetic Neuropathy: An Observational Study

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    Moharic, Metka

    2010-01-01

    Transcutaneous electrical nerve stimulation (TENS) is one of the therapies for painful neuropathy. Its analgesic mechanisms probably involve the gate control theory, the physiological block and the endogenous pain inhibitory system. The aim of the study was to determine whether TENS improves small fibre function diminished because of painful…

  17. Calcitonin receptor gene polymorphisms at codon 447 in patients with osteoporosis and chronic periodontitis in South Indian population – An observational study

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    Anuradha Ankam

    2017-01-01

    Full Text Available Context: Chronic periodontitis and osteoporosis are multifactorial diseases which share common risk factors. Interactions between genetic and other factors determine the likely hood of osteoporotic fractures and chronic periodontitis. Calcitonin receptor (CTR gene polymorphism is one of the important factors which contribute to the development of osteoporosis and chronic periodontitis. Aims: This study highlights the association of CTR gene polymorphisms at codon 447 in patients with osteoporosis and chronic periodontitis and healthy controls in south Indian population. Settings and Design: The study was designed as a case–control retrospective, observational clinical trial which was conducted to assess the role of CTR gene polymorphism in patients with osteoporosis and periodontitis as well as in healthy controls. Materials and Methods: A total of 50 subjects were taken into the study comprising of 20 healthy and 30 osteoporotic subjects with chronic periodontitis between the age group of 30–55 years. Within the limitations of our study, only 50 subjects were taken in the study due to the strict sampling method (Patients who were just diagnosed with osteoporosis and periodontitis and hence not taking any medication. 2 ml of blood sample was collected in ethylenediamine tetra acetic acid containing vials, and polymerase chain reaction was run to identify CTR gene polymorp