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Sample records for clinical outcome study

  1. Korean Clinic Based Outcome Measure Studies

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    Jongbae Park

    2003-02-01

    Full Text Available Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented briefly here including 1 Quality of Life of liver cancer patients after 8 Constitutional acupuncture; 2 Developing a Korean version of Measuring yourself Medical Outcome profile (MYMOP; and 3 Survey on 5 Shu points: a pilot In the first study, we have included 4 primary or secondary liver cancer patients collecting their diagnostic X-ray film and clinical data f개m their hospital, and asked them to fill in the European Organization Research and Treatment of Cancer, Quality of Life Questionnaire before the commencement of the treatment. The acupuncture treatment is set up format but not disclosed yet. The translation and developing a Korean version of outcome measures that is Korean clinician friendly has been sought for MYMOP is one of the most appropriate one. The permission was granted, the translation into Korean was done, then back translated into English only based on the Korean translation by the researcher who is bilingual in both languages. The back translation was compared by the original developer of MYMOP and confirmed usable. In order to test the existence of acupoints and meridians through popular forms of Korean acupuncture regimes, we aim at collecting opinions from 101 Korean clinicians that have used those forms. The questions asked include most effective symptoms, 5 Shu points, points those are least likely to use due to either adverse events or the lack of effectiveness, theoretical reasons for the above proposals, proposing outcome measures

  2. Controlled outcome studies of child clinical hypnosis.

    Science.gov (United States)

    Adinolfi, Barbara; Gava, Nicoletta

    2013-08-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem. PMID:24165457

  3. FETAL ECHOCARDIOGRAPHY: A STUDY OF CLINICAL OUTCOME

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    Rajanish

    2014-01-01

    Full Text Available BACKGROUND : S tructural abnormalities of the heart and great vessels are fairly common congenital lab normalities with the incidenceof8 in 1000 live births. With the advent of real time scanners fetal cardia can atomy can be analyze d echocardiographically. The earlier diagnosis will make an impact on clinical management of fetus with congenital heart disease. It helps intimely triage and optimal management of specific congenital heart disease either structural , functional orarrhythmia . OBJECTIVES : This study was conducted to note the spectrum of congenital heart diseases detected on fetal echo in pregnant mothers referred with high risk for CHD sand to assess the outcome of prenatally detected congenital heart diseases. MATERIAL S AND METHODS : T he study is aprospective descriptive study conducted in a tertiary care pediatric hospital in Mumbai over period of one year . P regnant mothers were referred for fetal echo , where pregnancy was considered as high risk for CHDs due to maternal , fetalfactorsorabnormallevel 1 scan.Fetal echowas performed by a trained pediatric cardiologistat 18 to 20 week of gestation using HP sonos 2000 echocardiographicmachinewith3/3.5 Hz transducer. Cardiac lesionsandoutcome of pregnancy was noted by postnatal follow - up of patients. RESULTS : A total of 170 patients underwent fetal echo , 13 patients have not delivered and 48 were lost to follow - up. Fetal echo was normal in 130(76.4% and abnormalities were detected in 40(23.5%.Structural anomalies were seen in 24(14.1% , arrhythmia in 5(2.9% and functional abnormalities in 11(6.4%.On outcome analysis84 (77.1% arealive , IUD /terminationof pregnancyoccurred in 18(16.5% , neonatal death in 6 (5.5% , infant death in 1 (0.9%. CONCLUSIONS : All ranges of CHDs can be diagnosed by fetal echocardiography . O utcome of prenatally detected complex congenital heart disease is poor ; nonetheless earlier detection provides a n opportunity for early interventions and

  4. Bioplastique at 6 years: clinical outcome studies.

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    Ersek, R A; Gregory, S R; Salisbury, A V

    1997-11-01

    Bioplastique is a biphasic polymer for the permanent augmentation of some soft tissues. It was developed in 1987, and clinical studies at this institution were begun in 1990. The combination of low molecular weight polyvinylpyrrolidone and solid polymer particles allows the implantation of permanent polymer spheres through a small needle under local anesthesia. In this study 127 cases are reviewed of consecutive patients who have received Bioplastique for scar revision, wrinkles, and augmentation for soft-tissue defects at 6 years after application. All patients who had not been in for follow-up recently were contacted by mail and questioned on the permanence of augmentation and migration of particles. About 30 percent of the patients were unreachable and had their charts reviewed for permanence and migration of particles. In eight of these cases, Bioplastique was removed because of overcorrection, two of them may have had infection. Bioplastique has gained wide use throughout the world and although some complications have been reported, in general, it functions quite well when used in selected cases. PMID:9385974

  5. Making the Best Match: Selecting Outcome Measures for Clinical Trials and Outcome Studies

    OpenAIRE

    Coster, Wendy J.

    2013-01-01

    Selecting an appropriate outcome measure is a critical step in designing valid and useful clinical trials and outcome studies. This selection process needs to extend beyond examining basic psychometric properties to consider additional features of instruments that may affect their validity and utility for the study’s purpose. This article discusses these additional factors and their potential impact on outcome measurement. Guidelines are proposed to help clinical researchers and consumers of ...

  6. ASSESSMENT OF SURGICAL OUTCOMES OF RHINOPLASTY – A CLINICAL STUDY

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    Tanthry Deepalakshmi

    2015-12-01

    Full Text Available Rhinoplasty is one of the most common cosmetic surgery performed by the otorhinolaryngologists. The main indication for rhinoplasty is cosmetic or functional or both. In regard to paucity of research regarding patient satisfaction after surgery, we have done this prospective clinical study in our hospital. 40 patients were included in the study from January 2012 to December 2012. Rhinoplasty Outcomes Evaluation (ROE Questionnaire was applied to all the patients and evaluation of the satisfaction pre op and post operatively was assessed and the results were statistically analysed. The age of the study group ranged from 20 yrs to 39 yrs with the mean age of 24.85 +/- 3.43 years. The average satisfaction mark of patients undergoing rhinoplasty in pre-operative state was 28.05 & post-operative it improved and reached to 67.91.The average satisfaction of female were 26.75 preoperatively reached to 63.68 postoperatively. The average satisfaction of male were 31.2 preoperatively reached upto 67.91 post operatively. The degree of the satisfaction pre and post operatively was compared using student t test and paired t test. It was 67.91 in males and 36.53 among females which was statistically significant (p < 0.05. Patient satisfaction is as important as technical aspects of rhinoplasty. Hence a novel attempt is made in this direction to assess and understand patient expectations to achieve realistic goals in rhinoplasty.

  7. Neurofeedback and biofeedback with 37 migraineurs: a clinical outcome study

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    Lappin Martha S

    2010-02-01

    Full Text Available Abstract Background Traditional peripheral biofeedback has grade A evidence for effectively treating migraines. Two newer forms of neurobiofeedback, EEG biofeedback and hemoencephalography biofeedback were combined with thermal handwarming biofeedback to treat 37 migraineurs in a clinical outpatient setting. Methods 37 migraine patients underwent an average of 40 neurofeedback sessions combined with thermal biofeedback in an outpatient biofeedback clinic. All patients were on at least one type of medication for migraine; preventive, abortive or rescue. Patients kept daily headache diaries a minimum of two weeks prior to treatment and throughout treatment showing symptom frequency, severity, duration and medications used. Treatments were conducted an average of three times weekly over an average span of 6 months. Headache diaries were examined after treatment and a formal interview was conducted. After an average of 14.5 months following treatment, a formal interview was conducted in order to ascertain duration of treatment effects. Results Of the 37 migraine patients treated, 26 patients or 70% experienced at least a 50% reduction in the frequency of their headaches which was sustained on average 14.5 months after treatments were discontinued. Conclusions All combined neuro and biofeedback interventions were effective in reducing the frequency of migraines with clients using medication resulting in a more favorable outcome (70% experiencing at least a 50% reduction in headaches than just medications alone (50% experience a 50% reduction and that the effect size of our study involving three different types of biofeedback for migraine (1.09 was more robust than effect size of combined studies on thermal biofeedback alone for migraine (.5. These non-invasive interventions may show promise for treating treatment-refractory migraine and for preventing the progression from episodic to chronic migraine.

  8. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic

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    Oguzhan Sıtkı Dizdar

    2016-02-01

    Full Text Available Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002 and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient’s admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40, 46.6% (n = 29, 39.7% (n = 27, 35.3% (n = 24, 14.1% (n = 9, respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission.

  9. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic.

    Science.gov (United States)

    Dizdar, Oguzhan Sıtkı; Baspınar, Osman; Kocer, Derya; Dursun, Zehra Bestepe; Avcı, Deniz; Karakükcü, Cigdem; Çelik, İlhami; Gundogan, Kursat

    2016-03-01

    Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002) and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient's admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40), 46.6% (n = 29), 39.7% (n = 27), 35.3% (n = 24), 14.1% (n = 9), respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission. PMID:26938553

  10. A CLINICAL STUDY OF OUTCOME OF LABOUR IN TRANSVERSE LIE

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    Vijayalakshmi

    2015-08-01

    Full Text Available Transverse lie complicates approximately 0.5% of birth and may result in neglected or impacted shoulder presentation leading to obstructed labour, rupture uterus and postpartum haemorrhage which may result in death of the mother, if not adequately managed in labour . A prospective observational study done in VI MS B ellary, Karnataka, aim of the study was to know the maternal and fetal outcome, to study caesarean rate, maternal and neonatal complications following caesarean. Objective of the study is to analyse the various modes of outcome of transverse lie to kno w the fetal and maternal mortality and morbidity , to improve the conditions which decreases these rates and guide us for better management of these cases. Out of 6116 deliveries100 cases were transverse lie during 2year period from April 1999 to January 20 01. Out of 100 cases , 76 were caesarean sections, 48 were live births, 7 were neonatal deaths, 45 were still births. Maternal morbidity was 2 cases required subtotal hysterectomy. There were no maternal deaths. Elective caesarean section should be advised in all booked cases with transverse lie at term, after ruling out congenital anomalies of the fetus by anomaly scan.

  11. Two-year radiographic and clinical outcomes from the Canadian Methotrexate and Etanercept Outcome study in patients with rheumatoid arthritis

    OpenAIRE

    Keystone, Edward C.; Pope, Janet E.; Thorne, J. Carter; Poulin-Costello, Melanie; Phan-Chronis, Krystene; Vieira, Andrew; Haraoui, Boulos

    2015-01-01

    Objective. To evaluate radiographic and clinical outcomes up to 24 months in patients with RA enrolled in the Canadian Methotrexate and Etanercept Outcome study. Methods. In this open-label non-inferiority trial, patients with inadequate response to MTX received etanercept plus MTX for 6 months and then were randomized to either etanercept monotherapy or continued etanercept plus MTX until 24 months. Radiographic data were analysed using the modified total Sharp score (mTSS), joint space narr...

  12. Clinical outcome of gliosarcoma compared with glioblastoma multiforme: a clinical study in Chinese patients.

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    Zhang, Guobin; Huang, Shengyue; Zhang, Junting; Wu, Zhen; Lin, Song; Wang, Yonggang

    2016-04-01

    Gliosarcoma (GSM) is a rare biphasic neoplasms of the central nervous system composed of a glioblastoma multiforme (GBM) admixed with a sarcomatous component. In clinical practice GSM is generally managed similarly to GBM. However, there are conflicting reports regarding their clinical aggressiveness, cell line of origin and possible prognosis compared with those of GBM. The objective of this study was to compare clinic-pathological features in GSM patients with the GBM patients during the same study period. 518 patients with GBM were treated at our hospital between 2008 and 2013, among them 51 were GSM. In this series the GSMs represented 9.8 % of all GBMs and included 58.8 % male with a median age of 44.7 years. The locations, all supratentorial, included temporal in 41.2 %, frontal in 25.5 %, parietal in 19.6 %, and occipital in 13.7 %. All patients underwent tumor resection followed by post-operative radiation and adjuvant chemotherapy. The O6-methylguanine-DNA methyltransferase promoter methylation studies were significantly more frequent in the GBMs than GSMs (80.1 % vs. 44.7 %, P GSM were 8.0 and 13.0 months, respectively, as compared with 9.0 and 14.0 months in the GBM group (log rank test P = 0.001 and 0.004, respectively). The Cox proportional hazards regression model indicated that the extent of tumor resection (HR = 1.518, P = 0.009) and pathological types (HR = 0.608, P = 0.002) were the significant prognostic factors in our own series. With regard to clinical features and outcomes, GSM and GBM cannot be distinguished clinically. GSM in China may be managed similarly to GBM, with maximal safe surgical resection followed by chemo-radiotherapy. Our study adds further evidence to support GSM as a unique clinical entity with a likely worse prognosis than GBM. PMID:26725096

  13. Midterm survivorship and clinical outcome of INDUS knee prosthesis: 5 year followup study

    OpenAIRE

    Sancheti, Kantilal H; Sancheti, Parag K; Rajeev S Joshi; Kailash R Patil; Shyam, Ashok K; Bhaskar, Raja R

    2016-01-01

    Background: INDUS knee implant has been designed as per the anatomical morphology of the Indian population and has shown good clinical outcome in short term studies. The purpose of the present study was to report the midterm survivorship and clinical outcome of this implant. Materials and Methods: Two hundred and twenty three primary total knee arthroplasties in 209 consecutive patients using the INDUS knee prosthesis were prospectively enrolled. There were 145 females (155 knees) and 64 male...

  14. Clinical and functional outcomes of the PCCP study : a multi-center prospective study in Italy

    OpenAIRE

    Antonini, G.; Giancola, R.; D. Berruti; E. Blanchietti; Pecchia, P.; Francione, V.; Greco, P.; T.C. Russo; L. Pietrogrande

    2013-01-01

    The standard surgical management of hip fractures is associated with tissue trauma and bleeding which are added to the fracture injury. The percutaneous compression plate (PCCP) is a minimally invasive device that has been demonstrated in previous studies to reduce postoperative complications and blood loss. This prospective, multi-center, observational study assessed clinical and functional outcomes with PCCP as treatment for trochanteric fractures. Patients with a stable or unstable proxima...

  15. A qualitative study of stakeholder views of the conditions for and outcomes of successful clinical networks

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    McInnes Elizabeth

    2012-02-01

    Full Text Available Abstract Background Clinical networks have been established to improve health outcomes and processes of care by implementing a range of innovations and undertaking projects based on perceived local need. Limited research exists on the necessary conditions required to bring about successful network outcomes and what characterises network success from the perspective of those involved in network initiatives. This qualitative study identified stakeholder views on i the conditions for effective clinical networks; and ii desirable outcomes of successful clinical networks. Methods Twenty-seven participants were interviewed using face-to-face audio-recorded semi-structured interviews. Transcribed data were coded and analysed to generate themes relating to the study aims. Results Five key factors represented as sub-themes were identified as important conditions for the establishment of successful clinical networks under the main theme of effective network structure, organisation and governance. These were: building relationships; effective leadership; strategic evidence-based workplans; adequate resources; and ability to implement and evaluate network initiatives. Two major themes encapsulated views on desirable outcomes of successful clinical networks: connecting and engaging which represented the outcomes of interdisciplinary and consumer collaboration and, partnerships with state health and local health services, and changing the landscape of care, which represented the importance of outcomes associated with improving services, care and patient health outcomes and implementing evidence-based practice. Conclusions This study provides new knowledge on the conditions needed to establish successful clinical networks and on desirable outcomes arising from network projects and initiatives that are considered to be valuable by those working in or associated with clinical networks. This provides health services with information on what needs to be in place

  16. Serum magnesium levels and clinical outcome of aneurysmal subarachnoid hemorrhage: a study in 60 patients

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    Habibi Z

    2008-06-01

    Full Text Available Background: Hypomagnesemia is commonly encountered in patients with a wide variety of diseases including subarachnoid hemorrhage (SAH, cardiovascular emergencies, head trauma, migraine attacks, seizure and preeclampsia. It seems to be associated with a poor clinical outcome. This study considers the prevalence and temporal distribution of hypomagnesemia after aneurysmal SAH and its correlation with the severity of SAH, delayed cerebral ischemia (DCI as well as the neurological outcome after a period of three months.Methods: Between 2003 and 2008, 60 patients were admitted to the emergency ward of Imam Khomeini Hospital with acute SAH. Serum magnesium levels were measured during the first 72 hours, days 4-7, and second and third weeks after SAH. The three-month outcome was assessed according to the Glasgow Outcome Scale (GOS. Clinical SAH grading was performed according to the criteria of the World Federation of Neurological Surgeons (WFNS and the patients were allocated to "Good" (GOS = 4, 5 and "Poor" (GOS= 1-3 outcome groups. The prevalence of hypomagnesemia was assessed in both patient groups. Fisher exact test was used to analyze data.Results: Hypomagnesemia occurred in 22% of patients during the first 72 hours after SAH. It was associated with more prevalent DCI (p<0.05, whereas low serum magnesium levels during days 4-7 17% of patients and the second week (22% of patients after SAH were correlated with poor clinical outcome (p<0.05. No correlation was found between first 72 hour-hypomagnesemia and poor clinical outcome at three months.Conclusion: Hypomagnesemia occurs after aneurysmal SAH and it may predict the occurrence of DCI, while low serum magnesium levels during days 4-7 and within the second week of event predict poor clinical outcome at three months. Treatment of this electrolyte disturbance may have a favourable effect on the clinical outcome of patients with aneurysmal SAH.

  17. Prospective study on the clinical course and outcomes in transfusion-related acute lung injury

    OpenAIRE

    Looney, MR; Roubinian, N; Gajic, O; Gropper, MA; Hubmayr, RD; Lowell, CA; Bacchetti, P.; Wilson, G.; Koenigsberg, M; Lee, DC; Wu, P; Grimes, B; Norris, PJ; Murphy, EL; Gandhi, MJ

    2014-01-01

    OBJECTIVE:: Transfusion-related acute lung injury is the leading cause of transfusion-related mortality. A prospective study using electronic surveillance was conducted at two academic medical centers in the United States with the objective to define the clinical course and outcomes in transfusion-related acute lung injury cases. DESIGN:: Prospective case study with controls. SETTING:: University of California, San Francisco and Mayo Clinic, Rochester. PATIENTS:: We prospectively enrolled 89 ...

  18. A Systematic Review of Studies That Aim to Determine Which Outcomes to Measure in Clinical Trials in Children

    OpenAIRE

    Sinha, Ian; Jones, Leanne; Smyth, Rosalind L; Williamson, Paula R

    2008-01-01

    Background In clinical trials the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. Selection of inappropriate outcomes can compromise the utility of a trial. However, the process of selecting the most suitable outcomes to include can be complex. Our aim was to systematically review studies that address the process of selecting outcomes or outcome domains to measure in clinical trials in children. Methods and Findings We searche...

  19. Clinical variables and implications of the personality on the outcome of bipolar illness: a pilot study

    OpenAIRE

    Casas-Barquero, Nieves; García-López, Olga; Fernández-Argüelles, Pedro; Camacho-Laraña, Manuel

    2007-01-01

    Outcome in bipolar patients is affected by comorbidity. Comorbid personality disorders are frequent and may complicate the course of bipolar illness. This pilot study examined a series of 40 euthymic bipolar patients (DSM-IV criteria) (bipolar I disorder 31, bipolar II disorder 9) to assess the effect of clinical variables and the influence of comorbid personality on the clinical course of bipolar illness. Bipolar patients with a diagnosis of comorbid personality disorder (n = 30) were compar...

  20. A STUDY ON CLINICAL, LABORATORY PROFILE AND OUTCOME OF DENGUE FEVER

    OpenAIRE

    Vanamali; Venugopal; Yeshwanth; Dilip

    2013-01-01

    ABSTRACT: BACKGROUND AND OBJECTIVES : In recent days there is an alarming increase in the incidence of dengue fever and has emerged as a serious international public health threat with almost half of the world's population at risk for infection . Very few studies have been conducted in this part of our country and hence this study was undertaken to study the clinical picture, la boratory profile and outcome of dengue fever in and around khammam. MATERIAL...

  1. Identifying the barriers to conducting outcomes research in integrative health care clinic settings - a qualitative study

    OpenAIRE

    Findlay-Reece Barbara; Kania Ania; Mulkins Andrea; Verhoef Marja J; Mior Silvano

    2010-01-01

    Abstract Background Integrative health care (IHC) is an interdisciplinary blending of conventional medicine and complementary and alternative medicine (CAM) with the purpose of enhancing patients' health. In 2006, we designed a study to assess outcomes that are relevant to people using such care. However, we faced major challenges in conducting this study and hypothesized that this might be due to the lack of a research climate in these clinics. To investigate these challenges, we initiated a...

  2. Clinical and functional outcomes of the PCCP study: a multi-center prospective study in Italy.

    Science.gov (United States)

    Antonini, G; Giancola, R; Berruti, D; Blanchietti, E; Pecchia, P; Francione, V; Greco, P; Russo, T C; Pietrogrande, L

    2013-04-01

    The standard surgical management of hip fractures is associated with tissue trauma and bleeding which are added to the fracture injury. The percutaneous compression plate (PCCP) is a minimally invasive device that has been demonstrated in previous studies to reduce postoperative complications and blood loss. This prospective, multi-center, observational study assessed clinical and functional outcomes with PCCP as treatment for trochanteric fractures. Patients with a stable or unstable proximal femoral fracture of type AO 31.A1 or 31.A2 were enrolled in eight hospitals in Italy. The primary outcome of interest was the recovery of the pre-fracture functional status at 1-year follow-up; secondary outcomes of interest included blood transfusions, surgical time, complications, and mortality. A total of 273 patients were enrolled. The ASA score was 3 or 4 in 72.5 % of patients. The mean surgical time was 44.1 min; the mean post-surgery blood transfusions was 0.9 units. At 1 year, 48 patients (17.6 %) died, 28 (10.2 %) were lost to follow-up, 4 patients (1.5 %) were excluded, hence 193 patients (70.3 %) were available for final evaluation. At the 1-year follow-up visit, 51.9 % of patients recovered or improved their pre-fracture modified Harris Hip Score, 49.1 % of patients improved or maintained their walking abilities, and 66.6 % of patients residing at home pre-surgery maintained their domicile. The overall mortality rate was 17.6 %. Major complications included two fracture collapses, one excessive sliding of the cephalic screw leading to a partial fracture collapse and one back-out of the diaphyseal screw. This study demonstrates that treatment of trochanteric fractures with PCCP gives good outcomes and significant advantages such as low blood loss, short surgical time, low risk of complications, and good functional recovery in the majority of the patients. PMID:23543403

  3. Identifying the barriers to conducting outcomes research in integrative health care clinic settings - a qualitative study

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    Findlay-Reece Barbara

    2010-01-01

    Full Text Available Abstract Background Integrative health care (IHC is an interdisciplinary blending of conventional medicine and complementary and alternative medicine (CAM with the purpose of enhancing patients' health. In 2006, we designed a study to assess outcomes that are relevant to people using such care. However, we faced major challenges in conducting this study and hypothesized that this might be due to the lack of a research climate in these clinics. To investigate these challenges, we initiated a further study in 2008, to explore the reasons why IHC clinics are not conducting outcomes research and to identify strategies for conducting successful in-house outcomes research programs. The results of the latter study are reported here. Methods A total of 25 qualitative interviews were conducted with key participants from 19 IHC clinics across Canada. Basic content analysis was used to identify key themes from the transcribed interviews. Results Barriers identified by participants fell into four categories: organizational culture, organizational resources, organizational environment and logistical challenges. Cultural challenges relate to the philosophy of IHC, organizational leadership and practitioner attitudes and beliefs. Participants also identified significant issues relating to their organization's lack of resources such as funding, compensation, infrastructure and partnerships/linkages. Environmental challenges such as the nature of a clinic's patient population and logistical issues such as the actual implementation of a research program and the applicability of research data also posed challenges to the conduct of research. Embedded research leadership, integration of personal and professional values about research, alignment of research activities and clinical workflow processes are some of the factors identified by participants that support IHC clinics' ability to conduct outcomes research. Conclusions Assessing and enhancing the broader

  4. The EMPA-REG outcome study: critical appraisal and potential clinical implications.

    Science.gov (United States)

    Perseghin, Gianluca; Solini, Anna

    2016-01-01

    Diabetes health care professionals have to face a study with results of incomparable success in secondary and tertiary cardiovascular disease prevention. In the past, no studies in patients with type 2 diabetes resulted to be successful in inducing an improvement of cardiovascular prognosis, no matter whether they were focused on a target, on life-style or on pharmacological intervention. On a clinical perspective, should the diabetologist's way to think about the anti-diabetic therapy of patients on secondary cardiovascular prevention change based on the results of Empa-Reg outcome? Due to the complexity of the clinical picture of patients with type 2 diabetes, a tailored therapy based on targets, complications, co-morbidity, familial and social environment, personal and cultural features must be conceived and applied in starting pharmacological therapy; however, the question whether should we consider empagliflozin as first choice therapy in individuals with type 2 diabetes exposed to high cardiovascular risk, the Empa-Reg outcome-like patient, awaits now for an answer. Waiting for data confirming the results of the Empa-Reg outcome study, this report goes through the good reasons in support of this way of thinking, but at the same time explores the many unanswered questions raising potential concerns about this clinical choice. PMID:27260022

  5. Sleep quality, the neglected outcome variable in clinical studies focusing on locomotor system; a construct validation study

    OpenAIRE

    Röder Christoph; Bohler Dieter; Sprott Haiko; Aghayev Emin; Müller Urs

    2010-01-01

    Abstract Background In addition to general health and pain, sleep is highly relevant to judging the well-being of an individual. Of these three important outcome variables, however, sleep is neglected in most outcome studies. Sleep is a very important resource for recovery from daily stresses and strains, and any alteration of sleep will likely affect mental and physical health, especially during disease. Sleep assessment therefore should be standard in all population-based or clinical studie...

  6. Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study

    DEFF Research Database (Denmark)

    La Cour, Jeppe Lerche; Brok, Jesper; Gøtzsche, Peter C

    2010-01-01

    To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity.......To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity....

  7. A STUDY ON CLINICAL, LABORATORY PROFILE AND OUTCOME OF DENGUE FEVER

    Directory of Open Access Journals (Sweden)

    Vanamali

    2013-12-01

    Full Text Available ABSTRACT: BACKGROUND AND OBJECTIVES : In recent days there is an alarming increase in the incidence of dengue fever and has emerged as a serious international public health threat with almost half of the world's population at risk for infection . Very few studies have been conducted in this part of our country and hence this study was undertaken to study the clinical picture, la boratory profile and outcome of dengue fever in and around khammam. MATERIALS AND METHODS: A prospective study was conducted over one year at Mamata General Hospital, during which 190 cases were diagnosed as dengue fever which were taken into study and eval uated for clinical, laboratory profile and their outcome. RESULTS : Out of 190 patients taken into study, fever was the most common presentation followed by headache. Thrombocytopenia was seen in 75% of the patients. Bleeding manifestations were seen in pat ients with platelet counts less than 40000/mm 3 . 18 patients were diagnosed as DHF, 6 patients were diagnosed as DSS. During our study 10 patients expired. CONCLUSION: The clinical and hematological picture of dengue fever is like any other viral fevers and the bleeding manifestations are seen in patients whose platelet counts decreases less than 40000/mm 3 only

  8. Impact of tofacitinib on patient outcomes in rheumatoid arthritis – review of clinical studies

    Directory of Open Access Journals (Sweden)

    Boyce EG

    2016-01-01

    Full Text Available Eric G Boyce, Deepti Vyas, Edward L Rogan, Cynthia S Valle-Oseguera, Kate M O'Dell Department of Pharmacy Practice, Thomas J Long School of Pharmacy and Health Sciences, University of the Pacific, Stockton, CA, USAAbstract: Rheumatoid arthritis is a chronic, progressive autoimmune disease associated with inflammation and destruction of joints and systemic effects, which result in significant impact on patient's quality of life and function. Tofacitinib was approved for the treatment of rheumatoid arthritis in the USA in 2012 and subsequently in other countries, but not by the European Medicines Agency. The goal of this review was to evaluate the impact of tofacitinib on patient-reported and patient-specific outcomes from prior clinical studies, focusing on quality of life, functionality, pain, global disease assessment, major adverse consequences, and withdrawals. A total of 13 reports representing 11 clinical studies on tofacitinib in rheumatoid arthritis were identified through PubMed and reference lists in meta-analyses and other reviews. Data on improvements in patient-driven composite tools to measure disease activity in rheumatoid arthritis, such as the Health Assessment Questionnaire, served as a major outcome evaluated in this review and were extracted from each study. Additional data extracted from those clinical studies included patient assessment of pain (using a 0–100 mm visual analog scale, patient global assessment of disease (using a 0–100 mm visual analog scale, patient withdrawals, withdrawals due to adverse effects or lack of effect, and risk of serious adverse effects, serious infections, and deaths. Tofacitinib 5 mg bid appears to have a favorable impact on patient outcomes related to efficacy and safety when compared with baseline values and with comparator disease-modifying antirheumatic drugs and placebo. Improvements were seen in the composite and individual measures of disease activity. Serious adverse effects, other

  9. RMI study and clinical correlations of ankle retinacula damage and outcomes of ankle sprain.

    Science.gov (United States)

    Stecco, Antonio; Stecco, Carla; Macchi, Veronica; Porzionato, Andrea; Ferraro, Claudio; Masiero, Stefano; De Caro, Raffaele

    2011-12-01

    Recent studies reveal the role of the ankle retinacula in proprioception and functional stability of the ankle, but there is no clear evidence of their role in the outcomes of ankle sprain. 25 patients with outcomes of ankle sprain were evaluated by MRI to analyze possible damage to the ankle retinacula. Patients with damage were subdivided into two groups: group A comprised cases with ankle retinacula damage only, and group B those also with anterior talofibular ligament rupture or bone marrow edema. Both groups were examined by VAS, CRTA and static posturography and underwent three treatments of deep connective tissue massage (Fascial Manipulation technique). All evaluations were repeated after the end of treatment and at 1, 3 and 6 months. At MRI, alteration of at least one of the ankle retinacula was evident in 21 subjects, and a further lesion was also identified in 7 subjects. After treatment, VAS and CRTA evaluations showed a statistically significant decrease in values with respect to those before treatment (p stabilometric platform results. No significant difference was found between groups A and B. The initial benefit was generally maintained at follow-up. The alteration of retinacula at MRI clearly corresponds to the proprioceptive damage revealed by static posturography and clinical examination. Treatment focused on the retinacula may improve clinical outcomes and stabilometric data. PMID:21305286

  10. Depressive symptoms, HIV medication adherence, and HIV clinical outcomes in Tanzania: a prospective, observational study.

    Directory of Open Access Journals (Sweden)

    Nadya M Belenky

    Full Text Available Depressive symptoms have been shown to independently affect both antiretroviral therapy (ART adherence and HIV clinical outcomes in high-income countries. We examined the prospective relationship between depressive symptoms and adherence, virologic failure, and suppressed immune function in people living with HIV/AIDS in Tanzania. Data from 403 study participants who were on stable ART and engaged in HIV clinical care were analyzed. We assessed crude and adjusted associations of depressive symptoms and ART adherence, both at baseline and at 12 months, using logistic regression. We used logistic generalized estimating equations to assess the association and 95% confidence intervals (CI between depressive symptoms and both virologic failure and suppressed immune function. Ten percent of participants reported moderate or severe depressive symptoms at baseline and 31% of participants experienced virologic failure (>150 copies/ml over two years. Depressive symptoms were associated with greater odds of reported medication nonadherence at both baseline (Odds Ratio [OR] per 1-unit increase = 1.18, 95% CI [1.12, 1.24] and 12 months (OR = 1.08, 95% CI [1.03, 1.14]. By contrast, increases in depressive symptom score were inversely related to both virologic failure (OR = 0.93, 95% CI [0.87, 1.00] and immune system suppression (OR = 0.88, 95% CI [0.79, 0.99], though the association between depressive symptoms and clinical outcomes was less precise than for the association with nonadherence. Findings indicate a positive association between depressive symptoms and nonadherence, and also an inverse relationship between depressive symptoms and clinical outcomes, possibly due to informative loss to follow-up.

  11. Electrophysiological Predictors of Clinical Outcome in Traumatic Neuropathies: A Multicenter Prospective Study

    Directory of Open Access Journals (Sweden)

    Palma Ciaramitaro

    2016-01-01

    Full Text Available Objectives. This prospective, observational, multicentre study aims to identify electrodiagnostic (EDX markers of clinical recovery in patients with traumatic neuropathy (TN receiving surgical (S and nonsurgical (NS treatments. Methods. Subjects referred to the Italian Traumatic Neuropathy Network between 2010 and 2011 (307 patients, for a total of 444 TN were evaluated with serial clinical/EDX evaluations at 6, 12, 24, and 36 months of follow-up. Results. Primary surgery was performed in 21 subjects with open lesions and evidence of neurotmesis, while closed lesions were treated with either conservative medical approach (216 patients or secondary surgery (70 patients, according to the clinical spontaneous recovery at 4–6 months. Clinical improvement correlated with the increase of the compound muscle action potential amplitude (OR 3.76; CI 1.61–8.76, particularly in the S group (OR 7.25; CI 1.2–43.87, and with sensory nerve action potential amplitude in the NS group (OR 4.35; CI 1.14–16.69. No correlations were found with needle electromyography qualitative evaluations, changes in maximal voluntary recruitment, age, and gender. Conclusions. Nerve conduction studies (NCS represent the more accurate neurophysiological markers of clinical outcome in patients with TN. Significance. Serial NCS assessments predict the functional recovery in TN, increasing the accuracy of peripheral nerves surgical decision-making process.

  12. Electrophysiological Predictors of Clinical Outcome in Traumatic Neuropathies: A Multicenter Prospective Study

    Science.gov (United States)

    Mondelli, Mauro; Battiston, Bruno; Sard, Arman; Pontini, Italo; Faccani, Giuliano; Migliaretti, Giuseppe; Cocito, Dario; Neuropathies, Italian Network for Traumatic

    2016-01-01

    Objectives. This prospective, observational, multicentre study aims to identify electrodiagnostic (EDX) markers of clinical recovery in patients with traumatic neuropathy (TN) receiving surgical (S) and nonsurgical (NS) treatments. Methods. Subjects referred to the Italian Traumatic Neuropathy Network between 2010 and 2011 (307 patients, for a total of 444 TN) were evaluated with serial clinical/EDX evaluations at 6, 12, 24, and 36 months of follow-up. Results. Primary surgery was performed in 21 subjects with open lesions and evidence of neurotmesis, while closed lesions were treated with either conservative medical approach (216 patients) or secondary surgery (70 patients), according to the clinical spontaneous recovery at 4–6 months. Clinical improvement correlated with the increase of the compound muscle action potential amplitude (OR 3.76; CI 1.61–8.76), particularly in the S group (OR 7.25; CI 1.2–43.87), and with sensory nerve action potential amplitude in the NS group (OR 4.35; CI 1.14–16.69). No correlations were found with needle electromyography qualitative evaluations, changes in maximal voluntary recruitment, age, and gender. Conclusions. Nerve conduction studies (NCS) represent the more accurate neurophysiological markers of clinical outcome in patients with TN. Significance. Serial NCS assessments predict the functional recovery in TN, increasing the accuracy of peripheral nerves surgical decision-making process. PMID:27547450

  13. Admissions to acute adolescent psychiatric units: a prospective study of clinical severity and outcome

    OpenAIRE

    Jensen Gunnar; Hatling Trond; Heyerdahl Sonja; Hanssen-Bauer Ketil; Olstad Pål; Stangeland Tormod; Tinderholt Tarje

    2011-01-01

    Abstract Background Several countries have established or are planning acute psychiatric in-patient services that accept around-the-clock emergency admission of adolescents. Our aim was to investigate the characteristics and clinical outcomes of a cohort of patients at four Norwegian units. Methods We used a prospective pre-post observational design. Four units implemented a clinician-rated outcome measure, the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA), which ...

  14. Clinical Outcomes of Conservative Treatment and Arthroscopic Repair of Rotator Cuff Tears: A Retrospective Observational Study

    Science.gov (United States)

    Lee, Woo Hyung; Do, Hyun Kyung; Lee, Joong Hoon; Kim, Bo Ram; Noh, Jee Hyun; Choi, Soo Hyun; Chung, Sun Gun; Lee, Shi-Uk; Choi, Ji Eun; Kim, Seihee; Kim, Min Jee

    2016-01-01

    Objective To compare the clinical outcomes following conservative treatment and arthroscopic repair in patients with a rotator cuff tear. Methods In this retrospective study, patients aged >50 years with a symptomatic rotator cuff tear were reviewed. The rotator cuff tendons were evaluated using ultrasonography, shoulder magnetic resonance imaging or MR arthrography, and the patients with either a high-grade partial-thickness or small-to-medium-sized (≤3 cm) full-thickness tear were included in this study. The primary outcome measures were a pain assessment score and range of motion (ROM) at 1-year follow-up. The secondary outcomes were the rate of tear progression or retear along with the rate of symptom aggravation after the treatments. Results A total of 357 patients were enrolled, including 183 patients that received conservative treatment and 174 patients who received an arthroscopic repair. The pain assessment score (p50 years old with a less than medium-sized rotator cuff tear in a 1-year follow-up period. Further study is warranted to find the optimal combination of conservative treatment for a symptomatic rotator cuff tear. PMID:27152275

  15. STUDY OF SEVERITY OF HYPONATRAEMIA AND ITS CLINICAL OUTCOME IN PATIENTS ADMITTED TO TERTIARY CARE ICU

    Directory of Open Access Journals (Sweden)

    Hareesh

    2016-06-01

    Full Text Available BACKGROUND OF THE STUDY Hyponatraemia is a commonly encountered plasma electrolyte abnormality noticed in the patients admitted to ICU, which has a diverse variety of manifestations. It can lead to a wide spectrum of clinical symptoms, from subtle to severe or even life-threatening and is associated with increased mortality and morbidity. OBJECTIVES To study the clinical profile at different levels of hyponatraemia in ICU patients and its clinical outcome at different levels. METHODOLOGY A retrospective descriptional study was done at Intensive Care Unit of Dr. B.R. Ambedkar Medical College and Hospital during the period from April 2015 to March 2016 among the patients having serum sodium levels less than 135 mEq/L. RESULTS Commonly involved age group is between 50 to 70 years. Severe form of Hyponatraemia is seen in elderly males. The most common underlying predisposing factor for hyponatraemia in our case series was sepsis (26% followed by gastrointestinal fluid loss (15.5%, diabetic ketoacidosis (10% and cirrhosis of liver (10%. Mortality was highest with severe hyponatraemia (10.5% who had pulmonary sepsis, metabolic encephalopathy, diabetic ketoacidosis and cirrhosis of liver. CONCLUSIONS Hyponatraemia is one of the good predictor of ICU mortality in association with wide variety of systemic diseases and wide spectrum of clinical profile.

  16. The clinical outcomes of surgical treatment of noncontiguous spinal tuberculosis: a retrospective study in 23 cases.

    Directory of Open Access Journals (Sweden)

    Jia Huang

    Full Text Available STUDY DESIGN: A retrospective clinical study. OBJECTIVE: To evaluate the clinical efficacy of the surgical treatment of noncontiguous spinal tuberculosis (NSTB, and to discuss its therapeutic strategies. METHODS: We performed a retrospective review of clinical and radiographic data that were prospectively collected on 550 consecutive spinal tubercular patients including 27 patients who were diagnosed and treated as NSTB in our institution from June 2005 to June 2011. Apart from 4 patients being treated conservatively, the remainder received surgery by posterior transforaminal debridement, interbody fusion with instrumentation, posterior instrumentation and anterior debridement with fusion in a single or two-stage operation. The clinical outcomes were evaluated before and after treatment in terms of hematologic and radiographic examinations, bone fusion and neurologic status. The Oswestry Disability Index score was determined before treatment and at the last follow-up visit. RESULTS: 23 patients (15 M/8F, averaged 44.6 ± 14.2 years old (range, 19 to 70 yd, who received surgical treatment, were followed up after surgery for a mean of 52.5 ± 19.5 months (range, 24 to 72 months. The kyphotic angle was changed significantly between pre- and postoperation (P<0.05. The mean amount of correction was 12.6 ± 7.2 degrees, with a small loss of correction at last follow-up. All patients achieved solid bone fusion. No patients with neurological deficit deteriorated postoperatively. Neither mortalities nor any major complications were found. There was a significant difference of Oswestry Disability Index scores between preoperation and the final follow-up. CONCLUSION: The outcomes of follow-up showed that posterior and posterior-anterior surgical treatment methods were both viable surgical options for NSTB. Posterior transforaminal debridement, interbody fusion and posterior instrumentation, as a less invasive technique, was feasible and effective to treat

  17. Clinical features and outcomes of vitrectomy in pediatric ocular injuries-eye injury vitrectomy study

    Directory of Open Access Journals (Sweden)

    Xuefeng Feng

    2014-01-01

    Full Text Available Context: Severe pediatric ocular injury remains a frequent and difficult problem. Vitrectomy is a major technique that has been used to manage severely damaged eyes. However, limited follow-up studies exist currently. Aims: To evaluate the clinical features and predictive factors of visual and anatomic outcomes in Eye Injury Vitrectomy Study (EIVS. Settings and Design: Retrospective, consecutive, interventional case series. Materials and Methods: Reviewing and analyzing records of children, aged 15 years or younger, who had undergone vitrectomy for eye injuries in EIVS database between January 1997 and December 2009. Statistical analysis used: Descriptive analyses and multiple Logistic regressions were employed for all variables using SPSS software (version 17.0, SPSS Inc.. Results: Eighty-seven children (89 eyes with more than 6 months follow-up and complete records identified in EIVS were included in this study. Average follow-up was 12.7 months. The mean age was 9.4 ± 3.8 years. Seventy-seven eyes (86.5% had open globe injuries, and 12 (13.5% had closed globe injuries. Seventeen eyes (19.3% presented with endophthalmitis. Seventy-five eyes (88.2% presented with visual acuity of 4/200 or worse; however, 42 eyes (47.7% achieved 4/200 or better vision with anatomical restoration after vitrectomy. Multiple analysis showed that choroidal damage, large scleral wound, and endophthalmitis were significantly associated with unfavorable outcome, the OR values were 16.7 (95% CI: 2.7-102.4, P = 0.002, 10.9 (95% CI: 1.7-71.6, P = 0.013, and 6.6 (95% CI: 1.0-42.4, P = 0.048, respectively. Conclusions: Vitrectomy intervention resulted in favorable visual and anatomic outcomes in almost half of the injured eyes. Choroidal damage, large scleral wound, and endophthalmitis were the prognostic indicators of unfavorable outcome.

  18. Comparison of 12-month clinical outcomes in diabetic and nondiabetic patients with chronic total occlusion lesions: a multicenter study

    OpenAIRE

    Rha, Seung-Woon; Choi, Cheol Ung; Na, Jin Oh; Lim, Hong Euy; Kim, Jin Won; Kim, Eung Ju; Park, Chang Gyu; Seo, Hong Seog; Oh, Dong Joo; Gwon, Hyeon-Cheol; Kim, Byeong-Keuk; Kim, Hyo-Soo; Yu, Cheol Woong; Park, Hun Sik; Chae, In-Ho

    2015-01-01

    Objective This study aimed to compare 1-year clinical outcomes in diabetic and nondiabetic patients with chronic total occlusion (CTO) lesions. Methods A total of 2865 patients (age 62.82±10.64 years; 74.0% men) undergoing percutaneous coronary intervention for CTO were analyzed. The patients were classified as diabetic (n=977) or nondiabetic (n=1888). One-year clinical outcomes were compared between the two groups. Results One year after percutaneous coronary intervention, 241 (8.4%) patient...

  19. A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children.

    Directory of Open Access Journals (Sweden)

    Ian Sinha

    2008-04-01

    Full Text Available BACKGROUND: In clinical trials the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. Selection of inappropriate outcomes can compromise the utility of a trial. However, the process of selecting the most suitable outcomes to include can be complex. Our aim was to systematically review studies that address the process of selecting outcomes or outcome domains to measure in clinical trials in children. METHODS AND FINDINGS: We searched Cochrane databases (no date restrictions in December 2006; and MEDLINE (1950 to 2006, CINAHL (1982 to 2006, and SCOPUS (1966 to 2006 in January 2007 for studies of the selection of outcomes for use in clinical trials in children. We also asked a group of experts in paediatric clinical research to refer us to any other relevant studies. From these articles we extracted data on the clinical condition of interest, description of the method used to select outcomes, the people involved in the selection process, the outcomes selected, and limitations of the method as defined by the authors. The literature search identified 8,889 potentially relevant abstracts. Of these, 70 were retrieved, and 25 were included in the review. These studies described the work of 13 collaborations representing various paediatric specialties including critical care, gastroenterology, haematology, psychiatry, neurology, respiratory paediatrics, rheumatology, neonatal medicine, and dentistry. Two groups utilised the Delphi technique, one used the nominal group technique, and one used both methods to reach a consensus about which outcomes should be measured in clinical trials. Other groups used semistructured discussion, and one group used a questionnaire-based survey. The collaborations involved clinical experts, research experts, and industry representatives. Three groups involved parents of children affected by the particular condition. CONCLUSIONS: Very few studies address the

  20. A clinical study of complications of acute pancreatitis and their outcome

    OpenAIRE

    Sajjad Hussain; Rakesh Saraf

    2015-01-01

    Aim: The aim was to study the complications of acute pancreatitis, the outcome of complications, and to find out methods of improving the outcome. Materials and Methods: This is a descriptive study of patients admitted with acute pancreatitis. The management and outcome of the complications were recorded in detail. For determining the severity and predicting the course of acute pan- creatitis, a multiple organ system failure (MOSF) scoring system was utilized. Results: 104 patients were...

  1. A Clinical Outcome-Based Prospective Study on Venous Thromboembolism After Cancer Surgery

    Science.gov (United States)

    Agnelli, Giancarlo; Bolis, Giorgio; Capussotti, Lorenzo; Scarpa, Roberto Mario; Tonelli, Francesco; Bonizzoni, Erminio; Moia, Marco; Parazzini, Fabio; Rossi, Romina; Sonaglia, Francesco; Valarani, Bettina; Bianchini, Carlo; Gussoni, Gualberto

    2006-01-01

    Summary Background Data: The epidemiology of venous thromboembolism (VTE) after cancer surgery is based on clinical trials on VTE prophylaxis that used venography to screen deep vein thrombosis (DVT). However, the clinical relevance of asymptomatic venography-detected DVT is unclear, and the population of these clinical trials is not necessarily representative of the overall cancer surgery population. Objective: The aim of this study was to evaluate the incidence of clinically overt VTE in a wide spectrum of consecutive patients undergoing surgery for cancer and to identify risk factors for VTE. Methods: @RISTOS was a prospective observational study in patients undergoing general, urologic, or gynecologic surgery. Patients were assessed for clinically overt VTE occurring up to 30 ± 5 days after surgery or more if the hospital stay was longer than 35 days. All outcome events were evaluated by an independent Adjudication Committee. Results: A total of 2373 patients were included in the study: 1238 (52%) undergoing general, 685 (29%) urologic, and 450 (19%) gynecologic surgery. In-hospital prophylaxis was given in 81.6% and postdischarge prophylaxis in 30.7% of the patients. Fifty patients (2.1%) were adjudicated as affected by clinically overt VTE (DVT, 0.42%; nonfatal pulmonary embolism, 0.88%; death 0.80%). The incidence of VTE was 2.83% in general surgery, 2.0% in gynecologic surgery, and 0.87% in urologic surgery. Forty percent of the events occurred later than 21 days from surgery. The overall death rate was 1.72%; in 46.3% of the cases, death was caused by VTE. In a multivariable analysis, 5 risk factors were identified: age above 60 years (2.63, 95% confidence interval, 1.21–5.71), previous VTE (5.98, 2.13–16.80), advanced cancer (2.68, 1.37–5.24), anesthesia lasting more than 2 hours (4.50, 1.06–19.04), and bed rest longer than 3 days (4.37, 2.45–7.78). Conclusions: VTE remains a common complication of cancer surgery, with a remarkable proportion

  2. Outcome Prediction in Clinical Treatment Processes.

    Science.gov (United States)

    Huang, Zhengxing; Dong, Wei; Ji, Lei; Duan, Huilong

    2016-01-01

    Clinical outcome prediction, as strong implications for health service delivery of clinical treatment processes (CTPs), is important for both patients and healthcare providers. Prior studies typically use a priori knowledge, such as demographics or patient physical factors, to estimate clinical outcomes at early stages of CTPs (e.g., admission). They lack the ability to deal with temporal evolution of CTPs. In addition, most of the existing studies employ data mining or machine learning methods to generate a prediction model for a specific type of clinical outcome, however, a mathematical model that predicts multiple clinical outcomes simultaneously, has not yet been established. In this study, a hybrid approach is proposed to provide a continuous predictive monitoring service on multiple clinical outcomes. More specifically, a probabilistic topic model is applied to discover underlying treatment patterns of CTPs from electronic medical records. Then, the learned treatment patterns, as low-dimensional features of CTPs, are exploited for clinical outcome prediction across various stages of CTPs based on multi-label classification. The proposal is evaluated to predict three typical classes of clinical outcomes, i.e., length of stay, readmission time, and the type of discharge, using 3492 pieces of patients' medical records of the unstable angina CTP, extracted from a Chinese hospital. The stable model was characterized by 84.9% accuracy and 6.4% hamming-loss with 3 latent treatment patterns discovered from data, which outperforms the benchmark multi-label classification algorithms for clinical outcome prediction. Our study indicates the proposed approach can potentially improve the quality of clinical outcome prediction, and assist physicians to understand the patient conditions, treatment inventions, and clinical outcomes in an integrated view. PMID:26573645

  3. The significance of clinical experience on learning outcome from resuscitation training-a randomised controlled study

    DEFF Research Database (Denmark)

    Jensen, Morten Lind; Lippert, Freddy; Hesselfeldt, Rasmus;

    2009-01-01

    retention of learning. Materials and methods: This was a prospective single blinded randomised controlled study of the learning outcome from a standard ALS course on a volunteer sample of the entire cohort of newly graduated doctors from Copenhagen University. The outcome measurement was ALS...... immediately following graduation. Results: Invitation to participate was accepted by 154/240 (64%) graduates and 117/154 (76%) completed the study. There was no difference between the intervention and control groups with regard to the imme- diate learning outcome. The intervention group had significantly...... small but statistically significant impact on the retention of learning, but not on the immediate learning outcome....

  4. A prospective clinical study of feto-maternal outcome in pregnancies with abnormal liquor volume

    Directory of Open Access Journals (Sweden)

    Rutwa J. Chavda

    2014-02-01

    Conclusions: A good clinical examination can pick up most subjects of abnormal liquor volume. Abnormal liquor volumes are associated with increased maternal morbidity and adverse perinatal outcome. [Int J Reprod Contracept Obstet Gynecol 2014; 3(1.000: 181-184

  5. Clinical profile and outcome of children presenting with poisoning or intoxication: a hospital based study.

    Science.gov (United States)

    Budhathoki, S; Poudel, P; Shah, D; Bhatta, N K; Dutta, A K; Shah, G S; Bhurtyal, K K; Agrawal, B; Shrivastava, M K; Singh, M K

    2009-09-01

    Poisoning is a common preventable cause of morbidity and mortality in children. Most of the poisoning in children less than 5 years of age is accidental. Objective of the study was to study the clinical profile and outcome of childhood poisoning and intoxication. This was a retrospective study done in patients who were admitted in pediatric wards and pediatric intensive care unit (PICU) of BP Koirala Institute of Health Sciences with history of ingestion of poison or intoxication or envenomation firom January 2005 to June 2008. The data collected were analyzed with SPSS 12.0 software. There were 122 children enrolled in study. Male: female ratio was 1.4:1. The mean age of presentation was 5.8 years. Among 122 patients, 43.4% received pre-referral treatment in the form of gastric lavage, atropine etc. Organophosphorus poisoning was the commonest poisoning seen in 55 (45.1%) patients followed by hydrocarbon 12 (9.8%), mushroom 10 (8.2%) and organochlorine 10 (8.2%) poisoning. During treatment, 50.0% received antidotes. 55.7% received antibiotics, gastric lavage and anticonvulsants were required in 43.4% and 13.9% respectively. Overall survival was 87.4%. The time interval between intoxication and presentation to hospital, mean Glasgow Coma Scale (GCS) and presence of coma (GCS cases. In conclusion, organophosphorus is the commonest agent involved in childhood poisoning. Overall, the outcome is good with 87.4% survival in our hospital. The time gap between the poisoning and presentation to hospital and presence of coma predict mortality. PMID:20334063

  6. Is there a need for biomedical CBIR systems in clinical practice? Outcomes from a usability study

    Science.gov (United States)

    Antani, Sameer; Xue, Zhiyun; Long, L. Rodney; Bennett, Deborah; Ward, Sarah; Thoma, George R.

    2011-03-01

    Articles in the literature routinely describe advances in Content Based Image Retrieval (CBIR) and its potential for improving clinical practice, biomedical research and education. Several systems have been developed to address particular needs, however, surprisingly few are found to be in routine practical use. Our collaboration with the National Cancer Institute (NCI) has identified a need to develop tools to annotate and search a collection of over 100,000 cervigrams and related, anonymized patient data. One such tool developed for a projected need for retrieving similar patient images is the prototype CBIR system, called CervigramFinder, which retrieves images based on the visual similarity of particular regions on the cervix. In this article we report the outcomes from a usability study conducted at a primary meeting of practicing experts. We used the study to not only evaluate the system for software errors and ease of use, but also to explore its "user readiness", and to identify obstacles that hamper practical use of such systems, in general. Overall, the participants in the study found the technology interesting and bearing great potential; however, several challenges need to be addressed before the technology can be adopted.

  7. A prospective clinical study of feto-maternal outcome in pregnancies with abnormal liquor volume

    OpenAIRE

    Rutwa J. Chavda; Hardev B. Saini

    2014-01-01

    Background: Evaluating feto-maternal outcome in pregnancies with abnormal liquor volume. Methods: 200 pregnant subjects between 20 and 42 weeks of gestation, who were clinically suspected to have an abnormal amniotic fluid volume (oligohydramnios or polyhydramnios) were subjected to ultrasonographic (USG) assessment of amniotic fluid index. The subjects were closely monitored during pregnancy, labour and puerperium. Results: Ultrasonically, abnormal liquor volume was confirmed in 90-93...

  8. Galectin-3, Renal Function, and Clinical Outcomes: Results from the LURIC and 4D Studies.

    Science.gov (United States)

    Drechsler, Christiane; Delgado, Graciela; Wanner, Christoph; Blouin, Katja; Pilz, Stefan; Tomaschitz, Andreas; Kleber, Marcus E; Dressel, Alexander; Willmes, Christoph; Krane, Vera; Krämer, Bernhard K; März, Winfried; Ritz, Eberhard; van Gilst, Wiek H; van der Harst, Pim; de Boer, Rudolf A

    2015-09-01

    Galectin-3 has been linked to incident renal disease, experimental renal fibrosis, and nephropathy. However, the association among galectin-3, renal function, and adverse outcomes has not been described. We studied this association in two large cohorts of patients over a broad range of renal function. We measured galectin-3 concentrations in baseline samples from the German Diabetes mellitus Dialysis (4D) study (1168 dialysis patients with type 2 diabetes mellitus) and the Ludwigshafen Risk and Cardiovascular Health (LURIC) study (2579 patients with coronary angiograms). Patients were stratified into three groups: eGFR of ≥90 ml/min per 1.73 m(2), 60-89 ml/min per 1.73 m(2), and <60 ml/min per 1.73 m(2). We correlated galectin-3 concentrations with demographic, clinical, and biochemical parameters. The association of galectin-3 with clinical end points was assessed by Cox proportional hazards regression within 10 years (LURIC) or 4 years (4D) of follow-up. Mean±SD galectin-3 concentrations were 12.8±4.0 ng/ml (eGFR≥90 ml/min per 1.73 m(2)), 15.6±5.4 ng/ml (eGFR 60-89 ml/min per 1.73 m(2)), 23.1±9.9 ng/ml (eGFR<60 ml/min per 1.73 m(2)), and 54.1±19.6 ng/ml (dialysis patients of the 4D study). Galectin-3 concentration was significantly associated with clinical end points in participants with impaired kidney function, but not in participants with normal kidney function. Per SD increase in log-transformed galectin-3 concentration, the risks of all-cause mortality, cardiovascular mortality, and fatal infection increased significantly. In dialysis patients, galectin-3 was associated with the combined end point of cardiovascular events. In conclusion, galectin-3 concentrations increased with progressive renal impairment and independently associated with cardiovascular end points, infections, and all-cause death in patients with impaired renal function. PMID:25568176

  9. Prognostic factors related to clinical outcome following thrombectomy in ischemic stroke (RECOST Study). 50 patients prospective study

    International Nuclear Information System (INIS)

    Background and aims: New thrombectomy devices allow successful and rapid recanalization in acute ischemic stroke. Nevertheless prognostics factors need to be systematically analyzed in the context of these new therapeutic strategies. The aim of this study was to analyze prognostic factors related to clinical outcome following Solitaire FR thrombectomy in ischemic stroke. Methods: Fifty consecutive ischemic stroke patients with large vessel occlusion were included. Three treatment strategies were applied; rescue therapy, combined therapy, and standalone thrombectomy. DWI ASPECT score < 5 was the main exclusion criterion after initial MRI (T2, T2*, TOF, FLAIR, DWI). Sexes, age, time to recanalization were prospectively collected. Clinical outcome was assessed post treatment, day one and discharge by means of a NIHSS. Three months mRS evaluation was performed by an independent neurologist. The probability of good outcome at 3 months was assessed by forward stepwise logistic regression using baseline NIHSS score, Glasgow score at entrance, hyperglycemia, dyslipidemia, blood–brain barrier disruption on post-operative CT, embolic and hemorrhagic post procedural complication, ischemic brain lesion extension on 24 h imaging, NIHSS at discharge, ASPECT score, and time to recanalization. All variables significantly associated with the outcome in the univariate analysis were entered in the model. The significance of adding or removing a variable from the logistic model was determined by the maximum likelihood ratio test. Odds-ratio (OR) and their 95% confidence intervals were calculated. Results: At 3 months 54% of patients had a mRS 0–2, 70% in MCA, 44% in ICA, and 43% in BA with an overall mortality rate of 12%. Baseline NIHSS score (p = 0.001), abnormal Glasgow score at entrance (p = 0.053) hyperglycemia (p = 0.023), dyslipidemia (p = 0.031), blood–brain barrier disruption (p = 0.022), embolic and hemorrhagic post procedural complication, ischemic brain lesion

  10. Prognostic factors related to clinical outcome following thrombectomy in ischemic stroke (RECOST Study). 50 patients prospective study

    Energy Technology Data Exchange (ETDEWEB)

    Costalat, V., E-mail: vincentcost@hotmail.com [CHU Montpellier, Neuroradiology, Montpellier (France); Lobotesis, K., E-mail: kyriakos@lobotesis.co.uk [CHU Montpellier, Neuroradiology, Montpellier (France); Machi, P., E-mail: paolo.machi@gmail.com [CHU Montpellier, Neuroradiology, Montpellier (France); Mourand, I., E-mail: i-mourand@chu-montpellier.fr [CHU Montpellier, Neurology, Montpellier (France); Maldonado, I., E-mail: imaldonado@terra.com.br [CHU Montpellier, Neuroradiology, Montpellier (France); Heroum, C., E-mail: c-heroum@chu-montpellier.fr [CHU Montpellier, Neurology, Montpellier (France); Vendrell, J.F., E-mail: jf-vendrell@chu-montpellier.fr [CHU Montpellier, Neuroradiology, Montpellier (France); Milhaud, D., E-mail: d-milhaud@chu-montpellier.fr [CHU Montpellier, Neurology, Montpellier (France); Riquelme, C., E-mail: c-riquelme@chu-montpellier.fr [CHU Montpellier, Neuroradiology, Montpellier (France); Bonafé, A., E-mail: a-bonafe@chu-montpellier.fr [CHU Montpellier, Neuroradiology, Montpellier (France); Arquizan, C., E-mail: c-arquizan@chu-montpellier.fr [CHU Montpellier, Neurology, Montpellier (France)

    2012-12-15

    Background and aims: New thrombectomy devices allow successful and rapid recanalization in acute ischemic stroke. Nevertheless prognostics factors need to be systematically analyzed in the context of these new therapeutic strategies. The aim of this study was to analyze prognostic factors related to clinical outcome following Solitaire FR thrombectomy in ischemic stroke. Methods: Fifty consecutive ischemic stroke patients with large vessel occlusion were included. Three treatment strategies were applied; rescue therapy, combined therapy, and standalone thrombectomy. DWI ASPECT score < 5 was the main exclusion criterion after initial MRI (T2, T2*, TOF, FLAIR, DWI). Sexes, age, time to recanalization were prospectively collected. Clinical outcome was assessed post treatment, day one and discharge by means of a NIHSS. Three months mRS evaluation was performed by an independent neurologist. The probability of good outcome at 3 months was assessed by forward stepwise logistic regression using baseline NIHSS score, Glasgow score at entrance, hyperglycemia, dyslipidemia, blood–brain barrier disruption on post-operative CT, embolic and hemorrhagic post procedural complication, ischemic brain lesion extension on 24 h imaging, NIHSS at discharge, ASPECT score, and time to recanalization. All variables significantly associated with the outcome in the univariate analysis were entered in the model. The significance of adding or removing a variable from the logistic model was determined by the maximum likelihood ratio test. Odds-ratio (OR) and their 95% confidence intervals were calculated. Results: At 3 months 54% of patients had a mRS 0–2, 70% in MCA, 44% in ICA, and 43% in BA with an overall mortality rate of 12%. Baseline NIHSS score (p = 0.001), abnormal Glasgow score at entrance (p = 0.053) hyperglycemia (p = 0.023), dyslipidemia (p = 0.031), blood–brain barrier disruption (p = 0.022), embolic and hemorrhagic post procedural complication, ischemic brain lesion

  11. Dynamic Cervical Implant versus Anterior Cervical Diskectomy and Fusion: A Prospective Study of Clinical and Radiologic Outcome.

    Science.gov (United States)

    Richter, Heiko; Seule, Martin; Hildebrandt, Gerhard; Fournier, Jean-Yves

    2016-07-01

    Objective To evaluate clinical and radiologic outcome in patients treated with a dynamic cervical implant (DCI) or anterior cervical diskectomy and fusion (ACDF). Study Design A prospective comparative cohort study. Methods The study included 60 patients with one- or two-level cervical degenerative disk disease (DDD) undergoing treatment with either DCI (n = 30) or ACDF (n = 30). Clinical and radiologic outcomes were assessed 3 and 12 months after surgery. Clinical scoring systems included the Visual Analog Scale for Neck (VAS-N) and Arm pain (VAS-A), the Neck Pain and Disability Scale (NPAD), and the European Quality of Life Scale (EQ-5D). Results Both the DCI and ACDF group showed significant clinical improvement 12 months after surgery using the VAS-N (p = 0.034 and p clinical outcome comparing both groups at the 3- and 12-month follow-up. The fusion rate at 12 months after surgery was 39.4% and 80.0% in the DCI and ACDF groups, respectively. Radiolucency was found in 90.9% in the DCI group at 12-month follow-up. Conclusion The clinical results for DCI treatment are equivalent to those for ACDF in the treatment of one- and two-level cervical DDD at 12 months after surgery. Further studies are necessary to investigate the high rates of radiolucency and fusion associated with DCI treatment. PMID:27088592

  12. A retrospective study of the association between shortening of the clavicle after fracture and the clinical outcome in 136 patients

    DEFF Research Database (Denmark)

    Rasmussen, Jeppe; Jensen, Steen L; Petersen, Jens; Falstie-Jensen, Thomas; Lausten, Gunnar; Olsen, Bo S

    2011-01-01

    The purpose of this retrospective study was to examine the association between shortening of the clavicle after a united midshaft fracture and clinical outcome. Second, the purpose was to compare the results obtained by conservative treatment with either a figure-of-eight bandage or a simple sling....

  13. CLINICAL OUTCOME MEASURES OF PSORIASIS

    Directory of Open Access Journals (Sweden)

    E. Berardesca

    2011-09-01

    Full Text Available Several tools have been introduced in clinical trials to quantify the severity and the response to a given therapeutic regimen of both psoriasis and psoriatic arthritis. Each method present specific advantages and limitations. Here we will discuss some of the most popular clinical outcome measures of both psoriasis (Psoriasis Severity Index, Physician Global Assessment, National Psoriasis Fundation-Psoriasis Score, Dermatology Life Quality Index and psoriatic arthritis (American College Rheumatology response criteria, Psoriatic Arthritis Response Criteria. Key words: Psoriasis, psoriatic arthritis, outcome

  14. Responsiveness of Clinical Outcome Measures

    DEFF Research Database (Denmark)

    Lauridsen, Henrik Hein

    Background The Oswestry Disability Index (ODI) is one of two standardised functional health measurement scales (HMS) recommended. Despite extensive psychometric testing, little is known about HMS behaviour and the minimal clinically important difference (MCID) in subgroups of LBP patients. Moreover...... in the primary (PrS) and secondary sectors (SeS) of the Danish health care system. The prospective acceptable outcome study. A method for estimating LBP patients' view of an acceptable change before treatment begins (MCIDpre was developed and compared to a well established retrospective method of determining...... measurement error and 1.5-4.5 times larger compared to the MCIDpost. Furthermore, the MCIDpre was almost comparable to patients' post-treatment acceptable change, but only for the pain scale. Conclusion The Danish version of the ODI is a reliable, valid and responsive HMS which is psychometrically more...

  15. Admissions to acute adolescent psychiatric units: a prospective study of clinical severity and outcome

    Directory of Open Access Journals (Sweden)

    Jensen Gunnar

    2011-01-01

    Full Text Available Abstract Background Several countries have established or are planning acute psychiatric in-patient services that accept around-the-clock emergency admission of adolescents. Our aim was to investigate the characteristics and clinical outcomes of a cohort of patients at four Norwegian units. Methods We used a prospective pre-post observational design. Four units implemented a clinician-rated outcome measure, the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA, which measures mental health problems and their severity. We collected also data about the diagnoses, suicidal problems, family situations, and the involvement of the Child Protection Service. Predictions of outcome (change in HoNOSCA total score were analysed with a regression model. Results The sample comprised 192 adolescents admitted during one year (response rate 87%. Mean age was 15.7 years (range 10-18 and 70% were girls. Fifty-eight per cent had suicidal problems at intake and the mean intake HoNOSCA total score was 18.5 (SD 6.4. The largest groups of main diagnostic conditions were affective (28% and externalizing (26% disorders. Diagnoses and other patient characteristics at intake did not differ between units. Clinical psychiatric disorders and developmental disorders were associated with severity (on HoNOSCA at intake but not with outcome. Of adolescents ≥ 16 years, 33% were compulsorily admitted. Median length of stay was 8.5 days and 75% of patients stayed less than a month. Compulsory admissions and length of stay varied between units. Mean change (improvement in the HoNOSCA total score was 5.1 (SD 6.2, with considerable variation between units. Mean discharge score was close to the often-reported outpatient level, and self-injury and emotional symptoms were the most reduced symptoms during the stay. In a regression model, unit, high HoNOSCA total score at intake, or involvement of the Child Protection Service predicted improvement during admission

  16. CLINICAL OUTCOME MEASURES OF PSORIASIS

    OpenAIRE

    E. Berardesca; Bonifati, C

    2011-01-01

    Several tools have been introduced in clinical trials to quantify the severity and the response to a given therapeutic regimen of both psoriasis and psoriatic arthritis. Each method present specific advantages and limitations. Here we will discuss some of the most popular clinical outcome measures of both psoriasis (Psoriasis Severity Index, Physician Global Assessment, National Psoriasis Fundation-Psoriasis Score, Dermatology Life Quality Index) and psoriatic arthritis (American College Rheu...

  17. A comparative study of clinical outcomes of post placental insertion versus interval insertion of Copper T 380A intrauterine device

    OpenAIRE

    Suchi Gupta; Shubha Sagar Trivedi; Ratna Biswas

    2015-01-01

    Background: The objective of this study was to study the safety and efficacy of PPIUCD insertion and to compare it with interval insertion. Methods: A prospective study was conducted enrolling 100 women as study group (PPIUCD) and 100 as control group (interval CuT insertion). All women were followed up for 6 months and clinical outcomes were measured in terms of safety, efficacy, effect on menstrual cycles and continuation rates. Chi square test was used to detect differences in the rate...

  18. Micro-dosimetric study for interpretation of outcomes from boron neutron capture therapy clinical trials

    International Nuclear Information System (INIS)

    Boron neutron capture therapy is a brachy-radiotherapy utilizing the 10B(n,α)7Li reaction that has been used to treat glioblastoma multiforme (GBM), melanoma and colon carcinoma liver metastases. GBM clinical trials resulted in modestly improved life expectancies compared with conventional therapies. Early results trials focused on malignant melanoma and colon carcinoma provide dramatically better results. Macro-dosimetry cannot explain these apparent differences. The dichotomy can only be understood using Micro-dosimetry techniques. A computer program has been created to provide an improved tissue model. This model permits the dose in each cell's cytoplasm, nucleus, and the interstitium to be calculated for ellipsoidal cells placed in either random or ordered locations. The nuclei can be centered or eccentric. The new model provides insight into the micro level for differences in the trials. The differences arise from the tissue's cellular geometry and the effects of neighboring cells. These results help to explain the observed clinical outcomes. (authors)

  19. Clinical characteristics, neurophysiological grade and outcome of patients with carpal tunnel syndrome A retrospective study

    Institute of Scientific and Technical Information of China (English)

    Jingxia Dang

    2007-01-01

    BACKGROUND: Carpal tunnel syndrome (CTS) is diagnosed mainly according to clinical symptoms, physical sign and neurodiagnostic laboratory examination. The therapeutic effect of conservative management and surgical operation in treating CTS need to be further observed and evaluated. OBJECTIVE: To analyze the clinical characteristics, neurophysiological grade and outcome in patients with CTS.DESIGN: Retrospective case-analysis.SETTING: Department of Neurology, First Affiliated Hospital, Medical College, Xi'an Jiaotong University. PARTICIPANTS: Totally 161 patients with suspected CTS from National Neuroscience Institute of Singapore referred to the Neurodiagnostic Laboratory for the confirmatory testing between January and September 2002. The involved patients, 137 male and 24 female, were aged 21-85 years. METHODS:①The condition of diabetes mellitus complicated by abnormal thyroid function was observed.②The effect on predominant hand, and paraesthesia were observed.③Neuroelectrophysiological studies were performed and the results were graded into mild, moderate and severe CTS according to the American Association of Electrodiagnostic Medicine (AAEM) criteria.④Conservative management and surgical intervention were followed up 3 months later, and symptoms and physical sign basically disappeared, and function was basically recovered, which indicated that disease condition improved.MAIN OUTCOME MEASURES:①Condition of CTS complicated by metabolic disease;②Effects on predominant hand and paraesthesia;③Electrophysiological grading; ④Prognosis.RESULTS: Totally 161 patients participated in the final analysis.①Condition of CTS complicated by metabolic disease: Among 161 patients, 17.4% (28/161) were documented to have diabetes mellitus and 7(4.3%) had hypothyroidism.②Effects on predominant hand and paraesthesia: Dominant hand involvement was present in 134 patients (83.2%) and more than 75% had onset of symptoms in the dominant hand. Sensory symptoms like

  20. Assessing clinical and functional outcomes in a gene-environment interaction study in first episode of psychosis (PEPs).

    Science.gov (United States)

    Bernardo, Miquel; Bioque, Miquel; Parellada, Mara; Saiz Ruiz, Jerónimo; Cuesta, Manuel J; Llerena, Adrián; Sanjuán, Julio; Castro-Fornieles, Josefina; Arango, Celso; Cabrera, Bibiana

    2013-01-01

    The PEPs study is a multicenter, naturalistic, prospective, longitudinal study designed to evaluate clinical, neuropsychological, neuroimaging, biochemical, environmental and pharmacogenetic variables in a sample of nearly 350 first episode of psychosis patients and 250 healthy controls. The PEPs project was conducted in Spain from January 2009 to December 2011. This article describes the rationale for the measurement approach adopted, providing an overview of the selected clinical and functional measures. The main objectives are: a) the thorough clinical and neurocognitive characterization of a sample of first episodes of psychosis, and b) the study of the interactions between the genetic and environmental variables selected to predict clinical and brain structural outcomes, and to determine the relationship of genetic polymorphisms involved in the pharmacokinetics and pharmacodynamics, and the responses and adverse effects of treatment. PMID:23206389

  1. Anticoagulation Management Practices and Outcomes in Elderly Patients with Acute Venous Thromboembolism: A Clinical Research Study.

    Directory of Open Access Journals (Sweden)

    Charlène Insam

    Full Text Available Whether anticoagulation management practices are associated with improved outcomes in elderly patients with acute venous thromboembolism (VTE is uncertain. Thus, we aimed to examine whether practices recommended by the American College of Chest Physicians guidelines are associated with outcomes in elderly patients with VTE. We studied 991 patients aged ≥65 years with acute VTE in a Swiss prospective multicenter cohort study and assessed the adherence to four management practices: parenteral anticoagulation ≥5 days, INR ≥2.0 for ≥24 hours before stopping parenteral anticoagulation, early start with vitamin K antagonists (VKA ≤24 hours of VTE diagnosis, and the use of low-molecular-weight heparin (LMWH or fondaparinux. The outcomes were all-cause mortality, VTE recurrence, and major bleeding at 6 months, and the length of hospital stay (LOS. We used Cox regression and lognormal survival models, adjusting for patient characteristics. Overall, 9% of patients died, 3% had VTE recurrence, and 7% major bleeding. Early start with VKA was associated with a lower risk of major bleeding (adjusted hazard ratio 0.37, 95% CI 0.20-0.71. Early start with VKA (adjusted time ratio [TR] 0.77, 95% CI 0.69-0.86 and use of LMWH/fondaparinux (adjusted TR 0.87, 95% CI 0.78-0.97 were associated with a shorter LOS. An INR ≥2.0 for ≥24 hours before stopping parenteral anticoagulants was associated with a longer LOS (adjusted TR 1.2, 95% CI 1.08-1.33. In elderly patients with VTE, the adherence to recommended anticoagulation management practices showed mixed results. In conclusion, only early start with VKA and use of parenteral LMWH/fondaparinux were associated with better outcomes.

  2. IQ Trajectory, Cognitive Reserve, and Clinical Outcome Following a First Episode of Psychosis: A 3-Year Longitudinal Study

    OpenAIRE

    Leeson, Verity C.; Sharma, Pranev; Harrison, Masuma; Ron, Maria A.; Barnes, Thomas R. E.; Joyce, Eileen M.

    2009-01-01

    Comparison of current and estimated premorbid IQ in schizophrenia suggests that there are subgroups with low IQ, deteriorated IQ (DIQ), or preserved IQ and that this is established by psychosis onset. There are no controlled studies examining the trajectory of these IQ subgroups longitudinally or their relationship with clinical and social outcomes. Of 129 individuals with first-episode schizophrenia or schizoaffective disorder, 25% showed stable low IQ, 31% showed stable IQ in the average/hi...

  3. Clinical characteristics and outcomes of patients with acute myelogenous leukemia admitted to intensive care: a case-control study

    OpenAIRE

    Roze des Ordons, Amanda L; Chan, Kris; Mirza, Imran; Townsend, Derek R; Bagshaw, Sean M

    2010-01-01

    Background There is limited epidemiologic data on patients with acute myelogenous (myeloid) leukemia (AML) requiring life-sustaining therapies in the intensive care unit (ICU). Our objectives were to describe the clinical characteristics and outcomes in critically ill AML patients. Methods This was a retrospective case-control study. Cases were defined as adult patients with a primary diagnosis of AML admitted to ICU at the University of Alberta Hospital between January 1st 2002 and June 30th...

  4. Sleep quality, the neglected outcome variable in clinical studies focusing on locomotor system; a construct validation study

    Directory of Open Access Journals (Sweden)

    Röder Christoph

    2010-09-01

    Full Text Available Abstract Background In addition to general health and pain, sleep is highly relevant to judging the well-being of an individual. Of these three important outcome variables, however, sleep is neglected in most outcome studies. Sleep is a very important resource for recovery from daily stresses and strains, and any alteration of sleep will likely affect mental and physical health, especially during disease. Sleep assessment therefore should be standard in all population-based or clinical studies focusing on the locomotor system. Yet current sleep assessment tools are either too long or too specific for general use. Methods Based on a literature review and subsequent patient-based rating of items, an expert panel designed a four-item questionnaire about sleep. Construct validation of the questionnaire in a random sample of the German-speaking Swiss population was performed in 2003. Reliability, correlation, and tests for internal consistency and validity were analyzed. Results Overall, 16,634 (70% out of 23,763 eligible individuals participated in the study. Test-retest reliability coefficients ranged from 0.72 to 0.87, and a Cronbach's alpha of 0.83 indicates good internal consistency. Results show a moderate to good correlation between sleep disturbances and health perception, and between sleep disturbances and overall pain. Conclusions The Sleep Standard Evaluation Questionnaire (SEQ-Sleep is a reliable and short tool with confirmed construct validity for sleep assessment in population-based observational studies. It is easy to administer and therefore suitable for postal surveys of the general population. Criterion validity remains to be determined.

  5. Incidence and Effects of Polypharmacy on Clinical Outcome among Patients Aged 80+: A Five-Year Follow-Up Study.

    Directory of Open Access Journals (Sweden)

    Rong Wang

    Full Text Available Polypharmacy is a problem of growing interest in geriatrics with the increase in drug consumption in recent years, is defined according to the WHO criteria as the, ''concurrent use of five or more different prescription medication". We investigated the clinical characteristics of polypharmacy and identified the effects of polypharmacy on clinical outcome among patients aged 80+ admitted to Chinese PLA general hospital.Older men aged ≥80 years (n = 1562 were included in this study. The included participants attended a structured clinical examination and an interview carried out by a geriatrician and trained nurses. A follow-up survey in 2014 was carried out on survivors in the same way as in 2009. The clinical outcome measured were adverse drug reactions, falls, frailty, disability, cognitive impairment, mortality. The association between polypharmacy and clinical outcome was assessed by logistic regression.The mean (range age of the included participants was 85.2 (80-104 years. Medication exposure was reported by 100% of the population. Mean number of medications reported in this population was 9.56±5.68. The prevalence of polypharmacy (≥6 medications in the present study was 70%. At the time of the follow-up survey, an increase in the number of taken medicines had occurred among half of the survivors. The risk of different outcomes in relation to number of medications rises significantly, the odds ratios were 1.21 (95% confidence interval [CI]1.17-1.28 for adverse drug reactions, 1.18 (95% CI 1.10-1.26 for falls, 1.16 (95% CI 1.09-1.24 for disability, and 1.19 (95% CI 1.12-1.23 for mortality. There was no association between increasing number of medications and cognitive impairment.Our study demonstrates that polypharmacy is very common in the very old patients, and observed that number of medications was a factor associated with difference clinical outcome independently of the age, type of medications prescribed and accompanied

  6. The EMPA-REG outcome study: critical appraisal and potential clinical implications

    OpenAIRE

    Perseghin, Gianluca; Solini, Anna

    2016-01-01

    Diabetes health care professionals have to face a study with results of incomparable success in secondary and tertiary cardiovascular disease prevention. In the past, no studies in patients with type 2 diabetes resulted to be successful in inducing an improvement of cardiovascular prognosis, no matter whether they were focused on a target, on life-style or on pharmacological intervention. On a clinical perspective, should the diabetologist’s way to think about the anti-diabetic therapy of pat...

  7. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton; Lundgren, Jens Dilling

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  8. Clinical Decision Making and Outcome in Routine Care for People with Severe Mental Illness (CEDAR: Study protocol

    Directory of Open Access Journals (Sweden)

    Nemes Zoltan

    2010-11-01

    Full Text Available Abstract Background A considerable amount of research has been conducted on clinical decision making (CDM in short-term physical conditions. However, there is a lack of knowledge on CDM and its outcome in long-term illnesses, especially in care for people with severe mental illness. Methods/Design The study entitled "Clinical decision making and outcome in routine care for people with severe mental illness" (CEDAR is carried out in six European countries (Denmark, Germany, Hungary, Italy, Switzerland and UK. First, CEDAR establishes a methodology to assess CDM in people with severe mental illness. Specific instruments are developed (and psychometric properties established to measure CDM style, key elements of CDM in routine care, as well as CDM involvement and satisfaction from patient and therapist perspectives. Second, these instruments are being put to use in a multi-national prospective observational study (bimonthly assessments during a one-year observation period; N = 560. This study investigates the immediate, short- and long-term effect of CDM on crucial dimensions of clinical outcome (symptom level, quality of life, needs by taking into account significant variables moderating the relationship between CDM and outcome. Discussion The results of this study will make possible to delineate quality indicators of CDM, as well as to specify prime areas for further improvement. Ingredients of best practice in CDM in the routine care for people with severe mental illness will be extracted and recommendations formulated. With its explicit focus on the patient role in CDM, CEDAR will also contribute to strengthening the service user perspective. This project will substantially add to improving the practice of CDM in mental health care across Europe. Trial register ISRCTN75841675.

  9. Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data

    OpenAIRE

    Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F.; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich

    2013-01-01

    Editors' Summary Background People assume that, when they are ill, health care professionals will ensure that they get the best available treatment. In the past, clinicians used their own experience to make decisions about which treatments to offer their patients, but nowadays, they rely on evidence-based medicine—the systematic review and appraisal of clinical trials, studies that investigate the benefits and harms of drugs and other medical interventions in patients. Evidence-based medicine...

  10. Clinical characterization and outcome of primary bone lymphoma: a retrospective study of 61 Chinese patients

    Science.gov (United States)

    Zhang, XuanYe; Zhu, Jun; Song, YuQin; Ping, LingYan; Zheng, Wen

    2016-01-01

    Primary bone lymphoma(PBL) is a rare disease. To assess the clinical characteristics, outcome, and prognostic factors of this entity in Chinese population, we retrospectively analyzed 61 PBL patients initially treated in our institution between 1997 and 2014. The median age was 45 years. The most common histological subtype was diffuse large B-cell lymphoma (DLBCL) (55.7%), followed by T-cell lymphoma (18.0%). All patients underwent systemic chemotherapy as initial treatment while 24 patients (39.3%) were additionally treated with radiotherapy. The 5-year overall survival (OS) and the 5-year progression-free survival (PFS) rates of 57 cases with completed follow-up were 52.3% and 40.1%, respectively. In further analysis of the primary bone DLBCL (PB-DLBCL) subgroup, the 5-year OS and PFS rates were 53.0% and 47.0%, and a multivariable analysis revealed that baseline Eastern Cooperative Oncology Group (ECOG) score and response to initial treatment (complete remission versus no complete remission) were independent prognostic factors for both OS and PFS. The proportion of T-cell lymphoma is higher in China than in western populations. High baseline ECOG scores (≥2) and unachieved CR in initial therapy were factors for poor PB-DLBCL prognosis. The role of radiotherapy and rituximab in PLB therapy remains to be confirmed in further investigation. PMID:27357354

  11. Fundamentals of Clinical Outcomes Assessment for Spinal Disorders: Clinical Outcome Instruments and Applications.

    Science.gov (United States)

    Vavken, Patrick; Ganal-Antonio, Anne Kathleen B; Quidde, Julia; Shen, Francis H; Chapman, Jens R; Samartzis, Dino

    2015-08-01

    Study Design A broad narrative review. Objectives Outcome assessment in spinal disorders is imperative to help monitor the safety and efficacy of the treatment in an effort to change the clinical practice and improve patient outcomes. The following article, part two of a two-part series, discusses the various outcome tools and instruments utilized to address spinal disorders and their management. Methods A thorough review of the peer-reviewed literature was performed, irrespective of language, addressing outcome research, instruments and tools, and applications. Results Numerous articles addressing the development and implementation of health-related quality-of-life, neck and low back pain, overall pain, spinal deformity, and other condition-specific outcome instruments have been reported. Their applications in the context of the clinical trial studies, the economic analyses, and overall evidence-based orthopedics have been noted. Additional issues regarding the problems and potential sources of bias utilizing outcomes scales and the concept of minimally clinically important difference were discussed. Conclusion Continuing research needs to assess the outcome instruments and tools used in the clinical outcome assessment for spinal disorders. Understanding the fundamental principles in spinal outcome assessment may also advance the field of "personalized spine care." PMID:26225283

  12. CLINICAL STUDY TO EVALUATE THE MATERNAL AND PERINATAL OUTCOME OF PREGNANCIES WITH POLYHYDRAMNIOS

    Directory of Open Access Journals (Sweden)

    Sudha

    2013-10-01

    Full Text Available ABSTRACT: BACKGROUND : Due to active involvement of fetal system in regulation of amn iotic fluid volume, AFI has been identified as indicator of intrauterine fetal status. USG has revolutionized the process of assessment of amniotic fluid thus becoming an integral part of fetal surveillance . Polyhydramnios is an obstetrical condition assoc iated with significant perinatal and maternal morbidity and mortality. In a low resource health facility as India with poor coverage of antenatal care and malnutrition it still becomes more important to screen pregnancies for such high risk factors. AIMS: 1. To study incidence of polyhydramnios. 2. To identify major etiological factors of polyhydramnios. 3. To study perinatal outcome. SETTINGS AND DESIGN: A hospital based cross section study for duration from 1 st May 2009 to 31 st October 2010. MATERIAL & ME THOD: All the cases identified as polyhydramnios according to AFI in four pocket were included in the study. The cases identified as having polyhydramnios but not delivered at the facility were excluded. OBSERVATION: Incidence of polyhydramnios is 0.72% of the total antenatal cases, multiparous ie, 52% more than primiparous cases. Majority were unbooked (77.3% 63% were from rural set up. 76% belonged to low socio economic status. Majority 66% of the cases had their 1 st antenatal visit at term. Increased in cidence of operative delivery was seen in the study. Associated maternal factors found with polyhydramnios were gestation hypertension (8.4%, preeclampsia (2.9%, eclampsia (2.9%, anaemia (11%, twins (8.4%, malpresentation (5%, RH negative factor (3.7 %, and diabetes (1.9%. Fetal complication include prematurity 21.6%, IUFT 20.7%, congenital malformation 21.6%, cord prolapse 3.7%, birth asphyxia 1.9%. Most common congenital anomaly was anencephaly i.e., 11%. CONCLUSION : The study gives us the underst anding of the impact of polyhydramnios on the maternal and fetal outcome. Our study demonstrate s

  13. Symptomatic reactions, clinical outcomes and patient satisfaction associated with upper cervical chiropractic care: A prospective, multicenter, cohort study

    Directory of Open Access Journals (Sweden)

    Hurwitz Eric L

    2011-10-01

    Full Text Available Abstract Background Observational studies have previously shown that adverse events following manipulation to the neck and/or back are relatively common, although these reactions tend to be mild in intensity and self-limiting. However, no prospective study has examined the incidence of adverse reactions following spinal adjustments using upper cervical techniques, and the impact of this care on clinical outcomes. Methods Consecutive new patients from the offices of 83 chiropractors were recruited for this practice-based study. Clinical outcome measures included 1 Neck pain disability index (100-point scale, 2 Oswestry back pain index (100-point scale, 3 11-point numerical rating scale (NRS for neck, headache, midback, and low back pain, 4 treatment satisfaction, and 5 Symptomatic Reactions (SR. Data were collected at baseline, and after approximately 2 weeks of care. A patient reaching sub-clinical status for pain and disability was defined as a follow-up score 30% based on an 11-point numeric rating scale occurring Results A total of 1,090 patients completed the study having 4,920 (4.5 per patient office visits requiring 2,653 (2.4 per patient upper cervical adjustments over 17 days. Three hundred thirty- eight (31.0% patients had SRs meeting the accepted definition. Intense SR (NRS ≥8 occurred in 56 patients (5.1%. Outcome assessments were significantly improved for neck pain and disability, headache, mid-back pain, as well as lower back pain and disability (p 5 million career upper cervical adjustments without a reported incidence of serious adverse event. Conclusions Upper cervical chiropractic care may have a fairly common occurrence of mild intensity SRs short in duration (

  14. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: Indications, Complications, and Outcomes in 5803 Patients

    NARCIS (Netherlands)

    J. de la Rosette; D. Assimos; M. Desai; J. Gutierrez; J. Lingeman; R. Scarpa; A. Tefekli

    2011-01-01

    Purpose: To assess the current indications, perioperative morbidity, and stone-free outcomes for percutaneous nephrolithotomy (PCNL) worldwide. Patients and Methods: The Clinical Research Office of the Endourological Society (CROES) collected prospective data for consecutive patients who were treate

  15. Pregnancy-Related Systemic Lupus Erythematosus: Clinical Features, Outcome and Risk Factors of Disease Flares — A Case Control Study

    OpenAIRE

    Huaxia Yang; Hui Liu; Dong Xu; Lidan Zhao; Qian Wang; Xiaomei Leng; Wenjie Zheng; Fengchun Zhang; Fulin Tang; Xuan Zhang

    2014-01-01

    OBJECTIVE: To investigate the clinical features, outcome, and risk factors of disease flares in patients with pregnancy-related lupus (PRL). METHODS: Medical charts of 155 consecutive PRL inpatients were systematically reviewed, including demographic data, clinical features, laboratory findings, treatment, complications, and outcome. RESULTS: PRL cases were divided into active (a-PRL) (n = 82, 53.0%) and stable lupus (s-PRL) (n = 73, 47.0%). Compared with nonpregnant active female systemic lu...

  16. Cardiovascular outcomes of sodium-glucose cotransporter 2 inhibitors: A comprehensive review of clinical and preclinical studies.

    Science.gov (United States)

    Ghosh, Raktim Kumar; Bandyopadhyay, Dhrubajyoti; Hajra, Adrija; Biswas, Monodeep; Gupta, Anjan

    2016-06-01

    Diabetes is a leading cause of morbidity and mortality worldwide. Management of diabetes is changing at a rapid pace. Three new classes of antidiabetic drugs including GLP-1 (Glucagon-like peptide 1), DPP-IV (Dipeptidyl peptidase IV) and SGLT2 (Sodium glucose cotransporter 2) inhibitors have been approved in the last few years. Treating diabetes with the antidiabetic drug does not always reduce the cardiovascular complications of diabetes. On the contrary, there was a huge controversy regarding the effect of rosiglitazone on cardiovascular risk reduction a few years ago. Since then, submission of postmarketing cardiovascular outcome study data has been mandated by US FDA and other drug regulatory agencies for newer antidiabetic medications. This is to avoid further premature claims regarding cardiovascular harm or safety of the newer classes. We already have some cardiovascular safety data available on DPP-IV and GLP-1 groups of medications. Dapagliflozin, canagliflozin, and empagliflozin are currently approved SGLT2 inhibitors. We do not have sufficient cardiovascular outcome data available for this novel class. However, this group of drugs, which act by increasing renal glucose excretion, have also shown some non-glycemic benefits including weight reduction, blood pressure control, diuretic action, renal protection, decrease in arterial stiffness and uric acid reduction. Empagliflozin, a new member of SGLT2 class, showed significant cardiovascular morbidity and mortality benefit in recently published EMPA-REG OUTCOME trial. The authors summarize all the published clinical and preclinical cardiovascular outcome data of SGLT2 inhibitors, including recently completed and ongoing major clinical trials in this comprehensive review. PMID:27017118

  17. A clinical study of complications of acute pancreatitis and their outcome

    Directory of Open Access Journals (Sweden)

    Sajjad Hussain

    2015-02-01

    Conclusion: Ascites was the most common local complication, whereas pleural effusion was the most common systemic complication. Shock, acute respiratory distress syndrome, acute renal failure, pancreatic abscess, infection of the pancre- atic necrosis, upper gastrointestinal bleed, hypocalcaemia, portal vein thrombosis, and hepatic encephalopathy were com- plications with the poorest prognosis. It is important to identify patients with acute pancreatitis who have an increased risk of complications and death. The MOSF scoring system is simple to use, has better clinical utility, and helps in directing pre- cious resources to patients who benefit the most from intensive therapy. Patients with severe pancreatitis require intensive monitoring and support of a failing system in intensive care unit, the lack of which resulted in higher mortality in our study. [Arch Clin Exp Surg 2015; 4(1.000: 1-13

  18. Health care associated infections, antibiotic resistance and clinical outcome: A surveillance study from Sanandaj, Iran

    Science.gov (United States)

    Soltani, Jafar; Poorabbas, Bahman; Miri, Neda; Mardaneh, Jalal

    2016-01-01

    AIM: To study the antibiotic susceptibility patterns of gram-negative healthcare associated bacterial infections at two tertiary hospitals in the Sanandaj city, Kurdistan Province, Iran. METHODS: From January 2012 to December 2012, all positive cultures from potentially sterile body fluids were gathered. They sent to professor Alborzi clinical microbiology center in Shiraz for further analysis and susceptibility testing. The antibiotic susceptibility was determined using the Kirby-Bauer method (disk diffusion technique). The Results were interpreted according to Clinical and Laboratory Standards Institute guidelines against a series of antimicrobials. World Health Organization definitions for Healthcare associated infections were followed. RESULTS: Seven hundred and thirty-two positive cultures were reported from both hospitals. Seventy-nine isolates/patients fulfilled the study criteria for health-care associated gram-negative infections. The most frequent bacterial cultures were from the pediatric wards (52%). Serratia marcescens (S. marcescens) (38%) Escherichia coli (E. coli) (19%), Klebsiella pneumoniae (K. pneumoniae) (19%), Acinetobacter baumannii (6%), Enterobacter species (6%), Serratia odorifera (4%) and Pseudomonas species (5%) were the most frequently isolated organisms. The susceptibility pattern of common isolates i.e., S. marcescens, E. coli and K. pneumoniae for commonly used antibiotics were as follows: Ampicillin 3.3%, 6.7%, 20%; gentamicin 73.3%, 73.3%, 46.7%; ceftazidim 80%, 73.3%, 33.3%; cefepim 80%, 86.7%, 46.7%; piperacillin/tazobactam 90%, 66.7%, 86.7%; ciprofloxacin 100%, 73.3%, 86.7%; imipenem 100%, 100%, 100%, respectively. CONCLUSION: The most effective antibiotics against gram-negative healthcare associated infections are imipenem followed by ciprofloxacin. The resistance rate is high against ampicillin and cephalothin. The high mortality rate (46.1%) associated with S. marcescens is alarming. PMID:26989670

  19. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study

    Directory of Open Access Journals (Sweden)

    Kristen Meldi Plasseraud

    2016-01-01

    Full Text Available Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evaluate the continued clinical validity and utility of DecisionDx-UM, beginning March 2010, 70 patients were enrolled in a prospective, multicenter, IRB-approved study to document patient management differences and clinical outcomes associated with low-risk Class 1 and high-risk Class 2 results indicated by DecisionDx-UM testing. Thirty-seven patients in the prospective study were Class 1 and 33 were Class 2. Class 1 patients had 100% 3-year metastasis-free survival compared to 63% for Class 2 (log rank test p=0.003 with 27.3 median follow-up months in this interim analysis. Class 2 patients received significantly higher-intensity monitoring and more oncology/clinical trial referrals compared to Class 1 patients (Fisher’s exact test p=2.1×10-13 and p=0.04, resp.. The results of this study provide additional, prospective evidence in an independent cohort of patients that Class 1 and Class 2 patients are managed according to the differential metastatic risk indicated by DecisionDx-UM. The trial is registered with Clinical Application of DecisionDx-UM Gene Expression Assay Results (NCT02376920.

  20. A CLINICAL STUDY ON LENS INDUCED GLAUCOMA AND ITS VISUAL OUTCOME IN PATIENTS VISITING RIMS, SRIKAKULAM

    Directory of Open Access Journals (Sweden)

    Rajkumar

    2015-07-01

    Full Text Available AIM: To Evaluate sex predominance, prevalence of different types of lens induced Glaucomas and its visual outcomes in patients visiting rims, srikakulam. MATERIAL AND METHODS : This prospective study was conducted in Ophthalmology department of Rajiv Gandhi Institute of Medical Sciences, Srikakulam, Andhra Pradesh from October 2014 to June 2015. 37 Patients visiting the Hospital with classical symptoms of Lens induced Glaucoma were taken into study. First all these patients underwent a through ocular examination using Slit lamp biomicroscopy, Schiotz tonometry and Applanation tonometer. T hese patients were operated after explaining the possible prognosis, by Small Incision Cataract Surgery with PCIOL implantation. Also a peripheral Iridectomy was performed to all the patients. Post operatively immense care was taken to prevent posterior synechiae formation using short acting Cycloplegics. During follow up a detailed Ocular examination was done including Refraction using snellens chart and IOP measurement using Schiotz tonometer and applanation tomometer. All the results were entered in Computer and evaluated. RESULTS: A Total of 37 patients were taken into this study in which 14(37.84% were male patients and 23(62.16% were Female. Among different LIG patients maximum patients had Phacomorphic Glaucoma accounting 67.57% (25 patients and Phacolytic Glaucoma 29.73%. Intra Ocular pressure was measured on admission before any medication and noted. Highest percentage was among 30 - 39mmHg (37.84% followed by 40 - 49mmHg (32.43% and 50 - 59mmHg (16.22%. After surgery during discharge all those patients were measured again for IOP and noted. Highest patients were between 10 - 19mmHg (78.38%. Rest were <10(10.8%. Similarly Visual acuity o n admission, highest patients were seen in Hand movements positive (37.84% followed by Perception of Light positive (29.73%. Even No PL were also seen (16.22% in higher proportion. On the day of follow up after 2 weeks

  1. “Basket weave technique” for medial patellofemoral ligament reconstruction: Clinical outcome of a prospective study

    Science.gov (United States)

    Kodkani, Pranjal S

    2016-01-01

    Background: Bone tunneling and implants with rigid fixations for medial patellofemoral ligament (MPFL) reconstruction are known to compromise results and are avoidable, especially in skeletally immature subjects. This study was to assess if these deficiencies were overcome with the technique devised by the author which avoids implants and bone tunnels. Results were assessed for complication rate and outcome. Materials and Methods: Fifty six knees of recurrent lateral patellar dislocation were treated in the past 49 months by MPFL reconstruction. Thirty nine were female and 17 male knees. The mean age was 20.6 years (range 9-48 years). Mean followup was 26 months. Five knees had previously failed stabilization procedures. Thirty one cases had Dejours Type A or B and 12 had Type C trochlear dysplasia. Arthroscopy was performed for associated injuries and loose bodies. Seven knees required loose body removal. Five knees underwent lateral retinacular release. Four knees had tibial tuberosity transfer. One knee had an associated anterior cruciate ligament reconstruction. An anatomical MPFL reconstruction was performed using hamstring autograft without the need for intraoperative fluoroscopy. Only soft tissue fixation was necessary with this newly devised technique and suturing. A rapid rehabilitation protocol was implemented with monthly followup until normalcy and 6 monthly thereafter. Results: All achieved full range of motion and normal mediolateral stability. There was no recurrence of dislocation. No major surgery related complications. One patella fracture at 8 months was due to a fall developed terminal restriction of flexion. Those in sports could return to their sporting activities (Tegner 1–9). Cases with osteochondral fractures had occasional pain that subsided in 1 year. Mean Kujala score improved from 64.3 to 99.69 with KOOS score near normal in all. Conclusion: This new method of MPFL reconstruction gives excellent results. It avoids complications

  2. Concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: Treatment outcomes of a prospective, multicentric clinical study

    International Nuclear Information System (INIS)

    Background and purpose: To evaluate long-term outcome in locoregionally advanced nasopharyngeal carcinoma (NPC) treated with intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy. Material and methods: Between January 2006 and August 2008, 249 patients with stage III–IVb NPC were treated by IMRT plus concurrent chemotherapy in this multicenter prospective study. Results: With a mean follow-up of 54.1 months, the 5-year actuarial rates of overall survival (OS), local recurrence-free survival (LRFS), regional recurrence-free survival (RRFS), and distant metastasis-free survival (DMFS) were 78.4%, 86.8%, 88.4%, 78.0%, respectively. There were 29 local recurrences, 25 regional recurrences and 52 distant metastases, respectively. Distant metastasis is the main cause of treatment failure. N-stage was an independent prognostic factor for LRFS, RRFS, DMFS and OS. Acute toxicity ⩾grade III mainly consisted of mucositis (34.9%), neutropenia (11.2%), xerostomia (5.6%), and dermatitis (5.2%). The main documented late toxicity was xerostomia, and the severity of xerostomia decreased over time. At 24 months after treatment, 13.2% of patients had grade 2 xerostomia, and none had grade 3 or 4 xerostomia. Conclusions: IMRT with concurrent cisplatin chemotherapy resulted in encouraging rates of local and distant control and overall survival with acceptable rates of acute and limited rates of late toxicity in patients with locoregionally advanced NPC. Distant metastasis remained the main cause of failure. More effective systemic therapy should be explored for patients with advanced N-stage

  3. CORRELATION OF LIVER FUNCTION TEST ABNORMALITIES WITH CLINICAL OUTCOMES IN PATIENT S WITH FEBRILE THROMBOCYTOPENIA : A CROSS SECTIONAL STUDY

    Directory of Open Access Journals (Sweden)

    Prakash Kikkeri

    2015-07-01

    Full Text Available Febrile thrombocytopenia is a common clinical condition encountered in medical wards especially so during Dengue fever epidemics. Hepatic dysfunction is a well - recognized feature of dengue infection manifested by mild to moderate increases in transaminase levels, although jaundice and acute liver failure are generally uncommon. We undertook this cross sectional clinical study to find out the pattern of liver function test abnormalities in patients with febrile thrombocytopenia and to know whether it has any adverse clinical outcome. One hundred patients aged 18 years and above with established fever and a platelet count of <1,00,000 w ho were admitted to medical wards of Victoria hospital, Bangalore during the dengue epidemic between May 2013 and August 2013 were enrolled into this study. Relevant laboratory tests were done including dengue serology to establish the cause of fever and to rule out liver disorders, ITP and other hematological disorders. There were 71 male patients and 29 females with majority in the age group 21 to 40 years. 65 patients tested positive on dengue serology (IgM antibody, NS1 antigen or both, and in 24 patients no cause of fever could be established. Liver function tests were normal in 54(54% patients. Among 46 patients who had LFT abnormalities, raised SGOT and raised ALP were the most common abnormalities present in 30% each of the patients. Raised total bilirubin was present in only 4% patients. There was no statistically significant difference in severity of thrombocytopenia in patients with LFT abnormalities as well as duration of hospital stay and requirement for platelet transfusions, when compared to patients with normal liver function. Derangement of LFT could be one manifestation of a systemic infective/ inflammatory process without any serious adverse clinical outcomes in patients with febrile thrombocytopenia.

  4. A comparative analytical study of clinical outcome of oligohydramnios at or beyond 34 weeks of gestation

    Directory of Open Access Journals (Sweden)

    Sunita TH

    2016-06-01

    Conclusions: Determination of AFI is a valuable parameter, which can be used as an adjunct to other fetal surveillance methods. It helps to identify neonates at risk of poor perinatal outcome. [Int J Reprod Contracept Obstet Gynecol 2016; 5(6.000: 1801-1808

  5. Nocardiosis: Risk Factors, Clinical Characteristics and Outcome

    OpenAIRE

    Alavi Darazam, Ilad; Shamaei, Masoud; Mobarhan, Mandana; Ghasemi, Shahin; Tabarsi, Payam; Motavasseli, Masoud; Mansouri, Davood

    2013-01-01

    Nocardiosis has been reported increasingly in recent two decades, probably due to improvement in isolation of the organism and increased burden of immune compromised patients. Nocardia occasionally has been reported in healthy people. A case series of definitive Nocardiosis (2002 to 2010), clinical characteristics, underlying diseases, immune status and in-patient outcome were studied in a tertiary referral center. Twenty one patients with definite diagnosis of Nocardiosis were studied. 17 ca...

  6. Clinical outcome of a two-piece implant system with an internal hexagonal connection: a prospective study.

    Science.gov (United States)

    Andreasi Bassi, M; Lopez, M A; Confalone, L; Gaudio, R M; Lombardo, L; Lauritano, D

    2016-01-01

    The purpose of this prospective clinical study was to evaluate the survival rate (SVR - i.e. fixtures still in place at the end of the observation period) and success rate (SCR - i.e. bone resorption around implant neck) of an implant system characterized by cylindrical and tapered implants, both provided with an internal hexagonal connection. In the period between January 1996 and October 2011, 52 implants with internal hexagonal connection were inserted in 21 females and 31 males, mean age 54±11 years. The mean post-surgical follow-up was 44.6±34.4 months. Several parameters were evaluated as potential outcome conditioners: age, gender, smoking, replaced tooth, periodontal disease, fixture shape (i.e. cylindrical or tapered), jaw location (i.e. maxilla or mandible), bone graft, immediate loading, post-extractive placement, type of prosthesis (i.e. single crown or bridge), edentulism, implant diameter and length. An SPSS statistical program was used and Cox regression analysis performed. SVR was 100% since no fixtures were lost. SCR, expressed through the mean marginal bone loss, was 77%. No significant differences were found, for most of the parameters analyzed, with the exception of prosthetic bridges, where implants supporting this type of rehabilitation showed a worse clinical outcome in comparison to single crown rehabilitations. Internal hexagonal connection is a reliable tool for oral rehabilitation. PMID:27469542

  7. Clinical Outcomes of Extracorporeal Shock Wave Therapy in Patients With Secondary Lymphedema: A Pilot Study

    OpenAIRE

    Bae, Hasuk; Kim, Ho Jeong

    2013-01-01

    Objective To investigate the clinical effect of extracorporeal shock wave therapy (ESWT) in patients with secondary lymphedema after breast cancer treatment. Methods In a prospective clinical trial, ESWT was performed consecutively 4 times over two weeks in 7 patients who were diagnosed with stage 3 secondary lymphedema after breast cancer treatment. Each patient was treated with four sessions of ESWT (0.056-0.068 mJ/mm2, 2,000 impulses). The parameters were the circumference of the arm, thic...

  8. Insular Ischemic Stroke: Clinical Presentation and Outcome

    OpenAIRE

    Lemieux, F.; Lanthier, S.; Chevrier, M.-C.; de Gioia, L.; I. Rouleau; Cereda, C.; Nguyen, D.K.

    2012-01-01

    Background The insula is a small but complex structure located in the depth of the sylvian fissure, covered by the frontal, parietal and temporal operculum. Ischemic strokes limited to the insula are rare and have not been well studied. Our objective is to better define the clinical presentation and outcome of insular ischemic strokes (IIS). Methods We reviewed the institutional prospective, consecutive stroke database from two centers to identify patients with IIS seen between 2008 and 2010....

  9. Follow-up study of the treatment outcomes at a psychiatric trauma clinic for refugees

    DEFF Research Database (Denmark)

    Buhmann, Cæcilie; Lykke Mortensen, Erik; Nordentoft, Merete;

    2015-01-01

    PURPOSE: To describe change in mental health after treatment with antidepressants and trauma-focused cognitive behavioral therapy. METHODS: Patients receiving treatment at the Psychiatric Trauma Clinic for Refugees in Copenhagen completed self-ratings of level of functioning, quality of life, and...

  10. Ebola outbreak in Conakry, Guinea: Epidemiological, clinical, and outcome features

    OpenAIRE

    Barry, M; Traoré, F A; Sako, F B; Kpamy, D O; Bah, E I; Poncin, M; S. Keita; Cisse, M; Touré, A.

    2014-01-01

    The authors studied the epidemiological, clinical, and outcome features of the Ebola virus disease in patients hospitalized at the Ebola treatment center (ETC) in Conakry to identify clinical factors associated with death.

  11. The characteristics and clinical outcome of drug-induced liver injury in a Chinese hospital: A retrospective cohort study.

    Science.gov (United States)

    Chen, Sheng-Sen; Yu, Kang-Kang; Huang, Chong; Li, Ning; Zheng, Jian-Ming; Bao, Su-Xia; Chen, Ming-Quan; Zhang, Wen-Hong

    2016-08-01

    The aim of this cohort study was to determine the characteristics and clinical outcome of 287 patients with drug-induced liver injury (DILI) in a Chinese hospital.Between January 2008 and January 2013, individuals who were diagnosed with DILI were selected. The complete medical records of each case were reviewed, and factors for the outcome of patients with DILI were extracted and analyzed using univariate and multivariate analysis.Two hundred eighty-seven cases identified as DILI were included in the study. A total of 105 different drugs were considered to be related to the hepatotoxicity. The main causative group of drugs was Chinese herb (n = 111). Liver failure developed in 9 (3.1%) patients, and 2 died (0.7%). Overall, complete recovery occurred in 92 (32.1%) patients. Univariate analysis and binary logistic regression analysis identified the digestive symptoms, jaundice, total bilirubin (TBIL), and direct bilirubin (DBIL) as independent factors for the non-recovery of DILI. Then the prediction model, including digestive symptoms, jaundice, TBIL, and DBIL, was built by using binary logistic regression analysis again. Receiver operating characteristic curve validated the strong power (area under the curve (AUC) = 0.907) of prediction model for predicting the DILI non-recovery.DILI is an important cause of liver test abnormalities, and Chinese herb represented the most common drug group. The factors such as digestive symptoms, jaundice, TBIL, and DBIL have effect on DILI outcomes. The prediction model, including digestive symptoms, jaundice, TBIL, and DBIL, established in this study is really an excellent predictive tool for non-recovery of DILI patients. PMID:27559976

  12. Clinical Outcomes after Traumatic Brain Injury.

    Science.gov (United States)

    Sandsmark, Danielle K

    2016-06-01

    Traumatic brain injury (TBI) is a major cause of death and disability that often affects young people. After injury, the degree of recovery can be highly variable, with some people regaining near complete function while others remain severely disabled. Understanding what factors influence recovery is important for counseling patients and families in the acute period after injury and can help guide therapeutic decisions in the acute period following injury. In this review, prognostic algorithms useful for clinicians are discussed. Tools for grading patient outcomes, their role in clinical care and research studies, and their limitations are reviewed. Ongoing work focusing on the development of biomarkers to track TBI recovery and the refinement of clinical outcome metrics is summarized. PMID:27072952

  13. Stevens Johnson syndrome, toxic epidermal necrolysis and SJS-TEN overlap: A retrospective study of causative drugs and clinical outcome

    Directory of Open Access Journals (Sweden)

    Sharma Vinod

    2008-01-01

    Full Text Available Background and Aims: Stevens Johnson syndrome (SJS, toxic epidermal necrolysis (TEN and SJS-TEN overlap are serious adverse cutaneous drug reactions. Drugs are often implicated in these reactions. Methods: A retrospective analysis of inpatients′ data with these dermatological diagnoses were carried out for three years, to study the causative drugs, clinical outcome, and mortality in these conditions. Results: Thirty patients (15 TEN, nine SJS-TEN overlap, and six SJS were admitted. In 21 cases, multiple drugs were implicated whereas single drugs were responsible in nine. Anticonvulsants (35.08% were the most commonly implicated drugs followed by antibiotics (33.33% and NSAIDS (24.56%. Twenty-five patients recovered whereas five died (four TEN, one SJS-TEN overlap. Conclusion: Anticonvulsants, antibiotics and NSAIDs were the most frequently implicated drugs. TEN causes higher mortality than both SJS and SJS-TEN overlap.

  14. Neurocognition: Clinical and Functional Outcomes in Schizophrenia

    OpenAIRE

    Lepage, Martin; Bodnar, Michael; Bowie, Christopher R.

    2014-01-01

    Schizophrenia is characterized by significant heterogeneity in outcome. The last decades have witnessed a significant interest in identifying factors that can moderate or influence clinical and functional outcomes in people with schizophrenia. One factor of particular interest is neurocognition, as performance on various measures of cognitive abilities, such as memory, attention, and executive functions, have been consistently related to functional outcome and, to a lesser extent, clinical ou...

  15. Incidence and Effects of Polypharmacy on Clinical Outcome among Patients Aged 80+: A Five-Year Follow-Up Study

    OpenAIRE

    Rong Wang; Lei Chen; Li Fan; Dewei Gao; Zhiru Liang; Jing He; Weiqin Gong; Linggen Gao

    2015-01-01

    Objectives Polypharmacy is a problem of growing interest in geriatrics with the increase in drug consumption in recent years, is defined according to the WHO criteria as the, ‘‘concurrent use of five or more different prescription medication”. We investigated the clinical characteristics of polypharmacy and identified the effects of polypharmacy on clinical outcome among patients aged 80+ admitted to Chinese PLA general hospital. Methods Older men aged ≥80 years (n = 1562) were included in th...

  16. Nutritional status and clinical outcome of children on continuous renal replacement therapy: a prospective observational study

    OpenAIRE

    Castillo Ana; Santiago Maria J; López-Herce Jesús; Montoro Sandra; López Jorge; Bustinza Amaya; Moral Ramón; Bellón Jose M

    2012-01-01

    Abstract Background No studies on continuous renal replacement therapy (CRRT) have analyzed nutritional status in children. The objective of this study was to assess the association between mortality and nutritional status of children receiving CRRT. Methods Prospective observational study to analyze the nutritional status of children receiving CRRT and its association with mortality. The variables recorded were age, weight, sex, diagnosis, albumin, creatinine, urea, uric acid, severity of il...

  17. Clinical outcome of 215 transmucosal implants with a conical connection: a retrospective study after 5-year follow-up.

    Science.gov (United States)

    Lopez, M A; Andreasi Bassi, M; Confalone, L; Gaudio, R M; Lombardo, L; Lauritano, D

    2016-01-01

    The purpose of this retrospective clinical study was to evaluate the survival rate (i.e. SVR – fixtures still in place at the end of the observation period) and success rate (i.e. SCR - bone resorption around implant neck) of an implant system characterized by cylindrical and tapered implants, both types of implant being equipped with a conical connection with an internal octagon (COC), both implant types having a 1.8 mm smooth neck, positioned above the bone crest level. A total of 65 subjects received 215 COCs between January 1996 and October 2011. All COCs were placed and restored by three experienced dental surgeons. The mean follow-up was 84±44 months. The patients involved in the study were both male (30) and female (35), of whom 30 were smokers (less than 20 cigarettes/day) and none was diabetic. The implants differed in terms of diameter and length, and were inserted both in the mandible (97) and in the maxilla (118). Sixty-seven implants were single tooth rehabilitations, and 148 prosthetic bridges. Fourteen had guided bone regeneration (GBR), and 10 were placed in post-extractive sites. Forty of the implants were provided with passing-screw abutments and 175 with full-screw abutments. The data were analyzed using descriptive statistics. None of the implants failed before prosthetic restoration, resulting in an SVR=100% after loading. The radiographic and clinical data revealed well-maintained, hard and soft tissue around the COCs, with an SCR=92.6%. Cox regression analyses did not detect any variables with statistical impact on the clinical outcome. In conclusion, Shiner XT implants are reliable tools for oral rehabilitation. PMID:27469549

  18. Association between nutritional risk and routine clinical laboratory measurements and adverse outcomes: a prospective study in hospitalized patients of wuhan tongji hospital

    OpenAIRE

    Chen, Z. Y.; Gao, C.; Ye, T; Zuo, X Z; G. H. Wang; Xu, X. S.; Yao, Y

    2014-01-01

    Background/Objectives: Nutritional risk screening (NRS-2002) and routine clinical laboratory measurements (RCLMs) had been shown to have a predictive value in adverse outcomes in some studies, respectively. This study analyzed the association between NRS-2002 and RCLMs and estimated their prospective value in predicting adverse outcomes. Subjects/Methods: A total of 916 hospitalized patients were screened on admission with NRS-2002 and Subjective Global Assessment; RCLMs, which include blood ...

  19. A CLINICAL STUDY OF MANAGEMENT AND OUTCOME OF 60 CUT THROAT INJURIES

    Directory of Open Access Journals (Sweden)

    Rajesh Kumar

    2013-12-01

    Full Text Available ABSTRACT: Cut throat injury have some open , incised or incised looking injury in the neck inflicted by sharp elements such as raz or, knives or broken bottle pieces and glasses which may be superficial or penetrating in nature. Any injury in the neck regards as fatal injury because it contains vital structures. In case of cut throat injury there is high chance of injury to the vital structures of the neck, which may leads to profuse hemorrhage from injured major blood vessels, air embolism and airway obstruction. There are few studies carried out on cut throat injury in our country, as a result actual incidence, mortality and morbidit y are not known .Present study attempts to overcome this lacuna, so that concerned authority and policy makers to initiate measure in order to minimize the mortality related to cut throat injury. This prospective observational type of study was undertaken in the department of Otorhinolaryngology in a Medical College of Eastern India. Total 60 cut throat patients were included in the study. After proper management it is found that 25 patients (25% completely cured, living normal life. Living with minor morb idity are 27 patients (45%. 18 patients (30% living with major problems. According to the result and analysis of this study it is established that early appropriate measure could save majority of the patient’s life. Morbidity and mortality are related t o delay in initiation of the treatment. Few deaths occur due to injury of great vessels and blood loss

  20. A STUDY ON CLINICAL ASSESSMENT OF VARICOSE VEINS BY CLINICAL SCORES AND VALIDATING THE OUTCOME OF TRENDELENBURG PROCEDURE IN VARICOSE VEINS OF LOWER LIMBS

    Directory of Open Access Journals (Sweden)

    Nilavi

    2016-06-01

    Full Text Available cose veins of Lower Limbs. This study was conducted in the Department of General Surgery, ESIC Hospital, over a period of 12 months. METHODS AND MATERIALS This analytical study group consisted of 92 patients between 20 to 80 yrs., inclusive of both males (n=78 and females (n=14. They were assessed for severity of varicose veins by documenting a detailed history, clinical examination findings, imaging studies on a pre-structured case sheet and the result of surgery. It was found that majority of the patients were ≤60 yrs. and the left lower limb was predominantly affected in both sexes. RESULTS Using the VCSS system, 19.57% (n=18 cases had mild disease, 67.39% (n=62 cases had moderate disease and 13.04% (n=12 had severe disease. In the present study as per the VDS system, majority of the patients (n=51 55.43% had grade III disability and 40.22% (n=37 of the patients had moderate grade of venous reflux, i.e. venous reflux duration <1 second. All 92 patients had surgery with majority had uneventful postoperative periods 58.17% (n=52, whereas a few had complications 44.44% (n=40. CONCLUSION A statistically significant result was found for the clinical assessment scores and also for the surgical outcome.

  1. Prolactinomas : clinical studies

    NARCIS (Netherlands)

    Kars, Marleen

    2008-01-01

    Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An

  2. An Approach to Acquiring, Normalizing, and Managing EHR Data From a Clinical Data Repository for Studying Pressure Ulcer Outcomes.

    Science.gov (United States)

    Padula, William V; Blackshaw, Leon; Brindle, C Tod; Volchenboum, Samuel L

    2016-01-01

    Changes in the methods that individual facilities follow to collect and store data related to hospital-acquired pressure ulcer (HAPU) occurrences are essential for improving patient outcomes and advancing our understanding the science behind this clinically relevant issue. Using an established electronic health record system at a large, urban, tertiary-care academic medical center, we investigated the process required for taking raw data of HAPU outcomes and submitting these data to a normalization process. We extracted data from 1.5 million patient shifts and filtered observations to those with a Braden score and linked tables in the electronic health record, including (1) Braden scale scores, (2) laboratory outcomes data, (3) surgical time, (4) provider orders, (5) medications, and (6) discharge diagnoses. Braden scores are important measures specific to HAPUs since these scores clarify the daily risk of a hospitalized patient for developing a pressure ulcer. The other more common measures that may be associated with HAPU outcomes are important to organize in a single data frame with Braden scores according to each patient. Primary keys were assigned to each table, and the data were processed through 3 normalization steps and 1 denormalization step. These processes created 8 tables that can be stored efficiently in a clinical database of HAPU outcomes. As hospitals focus on organizing data for review of HAPUs and other types of hospital-acquired conditions, the normalization process we describe in this article offers directions for collaboration between providers and informatics teams using a common language and structure. PMID:26727681

  3. Nutritional status and clinical outcome of children on continuous renal replacement therapy: a prospective observational study

    Directory of Open Access Journals (Sweden)

    Castillo Ana

    2012-09-01

    Full Text Available Abstract Background No studies on continuous renal replacement therapy (CRRT have analyzed nutritional status in children. The objective of this study was to assess the association between mortality and nutritional status of children receiving CRRT. Methods Prospective observational study to analyze the nutritional status of children receiving CRRT and its association with mortality. The variables recorded were age, weight, sex, diagnosis, albumin, creatinine, urea, uric acid, severity of illness scores, CRRT-related complications, duration of admission to the pediatric intensive care unit, and mortality. Results The sample comprised 174 critically ill children on CRRT. The median weight of the patients was 10 kg, 35% were under percentile (P 3, and 56% had a weight/P50 ratio of less than 0.85. Only two patients were above P95. The mean age for patients under P3 was significantly lower than that of the other patients (p = 0.03. The incidence of weight under P3 was greater in younger children (p = 0.007 and in cardiac patients and in those who had previous chronic renal insufficiency (p = 0.047. The mortality analysis did not include patients with pre-existing renal disease. Mortality was 38.9%. Mortality for patients with weight P3 (51% vs 33%; p = 0.037. In the univariate and multivariate logistic regression analyses, the only factor associated with mortality was protein-energy wasting (malnutrition (OR, 2.11; 95% CI, 1.067-4.173; p = 0.032. Conclusions The frequency of protein-energy wasting in children who require CRRT is high, and the frequency of obesity is low. Protein-energy wasting is more frequent in children with previous end-stage renal disease and heart disease. Underweight children present a higher mortality rate than patients with normal body weight.

  4. Antibiotic use and clinical outcomes in the acute setting under management by an infectious diseases acute physician versus other clinical teams: a cohort study

    Science.gov (United States)

    Jones, Nicola; Mistry, Vikash; Crook, Derrick; Peto, Tim; Walker, A Sarah

    2016-01-01

    Objectives To assess the magnitude of difference in antibiotic use between clinical teams in the acute setting and assess evidence for any adverse consequences to patient safety or healthcare delivery. Design Prospective cohort study (1 week) and analysis of linked electronic health records (3 years). Setting UK tertiary care centre. Participants All patients admitted sequentially to the acute medical service under an infectious diseases acute physician (IDP) and other medical teams during 1 week in 2013 (n=297), and 3 years 2012–2014 (n=47 585). Primary outcome measure Antibiotic use in days of therapy (DOT): raw group metrics and regression analysis adjusted for case mix. Secondary outcome measures 30-day all-cause mortality, treatment failure and length of stay. Results Antibiotic use was 173 vs 282 DOT/100 admissions in the IDP versus non-IDP group. Using case mix-adjusted zero-inflated Poisson regression, IDP patients were significantly less likely to receive an antibiotic (adjusted OR=0.25 (95% CI 0.07 to 0.84), p=0.03) and received shorter courses (adjusted rate ratio (RR)=0.71 (95% CI 0.54 to 0.93), p=0.01). Clinically stable IDP patients of uncertain diagnosis were more likely to have antibiotics held (87% vs 55%; p=0.02). There was no significant difference in treatment failure or mortality (adjusted p>0.5; also in the 3-year data set), but IDP patients were more likely to be admitted overnight (adjusted OR=3.53 (95% CI 1.24 to 10.03), p=0.03) and have longer length of stay (adjusted RR=1.19 (95% CI 1.05 to 1.36), p=0.007). Conclusions The IDP-led group used 30% less antibiotic therapy with no adverse clinical outcome, suggesting antibiotic use can be reduced safely in the acute setting. This may be achieved in part by holding antibiotics and admitting the patient for observation rather than prescribing, which has implications for costs and hospital occupancy. More information is needed to indicate whether any such longer admission will

  5. Does clinical management improve outcomes following self-harm? Results from the multicentre study of self-harm in England.

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    Nav Kapur

    Full Text Available BACKGROUND: Evidence to guide clinical management of self-harm is sparse, trials have recruited selected samples, and psychological treatments that are suggested in guidelines may not be available in routine practice. AIMS: To examine how the management that patients receive in hospital relates to subsequent outcome. METHODS: We identified episodes of self-harm presenting to three UK centres (Derby, Manchester, Oxford over a 10 year period (2000 to 2009. We used established data collection systems to investigate the relationship between four aspects of management (psychosocial assessment, medical admission, psychiatric admission, referral for specialist mental health follow up and repetition of self-harm within 12 months, adjusted for differences in baseline demographic and clinical characteristics. RESULTS: 35,938 individuals presented with self-harm during the study period. In two of the three centres, receiving a psychosocial assessment was associated with a 40% lower risk of repetition, Hazard Ratios (95% CIs: Centre A 0.99 (0.90-1.09; Centre B 0.59 (0.48-0.74; Centre C 0.59 (0.52-0.68. There was little indication that the apparent protective effects were mediated through referral and follow up arrangements. The association between psychosocial assessment and a reduced risk of repetition appeared to be least evident in those from the most deprived areas. CONCLUSION: These findings add to the growing body of evidence that thorough assessment is central to the management of self-harm, but further work is needed to elucidate the possible mechanisms and explore the effects in different clinical subgroups.

  6. PROSPECTIVE STUDY OF ETIOLOGY, CLINICAL PROFILE AND OUTCOME IN PATIENTS WITH FEVER, JAUNDICE AND ACUTE KIDNEY INJURY

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    Pradeep

    2015-09-01

    Full Text Available OBJECTIVE: To study etiology, risk factors, various clinical and lab parameters and outcome of patients presenting with fever, jaundice and acute kidney injury. MATERIALS AND METHODS : An open prospective study was done on 100 patients presented with triad of fever, jaundice and acute kidney injury (AKI in the Depar tment of Medicine of G R Medical College and JA Group of Hospitals, Gwalior, MP from September 2011 to November 2012. Patients having temperature more than >100 0 F, serum creatinine ≥1.3 mg/dL or a 50 % increase from baseline or a reduction in urine output (documented oliguria of 6 hours, serum bilirubin >1.8 mg/dL were included in the study. A detailed history, clinical examination and investigations were done to find the cause of these derangements and all the patients were managed acc ordingly. RESULTS: A total 100 patients were included in study out of which 70% were males. Out of 100 patients, 50% were of septicemia, 34% were having malaria, 12% had acute pancreatitis and 4% patients were of dengue. Out of 50 septicemia patients, 35(7 0% were male, out of which 11(31.42% were of 56 - 65 years of age. Out of 17 deaths, 13(76% were males. Among total death, 11(22% were in septicemia followed by 5(14.70% in malaria patients. CONCLUSION: Many infectious and non - infectious diseases like malaria, septicemia, acute pancreatitis, dengue fever etc. can present with fever, jaundice and deranged renal functions. This triad of presentation is associated wi th high morbidity and mortality and the advanced age, male gender presences of anemia were the risk factors for high mortality. AKI occurs most commonly in association with P. falciparum malaria. Early diagnosis and prompt management including dialysis can reduce mortality and expedite recovery of renal function

  7. CLINICAL MANIFESTATIONS, RADIOLOGICAL FINDINGS AND OUTCOME IN CEREBRAL VEIN AND DURAL SINUS THROMBOSIS: A PROSPECTIVE STUDY

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    Thota

    2015-09-01

    Full Text Available Cerebral vein and dural sinus thrombosis (CVT is a type of cerebrovascular disease marked by thrombosis of blood in cerebral veins, or dural sinuses, and, in rare cases, cortical veins. CVT is now a days a disease that is easy to diagnose with MRI provide d the clinician suspect CVT in patients. Before CT and MRI evolution, CVT was considered as a disorder of infectious origin. Between November 2012 and December 2013, 50 patients with CVT in the neurology at the Sri Venkateswara Institute of Medical Science s (SVIMS, Tirupati, confirmed with radioimaging, were included and studied. The mean age of the patients was 27.67±9.1 years. Most of the patients were in the third decade of life; majority were women (70%. CVT. Procoagulant state is found to be major ri sk factor with majority belonging to postpartum state (32% followed by dehydration (30%. Postpartum in combination with dehydration constituted the major risk factor because of local ritual belief that water should not be taken by the postpartum mother f or initial few days after delivery, found to be a modifiable risk factor. Superior sagittal sinus is the commonest sinus involved (58% with transverse sinus being the second most common sinus involved and most (64% of the patients with CVT had involvemen t of more than 1 venous sinus and site of thrombosis didn’t show any correlation with presenting features. MRV brain detected CVT in all the 50 patients in the study but in 28% of the patients no evidence of CVT was found on CT brain plain and contrast sug gesting the sensitivity of MRV over the CT. 70% of the patients had complete functional recovery at the end of hospital stay where as 6% of the patients died. Early diagnosis and prompt institution of anticoagulation irrespective, antioedema measures and a ntiepileptic drugs brings down the mortality and morbidity in patients with CVT. Decompressive craniectomy is an effective procedure decreasing morbidity and mortality and should be

  8. STUDY OF ACUTE KIDNEY INJURY IN CHILDREN: ITS AETIOLOGY, CLINICAL PROFILE AND OUTCOME

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    Garuda

    2015-03-01

    Full Text Available OBJECTIVES : To determine the incidence , age & sex ratio , analyse the spectrum of Acute Kidney Injury (AKI in its aetiopathology , complications including mortality , prognostic factors and the role of dialysis in the management. METHODS : This prospective observational study was conducted on serial cases of 30 patients a dmitted in Paediatrics department from Feb 2012 - Aug 2014 (30 months. RESULTS : The incidence of AKI was 0.44%. Children in age group of 0 - 4 yrs were affected most , predominantly males. Distribution of AKI according to aetiopathogenesis was Acute Tubular Necrosis (ATN 50% , Haemolytic Uraemic Syndrome (HUS 19.8% , Glomerulonephritis (GN 13.2% , Obstructive uropathy 9.9% and Acute on Chronic renal failure (CRF 6.6%. Dialysis was required in 53.3% of patients. Mortality was 57%. Patients with complications of sepsis , neurological & respiratory problems , hyperkalemia , metabolic acidosis and gastrointestinal bleeding were associated with high mortality. CONCLUSIONS : AKI is a common life threatening condition seen in childhood. Early referral , proper assessment , adequate & timely treatment and prompt institution of dialysis helps in decreasing mortality.

  9. Multisystemic Therapy: Clinical Foundations and Research Outcomes

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    Scott W. Henggeler

    2012-07-01

    Full Text Available Multisystemic therapy (MST is an intensive family and community-based treatment for adolescents presenting serious antisocial behavior and their families. Using a home-based model of service delivery to overcome barriers to service access and a strong quality assurance system to promote treatment fidelity, MST therapists address known risk factors (i.e., at individual, family, peer, school, and community levels strategically and comprehensively. The family is viewed as central to achieving favorable outcomes, and mediation research supports the emphasis of MST on promoting family functioning as the key mechanism of clinical change. Importantly, 22 MST outcome studies have been published, many of which are independent randomized clinical trials, and the vast majority, including those conducted in Europe, support the capacity of MST to reduce youth antisocial behavior and out-of-home placements. Such outcomes, combined with the advocacy of many juvenile justice stakeholders, have led to the transport of MST programs to more than 500 sites, including 10 nations in Europe.

  10. Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials

    OpenAIRE

    Hodkinson, Alex; Gamble, Carrol; Smith, Catrin Tudur

    2016-01-01

    Background The quality of harms reporting in journal publications is often poor, which can impede the risk-benefit interpretation of a clinical trial. Clinical study reports can provide more reliable, complete, and informative data on harms compared to the corresponding journal publication. This case study compares the quality and quantity of harms data reported in journal publications and clinical study reports of orlistat trials. Methods Publications related to clinical trials of orlistat w...

  11. The value of lateral spread response monitoring in predicting the clinical outcome after microvascular decompression in hemifacial spasm: a prospective study on 100 patients.

    Science.gov (United States)

    El Damaty, Ahmed; Rosenstengel, Christian; Matthes, Marc; Baldauf, Joerg; Schroeder, Henry W S

    2016-07-01

    Microvascular decompression represents an effective treatment for hemifacial spasm. The use of lateral spread response (LSR) monitoring remains a useful intraoperative tool to ensure adequate decompression of the facial nerve. The aim of this study was to assess the value of LSRs intraoperative monitoring as a prognostic indicator for the outcome of microvascular decompression in hemifacial spasm. Our study included 100 patients prospectively. The patients were classified into four groups whether LSRs were totally, partially, not relieved, or not detected from the start. According to clinical outcome, the patients were classified into four groups depending on the clinical course after surgery and the residual symptoms if any. Then, correlations were made between LSR events and treatment outcome to detect its reliability as a prognostic indicator. LSRs were relieved totally in 56 % of the patients, partially relieved in 14 %, not relieved in 10 %, and were not detected in 20 % of the patients from the start. HFS was relieved directly after operation in 62 % with clinical improvement of 90-100 %. Thirty-one percent described 50-90 % improvement over the next 3 months after surgery. Almost all of these 31 % (28 out of 31 patients) reported further clinical improvement of 90-100 % within 1 year after surgery. Three percent suffered from a relapse after a HFS-free period, and 4 % reported minimal or no improvement describing 0-50 % of the preoperative state. The percentage of the satisfied patients with the clinical outcome who reported after 1 year a clinical improvement of 90-100 % was 90 %. Statistical analysis did not find a significant correlation between the relief of LSRs and clinical outcome. LSRs may only represent an intraoperative tool to guide for an adequate decompression but failed to represent a reliable prognostic indicator for treatment outcome. PMID:27053220

  12. Incidences and clinical outcomes of acute kidney injury in ICU: a prospective observational study in Sri Lanka

    OpenAIRE

    Wijewickrama, Eranga S; Ratnayake, Gowri M; Wikramaratne, Chaminda; Sheriff, Rezvi; Rajapakse, Senaka

    2014-01-01

    Background Acute kidney injury (AKI) is a common and a serious complication among patients admitted to intensive care units (ICUs), and has been the focus of many studies leading to recent advances in diagnosis and classification. The incidence and outcome of AKI in Sri Lankan ICUs is largely unknown. The aim of this study was to describe the incidence, severity and outcome of AKI among patients admitted to the medical ICU, National Hospital, Colombo, Sri Lanka (NHSL). Methods Patients admitt...

  13. STUDY ON CLINICAL PROFILE, COMPLICATIONS AND OUTCOME OF COPPER SULPHATE POISONING AT A TERTIARY CARE CENTRE IN SOUTH INDIA

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    Vasanthi

    2016-06-01

    Full Text Available BACKGROUND Copper Sulphate ingestion is a relatively common method of committing suicide in South India. It can be life-threatening with high mortality due to its deleterious effects on upper GIT, kidney, liver and blood. AIM To analyse the clinical profile, complications and outcome of patients admitted with alleged Copper Sulphate poisoning in intensive medical care unit at Govt. Stanley Medical College Hospital. SETTINGS AND DESIGN A prospective observational study. MATERIALS AND METHODS Study was carried out at the Toxicology Unit of Intensive Medical Care Unit and Medical Wards of Govt. Stanley Hospital, Chennai, from August 2011 to November 2013. All patients above the age of 13 years were included in this study. Patients admitted with mixed poisoning, liver and kidney diseases, bleeding disorders were all excluded from this study. RESULTS Of the 60 patients studied, 37 were females and 27 were males. Mode of poisoning was suicidal in 58 patients and accidental in 2 patients. Mean age in males was 31.24 years and in females 25.52. In this study group, 32 were married and 28 were unmarried. The frequency of symptoms the patients presented with decreasing frequency were vomiting (21, icterus (15, abdominal pain (14, cyanosis (8 and oliguria (4. CONCLUSIONS Copper sulphate poisoning presenting with fulminant hepatitis has 26 times more chance of death (P value 0.0008, acute kidney injury 17 times more chance of death (P value 0.0006, Gastritis by upper GI endoscopy has 7 times more chance of death (P value 0.01.

  14. Pyogenic sacroiliitis: diagnosis, management and clinical outcome

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    Kucera, Tomas; Sponer, Pavel [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Orthopaedic Surgery, Hradec Kralove (Czech Republic); Brtkova, Jindra [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Diagnostic Radiology, Hradec Kralove (Czech Republic); Ryskova, Lenka [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Clinical Microbiology, Hradec Kralove (Czech Republic); Popper, Eduard [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Rehabilitation, Hradec Kralove (Czech Republic); Frank, Martin [Charles University in Prague, Faculty of Medicine and University Hospital in Hradec Kralove, Department of Surgery, Hradec Kralove (Czech Republic); Kucerova, Marie [Regional Hospital in Pardubice, Department of Neurosurgery, Hradec Kralove (Czech Republic)

    2015-01-15

    The purpose of the present study was to evaluate the role of diagnostic tools and management options for patients with pyogenic sacroiliitis, including potential complications. This retrospective study included 16 patients with pyogenic sacroiliitis who were admitted to a single orthopaedic centre between 2007 and 2012. The following data were collected: demographics, history, radiography, magnetic resonance images (MRI), biological data, type of pathogenic agent, abscess formation, type of management, and clinical outcome. Our study demonstrated that only one-fifth of the patients with lumbogluteal or hip pain had established diagnoses of suspected pyogenic sacroiliitis upon admission. MRIs confirmed this diagnosis in all cases. MRI examinations revealed joint fluid in the sacroiliac joint and significant oedema of the adjacent bone and soft tissues. In 12 of the 16 cases, erosions of the subchondral bone were encountered. Contrast-enhanced MRI revealed that 9 patients had abscesses. All patients received antibiotic therapy. Antibiotic treatment was only successful in 9 cases. The other 7 patients underwent computed tomography (CT)-guided abscess drainage. Drainage was sufficient for 4 patients, but 3 patients required open surgery. One patient required sacroiliac arthrodesis. The clinical outcomes included minimal disability (n = 10), moderate disability (n = 5), and full disability (n = 1) of the spine. Contrast-enhanced MRI is mandatory for a reliable diagnosis. Abscess formation was observed in approximately half of the MRI-diagnosed sacroiliitis cases and required minimally invasive drainage under CT guidance or frequently open surgery. (orig.)

  15. Pyogenic sacroiliitis: diagnosis, management and clinical outcome

    International Nuclear Information System (INIS)

    The purpose of the present study was to evaluate the role of diagnostic tools and management options for patients with pyogenic sacroiliitis, including potential complications. This retrospective study included 16 patients with pyogenic sacroiliitis who were admitted to a single orthopaedic centre between 2007 and 2012. The following data were collected: demographics, history, radiography, magnetic resonance images (MRI), biological data, type of pathogenic agent, abscess formation, type of management, and clinical outcome. Our study demonstrated that only one-fifth of the patients with lumbogluteal or hip pain had established diagnoses of suspected pyogenic sacroiliitis upon admission. MRIs confirmed this diagnosis in all cases. MRI examinations revealed joint fluid in the sacroiliac joint and significant oedema of the adjacent bone and soft tissues. In 12 of the 16 cases, erosions of the subchondral bone were encountered. Contrast-enhanced MRI revealed that 9 patients had abscesses. All patients received antibiotic therapy. Antibiotic treatment was only successful in 9 cases. The other 7 patients underwent computed tomography (CT)-guided abscess drainage. Drainage was sufficient for 4 patients, but 3 patients required open surgery. One patient required sacroiliac arthrodesis. The clinical outcomes included minimal disability (n = 10), moderate disability (n = 5), and full disability (n = 1) of the spine. Contrast-enhanced MRI is mandatory for a reliable diagnosis. Abscess formation was observed in approximately half of the MRI-diagnosed sacroiliitis cases and required minimally invasive drainage under CT guidance or frequently open surgery. (orig.)

  16. Clinical and economic outcomes in an observational study of COPD maintenance therapies: multivariable regression versus propensity score matching

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    Roberts MH

    2012-03-01

    Full Text Available Melissa H Roberts1, Anand A Dalal21Lovelace Clinic Foundation, (Lovelace Respiratory Research Institute at the time of the study, Albuquerque, NM, 2US Health Outcomes, GlaxoSmithKline, Durham, NC, USAPurpose: To investigate equivalency of results from multivariable regression (MR and propensity score matching (PSM models, observational research methods used to mitigate bias stemming from non-randomization (and consequently unbalanced groups at baseline, using, as an example, a large study of chronic obstructive pulmonary disease (COPD initial maintenance therapy.Methods: Patients were 32,338 health plan members, age ≥40 years, with COPD initially treated with fluticasone propionate/salmeterol combination (FSC, tiotropium (TIO, or ipratropium (IPR alone or in combination with albuterol. Using MR and PSM methods, the proportion of patients with COPD-related health care utilization, mean costs, odds ratios (ORs, and incidence rate ratios (IRRs for utilization events were calculated for the 12 months following therapy initiation.Results: Of 12,595 FSC, 9126 TIO, and 10,617 IPR patients meeting MR inclusion criteria, 89.1% (8135 of TIO and 80.2% (8514 of IPR patients were matched to FSC patients for the PSM analysis. Methods produced substantially similar findings for mean cost comparisons, ORs, and IRRs for most utilization events. In contrast to MR, for TIO compared to FSC, PSM did not produce statistically significant ORs for hospitalization or outpatient visit with antibiotic or significant IRRs for hospitalization or outpatient visit with oral corticosteroid. As in the MR analysis, compared to FSC, ORs and IRRs for all other utilization events, as well as mean costs, were less favorable for IPR and TIO.Conclusion: In this example of an observational study of maintenance therapy for COPD, more than 80% of the original treatment groups used in the MR analysis were matched to comparison treatment groups for the PSM analysis. While some sample

  17. A Comparative Study of Nurses as Case Manager and Telephone Follow-up on Clinical Outcomes of Patients with Severe Mental Illness

    OpenAIRE

    Malakouti, Seyed Kazem; Nojomi, Marzieh; MIRABZADEH, Arash; Mottaghipour, Yasaman; Zahiroddin, Alireza; Kangrani, Hamed Mohammadi

    2016-01-01

    Background: Providing community-based mental health services is crucial and is an agreed plan between the Iranian Mental Health Office and the Regional Committee for the Eastern Mediterranean (affiliated with WHO). The aim of this study was to determine the effectiveness of home-visit clinical case-management services on the hospitalization rate and other clinical outcomes in patients with severe mental illness. Methods: A total of 182 patients were randomly allocated into three groups, namel...

  18. Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study [v2; ref status: indexed, http://f1000r.es/5bj

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    Sreeram V Ramagopalan

    2015-04-01

    Full Text Available Background: We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. Methods: A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Findings: 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3% had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome. Conclusions: Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

  19. Predicting functional remission in patients with schizophrenia: a cross-sectional study of symptomatic remission, psychosocial remission, functioning, and clinical outcome

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    Valencia M

    2015-09-01

    Full Text Available Marcelo Valencia,1 Ana Fresán,2 Yoram Barak,3 Francisco Juárez,1 Raul Escamilla,4 Ricardo Saracco41Division of Epidemiological and Psychosocial Research, 2Division of Clinical Research, National Institute of Psychiatry Ramón de la Fuente, Mexico City, Mexico; 3Psychiatry Department, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; 4Schizophrenia Clinic, National Institute of Psychiatry Ramón de la Fuente, Mexico City, MexicoBackground: New approaches to assess outcome in schizophrenia include multidimensional measures such as remission, cognition, psychosocial functioning, and quality of life. Clinical and psychosocial measures have been recently introduced to assess functional outcome.Objective: The study presented here was designed to examine the rates of symptomatic remission, psychosocial remission, global functioning, and clinical global impressions in a sample of schizophrenia outpatients in order to assess functional remission and to identify predictive factors for functional remission.Methods: A total of 168 consecutive Mexican outpatients receiving pharmacological treatment at the National Institute of Psychiatry in Mexico City were enrolled in a cross-sectional study. Symptomatic remission was assessed according to the definition and criteria proposed by the Remission in Schizophrenia Working Group using the Positive and Negative Symptom Scale. Psychosocial remission was assessed according to Barak criteria using the Psychosocial Remission in Schizophrenia scale. Functioning was measured with the Global Assessment of Functioning, and clinical outcome with the Clinical Global Impressions (CGI Scale.Results: Findings showed that 45.2% of patients fulfilled the symptomatic remission criteria, 32.1% achieved psychosocial remission, and 53% reported adequate functioning. However, the combination of these three outcome criteria – symptomatic, psychosocial remission, and functioning – indicated that 14.9% of the

  20. Clinical outcomes of osteonecrosis of the femoral head after autologous bone marrow stem cell implantation: a meta-analysis of seven case-control studies

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    Heng-feng Yuan

    2016-02-01

    Full Text Available The purpose of this study was to evaluate the clinical outcomes of osteonecrosis of the femoral head after autologous bone marrow stem cell implantation. We searched the PubMed, Embase and Web of Science databases and included all case-control trials that reported on the clinical outcomes of osteonecrosis progression, incidence of total hip arthroplasty and improvement in Harris hip scores. Overall, seven case-control trials were included. Compared with the controls, patients treated with the bone marrow stem cells implantation treatment showed improved clinical outcomes with delayed osteonecrosis progression (odds ratio = 0.17, 95% CI: 0.09 - 0.32; p<0.001, a lower total hip arthroplasty incidence (odds ratio = 0.30, 95% CI: 0.12 - 0.72; p<0.01 and increased Harris hip scores (mean difference = 4.76, 95% CI: 1.24 - 8.28; p<0.01. The heterogeneity, publication bias, and sensitivity analyses showed no statistical difference significant differences between studies. Thus, our study suggests that autologous bone marrow stem cells implantation has a good therapeutic effect on osteonecrosis of the femoral, resulting in beneficial clinical outcomes. However, trials with larger sample sizes are needed to confirm these findings.

  1. Clinical outcomes of osteonecrosis of the femoral head after autologous bone marrow stem cell implantation: a meta-analysis of seven case-control studies.

    Science.gov (United States)

    Yuan, Heng-Feng; Zhang, Jing; Guo, Chang-An; Yan, Zuo-Qin

    2016-02-01

    The purpose of this study was to evaluate the clinical outcomes of osteonecrosis of the femoral head after autologous bone marrow stem cell implantation. We searched the PubMed, Embase and Web of Science databases and included all case-control trials that reported on the clinical outcomes of osteonecrosis progression, incidence of total hip arthroplasty and improvement in Harris hip scores. Overall, seven case-control trials were included. Compared with the controls, patients treated with the bone marrow stem cells implantation treatment showed improved clinical outcomes with delayed osteonecrosis progression (odds ratio = 0.17, 95% CI: 0.09 - 0.32; p <0.001), a lower total hip arthroplasty incidence (odds ratio = 0.30, 95% CI: 0.12 - 0.72; p <0.01) and increased Harris hip scores (mean difference = 4.76, 95% CI: 1.24 - 8.28; p<0.01). The heterogeneity, publication bias, and sensitivity analyses showed no statistical difference significant differences between studies. Thus, our study suggests that autologous bone marrow stem cells implantation has a good therapeutic effect on osteonecrosis of the femoral, resulting in beneficial clinical outcomes. However, trials with larger sample sizes are needed to confirm these findings. PMID:26934241

  2. Scrub typhus: Clinical spectrum and outcome

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    Pradeep M Venkategowda

    2015-01-01

    Full Text Available Background: Scrub typhus is one of the differential diagnoses for fever with thrombocytopenia. ARDS associated with Scrub typhus has high morbidity and mortality. Aims: To evaluate clinical features, lab values, and outcome in patients with scrub typhus and comparison in patients with or without ARDS. Methods: A prospective observational study was conducted on 109 patients with febrile illness and thrombocytopenia during a period of 12 months. All 109 patients were tested with both Immune-chromatography test and Weil felix test. Patients having either Immune-chromatography test/Weil felix test positive have been included and considered as scrub typhus positive whereas negative for both Immune-chromatography and Weil felix test were excluded. Clinical features, lab parameters, and outcome were evaluated in all patients with scrub typhus. Statistical analysis used in this study was T-test. Results: Among 58 patients who were included (After exclusion of 51 patients among total of 109 patients 34 patients had no ARDS and 24 patients had ARDS. The clinical feature like dyspnoea, cough, low blood pressure (MAP<65 mmHg, IVC collapsibility (by ultrasound and laboratory parameters like decreased Hemoglobin, Hematocrit, Serum albumin, and increased serum creatinine, serum total bilirubin, SGOT, SGPT, LDH, CPK, and serum lactate were statistically significant (P < 0.0001 in scrub typhus patients group with ARDS. The higher titers of Weil-felix can be correlated with more severe form of disease according to our observation. All 34 Scrub typhus patients without ARDS recovered completely. Among 24 Scrub typhus patients with ARDS, 22 patients recovered, and 2 patients died. Conclusion: Scrub typhus is an important differential diagnosis in a patients having fever with thrombocytopenia. Scrub typhus associated with ARDS has high morbidity and mortality. Early diagnosis and treatment with doxycycline can prevent the occurrence of ARDS

  3. Determination of the optimal minimum radioiodine dose in patients with Graves' disease: a clinical outcome study

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    Howarth, D.; Tan, P.; Booker, J. [Pacific Medical Imaging, Newcastle, NSW (Australia); Epstein, M. [Dept. of Endocrinology, John Hunter Hospital, Newcastle, NSW (Australia); Lan, L. [High-Dependency Unit, St. George Hospital, Sydney, NSW (Australia)

    2001-10-01

    The study was performed under the auspices of the International Atomic Energy Commission, Vienna, Austria, with the aim of determining the optimal minimum therapeutic dose of iodine-131 for Graves' disease. The study was designed as a single-blinded randomised prospective outcome trial. Fifty-eight patients were enrolled, consisting of 50 females and 8 males aged from 17 to 75 years. Each patient was investigated by clinical assessment, biochemical and immunological assessment, thyroid ultrasound, technetium-99m thyroid scintigraphy and 24-h thyroid {sup 131}I uptake. Patients were then randomised into two treatment groups, one receiving 60 Gy and the other receiving 90 Gy thyroid tissue absorbed dose of radioiodine. The end-point markers were clinical and biochemical response to treatment. The median follow-up period was 37.5 months (range, 24-48 months). Among the 57 patients who completed final follow-up, a euthyroid state was achieved in 26 patients (46%), 27 patients (47%) were rendered hypothyroid and four patients (7%) remained hyperthyroid. Thirty-four patients (60%) remained hyperthyroid at 6 months after the initial radioiodine dose (median dose 126 MBq), and a total of 21 patients required additional radioiodine therapy (median total dose 640 MBq; range 370-1,485 MBq). At 6-month follow-up, of the 29 patients who received a thyroid tissue dose of 90 Gy, 17 (59%) remained hyperthyroid. By comparison, of the 28 patients who received a thyroid tissue dose of 60 Gy, 17 (61%) remained hyperthyroid. No significant difference in treatment response was found (P=0.881). At 6 months, five patients in the 90-Gy group were hypothyroid, compared to two patients in the 60-Gy group (P=0.246). Overall at 6 months, non-responders to low-dose therapy had a significantly larger thyroid gland mass (respective means: 35.9 ml vs 21.9 ml) and significantly higher levels of serum thyroglobulin (respective means: 597.6 {mu}g/l vs 96.9 {mu}g/l). Where low-dose radioiodine

  4. Abdominal tuberculosis: clinical presentation and outcome

    International Nuclear Information System (INIS)

    To study the clinical presentation and outcome of cases of Abdominal Tuberculosis. Fifty four patients of Abdominal Tuberculosis were seen during the study period. Four patients were lost to follow-up, which were excluded. Detailed information of all the patients including age, sex, symptoms, signs, investigations and management was recorded, analyzed and compared with local and international data. Out of the 50 patients with Abdominal Tuberculosis, 31 were females and 19 males. Their ages ranged from 17 to 63 years, with a mean age of 25.1 years. Thirty five cases were admitted through Emergency and 15 through Outpatients departments. Abdominal pain was the most common symptom found in 44 (88%) patients followed by vomiting in 33 (66%). Abdominal tenderness was seen in 22 (44%) patients, while 16 (32%) patients had rigidity and other features of peritonitis. Surgery was performed in all these patients, limited right hemicolectomy in 17 (34%), segmental resection and anastomosis in 12 (24%), ileostomy and strictureplasty in six (12%) each, repair of perforation in five (10%) and adhesiolysis in four (8%) patients. Overall mortality was 8% due to septicaemia and multiorgan failure. Abdominal Tuberculosis is a significant clinical entity with lethal complications in neglected cases. It affects a younger age group and is more common in females. Clinical features are rather non-specific but vague ill health, low grade fever, weight loss and anorexia may help to diagnose the case. (author)

  5. Incidence and impact on clinical outcome of infections with piperacillin/tazobactam resistant Escherichia coli in ICU: A retrospective study

    Directory of Open Access Journals (Sweden)

    Mounier Roman

    2008-05-01

    Full Text Available Abstract Background Escherichia coli infections are frequent in ICU patients. The increased resistance to fluoroquinolones and amoxicillin/clavulanate of this pathogen mandates the prescription of broad-spectrum antibiotics such as piperacillin/tazobactam (PIP-TAZ or third generation cephalosporins (3GC. Methods To assess incidence and impact on clinical outcome of infections with PIP-TAZ resistant E. coli in ICU patients, we conducted a retrospective cohort study with infections due to PIP-TAZ resistant (PIP-TAZ R or to PIP-TAZ susceptible strains (PIP-TAZ S between 1 January 2002 and 30 June 2004. Results Of 83 strains, 13 were PIP-TAZ R: 2 strains produced an extended-spectrum β-lactamase (2%, 11 produced a high level penicillinase (13%. Prior amoxicillin or amoxicillin/clavulanate prescription was reported in 7 cases (54% of infections with PIP-TAZ R isolates and in 15 cases (21% of infections with PIP-TAZ S isolates (p = 0.03. Time of onset of the infection from hospital admission was longer in case of infections with PIP-TAZ R than with PIP-TAZ S isolates (22 ± 32 vs 10 ± 21 days, p = 0.01. The overall ICU mortality rate was 38%. Mortality and length of stay in ICU were similar in case of infections with PIP-TAZ R isolates and with PIP-TAZ S isolates. Conclusion Infections with PIP-TAZ R E. coli are frequent in ICU patients. No prognostic impact of this pattern of resistance was found. Prescription of PIP-TAZ for empirical treatment of E. coli infections in ICU however exposes to inappropriate therapy.

  6. Clinical outcome of an alternative fotemustine schedule in elderly patients with recurrent glioblastoma: a mono-institutional retrospective study.

    Science.gov (United States)

    Lombardi, Giuseppe; Bellu, Luisa; Pambuku, Ardi; Della Puppa, Alessandro; Fiduccia, Pasquale; Farina, Miriam; D'Avella, Domenico; Zagonel, Vittorina

    2016-07-01

    The optimal treatment of recurrent glioblastoma (GBM) in elderly patients is unclear. Fotemustine (FTM) is a third-generation nitrosourea showing efficacy in gliomas and it has been used with different schedules in adult patients. We performed, for the first time anywhere, a mono-institutional retrospective study to analyze the clinical outcome of an alternative fotemustine schedule in elderly patients with recurrent GBM. Retrospectively, we analyzed all GBM patients 65 years or older previously treated with the combination of radiation therapy and temozolomide (TMZ), receiving an alternative FTM schedule as second-line treatment at our Oncological Center from October 2011 to October 2014 with an ECOG PS ≤ 2. FTM was administrated at 80 mg/m(2) every 2 weeks for five consecutive administrations (induction phase), and then every 4 weeks at 80 mg/m(2) as maintenance. We enrolled 44 patients, 33 males and 11 females; average age was 70 years. ECOG PS was 0-1 in 80 % of the patients. 38 patients relapsed during temozolomide (TMZ) therapy. MGMT methylation status was analyzed in 34 patients and MGMT was methylated in 53 % of the patients. The median progression free survival (PFS) and overall survival (OS) from FTM treatment was 4.1 months (95 % CI 3.1-5.2) and 7 months (95 % CI 5.2-8.4), respectively. Patients with MGMT methylated status and patients who relapsed after completing TMZ therapy had a longer PFS and OS from the beginning of FTM. Thrombocytopenia was the most frequent grade 3-4 haematological toxicity (9 %). The alternative schedule of FTM may be an active and safe treatment for elderly patients with recurrent glioblastoma, especially patients with methylated MGMT and who relapsed after completing temozolomide therapy. PMID:27165580

  7. Clinical outcome of pneumococcal meningitis during the emergence of pencillin-resistant Streptococcus pneumoniae: an observational study

    Directory of Open Access Journals (Sweden)

    Gouveia Edilane L

    2011-11-01

    Full Text Available Abstract Background Prior to the availability of generic third-generation cephalosporins, penicillins were widely used for treatment of pneumococcal meningitis in developing countries despite concerns about rising levels of penicillin resistance among pneumococcal isolates. We examined the impact of penicillin resistance on outcomes of pneumococcal meningitis over a ten year period in an infectious diseases hospital in Brazil. Methods Clinical presentation, antimicrobial therapy and outcomes were reviewed for 548 patients with culture-confirmed pneumococcal meningitis from December, 1995, to November, 2005. Pneumococcal isolates from meningitis patients were defined as penicillin-resistant if Minimum Inhibitory Concentrations for penicillin were greater than 0.06 μg/ml. Proportional hazards regression was used to identify risk factors for fatal outcomes. Results During the ten-year period, ceftriaxone replaced ampicillin as first-line therapy for suspected bacterial meningitis. In hospital case-fatality for pneumococcal meningitis was 37%. Of 548 pneumococcal isolates from meningitis cases, 92 (17% were resistant to penicillin. After controlling for age and severity of disease at admission, penicillin resistance was associated with higher case-fatality (Hazard Ratio [HR], 1.62; 95% Confidence Interval [CI], 1.08-2.43. Penicillin-resistance remained associated with higher case-fatality when initial therapy included ceftriaxone (HR, 1.68; 95% CI 1.02-2.76. Conclusions Findings support the use of third generation cephalosporin antibiotics for treatment of suspected pneumococcal meningitis even at low prevalence of pneumococcal resistance to penicillins.

  8. Clinical and Radiographic Mid-Term Outcomes After Total Shoulder Replacement: A Retrospective Study Protocol Including 400 Anatomical and Reverse Prosthetic Implants

    Science.gov (United States)

    Merolla, Giovanni; Tartarone, Antonio; Porcellini, Giuseppe

    2016-01-01

    Objectives: To obtain outcomes data on anatomical and reverse total shoulder arthroplasty by analysis of clinical scores and standard radiographs. Subject selection and enrollment: 400 consecutive series of patients replaced with anatomical and reverse total shoulder arthroplasty (minimum 3 years follow-up). Study Design: retrospective monocenter. Preoperative assessment: Demographics, clinical scores (Constant-Murley) as available, shoulder X-ray (AP, outlet and axillary views) . Last follow-up: Postoperative radiographhs and clinical scores. Adverse events and complications to be reported as occurred since implantation. Statistical analysis: Data collected will be summarized and analyzed for statistical significance. PMID:27326389

  9. A retrospective, multi-center cohort study evaluating the severity- related effects of cerebrolysin treatment on clinical outcomes in traumatic brain injury.

    Science.gov (United States)

    Muresanu, Dafin F; Ciurea, Alexandru V; Gorgan, Radu M; Gheorghita, Eva; Florian, Stefan I; Stan, Horatiu; Blaga, Alin; Ianovici, Nicolai; Iencean, Stefan M; Turliuc, Dana; Davidescu, Horia B; Mihalache, Cornel; Brehar, Felix M; Mihaescu, Anca S; Mardare, Dinu C; Anghelescu, Aurelian; Chiparus, Carmen; Lapadat, Magdalena; Pruna, Viorel; Mohan, Dumitru; Costea, Constantin; Costea, Daniel; Palade, Claudiu; Bucur, Narcisa; Figueroa, Jesus; Alvarez, Anton

    2015-01-01

    Traumatic brain injury (TBI) is a leading cause of death and disability for which there is currently no effective drug therapy available. Because drugs targeting a single TBI pathological pathway have failed to show clinical efficacy to date, pleiotropic agents with effects on multiple mechanisms of secondary brain damage could represent an effective option to improve brain recovery and clinical outcome in TBI patients. In this multicenter retrospective study, we investigated severity-related efficacy and safety of the add-on therapy with two concentrations (20 ml/day or 30 ml/day) of Cerebrolysin (EVER Neuro Pharma, Austria) in TBI patients. Adjunctive treatment with Cerrebrolysin started within 48 hours after TBI and clinical outcomes were ranked according to the Glasgow Outcome Scale and the Modified Rankin Disability Score at 10 and 30 days post-TBI. Analyses of efficacy were performed separately for subgroups of patients with mild, moderate or severe TBI according to Glasgow Coma Scale scores at admission. Compared to standard medical care alone (control group), both doses of Cerebrolysin were associated with improved clinical outcome scores at 10 days post-TBI in mild patients and at 10 and 30 days in moderate and severe cases. A dose-dependent effect of Cerebrolysin on TBI recovery was supported by the dose-related differences and the significant correlations with treatment duration observed for outcome measures. The safety and tolerability of Cerebrolysin in TBI patients was very good. In conclusion, the results of this large retrospective study revealed that early Cerebrolysin treatment is safe and is associated to improved TBI outcome. PMID:25924999

  10. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton;

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and k...

  11. Measuring, comparing and improving clinical outcomes in gastrointestinal cancer surgery

    OpenAIRE

    Henneman, D.

    2016-01-01

    In this thesis, hospital variation concerning various surgical outcomes is illustrated, thereby exploring the usability of these outcomes for hospital comparisons, both from a clinical and methodological point of view. Moreover, the studies provide insight in risk factors for adverse events in colorectal and oesophageal cancer surgery, focusing on the mechanism behind postoperative complications leading to mortality or not.

  12. Prolactinomas: clinical studies

    OpenAIRE

    Kars, Marleen

    2008-01-01

    Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An increased risk of cardiac valve disease has been reported in patients treated with cabergoline for Parkinson’s disease. Stimulation of serotonin receptors on cardiac valves by dopamine agonists re...

  13. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2013-01-01

    BACKGROUND: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS: We...... conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...... investigators agreed on the inclusion of trials and the outcome scale. For each trial, we calculated the difference in effect size (i.e., standardized mean difference between nonblinded and blinded assessments). A difference in effect size of less than 0 suggested that nonblinded assessors generated more...

  14. Menopause Analytical Hormonal Correlate Outcome Study (MAHCOS and the association to brain electrophysiology (P300 in a clinical setting.

    Directory of Open Access Journals (Sweden)

    Eric R Braverman

    Full Text Available Various studies have demonstrated that increased leptin levels and obesity are inversely related to cognitive decline in menopausal women. It is hypothesized that adiposity is inversely correlated with cognitive decline, as women with increased weight are less vulnerable to diminishing cognition. However, it is increasingly observed that menopausal women, even with increased adiposity, experience significant cognitive decline. Positron emission tomography (PET has been used to analyze cognitive function and processing in menopausal women. Evoked potentials (P300 and neurophysiologic tests have validated brain metabolism in cognitively impaired patients. Post-hoc analyses of 796 female patients entering PATH Medical Clinic, between January 4, 2009 and February 24, 2013, were performed as part of the "Menopause Analytical Hormonal Correlate Outcome Study" (MAHCOS. Patient age range was 39-76 years (46.7 ± 0.2. P300 latency and amplitude correlated with a number of hormones: follicle stimulating hormone (FSH, luteinizing hormone (LH, estradiol, estrone, estriol, DHEA, pregnenolone, progesterone, free and total testosterone, thyroid stimulating hormone (TSH, Vitamins D 1.25 and D 25OH, leptin, and insulin-like growth factor-binding protein 3 (IGF-BP3. Corrected statistics did not reveal significant associations with P300 latency or amplitude for these hormones except for leptin plasma levels. However, factor analysis showed that FSH and LH clustered together with Vitamin D1.25 and Vitamin D25OH, P300 latency (not amplitude, and log leptin were found to be associated in the same cluster. Utilizing regression analysis, once age adjusted, leptin was the only significant predictor for latency or speed (p = 0.03 with an effect size of 0.23. Higher plasma leptin levels were associated with abnormal P300 speed (OR = 0.98. Our findings show a significant relationship of higher plasma leptin levels, potentially due to leptin resistance, and prolonged P300

  15. Endoscopic ultrasonic dacryocystorhinostomy: clinical profile and outcomes.

    Science.gov (United States)

    Ali, Mohammad Javed; Singh, Manpreet; Chisty, Naja; Kamal, Saurabh; Naik, Milind N

    2016-07-01

    Ultrasonic endoscopic dacryocystorhinostomy (UEnDCR) is emerging alternative modality of managing nasolacrimal duct obstructions. The aim of this study was to report the clinical profile and outcomes with a UEnDCR with mitomycin C and silicone intubation. Prospective interventional case series performed on all consecutive patients undergoing an ultrasonic endoscopic dacryocystorhinostomy over a 1-year period from September 2013 to October 2014. All surgeries were performed by a single surgeon (MJA). Data collected include demographics, presentation, indications for surgery, past interventions, intraoperative and post-operative complications and outcomes. The main outcome measures were anatomical and functional success of the surgery. 44 procedures were performed in 41 patients. The mean age was 31.6 years. Children with complex congenital nasolacrimal duct obstructions refractory to probing and intubation accounted for 17 % (7/41) of the cohort. Past history of acute dacryocystitis was noted in 35.6 % (15/41). Two patients (4.9 %, 2/41) had failed external DCR. A minimal follow-up of 6 months following surgery was taken for final analysis. Complications included intraoperative focal epithelial burn in one patient that healed spontaneously and post-operative ostium granulomas in 15.9 % (7/44) of the ostia. At the 6-month follow-up, anatomical and functional successes were noted in 93.1 % (41/44) and 88.6 % (39/44), respectively. Ultrasonic dacryocystorhinostomy is a safe and effective alternative modality in the management of nasolacrimal duct obstructions in pediatric and adult age groups. Setup was easy and no additional technical difficulties were observed. PMID:26530294

  16. Clinical Outcome of Inter-Proximal Papilla between a Tooth and a Single Implant Treated with CAD/CAM Abutments: a Cross-Sectional Study

    OpenAIRE

    Tiago Borges; Tiago Lima; Ágata Carvalho; Vasco Carvalho

    2012-01-01

    ABSTRACT Objectives The aim of this study was to assess the clinical outcomes achieved with Computer-Assisted Design/Computer-Assisted Manufacturing implant abutments in the anterior maxilla. Material and Methods Nineteen patients with a mean age of 41 (range form 26 to 63) years, treated with 21 single tooth implants and 21 Computer-Assisted Design/Computer-Assisted Manufacturing (CAD/CAM) abutments in the anterior maxillary region were included in this study. The patients followed 4 criteri...

  17. Acute demyelinating encephalomyelitis: Clinical characteristics and outcome

    Directory of Open Access Journals (Sweden)

    Ahmed Farag Elhassanien

    2013-01-01

    Full Text Available Background: ADEM, although relatively uncommon, is probably under-recognized. Objectives: To spotlight the clinical profile and therapeutic outcome of children with ADEM. Materials and Methods: This is a prospective study of patients with ADEM who were admitted to the Pediatric Departments in Aladan and Alfarawanya Hospitals in Kuwait, from January 2009 to January 2011. Clinical, microbiological and radiological data were analyzed. Results: Of 48 patients presented with acute neurological symptoms and signs, 21 patients fulfilled criteria for ADEM. 80.95% of cases were presenting in winter and spring, 57% of patients had a history of upper respiratory tract illness. The commonest presentations were motor deficits, convulsions and altered consciousness. CSF virology studies showed herpes simplex virus (HSV and Epstein-Barr virus (EBV (3 patients whereas nasal and nasopharyngeal swab showed evidence of influenza H1N1 virus (1 patient. Brain MRI was performed in all patients and revealed multiple hyperintense supratentorial brain lesions on T2/FLAIR images. 85.7% of patients had cortical and/or subcortical white matter lesions which were bilateral and asymmetric in location and size. Conclusion: ADEM although rare must be considered in children with acute onset of neurological signs and symptoms and must be distinguished from any acute neurological insult.

  18. Esthetic Outcomes of Single-Tooth Implant-Supported Restorations Using Metal-Ceramic Restorations with Zirconia or Titanium Abutments: A Randomized Controlled Clinical Study.

    Science.gov (United States)

    Baldini, Nicola; D'Elia, Chiara; Clementini, Marco; Carrillo de Albornoz, Ana; Sanz, Mariano; De Sanctis, Massimo

    2016-01-01

    The aim of this study was to test whether zirconia abutments exhibit the same clinical and esthetic outcomes as titanium abutments in single-tooth implant restorations in the esthetic area. The 24 treated patients were randomly assigned to a test (zirconia abutment) or control (titanium abutment) group. Objective evaluations were carried out using the Implant Crown Aesthetic Index (ICAI) and the Papilla Index (PI) at the 1-month and 12-month follow-up examinations after crown cementation. No significant differences, either in ICAI or in other periodontal or radiographic measurements, were observed. At 1 year, zirconia and titanium abutments exhibited the same esthetic outcomes. PMID:27333019

  19. Prospective Study Examining Clinical Outcomes Associated with a Negative Pressure Wound Therapy System and Barker’s Vacuum Packing Technique

    OpenAIRE

    Cheatham, Michael L.; Demetriades, Demetrios; Fabian, Timothy C; Kaplan, Mark J.; Miles, William S.; Schreiber, Martin A; Holcomb, John B.; Bochicchio, Grant; Sarani, Babak; Rotondo, Michael F.

    2013-01-01

    Background The open abdomen has become a common procedure in the management of complex abdominal problems and has improved patient survival. The method of temporary abdominal closure (TAC) may play a role in patient outcome. Methods A prospective, observational, open-label study was performed to evaluate two TAC techniques in surgical and trauma patients requiring open abdomen management: Barker’s vacuum-packing technique (BVPT) and the ABTheraTM open abdomen negative pressure therapy system ...

  20. Pregnancy-related systemic lupus erythematosus: clinical features, outcome and risk factors of disease flares--a case control study.

    Directory of Open Access Journals (Sweden)

    Huaxia Yang

    Full Text Available OBJECTIVE: To investigate the clinical features, outcome, and risk factors of disease flares in patients with pregnancy-related lupus (PRL. METHODS: Medical charts of 155 consecutive PRL inpatients were systematically reviewed, including demographic data, clinical features, laboratory findings, treatment, complications, and outcome. RESULTS: PRL cases were divided into active (a-PRL (n = 82, 53.0% and stable lupus (s-PRL (n = 73, 47.0%. Compared with nonpregnant active female systemic lupus erythematosus (SLE patients, a-PRL including new-onset lupus (n-PRL and flare lupus (f-PRL (n = 41 respectively, had a higher incidence of renal and hematological involvement but less mucocutaneous and musculoskeletal involvement (p<0.05. The incidence of preeclampsia/eclampsia, fetal loss, and preterm birth were significantly higher in a-PRL than in s-PRL (p<0.05. Despite receiving a more vigorous glucocorticoid treatment, a-PRL mothers had a poorer prognosis (p<0.001. Five (6.1% of them died and 13 (15.9% developed severe irreversible organ failure, whereas none of these events was observed in the s-PRL group. Multivariate logistic analysis indicated that a history of lupus flares and serological activity (hypocomplementemia and/or anti-dsDNA positivity at the time of conception were associated with lupus flares in PRL mothers. CONCLUSIONS: SLE patients with a flare history and serological activity at the time of conception were at an increased risk of disease flares during pregnancy and puerperium. a-PRL patients were more prone to renal and hematological involvement, pregnancy complications, and a poorer prognosis despite more vigorous glucocorticoid treatment.

  1. A STUDY OF CLINICAL PROFILE AND OUTCOME OF RESPIRATORY DISTRESS IN NEWBORN BABIES IN KING GEORGE HOSPITAL, ANDHRA MEDICAL COLLEGE, VISAKHAPATNAM, ANDHRA PRADESH, INDIA: A PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Rapaka Sujatha Devi

    2016-06-01

    Full Text Available BACKGROUND A variety of disorders of respiratory system and non-respiratory disorders like intracranial injury, cardiac failure metabolic disorders, septicaemia and congenital malformations can manifest clinically with respiratory distress. (1,2 RDS DEFINITION = RESPIRATORY DISTRESS (RDS Is diagnosed clinically by the presence of at least two of the following criteria namely, respiratory rate of >60/minute, retractions, flaring of the alae nasi, expiratory grunt and cyanosis at room air on two consecutive examinations at least hour apart. AIMS OF THE STUDY To assess the clinical outcome of respiratory distress in new-born. To study the various Risk factors associated with development of severe respiratory distress in the new-born. To study the usefulness of chest x-ray to identify the cause of respiratory distress in neonate. METHODS The study was carried out in the Department of Paediatrics, AMC, KGH. Prospective study of 200 new-borns with respiratory distress who were admitted in NICU, between July 2014 to August 2015. INCLUSION CRITERIA All new-borns admitted to NICU within 24 hrs. of birth with RDS in both pre and term babies. EXCLUSION CRITERIA All new-borns admitted to NICU after 24 hrs. of birth with RDS. The severity was assessed by using Downes. (3 clinical scoring and X-rays. Therapy/Treatment and mortality was documented to assess the severity of RDS. RESULTS 154 cases with distress are of respiratory system in origin out of which 45% were due to Meconium aspiration syndrome, 56% of other conditions responsible for RDS. CONCLUSION Meconium aspiration syndrome (MSA is the most common cause of RDS in new-born, risk factors like meconium stained liquor, vaginally delivered new-borns, preterm gestation age, & female sex.

  2. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

    Science.gov (United States)

    Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2013-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765

  3. Extra-pleural pneumonectomy versus no extra-pleural pneumonectomy for patients with malignant pleural mesothelioma: clinical outcomes of the Mesothelioma and Radical Surgery (MARS) randomised feasibility study

    OpenAIRE

    Treasure, T; Lang-Lazdunski, L.; Waller, D; Bliss, J M; Tan, C.; Entwisle, J; Snee, M.; O Brien, M.; Thomas, G.; Senan, S; O'Byrne, K; Kilburn, L S; Spicer, J; Landau, D; Edwards, J.

    2011-01-01

    Summary Background The effects of extra-pleural pneumonectomy (EPP) on survival and quality of life in patients with malignant pleural mesothelioma have, to our knowledge, not been assessed in a randomised trial. We aimed to assess the clinical outcomes of patients who were randomly assigned to EPP or no EPP in the context of trimodal therapy in the Mesothelioma and Radical Surgery (MARS) feasibility study. Methods MARS was a multicentre randomised controlled trial in 12 UK hospitals. Patient...

  4. Correlating anterior insula gray matter volume changes in young people with clinical and neurocognitive outcomes: an MRI study

    OpenAIRE

    Hatton Sean N; Lagopoulos Jim; Hermens Daniel F; Naismith Sharon L; Bennett Maxwell R; Hickie Ian B

    2012-01-01

    Abstract Background The anterior insula cortex is considered to be both the structural and functional link between experience, affect, and behaviour. Magnetic resonance imaging (MRI) studies have shown changes in anterior insula gray matter volume (GMV) in psychosis, bipolar, depression and anxiety disorders in older patients, but few studies have investigated insula GMV changes in young people. This study examined the relationship between anterior insula GMV, clinical symptom severity and ne...

  5. Villitis of unknown aetiology: correlation of recurrence with clinical outcome.

    LENUS (Irish Health Repository)

    Feeley, L

    2010-01-01

    Villitis of unknown aetiology (VUA) is associated with adverse pregnancy outcome. Consequently, an ability to predict recurrence could be clinically relevant. We examined placentas where villitis was diagnosed in a previous pregnancy to establish the risk of recurrence and outcome. A total of 304 cases of VUA were diagnosed in our laboratory over a 4-year period. Subsequently, 19 of this cohort had a second placenta examined histologically. Recurrence and clinical outcome were recorded. Villitis recurred in 7 of 19 cases (37%). There was a high level of adverse pregnancy outcome in this cohort overall, characterised by small for gestational age infants and stillbirth, particularly in cases with high-grade villitis. We identified recurrent villitis more frequently than previously reported. Our findings confirm an association between high-grade villitis and poor outcome. Adequately powered prospective studies are required to determine if enhanced surveillance of subsequent pregnancies is indicated following a diagnosis of villitis.

  6. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2013-01-01

    BACKGROUND: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS: We...... conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...... optimistic estimates of effect. We pooled the differences in effect size using inverse variance random-effects meta-analysis and used metaregression to identify potential reasons for variation. RESULTS: We included 24 trials in our review. The main meta-analysis included 16 trials (involving 2854 patients...

  7. Clinical manifestations and outcome in Staphylococcus aureus endocarditis among injection drug users and nonaddicts: a prospective study of 74 patients

    Directory of Open Access Journals (Sweden)

    Ruotsalainen Eeva

    2006-09-01

    Full Text Available Abstract Background Endocarditis is a common complication in Staphylococcus aureus bacteremia (SAB. We compared risk factors, clinical manifestations, and outcome in a large, prospective cohort of patients with S. aureus endocarditis in injection drug users (IDUs and in nonaddicts. Methods Four hundred and thirty consecutive adult patients with SAB were prospectively followed up for 3 months. Definite or possible endocarditis by modified Duke criteria was found in 74 patients: 20 patients were IDUs and 54 nonaddicts. Results Endocarditis was more common in SAB among drug abusers (46% than in nonaddicts (14% (odds ratio [OR], 5.12; 95% confidence interval [CI], 2.65–9.91; P P P P = 0.03, and their SAB was more often community-acquired (95% vs 39%, P P P = 0.70. Arterial thromboembolic events and severe sepsis were also equally common in both groups. There was no difference in mortality between the groups at 7 days, but at 3 months it was lower among IDUs (10% compared with nonaddicts (39% (OR, 5.73; 95% CI, 1.20–27.25; P = 0.02. Conclusion S. aureus endocarditis in IDUs was associated with as high complication rates including extracardiac deep infections, thromboembolic events, or severe sepsis as in nonaddicts. Injection drug abuse in accordance with younger age and lack of underlying diseases were associated with lower mortality, but after adjusting by age and underlying diseases injection drug abuse was not significantly associated with mortality.

  8. Multicenter study of radiosynoviorthesis. Clinical outcome in osteoarthritis and other disorders with concomitant synovitis in comparison with rheumatoid arthritis

    International Nuclear Information System (INIS)

    Aim: evaluation of the effectiveness of radiosynoviorthesis (RSO) in osteoarthritis and other disorders with concomitant synovitis versus rheumatoid arthritis by means of a standardized questionnaire. Patients, methods: 803 RSO treatments were monitored in 691 patients by standardized questionnaires of 7 centers in 3 countries. Patients were assigned to 3 groups according to their age (20-40, 41-60, 61-80 years). Additionally, the data were analyzed separately for patients with rheumatoid arthritis (group A) and those with osteoarthritis, psoriasis arthritis, pigmental villonodular synovitis or persistent effusions after joint replacement (group B). Results: ameliorations of joint pain, swelling/effusion or flexibility were found in 80% of group A and 56% of group B (p <0.01). Quality of life improved in 78% of group A and 59% of group B (p <0.01). The response rate was similar for small- and large-sized joints in group A, but significantly higher for large-sized joints in group B (p <0.01). The positive effects on joint pain, swelling/effusion or flexibility lasted longer in group A (p <0.01). Repeated RSOs were as effective as initial ones. The clinical outcome was neither influenced by age, nor gender, nor transient immobilisation for 48 hours after RSO. Conclusion: although slightly more efficient in rheumatoid arthritis, RSO represents an effective treatment option also in osteoarthritis and other disorders with concomitant synovitis. (orig.)

  9. Biocompatible Peritoneal Dialysis Fluids: Clinical Outcomes

    Directory of Open Access Journals (Sweden)

    Yeoungjee Cho

    2012-01-01

    Full Text Available Peritoneal dialysis (PD is a preferred home dialysis modality and has a number of added advantages including improved initial patient survival and cost effectiveness over haemodialysis. Despite these benefits, uptake of PD remains relatively low, especially in developed countries. Wider implementation of PD is compromised by higher technique failure from infections (e.g., PD peritonitis and ultrafiltration failure. These are inevitable consequences of peritoneal injury, which is thought to result primarily from continuous exposure to PD fluids that are characterised by their “unphysiologic” composition. In order to overcome these barriers, a number of more biocompatible PD fluids, with neutral pH, low glucose degradation product content, and bicarbonate buffer have been manufactured over the past two decades. Several preclinical studies have demonstrated their benefit in terms of improvement in host cell defence, peritoneal membrane integrity, and cytokine profile. This paper aims to review randomised controlled trials assessing the use of biocompatible PD fluids and their effect on clinical outcomes.

  10. Defining the effect and mediators of two knowledge translation strategies designed to alter knowledge, intent and clinical utilization of rehabilitation outcome measures: a study protocol [NCT00298727

    Directory of Open Access Journals (Sweden)

    Law Mary

    2006-07-01

    Full Text Available Abstract Background A substantial number of valid outcome measures have been developed to measure health in adult musculoskeletal and childhood disability. Regrettably, national initiatives have merely resulted in changes in attitude, while utilization remains unacceptably low. This study will compare the effectiveness and mediators of two different knowledge transfer (KT interventions in terms of their impact on changing knowledge and behavior (utilization and clinical reasoning related to health outcome measures. Method/Design Physical and occupational therapists (n = 144 will be recruited in partnership with the national professional associations to evaluate two different KT interventions with the same curriculum: 1 Stakeholder-Hosted Interactive Problem-Based Seminar (SHIPS, and 2 Online Problem-Based course (e-PBL. SHIPS will consist of face-to-face problem-based learning (PBL for 2 1/2 days with outcome measure developers as facilitators, using six problems generated in consultation with participants. The e-PBL will consist of a 6-week web-based course with six generic problems developed by content experts. SHIPS will be conducted in three urban centers in Canada. Participants will be block-allocated by a minimization procedure to either of the two interventions to minimize any prognostic differences. Trained evaluators at each site will conduct chart audits and chart-stimulated recall. Trained interviewers will conduct semi-structured interviews focused on identifying critical elements in KT and implementing practice changes. Interviews will be transcribed verbatim. Baseline predictors including demographics, knowledge, attitudes/barriers regarding outcome measures, and Readiness to Change will be assessed by self-report. Immediately post-intervention and 6 months later, these will be re-administered. Primary qualitative and quantitative evaluations will be conducted 6-months post-intervention to assess the relative effectiveness of KT

  11. Survival and clinical outcome of dogs with ischaemic stroke

    DEFF Research Database (Denmark)

    Gredal, Hanne Birgit; Toft, Nils; Westrup, Ulrik;

    2013-01-01

    survivors was 505days. Four dogs (18%) were still alive by the end of the study. Right-sided lesions posed a significantly increased risk of mortality with a median survival time in dogs with right-sided lesions of 24days vs. 602days in dogs with left sided lesions (P=0.006). Clinical outcome was considered...... in terms of survival and clinical outcome. However, owners should be informed of the risk of acute death within 30days and of the possibility of new neurological events in survivors. Mortality was increased in dogs with right-sided lesions in this study....

  12. Correlating anterior insula gray matter volume changes in young people with clinical and neurocognitive outcomes: an MRI study

    Directory of Open Access Journals (Sweden)

    Hatton Sean N

    2012-05-01

    Full Text Available Abstract Background The anterior insula cortex is considered to be both the structural and functional link between experience, affect, and behaviour. Magnetic resonance imaging (MRI studies have shown changes in anterior insula gray matter volume (GMV in psychosis, bipolar, depression and anxiety disorders in older patients, but few studies have investigated insula GMV changes in young people. This study examined the relationship between anterior insula GMV, clinical symptom severity and neuropsychological performance in a heterogeneous cohort of young people presenting for mental health care. Methods Participants with a primary diagnosis of depression (n = 43, bipolar disorder (n = 38, psychosis (n = 32, anxiety disorder (n = 12 or healthy controls (n = 39 underwent structural MRI scanning, and volumetric segmentation of the bilateral anterior insula cortex was performed using the FreeSurfer application. Statistical analysis examined the linear and quadratic correlations between anterior insula GMV and participants’ performance in a battery of clinical and neuropsychological assessments. Results Compared to healthy participants, patients had significantly reduced GMV in the left anterior insula (t = 2.05, p = .042 which correlated with reduced performance on a neuropsychological task of attentional set-shifting (ρ = .32, p = .016. Changes in right anterior insula GMV was correlated with increased symptom severity (r = .29, p = .006 and more positive symptoms (r = .32, p = .002. Conclusions By using the novel approach of examining a heterogeneous cohort of young depression, anxiety, bipolar and psychosis patients together, this study has demonstrated that insula GMV changes are associated with neurocognitive deficits and clinical symptoms in such young patients.

  13. Creating clinical trial designs that incorporate clinical outcome assessments.

    Science.gov (United States)

    Gilbert, Mark R; Rubinstein, Lawrence; Lesser, Glenn

    2016-03-01

    Clinical outcome assessments (COAs) are increasingly being used in determining the efficacy of new treatment regimens. This was typified in the recent use of a symptom-based instrument combined with an organ-based measure of response for the approval of ruxolitinib in myelofibrosis. There are challenges in incorporating these COAs into clinical trials, including designating the level of priority, incorporating these measures into a combined or composite endpoint, and dealing with issues related to compliance and interpretation of results accounting for missing data. This article describes the results of a recent panel discussion that attempted to address these issues and provide guidance to the incorporation of COAs into clinical trials, including novel statistical designs, so that the testing of new treatments in patients with cancers of the central nervous system can incorporate these important clinical endpoints. PMID:26989129

  14. Predictors of clinical outcome following lumbar disc surgery

    DEFF Research Database (Denmark)

    Hebert, Jeffrey J; Fritz, Julie; Koppenhaver, S.L.;

    2016-01-01

    PURPOSE: Explore the relationships between preoperative findings and clinical outcome following lumbar disc surgery, and investigate the prognostic value of physical examination findings after accounting for information acquired from the clinical history. METHODS: We recruited 55 adult patients...... of leg pain to LBP, pain medication use, greater time to surgery, and no history of previous physical or injection therapy. Physical examination predictors were a positive straight or cross straight leg raise test, diminished lower extremity strength, sensation or reflexes, and the presence of...... outcome. CONCLUSIONS: Information gleaned from the clinical history and physical examination helps to identify patients more likely to succeed with lumbar disc surgery. While this study helps to inform clinical practice, additional research confirming these results is required prior to confident clinical...

  15. Clinical and radiological outcome after periacetabular osteotomy

    DEFF Research Database (Denmark)

    Dahl, Line B; Dengsø, Kristine; Bang-Christiansen, Karl;

    2014-01-01

    PURPOSE: Few papers have described results after periacetabular osteotomy (PAO) and risk factors for conversion to total hip arthroplasty (THA). The aim of the present paper was to analyse clinical and radiographic outcome, survival of the hip joint and risk factors of early conversion to THA in ...... 12 years survival data, are comparable with the literature. PAO is considered as an effective treatment for young adults with painful hip dysplasia, especially when preoperative criteria for conversion to THA are highlighted.......PURPOSE: Few papers have described results after periacetabular osteotomy (PAO) and risk factors for conversion to total hip arthroplasty (THA). The aim of the present paper was to analyse clinical and radiographic outcome, survival of the hip joint and risk factors of early conversion to THA...... in patients with PAO. BASIC PROCEDURES: In the period 1999-2008, 93 patients (127 hips, median patient age 31, range 13-49 years) were operated on with PAO. Median follow-up was 7 (SD 2.1) years. Analyses of clinical and radiographic examinations, including WOMAC, were performed. Osteoarthritis was measured...

  16. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida; Tendal, Britta; Hilden, Jørgen; Boutron, Isabelle; Ravaud, Philippe; Brorson, Stig

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  17. Mediterranean diet or extended fasting's influence on changing the intestinal microflora, immunoglobulin A secretion and clinical outcome in patients with rheumatoid arthritis and fibromyalgia: an observational study

    Directory of Open Access Journals (Sweden)

    Schwickert Myriam

    2005-12-01

    Full Text Available Abstract Background Alterations in the intestinal bacterial flora are believed to be contributing factors to many chronic inflammatory and degenerative diseases including rheumatic diseases. While microbiological fecal culture analysis is now increasingly used, little is known about the relationship of changes in intestinal flora, dietary patterns and clinical outcome in specific diseases. To clarify the role of microbiological culture analysis we aimed to evaluate whether in patients with rheumatoid arthritis (RA or fibromyalgia (FM a Mediterranean diet or an 8-day fasting period are associated with changes in fecal flora and whether changes in fecal flora are associated with clinical outcome. Methods During a two-months-period 51 consecutive patients from an Integrative Medicine hospital department with an established diagnosis of RA (n = 16 or FM (n = 35 were included in the study. According to predefined clinical criteria and the subjects' choice the patients received a mostly vegetarian Mediterranean diet (n = 21; mean age 50.9 +/-13.3 y or participated in an intermittent modified 8-day fasting therapy (n = 30; mean age 53.7 +/- 9.4 y. Quantitative aerob and anaerob bacterial flora, stool pH and concentrations of secretory immunoglobulin A (sIgA were analysed from stool samples at the beginning, at the end of the 2-week hospital stay and at a 3-months follow-up. Clinical outcome was assessed with the DAS 28 for RA patients and with a disease severity rating scale in FM patients. Results We found no significant changes in the fecal bacterial counts following the two dietary interventions within and between groups, nor were significant differences found in the analysis of sIgA and stool ph. Clinical improvement at the end of the hospital stay tended to be greater in fasting vs. non-fasting patients with RA (p = 0.09. Clinical outcome was not related to alterations in the intestinal flora. Conclusion Neither Mediterranean diet nor fasting

  18. Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data

    Directory of Open Access Journals (Sweden)

    Andrzej Kotela

    2015-01-01

    Full Text Available Total knee arthroplasty (TKA is a frequently performed procedure in orthopaedic surgery. Recently, patient-specific instrumentation was introduced to facilitate correct positioning of implants. The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique. A prospective, randomized controlled trial on 112 patients was performed between January 2011 and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients who received the Signature CT-based implant positioning system, and the control group consisted of 60 patients with conventional instrumentation. Clinical outcomes were evaluated with the KSS scale, WOMAC scale, and VAS scales to assess knee pain severity and patient satisfaction with the surgery. Specified in-hospital data were recorded. Patients were followed up for 12 months. At one year after surgery, there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data, including operative time, blood loss, hospital length of stay, intraoperative observations, and postoperative complications. Further high-quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA.

  19. Correlation of Reconstructed Scaphoid Morphology with Clinical Outcomes

    OpenAIRE

    Ahmadreza Afshar; Afshin Mohammadi; Kian Zohrabi; Nasrin Navaeifar; Sam Sami; Hassan Taleb

    2015-01-01

    Background: Scaphoid malunion alters the carpal kinematics and impairs clinical outcome because of pain, weakness, restricted range of motion and predisposing the wrist joint to early osteoarthritis. The aim of this study was to evaluate the influence of the scaphoid morphological angles on clinical outcomes in patients with reconstructed scaphoid by non-vascularized bone graft. Methods: Seventeen male patients with the mean age of 31.7±3.7 years and mean non-union time of 31.5±14.7 months we...

  20. Impact of sirolimus-eluting stent fractures without early cardiac events on long-term clinical outcomes: A multislice computed tomography study

    Energy Technology Data Exchange (ETDEWEB)

    Ito, Tsuyoshi [Toyohashi Heart Center, Oyama-cho, Toyohashi (Japan); Nagoya City University Graduate School of Medical Sciences, Department of Cardio-Renal Medicine and Hypertension, Nagoya (Japan); Kimura, Masashi; Ehara, Mariko; Terashima, Mitsuyasu; Nasu, Kenya; Kinoshita, Yoshihisa; Habara, Maoto; Tsuchikane, Etsuo; Suzuki, Takahiko [Toyohashi Heart Center, Oyama-cho, Toyohashi (Japan)

    2014-05-15

    This study sought to evaluate the impact of sirolimus-eluting stent (SES) fractures on long-term clinical outcomes using multislice computed tomography (MSCT). In this study, 528 patients undergoing 6- to 18-month follow-up 64-slice MSCT after SES implantation without early clinical events were followed clinically (the median follow-up interval was 4.6 years). A CT-detected stent fracture was defined as a complete gap with Hounsfield units (HU) <300 at the site of separation. The major adverse cardiac events (MACEs), including cardiac death, stent thrombosis, and target lesion revascularisation, were compared according to the presence of stent fracture. Stent fractures were observed in 39 patients (7.4 %). MACEs were more common in patients with CT-detected stent fractures than in those without (46 % vs. 7 %, p < 0.01). Univariate Cox regression analysis indicated a significant relationship between MACE and stent fracture [hazard ratio (HR) 7.65; p < 0.01], age (HR 1.03; p = 0.04), stent length (HR 1.03; p < 0.01), diabetes mellitus (HR 1.77; p = 0.04), and chronic total occlusion (HR 2.54; p = 0.01). In the multivariate model, stent fracture (HR 5.36; p < 0.01) and age (HR 1.03; p = 0.04) remained significant predictors of MACE. An SES fracture detected by MSCT without early clinical events was associated with long-term clinical adverse events. (orig.)

  1. Implementation of a clinical pathway may improve alcohol treatment outcome

    DEFF Research Database (Denmark)

    Nielsen, Anette Søgaard; Nielsen, Bent

    drinking no more than 21 standard drinks per week). Patients with harmful alcohol use or dependence as their primary problem who were seeking psychosocial treatment at one of four alcohol clinics in Denmark participated in the study. After implementation of the clinical pathway system, which incorporated a...... structured intake, a referral and independent follow-up system, checklists, audit, and feedback, there was no change in length of stay, but significantly more patients had a good clinical outcome (stopped or moderated their consumption) at the end of treatment (OR = 1.9; 1.2–3.1). The study documents the...... feasibility of using a clinical pathway framework, incorporating a local monitoring system, checklists, audit, and feedback to enhance treatment quality and improve outcomes for alcohol use disorders...

  2. Clinical characteristics and favorable long-term outcomes for patients with idiopathic inflammatory myopathies: a retrospective single center study in China

    Directory of Open Access Journals (Sweden)

    Shu Xiao

    2011-11-01

    Full Text Available Abstract Background Little is known about the clinical features and true survival risk factors in Chinese Han population. We conducted the current study to investigate the clinical features, long-term outcome and true potential indicators associated with mortality of idiopathic inflammatory myopathies (IIM in China. Methods We restrospectvely investigated 188 patients diagnosed with IIM at our hospital from January 1986 to April 2009. The primary outcome was determined with mortality. The secondary outcomes for survival patients were organ damage and disease activity, health status, and disability, which were assessed with Myositis Damage Index, Myositis Disease Activity Assessment Visual Analogue Scales, Health Assessment Questionnaire Disability Index, and the Modified Rankin Scale, respectively. Potential prognostic factors for mortality were analyzed with the multivariate Cox regression model. Results Mean age at disease onset was 43.8 ± 15.8 years and male to female ratio was 1:2.1 in this cohort. The 1-, 5-, 10-, 15- and 20-year survival rates were 93.6%, 88.7%, 81%, 73.6% and 65.6%. The independent predicators for mortality were age at disease onset [hazard ratio (HR:1.05, 95% CI 1.02 - 1.08], presence of cancer (HR:3.68, 95%CI 1.39 - 9.74, and elevated IgA level at diagnosis (HR:2.80, 95% CI 1.16-6.74. At the end of the follow-up, 29 patients manifested drug withdrawal within an average 4.1 years (range 0.5-15.2 year, most patients (85.9% had no disease activity and 130 patients (83.4% had no disability. Conclusions The long-term outcomes of IIM patients in our cohort have improved dramatically. Those patients most likely to survive had a high chance of reaching stable disease status, and obtained long-term or possibly permanent remission to a large extent.

  3. A CLINICAL STUDY OF EFFECTS OF POLY AND OLIGOHY DROMNIOS ON OBSTETRIC OUTCOME WITH A SP E C I AL REF ERENCE TO PERINATAL MORTALITY AND MORBI D ITY

    OpenAIRE

    Sunanda Bai

    2015-01-01

    OBJECTIVES: To study the obstetric outcome in pregnancies with oligohydramnios and polyhydramnios. To determine the perinatal outcome in pregnancies complicated with oligohydramnios and polyhydramnios. METHODS: This study is conducted on pregnant woman with abnormal liquor volume who attended the antenatal clinic at Institute of obstetrics and gynecology , Bowring and Lady curzon Hospital attached to BMCRI Bengaluru Ja...

  4. Clinical Outcome Metrics for Optimization of Robust Training

    Science.gov (United States)

    Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M.; Reyes, D.; Young, M.

    2016-01-01

    Introduction: The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capability's (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-Flight Medical Capabilities." Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes. Methods: Medical simulations will systematically compare success of individual diagnostic and therapeutic procedure simulations performed by physician and non-physician crew medical officer (CMO) analogs using clearly defined short-term (individual procedure) outcome metrics. In the subsequent step of the project, the procedure simulation outcomes will be used as input to a modified version of the NASA Integrated Medical Model (IMM) to analyze the effect of the outcome (degree of success) of individual procedures (including successful, imperfectly performed, and failed procedures) on overall long-term clinical outcomes and the consequent mission impacts. The procedures to be simulated are endotracheal intubation, fundoscopic examination, kidney/urinary ultrasound, ultrasound-guided intravenous catheter insertion, and a differential diagnosis exercise. Multiple assessment techniques will be used, centered on medical procedure simulation studies occurring at 3, 6, and 12 months after initial training (as depicted in the following flow diagram of the experiment design). Discussion: Analysis of procedure outcomes in the physician and non-physician groups and their subsets (tested at different elapsed times post training) will allow the team to 1) define differences between physician and non-physician CMOs in terms of both procedure performance

  5. 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.

  6. Clinical Outcomes of Primary Palatal Surgery in Children with Nonsyndromic Cleft Palate with and without Lip

    OpenAIRE

    Seunghee Ha; Kyung S. Koh; Heewon Moon; Seungeun Jung; Tae Suk Oh

    2015-01-01

    This study presents clinical outcomes of primary cleft palate surgery, including rate of oronasal fistula development, rate of velopharyngeal insufficiency (VPI) requiring secondary surgery, and speech outcomes. We examined the effect of cleft type on the clinical outcomes. Retrospective analysis was performed using clinical records of all patients who received a primary palatoplasty at the Cleft Palate Clinic at Seoul Asan Medical Center, South Korea, between 2007 and 2012. The study include...

  7. Diffusion tensor imaging during recovery from severe traumatic brain injury and relation to clinical outcome: A longitudinal study

    DEFF Research Database (Denmark)

    Sidaros, A.; Engberg, A.W.; Sidaros, K.;

    2008-01-01

    the cerebral peduncle and in corpus callosum, λ∥ and λ⊥ both increased during the scan interval and, particularly in patients with unfavourable outcome, fractional anisotropy remained depressed. No significant DTI parameter changes over time were found in controls, or in CSF of patients. These...

  8. Influence of HIV infection on the clinical presentation and outcome of adults with acute community-acquired pneumonia in Yaounde, Cameroon: a retrospective hospital-based study

    Directory of Open Access Journals (Sweden)

    Yone Eric Walter

    2012-08-01

    Full Text Available Abstract Background The impact of HIV infection on the evolution of acute community-acquired pneumonia (CAP is still controversial. The aim of this study was to investigate possible differences in the clinical presentation and in-hospital outcomes of patients with CAP with and without HIV infection in a specialised service in Yaounde. Methods Medical files of 106 patients (51 men aged 15 years and above, admitted to the Pneumology service of the Yaounde Jamot Hospital between January 2008 and May 2012, were retrospectively studied. Results Sixty-two (58.5% patients were HIV infected. The median age of all patients was 40 years (interquartile range: 31.75-53 and there was no difference in the clinical and radiological profile of patients with and without HIV infection. The median leukocyte count (interquartile range was 14,600/mm3 (10,900-20,600 and 10,450/mm3 (6,400-16,850 respectively in HIV negative and HIV positive patients (p = 0.002. Median haemoglobin level (interquartile range was 10.8 g/dl (8.9-12 in HIV negative and 9.7 g/dl (8–11.6 in HIV positive patients (p = 0.025. In-hospital treatment failure on third day (39.5% vs. 25.5.1%, p = 0.137 and mortality rates (9% vs. 14.5%, p = 0.401 were similar between HIV negative and HIV positive patients. Conclusion Clinical and radiological features as well as response to treatment and in hospital fatal outcomes are similar in adult patients hospitalised with acute community-acquired pneumonia in Yaounde. In contrast, HIV infected patients tend to be more anaemic and have lower white cell counts than HIV negative patients. Larger prospective studies are needed to consolidate these findings.

  9. Comparative changes in treatment practices and clinical outcomes following implementation of a prospective payment system: the STEPPS study

    OpenAIRE

    Monda, Keri L.; Joseph, Parveen Nedra; Peter J. Neumann; Bradbury, Brian D.; Rubin, Robert J.

    2015-01-01

    Background The aim of the US dialysis Prospective Payment System bundle, launched in January 2011, was reduction and more accurate prediction of costs of services, whilst maintaining or improving patient care. Dialysis facilities could either adopt the bundle completely (100%) in the first year of launch, or phase-in (25%) over four years. Differences in practice patterns and patient outcomes were hypothesized to occur in facilities that phased-in 25% compared to those that did not. Methods D...

  10. The effect of osteoporotic treatment on the functional outcome, re-fracture rate, quality of life and mortality in patients with hip fractures: a prospective functional and clinical outcome study on 520 patients.

    Science.gov (United States)

    Makridis, Konstantinos G; Karachalios, Theofilos; Kontogeorgakos, Vasilios A; Badras, Leonidas S; Malizos, Konstantinos N

    2015-02-01

    Numerous high quality studies have shown the positive effects of various osteoporotic medical treatment regimens on bone mass and on the reduction of risk for new spinal, hip and non-spinal fractures in osteoporotic patients. However, the effect of osteoporotic treatment on the functional and clinical outcome of patients who have sustained hip fractures and been treated surgically has not yet been addressed. Five hundred and twenty patients out of 611 who were admitted (2009-2011), operated on due to a hip fracture and completed their follow-up evaluations were included in this study. Data related to functional outcome scores, re-fracture rate, quality of life and mortality rate were prospectively recorded, analysed and correlated to osteoporotic medical treatment. There were 151 (25%) men and 369 (71%) women with a mean age of 80.7 years (range, 60 to 90 years). At a mean follow-up of 27.5 months (range, 24 to 36 months) a mortality rate of 23.6% at 2 years was recorded. Mean values of functional and quality of life scores were found to have progressively improved within two years after surgery. Seventy-eight (15%) patients were taking osteoporotic treatment before their hip fracture and 89 (17.1%) started afterwards. Osteoporotic treatment proved to be an important predictor of functional recovery (all p valuesquality of life (EQ-5D, all dimensions, p values<0.05). Osteoporotic treatment did not affect post-fracture mortality rates. Osteoporotic treatment taken before or initiated after fracture is a strong predictor of functional and clinical outcome in patients with hip fractures treated surgically. PMID:25541417

  11. Comparison of toxin removal outcomes in online hemodiafiltration and intra-dialytic exercise in high-flux hemodialysis: A prospective randomized open-label clinical study protocol

    Directory of Open Access Journals (Sweden)

    Maheshwari Vaibhav

    2012-11-01

    Full Text Available Abstract Background Maintenance hemodialysis (HD patients universally suffer from excess toxin load. Hemodiafiltration (HDF has shown its potential in better removal of small as well as large sized toxins, but its efficacy is restricted by inter-compartmental clearance. Intra-dialytic exercise on the other hand is also found to be effective for removal of toxins; the augmented removal is apparently obtained by better perfusion of skeletal muscles and decreased inter-compartmental resistance. The aim of this trial is to compare the toxin removal outcome associated with intra-dialytic exercise in HD and with post-dilution HDF. Methods/design The main hypothesis of this study is that intra-dialytic exercise enhances toxin removal by decreasing the inter-compartmental resistance, a major impediment for toxin removal. To compare the HDF and HD with exercise, the toxin rebound for urea, creatinine, phosphate, and β2-microglobulin will be calculated after 2 hours of dialysis. Spent dialysate will also be collected to calculate the removed toxin mass. To quantify the decrease in inter-compartmental resistance, the recently developed regional blood flow model will be employed. The study will be single center, randomized, self-control, open-label prospective clinical research where 15 study subjects will undergo three dialysis protocols (a high flux HD, (b post-dilution HDF, (c high flux HD with exercise. Multiple blood samples during each study session will be collected to estimate the unknown model parameters. Discussion This will be the first study to investigate the exercise induced physiological change(s responsible for enhanced toxin removal, and compare the toxin removal outcome both for small and middle sized toxins in HD with exercise and HDF. Successful completion of this clinical research will give important insights into exercise effect on factors responsible for enhanced toxin removal. The knowledge will give confidence for implementing

  12. An analysis of the demographic profile, clinical manifestations, investigations and outcome of paediatric myelodysplastic syndrome: A single centre, cross-sectional study

    Directory of Open Access Journals (Sweden)

    Appaji Lingegowda

    2015-09-01

    Full Text Available Purpose: Pediatric myelodysplastic syndrome (MDS is a relatively rare entity, with distinct clinical features and more aggressive course than its adult counterpart. The aim of this study was to analyze the incidence of pediatric myelodysplastic syndrome at a tertiary cancer care center in southern India along with clinical manifestations, investigations and outcome.Methods: On retrospective analysis of 1094 cases of pediatric hematological malignancies over a five-year period from September 2009 to August 2014, a total of seven cases of pediatric myelodysplastic syndrome were identified. Presenting complaints, physical examination, investigations including haemogram, biochemistry, bone marrow examination and cytogenetics were reviewed. The diagnosis of MDS was made if there was dysplasia in at least 10% of cells in two or more cell lineages. All patients were risk stratified using the revised IPSS. Results: Out of 1094 cases of pediatric hematological malignancies presenting at our institute within the study period, there were only seven cases of pediatric MDS with an incidence of 0.65%. There were no genetic predispositions nor any cases of therapy related MDS. The most common presentation was with fever and all patients had significant splenomegaly. All patients had anemia (Median-6.2 gm / dL with elevated WBC counts (Median-30,900 / uL and thrombocytopenia (Median-50,000 / uL. The marrow cytogenetics was normal in five patients. Most patients fell into the high and very high-risk category of the revised IPSS, with only two patients of low risk. All seven patients were given only supportive care but one progressed to AML for which he was treated with remission induction. Only two patients were alive at the time of analysis and median survival was 9 months. Conclusion: Pediatric MDS is a rare disease with a short clinical history, aggressive course and generally poor outcomes as compared to the adult variant. A hematopoietic stem cell

  13. Clinical Features and Outcome of Mucormycosis

    Directory of Open Access Journals (Sweden)

    Carlos Rodrigo Camara-Lemarroy

    2014-01-01

    Full Text Available Mucormycosis (MCM is a life-threatening infection that carries high mortality rates despite recent advances in its diagnosis and treatment. The objective was to report 14 cases of mucormycosis infection and review the relevant literature. We retrospectively analyzed the demographic and clinical data of 14 consecutive patients that presented with MCM in a tertiary-care teaching hospital in northern Mexico. The mean age of the patients was 39.9 (range 5–65. Nine of the patients were male. Ten patients had diabetes mellitus as the underlying disease, and 6 patients had a hematological malignancy (acute leukemia. Of the diabetic patients, 3 had chronic renal failure and 4 presented with diabetic ketoacidosis. All patients had rhinocerebral involvement. In-hospital mortality was 50%. All patients received medical therapy with polyene antifungals and 11 patients underwent surgical therapy. Survivors were significantly younger and less likely to have diabetes than nonsurvivors, and had higher levels of serum albumin on admission. The clinical outcome of patients with MCM is poor. Uncontrolled diabetes and age are negative prognostic factors.

  14. The National Anesthesia Clinical Outcomes Registry.

    Science.gov (United States)

    Liau, Adrian; Havidich, Jeana E; Onega, Tracy; Dutton, Richard P

    2015-12-01

    The Anesthesia Quality Institute (AQI) was chartered in 2008 by the American Society of Anesthesiologists to develop the National Anesthesia Clinical Outcomes Registry (NACOR). In this Technical Communication, we will describe how data enter NACOR, how they are authenticated, and how they are analyzed and reported. NACOR accepts case-level administrative, clinical, and quality capture data from voluntarily participating anesthesia practices and health care facilities in the United States. All data are transmitted to the AQI in summary electronic files generated by billing, quality capture, and electronic health care record software, typically on a monthly basis. All data elements are mapped to fields in the NACOR schema in accordance with a publicly available data dictionary. Incoming data are loaded into NACOR by AQI technologists and are subject to both manual and automated review to identify systematically missing elements, miscoding, and inadvertent corruption. Data are deidentified in compliance with Health Insurance Portability and Accountability Act regulations. The database server of AQI, which houses the NACOR database, is protected by 2 firewalls within the American Society of Anesthesiologists' network infrastructure; this system has not been breached. The NACOR Participant User File, a deidentified case-level dataset of information from NACOR, is available to researchers at participating institutions. NACOR architecture and the nature of the Participant User File include both strengths and weaknesses. PMID:26579661

  15. No red cell alloimmunization or change of clinical outcome after using fresh frozen cancellous allograft bone for acetabular reconstruction in revision hip arthroplasty: a follow up study

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    Mittag Falk

    2012-09-01

    Full Text Available Abstract Background Possible immunization to blood group or other antigens and subsequent inhibition of remodeling or incorporation after use of untreated human bone allograft was described previously. This study presents the immunological, clinical and radiological results of 30 patients with acetabular revisions using fresh frozen non-irradiated bone allograft. Methods AB0-incompatible (donor-recipient bone transplantation was performed in 22 cases, Rh(D incompatible transplantation in 6 cases. The mean follow up of 23 months included measuring Harris hip score and radiological examination with evaluation of remodeling of the bone graft, implant migration and heterotopic ossification. In addition, all patients were screened for alloimmunization to Rh blood group antigens. Results Compared to the whole study group, there were no differences in clinical or radiological measurements for the groups with AB0- or Rh(D-incompatible bone transplantation. The mean Harris Hip Score was 80.6. X-rays confirmed total remodeling of all allografts with no acetabular loosening. At follow up, blood tests revealed no alloimmunization to Rh blood group donor antigens. Conclusions The use of fresh frozen non-irradiated bone allograft in acetabular revision is a reliable supplement to reconstruction. The risk of alloimmunization to donor-blood group antigens after AB0- or Rh-incompatible allograft transplantation with a negative long-term influence on bone-remodeling or the clinical outcome is negligible.

  16. Is Real-Time Feedback of Burn-Specific Patient-Reported Outcome Measures in Clinical Settings Practical and Useful? A Pilot Study Implementing the Young Adult Burn Outcome Questionnaire.

    Science.gov (United States)

    Ryan, Colleen M; Lee, Austin F; Kazis, Lewis E; Shapiro, Gabriel D; Schneider, Jeffrey C; Goverman, Jeremy; Fagan, Shawn P; Wang, Chao; Kim, Julia; Sheridan, Robert L; Tompkins, Ronald G

    2016-01-01

    Long-term follow-up care of survivors after burn injuries can potentially be improved by the application of patient-reported outcome measures (PROMs). PROMs can inform clinical decision-making and foster communication between the patient and provider. There are no previous reports using real-time, burn-specific PROMs in clinical practice to track and benchmark burn recovery over time. This study examines the feasibility of a computerized, burn-specific PROM, the Young Adult Burn Outcome Questionnaire (YABOQ), with real-time benchmarking feedback in a burn outpatient practice. The YABOQ was redesigned for formatting and presentation purposes using images and transcribed to a computerized format. The redesigned questionnaire was administered to young adult burn survivors (ages 19-30 years, 1-24 months from injury) via an ipad platform in the office before outpatient visits. A report including recovery curves benchmarked to a nonburned relatively healthy age-matched population and to patients with similar injuries was produced for the domains of physical function and social function limited by appearance. A copy of the domain reports as well as a complete copy of the patient's responses to all domain questions was provided for use during the clinical visit. Patients and clinicians completed satisfaction surveys at the conclusion of the visit. Free-text responses, included in the satisfaction surveys, were treated as qualitative data adding contextual information about the assessment of feasibility. Eleven patients and their providers completed the study for 12 clinical visits. All patients found the ipad survey and report "easy" or "very easy" to use. In nine instances, patients "agreed" or "strongly agreed" that it helped them communicate their situation to their doctor/nurse practitioner. Patients "agreed" or "strongly agreed" that the report helped them understand their course of recovery in 10 visits. In 11 visits, the patients "agreed" or "strongly agreed" that

  17. Two-year clinical outcomes after coronary drug-eluting stent placement in Chinese men and women: a multicenter, prospective registry study

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    Shrestha R

    2013-07-01

    Full Text Available Rajiv Shrestha,1 Sandeep Gami,1 Jing Xu,2 Du-Jiang Xie,2 Zhi-Zhong Liu,2 Tian Xu,1 Fei Ye,2 Shi-Qing Din,3 Xue-Song Qian,4 Song Yang,5 Yue-Qiang Liu,6 Feng Li,7 Ai-Ping Zhang,8 Shao-Liang Chen2 1Nanjing Medical University, Nanjing, 2Nanjing First Hospital, Nanjing Medical University, Nanjing, 3Huainan Xinhua Hospital, Huainan, 4Zhangjiagang People's Hospital, Zhangjiagang, 5Yixin People's Hospital, Yixin, 6Jintan People's Hospital, Jintan, 7Huainan Oriental General Hospital, Huainan, 8Huainan People's Hospital, Huainan, People's Republic of China Background: Previous studies have reported a discrepancy in baseline characteristics and outcomes after percutaneous coronary intervention between men and women. However, this finding has never been verified in the Chinese population. The present study analyzed two-year clinical outcomes after placement of coronary drug-eluting stents in Chinese men and women. Methods: From January 2005 to December 2010, a total of 3804 Chinese patients (2776 men, 1028 women who underwent drug-eluting stent implantation were studied prospectively. The primary endpoint was the composite major adverse cardiac event (MACE rate, including myocardial infarction, cardiac death, and target vessel revascularization at two years. Stent thrombosis served as the safety endpoint. Propensity score matching was used to compare the adjusted MACE rate between the two groups. Results: At two-year follow-up, unadjusted rates of myocardial infarction, non-ST segment elevation myocardial infarction, target vessel revascularization, and MACE were significantly different between men (6.84%, 4.6%, 13.1%, and 21.7%, respectively and women (3.8% [P = 0.001], 2.0% [P < 0.001] 10.3% [P = 0.025], and 16.3% [P < 0.001], respectively. After propensity score matching, there were no significant differences in composite MACE and individual endpoints at two years between the genders. Conclusion: Despite all the unfavorable risk factor clustering in

  18. Etiology of community-acquired pneumonia in a population-based study: Link between etiology and patients characteristics, process-of-care, clinical evolution and outcomes

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    Capelastegui Alberto

    2012-06-01

    Full Text Available Abstract Background The etiologic profile of community-acquired pneumonia (CAP for each age group could be similar among inpatients and outpatients. This fact brings up the link between etiology of CAP and its clinical evolution and outcome. Furthermore, the majority of pneumonia etiologic studies are based on hospitalized patients, whereas there have been no recent population-based studies encompassing both inpatients and outpatients. Methods To evaluate the etiology of CAP, and the relationship among the different pathogens of CAP to patients characteristics, process-of-care, clinical evolution and outcomes, a prospective population-based study was conducted in Spain from April 1, 2006, to June 30, 2007. Patients (age >18 with CAP were identified through the family physicians and the hospital area. Results A total of 700 patients with etiologic evaluation were included: 276 hospitalized and 424 ambulatory patients. We were able to define the aetiology of pneumonia in 55.7% (390/700. The most frequently isolated organism was S. pneumoniae (170/390, 43.6%, followed by C. burnetti (72/390, 18.5%, M. pneumoniae (62/390, 15.9%, virus as a group (56/390, 14.4%, Chlamydia species (39/390, 106%, and L. pneumophila (17/390, 4.4%. The atypical pathogens and the S. pneumoniae are present in pneumonias of a wide spectrum of severity and age. Patients infected by conventional bacteria were elderly, had a greater hospitalization rate, and higher mortality within 30 days. Conclusions Our study provides information about the etiology of CAP in the general population. The microbiology of CAP remains stable: infections by conventional bacteria result in higher severity, and the S. pneumoniae remains the most important pathogen. However, atypical pathogens could also infect patients in a wide spectrum of severity and age.

  19. Objective clinical performance outcome of total knee prostheses. A study of mobile bearing knees using fluoroscopy, electromyography and roentgenstereophotogrammetry

    OpenAIRE

    Garling, Eric Harald

    2008-01-01

    The aim of the thesis was to to assess with accurate and objective methods the function and fixation of total knee prostheses with special emphasis on mobile bearing total knee designs. The mobile bearing of a rotating platform design showed limited motion or no motion during a step-up task thereby nullifying the theoretical advantages of a mobile bearing prosthesis. Apatite coated implants show excellent mid-term Roentgen Stereophotogrammetric Analysis (RSA) results and offer some clinical a...

  20. A phase IIa randomized controlled pilot study evaluating the safety and clinical outcomes following the use of rhGDF-5/β-TCP in regenerative periodontal therapy.

    Science.gov (United States)

    Windisch, Péter; Stavropoulos, Andreas; Molnár, Bálint; Szendröi-Kiss, Dóra; Szilágyi, Emese; Rosta, Péter; Horváth, Attila; Capsius, Björn; Wikesjö, Ulf M E; Sculean, Anton

    2012-08-01

    To present the safety profile, the early healing phase and the clinical outcomes at 24 weeks following treatment of human intrabony defects with open flap debridement (OFD) alone or with OFD and rhGDF-5 adsorbed onto a particulate β-tricalcium phosphate (β-TCP) carrier. Twenty chronic periodontitis patients, each with at least one tooth exhibiting a probing depth ≥6 mm and an associated intrabony defect ≥4 mm entered the study. Ten subjects (one defect/patient) were randomized to receive OFD alone (control) and ten subjects OFD combined with rhGDF-5/β-TCP. Blood samples were collected at screening, and at weeks 2 and 24 to evaluate routine hematology and clinical chemistry, rhGDF-5 plasma levels, and antirhGDF-5 antibody formation. Plaque and gingival indices, bleeding on probing, probing depth, clinical attachment level, and radiographs were recorded pre- and 24 weeks postsurgery. Comparable safety profiles were found in the two treatment groups. Neither antirhGDF-5 antibody formation nor relevant rhGDF-5 plasma levels were detected in any patient. At 6 months, treatment with OFD + rhGDF-5/β-TCP resulted in higher but statistically not significant PD reduction (3.7 ± 1.2 vs. 3.1 ± 1.8 mm; p = 0.26) and CAL gain (3.2 ± 1.7 vs. 1.7 ± 2.2 mm; p = 0.14) compared to OFD alone. In the tested concentration, the use of rhGDF-5/β-TCP appeared to be safe and the material possesses a sound biological rationale. Thus, further adequately powered, randomized controlled clinical trials are warranted to confirm the clinical relevance of this new approach in regenerative periodontal therapy. rhGDF-5/β-TCP may represent a promising new techology in regenerative periodontal therapy. PMID:21887500

  1. Clinical characteristics and outcomes in biclonal gammopathies.

    Science.gov (United States)

    Mullikin, Trey C; Rajkumar, S Vincent; Dispenzieri, Angela; Buadi, Francis K; Lacy, Martha Q; Lin, Yi; Dingli, David; Go, Ronald S; Hayman, Suzanne R; Zeldenrust, Steven R; Russell, Stephen J; Lust, John A; Leung, Nelson; Kapoor, Prashant; Kyle, Robert A; Gertz, Morie A; Kumar, Shaji K

    2016-05-01

    A single monoclonal protein typically characterizes monoclonal gammopathies, but a small proportion may have more than one M protein identifiable. In the setting of symptomatic multiple myeloma (MM), the development of a new monoclonal protein following therapy is associated with better outcomes. As for the precursor conditions, monoclonal gammopathy undetermined significance (MGUS) and smoldering multiple myeloma (SMM), there is limited information on the impact of a second monoclonal protein on the disease course, including progression and response to treatment. The outcomes of patients with MGUS and SMM with more than one monoclonal protein, after identifying 539 patients with biclonal proteins on electrophoresis and/or immunofixation, were reported. About 22 of 393 patients with MGUS/biclonal gammopathy of undetermined significance (BGUS) progressed to SMM (6), MM (11), AL (3), or WM (2), and 5 of 16 patients with biclonal SMM progressed to MM. The rate of progression for BGUS was approximately 1% per year, which is similar to MGUS with one monoclonal protein. The median estimated time of progression of biclonal SMM was 2.6 years; similar to monoclonal SMM. For patients with biclonal MM, both M spikes responded to treatment and, upon relapse, the original dominant M protein remained dominant as the disease progressed. In conclusion, the presence of a second monoclonal protein does not appear to affect the progression of precursor states and suggests multiple monoclonal proteins do not clinically impact one another in the course of the disease. Am. J. Hematol. 91:473-475, 2016. © 2016 Wiley Periodicals, Inc. PMID:26840395

  2. Clinical outcomes and prognostic factors in patients with breast diffuse large B cell lymphoma; Consortium for Improving Survival of Lymphoma (CISL study

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    Lee Je-Jung

    2010-06-01

    Full Text Available Abstract Background The breast is a rare extranodal site of non-Hodgkin lymphoma, and primary breast lymphoma (PBL has been arbitrarily defined as disease localized to one or both breasts with or without regional lymph nodes involvement. The aim of this study was to evaluate the clinical outcomes in patients with diffuse large B cell lymphoma (DLBCL and breast involvement, and to find the criteria of PBL reflecting the outcome and prognosis. Methods We retrospectively analyzed data from 68 patients, newly diagnosed with DLBCL and breast involvement at 16 Korean institutions between January 1994 and June 2009. Results Median age at diagnosis was 48 years (range, 20-83 years. Forty-three (63.2% patients were PBL according to previous arbitrary criteria, sixteen (23.5% patients were high-intermediate to high risk of international prognostic index. The patients with one extranodal disease in the breast (OED with or without nodal disease were 49 (72.1%, and those with multiple extranodal disease (MED were 19 (27.9%. During median follow-up of 41.5 months (range, 2.4-186.0 months, estimated 5-year progression-free survival (PFS was 53.7 ± 7.6%, and overall survival (OS was 60.3 ± 7.2%. The 5-year PFS and OS was significantly higher for patients with the OED group than those with the MED group (5-year PFS, 64.9 ± 8.9% vs. 27.5 ± 11.4%, p = 0.001; 5-year OS, 74.3 ± 7.6% vs. 24.5 ± 13.0%, p Conclusions Our results show that the patients included in OED group, reflecting different treatment outcome, prognosis and pattern of progression, should be considered as PBL in the future trial. Further studies are warranted to validate our suggested criteria.

  3. Dietitians Meet the NHS Agenda for Improved Patient Care and Clinical Outcomes through Nutrition Support Study as a Module Masters Level - A Preliminary Report

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    Fiona McCullough

    2014-01-01

    Full Text Available "Aim: The aim of the project was to evaluate the impact of a Master's module in nutrition support to provide dietetic managers with evidence of changed practice from their staff including improved knowledge, confidence and change in practice including patient outcomes as part of a continuing education approach. Background: From 2008/09 the East Midlands Strategic Health Authority provided LBR (Learning beyond registration funding for a Masters module in Nutrition Support for graduate dietitians with 1-4 years experience working in its catchment area (known as band 5 and 6. The module comprised elements of pre-course work, taught and interactive peer working sets, a work place audit and a written case study. Method: Delegates from the first two modules were invited by means of an electronic questionnaire (covering a range of questions including about the content that had been learnt and the resulting effect on patient care to evaluate the course and to see whether it had had any effect on practice. Results: Feedback was very positive in that delegates felt more confident that they were working with a strong evidenced based knowledge which made them more pro-active in interpreting biochemistry and recommending appropriate interventions for complex cases. This, in addition to completion of a small audit project changed practice and improved patient care. Delegates self assessed themselves against nine clinical activities, two thirds of which were rated >7/10. Ratings for the lowest third were: nutrition diagnosis (4.2, objective setting (6.4, critically analysis of the working practice (6.7. Conclusion: The participants felt, based on personal reflection, that the module had changed clinical practice and equipped delegates to take on more specialist roles in the future. However, both the module and this evaluation highlighted shortfalls in relation to clinical objective setting and measuring outcomes. The aim of the present project was to evaluate

  4. Outcome Modeling Using Clinical DVH Data

    CERN Document Server

    Gordon, JJ

    2015-01-01

    Purpose: To quantify the ability of correlation and regression analysis to extract the normal lung dose-response function from dose volume histogram (DVH) data. Methods: A local injury model is adopted, in which radiation-induced damage (functional loss) G is the integral of the DVH with function R(D). RP risk is H(G) where H() is the sigmoid cumulative distribution of functional reserve. RP incidence is a Bernoulli function of risk. A homogeneous patient cohort is assumed, allowing non-dose-related factors to be ignored. Clinically realistic DVHs are combined with the injury model to simulate RP data. Results: Correlation analysis is often used to identify predictor variables that are correlated with outcome, for inclusion in a predictive model. In the local injury model, all DVH metrics VD contribute to damage. Correlation analysis therefore has limited value. The subset of VD significantly correlated with incidence varies randomly from trial to trial due to random variations in the DVH set, and does not ne...

  5. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

    OpenAIRE

    Eisenstein, Eric L.; Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2010-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators ...

  6. THORACOLUMBAR BURST FRACTURE: STRUCTURAL CHANGES AND CLINICAL OUTCOME OF TREATMENT

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    Rodrigo Arnold Tisot

    2016-03-01

    Full Text Available ABSTRACT Objective: To evaluate the correlation between structural changes in burst fractures of thoracic and lumbar spine with clinical outcome of the treatment. Methods: A retrospective study in 25 patients with fractures of thoracic and lumbar spine burst fractures without neurological deficit. Eleven patients underwent conservative treatment and for the remaining the treatment was surgical. All patients were followed up for at least 24 months. The cases were evaluated by a protocol that included: posttraumatic measurement of kyphosis, vertebral body collapse and narrowing of the spinal canal, the visual analog scale of pain, and the quality of life questionnaire SF-36 at the follow-up. For statistical analysis, the significance level was 5% and the software SPSS 18.0 was used. Results: No statistically significant difference was observed when comparing the clinical outcomes of one treatment over another. Similarly, there was no statistically significant correlation between kyphosis and post-traumatic narrowing of the spinal canal with clinical worsening in the follow-up, regardless of the treatment used. We found a positive correlation (p<0.05 between initial collapse and SF-36 domains in both groups (operated and non-operated. Conclusion: There was no significant superiority of one treatment over the other, and no correlation was found between kyphosis and spinal canal narrowing in burst fractures of the thoracic and lumbar spine without neurological deficit. However, there was correlation between initial collapse and clinical outcome in some domains of the SF-36 questionnaire.

  7. Scaphoid morphology and clinical outcomes in scaphoid reconstructions.

    Science.gov (United States)

    Megerle, K; Harenberg, P S; Germann, G; Hellmich, S

    2012-03-01

    Scaphoid malunion and carpal malalignment can result after scaphoid reconstruction, if the two fragments are not properly reduced before fixation. However, currently there is no information about which degree of deformity or malalignment can be tolerated without impairing clinical function. The purpose of this study was to investigate the influence of the scaphoid morphology and carpal alignment on clinical outcomes after scaphoid reconstruction. A total of 65 patients with an average age of 29 years were followed-up after a mean period of 45 months. In all patients, osseous union after a first-time scaphoid reconstruction in the middle third had been confirmed. Scapholunate (SL) and radiolunate (RL) angles were obtained on plain radiographs as were intrascaphoid (ISA) and dorsal cortical (DCA) angles and the height/length (H/L) ratio of the reconstructed scaphoid on computed tomography (CT) scans. These parameters were correlated with clinical outcome measures. RL angles correlated significantly with wrist range of motion, grip strength and pain levels, whilst SL angles, ISA, DCA and H/L ratio failed to show significant correlations. Our data suggest that clinical outcome is correlated with correct restoration of bone morphology and carpal alignment. After reconstruction, the RL angle should not exceed 10°. PMID:21903213

  8. Correlation of Reconstructed Scaphoid Morphology with Clinical Outcomes

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    Ahmadreza Afshar

    2015-09-01

    Full Text Available Background: Scaphoid malunion alters the carpal kinematics and impairs clinical outcome because of pain, weakness, restricted range of motion and predisposing the wrist joint to early osteoarthritis. The aim of this study was to evaluate the influence of the scaphoid morphological angles on clinical outcomes in patients with reconstructed scaphoid by non-vascularized bone graft. Methods: Seventeen male patients with the mean age of 31.7±3.7 years and mean non-union time of 31.5±14.7 months were enrolled in this retrospective study. Average follow up was 48.8±9.4 months. At the last follow-up, the patients were evaluated clinically for pain, wrist range of motion, grip strength, and wrist functional status. They were also evaluated radiologically by wrist radiographs and computerized tomography (CT. The overall clinical outcomes were evaluated by the Cooney wrist function score. The morphology of the reconstructed scaphoids was evaluated by the lateral intrascaphoid angle, antroposterior intrascaphoid angle, dorsal cortical angle, measuring the length (mm, and height-to-length ratio on CT scan. The radiological measurements were compared against the overall clinical outcomes. Results: There were 7 excellent, 7 good, 3 fair clinical results. The mean Cooney wrist function score was 83±4. The mean lateral intrascaphoid angle was 34.8±1.4 degrees, mean antroposterior intrascaphoid angle was 33.4±2.2 degrees, mean dorsal cortical angle was 158.3±4.8 degrees, mean scaphoid length was 22.1± 0.7 mm, and mean scaphoid height-to-length ratio was 0.74±0.04. There were no significant statistical correlations between the lateral intrascaphoid angles, antroposterior intrascaphoid angles, dorsal cortical angles, scaphoid lengths and scaphoid height-to-length ratios and Cooney wrist scores in the patients. Conclusion: In the current study, all the patients had some degree of scaphoid malunion; however, the radiological measurements of the reconstructed

  9. Radiologic Predictors for Clinical Stage IA Lung Adenocarcinoma with Ground Glass Components: A Multi-Center Study of Long-Term Outcomes.

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    Zhao Li

    Full Text Available This study was to define preoperative predictors from radiologic findings for the pathologic risk groups based on long-term surgical outcomes, in the aim to help guide individualized patient management.We retrospectively reviewed 321 consecutive patients with clinical stage IA lung adenocarcinoma with ground glass component on computed tomography (CT scanning. Pathologic diagnosis for resection specimens was based on the 2011 IASLC/ATS/ERS classification of lung adenocarcinoma. Patients were classified into different pathologic risk grading groups based on their lymph node status, local regional recurrence and overall survival. Radiologic characteristics of the pulmonary nodules were re-evaluated by reconstructed three-dimension CT (3D-CT. Univariate and multivariate analysis identifies independent radiologic predictors from tumor diameter, total volume (TV, average CT value (AVG, and solid-to-tumor (S/T ratio. Receiver operating characteristic curves (ROC studies were carried out to determine the cutoff value(s for the predictor(s. Univariate cox regression model was used to determine the clinical significance of the above findings.A total of 321 patients with clinical stage IA lung adenocarcinoma with ground glass components were included in our study. Patients were classified into two pathologic low- and high- risk groups based on their distinguished surgical outcomes. A total of 134 patients fell into the low-risk group. Univariate and multivariate analyses identified AVG (HR: 32.210, 95% CI: 3.020-79.689, P<0.001 and S/T ratio (HR: 12.212, 95% CI: 5.441-27.408, P<0.001 as independent predictors for pathologic risk grading. ROC curves studies suggested the optimal cut-off values for AVG and S/T ratio were-198 (area under the curve [AUC] 0.921, 2.9 (AUC 0.996 and 54% (AUC 0.907, respectively. The tumor diameter and TV were excluded for the low AUCs (0.778 and 0.767. Both the cutoff values of AVG and S/T ratio were correlated with pathologic

  10. A comparable study of clinical and optical outcomes after 1.8, 2.0 mm microcoaxial and 3.0 mm coaxial cataract surgery

    Science.gov (United States)

    Yu, Yi-Bo; Zhu, Ya-Nan; Wang, Wei; Zhang, Yi-Dong; Yu, Yin-Hui; Yao, Ke

    2016-01-01

    AIM To evaluate the clinical and optical outcomes after clear corneal incision cataract surgery (CICS) with three different incision sizes (1.8, 2.0 and 3.0 mm). METHODS Eyes of 150 patients with age-related cataract scheduled for coaxial cataract surgery were randomized to three groups: 1.8, 2.0, or 3.0 mm CICS. Intraoperative data and postoperative outcomes including surgically induced astigmatism (SIA), the corneal incision thickness, wavefront aberrations and modulation transfer function (MTF) of cornea were obtained. RESULTS There were no significant differences among the three groups in demographic characteristics and intraoperative outcome. The 1.8 and 2.0 mm microincisions showed more satisfactory clinical outcomes than the 3.0 mm incision. The 1.8 mm incision showed significantly less SIA than the 2.0 mm incision until postoperative 1mo (P0.05). CONCLUSION Converting from 3.0 mm CICS to 1.8 or 2.0 mm CICS result in better clinical and optical outcomes. However, when incision is 1.8 mm, the benefits from further reduction in size compared with 2.0 mm are limited. The necessity to reduce the incision size is to be deliberated. PMID:27158610

  11. Clinical Outcome after the Use of a New Craniocaudal Expandable Implant for Vertebral Compression Fracture Treatment: One Year Results from a Prospective Multicentric Study

    Science.gov (United States)

    Noriega, David; Krüger, Antonio; Ardura, Francisco; Hansen-Algenstaedt, Nils; Hassel, Frank; Barreau, Xavier; Beyerlein, Jörg

    2015-01-01

    The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period. PMID:25667929

  12. Clinical Outcome after the Use of a New Craniocaudal Expandable Implant for Vertebral Compression Fracture Treatment: One Year Results from a Prospective Multicentric Study

    Directory of Open Access Journals (Sweden)

    David Noriega

    2015-01-01

    Full Text Available The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

  13. Clinical outcome of narrow diameter implants inserted into allografts

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    Maurizio Franco

    2009-08-01

    Full Text Available OBJECTIVE: Narrow diameter implants (NDI (i.e. diameter <3.75 mm are a potential solution for specific clinical situations, such as reduced interradicular bone, thin alveolar crest and replacement of teeth with small cervical diameter. NDI have been available in clinical practice since the 1990s, but only few studies have analyzed their clinical outcome and no study have investigated NDI inserted in fresh-frozen bone (FFB grafts. Thus, a retrospective study on a series of NDI placed in homologue FFB was designed to evaluate their clinical outcome. MATERIAL AND METHODS: In the period between December 2003 and December 2006, 36 patients (22 females and 14 males, mean age 53 years with FFB grafts were selected and 94 different NDI were inserted. The mean follow-up was 25 months. To evaluate the effect of several host-, surgery-, and implant-related factors, marginal bone loss (MBL was considered an indicator of success rate (SCR. The Kaplan Meier algorithm and Cox regression were used. RESULTS: Only 5 out of 94 implants were lost (i.e. survival rate - SVR 95.7% and no differences were detected among the studied variables. On the contrary, the Cox regression showed that the graft site (i.e. maxilla reduced MBL. CONCLUSIONS: NDI inserted in FFB have a high SVR and SCR similar to those reported in previous studies on regular and NDI inserted in non-grafted jaws. Homologue FFB is a valuable material in the insertion of NDI.

  14. Clinical and radiographic outcomes with L4–S1 axial lumbar interbody fusion (AxiaLIF and posterior instrumentation: a multicenter study

    Directory of Open Access Journals (Sweden)

    Tobler WD

    2013-09-01

    Full Text Available William D Tobler,1 Miguel A Melgar,2 Thomas J Raley,3 Neel Anand,4 Larry E Miller,5 Richard J Nasca6 1Department of Neurosurgery, University of Cincinnati College of Medicine, Mayfield Clinic, and The Christ Hospital, Cincinnati, OH, USA; 2Department of Neurosurgery, Tulane University, New Orleans, LA, USA; 3Advanced Spine and Pain, Arlington, VA, USA; 4Spine Trauma, Minimally Invasive Spine Surgery Spine Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA; 5Miller Scientific Consulting, Inc, Arden, NC, USA; 6Orthopaedic and Spine Surgery, Wilmington, NC, USA Introduction: Previous studies have confirmed the benefits and limitations of the presacral retroperitoneal approach for L5–S1 interbody fusion. The purpose of this study was to determine the safety and effectiveness of the minimally invasive axial lumbar interbody approach (AxiaLIF for L4–S1 fusion. Methods: In this retrospective series, 52 patients from four clinical sites underwent L4–S1 interbody fusion with the AxiaLIF two-level system with minimum 2-year clinical and radiographic follow-up (range: 24–51 months. Outcomes included back pain severity (on a 10-point scale, the Oswestry Disability Index (ODI, and Odom's criteria. Flexion and extension radiographs, as well as computed tomography scans, were evaluated to determine fusion status. Longitudinal outcomes were assessed with repeated measures analysis of variance. Results: Mean subject age was 52 ± 11 years and the male:female ratio was 1:1. Patients sustained no intraoperative bowel or vascular injury, deep infection, or neurologic complication. Median procedural blood loss was 220 cc and median length of hospital stay was 3 days. At 2-year follow-up, mean back pain had improved 56%, from 7.7 ± 1.6 at baseline to 3.4 ± 2.7 (P < 0.001. Back pain clinical success (ie, ≥30% improvement from baseline was achieved in 39 (75% patients at 2 years. Mean ODI scores improved 42%, from 60% ± 16% at baseline to 35% ± 27

  15. The clinical outcome of scaphoid fracture malunion at 1 year.

    Science.gov (United States)

    Forward, D P; Singh, H P; Dawson, S; Davis, T R C

    2009-02-01

    The aim of this study was to assess the effect of malunion of scaphoid fractures on the clinical outcome at 1 year. Forty-two consecutive patients with united scaphoid waist fractures which had been treated non-operatively underwent longitudinal CT scans to confirm union and assess malunion at 12 to 18 weeks after injury. A blind clinical assessment was made and the Patient Evaluation Measure (PEM) and DASH questionnaires were completed by all the patients 1 year after injury. The group consisted of 38 men and four women with a mean age of 31 years at the time of injury. Correlation analysis revealed no significant relationships between any of the outcome measures (range of motion, grip strength and PEM and DASH scores) and any of the three measures of malunion (height-to-length ratio, the dorsal cortical angle and the lateral intra-scaphoid angle). PMID:19129358

  16. Community-based participatory research to improve life quality and clinical outcomes of patients with breast cancer (DianaWeb in Umbria pilot study)

    Science.gov (United States)

    Villarini, Milena; Lanari, Chiara; Nucci, Daniele; Gianfredi, Vincenza; Marzulli, Tiziana; Berrino, Franco; Borgo, Alessandra; Bruno, Eleonora; Gargano, Giuliana; Moretti, Massimo; Villarini, Anna

    2016-01-01

    Introduction Breast cancer (BC) is the most frequent cancer in Europe and the International Agency for Research on Cancer (IARC) has estimated over 460 000 incident cases per year. Survival among patients with BC has increased in the past decades and EUROCARE-5 has estimated a 5-year relative survival rate of 82% for patients diagnosed in 2000–2007. There is growing evidence that lifestyle (such as a diet based on Mediterranean principles associated with moderate physical activity) may influence prognosis of BC; however, this information is not currently available to patients and is not considered in oncology protocols. Only a few epidemiological studies have investigated the role of diet in BC recurrence and metastasis. Methods and analysis DianaWeb is a community-based participatory research dedicated to patients with BC and represents a collaborative effort between participants and research institutions to determine if specified changes in lifestyle would result in improved outcomes in terms of quality of life or survival. The aim of the study is to recruit a large number of participants, to monitor their lifestyle and health status over time, to provide them tips to encourage sustainable lifestyle changes, to analyse clinical outcomes as a function of baseline risk factors and subsequent changes, and to share with patients methodologies and results. DianaWeb uses a specific interactive website (http://www.dianaweb.org/) and, with very few exceptions, all communications will be made through the web. In this paper we describe the pilot study, namely DianaWeb in Umbria. Ethics and dissemination DianaWeb does not interfere with prescribed oncological treatments; rather, it recommends that participants should follow the received prescriptions. The results will be used to plan guidelines for nutrition and physical activity for patients with BC. The pilot study was approved by the ethics committee of the University of Perugia (reference number 2015-002), and is

  17. Hepatocellular Carcinoma in the Pediatric Population: A Population Based Clinical Outcomes Study Involving 257 Patients from the Surveillance, Epidemiology, and End Result (SEER Database (1973–2011

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    Christine S. M. Lau

    2015-01-01

    Full Text Available Introduction. Hepatocellular carcinoma (HCC is a rare pediatric cancer accounting for 0.5% of all pediatric malignancies. This study examines a large cohort of HCC patients in an effort to define the factors impacting clinical outcomes in pediatric HCC patients compared to adults. Methods. Demographic and clinical data on 63,771 HCC patients (257 pediatric patients ≤ 19 and 63,514 adult patients age ≥ 20 were abstracted from the SEER database (1973–2011. Results. HCC was more common among males (59.5% pediatric and 75.1% adults and Caucasians (50.4% and 50.5%, p 4 cm in size (79.6% versus 62.0%, p=0.02. Pediatric HCC patients undergoing surgery (13.107 versus 8.324 years, p4 cm in Caucasian males. Children with HCC achieve significantly longer mean overall survival compared to adults with HCC, primarily attributable to the more favorable fibrolamellar histologic variant, and more aggressive surgical intervention, which significantly improves survival.

  18. Childhood Pars Planitis; Clinical Features and Outcomes

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    Homayoon Nikkhah

    2011-01-01

    Full Text Available Purpose: To evaluate the demographic and clinical features of childhood pars planitis, and to determine the therapeutic and visual outcomes of the disease. Methods: Medical records of pediatric patients (less than 16 years of age at diagnosis with pars planitis and at least 6 months of follow-up who were referred to Labbafinejad Medical Center, Tehran, Iran over a 22 year period were reviewed. Results: Overall, 117 eyes of 61 patients including 51 (83.6% male subjects were included. Mean age at the time of diagnosis was 7.8΁3.2 (range, 3-16 years. Mean best corrected visual acuity (BCVA was 0.88΁0.76 logMAR at presentation which improved to 0.39΁0.51 logMAR at final visit (P<0.001. Endotheliitis was present in 23 (19.6% eyes and was significantly more prevalent in subjects younger than 9 years (P=0.025. Cataract formation (41.9% and cystoid macular edema (19.7% were the most prevalent complications. Univariate regression analysis showed that better baseline visual acuity (OR=0.38, 95%CI 0.21-0.70, P=0.002, age older than 5 years at disease onset (OR=0.36, 95%CI 0.14-0.9, P=0.029, absence of endotheliitis (OR=0.39, 95%CI 0.15-0.99, P=0.047 and female gender (OR=3.77, 95%CI 1.03-13.93, P=0.046 were significantly associated with final BCVA of 20/40 or better. Conclusion: Childhood pars planitis was much more common among male subjects. Endotheliitis may be a sign of inflammation spillover and is more prevalent in younger patients. Visual prognosis is favorable in most patients with appropriate treatment.

  19. Polymorphisms in XPD gene could predict clinical outcome of platinum-based chemotherapy for non-small cell lung cancer patients: a meta-analysis of 24 studies.

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    Qin Qin

    Full Text Available OBJECTIVE: Xeroderma pigmentosum group D (XPD is an essential gene involved in the nucleotide excision repair (NER pathway. Two commonly studied single nucleotide polymorphisms (SNPs of XPD (Lys751Gln, A>C, rs13181; Asp312Asn, G>A, rs1799793 are implicated in the modulation of DNA repair capacity, thus related to the responses to platinum-based chemotherapy. Here we performed a meta-analysis to better evaluate the association between the two XPD SNPs and clinical outcome of platinum-based chemotherapy in non-small cell lung cancer (NSCLC patients. METHODS: A comprehensive search of PubMed database was conducted to identify relevant articles. Primary outcomes included objective response (i.e., complete response + partial response vs. stable disease + progressive disease, progression-free survival (PFS and overall survival (OS. The pooled and 95% confidence intervals (CIs of ORs (odds ratios and HRs (hazard ratios were estimated using the fixed or random effect model. RESULTS: Twenty-four studies were eligible according to the inclusion criteria. None of the XPD Lys751Gln/Asp312Asn polymorphisms was associated with objective response, PFS or OS in NSCLC patients treated with platinum drugs. However, in stratified analysis by ethnicity, the XPD Lys751Gln (A>C polymorphism was not significantly associated with increased response in Caucasians (OR=1.35, 95%CI=1.0-1.83, P=0.122 for heterogeneity but was associated with decreased PFS in Asians (HR=1.39, 95%CI=1.07-1.81, P=0.879 for heterogeneity. Furthermore, a statistically significant difference existed in the estimates of effect between the two ethnicities (P=0.014 for TR; PC may have inverse predictive and prognostic role in platinum-based treatment of NSCLC according to different ethnicities. Further studies are needed to validate our findings.

  20. Epidemiology and clinical outcome of virus-positive respiratory samples in ventilated patients: a prospective cohort study.

    OpenAIRE

    Daubin, Cédric; Parienti, Jean-Jacques; Vincent, Sophie; Vabret, Astrid; du Cheyron, Damien; Ramakers, Michel; Freymuth, François; Charbonneau, Pierre

    2006-01-01

    INTRODUCTION: Respiratory viruses are a major cause of respiratory tract infections. The prevalence of a virus-positive respiratory sample and its significance in patients requiring mechanical ventilation remain unknown. METHODS: We conducted a cohort study in all consecutive adults ventilated for more than 48 hours admitted to a 22-bed medical intensive care unit during a 12-month period. Respiratory samples at the time of intubation were assessed by culture, by indirect immunofluorescence a...

  1. Menopause Analytical Hormonal Correlate Outcome Study (MAHCOS) and the Association to Brain Electrophysiology (P300) in a Clinical Setting

    OpenAIRE

    Eric R. Braverman; David Han; Marlene Oscar-Berman; Tatiana Karikh; Courtney Truesdell; Kristina Dushaj; Florian Kreuk; Mona Li; Danielle Stratton; Kenneth Blum

    2014-01-01

    Various studies have demonstrated that increased leptin levels and obesity are inversely related to cognitive decline in menopausal women. It is hypothesized that adiposity is inversely correlated with cognitive decline, as women with increased weight are less vulnerable to diminishing cognition. However, it is increasingly observed that menopausal women, even with increased adiposity, experience significant cognitive decline. Positron emission tomography (PET) has been used to analyze cognit...

  2. Clinical outcomes resulting from telemedicine interventions: a systematic review

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    Kraemer Dale

    2001-11-01

    Full Text Available Abstract Background The use of telemedicine is growing, but its efficacy for achieving comparable or improved clinical outcomes has not been established in many medical specialties. The objective of this systematic review was to evaluate the efficacy of telemedicine interventions for health outcomes in two classes of application: home-based and office/hospital-based. Methods Data sources for the study included deports of studies from the MEDLINE, EMBASE, CINAHL, and HealthSTAR databases; searching of bibliographies of review and other articles; and consultation of printed resources as well as investigators in the field. We included studies that were relevant to at least one of the two classes of telemedicine and addressed the assessment of efficacy for clinical outcomes with data of reported results. We excluded studies where the service did not historically require face-to-face encounters (e.g., radiology or pathology diagnosis. All included articles were abstracted and graded for quality and direction of the evidence. Results A total of 25 articles met inclusion criteria and were assessed. The strongest evidence for the efficacy of telemedicine in clinical outcomes comes from home-based telemedicine in the areas of chronic disease management, hypertension, and AIDS. The value of home glucose monitoring in diabetes mellitus is conflicting. There is also reasonable evidence that telemedicine is comparable to face-to-face care in emergency medicine and is beneficial in surgical and neonatal intensive care units as well as patient transfer in neurosurgery. Conclusions Despite the widespread use of telemedicine in virtually all major areas of health care, evidence concerning the benefits of its use exists in only a small number of them. Further randomized controlled trials must be done to determine where its use is most effective.

  3. Early Clinical Outcomes and Toxicity of Intensity Modulated Versus Conventional Pelvic Radiation Therapy for Locally Advanced Cervix Carcinoma: A Prospective Randomized Study

    Energy Technology Data Exchange (ETDEWEB)

    Gandhi, Ajeet Kumar, E-mail: ajeetgandhi23@gmail.com [Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi (India); Sharma, Daya Nand; Rath, Goura Kisor; Julka, Pramod Kumar; Subramani, Vellaiyan; Sharma, Seema; Manigandan, Durai; Laviraj, M.A. [Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi (India); Kumar, Sunesh [Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi (India); Thulkar, Sanjay [Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi (India)

    2013-11-01

    Purpose: To evaluate the toxicity and clinical outcome in patients with locally advanced cervical cancer (LACC) treated with whole pelvic conventional radiation therapy (WP-CRT) versus intensity modulated radiation therapy (WP-IMRT). Methods and Materials: Between January 2010 and January 2012, 44 patients with International Federation of Gynecology and Obstetrics (FIGO 2009) stage IIB-IIIB squamous cell carcinoma of the cervix were randomized to receive 50.4 Gy in 28 fractions delivered via either WP-CRT or WP-IMRT with concurrent weekly cisplatin 40 mg/m{sup 2}. Acute toxicity was graded according to the Common Terminology Criteria for Adverse Events, version 3.0, and late toxicity was graded according to the Radiation Therapy Oncology Group system. The primary and secondary endpoints were acute gastrointestinal toxicity and disease-free survival, respectively. Results: Of 44 patients, 22 patients received WP-CRT and 22 received WP-IMRT. In the WP-CRT arm, 13 patients had stage IIB disease and 9 had stage IIIB disease; in the IMRT arm, 12 patients had stage IIB disease and 10 had stage IIIB disease. The median follow-up time in the WP-CRT arm was 21.7 months (range, 10.7-37.4 months), and in the WP-IMRT arm it was 21.6 months (range, 7.7-34.4 months). At 27 months, disease-free survival was 79.4% in the WP-CRT group versus 60% in the WP-IMRT group (P=.651), and overall survival was 76% in the WP-CRT group versus 85.7% in the WP-IMRT group (P=.645). Patients in the WP-IMRT arm experienced significantly fewer grade ≥2 acute gastrointestinal toxicities (31.8% vs 63.6%, P=.034) and grade ≥3 gastrointestinal toxicities (4.5% vs 27.3%, P=.047) than did patients receiving WP-CRT and had less chronic gastrointestinal toxicity (13.6% vs 50%, P=.011). Conclusion: WP-IMRT is associated with significantly less toxicity compared with WP-CRT and has a comparable clinical outcome. Further studies with larger sample sizes and longer follow-up times are warranted to justify

  4. Early Clinical Outcomes and Toxicity of Intensity Modulated Versus Conventional Pelvic Radiation Therapy for Locally Advanced Cervix Carcinoma: A Prospective Randomized Study

    International Nuclear Information System (INIS)

    Purpose: To evaluate the toxicity and clinical outcome in patients with locally advanced cervical cancer (LACC) treated with whole pelvic conventional radiation therapy (WP-CRT) versus intensity modulated radiation therapy (WP-IMRT). Methods and Materials: Between January 2010 and January 2012, 44 patients with International Federation of Gynecology and Obstetrics (FIGO 2009) stage IIB-IIIB squamous cell carcinoma of the cervix were randomized to receive 50.4 Gy in 28 fractions delivered via either WP-CRT or WP-IMRT with concurrent weekly cisplatin 40 mg/m2. Acute toxicity was graded according to the Common Terminology Criteria for Adverse Events, version 3.0, and late toxicity was graded according to the Radiation Therapy Oncology Group system. The primary and secondary endpoints were acute gastrointestinal toxicity and disease-free survival, respectively. Results: Of 44 patients, 22 patients received WP-CRT and 22 received WP-IMRT. In the WP-CRT arm, 13 patients had stage IIB disease and 9 had stage IIIB disease; in the IMRT arm, 12 patients had stage IIB disease and 10 had stage IIIB disease. The median follow-up time in the WP-CRT arm was 21.7 months (range, 10.7-37.4 months), and in the WP-IMRT arm it was 21.6 months (range, 7.7-34.4 months). At 27 months, disease-free survival was 79.4% in the WP-CRT group versus 60% in the WP-IMRT group (P=.651), and overall survival was 76% in the WP-CRT group versus 85.7% in the WP-IMRT group (P=.645). Patients in the WP-IMRT arm experienced significantly fewer grade ≥2 acute gastrointestinal toxicities (31.8% vs 63.6%, P=.034) and grade ≥3 gastrointestinal toxicities (4.5% vs 27.3%, P=.047) than did patients receiving WP-CRT and had less chronic gastrointestinal toxicity (13.6% vs 50%, P=.011). Conclusion: WP-IMRT is associated with significantly less toxicity compared with WP-CRT and has a comparable clinical outcome. Further studies with larger sample sizes and longer follow-up times are warranted to justify its use

  5. Myasthenia gravis and pregnancy: clinical implications and neonatal outcome

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    Estanol Bruno

    2004-11-01

    Full Text Available Abstract Background The myasthenia gravis is twice as common in women as in men and frequently affects young women in the second and third decades of life, overlapping with the childbearing years. Generally, during pregnancy in one third of patients the disease exacerbates, whereas in two thirds it remains clinically unchanged. Complete remission can occur in some patients. Methods To describe the clinical course, delivery and neonatal outcome of 18 pregnant women with the diagnosis of myasthenia gravis. Retrospective chart review of pregnant patients with myasthenia gravis, followed at the National Institute of Perinatology in Mexico City over an 8-year period. Data was abstracted from the medical records on the clinical course during pregnancy, delivery and neonatal outcome. Results From January 1, 1996 to December 31, 2003 18 patients with myasthenia gravis were identified and included in the study. The mean ± SD maternal age was 27.4 ± 4.0 years. During pregnancy 2 women (11% had an improvement in the clinical symptoms of myasthenia gravis, 7 women (39% had clinical worsening of the condition of 9 other patients (50% remained clinically unchanged. Nine patients delivered vaginally, 8 delivered by cesarean section and 1 pregnancy ended in fetal loss. Seventeen infants were born at mean ± SD gestational age of 37.5 ± 3.0 weeks and a mean birth weight of 2710 ± 73 g. Only one infant presented with transient neonatal myasthenia gravis. No congenital anomalies were identified in any of the newborns. Conclusions The clinical course of myasthenia gravis during pregnancy is variable, with a significant proportion of patients experiencing worsening of the clinical symptoms. However, neonatal transient myasthenia was uncommon in our patient population.

  6. A RETROSPECTIVE STUDY OF EPIDEMIOLOGY CLINICAL COURSE AND TREATMENT OUTCOME OF SCORPION STING IN PAEDIATRIC AGE GROUP

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    Ramesh

    2015-12-01

    Full Text Available INTRODUCTION We know that habitat of scorpion is warm, and dry region. They inhibit commonly under logs, debris, paddy husk, sugar cane fields, and Coconut and banana plantations. (1 Konaseema region of Andhra Pradesh is famous for paddy, banana and coconut which are good habitat for scorpion. It is a retrospective study in which all the date of scorpion sting cases admitted in Konaseema institute of medical science and general hospital the only referral hospital in Konaseema region in last 3 years that is from Oct 2012 to Nov 2015 was collected. Mesobuthus tamulus is common in Andhra Pradesh. With the combined use of SAV and prazosin mortality has been reduced. But the awareness about the scorpion to the parent and its habitat will prevent the sting.

  7. Midterm clinical outcomes following arthroscopic transosseous rotator cuff repair

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    Brody A Flanagin

    2016-01-01

    Full Text Available Purpose: Arthroscopic transosseous (TO rotator cuff repair has recently emerged as a new option for surgical treatment of symptomatic rotator cuff tears. Limited data is available regarding outcomes using this technique. This study evaluated midterm clinical outcomes following a novel arthroscopic TO (anchorless rotator cuff repair technique. Materials and Methods: A consecutive series of 107 patients and 109 shoulders underwent arthroscopic TO (anchorless rotator cuff repair for a symptomatic full-thickness tear. Pre and postoperative range of motion (ROM was compared at an average of 11.8 months. Postoperative outcome scores were obtained at an average of 38.0 months. Statistical analysis was performed to compare pre and postoperative ROM data. Univariate analysis was performed using Student′s t-test to compare the effect of other clinical characteristics on final outcome. Results: Statistically significant improvements were noted in forward flexion, external rotation and internal rotation (P < 0.0001. Average postoperative subjective shoulder value was 93.7, simple shoulder test 11.6, and American Shoulder and Elbow Surgeons (ASES score 94.6. According to ASES scores, results for the 109 shoulders available for final follow-up were excellent in 95 (87.1%, good in 8 (7.3%, fair in 3 (2.8%, and poor in 3 (2.8%. There was no difference in ROM or outcome scores in patients who underwent a concomitant biceps procedure (tenodesis or tenotomy compared with those who did not. Furthermore, there was no significant difference in outcome between patients who underwent either biceps tenodesis or tenotomy. Age, history of "injury" preceding the onset of pain, tear size, number of TO tunnels required to perform the repair, and presence of fatty infiltration did not correlate with postoperative ROM or subjective outcome measures at final follow-up. Two complications and four failures were noted. Conclusions: Arthroscopic TO rotator cuff repair technique

  8. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G;

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial...

  9. Care needs and clinical outcomes of older people with dementia: a population-based propensity score-matched cohort study.

    Directory of Open Access Journals (Sweden)

    Fei-Yuan Hsiao

    Full Text Available To explore the healthcare resource utilization, psychotropic drug use and mortality of older people with dementia.A nationwide propensity score-matched cohort study.National Health Insurance Research database.A total of 32,649 elderly people with dementia and their propensity-score matched controls (n=32,649.Outpatient visits, inpatient care, psychotropic drug use, in-hospital mortality and all-cause mortality at 90 and 365 days.Compared to the non-dementia group, a higher proportion of patients with dementia used inpatient services (1 year after index date: 20.91% vs. 9.55%, and the dementia group had more outpatient visits (median [standard deviation]: 7.00 [8.87] vs. 3.00 [8.30]. Furthermore, dementia cases with acute admission had the highest psychotropic drug utilization both at baseline and at the post-index dates (difference-in-differences: all <0.001. Dementia was associated with an increased risk of all-cause mortality (90 days, Odds ratio (OR=1.85 [95%CI 1.67-2.05], p<0.001; 365 days, OR=1.59 [1.50-1.69], p<0.001 and in-hospital mortality (90 days, OR=1.97 [1.71-2.27], p<0.001; 365 days, OR=1.82 [1.61-2.05], p<0.001 compared to matched controls.When older people with dementia are admitted for acute illnesses, they may increase their use of psychotropic agents and their risk of death, particularly in-hospital mortality.

  10. Nutrition and Chronic Wounds: Improving Clinical Outcomes.

    Science.gov (United States)

    Molnar, Joseph A; Vlad, Lucian G; Gumus, Tuna

    2016-09-01

    There is increasing awareness that chronic wound healing is very dependent on the patient's nutritional status, but there are no clearly established and accepted assessment protocols or interventions in clinical practice. Much of the data used as guidelines for chronic wound patients are extrapolated from acutely wounded trauma patients, but the 2 groups are very different patient populations. While most trauma patients are young, healthy, and well-nourished before injury, the chronic wound patient is usually old, with comorbidities and frequently malnourished. We suggest the assumption that all geriatric wound patients are malnourished until proved otherwise. Evaluation should include complete history and physical and a formal nutritional evaluation should be obtained. Laboratory studies can be used in conjunction with this clinical information to confirm the assessment. While extensive studies are available in relation to prevention and treatment of pressure ulcers and perioperative nutrition, less is known of the effect of nutritional deficits and supplementation of the diabetic foot ulcer and venous stasis ulcer patient. This does not necessarily mean that nutritional support of these patients is not helpful. In the pursuit of wound healing, we provide systemic support of cardiac and pulmonary function and cessation of smoking, improve vascular inflow, improve venous outflow, decrease edema, and treat with hyperbaric oxygen. If we address all of these other conditions, why would we not wish to support the most basic of organismal needs in the form of nutrition? PMID:27556777

  11. Implant Optimisation for Primary Hip Replacement in Patients over 60 Years with Osteoarthritis: A Cohort Study of Clinical Outcomes and Implant Costs Using Data from England and Wales.

    Directory of Open Access Journals (Sweden)

    Simon S Jameson

    Full Text Available Hip replacement is one of the most commonly performed surgical procedures worldwide; hundreds of implant configurations provide options for femoral head size, joint surface material and fixation method with dramatically varying costs. Robust comparative evidence to inform the choice of implant is needed. This retrospective cohort study uses linked national databases from England and Wales to determine the optimal type of replacement for patients over 60 years undergoing hip replacement for osteoarthritis.Implants included were the commonest brand from each of the four types of replacement (cemented, cementless, hybrid and resurfacing; the reference prosthesis was the cemented hip procedure. Patient reported outcome scores (PROMs, costs and risk of repeat (revision surgery were examined. Multivariable analyses included analysis of covariance to assess improvement in PROMs (Oxford hip score, OHS, and EQ5D index (9159 linked episodes and competing risks modelling of implant survival (79,775 procedures. Cost of implants and ancillary equipment were obtained from National Health Service procurement data.EQ5D score improvements (at 6 months were similar for all hip replacement types. In females, revision risk was significantly higher in cementless hip prostheses (hazard ratio, HR = 2.22, p<0.001, when compared to the reference hip. Although improvement in OHS was statistically higher (22.1 versus 20.5, p<0.001 for cementless implants, this small difference is unlikely to be clinically important. In males, revision risk was significantly higher in cementless (HR = 1.95, p = 0.003 and resurfacing implants, HR = 3.46, p<0.001, with no differences in OHS. Material costs were lowest with the reference implant (cemented, range £1103 to £1524 and highest with cementless implants (£1928 to £4285. Limitations include the design of the study, which is intrinsically vulnerable to omitted variables, a paucity of long-term implant survival data (reflecting the

  12. Cytokines and signaling molecules predict clinical outcomes in sepsis.

    Directory of Open Access Journals (Sweden)

    Christopher D Fjell

    Full Text Available INTRODUCTION: Inflammatory response during sepsis is incompletely understood due to small sample sizes and variable timing of measurements following the onset of symptoms. The vasopressin in septic shock trial (VASST compared the addition of vasopressin to norepinephrine alone in patients with septic shock. During this study plasma was collected and 39 cytokines measured in a 363 patients at both baseline (before treatment and 24 hours. Clinical features relating to both underlying health and the acute organ dysfunction induced by the severe infection were collected during the first 28 days of admission. HYPOTHESIS: Cluster analysis of cytokines identifies subgroups of patients at differing risk of death and organ failure. METHODS: Circulating cytokines and other signaling molecules were measured using a Luminex multi-bead analyte detection system. Hierarchical clustering was performed on plasma values to create patient subgroups. Enrichment analysis identified clinical outcomes significantly different according to these chemically defined patient subgroups. Logistic regression was performed to assess the importance of cytokines for predicting patient subgroups. RESULTS: Plasma levels at baseline produced three subgroups of patients, while 24 hour levels produced two subgroups. Using baseline cytokine data, one subgroup of 47 patients showed a high level of enrichment for severe septic shock, coagulopathy, renal failure, and risk of death. Using data at 24 hours, a larger subgroup of 81 patients that largely encompassed the 47 baseline subgroup patients had a similar enrichment profile. Measurement of two cytokines, IL2 and CSF2 and their product were sufficient to classify patients into these subgroups that defined clinical risks. CONCLUSIONS: A distinct pattern of cytokine levels measured early in the course of sepsis predicts disease outcome. Subpopulations of patients have differing clinical outcomes that can be predicted accurately from

  13. Patient-reported outcomes in lupus clinical trials with biologics.

    Science.gov (United States)

    Annapureddy, N; Devilliers, H; Jolly, M

    2016-09-01

    Therapeutic advances in systemic lupus erythematosus (SLE) are greatly needed. Despite advances in our knowledge of pathogenesis of the disease and targets, treatment remains a significant challenge. Finding effective and relatively safe medications remains one of the top priorities. SLE significantly impairs quality of life (QoL), and patient-reported outcomes (PROs) measure a unique aspect of the disease not captured by disease activity. Inclusion of PRO measurements is encouraged in SLE clinical trials, as they allow capturing benefits of a proposed intervention in language patients can relate to and in areas deemed pertinent and important to and by patients. Availability of patient-reported and patient-centric clinical trials data may facilitate patients in informed and shared decision making, and allow for comparative cost-effectiveness evaluation for future resource allocation and reimbursements. Herein we review clinical trials with biologic therapies wherein PRO tools were included in the study design. PMID:27497256

  14. Clinical outcomes of a novel therapeutic vaccine with Tax peptide-pulsed dendritic cells for adult T cell leukaemia/lymphoma in a pilot study.

    Science.gov (United States)

    Suehiro, Youko; Hasegawa, Atsuhiko; Iino, Tadafumi; Sasada, Amane; Watanabe, Nobukazu; Matsuoka, Masao; Takamori, Ayako; Tanosaki, Ryuji; Utsunomiya, Atae; Choi, Ilseung; Fukuda, Tetsuya; Miura, Osamu; Takaishi, Shigeo; Teshima, Takanori; Akashi, Koichi; Kannagi, Mari; Uike, Naokuni; Okamura, Jun

    2015-05-01

    Adult T cell leukaemia/lymphoma (ATL) is a human T cell leukaemia virus type-I (HTLV-I)-infected T cell malignancy with poor prognosis. We herein developed a novel therapeutic vaccine designed to augment an HTLV-I Tax-specific cytotoxic T lymphocyte (CTL) response that has been implicated in anti-ATL effects, and conducted a pilot study to investigate its safety and efficacy. Three previously treated ATL patients, classified as intermediate- to high-risk, were subcutaneously administered with the vaccine, consisting of autologous dendritic cells (DCs) pulsed with Tax peptides corresponding to the CTL epitopes. In all patients, the performance status improved after vaccination without severe adverse events, and Tax-specific CTL responses were observed with peaks at 16-20 weeks. Two patients achieved partial remission in the first 8 weeks, one of whom later achieved complete remission, maintaining their remission status without any additional chemotherapy 24 and 19 months after vaccination, respectively. The third patient, whose tumour cells lacked the ability to express Tax at biopsy, obtained stable disease in the first 8 weeks and later developed slowly progressive disease although additional therapy was not required for 14 months. The clinical outcomes of this pilot study indicate that the Tax peptide-pulsed DC vaccine is a safe and promising immunotherapy for ATL. PMID:25612920

  15. Bone scintigraphy and clinical outcome in rheumatoid gonarthritis

    International Nuclear Information System (INIS)

    Aim: For evaluation of the effect of radiosynoviorthesis (RSO) on the early and delayed uptake of 99mTc-biphosphonates and its relation to clinical outcome we studied these variables before and after radiosynoviorthesis performed on 41 knees affected by rheumatoid arthritis. Method: Thirty-seven patients with rheumatoid gonarthritis were treated by intraarticular injection with 185 MBq yttrium-90 citrate. In four of them both knees were treated so that 41 therapies were evaluated. On the average 35 days before and 120 days after radiosynoviorthesis, the early and delayed uptake of 99mTc-diphosphonate (DPD) was measured with a planar gamma camera. Early and late DPD uptake was quantified as a ratio between count values derived from rectangular ROIs placed on the knee treated and on the ipsilateral thigh. The severity of clinical symptoms was assessed on two 3-point rating scales averaged. Results: 30 of the 41 cases favorably responded to radiosynoviorthesis. There was a significant correlation between clinical outcomeand pretherapeutic early DPD uptake (EDU) (p0.05). In 25 of the 30 responders EDU decreased; EDU increased or remained constant in five of the eleven non-responders. The correlation between outcome and the difference in EDU was significant (r = 0.344; p<0.05). There was no such significant relationship between the difference between pre- and posttherapeutic DDU and clinical course. Conclusion: Three-phase bone scintigraphy may contribute to predict and assess the success of radiosynoviorthesis in rheumatoid arthritis of the knee joint. (orig.)

  16. Relation between stimulation characteristics and clinical outcome in studies using electrical stimulation to improve motor control of the upper extremity in stroke

    OpenAIRE

    Kroon, de, H.; IJzerman, M.J.; Chae, J; Lankhorst, G.J.; Zilvold, G.

    2005-01-01

    Objective: Electrical stimulation can be applied in a variety of ways to the hemiparetic upper extremity following stroke. The aim of this review is to explore the relationship between characteristics of stimulation and the effect of electrical stimulation on the recovery of upper limb motor control following stroke. Methods: A systematic literature search was performed to identify clinical trials evaluating the effect of electrical stimulation on motor control. The reported outcomes were exa...

  17. Antibiotic therapy for cat-scratch disease: clinical study of therapeutic outcome in 268 patients and a review of the literature.

    Science.gov (United States)

    Margileth, A M

    1992-06-01

    During 24 months in an uncontrolled, retrospective study of 268 patients with cat-scratch disease (CSD), 202 were treated with 18 different antimicrobial agents. Criteria for antibiotic effectiveness were established. One or two antibiotics were taken separately for at least 3 to 5 days by 202 patients with CSD. Outcome was determined by follow-up examinations and telephone. Effectiveness of antibiotic therapy was based upon 3 or more days of therapy and clinical improvement of the patient with absence of and/or a decrease in malaise, fatigue, fever, headache, anorexia, lymphadenopathy and, in 90 patients, a declining or normal sedimentation rate. Of 18 different antimicrobials prescribed, 14 commonly used antibiotics were judged to be of little or no value in treatment of CSD. Four antimicrobials were efficacious. Efficacy of the three oral drugs in decreasing order was: rifampin 87%, ciprofloxacin 84%, trimethoprim-sulfamethoxazole 58%. Gentamicin sulfate intramuscular was 73% effective. Antibiotic therapy can be considered for patients with severe cat scratch disease. Conservative, symptomatic treatment is recommended for the majority of patients with mild or moderate CSD. PMID:1608685

  18. Impact of dehydroepiandrosterone on clinical outcome in poor responders: A pilot study in women undergoing in vitro fertilization, using bologna criteria

    Directory of Open Access Journals (Sweden)

    Padma Rekha Jirge

    2014-01-01

    Full Text Available Objective: To evaluate the role of dehydroepiandrosterone (DHEA supplementation in women with poor ovarian response (POR undergoing in vitro fertilization (IVF. Design: Prospective case-control study. Setting: Private tertiary fertility clinic. MATERIALS AND Methods: 31 infertile women with POR diagnosed as per the Bologna criteria. Interventions: DHEA supplementation for 2 months and a subsequent IVF cycle, after two previous IVF cycles with POR. Main Outcome Measure(S: Dose and duration of gonadotropin therapy, oocyte yield, embryo number and quality, pregnancy and live birth rate. Results: No difference was seen in gonadotropin requirement before and after DHEA supplementation. There was a significant increase in total and metaphase II oocytes (5.9 ± 0.68 vs. 2.73 ± 0.24; 4.45 ± 0.47 vs. 2.09 ± 0.26, fertilization (3.65 ± 0.49 vs. 2.00 ± 0.27, Grade I embryos (1.52 ± 0.25 vs. 0.55 ± 0.18, pregnancy rate (30% vs. 9.1% and live birth rate (25% vs 0% in those who completed the cycle, following DHEA supplementation. Conclusions: Dehydroepiandrosterone supplementation results in an improvement in oocyte yield, embryo quality, and live birth rate in a group of women with POR having undergone at least two previous failures due to POR.

  19. Prognostic factors influencing clinical outcomes of glioblastoma multiforme

    Institute of Scientific and Technical Information of China (English)

    LI Shou-wei; QIU Xiao-guang; CHEN Bao-shi; ZHANG Wei; REN Huan; WANG Zhong-cheng; JIANG Tao

    2009-01-01

    Background Glioblastoma multiforme (GBM) is the most malignant kind of astrocytic tumors and is associated with a poor prognosis. In this retrospective study, we assessed the clinical, radiological, genetic molecular and treatment factors that influence clinical outcomes of patients with GBM.Methods A total of 116 patients with GBM who received surgery and radiation between January 2006 and December 2007 were included in this study. Kaplan-Meier survival analysis and Cox regression analysis were used to find the factors independently influencing patients' progression free survival (PFS) time and overall survival (OS) time.Results Age, preoperative Kamofsky Performance Scale (KPS) score, KPS score change at 2 weeks after operation, neurological deficit symptoms, tumor resection extent, maximal tumor diameter, involvement of eloquent cortex or deep structure, involvement of brain lobe, Ki-67 expression level and adjuvant chemotherapy were statistically significant factors (P <0.05) for both PFS and OS in the univariate analysis. Cox proportional hazards modeling revealed that age ≤50 years, preoperative KPS score ≥80, KPS score change after operation ≥0, involvement of single frontal lobe,non-eloquent area or deep structure involvement, low Ki-67 expression and adjuvant chemotherapy were independent favorable factors (P <0.05) for patients' clinical outcomes.Conclusions Age at diagnosis, preoperative KPS score, KPS score change at 2 weeks postoperation, involvement of brain lobe, involvement of eloquent cortex or deep structure, Ki-67 expression level and adjuvant chemotherapy correlate significantly with the prognosis of patients with GBM.

  20. Combining clinical variables to optimize prediction of antidepressant treatment outcomes.

    Science.gov (United States)

    Iniesta, Raquel; Malki, Karim; Maier, Wolfgang; Rietschel, Marcella; Mors, Ole; Hauser, Joanna; Henigsberg, Neven; Dernovsek, Mojca Zvezdana; Souery, Daniel; Stahl, Daniel; Dobson, Richard; Aitchison, Katherine J; Farmer, Anne; Lewis, Cathryn M; McGuffin, Peter; Uher, Rudolf

    2016-07-01

    The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug. PMID:27089522

  1. Technology Deployment to Improve Clinical Outcomes

    Institute of Scientific and Technical Information of China (English)

    TM Judd; L Jacobs; M Jansen; B Birch

    2016-01-01

    2015年10月21日,《中国医疗设备》杂志社独家承办了“第一届国际临床工程与医疗技术管理大会”(ICEHTMC 2015),大会主席由美国FDA医疗设备顾问委员会主席、美国临床医学工程学会主席Yadin David先生和301医院周丹主任共同担任。来自14个国家的临床医学工程学会的主席、23个国家的60多位医学工程的领军人物、世界卫生组织医疗器械委员会的协调员及国内580多医工专家与会交流,共同搭建世界临床医学工程的学术平台。%Improved child, newborn, and maternal health (CNM) is a top priority in developing countries. Many factors must be addressed simultaneously to improve clinical outcomes for CNM. A public-private project in Haiti that will deploy the World Health Organization (WHO) evidence-based medicine (EBM) and essential interventions utilizing CNM healthcare technologies (HT), is expected to be a model for improving national health systems. The CNM mortality rates in Haiti are the highest in the western hemisphere with rates similar to those found in Afghanistan and several African countries. Several factors perpetuating this crisis are noted, as well as the most cost-effective interventions proven to decrease CNM mortality rates in low-and middle-income countries. To create major change in health system infrastructure, two strategies are presented, requiring appropriate and leading-edge health technologies (HT),e.g., wireless cellular-network-based Telemedicine (TM): (1) Development of a countrywide network of geographical“Community Care Grids” to facilitate implementation of frontline interventions; (2) The construction of a central hospital (called Bethesda Referral and Teaching Hospital-BRTH NGO) that will provide secondary and tertiary care for communities throughout the country, including helping local hospitals and clinics practice EBM care. We believe that these strategies-supported by HT will fast track improvement in

  2. Technology Deployment to Improve Clinical Outcomes

    Institute of Scientific and Technical Information of China (English)

    TM Judd; L Jacobs; M Jansen; B Birch

    2016-01-01

    Improved child, newborn, and maternal health (CNM) is a top priority in developing countries. Many factors must be addressed simultaneously to improve clinical outcomes for CNM. A public-private project in Haiti that will deploy the World Health Organization (WHO) evidence-based medicine (EBM) and essential interventions utilizing CNM healthcare technologies (HT), is expected to be a model for improving national health systems. The CNM mortality rates in Haiti are the highest in the western hemisphere with rates similar to those found in Afghanistan and several African countries. Several factors perpetuating this crisis are noted, as well as the most cost-effective interventions proven to decrease CNM mortality rates in low-and middle-income countries. To create major change in health system infrastructure, two strategies are presented, requiring appropriate and leading-edge health technologies (HT),e.g., wireless cellular-network-based Telemedicine (TM): (1) Development of a countrywide network of geographical“Community Care Grids” to facilitate implementation of frontline interventions; (2) The construction of a central hospital (called Bethesda Referral and Teaching Hospital-BRTH NGO) that will provide secondary and tertiary care for communities throughout the country, including helping local hospitals and clinics practice EBM care. We believe that these strategies-supported by HT will fast track improvement in CNM mortality rates throughout the country and that in a relatively short period of time Haiti’s health care system will be among the leaders in the region. Primary factors contributing to the CNM crisis, all addressed by TM: (1) Limited access: demographics, geography, cost, transportation; (2) Inadequate health care facilities: less than 20 NICU beds for 10 million population; BRTH to provide 80 bed NICU and 40 bed PICU in 225 bed hospital; (3) Health care practitioners: inadequate numbers and training; (4) Low% of skilled attendants now at

  3. Clinical profile and outcome of acute kidney injury related to pregnancy in developing countries: a single-center study from India.

    Science.gov (United States)

    Godara, Suraj M; Kute, Vivek B; Trivedi, Hargovind L; Vanikar, Aruna V; Shah, Pankaj R; Gumber, Manoj R; Patel, Himanshu V; Gumber, Vandana M

    2014-07-01

    Acute kidney injury (AKI) is one of the most challenging and serious complications of pregnancy. We present our experience on the clinical profile and outcome of 57 patients with pregnancy-related AKI, of a total of 580 patients with AKI seen during the study period. This is a prospective single-center study in a civil hospital conducted from January to December 2010. The most common age group of the study patients was 20-25 years; 43.8% of the patients had received antenatal care. AKI was observed in the puerperium (n = 34), early pregnancy (n = 10) and late pregnancy (n = 13). The cause of AKI included puerperal sepsis (63.1%), pregnancy-induced hypertension (PIH) (33.33%), post-abortion (22.80%), ante-partum hemorrhage (APH) (14%) and post-partum hemorrhage (PPH) (8%). Complete, partial and no renal recovery was observed in 52.64%, 21.05% and 26.31% of the patients, respectively. Low platelet count and plasma fibrinogen and high bilirubin, D-dimer and activated partial thromboplast in time were observed more commonly in patients with partial recovery. Of the 57 patients, 50 received hemodialysis, three received peritoneal dialysis and seven patients were managed conservatively. A total of 13 patients developed cortical necrosis that was associated with sepsis in six, PPH and pre-eclampsia/eclampsia in three patients each and APH in one. Nine patients died, and the cause of death was septicemia in four, pre-eclampsia in three and APH and PPH in one patient each. In our study, puerperal sepsis was the most common etiological factor for pregnancy-related AKI. Prolonged oliguria or anuria were bad prognostic factors for renal recovery. Sepsis, thrombocytopenia, disseminated intra-vascular coagulation and liver involvement were associated with increased mortality. PMID:24969215

  4. Clinical profile and outcome of acute kidney injury related to pregnancy in developing countries: A single-center study from India

    Directory of Open Access Journals (Sweden)

    Suraj M Godara

    2014-01-01

    Full Text Available Acute kidney injury (AKI is one of the most challenging and serious complications of pregnancy. We present our experience on the clinical profile and outcome of 57 patients with pregnancy-related AKI, of a total of 580 patients with AKI seen during the study period. This is a prospective single-center study in a civil hospital conducted from January to December 2010. The most common age group of the study patients was 20-25 years; 43.8% of the patients had received antenatal care. AKI was observed in the puerperium (n = 34, early pregnancy (n = 10 and late pregnancy (n = 13. The cause of AKI included puerperal sepsis (63.1%, pregnancy-induced hypertension (PIH (33.33%, post-abortion (22.80%, ante-partum hemorrhage (APH (14% and post-partum hemorrhage (PPH (8%. Complete, partial and no renal recovery was observed in 52.64%, 21.05% and 26.31% of the patients, respectively. Low platelet count and plasma fibrinogen and high bilirubin, D-dimer and activated partial throm-boplastin time were observed more commonly in patients with partial recovery. Of the 57 patients, 50 received hemodialysis, three received peritoneal dialysis and seven patients were managed conserva-tively. A total of 13 patients developed cortical necrosis that was associated with sepsis in six, PPH and pre-eclampsia/eclampsia in three patients each and APH in one. Nine patients died, and the cause of death was septicemia in four, pre-eclampsia in three and APH and PPH in one patient each. In our study, puerperal sepsis was the most common etiological factor for pregnancy-related AKI. Prolonged oliguria or anuria were bad prognostic factors for renal recovery. Sepsis, thrombocytopenia, disseminated intra-vascular coagulation and liver involvement were associated with increased mortality.

  5. Clinical and neurocognitive outcome in symptomatic isovaleric acidemia

    Directory of Open Access Journals (Sweden)

    Grünert Sarah C

    2012-01-01

    Full Text Available Abstract Background Despite its first description over 40 years ago, knowledge of the clinical course of isovaleric acidemia (IVA, a disorder predisposing to severe acidotic episodes during catabolic stress, is still anecdotal. We aimed to investigate the phenotypic presentation and factors determining the neurological and neurocognitive outcomes of patients diagnosed with IVA following clinical manifestation. Methods Retrospective data on 21 children and adults with symptomatic IVA diagnosed from 1976 to 1999 were analyzed for outcome determinants including age at diagnosis and number of catabolic episodes. Sixteen of 21 patients were evaluated cross-sectionally focusing on the neurological and neurocognitive status. Additionally, 155 cases of patients with IVA published in the international literature were reviewed and analyzed for outcome parameters including mortality. Results 57% of study patients (12/21 were diagnosed within the first weeks of life and 43% (9/21 in childhood. An acute metabolic attack was the main cause of diagnostic work-up. 44% of investigated study patients (7/16 showed mild motor dysfunction and only 19% (3/16 had cognitive deficits. No other organ complications were found. The patients' intelligence quotient was not related to the number of catabolic episodes but was inversely related to age at diagnosis. In published cases, mortality was high (33% if associated with neonatal diagnosis, following manifestation at an average age of 7 days. Conclusions Within the group of "classical" organic acidurias, IVA appears to be exceptional considering its milder neuropathologic implications. The potential to avoid neonatal mortality and to improve neurologic and cognitive outcome under early treatment reinforces IVA to be qualified for newborn screening.

  6. Clinical characteristics and outcome of cancer diagnosed during pregnancy

    Science.gov (United States)

    Shim, Min Hee; Mok, Chi-Won; Chang, Kylie Hae-Jin; Sung, Ji-Hee; Oh, Soo-young; Roh, Cheong-Rae; Kim, Jong-Hwa

    2016-01-01

    Objective The aim of this study is to describe the clinical characteristics and outcome of cancer diagnosed during pregnancy. Methods This is a retrospective cohort study of women who were diagnosed with cancer during pregnancy at a tertiary academic hospital between 1995 and 2013. Maternal characteristics, gestational age at diagnosis, and type, stage, symptoms and signs of cancer for each patient were retrieved from the medical records. The cancer treatment, pregnancy management and the subsequent perinatal and maternal outcomes for each cancer were assessed. Results A total of 87 women were diagnosed with cancer during pregnancy (172.6 cases per 100,000 deliveries). The most common cancer was breast cancer (n=20), followed by gastrointestinal (n=17), hematologic (n=13), thyroid (n=11), central nervous system (n=7), cervical (n=7), ovarian (n=5), lung (n=3), and other cancers (n=4). Eighteen (20.7%) patients terminated their pregnancies. In the 69 (79.3%) patients who maintained their pregnancies, one patient miscarried and 34 patients delivered preterm. Of the preterm babies, 24 (70.6%) were admitted to the neonatal intensive care unit and 3 (8.8%) of those expired. The maternal mortality rate was 31.0%, with highest rate seen with lung cancers (66.7%), followed by gastrointestinal (50.0%), central nervous system (50.0%), hematologic (30.8%), breast (25.0%), ovarian (20.0%) cervical (14.3%), and thyroid cancers (0%). Conclusion The clinical characteristics and outcome of cancer during pregnancy were highly variable depending on the type of cancer. However, timely diagnosis and appropriate management of cancer during pregnancy may improve both maternal and neonatal outcome. PMID:26866029

  7. Evaluation of the reliability and validity of the Medical Outcomes Study sleep scale in patients with painful diabetic peripheral neuropathy during an international clinical trial

    Directory of Open Access Journals (Sweden)

    Hays Ron D

    2008-12-01

    Full Text Available Abstract Background Sleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOS-Sleep includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. A sleep problems index, grouping items from each of the former domains, is also available. This study evaluates the psychometric properties of MOS-Sleep Scale in a painful diabetic peripheral neuropathic population based on a clinical trial conducted in six countries. Methods Clinical data and health-related quality of life data were collected at baseline and after 12 weeks of follow-up. Overall, 396 patients were included in the analysis. Psychometric properties of the MOS-Sleep were assessed in the overall population and per country when the sample size was sufficient. Internal consistency reliability was assessed by Cronbach's alpha; the structure of the instrument was assessed by verifying item convergent and discriminant criteria; construct validity was evaluated by examining the relationships between MOS-Sleep scores and sleep interference and pain scores, and SF-36 scores; effect-sizes were used to assess the MOS-Sleep responsiveness. The study was conducted in compliance with United States Food and Drug Administration regulations for informed consent and protection of patient rights. Results Cronbach's alpha ranged from 0.71 to 0.81 for the multi-item dimensions and the sleep problems index. Item convergent and discriminant criteria were satisfied with item-scale correlations for hypothesized dimensions higher than 0.40 and tending to exceed the correlations of items with other dimensions, respectively. Taken individually, German, Polish and English language versions had good internal consistency reliability and dimension structure. Construct validity was supported with lower sleep adequacy score and greater sleep problems index scores associated with

  8. Clinical Outcome of Inter-Proximal Papilla between a Tooth and a Single Implant Treated with CAD/CAM Abutments: a Cross-Sectional Study

    Science.gov (United States)

    Lima, Tiago; Carvalho, Ágata; Carvalho, Vasco

    2012-01-01

    ABSTRACT Objectives The aim of this study was to assess the clinical outcomes achieved with Computer-Assisted Design/Computer-Assisted Manufacturing implant abutments in the anterior maxilla. Material and Methods Nineteen patients with a mean age of 41 (range form 26 to 63) years, treated with 21 single tooth implants and 21 Computer-Assisted Design/Computer-Assisted Manufacturing (CAD/CAM) abutments in the anterior maxillary region were included in this study. The patients followed 4 criteria of inclusion: (1) had a single-tooth implant in the anterior maxilla, (2) had a CAD/CAM abutment, (3) had a contralateral natural tooth, (4) the implant was restored and in function for at least 6 months up to 2 years. Cases without contact point were excluded. Presence/absence of the interproximal papilla, inter tooth-implant distance (ITD) and distance from the base of the contact point to dental crest bone of adjacent tooth (CPB) were accessed. Results Forty interproximal spaces were evaluated, with an average mesial CPB of 5.65 (SD 1.65) mm and distal CPB of 4.65 (SD 1.98) mm. An average mesial ITD of 2.49 (SD 0.69) mm and an average distal ITD of 1.89 (SD 0.63) mm were achieved. Papilla was present in all the interproximal spaces accessed. Conclusions The restoration of dental implants using CAD/CAM abutments is a predictable treatment with improved aesthetic results. These type of abutments seem to help maintaining a regular papillary filling although the variations of the implant positioning or the restoration teeth relation. PMID:24422016

  9. Clinical Outcome of Inter-Proximal Papilla between a Tooth and a Single Implant Treated with CAD/CAM Abutments: a Cross-Sectional Study

    Directory of Open Access Journals (Sweden)

    Tiago Borges

    2012-09-01

    Full Text Available Objectives: The aim of this study was to assess the clinical outcomes achieved with Computer-Assisted Design/Computer-Assisted Manufacturing implant abutments in the anterior maxilla.Material and Methods: Nineteen patients with a mean age of 41 (range form 26 to 63 years, treated with 21 single tooth implants and 21 Computer-Assisted Design/Computer-Assisted Manufacturing (CAD/CAM abutments in the anterior maxillary region were included in this study. The patients followed 4 criteria of inclusion: (1 had a single-tooth implant in the anterior maxilla, (2 had a CAD/CAM abutment, (3 had a contralateral natural tooth, (4 the implant was restored and in function for at least 6 months up to 2 years. Cases without contact point were excluded. Presence/absence of the interproximal papilla, inter tooth-implant distance (ITD and distance from the base of the contact point to dental crest bone of adjacent tooth (CPB were accessed. Results: Forty interproximal spaces were evaluated, with an average mesial CPB of 5.65 (SD 1.65 mm and distal CPB of 4.65 (SD 1.98 mm. An average mesial ITD of 2.49 (SD 0.69 mm and an average distal ITD of 1.89 (SD 0.63 mm were achieved. Papilla was present in all the interproximal spaces accessed. Conclusions: The restoration of dental implants using CAD/CAM abutments is a predictable treatment with improved aesthetic results. These type of abutments seem to help maintaining a regular papillary filling although the variations of the implant positioning or the restoration teeth relation.

  10. Are there long-term benefits of experiential, interprofessional education for non-specialists on clinical behaviours and outcomes in diabetes care? A cohort study

    Science.gov (United States)

    Ching, Daniel; Forte, Denise; Aitchison, Elizabeth; Earle, Kenneth

    2016-01-01

    Objectives Our aim was to assess the impact of an educational initiative for non-specialist, healthcare professionals in the community on the process and quality measures of diabetes care delivered, and changes in their learning experiences and clinical management behaviour in the short and long term. Setting Single locality of 26 primary care practices associated with one secondary centre. Participants General practitioners and practice nurses managing 4167 patients with diabetes. Intervention A rolling 10-week, experiential, interprofessional education programme delivered to 57 practitioners and observations in practice. Primary and secondary outcome measures Primary outcomes were changes in the proportion of patients receiving foot care, urine albumin:creatinine ratio assessments and achieving National Quality Outcome Framework targets for blood pressure (86 mmol/mol (10%) and 85 mmol/mol (10%) was significantly higher (44% vs 53% p=0.0001) and lower (12.5% vs 10%; p=0.002) respectively. There was an increase in the proportion (95% CI) of patients receiving foot care reviews (+26.0% (24.0% to 28.1%)), microalbuminuria screening (+29.8% (27.7% to 31.9%)) and who achieved targets for blood pressure (+9.6% (7.5% to 11.6%)) and total cholesterol (+14.4% (12.3% to 16.5%); p<0.001). 241 fewer patients were referred to secondary care. Increases in the healthcare professional's confidence and collaborative clinical behaviour were evident 3 years after completing the programme. Conclusions An experiential, interprofessional intervention can result in significant improvements in quality outcomes in association with a sustained impact on behaviours and practices. PMID:26747032

  11. Subacute Thyroiditis: Clinical Presentation and Long Term Outcome

    Directory of Open Access Journals (Sweden)

    Assim A. Alfadda

    2014-01-01

    Full Text Available Few studies have been reported from the Kingdom of Saudi Arabia (SA to describe the clinical presentation and long term outcomes of subacute thyroiditis (SAT. Our aim was to review the demographic, anthropometric, clinical presentation, laboratory results, treatment, and disease outcome in Riyadh region and to compare those with results from different regions of the Kingdom and different parts of the world. We reviewed the medical files of patients who underwent thyroid uptake scan during an 8-year period in King Khalid University Hospital. Only 25 patients had confirmed diagnosis of thyroiditis. Age and gender distribution were similar to other studies. Most patients presented with palpitation, goiter, and weight change. Elevated thyroid hormones, suppressed thyroid-stimulating hormone, and elevated ESR were reported. Among those, 7 cases of SAT were recorded. β-Blockers were prescribed to 57% and nonsteroidal anti-inflammatory drugs to 29% of SAT. Long follow-up demonstrated that 85.7% of SAT cases recovered, while 14.3% developed permanent hypothyroidism. In conclusion, SAT is uncommon in the central region of SA. Compared to the western region, corticosteroid is not commonly prescribed, and permanent hypothyroidism is not uncommon. A nation-wide epidemiological study to explain these interprovincial differences is warranted.

  12. Similar clinical outcome after unicompartmental knee arthroplasty using a conventional or accelerated care program: a randomized, controlled study of 40 patients

    DEFF Research Database (Denmark)

    Borgwardt, Lotte; Zerahn, Bo; Bliddal, Henning; Christiansen, Christian; Sylvest, Jesper; Borgwardt, Arne

    2009-01-01

    within 3 months, contact with a general physician or nurse, and level of satisfaction were registered. Patients in the A group attended an information meeting. An intraarticular infiltration with Marcaine and adrenaline was used peroperatively. Patients in the C group had an epidural pump for 2 or 3 days......, average pain on days 1 and 2, use of opioids (during the first week postoperatively), KSS, contact with primary sector, level of satisfaction, or level of confidence. INTERPRETATION: We achieved a reduction in LOS of 5 days without affecting the clinical outcome....

  13. Clinical outcome in measles patients hospitalized with complications

    International Nuclear Information System (INIS)

    Measles is a highly communicable viral illness and is common cause of childhood mortality and morbidity. Keeping in view the high prevalence of measles in the developing world, we carried out this study to look into the complicated measles cases and clinical outcome in patients admitted in children ward of Ayub Teaching Hospital. Detailed history and physical examination of all the hospitalized patients with complication of measles were recorded in a proforma. Immunization and nutritional status of each admitted patient was assessed and the clinical outcome of measles was compared with demographic profile. one hundred thirty six hospitalized patients with complications of measles were studied. There was 60.3% male and 57.3% of patients were vaccinated against measles. Malnourished patients were 71.35% and had longer hospital stay (>5 days). Pneumonia (39.7%) and diarrhoea (38.2%) were the commonest complications. Seven children died and encephalitis (57.1%) was the commonest cause of death. The most common complications of measles are pneumonia and diarrhoea with dehydration requiring admission. Malnutrition results in more complications and longer hospital stay. Mortality is significantly associated with encephalitis. (author)

  14. Individual risk alleles of susceptibility to schizophrenia are associated with poor clinical and social outcomes.

    Science.gov (United States)

    Sakamoto, Shinji; Takaki, Manabu; Okahisa, Yuko; Mizuki, Yutaka; Inagaki, Masatoshi; Ujike, Hiroshi; Mitsuhashi, Toshiharu; Takao, Soshi; Ikeda, Masashi; Uchitomi, Yosuke; Iwata, Nakao; Yamada, Norihito

    2016-04-01

    Many patients with schizophrenia have poor clinical and social outcomes. Some risk alleles closely related to the onset of schizophrenia have been reported to be associated with their clinical phenotypes, but the direct relationship between genetic vulnerability to schizophrenia and clinical/social outcomes of schizophrenia, as evaluated by both practical clinical scales and 'real-world' function, has not been investigated. We evaluated the clinical and social outcomes of 455 Japanese patients with schizophrenia by severity of illness according to the Clinical Global Impression-Severity Scale (CGI-S) and social outcomes by social adjustment/maladjustment at 5 years after the first visit. We examined whether 46 single nucleotide polymorphisms (SNPs) selected from a Japanese genome-wide association study of susceptibility to schizophrenia were associated with clinical and social outcomes. We also investigated the polygenic risk scores of 46 SNPs. Allele-wise association analysis detected three SNPs, including rs2623659 in the CUB and Sushi multiple domains-1 (CSMD1) gene, associated with severity of illness at end point. The severity of illness at end point was associated with treatment response, but not with the severity of illness at baseline. Three SNPs, including rs2294424 in the C6orf105 gene, were associated with social outcomes. Point estimates of odds ratios showed positive relationships between polygenic risk scores and clinical/social outcomes; however, the results were not statistically significant. Because these results are exploratory, we need to replicate them with a larger sample in a future study. PMID:26674612

  15. A Five-Phase Model for Clinical-Outcome Research

    Science.gov (United States)

    Robey, Randall R.

    2004-01-01

    Through a variety of approaches, speech-language pathologists and audiologists have produced strong evidence that treatments are generally potent. However, we have largely ignored the accepted standards for clinical-outcome testing used throughout the broader research community (e.g., by other clinical disciplines, federal regulators, and…

  16. Non-specific low back pain in primary care in the Spanish National Health Service: a prospective study on clinical outcomes and determinants of management

    Directory of Open Access Journals (Sweden)

    Muriel Alfonso

    2006-05-01

    Full Text Available Abstract Background The Spanish National Health Service is a universal and free health care system. Non-specific low back pain (LBP is a prevalent disorder, generating large health and social costs. The objectives of this study were to describe its management in primary care, to assess patient characteristics that influence physicians' decisions, and to describe clinical outcome at 2 months. Methods A cross-sectional sample of 648 patients with non-specific low back pain was recruited by 75 physicians (out of 361 – 20.8% working in 40 primary care centers in 10 of the 17 administrative regions in Spain, covering 693,026 out of the 40,499,792 inhabitants. Patients were assessed on the day they were recruited, and prospectively followed-up 14 and 60 days later. The principal patient characteristics that were analyzed were: sex, duration of the episode, history of LBP, working status, severity of LBP, leg pain and disability, and results of straight leg raising test. Descriptors of management were: performance of the straight leg raising test, ordering of diagnostic procedures, prescription of drug treatment, referral to physical therapy, rehabilitation or surgery, and granting of sick leave. Regression analysis was used to analyze the relationship between patients' baseline characteristics and physicians' management decisions. Only workers were included in the models on sick leave. Results Mean age (SD of included patients was 46.5 (15.5 years, 367 (56.6% were workers, and 338 (52.5% were females. Median (25th–75th interquartile range duration of pain when entering the study was 4 (2–10 days and only 28 patients (4.3% had chronic low back pain. Diagnostic studies included plain radiographs in 43.1% of patients and CT or MRI scans in 18.8%. Drug medication was prescribed to 91.7% of patients, 19.1% were sent to physical therapy or rehabilitation, and 9.6% were referred to surgery. The main determinants of the clinical management were duration

  17. Clinical Features and Outcome of Mucormycosis

    OpenAIRE

    Carlos Rodrigo Camara-Lemarroy; Emmanuel Irineo González-Moreno; René Rodríguez-Gutiérrez; Erick Joel Rendón-Ramírez; Ana Sofía Ayala-Cortés; Martha Lizeth Fraga-Hernández; Laura García-Labastida; Dionicio Ángel Galarza-Delgado

    2014-01-01

    Mucormycosis (MCM) is a life-threatening infection that carries high mortality rates despite recent advances in its diagnosis and treatment. The objective was to report 14 cases of mucormycosis infection and review the relevant literature. We retrospectively analyzed the demographic and clinical data of 14 consecutive patients that presented with MCM in a tertiary-care teaching hospital in northern Mexico. The mean age of the patients was 39.9 (range 5–65). Nine of the patients were male. Ten...

  18. Smoking status influences clinical outcome in collagenous colitis

    DEFF Research Database (Denmark)

    Andreas, Munch; Curt, Tysk; Johan, Bohr; Ahmed, Madisch; Bonderup, Ole Kristian; Ralf, Mohrbacher; Ralph, Mueller; Roland, Greinwald; Magnus, Ström; Stephan, Miehlke

    2015-01-01

    BACKGROUND: The relationship between clinical and histological parameters in collagenous colitis (CC) is poorly understood. Smoking is a risk factor for CC, whereas its impact on clinical activity and outcome is not well-known. METHODS: In a post-hoc analysis from pooled data of two randomized...... collagen band, inflammation of the lamina propria, total numbers of intraepithelial lymphocytes, degeneration). Moreover, we analyzed the predictive value of baseline parameters on clinical outcome in a logistic regression model. RESULTS: Pooled data from 202 patients with active CC were available thereof...

  19. A hospital-based matched case–control study to identify clinical outcome and risk factors associated with carbapenem-resistant Klebsiella pneumoniae infection

    Directory of Open Access Journals (Sweden)

    Correa Luci

    2013-02-01

    Full Text Available Abstract Background Healthcare-associated infections caused by Klebsiella pneumoniae isolates are increasing and few effective antibiotics are currently available to treat patients. We observed decreased carbapenem susceptibility among K. pneumoniae isolated from patients at a tertiary private hospital that showed a phenotype compatible with carbapenemase production although this group of enzymes was not detected in any sample. The aim of this study was to describe the epidemiology and clinical outcomes associated with carbapenem-resistant K. pneumoniae and to determine the antimicrobial resistance mechanisms. Methods Risk factors associated with carbapenem-resistant K. pneumoniae infections were investigated by a matched case–control study from January 2006 through August 2008. A cohort study was also performed to evaluate the association between carbapenem resistance and in-hospital mortality. Bacterial identification and antimicrobial susceptibility were determined by Vitek 2 and Etest. Carbapenemase activity was detected using spectrophotometric assays. Production of beta-lactamases and alterations in genes encoding K. pneumoniae outer membrane proteins, OmpK35 and OmpK36, were analyzed by PCR and DNA sequencing, as well as SDS-Page. Genetic relatedness of carbapenem resistant isolates was evaluated by Pulsed Field Gel Electrophoresis. Results Sixty patients were included (20 cases and 40 controls in the study. Mortality was higher for patients with carbapenem-resistant K. pneumoniae infections compared with those with carbapenem-susceptible K. pneumoniae (50.0% vs 25.7%. The length of central venous catheter use was independently associated with carbapenem resistance in the multivariable analysis. All strains, except one, carried blaCTX-M-2, an extended-spectrum betalactamase gene. In addition, a single isolate also possessed blaGES-1. Genes encoding plasmid-mediated AmpC beta-lactamases or carbapenemases (KPC, metallo-betalactamases or

  20. A hospital-based matched case–control study to identify clinical outcome and risk factors associated with carbapenem-resistant Klebsiella pneumoniae infection

    Science.gov (United States)

    2013-01-01

    Background Healthcare-associated infections caused by Klebsiella pneumoniae isolates are increasing and few effective antibiotics are currently available to treat patients. We observed decreased carbapenem susceptibility among K. pneumoniae isolated from patients at a tertiary private hospital that showed a phenotype compatible with carbapenemase production although this group of enzymes was not detected in any sample. The aim of this study was to describe the epidemiology and clinical outcomes associated with carbapenem-resistant K. pneumoniae and to determine the antimicrobial resistance mechanisms. Methods Risk factors associated with carbapenem-resistant K. pneumoniae infections were investigated by a matched case–control study from January 2006 through August 2008. A cohort study was also performed to evaluate the association between carbapenem resistance and in-hospital mortality. Bacterial identification and antimicrobial susceptibility were determined by Vitek 2 and Etest. Carbapenemase activity was detected using spectrophotometric assays. Production of beta-lactamases and alterations in genes encoding K. pneumoniae outer membrane proteins, OmpK35 and OmpK36, were analyzed by PCR and DNA sequencing, as well as SDS-Page. Genetic relatedness of carbapenem resistant isolates was evaluated by Pulsed Field Gel Electrophoresis. Results Sixty patients were included (20 cases and 40 controls) in the study. Mortality was higher for patients with carbapenem-resistant K. pneumoniae infections compared with those with carbapenem-susceptible K. pneumoniae (50.0% vs 25.7%). The length of central venous catheter use was independently associated with carbapenem resistance in the multivariable analysis. All strains, except one, carried blaCTX-M-2, an extended-spectrum betalactamase gene. In addition, a single isolate also possessed blaGES-1. Genes encoding plasmid-mediated AmpC beta-lactamases or carbapenemases (KPC, metallo-betalactamases or OXA-carbapenemases) were not

  1. Developing core outcome sets for clinical trials: issues to consider

    Directory of Open Access Journals (Sweden)

    Williamson Paula R

    2012-08-01

    Full Text Available Abstract The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus.

  2. Functional outcomes for clinical evaluation of implant restorations.

    Science.gov (United States)

    Bassi, Francesco; Carr, Alan B; Chang, Ting-Ling; Estafanous, Emad W; Garrett, Neal R; Happonen, Risto-Pekka; Koka, Sreenivas; Laine, Juhani; Osswald, Martin; Reintsema, Harry; Rieger, Jana; Roumanas, Eleni; Salinas, Thomas J; Stanford, Clark M; Wolfaardt, Johan

    2013-01-01

    The functional outcomes related to treating patients afflicted with tooth loss are an important hallmark in substantiating prosthodontic intervention. The Oral Rehabilitation Outcomes Network (ORONet) conducted two international workshops to develop a core set of outcome measures, including a functional domain. The process followed the general format used in the Outcome Measures in Rheumatology (OMERACT) workshops to develop consensus for clinical outcome measures in arthritis research, which included: developing a comprehensive list of potential outcomes in the literature; submitting them to a filter for validity, clinical discrimination, and feasibility; and ranking those measures meeting all the filter criteria for relative value. The search was conducted to include functional assessments of speech, swallowing, mastication, nutrition, sensation, and motor function as they relate to dental implant therapies. This literature review surveyed 173 papers that produced some result of these descriptors in the functional domain. Of these, 67 papers reported on functional assessments and further defined objective and subjective outcomes. Many of these results were patient-perceived improvements in function, while others were objective assessments based on established methodologies and instruments. Objective evaluations of masticatory function and speech may meet criteria for validity and discriminability for selected interventions, but are generally not feasible for routine use in clinical care settings. The current recommendation is to employ a well-validated survey instrument that covers mastication and speech, such as the Oral Health Impact Profile (OHIP-14, short form), recognizing that patient perceptions of function may differ from objective ability. PMID:23998137

  3. Evaluation of the reliability and validity of the Medical Outcomes Study sleep scale in patients with painful diabetic peripheral neuropathy during an international clinical trial

    OpenAIRE

    Hays Ron D; Guillemin Isabelle; Martin Susan; Viala-Danten Muriel

    2008-01-01

    Abstract Background Sleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. A sleep problems index, grouping items from each of the former domains, is also available. This study evaluates the psychometric properties of MOS-Sleep Scale in a painful diabetic peripheral neuropathic populati...

  4. Short-term clinical outcomes of laser supported periodontal treatment concept using Er,Cr:YSGG (2780nm) and diode (940 nm): a pilot study

    Science.gov (United States)

    Odor, Alin A.; Violant, Deborah; Badea, Victoria; Gutknecht, Norbert

    2016-03-01

    Backgrounds: Er,Cr:YSGG (2780nm) and diode (940 nm) lasers can be used adjacent to the conventional periodontal treatment as minimally invasive non-surgical devices. Aim: To describe the short-term clinical outcomes by combining Er,Cr:YSGG (2780nm) and diode 940 nm lasers in non-surgical periodontal treatment. Materials and methods: A total of 10 patients with periodontal disease (mild, moderate, severe) - 233 teeth and 677 periodontal pockets ranging from 4 mm to 12 mm - were treated with Er,Cr:YSGG (2780nm) and diode (940 nm) lasers in adjunct to manual and piezoelectric scaling and root planning (SRP). Periodontal parameters such as mean probing depth (PD), mean clinical attachment level (CAL) and mean bleeding on probing (BOP) were evaluated at baseline and 6 months after the laser treatment using an electronic periodontal chart. Results: At baseline, the mean PD was 4.06 ± 1.06 mm, mean CAL was 4.56 ± 1.43 mm, and mean BOP was 43.8 ± 23.84 %. At 6 months after the laser supported periodontal treatments the mean PD was 2.6 ± 0.58 mm (p periodontal clinical parameters such as PD, CAL and BOP. Keywords: Laser supported periodontal treatment concept, Er,Cr:YSGG and diode 940nm lasers, Scaling and root planning, Minimally invasive non-surgical device

  5. Relationship between Angiographic Late Loss and 5-Year Clinical Outcome after Drug-Eluting Stent Implantation

    OpenAIRE

    Yang, Young-June; Shin, Sanghoon; Kim, Byeong-Keuk; Kim, Jung-Sun; Shin, Dong-Ho; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

    2012-01-01

    Purpose Currently, insufficient data exist to evaluate the relationship between angiographic late loss (LL) and long-term clinical outcome after drug-eluting stent (DES) implantation. In this study, we hypothesized that angiographic LL between 0.3 and 0.6 mm correlate with favorable long-term clinical outcomes. Materials and Methods Patients were enrolled in the present study if they had undergone both DES implantation in single coronary vessel and a subsequent follow-up angiogram (n=634). Th...

  6. Comparative study on the clinical outcomes of direct PTA and intravenous rtPA thrombolytic therapy for acute cerebral ischemic stroke

    International Nuclear Information System (INIS)

    The outcomes of direct percutaneous transluminal angioplasty (PTA) and intravenous recombinant tissue plasminogen activator (rtPA) were compared in the treatment of acute cerebral infarction. The comparative study was conducted on 25 consecutive cases treated by direct PTA before October 2005 and 25 cases treated by intravenous rtPA between October 2005 and March 2007. In the treatments with direct PTA for acute cerebral arterial occlusion, the blood clot was broken up with a balloon using MRI and MR angiography (MRA) as an indication, and urokinase was administered. In the direct PTA treatment group, the recanalization rate was 88%, the good outcome rate (mRS 0-2) was 52%, and the bleeding complication rate was 16%. In the intravenous rtPA group, on the other hand, comparable results were obtained with a good outcome rate (mRS 0-2) of 56% and a bleeding complication rate of 12%. The recanalization rate was higher in the direct PTA group, while the outcome and the complication rate were similar to those in the intravenous rtPA group. These findings suggest that the time elapsed after stoke until recanalization, rather than the recanalization rate, represents an important prognostic determinant in acute cerebral arterial occlusive diseases. (author)

  7. Clinical Features and Outcomes of Takotsubo (Stress) Cardiomyopathy

    OpenAIRE

    Templin, Christian; Ghadri, J R; Diekmann, J.; Napp, L C; Seifert, Burkhardt; et al

    2015-01-01

    BACKGROUND The natural history, management, and outcome of takotsubo (stress) cardiomyopathy are incompletely understood. METHODS The International Takotsubo Registry, a consortium of 26 centers in Europe and the United States, was established to investigate clinical features, prognostic predictors, and outcome of takotsubo cardiomyopathy. Patients were compared with age- and sex-matched patients who had an acute coronary syndrome. RESULTS Of 1750 patients with takotsubo cardiomyopathy, ...

  8. New Algorithm for Managing Childhood Illness Using Mobile Technology (ALMANACH): A Controlled Non-Inferiority Study on Clinical Outcome and Antibiotic Use in Tanzania

    Science.gov (United States)

    Shao, Amani Flexson; Rambaud-Althaus, Clotilde; Samaka, Josephine; Faustine, Allen Festo; Perri-Moore, Seneca; Swai, Ndeniria; Mitchell, Marc; Genton, Blaise; D’Acremont, Valérie

    2015-01-01

    Introduction The decline of malaria and scale-up of rapid diagnostic tests calls for a revision of IMCI. A new algorithm (ALMANACH) running on mobile technology was developed based on the latest evidence. The objective was to ensure that ALMANACH was safe, while keeping a low rate of antibiotic prescription. Methods Consecutive children aged 2–59 months with acute illness were managed using ALMANACH (2 intervention facilities), or standard practice (2 control facilities) in Tanzania. Primary outcomes were proportion of children cured at day 7 and who received antibiotics on day 0. Results 130/842 (15∙4%) in ALMANACH and 241/623 (38∙7%) in control arm were diagnosed with an infection in need for antibiotic, while 3∙8% and 9∙6% had malaria. 815/838 (97∙3%;96∙1–98.4%) were cured at D7 using ALMANACH versus 573/623 (92∙0%;89∙8–94∙1%) using standard practice (pantibiotics were prescribed to 15∙4% (12∙9–17∙9%) using ALMANACH versus 84∙3% (81∙4–87∙1%) using standard practice (pantibiotic secondarily. Conclusion Management of children using ALMANACH improve clinical outcome and reduce antibiotic prescription by 80%. This was achieved through more accurate diagnoses and hence better identification of children in need of antibiotic treatment or not. The building on mobile technology allows easy access and rapid update of the decision chart. Trial Registration Pan African Clinical Trials Registry PACTR201011000262218 PMID:26161535

  9. Mushroom poisoning in children: clinical presentation and outcome

    International Nuclear Information System (INIS)

    A variable clinical picture characterizes mushroom poisoning. The Amatoxin, the main toxic component of these fungi, are responsible for gastrointestinal symptoms as well as hepatic and renal failure. As acute gastroenteritis is extremely common in our set up, so every patient presenting with these symptoms is treated as gastroenteritis of viral aetiology. The authors present the clinical picture of the phalloid syndrome, its treatment and immediate outcome. All children age less than 16 years admitted in Saidu Hospital Swat from January to December 2006 with mushroom poisoning were included in the study. Patients with doubtful history or with associated illness were not included. The diagnosis was based on the clinical picture of the patient, history and the laboratory data. In addition to maintenance of fluid and electrolyte balance and treating sepsis, oral Silymarin and intravenous penicillin was started. Liver function tests, renal functions tests, serum electrolytes and coagulation profile was done in all the patients. The severity of poisoning was graded according to hepatic transaminase elevations and prolongation of prothrombin time. Of the 18 patients, fifteen were above five years of age. Female were twice in number. Fifteen patients developed hepatic failure and three patients developed renal failure. Thirteen patients expired. To start timely management, Mushroom poisoning should be considered in the differential diagnosis in patients presenting with food poisoning particularly coming in groups. Delay in diagnosis is associated with high mortality. (author)

  10. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Children & Clinical Studies NHLBI Trials Clinical Trial Websites Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to ...

  11. Clinical Profile and Outcome of Japanese Encephalitis in Children Admitted with Acute Encephalitis Syndrome

    OpenAIRE

    Gitali Kakoti; Prafulla Dutta; Bishnu Ram Das; Jani Borah; Jagadish Mahanta

    2013-01-01

    Japanese encephalitis (JE) is an arthropod borne viral disease. Children are most commonly affected in Southeast Asian region showing symptoms of central nervous system with several complications and death. The clinical characteristics and outcomes in pediatric JE patients hospitalized with acute encephalitis syndrome (AES) are still poorly understood. A prospective study was conducted in pediatric ward of Assam Medical College Hospital to evaluate the clinical profile and outcome of JE in ch...

  12. Thoracic outlet syndrome: do we have clinical tests as predictors for the outcome after surgery?

    Directory of Open Access Journals (Sweden)

    Sadeghi-Azandaryani M

    2009-09-01

    Full Text Available Abstract Objective Thoracic outlet syndrome (TOS is a clinical phenomenon resulting from compression of the neurovascular structures at the superior aperture of the thorax which presents with varying symptoms. Regarding to the varying symptoms, the diagnosis of TOS seems to be a challenge and predictors for the outcome are rare. The purpose of this study was therefore to analyze the different clinical examinations and tests relative to their prediction of the clinical outcome subsequent to surgery. Methods During a period of five years, 56 patients were diagnosed with TOS. Medical history, clinical tests, operative procedure and complications were recorded and analysed. Mean follow-up of the patients was 55.6 ± 45.5 months, median age of the patients was 36.4 ± 12.5 years. Results Different clinical tests for TOS showed an acceptable sensitivity overall, but a poor specificity. A positive test was not associated with a poor outcome. Analyses of the systolic blood pressure before and after exercise showed, that a distinct decrease in blood pressure of the affected side after exercises was associated with a poor outcome (p = 0.0027. Conclusions Clinical tests for TOS show a good sensitivity, but a poor specificity and cannot be used as predictors for the outcome. A distinct decrease in blood pressure of the affected side after exercises was associated with poor outcome and might be useful to predict the patients' outcome.

  13. Patterns and clinical outcomes of lithium treatment

    OpenAIRE

    Wilting, I.

    2008-01-01

    Patterns and consequences of lithium use’. In chapter 2.1 we studied lithium use patterns in out-patients within the last decade. In line with the increase in alternatives and the Dutch guidelines, we observed an increase in use of atypical antipsychotics and valproic acid and a decrease in use tricyclic antidepressants next to lithium. In chapter 2.2 we assessed the association between mood state and patient reported ADRs. The prevalence and the severity of ADRs increased with decreasing moo...

  14. Short Term Clinical Outcome of Percutaneous Vertebroplasty

    Directory of Open Access Journals (Sweden)

    Masoud Nemati

    2009-01-01

    Full Text Available "nIntroduction: The first case of percutaneous vertebroplasty (PV was performed by French radiologists in 1984 for the treatment of vertebral hemangioma. Nowadays this procedure is useful in the treatment of osteoporotic compression fracures, hemangiomas, osteolytic metastasis and vertebral involvement by multiple myeloma. We carried out this study to clarify the short term results of PV in reducing the pain and disabilities of these patients. "nMaterials and Methods: From September 2008 to December 2008, 20 patients with compression fracture, hemangioma and metastasis to the lumbar vertebral bodies underwent PV and short term postprocedural results were studied by Visual Analogue Scale (VAS and Oswestry Low Back Pain Disability Questionnaire (Oswestry LBPDQ and the results were compared with preprocedural measurements. "nResults: Comparison of pre and postprocedural VAS and Oswestry LBPDQ, showed a statistically meaningful decrease in pain intensity and improvement in functional ability of these patients post PV. No other significant side effect was detected. "nConclusion: PV is safe and effective in the treatment of vertebral compression fractures in the above mentioned groups. "nKeywords: Percutaneous Vertebroplasty (PV, Visual Analogue Scale (VAS, Oswestry Low Back Pain, Diasability Questionnaire  

  15. Introducing an online community into a clinical education setting: a pilot study of student and staff engagement and outcomes using blended learning

    Directory of Open Access Journals (Sweden)

    Tobin Jacinta

    2010-01-01

    Full Text Available Abstract Background There are growing reasons to use both information and communication functions of learning technologies as part of clinical education, but the literature offers few accounts of such implementations or evaluations of their impact. This paper details the process of implementing a blend of online and face-to-face learning and teaching in a clinical education setting and it reports on the educational impact of this innovation. Methods This study designed an online community to complement a series of on-site workshops and monitored its use over a semester. Quantitative and qualitative data recording 43 final-year medical students' and 13 clinical educators' experiences with this blended approach to learning and teaching were analysed using access, adoption and quality criteria as measures of impact. Results The introduction of the online community produced high student ratings of the quality of learning and teaching and it produced student academic results that were equivalent to those from face-to-face-only learning and teaching. Staff had mixed views about using blended learning. Conclusions Projects such as this take skilled effort and time. Strong incentives are required to encourage clinical staff and students to use a new mode of communication. A more synchronous or multi-channel communication feedback system might stimulate increased adoption. Cultural change in clinical teaching is also required before clinical education can benefit more widely from initiatives such as this.

  16. Clinical outcome of endonasal KTP laser assisted dacryocystorhinostomy

    Directory of Open Access Journals (Sweden)

    Carrie Sean

    2005-03-01

    Full Text Available Abstract Background To evaluate the clinical outcome of primary endonasal laser assisted dacryocystorhinostomy (ENL-DCR using the potassium-titanyl-phosphate laser. Methods We retrospectively reviewed all primary ENL-DCRs performed within a period of twelve months by the same combined Ophthalmology and Otorhinolaringology team in Freeman Hospital, Newcastle upon Tyne, UK. The main outcome measure for success was resolution or significant improvement of epiphora. Details of surgery, intraoperative and postoperative complications, as well as pathology associated with failure were also studied. Patients were followed up for at least 12 months. Results A total of 41 consecutive ENL-DCRs on 29 patients (22 females, 7 males, mean age 75 years were analysed. All patients had bicanalicular silicone intubation for at least 4 months. The success rate at 12 months postoperatively was 78.1%. Pathology associated with failure included: intranasal pathology (12.2%, mucocele (7.3%, and systemic sarcoidosis (2.4%. No significant intra-operative complications were recorded. Conclusion The ENL-DCR with potassium-titanyl-phosphate laser can be considered as a safe and efficient primary procedure for the treatment of nasolacrimal duct obstruction.

  17. Myasthenia gravis and pregnancy: clinical implications and neonatal outcome

    OpenAIRE

    Estanol Bruno; Salinas Vicente; Hernández-Ronquillo Lizbeth; Téllez-Zenteno José F; da Silva Orlando

    2004-01-01

    Abstract Background The myasthenia gravis is twice as common in women as in men and frequently affects young women in the second and third decades of life, overlapping with the childbearing years. Generally, during pregnancy in one third of patients the disease exacerbates, whereas in two thirds it remains clinically unchanged. Complete remission can occur in some patients. Methods To describe the clinical course, delivery and neonatal outcome of 18 pregnant women with the diagnosis of myasth...

  18. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & Clinical Studies NHLBI Trials Clinical Trial Websites ...

  19. Centralization of Esophageal Cancer Surgery: Does It Improve Clinical Outcome?

    NARCIS (Netherlands)

    M.W.J.M. Wouters (Michael); H.E. Karim-Kos (Henrike); S. le Cessie (Saskia); B.P.L. Wijnhoven (Bas); L.P. Stassen; W.H. Steup (Willem Hans); H.W. Tilanus (Hugo); R.A.E.M. Tollenaar (Rob)

    2009-01-01

    textabstractBackground: The volume-outcome relationship for complex surgical procedures has been extensively studied. Most studies are based on administrative data and use in-hospital mortality as the sole outcome measure. It is still unknown if concentration of these procedures leads to improvement

  20. Multisystemic Therapy(®) : Clinical Overview, Outcomes, and Implementation Research.

    Science.gov (United States)

    Henggeler, Scott W; Schaeffer, Cindy M

    2016-09-01

    Multisystemic therapy (MST) is an evidence-based treatment originally developed for youth with serious antisocial behavior who are at high risk for out-of-home placement and their families; and subsequently adapted to address other challenging clinical problems experience by youths and their families. The social-ecological theoretical framework of MST is presented as well as its home-based model of treatment delivery, defining clinical intervention strategies, and ongoing quality assurance/quality improvement system. With more than 100 peer-reviewed outcome and implementation journal articles published as of January 2016, the majority by independent investigators, MST is one of the most extensively evaluated family based treatments. Outcome research has yielded almost uniformly favorable results for youths and families, and implementation research has demonstrated the importance of treatment and program fidelity in achieving such outcomes. PMID:27370172

  1. Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure

    Science.gov (United States)

    Trujillo, Adriana; Feixas, Guillem; Bados, Arturo; García-Grau, Eugeni; Salla, Marta; Medina, Joan Carles; Montesano, Adrián; Soriano, José; Medeiros-Ferreira, Leticia; Cañete, Josep; Corbella, Sergi; Grau, Antoni; Lana, Fernando; Evans, Chris

    2016-01-01

    Objective The objective of this paper is to assess the reliability and validity of the Spanish translation of the Clinical Outcomes in Routine Evaluation – Outcome Measure, a 34-item self-report questionnaire that measures the client’s status in the domains of Subjective well-being, Problems/Symptoms, Life functioning, and Risk. Method Six hundred and forty-four adult participants were included in two samples: the clinical sample (n=192) from different mental health and primary care centers; and the nonclinical sample (n=452), which included a student and a community sample. Results The questionnaire showed good acceptability and internal consistency, appropriate test–retest reliability, and acceptable convergent validity. Strong differentiation between clinical and nonclinical samples was found. As expected, the Risk domain had different characteristics than other domains, but all findings were comparable with the UK referential data. Cutoff scores were calculated for clinical significant change assessment. Conclusion The Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure showed acceptable psychometric properties, providing support for using the questionnaire for monitoring the progress of Spanish-speaking psychotherapy clients.

  2. Total elbow arthroplasty: a radiographic outcome study

    Energy Technology Data Exchange (ETDEWEB)

    Bai, Xue Susan [University of Washington, Department of Radiology, Box 357115, Seattle, WA (United States); Petscavage-Thomas, Jonelle M. [Penn State Hershey Medical Center, Department of Radiology, Hershey, PA (United States); Ha, Alice S. [University of Washington, Department of Radiology, Box 354755, Seattle, WA (United States)

    2016-06-15

    Total elbow arthroplasty (TEA) is becoming a popular alternative to arthrodesis for patients with end-stage elbow arthrosis and comminuted distal humeral fractures. Prior outcome studies have primarily focused on surgical findings. Our purpose is to determine the radiographic outcome of TEA and to correlate with clinical symptoms such as pain. This is an IRB-approved retrospective review from 2005 to 2015 of all patients with semiconstrained TEA. All available elbow radiographs and clinical data were reviewed. Data analysis included descriptive statistics and Kaplan-Meier survival curves for radiographic and clinical survival. A total of 104 total elbow arthroplasties in 102 patients were reviewed; 75 % were in women and the mean patient age was 63.1 years. Mean radiographic follow-up was 826 days with average of four radiographs per patient. Seventy TEAs (67 %) developed radiographic complications, including heterotopic ossification (48 %), perihardware lucency (27 %), periprosthetic fracture (23 %), hardware subluxation/dislocation (7 %), polyethylene wear (3 %), and hardware fracture/dislodgement (3 %); 56 patients (55 %) developed symptoms of elbow pain or instability and 30 patients (30 %) underwent at least one reoperation. In patients with radiographic complications, 66 % developed elbow pain, compared to 19 % of patients with no radiologic complications (p = 0.001). Of the patients with radiographic complications, 39 % had at least one additional surgery compared to 0 % of patients without radiographic complications (p = 0.056). Radiographic complications are common in patients after total elbow arthroplasty. There is a strong positive association between post-operative radiographic findings and clinical outcome. Knowledge of common postoperative radiographic findings is important for the practicing radiologist. (orig.)

  3. COMPARATIVE STUDY OF CLINICAL OUTCOME OF ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION BONE PATELLAR TENDON BONE GRAFT V/S HAMSTRING GRAFT

    Directory of Open Access Journals (Sweden)

    Priyank

    2015-08-01

    fulfilling the predetermined inclusion and exclusion criteria were included in the study. STATISTICAL METHODS : Intergroup comparison was analysed by K - Independent sample t test. Intragroup comparison was analysed by Paired t - test. RESULTS : Patients were divided into two groups and treated with using Bone - patellar tendon - bone graft and Hamstring graft respectively. Mean age group of patients was 29.16 yrs. (range 16 - 51yrs and 30.88 yrs. (range 19 - 48yrs in group A and B respectively we found the incidence of ACL injury in 15 - 44 years age group to be greater than twice the general population. A mean delay in surgery of 4.66 months (range 2 - 12 months since the time of injury in group A and 4.46 months (range 2 - 7 months in group B was observed. Subjective IKDC evaluation was done at the end of 12 months. Ther e was no difference in both the groups in the terms of effusion, passive motion, knee compartment findings, ligament examination, X - ray findings. Functional test and IKDC grade of both the groups showed statistically very highly significant improvement. Ho wever, there was statistically very high Harvest site pathology in group A. CONCLUSION : We found that there is statistically no significant difference in the overall clinical outcome between hamstring autograft with transfix and bone - patellar tendon bone autograft with interference screw except that the patellar tendon group had a greater tendency of having donor site morbidity compared to the hamstring tendon group.

  4. Clinical presentations and outcomes of Filipino juvenile systemic lupus erythematosus

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    Dans Leonila F

    2011-02-01

    Full Text Available Abstract Objective Juvenile Systemic Lupus Erythematosus (SLE varies by location and ethnicity. This study describes the clinical, laboratory profile and outcome of juvenile SLE seen at Philippine General Hospital (PGH from 2004-2008. Method Medical charts of all Filipino Juvenile SLE cases admitted at PGH during the 5-year period were reviewed collecting demographic profile, clinical and laboratory manifestations and treatment during disease course. Results Seventy-eight cases of juvenile SLE were reviewed. There were 7 boys and 71 girls. The mean age at diagnosis was 14 years (SD 2.7 with a range of 8-18 years. Fever (52.5% and malar rash (41.0% were the most common features at disease onset. At the time of diagnosis, the most common features were malar rash (65.3%, renal involvement (62.8% and photosensitivity (55.1%. Mucocutaneous (92.3%, renal (71.7% and hematologic (69.2% involvement were the most common features during the entire course of illness. Infection (34.5% and neurologic (19.0% complications were observed most frequently. Corticocosteroid treatment was given in most of the patients in the form of prednisone (97.4% and concomitant methylprednisolone intravenous pulses (29.4%. Nine patients died during the study period. The overall 5-year mortality rate was 11.5%. Infection (77.0% was the most frequent cause of death. Conclusion Malar rash was a common feature at disease onset and at diagnosis among Filipinos with juvenile SLE. Throughout the disease course, renal involvement occurs in 71.7% of patients. Infection was the leading cause of complication and death. The clinical presentations of Filipinos with juvenile SLE were similar to juvenile SLE in other countries.

  5. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis

    Science.gov (United States)

    Goldman, Myla D.; Motl, Robert W.; Rudick, Richard A.

    2010-01-01

    Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite (MSFC). These measures each have strengths and some weakness. Two additional measures, the six-minute walk and accelerometry, show promise in augmenting current measures. MS therapeutics is a quickly advancing field which requires sensitive clinical outcome measures that can detect small changes in disability that reliably reflect long-term changes in sustained disease progression in a complex population. A single clinical outcome measure of sustained disease progression may remain elusive. Rather, an integration of current and new outcome measures may be most appropriate and utilization of different measures depending on the MS population and stage of the disease may be preferred. PMID:21179614

  6. Metaphyseal locking plate as a definitive external fixator for treating open tibial fractures--clinical outcome and a finite element study.

    Science.gov (United States)

    Ma, Ching-Hou; Wu, Chin-Hsien; Tu, Yuan-Kun; Lin, Ting-Sheng

    2013-08-01

    We evaluated both the outcome of using a locking plate as a definitive external fixator for treating open tibial fractures and, using finite element analysis, the biomechanical performance of external and internal metaphyseal locked plates in treating proximal tibial fractures. Eight open tibial patients were treated using a metaphyseal locked plate as a low-profile definitive external fixator. Then, finite element models of internal (IPF) as well as two different external plate fixations (EPFs) for proximal tibial fractures were reconstructed. The offset distances from the bone surface to the EPFs were 6 cm and 10 cm. Both axial stiffness and angular stiffness were calculated to evaluate the biomechanical performance of these three models. The mean follow-up period was 31 months (range, 18-43 months). All the fractures united and the mean bone healing time was 37.5 weeks (range, 20-52 weeks). All patients had excellent or good functional results and were walking freely at the final follow-up. The finite element finding revealed that axial stiffness and angular stiffness decreased as the offset distance from the bone surface increased. Compared to the IPF models, in the two EPF models, axial stiffness decreased by 84-94%, whereas the angular stiffness decreased by 12-21%. The locking plate used as a definitive external fixator provided a high rate of union. While the locking plate is not totally rigid, it is clinically stable and may be advisable for stiffness reduction of plating constructs, thus promoting fracture healing by callus formation. Our patients experienced a comfortable clinical course, excellent knee and ankle joint motion, satisfactory functional results and an acceptable complication rate. PMID:23706173

  7. Are the outcomes of clinical pathways evidence-based? A critical appraisal of clinical pathway evaluation research

    OpenAIRE

    El Baz, N.; Middel, B.; van Dijk, J. P.; Oosterhof, A.; Boonstra, P.W.; Reijneveld, S.A.

    2007-01-01

    Aim and objective To evaluate the validity of study outcomes of published papers that report the effects of clinical pathways (CP). Method Systematic review based on two search strategies, including searching Medline, CINAHL, Embase, Psychinfo and Picarta from 1995 till 2005 and ISI Web of Knowledge (SM). We included randomized controlled or quasi-experimental studies evaluating the efficacy of clinical pathway application. Assessment of the methodological quality of the studies included rand...

  8. Clinical outcomes assessment in clinical trials to assess treatment of femoroacetabular impingement

    DEFF Research Database (Denmark)

    Harris-Hayes, Marcie; McDonough, Christine M; Leunig, Michael;

    2013-01-01

    Patient-reported outcome measures are an important component of outcomes assessment in clinical trials to assess the treatment of femoroacetabular impingement (FAI). This review of disease-specific measures and instruments used to assess the generic quality of life and physical activity levels of...

  9. Clinical outcomes and prediction of survival following percutaneous biliary drainage for malignant obstructive jaundice

    OpenAIRE

    Zhang, Guang Yuan; LI, WEN TAO; PENG, WEI JUN; LI, GUO DONG; HE, XIN HONG; XU, LI CHAO

    2014-01-01

    The present study aimed to investigate the clinical outcomes of percutaneous transhepatic biliary drainage in patients with obstructive jaundice and identify potential predictors of patient survival. Clinical data from 102 patients (66 males and 36 females; median age, 63.50 years; range, 29–84 years) with a mean (± standard deviation) pre-drainage serum bilirubin level of 285.4 (±136.7 μmol/l), were retrospectively studied. Technical and clinical success, complications and survival time were...

  10. Preoperative indicators of clinical outcome following stereotaxic pallidotomy.

    Science.gov (United States)

    Kazumata, K; Antonini, A; Dhawan, V; Moeller, J R; Alterman, R L; Kelly, P; Sterio, D; Fazzini, E; Beric, A; Eidelberg, D

    1997-10-01

    We assessed the utility of preoperative clinical assessment and functional brain imaging with 18F-fluorodeoxyglucose (FDG) and positron emission tomography (PET) in predicting the clinical outcome of stereotaxic pallidotomy for the treatment of advanced Parkinson's disease (PD). Twenty-two PD patients undergoing posteroventral pallidotomy were assessed preoperatively with the Core Assessment Program for Intracerebral Transplantation (CAPIT) ratings measured on and off levodopa; quantitative FDG/PET was also performed before surgery. Preoperative clinical and metabolic measurements were correlated with changes in off-state CAPIT ratings determined 3 months after surgery. Clinical outcome following pallidotomy was also correlated with intraoperative measures of spontaneous pallidal single-unit activity as well as postoperative MRI measurements of lesion volume and location. We found that unilateral pallidotomy resulted in variable clinical improvement in off-state CAPIT scores for the contralateral limbs (mean change 30.9 +/- 15.5%). Postoperative MRI revealed that pallidotomy lesions were comparable in location and volume across the patients. Clinical outcome following surgery correlated significantly with preoperative measures of CAPIT score change with levodopa administration (r = 0.60, p < 0.005) and with preoperative FDG/PET measurements of lentiform glucose metabolism (r = 0.71, p < 0.0005). Operative outcome did not correlate with intraoperative measures of spontaneous pallidal neuronal firing rate. We conclude that preoperative measurements of lentiform glucose metabolism and levodopa responsiveness may be useful indicators of motor improvement following pallidotomy. Both preoperative quantitative measures, either singly or in combination, may be helpful in selecting optimal candidates for surgery. PMID:9339694

  11. Clinical outcome study and radiological findings of Zweymuller metal on metal total hip arthroplasty. a follow-up of 6 to 15 years.

    Science.gov (United States)

    Paleochorlidis, Ilias S; Badras, Leonidas S; Skretas, Efstathios F; Georgaklis, Vasilios A; Karachalios, Theofilos S; Malizos, Konstantinos N

    2009-01-01

    We report the clinical and radiological outcome of 99 Zweymuller metal on metal total hip arthroplasties in 84 patients followed up prospectively for a mean period of 9.5 (range, 6-15) years. There were 29 (34.5%) male and 55 (65.5%) female patients with a mean age of 62.85 years (range, 50-70 years) at the time of surgery. All patients had osteoarthritis. One acetabular component and one stem were revised due to aseptic loosening. One femoral stem was revised due to a periprosthetic fracture. HHS score improved from a preoperative mean of 62.56 points (SD 8.87) to a final postoperative follow-up mean of 93.48 (SD 7.7). Cumulative success rate for both implants at 13 years, with aseptic loosening as the end point, was 97.05%, while for both implants at 13 years, with revision for any reason as the end point, it was 91.17%. Satisfactory results were observed with the use of this prosthesis. PMID:20041375

  12. The NordiNet® International Outcome Study and NovoNet® ANSWER Program®: rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin®

    Directory of Open Access Journals (Sweden)

    Höybye C

    2013-04-01

    Full Text Available Charlotte Höybye,1 Lars Sävendahl,2 Henrik Thybo Christesen,3 Peter Lee,4 Birgitte Tønnes Pedersen,5 Michael Schlumpf,6 John Germak,7 Judith Ross8 1Department of Molecular Medicine and Surgery, Karolinska Institute and Department of Endocrinology, Metabolism and Diabetes, 2Department of Women’s and Children’s Health, Karolinska Institute and Division of Pediatrics, Karolinska University Hospital, Stockholm, Sweden; 3Hans Christian Andersen Children’s Hospital, Odense University Hospital, Odense, Denmark; 4Department of Pediatrics, Penn State College of Medicine, Hershey, PA, USA; 5Global Development, Novo Nordisk A/S, Søborg, Denmark; 6Global Medical Affairs Biopharm, Novo Nordisk Health Care AG, Zurich, Switzerland; 7Clinical Development and Medical Affairs, Novo Nordisk Inc, Princeton, NJ, USA; 8Department of Pediatrics, Thomas Jefferson University, Philadelphia, PA, USA Objective: Randomized controlled trials have shown that growth hormone (GH therapy has effects on growth, metabolism, and body composition. GH therapy is prescribed for children with growth failure and adults with GH deficiency. Carefully conducted observational study of GH treatment affords the opportunity to assess long-term treatment outcomes and the clinical factors and variables affecting those outcomes, in patients receiving GH therapy in routine clinical practice. Design: The NordiNet® International Outcome Study (IOS and the American Norditropin® Studies: Web Enabled Research (ANSWER Program® are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepidemiological data. Patients: The studies include pediatric and adult patients receiving Norditropin®, as prescribed by their physicians. Measurements: The studies gather long-term data on the safety and effectiveness of real-life treatment with the recombinant human GH, Norditropin®. We describe the origins, aims, objectives, and design methodology of

  13. Treatment outcomes in patients with internet addiction: a clinical pilot study on the effects of a cognitive-behavioral therapy program.

    Science.gov (United States)

    Wölfling, K; Beutel, M E; Dreier, M; Müller, K W

    2014-01-01

    Internet addiction is regarded as a growing health concern in many parts of the world with prevalence rates of 1-2% in Europe and up to 7% in some Asian countries. Clinical research has demonstrated that Internet addiction is accompanied with loss of interests, decreased psychosocial functioning, social retreat, and heightened psychosocial distress. Specialized treatment programs are needed to face this problem that has recently been added to the appendix of the DSM-5. While there are numerous studies assessing clinical characteristics of patients with Internet addiction, the knowledge about the effectiveness of treatment programs is limited. Although a recent meta-analysis indicates that those programs show effects, more clinical studies are needed here. To add knowledge, we conducted a pilot study on the effects of a standardized cognitive-behavioral therapy program for IA. 42 male adults meeting criteria for Internet addiction were enrolled. Their IA-status, psychopathological symptoms, and perceived self-efficacy expectancy were assessed before and after the treatment. The results show that 70.3% of the patients finished the therapy regularly. After treatment symptoms of IA had decreased significantly. Psychopathological symptoms were reduced as well as associated psychosocial problems. The results of this pilot study emphasize findings from the only meta-analysis conducted so far. PMID:25097858

  14. Investigation into the causes of indwelling urethral catheter implementation and its effects on clinical outcomes and health care resources among dementia patients with pneumonia: A retrospective cohort study.

    Science.gov (United States)

    Maeda, Toshiki; Babazono, Akira; Nishi, Takumi; Yasui, Midori; Harano, Yumi

    2016-08-01

    There is a possibility that unnecessary treatments and low-quality medical care, such as inappropriate indwelling urethral catheter use, are being provided to older Japanese individuals.The aim of this study was to investigate contextual effects relating to indwelling urethral catheters in older people with dementia and to clarify the effects of indwelling urethral catheter use on patients' mortality, length of stay (LOS), and health care spending. This retrospective cohort study involved 4501 male and female Japanese participants. Those who were aged 75 or older with dementia and had a primary diagnosis of acute lower respiratory disease with antibiotics administered during hospitalization were eligible for inclusion. Patient mortality, LOS, and total charge during hospitalization were the main study outcomes. This study showed that indwelling urethral catheter use was significantly associated with higher mortality, longer LOS, and higher total charge for hospitalization. The pattern of indwelling urethral catheter use was clustered by care facility level. Physician density was significantly associated with indwelling urethral catheter use; the relationship was not linear but U-shaped, such that the approximate median had the lowest rate of urethral catheter use and this increased gradually toward both lower and higher physician densities. Our study found considerable variation in indwelling urethral catheter use between care facilities in older people with dementia. Additionally, indwelling urethral catheter use was related to poor outcomes. Based on these findings, we consider there to be an urgent need for constructing a framework to measure, report on, and promote the improvement of care quality for older individuals in Japan. PMID:27583898

  15. Beyond the Basics of Clinical Outcomes Assessment: Selecting Appropriate Patient-Rated Outcomes Instruments for Patient Care

    Science.gov (United States)

    Valier, Alison R.; Lam, Kenneth C.

    2015-01-01

    The fifth edition of the "Athletic Training Education Competencies" emphasizes the concepts of clinical outcomes assessment. In athletic training, clinical outcomes assessment, especially as it relates to patient-rated outcomes (PRO) instruments, is new, which produces uncertainty with regard to how to integrate PROs into athletic…

  16. Clinical attributes and surgical outcomes of angiocentric gliomas.

    Science.gov (United States)

    Ampie, Leonel; Choy, Winward; DiDomenico, Joseph D; Lamano, Jonathan B; Williams, Christopher Kazu; Kesavabhotla, Kartik; Mao, Qinwen; Bloch, Orin

    2016-06-01

    Angiocentric gliomas (AG) are exceedingly rare low-grade neoplasms which often present in the form of intractable epilepsy within younger patients. The current study extensively reviews all reported cases which were pathologically verified as AG in the literature to analyze clinical attributes and surgical outcomes of this neoplasm. There were 88 patients with AG reported in the literature consisting mostly of pediatric cases. The sex distribution consisted of 45 males and 36 females with the remaining seven cases not documenting sex. The average age of initial diagnosis was 16years with almost half of all diagnosed patients being within the first decade of life. In cases where extent of resection was reported, gross total resection (GTR) was achieved in 54 patients, subtotal resection (STR) in 16, and biopsy only in three. Post-operative complications were transient and only occurred in three patients with no reports of death following surgery. Only five cases reported tumor recurrence on follow-up. Eight patients had seizure recurrence post-operatively and GTR offered improved rates of seizure control when compared to STR (p=0.0005). Nearly half of the cases of AG are diagnosed within the first decade of life and they usually manifest with intractable seizures. GTR appears to offer better seizure control in the post-operative period. Surgical resection is the mainstay therapy for AG as post-operative complications and tumor recurrence remain uncommon. Since the number of reported cases is limited, future studies with longer follow-up periods will help elaborate more long-term outcomes. PMID:26778052

  17. Sex differences in clinical characteristics and outcomes after myocardial infarction

    DEFF Research Database (Denmark)

    Lam, Carolyn S P; McEntegart, Margaret; Claggett, Brian;

    2015-01-01

    BACKGROUND: We examined the association of sex with clinical characteristics and outcomes in patients following myocardial infarction (MI) in the Valsartan in Acute Myocardial Infarction Trial (VALIANT). METHODS AND RESULTS: A total of 4570 women and 10 133 men with heart failure (HF), left...... ejection fractions and similar changes in ventricular volumes from baseline to 1 month and 20 months. CONCLUSIONS: In VALIANT, the risk of HF following MI was higher in women than men after adjusting for age and comorbidities, although the risk of other fatal and non-fatal outcomes were similar. The higher...

  18. Conduct problems in children. Characteristics of families recruited for a clinical outcome trial as compared to families in an implementation study

    OpenAIRE

    Solholm, Roar; Ogden, Terje; Jakobsen, Reidar

    2014-01-01

    The implementation of empirically supported treatments (EST) is recommended as a way to transfer knowledge fromresearch to clinical practice and to improve service quality. One area of concern has been client representativeness, that is to which degree participants in EST studies resembles the target group in usual care settings. For childrenwith conduct problems the recommended ESTs have been parent training or parentmediated programs. The aimof this article is to explore and des...

  19. Clinical spectrum and outcome of pulmonary nocardiosis: 5-year experience

    Science.gov (United States)

    Singh, Akashdeep; Chhina, Deepinder; Soni, RK; Kakkar, Chandan; Sidhu, US

    2016-01-01

    Background: Pulmonary nocardiosis is a rare but a life-threatening infection caused by Nocardia spp. The diagnosis is often missed and delayed resulting in delay in appropriate treatment and thus higher mortality. Aim: In this study, we aim to evaluate the clinical spectrum and outcome of patients with pulmonary nocardiosis. Methods: A retrospective, 5-year (2009–2014) review of demographic profile, risk factors, clinical manifestations, imaging findings, treatment, and outcome of patients with pulmonary nocardiosis admitted to a tertiary care hospital. Results: The median age of the study subjects was 54 years (range, 16–76) and majority of them (75%) were males. The risk factors for pulmonary nocardiosis identified in our study were long-term steroid use (55.6%), chronic lung disease (52.8%), diabetes (27.8%), and solid-organ transplantation (22.2%). All the patients were symptomatic, and the most common symptoms were cough (91.7%), fever (78%), and expectoration (72%). Almost two-third of the patients were initially misdiagnosed and the alternative diagnosis included pulmonary tuberculosis (n = 7), community-acquired pneumonia (n = 5), lung abscess (n = 4), invasive fungal infection (n = 3), lung cancer (n = 2), and Wegener's granulomatosis (n = 2). The most common radiographic features were consolidation (77.8%) and nodules (56%). The mortality rate for indoor patients was 33% despite treatment. Higher mortality rate was observed among those who had brain abscess (100.0%), HIV positivity (100%), need for mechanical ventilation (87.5%), solid-organ transplantation (50%), and elderly (age > 60 years) patients (43%). Conclusion: The diagnosis of pulmonary nocardiosis is often missed and delayed resulting in delay in appropriate treatment and thus high mortality. A lower threshold for diagnosing pulmonary nocardiosis needs to be exercised, in chest symptomatic patients with underlying chronic lung diseases or systemic immunosuppression, for the early diagnosis

  20. Effect of prehospital ultrasound on clinical outcomes of non-trauma patients

    DEFF Research Database (Denmark)

    Rudolph, Søren Steemann; Sørensen, Martin Kryspin; Svane, Christian;

    2014-01-01

    BACKGROUND: Advances in technology have made prehospital ultrasound (US) examination available. Whether US in the prehospital setting can lead to improvement in clinical outcomes is yet unclear. OBJECTIVE: The aim of this systematic review was to assess whether prehospital US improves clinical...... studies were of large heterogeneity and all showed a high risk of bias. We were thus unable to assess the effect of prehospital US on clinical outcomes. However, consistent reports suggested that US may improve patient management with respect to diagnosis, treatment, and hospital referral....

  1. Long-term clinical outcome in patients with stage-i nonseminomatous germ cell cancer: a critical review of own treatment modalities in a retrospective study

    Directory of Open Access Journals (Sweden)

    Sandra Seseke

    2008-12-01

    Full Text Available PURPOSE: The optimal management of patients with clinical stage I non-seminomatous germ cell testicular cancer (NSGCT I was considered controversial until the European Germ Cell Cancer Consensus Group determined unambiguous treatment strategies. In order to assess the long-term outcome we evaluated the data of patients with NSGCT I. MATERIALS AND METHODS: In a retrospective evaluation, we included 52 patients with a mean age of 26 years (range 15-58 who were treated with different modalities at our department between 1989 and 2003. Mean follow-up was 5.9 years (range 2-14 years. After orchiectomy, 39 patients were treated with chemotherapy, 7 patients underwent retroperitoneal lymph node dissection and 6 men were managed using a surveillance strategy. Survival, recurrence rate and time of recurrence were evaluated. The histological staging and treatment modality was related to the relapse. RESULTS: Tumor specific overall mortality was 3.8%. The mortality and relapse rate of the surveillance strategy, retroperitoneal lymph node dissection and chemotherapy was 16.7% / 50%, 14.3% / 14.3% and 0% / 2.5% respectively. All relapsed patients in the surveillance group as well as in the RPLND group had at least one risk factor for developing metastatic disease. CONCLUSIONS: Following the European consensus on diagnosis and treatment of germ cell cancer in patients with NSGCT Stage I any treatment decision must be individually related to the patient according to prognostic factors and care capacity of the treating centre. In case of doubt, adjuvant chemotherapy should be the treatment of choice, as it provides the lowest risk of relapse or tumor related death.

  2. Clinical outcome of stereotactic body radiotherapy for primary and oligometastatic lung tumors: a single institutional study with almost uniform dose with different five treatment schedules

    International Nuclear Information System (INIS)

    To evaluate clinical outcomes of stereotactic body radiotherapy (SBRT) for localized primary and oligometastatic lung tumors by assessing efficacy and safety of 5 regimens of varying fraction size and number. One-hundred patients with primary lung cancer (n = 69) or oligometastatic lung tumors (n = 31), who underwent SBRT between May 2003 and August 2010, were included. The median age was 75 years (range, 45–88). Of them, 98 were judged to have medically inoperable disease, predominantly due to chronic illness or advanced age. SBRT was performed using 3 coplanar and 3 non-coplanar fixed beams with a standard linear accelerator. Fraction sizes were escalated by 1 Gy, and number of fractions given was decreased by 1 for every 20 included patients. Total target doses were between 50 and 56 Gy, administered as 5–9 fractions. The prescribed dose was defined at the isocenter, and median overall treatment duration was 10 days (range, 5–22). The median follow-up was 51.1 months for survivors. The 3-year local recurrence rates for primary lung cancer and oligometastasis was 6 % and 3 %, respectively. The 3-year local recurrence rates for tumor sizes ≤3 cm and >3 cm were 3 % and 14 %, respectively (p = 0.124). Additionally, other factors (fraction size, total target dose, and BED10) were not significant predictors of local control. Radiation pneumonia (≥ grade 2) was observed in 2 patients. Radiation-induced rib fractures were observed in 22 patients. Other late adverse events of greater than grade 2 were not observed. Within this dataset, we did not observe a dose response in BED10 values between 86.4 and 102.6 Gy. SBRT with doses between 50 and 56 Gy, administered over 5–9 fractions achieved acceptable tumor control without severe complications

  3. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... NHLBI Trials Clinical Trial Websites Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept medicines and ...

  4. Clinical Manifestations and Outcomes of West Nile Virus Infection

    Directory of Open Access Journals (Sweden)

    James J. Sejvar

    2014-02-01

    Full Text Available Since the emergence of West Nile virus (WNV in North America in 1999, understanding of the clinical features, spectrum of illness and eventual functional outcomes of human illness has increased tremendously. Most human infections with WNV remain clinically silent. Among those persons developing symptomatic illness, most develop a self-limited febrile illness. More severe illness with WNV (West Nile neuroinvasive disease, WNND is manifested as meningitis, encephalitis or an acute anterior (polio myelitis. These manifestations are generally more prevalent in older persons or those with immunosuppression. In the future, a more thorough understanding of the long-term physical, cognitive and functional outcomes of persons recovering from WNV illness will be important in understanding the overall illness burden.

  5. PERFORATED PEPTIC ULCER: A CLINICAL ANALYSIS AND OUTCOME

    Directory of Open Access Journals (Sweden)

    Bijit

    2016-03-01

    Full Text Available BACKGROUND The incidence of perforated peptic ulcer is approximately 7-10 cases per one lakh population per year. Perforation is seen in about 7% of patients hospitalized for peptic ulcer disease. Peptic ulcer perforation, which can be gastric/duodenal perforation can be a serious life-threatening condition if not detected early and treated urgently. Peptic ulcer disease has decreased considerably worldwide with the advent of potent anti-ulcer medicines, but its complication like peptic ulcer perforation has not. Our study is to analyse the clinical, radiological and management related findings in influencing the outcome of patients of peptic ulcer perforation after surgery. MATERIALS AND METHODS A series of 47 patients of peptic ulcer perforation were evaluated. Patients expiring within six hours of admission were not included in this study. RESULTS Age of the patients ranged from 17-80 years. The incidence of perforation was highest in the age group of 41-50 years (31.9%. Out of 47 patients, 41 (87.2% survived. CONCLUSION The incidence of perforation was highest in the age group of 41-50 years. Prognosis becomes poor with age, delayed treatment, shock at admission and concomitant diseases. Direct repair of the perforation with pedicled omentum gave excellent results.

  6. Clinical outcomes in low risk coronary artery disease patients treated with different limus-based drug-eluting stents--a nationwide retrospective cohort study using insurance claims database.

    Directory of Open Access Journals (Sweden)

    Chao-Lun Lai

    Full Text Available The clinical outcomes of different limus-based drug-eluting stents (DES in a real-world setting have not been well defined. The aim of this study was to investigate the clinical outcomes of three different limus-based DES, namely sirolimus-eluting stent (SES, Endeavor zotarolimus-eluting stent (E-ZES and everolimus-eluting stent (EES, using a national insurance claims database. We identified all patients who received implantation of single SES, E-ZES or EES between January 1, 2007 and December 31, 2009 from the National Health Insurance claims database, Taiwan. Follow-up was through December 31, 2011 for all selected clinical outcomes. The primary end-point was all-cause mortality. Secondary end-points included acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. Cox regression model adjusting for baseline characteristics was used to compare the relative risks of different outcomes among the three different limus-based DES. Totally, 6584 patients were evaluated (n=2142 for SES, n=3445 for E-ZES, and n=997 for EES. After adjusting for baseline characteristics, we found no statistically significant difference in the risk of all-cause mortality in three DES groups (adjusted hazard ratio [HR]: 1.14, 95% confidence interval [CI]: 0.94-1.38, p=0.20 in E-ZES group compared with SES group; adjusted HR: 0.77, 95% CI: 0.54-1.10, p=0.15 in EES group compared with SES group. Similarly, we found no difference in the three stent groups in risks of acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. In conclusion, we observed no difference in all-cause mortality, acute coronary events, heart failure needing hospitalization, and cerebrovascular disease in patients treated with SES, E-ZES, and EES in a real-world population-based setting in Taiwan.

  7. Association of Postburn Fatty Acids and Triglycerides with Clinical Outcome in Severely Burned Children

    Science.gov (United States)

    Kraft, Robert; Herndon, David N.; Finnerty, Celeste C.; Hiyama, Yaeko

    2013-01-01

    Context: Free fatty acids (FFAs) and triglycerides (TGs) are altered postburn, but whether these alterations are associated with postburn outcomes is not clear. Objective: The aim of the present study was to analyze lipid metabolic profiles in pediatric burn patients and to correlate these profiles with patient outcomes and hospital courses. Design and Setting: We conducted a prospective cohort study at an academic pediatric hospital burn center. Patients: Our study included 219 pediatric burn patients. Main Outcome Measures: Patients were stratified according to their plasma TG and FFA levels. Main patient outcomes, such as postburn morbidity and mortality, and clinical metabolic markers were analyzed. Results: All groups were similar in demographics and injury characteristics. Patients with elevated TGs had significantly worse clinical outcomes associated with increased acute-phase protein synthesis indicating augmented inflammation and hypermetabolism, whereas increased FFAs did not seem to profoundly alter postburn outcomes. Conclusions: Elevated TGs, but not FFAs, postburn are associated with worsened organ function and clinical outcomes. PMID:23150682

  8. Stents and statins: history, clinical outcomes and mechanisms.

    Science.gov (United States)

    Nair, Pradeep K; Mulukutla, Suresh R; Marroquin, Oscar C

    2010-09-01

    The 1980s witnessed the inception of both stents and 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitors (statins). While they evolved separately, it was soon realized that they each offered a unique and powerful mechanism for targeting the major offender in cardiovascular disease, namely atherosclerosis. Coincidentally, the first statin was approved by the US FDA in 1987, the same year that the coronary stent was conceived. Since that time, stents and statins have revolutionized the field of cardiovascular medicine and their paths have been intertwined. Several pivotal randomized clinical trials have established statins as an effective therapy for improving clinical outcomes after percutaneous coronary intervention (PCI) among patients presenting with stable coronary artery disease and acute coronary syndromes. In addition, chronic statin therapy and acute loading of statins prior to PCI has consistently been shown to limit periprocedural myocardial necrosis. The mechanism for improved clinical outcomes with statins has clearly been associated with statin-induced reductions in LDL. In addition, statins may also exert 'pleiotropic' effects, independent of LDL lowering, that might counteract the inflammatory and prothrombotic mileu created with PCI. This article provides a brief historical perspective of the evolution of the use of statins and stents in patients with coronary artery disease, an evaluation of the available clinical data supporting the use of statins in patients undergoing PCI across a wide spectrum of clinical scenarios, and a discussion of the potential mechanisms of the benefit of statins in these patients. PMID:20828351

  9. Combination of clinical and v/q scan assessment for the diagnosis of pulmonary embolism: a 2-year outcome prospective study

    Energy Technology Data Exchange (ETDEWEB)

    Barghouth, G.; Boubaker, A.; Delaloye, A.B. [Univ. Hospital, Lausanne (Switzerland). Dept. of Nuclear Medicine; Yersin, B. [Dept. of Internal Medicine, Univ. Hospital, Lausanne (Switzerland); Doenz, F.; Schnyder, P. [Centre Hospitalier Universitaire Vaudois, Lausanne (Switzerland). Dept. of Radiology

    2000-09-01

    With the aim of evaluating the efficiency of our diagnositc approach in patients with suspected acute pulmonary embolism (PE), we prospectively studied 143 patients investigated by means of a ventilation/perfusion (V/Q) lung scan. A pre-test clinical probability of PE (P{sub clin}) was assigned to all patients by the clinicians and scans were interpreted blinded to clinical assessment. A 2-year follow-up of our patients was systematically performed and possible in 134 cases. Distribution of clinical probabilities was high P{sub clin} in 22.5%, intermediate P{sub clin} in 24% and low P{sub clin} in 53.5%, whereas the distribution of scan categories was high P{sub scan} in 14%, intermediate P{sub scan} in 18%, low P{sub scan} in 57% and normal P{sub scan} in 11%. The final prevalence of PE was 24.5%. High P{sub scan} and normal P{sub scan} were always conclusive (19 and 15 cases respectively). Low P{sub scan} associated with low P{sub clin} could exclude PE in 43/45 cases (96%). Noe of the patients in whom the diagnosis of PE was discarded had a major event related to PE during the 2-year follow-up. Overall, the combined assessment of clinical and scintigraphic probabilities allowed confirmation or exclusion of PE in 80% of subjects (107/134) and proved to be a valuable tool for selecting patients who needed pulmonary angiography, which was required in 20% of our patients (27/134). (orig.)

  10. Impact of lesion morphology on angiographic and clinical outcomes in patients with chronic total occlusion after recanalization with drug-eluting stents: a multislice computed tomography study

    Energy Technology Data Exchange (ETDEWEB)

    Ito, Tsuyoshi [Toyohashi Heart Center, Toyohashi (Japan); Nagoya City University Graduate School of Medical Sciences, Department of Cardio-Renal Medicine and Hypertension, Nagoya (Japan); Tsuchikane, Etsuo; Nasu, Kenya; Kimura, Masashi; Terashima, Mitsuyasu; Kinoshita, Yoshihisa; Habara, Maoto; Suzuki, Takahiko [Toyohashi Heart Center, Toyohashi (Japan); Suzuki, Yoriyasu; Ehara, Mariko [Nagoya Heart Center, Nagoya (Japan); Ohte, Nobuyuki [Nagoya City University Graduate School of Medical Sciences, Department of Cardio-Renal Medicine and Hypertension, Nagoya (Japan)

    2015-10-15

    The aim of this study was to investigate the multislice computed tomography (MSCT) parameters associated with adverse outcomes after chronic total occlusion percutaneous coronary intervention (CTO-PCI) with drug-eluting stents. A total of 285 patients who underwent MSCT before CTO-PCI were analyzed. Lesion morphology was assessed with MSCT. Angiographic restenosis, reocclusion, and MACE (a composite of cardiac death, myocardial infarction, stent thrombosis, and target lesion revascularization) were analyzed. MACE was observed in 36 patients (13.6 %). Occlusion length was greater (39.5 ± 19.9 mm vs. 22.3 ± 13.7 mm, p < 0.01), minimal vessel area smaller (11.2 ± 5.7 mm{sup 2} vs. 14.5 ± 5.6 mm{sup 2}, p < 0.01), and severe calcification more common (36 % vs. 12 %, p < 0.01) in the MACE group compared to the non-MACE group. We defined occluded length >25.4 mm, minimal vessel area <11.9 mm{sup 2}, which were identified by receiver operating characteristic analysis, and severe calcification as CT-derived risk factors. Angiographic restenosis (60 % vs. 12 % vs. 7 %, p < 0.01), reocclusion (29 % vs. 2 % vs. 2 %, p < 0.01), and MACE (43 % vs. 6 % vs. 3 %, p < 0.01) were more common in patients with 2 or more risk factors than in those with 1 or 0. MSCT characteristics associated with adverse outcomes after CTO-PCI were occlusion length, minimal vessel area, and severe calcification. (orig.)

  11. Warwick Hip Trauma Study: a randomised clinical trial comparing interventions to improve outcomes in internally fixed intracapsular fractures of the proximal femur. Protocol for The WHiT Study

    Directory of Open Access Journals (Sweden)

    Griffin Xavier

    2010-08-01

    Full Text Available Abstract Background Controversy exists regarding the optimal treatment for patients with displaced intracapsular fractures of the proximal femur. The recognised treatment alternatives are arthroplasty and internal fixation. The principal criticism of internal fixation is the high rate of non-union; up to 30% of patients will have a failure of the fixation leading to revision surgery. We believe that improved fracture healing may lead to a decreased rate of failure of fixation. We therefore propose to investigate strategies to both accelerate fracture healing and improve fixation that may significantly improve outcomes after internal fixation of intracapsular femoral fractures. We aim to test the clinical effectiveness of the osteoinductive agent platelet rich plasma and conduct a pilot study of a novel fixed-angle fixation system. Design We have planned a three arm, single centre, standard-of-care controlled, double blinded, pragmatic, randomised clinical trial. The trial will include a standard two-way comparison between platelet-rich plasma and standard-of-care fixation versus standard-of-care fixation alone. In addition there will be a subsidiary pilot arm testing a fixed-angle screw and plate fixation system. Trial Registration Current Controlled Trials ISRCTN49197425

  12. Clinical and economic outcomes assessment in nuclear cardiology

    International Nuclear Information System (INIS)

    The future of nuclear medicine procedures, as understood within our current economic climate, depends upon its ability to provide relevant clinical information at similar or lower comparative costs. With an ever-increasing emphasis on cost containment, outcome assessment forms the basis of preserving the quality of patient care. Today, outcomes assessment encompasses a wide array of subjects including clinical, economic, and humanistic (i.e., quality of life) outcomes. For nuclear cardiology, evidence-based medicine would require a threshold level of evidence in order to justify the added cost of any test in a patient's work-up. This evidence would include large multicenter, observational series as well as randomized trial data in sufficiently large and diverse patient populations. The new movement in evidence-based medicine is also being applied to the introduction of new technologies, in particular when comparative modalities exist. In the past 5 years, it has seen a dramatic shift in the quality of outcomes data published in nuclear cardiology. This includes the use of statistically rigorous risk-adjusted techniques as well as large populations (i.e., >500 patients) representing multiple diverse medical care settings. This has been the direct result of the development of multiple outcomes databases that have now amassed thousands of patients worth of data. One of the benefits of examining outcomes in large patient datasets is the ability to assess individual endpoints (e.g., cardiac death) as compared with smaller datasets that often assess combined endpoints (e.g., death, myocardial infarction, or unstable angina). New technologies for the diagnosis of coronary artery disease have contributed to the rising costs of care. In the United States and in Europe, costs of care have risen dramatically, consuming an ever-increasing amount of available resources. The overuse of diagnostic angiography often leads to unnecessary revascularization that does not lead to

  13. Factors influencing outcomes of clinical information systems implementation: a systematic review.

    Science.gov (United States)

    Gruber, Dianne; Cummings, Greta G; LeBlanc, Lisa; Smith, Donna L

    2009-01-01

    Healthcare agencies spend significant resources to acquire or develop clinical information systems. However, implementation of clinical information systems often report significant failures. A systematic review of the research literature identified processes and outcomes of clinical information system implementation and factors that influenced success or failure. Of 124 original papers, 18 met the primary inclusion criteria-clinical systems implementation, healthcare facility, and outcome measures. Data extraction elements included study characteristics, outcomes, and implementation risk factors classified according to the Expanded Systems Life Cycle. The quality of each study was also assessed. Forty-nine outcomes of clinical information system implementation were identified. No single implementation strategy proved completely effective. The findings of this synthesis direct the attention of managers and decision makers to the importance of clinical context to successful implementation of clinical information systems. The highest number of factors influencing success or failure was reported during implementation and system "go-live." End-user support or lack thereof was the important factor in both successful and failed implementations, respectively. Following the Expanded Systems Life Cycle management model instead of a traditional project management approach may contribute to greater success over time, by paying particular attention to the underrecognized maintenance phase of implementation. PMID:19411944

  14. Clinical outcomes of serial transverse enteroplasty: a preliminary study%系列横行肠管成形术的临床疗效初探

    Institute of Scientific and Technical Information of China (English)

    沈淳; 朱海涛; 肖现民; 郑珊

    2015-01-01

    Objective To summarize our clinical experiences of serial transverse enteroplasty (STEP).Methods From July 2011 to June 2014, 2 cases underwent STEP at our hospital.Their nutritional conditions before and after surgery were compared.And the essential operative points and outcomes of STEP were summarized.Results In July 2011, a 13-year-old boy of intestinal malformation diagnosed at another hospital underwent Ladd's procedure plus intestinal resection and anastomosis.Postoperative intestinal obstruction occurred along with intestinal expansion and severe malnutrition.At Days 5 and 14 post-operation, jejunal nutrition tube feeding and oral feeding were initiated.Discharge occurred at Day 16 post-operation.At 6 months, a weight gain of 15 kg was achieved with a normal diet.In June 2014, another 44-day-old girl of congenital intestinal atresia with small intestinal stoma and postoperative weight loss were transferred to our hospital.During the second and third operations, there were short bowel syndrome and proximal small bowel expansion.After STEP and Santulli-blanc stoma, both parenteral and enteral nutrition were provided postoperatively.At 4 weeks, there was a weight gain of 0.6 kg.After a second stoma, there was another weight gain of 0.5 kg at 4 weeks.At 2 months, another case developed abdominal distention, vomiting and fever.And upper gastrointestinal angiography showed proximal small bowel expansion.And anti-inflammatory conservative treatment improved clinical symptoms.However at 3 months after STEP, during total enteral nutrition, severe infection resulted in extensive lethal drug-resistant E.coli septicemia.Conclusions Short bowel with expanded intestinal canal should be selected.And multiincision is adopted for avoiding excessive intestinal narrowing.STEP may reduce no area of intestinal mucosa absorption, shrink intestinal diameter, extend intestinal length, boost enteral feeding tolerance and improve clinical outcomes.%目的 总结

  15. The role of clinical pathway on the outcomes of ischemic stroke patients at Bethesda Hospital Yogyakarta

    Directory of Open Access Journals (Sweden)

    Francisca Diana Alexandra, Iwan Dwiprahasto, Rizaldy Pinzon

    2014-04-01

    Full Text Available Stroke becomes world health problem all over the world because it is the causal factor of high mortality and disability. Good and well-organized process of healthcare service will improve the outcome of the patients with stroke. Clinical pathway may be used as clear standard to help reduce unnecessary variations of medical treatment and measure. The study aimed at finding out the correlation between the use of clinical pathway and the outcome of the patients with ischemic stroke in Bethesda Hospital Yogyakarta. It was an observational and analytic study with cohort restorative study design. The author compared the outcomes of acute ischemic stroke between the group with clinical pathway and the group without the clinical pathway. Data was collected using consecutive sampling from the electronic registry and medical record data of the patients from January 1st, 2011 to December 31st, 2011. It was conducted to 124 patients with ischemic stroke assigned to two groups (the first groups of 62 patients with clinical pathway and the second groups of 62 patients without clinical pathway. The basic characteristics of the two groups were the same. The results of the analysis showed that there was a significant decrease in the incidence of complication and a significant increase in the use of antiplatelete drugs, antidiabetic drugs and statin as secondary preventive measure of the recurrent stroke. There was not any significant difference in the duration of the hospitalized healthcare, the financing and the mortality between the two observation groups. The study indicated that the use of the clinical pathway in the stroke treatment improved the outcome of the patients with stroke. It was necessary to conduct further study to evaluate the effectiveness of the clinical pathway in improving the outcome of the patients with bigger number of the subjects and the longer period of time.

  16. Clinical and Outcome Research in oncology The need for integration

    Directory of Open Access Journals (Sweden)

    Apolone Giovanni

    2003-04-01

    Full Text Available Abstract Cancer is one of the main healthcare problems in Europe. Although significant progress has recently been made, long-term survival is still disappointing for most common solid tumours. The explosion of information has strengthened the need to create and sustain coordinated interaction between technology, biology, clinical research, clinical practice and health policy. A simple process based on automatic and passive translation from bench to clinical research and eventually to the bed side is usually assumed but cannot be taken for granted. A critical role might be played by Outcome Research (OR, defined as the discipline that describes, interprets, and predicts the impact of various influences, especially interventions, on final endpoints (from survival to satisfaction with care that matter to decision makers (from patients to society at large, with special emphasis on the use of patient-reported outcomes (PRO. Recently, under pressure from several parts of society, the FDA, recognizing the need for faster drug approval, has modified existing regulations and created new rules to allow anti-cancer drugs to be approved more quickly and, in certain but quite common circumstances, single arm trials and surrogate endpoints to be used as measures of clinical benefit. In this context, the faster approval process may lead to drugs being marketed without there being a complete picture of how effective or safe they are. The FDA move to speed up drug approval, together with the use of not fully validated surrogate endpoints, give OR the unique opportunity to help understand the value of drugs that have received accelerated approval. Despite this opportunity, OR has yet to demonstrate its role in this specific setting and provide proof of the validity, reliability and added value of its primary endpoint measures when evaluated in a broader context. The implementation of lines of OR in the development and evaluation of anti-cancer drugs hinges upon

  17. Clinical outcomes of HER2-positive metastatic breast cancer patients with brain metastasis treated with lapatinib and capecitabine: an open-label expanded access study in Korea

    Directory of Open Access Journals (Sweden)

    Ro Jungsil

    2012-07-01

    Full Text Available Abstract Background To evaluate efficacy in patients with brain metastasis (BM on entry into the lapatinib expanded access program (LEAP. Methods LEAP is a worldwide, single-arm, open-label study. HER2-positive, locally-advanced or metastatic breast cancer patients with progression after an anthracycline, taxane, and trastuzumab were eligible. Patients received capecitabine 2000 mg/m2 daily in two divided doses, days 1–14, every 21 days and lapatinib 1250 mg once daily. Results Among 186 patients enrolled in 6 Korean centers, 58 had BM. Progression-free survival (PFS was 18.7 weeks in patients with BM and 19.4 weeks without BM (P = 0.88. In patients with BM, brain response was synchronized with systemic responses (P = 0.0001. Overall survival (OS was 48.9 weeks in patients with BM and 64.6 weeks without BM (P = 0.23. Multivariable analysis found hormone receptor positivity (P = 0.003 and clinical benefit rate (CBR of combined systemic and brain disease (P  Conclusion Lapatinib plus capecitabine is equally effective in patients with or without BM. Trial registration ClinicalTrials.gov (NCT00338247

  18. Propionic acidemia: clinical course and outcome in 55 pediatric and adolescent patients

    OpenAIRE

    Grünert Sarah C; Müllerleile Stephanie; De Silva Linda; Barth Michael; Walter Melanie; Walter Kerstin; Meissner Thomas; Lindner Martin; Ensenauer Regina; Santer René; Bodamer Olaf A; Baumgartner Matthias R; Brunner-Krainz Michaela; Karall Daniela; Haase Claudia

    2013-01-01

    Abstract Background Propionic acidemia is an inherited disorder caused by deficiency of propionyl-CoA carboxylase. Although it is one of the most frequent organic acidurias, information on the outcome of affected individuals is still limited. Study design/methods Clinical and outcome data of 55 patients with propionic acidemia from 16 European metabolic centers were evaluated retrospectively. 35 patients were diagnosed by selective metabolic screening while 20 patients were identified by newb...

  19. Factors associated with the clinical outcomes of paediatric out-of-hospital cardiac arrest in Japan

    OpenAIRE

    Nagata, Takashi; Abe, Takeru; Noda, Eiichiro; Hasegawa, Manabu; Hashizume, Makoto; Hagihara, Akihito

    2014-01-01

    Objectives To better understand and predict clinical outcomes of paediatric out-of-hospital cardiac arrest (OHCA). Design A population-based, observational study. Setting The National Japan Utstein Registry. Participants 2900 children aged 5–17 years who experienced OHCA and received resuscitation by emergency responders. Signal detection analysis using 17 variables was applied to identify factors associated with OHCA outcomes; the primary endpoint was cerebral performance category (CPC) 1 or...

  20. CT Follow-Up and Clinical Outcome in Severe Traumatic Injury Patients

    OpenAIRE

    Belina, Stanko; Kovačić, Sanja

    2011-01-01

    Determining a patient’s prognosis after severe traumatic brain injury remains difficult and complex. The purpose of the present study was following up patients with severe traumatic brain injury by correlating their clinical outcome and sequential computer tomography (CT) findings. We investigated 51 patients who survived the first year following an accident. All patients underwent successive CT examinations within a maximum period of 2 years. The patients’ outcomes depended on th...

  1. Clinical and radiographic findings, treatment, and outcome in cattle with osteochondrosis: 29 cases (1986-1996)

    International Nuclear Information System (INIS)

    Objective-To summarize the radiographic and clinical findings, treatment, and outcome in cattle with osteochondrosis diagnosed radiographically. Design-Retrospective case series. Sample Population-29 cattle with radiographic evidence of osteochondrosis. Procedures-Medical records were reviewed, and owners or referring veterinarians were contacted for outcome assessment. Data were analyzed for potential interactions between osteochondrosis classification (osteochondritis dessicans vs subchondral cyst-like lesions), clinical and radiographic findings, treatment, and outcome, using Fisher's exact test and descriptive statistics. Results-Osteochondrosis was associated with young, male, purebred cattle, clinical evidence of lameness, and radiographic evidence of concurrent degenerative joint disease. Osteochondritis dissecans and subchondral cyst-like lesions had similar clinical findings and outcomes but varied significantly in their radiographic distribution among joints. Osteochondrosis often manifests clinically as a unilateral condition, but bilateral lesions were often found (88%) when limbs were radiographically examined. Cattle managed conservatively tended to be culled (within 6 months of diagnosis because of lameness) more often than those managed surgically, despite the lack of treatment bias. ClinicalImplications-Osteochondrosis in cattle is often associated with lameness or degenerative joint disease. Conservative management does not result in a favorable clinical prognosis for long-term, lameness-free survival, and more studies need to be completed to evaluate the efficacy of surgical treatment of osteochondrosis in cattle

  2. Clinical Profile and Outcome of Complicated Plasmodium falciparum Malaria

    Directory of Open Access Journals (Sweden)

    Virendra C patil

    2012-01-01

    Full Text Available Context: Complicated Plasmodium falciparum Malaria is a syndrome and a disease of protean, clinical manifestations including jaundice, ARF, ARDS and multi-organ failure. Aims: The objectives of the present study are to study clinical features, complications and factors affecting outcome of patients with complicated P. falciparum Malaria. Settings and Design: This retrospective descriptive study was conducted at tertiary care centre in western Maharashtra from January 2010 to December 2010. Methods and Material: Total 73 patients with complicated P. falciparum malaria who presented with fever having positive trophozoites of P. falciparum in blood smear were included. SPSS (version-10 software was used for all statistical calculations. Results: A total 73 patients had complicated P. falciparum malaria with 52 were males and 21 were female patients. Total 9 (12.32 % patients were presented with shock as a presenting feature. Four (5.47 % patients had hypoglycaemia at the time of admission. Total 43 (58.90 % patients had jaundice, 37 (50.68 % had anaemia, 28 (38.35 % had cerebral malaria, 7 (9.58 % had acute renal failure, 5 (6.84 % had ARDS and 5 (6.84 % had thrombocytopenia. Total 46 patients had single complication in the form of cerebral malaria 14 (19.17 %, jaundice 15 (20.54 % and anaemia 16 (21.91 %. Total 14 patients had two complications in the form of jaundice with ARF 02 (2.73 % with one (50 % death and jaundice with anaemia 12 (16.43 %. Total 9 (12.32 % patients had three complications in the form of cerebral malaria with jaundice with anaemia with 3 deaths (33.33 %. Total 5 (6.84 % patients had multiple complications in the form of cerebral malaria with ARF with ARDS with thrombocytopenia with 4 (80 % death. Case fatality rate was 10.95 %. The case fatality rate with ARDS was 80 % (4/5, with ARF was 57.14 % (4/7 and with cerebral malaria it was 25 % (7/28. Case fatality rate was highest in patients with pulmonary complication (ARDS

  3. Correlation of clinical outcome to the estimated radiation dose from Boron Neutron Capture Therapy (BNCT)

    Energy Technology Data Exchange (ETDEWEB)

    Chadha, M. [Beth Israel Medical Center, NY (United States). Dept. of Radiation Oncology; Coderre, J.A.; Chanana, A.D. [Brookhaven National Lab., Upton, NY (United States)] [and others

    1996-12-31

    A phase I/II trial delivering a single fraction of BNCT using p-Boronophenylalanine-Fructose and epithermal neutrons at the the Brookhaven Medical Research Reactor was initiated in September 1994. The primary endpiont of the study was to evaluate the feasibility and safety of a given BNCT dose. The clinical outcome of the disease was a secondary endpoint of the study. The objective of this paper is to evaluate the correlation of the clinical outcome of patients to the estimated radiation dose from BNCT.

  4. Correlation of clinical outcome to the estimated radiation dose from Boron Neutron Capture Therapy (BNCT)

    International Nuclear Information System (INIS)

    A phase I/II trial delivering a single fraction of BNCT using p-Boronophenylalanine-Fructose and epithermal neutrons at the the Brookhaven Medical Research Reactor was initiated in September 1994. The primary endpiont of the study was to evaluate the feasibility and safety of a given BNCT dose. The clinical outcome of the disease was a secondary endpoint of the study. The objective of this paper is to evaluate the correlation of the clinical outcome of patients to the estimated radiation dose from BNCT

  5. Neurocognitive clinical outcome assessments for inborn errors of metabolism and other rare conditions.

    Science.gov (United States)

    Shapiro, Elsa; Bernstein, Jessica; Adams, Heather R; Barbier, Ann J; Buracchio, Teresa; Como, Peter; Delaney, Kathleen A; Eichler, Florian; Goldsmith, Jonathan C; Hogan, Melissa; Kovacs, Sarrit; Mink, Jonathan W; Odenkirchen, Joanne; Parisi, Melissa A; Skrinar, Alison; Waisbren, Susan E; Mulberg, Andrew E

    2016-06-01

    Well-defined and reliable clinical outcome assessments are essential for determining whether a drug provides clinically meaningful treatment benefit for patients. In 2015, FDA convened a workshop, "Assessing Neurocognitive Outcomes in Inborn Errors of Metabolism." Topics covered included special challenges of clinical studies of inborn errors of metabolism (IEMs) and other rare diseases; complexities of identifying treatment effects in the context of the dynamic processes of child development and disease progression; and the importance of natural history studies. Clinicians, parents/caregivers, and participants from industry, academia, and government discussed factors to consider when developing measures to assess treatment outcomes, as well as tools and methods that may contribute to standardizing measures. Many issues examined are relevant to the broader field of rare diseases in addition to specifics of IEMs. PMID:27132782

  6. Preliminary Evaluation of Clinical and Angiographic Outcomes with Biodegradable Polymer Coated Sirolimus-Eluting Stent in De Novo Coronary Artery Disease: Results of the MANIPAL-FLEX Study.

    Science.gov (United States)

    Shetty, Ranjan; Prajapati, Jayesh; Pai, Umesh; Shetty, Kiran

    2016-01-01

    Objective. The objective of the MANIPAL-FLEX study was to evaluate the feasibility, preliminary safety, and efficacy of the Supraflex sirolimus-eluting stent (SES) implantation, in de novo coronary artery disease, using clinical and quantitative coronary angiography (QCA) follow-ups. Methods. This was a prospective, nonrandomized, multicenter, single-arm study that enrolled 189 patients with de novo coronary artery disease who were treated with the Supraflex SES. Of 189 patients enrolled, the first 61 consecutive patients who consented to a 9-month follow-up evaluation by QCA, irrespective of presence of symptoms, were to be followed up with angiography at 9 months. The primary endpoint of the study was target lesion failure (TLF), including cardiac death, myocardial infarction, and target lesion revascularization during 12-month follow-up after the index procedure. Results. The mean age of the study population was 58 ± 11 years, with 51.3% (97/189) of hypertensive patients. Total of 66 lesions, analyzed by offline QCA, showed good scaffolding of the target vessel with in-stent late lumen loss at 9 months of 0.18 ± 0.23 mm. The observed TLF at 30-day, 6-month, and 12-month follow-up were 2 (1.1%), 6 (3.2%), and 10 (5.3%), respectively. Conclusion. This study provides preliminary evidence for the feasibility, safety, and efficacy of the Supraflex sirolimus-eluting stent. PMID:27597929

  7. Neurobrucellosis: clinical, diagnostic, therapeutic features and outcome. Unusual clinical presentations in an endemic region

    Directory of Open Access Journals (Sweden)

    Nurgul Ceran

    2011-02-01

    Full Text Available Brucellosis is a zoonotic infection and has endemic characteristics. Neurobrucellosis is an uncommon complication of this infection. The aim of this study was to present unusual clinical manifestations and to discuss the management and outcome of a series of 18 neurobrucellosis cases. Initial clinical manifestations consist of pseudotumor cerebri in one case, white matter lesions and demyelinating syndrome in three cases, intracranial granuloma in one case, transverse myelitis in two cases, sagittal sinus thrombosis in one case, spinal arachnoiditis in one case, intracranial vasculitis in one case, in addition to meningitis in all cases. Eleven patients were male and seven were female. The most prevalent symptoms were headache (83% and fever (44%. All patients were treated with rifampicin, doxycycline plus trimethoprim-sulfamethoxazole or ceftriaxone. Duration of treatment (varied 3-12 months was determined on basis of the CSF response. In four patients presented with left mild sequelae including aphasia, hearing loss, hemiparesis. In conclusion, although mortality is rare in neurobrucellosis, its sequelae are significant. In neurobrucellosis various clinical and neuroradiologic signs and symptoms can be confused with other neurologic diseases. In inhabitants or visitors of endemic areas, neurobrucellosis should be kept in mind in cases that have unusual neurological manifestations.

  8. Pulmonary embolism in intensive care unit: Predictive factors, clinical manifestations and outcome

    OpenAIRE

    Bahloul Mabrouk; Chaari Anis; Kallel Hatem; Abid Leila; Hamida Chokri Ben; Dammak Hassen; Rekik Noureddine; Mnif Jameleddine; Chelly Hedi; Bouaziz Mounir

    2010-01-01

    Objective : To determine predictive factors, clinical and demographics characteristics of patients with pulmonary embolism (PE) in ICU, and to identify factors associated with poor outcome in the hospital and in the ICU. Methods : During a four-year prospective study, a medical committee of six ICU physicians prospectively examined all available data for each patient in order to classify patients according to the level of clinical suspicion of pulmonary thromboembolism. During the study...

  9. Clinical profile and outcome of Hantavirus infection with renal involvement in India

    OpenAIRE

    Alok Kumar; Dorchhom Khrime; Nitin Bansal; Amar Nath Pandey; Shakeel Ahmad; Varma Amit

    2014-01-01

    Background: Hantavirus infections are found all over world but there is paucity of information about clinical features of Hantavirus infection in India. Aim of current study was to study clinical profile and outcome of patients with Hantavirus infection and renal insufficiency who presented at our institute. Methods: All patients who were admitted in department of medicine with Hantavirus infection and renal insufficiency were included. Their basic demographic profile with relevant labora...

  10. Clinical profile and outcome of posterior reversible encephalopathy syndrome (PRES

    Directory of Open Access Journals (Sweden)

    Virendra C Patil

    2015-01-01

    Full Text Available Background: Posterior reversible encephalopathy syndrome (PRES is a clinico-radiographic syndrome of multiple etiologies. Still, the exact pathophysiology of PRES is not clear. Aims and Objectives: To study demographic, etiological, and clinic-radiological profiles of patients presenting with PRES and their outcome at the tertiary care teaching hospital. Materials and Methods: A retrospective observational and non-interventional study was conducted at tertiary care center in from January 2009 to December 2013 at Krishna Institute of Medical Sciences, Karad. Inclusion Criteria: The clinical history of acute neurologic change including headache, encephalopathy, seizure, visual disturbance, or focal deficit with magnetic resonance imaging (MRI brain imaging findings of focal vasogenic edema with clinical or radiologic proof of reversibility. Results: Of a total 43 patients with suspected diagnosis of PRES, 29 patients were included fulfilling all inclusion criteria of PRES. Of total the 29 patients with confirmed diagnosis of PRES, 22 (75.86% were female and 7 (24.13% were male patients, predominated by female population (relative risk [RR]: 3.14; odds ration [OR]: 9.87; ′P′ < 0.001. The overall mean age was 33.65 years (±15.26 and mean duration of stay was 10.13 days (±4.98. The most common clinical presentation was generalized tonic-clonic seizures, seen in 23 (79.31% patients, headache in 21 (72.41% patients, and visual disturbances 13 (44.82% patients. A total of 18 (62.06% patients were hypertensive and 11 (37.93% were normotensive [RR: 1.63]. A total of 6 (27.27% females and 5 (71.42% males were normotensive and total 16 (72.72% females and 2 (28.57% males were hypertensive (RR: 1.12. Of a total of 22 female patients with PRES, 19 (86.36% were in a postpartum state, one (4.45% had systemic lupus erythematous (SLE, one (4.54% had community-acquired pneumonia (CAP with acute respiratory distress syndrome (ARDS with septicemia and one (4

  11. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

    Directory of Open Access Journals (Sweden)

    Amelia Scott

    Full Text Available To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Any clinical trial (as defined by ICMJE published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry and conducted after July 2005 (or 2007 for two journals was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6% were deemed unregistered, 61 (33.7% were retrospectively registered, 37 (20.4% had unclear POMs either in the article or the registry and 2 (1.1% were registered in an inaccessible trial registry. Only 60 (33.1% studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3% showed evidence of selective outcome reporting and 16 (26.7% demonstrated a change in participant numbers of 20% or more; only 26 (14

  12. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations

    DEFF Research Database (Denmark)

    Dworkin, R.H.; Turk, D.C.; Wyrwich, K.W.;

    2008-01-01

    IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory...... and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome...

  13. Disability outcome measures in multiple sclerosis clinical trials

    DEFF Research Database (Denmark)

    Cohen, Jeffrey A; Reingold, Stephen C; Polman, Chris H;

    2012-01-01

    Many of the available disability outcome measures used in clinical trials of multiple sclerosis are insensitive to change over time, inadequately validated, or insensitive to patient-perceived health status or quality of life. Increasing focus on therapies that slow or reverse disability...... progression makes it essential to refine existing measures or to develop new tools. Major changes to the expanded disability status scale should be avoided to prevent the loss of acceptance by regulators as a measure for primary outcomes in trials that provide substantial evidence of effectiveness. Rather, we......, and measurement of biomarkers, show promise as adjuncts to the current disability measures, but are insufficiently validated to serve as substitutes. A collaborative approach that involves academic experts, regulators, industry representitives, and funding agencies is needed to most effectively develop disability...

  14. Factor xiii deficiency in children-clinical presentation and outcome

    International Nuclear Information System (INIS)

    To determine the demographic features and clinical outcome of children with Factor XIII deficiency. Records of all hospitalized pediatric patients with discharge diagnosis of FXIII D, on the basis of factor XIII assay 5 mol/L urea test were retrospectively reviewed and abstracted on a pre-specified proforma. Demographic features, coagulation profile, family history and outcomes were noted. A total of 10 charts were reviewed. There were 5 boys and 5 girls. Almost all the children (9/10) were less than 5 years of age, out of whom 5 (50%) were infants, and 3 were neonates. Bruises and prolonged bleeding after trauma was the major presenting complaints in 80%, followed by prolonged bleeding from the umbilical stump in 2 patients. Nine patients had past history of prolonged umbilical bleeding. Two patients had history of FXIII D in siblings, while 2 had history of prolonged bleeding in other family members (cause unknown). Consanguinity was present in 80% of the families. Initial coagulation screen were normal in all patients. Two patients had intracranial hemorrhage, proved on neuro-imaging, were managed with plasma infusions and required craniotomy. The rest were managed conservatively with plasma transfusions. All were discharged alive in good clinical condition. Almost all were followed regularly in clinic with monthly cryoprecipitate transfusions. Although factor XIII deficiency is a rare genetic disorder in children with history of bruising, prolonged umbilical bleeding, family history of bleeding and consanguinity with normal initial coagulation screen (PT, APTT and platelets), FXIII D should be ruled out. (author)

  15. The clinical outcome of thymectomy in myasthenia gravis

    Directory of Open Access Journals (Sweden)

    Mirsharifi R

    2009-02-01

    Full Text Available "nBackground: Myasthenia Gravis (MG is a neuromuscular disorder with weakness of skeletal muscles. Thymectomy is now recognized as a treatment modality in MG. The aim of this study was to evaluate the clinical effect of thymectomy on MG. "nMethods: MG patients with history of thymectomy at a tertiary referral center during twelve year period were included. The medical records were reviewed and telephone survey was conducted to evaluate the effects of thymectomy. "nResults: Sixty MG patients, 46 females and 14 males, aged 30.4±11.1 years, underwent open (n=48 or video-assisted thoracoscopic thymectomy (n=12 during study period. The mean dosage of preoperative pyridostigmine was 235.4±86.2mg/day. This figure reached to 129±18mg/day after thymectomy (p<0.0001. 17 patients (28.3% had complete remission (complete freedom of symptoms without medications. Improve-ment (improved symptoms or less medication requirement was seen in 34 patients (56.6%. There was no response to surgical therapy in six patients (10%. Three patients (5% had experienced progression of disease postoperatively. Overall, benefit of thymectomy was observed in 85% of patients. Age, sex, duration and severity of disease, quantity of preoperative drugs, surgical approach, and presence of thymoma did not affect the outcome. Satisfaction was stated as excellent in 17%, good in 43%, moderate in 35% and poor in 5% of patients after operation. "nConclusion: Thymectomy is an effective treatment for MG which leads to less severity of disease and less drug requirement. It would be considered in all myasthenic patients regardless of age, sex, duration and severity of disease and presence of thymoma.

  16. 75 FR 32496 - Housing Counseling Outcomes Study

    Science.gov (United States)

    2010-06-08

    ... URBAN DEVELOPMENT Housing Counseling Outcomes Study AGENCY: Office of the Chief Information Officer, HUD... the study. In granting their informed consent to participate in the study, these counseling clients... lists the following information: Title of Proposal: Housing Counseling Outcomes Study. OMB...

  17. CLINICAL STUDY ON ACUTE PANCREATITIS

    Directory of Open Access Journals (Sweden)

    Suhaib Rehaman

    2015-07-01

    Full Text Available INTRODUCTION : Early diagnosis and severity evaluation on patients with acute pancreatitis are very important due to its potential morbidity and mortality. Given the wide spectrum of disease seen, the care of patients with pancreatitis must be highly individualized. Sev eral clinical, laboratory and radiologic factors and many scoring systems have been proposed for outcome prediction. AIMS AND OBJECTIVES: To study the symptomatology, clinical presentation and management in pancreatitis . To study the severity of acute panc reatitis according to Glasgow Scale . METHODS: Present study includes consecutive 38 patients hospitalized in CSI Holdsworth Memorial Hospital over the period of 2 years. All patients were thoroughly investigated and were stratified according to the Glasgow criteria. Data was collected on complications, investigations and interventions undertaken, outcome, duration of stay in hospital and ICU. STATISTICAL ANALYSIS USED: Descriptive, Chi square tests, Crosstabs (Contingency coefficient analysis . RESULTS : Mean age of presentation in our study was 43.1 years. There was a male predominance accounting for 68.4% compared to 31.6% females. Alcohol was the main etiological factor in about 50% of the patients. Sensitivity to S. amylase was about 100%. Accuracy of USG abdomen in diagnosing pancreatitis was about 88.5%. Ascitis was the commonest complication seen in 13.2%. Mean duration of hospital stay was 6.2 days. The patient were stratified according to Glasgow scoring system into mild (0 - 3 and severe (>3 panc reatitis. In our study 32 people were graded with mild pancreatitis, all improved and in 6 people who were graded with severe pancreatitis, 83.3 % improved and 2.6% expired because of complications. Test statistics showed Contingency coefficient 0.355 and P 0.019 (NS. CONCLUSION : Glasgow scoring system remains a valid predicting system for the outcome in patients with acute pancreatitis. It is simple easy to apply with

  18. Clinical practice and outcome of radiotherapy for esophageal cancer between 1999 and 2003. The Japanese Radiation Oncology Study Group (JROSG) survey

    International Nuclear Information System (INIS)

    The background of this study was to determine the clinical results of radiotherapy (RT) for esophageal cancer in Japan. A questionnaire-based survey was conducted for esophageal cancer treated by definitive RT between 1999 and 2003. Clinical results of definitive RT for patients were collected from 9 major institutions. Only patients with good performance status (PS 0-2) who received a total dose of 50 Gy or more were included. Patients were classified into three groups: (A) stage I, (B) resectable stages II-III, (C) unresectable stages III-IVA. For group A, all patients treated by RT alone or chemo-radiotherapy (CRT) were included. For groups B and C, only those treated by CRT were included. In total, 167 patients were included in group A, 239 in group B, and 244 in group C. Approximately half of the patients in group A were treated by CRT. The median total RT dose ranged from 60 to 66 Gy. The median and range of the 5-year overall survival rates were 56% (48-83%) for group A, 29% (12-52%) for group B, and 19% (0-31%) for group C, respectively. A wide disparity in overall survival rates was noted among the institutions. A significant correlation between the number of patients treated per year and the 5-year overall survival rate was noted for groups B and C (both p<0.05). Although the overall survival rates for stage I esophageal cancer were excellent, a significant disparity in survival rates was noted among the institutions for stage II-IVA tumors treated by CRT. (author)

  19. Presence of the Panton-Valentine Leukocidin Genes in Methicillin-Resistant Staphylococcus aureus Is Associated with Severity and Clinical Outcome of Hospital-Acquired Pneumonia in a Single Center Study in China.

    Science.gov (United States)

    Zhang, Chuanling; Guo, Liang; Chu, Xu; Shen, Limeng; Guo, Yuanyu; Dong, Huali; Mao, Jianfeng; van der Veen, Stijn

    2016-01-01

    The Panton-Valentine leukocidin (PVL) genes of methicillin-resistant Staphylococcus aureus (MRSA) have previously been associated with severe infections. Here, the impact of the PVL genes on severity of disease and clinical outcome of patients with hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP) due to MRSA was investigated in a single center observational study in a hospital in China. HAP due to MRSA was diagnosed in 100 patients and 13 of the patients were PVL positive, while VAP was diagnosed in 5 patients and 2 were PVL positive. The PVL positive patient group showed a significantly higher Acute Physiology and Chronic Health Evaluation (APACHE) II score (14.3 ±7.8 vs. 10.1 ±4.7, P = 0.005) and significantly more patients with CRP levels >80 mg/L (8/15 vs. 12/90, P = 0.006) or WBC counts >15x109/L (7/15 vs. 12/90, P = 0.006), indicating that the severity of disease is affected by the presence of the PVL genes. The outcome of the study was defined by 30-day mortality. Four (27%) of the PVL positive patients and four (4%) of the PVL negative patients died within 30 days (P = 0.01, Fisher exact test). Kaplan-Meier survival curves were generated for the PVL positive and PVL negative patient groups, which differed significantly (P = 0.003). Among the patients that died, the mean interval between diagnosis and death was shorter for the PVL positive patients (9.3 ±5.6 vs. 40.8 ±6.6 days, P = 0.013). Further analysis within the HAP and VAP patient groups showed that the presence of PVL in MRSA impacted the severity of disease and clinical outcome of HAP, but for VAP the number of patients included in the study was too low. In conclusion, in this single center study in a Chinese hospital the presence of the PVL genes in MRSA impacted the severity of disease and clinical outcome in patients with HAP due to MRSA. PMID:27249225

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

    Science.gov (United States)

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

    2015-09-01

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

  1. The impact of patient support programs on adherence, clinical, humanistic, and economic patient outcomes: a targeted systematic review

    Science.gov (United States)

    Ganguli, Arijit; Clewell, Jerry; Shillington, Alicia C

    2016-01-01

    Background Patient support programs (PSPs), including medication management and counseling, have the potential to improve care in chronic disease states with complex therapies. Little is known about the program’s effects on improving clinical, adherence, humanistic, and cost outcomes. Purpose To conduct a targeted review describing medical conditions in which PSPs have been implemented; support delivery components (eg, face-to-face, phone, mail, and internet); and outcomes associated with implementation. Data sources MEDLINE – 10 years through March 2015 with supplemental handsearching of reference lists. Study selection English-language trials and observational studies of PSPs providing at minimum, counseling for medication management, measurement of ≥1 clinical outcome, and a 3-month follow-up period during which outcomes were measured. Data extraction Program characteristics and related clinical, adherence, humanistic, and cost outcomes were abstracted. Study quality and the overall strength of evidence were reviewed using standard criteria. Data synthesis Of 2,239 citations, 64 studies met inclusion criteria. All targeted chronic disease processes and the majority (48 [75%]) of programs offered in-clinic, face-to-face support. All but 9 (14.1%) were overseen by allied health care professionals (eg, nurses, pharmacists, paraprofessionals). Forty-one (64.1%) reported at least one significantly positive clinical outcome. The most frequent clinical outcome impacted was adherence, where 27 of 41 (66%) reported a positive outcome. Of 42 studies measuring humanistic outcomes (eg, quality of life, functional status), 27 (64%) reported significantly positive outcomes. Only 15 (23.4%) programs reported cost or utilization-related outcomes, and, of these, 12 reported positive impacts. Conclusion The preponderance of evidence suggests a positive impact of PSPs on adherence, clinical and humanistic outcomes. Although less often measured, health care utilization and

  2. Radiofrequency thermocoagulation for V2/V3 idiopathic trigeminal neuralgia: effect of treatment temperatures on long-term clinical outcomes: A Cohort Study.

    Science.gov (United States)

    Yao, Peng; Deng, Yi-Yong; Hong, Tao; Wang, Zhi-Bin; Ma, Jia-Ming; Zhu, Yong-Qiang; Li, Hong-Xi; Ding, Yuan-Yuan; Pan, Shi-Nong

    2016-06-01

    Radiofrequency thermocoagulation (RFT) is widely used to treat trigeminal neuralgia (TN); however, the optimal temperature at which RFT is most efficacious remains under much debate. Thus, the aim of the present study was to determine the lowest temperature at which morbidity could be minimized and patient outcomes maximized.A multivariate analysis was used to study 1354 patients who underwent computed tomography (CT)-guided RFT for V2/V3 idiopathic trigeminal neuralgia (ITN) during from June 2006 to May 2015. RFT was carried out at 62, 65, and 68°C, while keeping all other RF parameters the same. This was a prospective cohort study, in which we assessed intra- and postoperative complications, pain relief, and long-term health-related quality of life (HRQoL).The intraoperative and in-hospital complications of patients were mainly facial hematoma, mouth and external auditory meatus penetration, nausea, vomiting, dizziness, and headache, which were all treated symptomatically. In long-term follow-up, patients with pain relief (defined as no pain and no required drug intervention) at 62, 65, and 68°C accounted for 94.2%, 98.3%, and 98.8% (at discharge); 83.8%, 90.1%, and 91.4% (at 1 year); 66.7%, 80.5%, and 88.2% (at 3 years); 59.0%, 64.3%, and 77.2% (at 5 years); 48.7%, 57.8%, and 72.3% (at 7 years); 40.6%, 53.7%, and 60.3% (at 9 years), respectively. The number of patients with facial numbness, masticatory atonia, or corneal hypoesthesia was increased with the elevation of temperature, but these complications were all mild. No blindness, deafness, intracranial hemorrhage, or death as a result of the surgical intervention occurred in any patients. SF-36 scores showed highest HRQoL in the group treated at 68°C, followed by the 65 and 62°C groups, respectively.Our results demonstrate that 68°C is a good choice for RFT of V2/V3 ITN. The alternative option is 65 or 62°C for RFT to minimize the occurrence of complications including facial numbness, yet which often

  3. Primary endpoint results of the OMEGA Study: One-year clinical outcomes after implantation of a novel platinum chromium bare metal stent

    Energy Technology Data Exchange (ETDEWEB)

    Wang, John C., E-mail: john.wang@medstar.net [MedStar Union Memorial Hospital, Baltimore MD (United States); Carrié, Didier, E-mail: carrie.didier@chu-toulouse.fr [Centre Hôpital Universitaire Rangueil, Toulouse (France); Masotti, Monica, E-mail: MASOTTI@clinic.ub.es [Hospital Clinic, University of Barcelona (Spain); Erglis, Andrejs, E-mail: a.a.erglis@stradini.lv [Pauls Stradins Clinical University Hospital, University of Latvia, Riga (Latvia); Mego, David, E-mail: David.Mego@arheart.com [Arkansas Heart Hospital, Little Rock, AR (United States); Watkins, Matthew W., E-mail: Matthew.Watkins@vtmednet.org [University of Vermont Medical Center, Burlington VT (United States); Underwood, Paul, E-mail: Paul.underwood@bsci.com [Boston Scientific, Marlborough MA USA (United States); Allocco, Dominic J., E-mail: Dominic.allocco@bsci.com [Boston Scientific, Marlborough MA USA (United States); Hamm, Christian W., E-mail: C.Hamm@kerckhoff-klinik.de [Kerckhoff Heart and Thoraxcenter, Bad Nauheim (Germany)

    2015-03-15

    Background/purpose: Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) compared to drug-eluting stents (DES). DES lower repeat revascularization rates compared to BMS, but may have higher rates of late stent thrombosis (ST) potentially due to impaired endothelialization requiring longer dual anti-platelet therapy (DAPT). OMEGA evaluated a novel BMS designed to have improved deliverability and radiopacity, in comparison to currently available platforms. Methods/materials: OMEGA was a prospective, multicenter, single-arm study enrolling 328 patients at 37 sites (US and Europe). Patients received the OMEGA stent (bare platinum chromium element stent) for the treatment of de novo native coronary artery lesions (≤ 28 mm long; diameter ≥ 2.25 mm to ≤ 4.50 mm). The primary endpoint was 9-month target lesion failure (TLF: cardiac death, target vessel-related MI, target lesion revascularization [TLR]) compared to a prespecified performance goal (PG) based on prior generation BMS. All major cardiac events were independently adjudicated. DAPT was required for a minimum of 1 month post procedure. Results: In the OMEGA study, the mean age was 65; 17% had diabetes mellitus. The primary endpoint was met; 9 month TLF rate was 11.5%, and the upper 1-sided 95% confidence bound of 14.79% was less than the prespecified PG of 21.2% (p < 0.0001). One-year event rates were low including a TLF rate of 12.8% and an ST rate of 0.6% at 12 months. Conclusions: One-year outcomes of OMEGA show low rates of TLF, revascularization and ST. This supports safety and efficacy of the OMEGA BMS for the treatment of coronary artery disease. - Highlights: • The OMEGA study evaluated a novel platinum chromium bare metal stent. • OMEGA enrolled 328 patients at 37 sites (US and Europe). • The primary endpoint of 9 month target lesion failure was 11.5%. • One-year event rates were low including an ST rate of 0.6% at 12 months.

  4. Primary endpoint results of the OMEGA Study: One-year clinical outcomes after implantation of a novel platinum chromium bare metal stent

    International Nuclear Information System (INIS)

    Background/purpose: Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) compared to drug-eluting stents (DES). DES lower repeat revascularization rates compared to BMS, but may have higher rates of late stent thrombosis (ST) potentially due to impaired endothelialization requiring longer dual anti-platelet therapy (DAPT). OMEGA evaluated a novel BMS designed to have improved deliverability and radiopacity, in comparison to currently available platforms. Methods/materials: OMEGA was a prospective, multicenter, single-arm study enrolling 328 patients at 37 sites (US and Europe). Patients received the OMEGA stent (bare platinum chromium element stent) for the treatment of de novo native coronary artery lesions (≤ 28 mm long; diameter ≥ 2.25 mm to ≤ 4.50 mm). The primary endpoint was 9-month target lesion failure (TLF: cardiac death, target vessel-related MI, target lesion revascularization [TLR]) compared to a prespecified performance goal (PG) based on prior generation BMS. All major cardiac events were independently adjudicated. DAPT was required for a minimum of 1 month post procedure. Results: In the OMEGA study, the mean age was 65; 17% had diabetes mellitus. The primary endpoint was met; 9 month TLF rate was 11.5%, and the upper 1-sided 95% confidence bound of 14.79% was less than the prespecified PG of 21.2% (p < 0.0001). One-year event rates were low including a TLF rate of 12.8% and an ST rate of 0.6% at 12 months. Conclusions: One-year outcomes of OMEGA show low rates of TLF, revascularization and ST. This supports safety and efficacy of the OMEGA BMS for the treatment of coronary artery disease. - Highlights: • The OMEGA study evaluated a novel platinum chromium bare metal stent. • OMEGA enrolled 328 patients at 37 sites (US and Europe). • The primary endpoint of 9 month target lesion failure was 11.5%. • One-year event rates were low including an ST rate of 0.6% at 12 months

  5. Clinical outcomes for patients with synovial sarcoma of the hand

    OpenAIRE

    Outani, Hidetatsu; Hamada, Kenichiro; Oshima, Kazuya; Joyama, Susumu; Naka, Norifumi; Araki, Nobuhito; Ueda, Takafumi; Yoshikawa, Hideki

    2014-01-01

    Purpose Soft tissue sarcoma of the hand is rare, and one of the most common histological diagnosis is synovial sarcoma. We report the clinical outcomes of patients with synovial sarcoma of the hand and discuss treatment strategies. Methods We reviewed five patients with synovial sarcoma of the hand treated at our institutions from 1983 to 2013. The mean patient age at the time of diagnosis was 36.6 years (range, 20–62 years). Two patients underwent marginal excision after neoadjuvant chemothe...

  6. Perfusion CT in acute stroke: prediction of vessel recanalization and clinical outcome in intravenous thrombolytic therapy

    International Nuclear Information System (INIS)

    This study evaluated perfusion computed tomography (PCT) for the prediction of vessel recanalization and clinical outcome in patients undergoing intravenous thrombolysis. Thirty-nine patients with acute ischemic stroke of the middle cerebral artery territory underwent intravenous thrombolysis within 3 h of symptom onset. They all had non-enhanced CT (NECT), PCT, and CT angiography (CTA) before treatment. The Alberta Stroke Program Early Computed Tomography (ASPECT) score was applied to NECT and PCT maps to assess the extent of ischemia. CTA was assessed for the site of vessel occlusion. The National Institute of Health Stroke Scale (NIHSS) score was used for initial clinical assessment. Three-month clinical outcome was assessed using the modified Rankin scale. Vessel recanalization was determined by follow-up ultrasound. Of the PCT maps, a cerebral blood volume (CBV) ASPECT score of >6 versus ≤6 was the best predictor for clinical outcome (odds ratio, 31.43; 95% confidence interval, 3.41-289.58; P < 0.002), and was superior to NIHSS, NECT and CTA. No significant differences in ASPECT scores were found for the prediction of vessel recanalization. ASPECT score applied to PCT maps in acute stroke patients predicts the clinical outcome of intravenous thrombolysis and is superior to both early NECT and clinical parameters. (orig.)

  7. Measurement scales in clinical research of the upper extremity, part 2: outcome measures in studies of the hand/wrist and shoulder/elbow.

    Science.gov (United States)

    Badalamente, Marie; Coffelt, Laureen; Elfar, John; Gaston, Glenn; Hammert, Warren; Huang, Jerry; Lattanza, Lisa; Macdermid, Joy; Merrell, Greg; Netscher, David; Panthaki, Zubin; Rafijah, Greg; Trczinski, Douglas; Graham, Brent

    2013-02-01

    Part 1 of this article outlined the basic characteristics of useful clinical measurement instruments and described scales used to measure general health, pain, and patient satisfaction. Part 2 describes the features of some of the scales most commonly used in clinical research in the hand, wrist, elbow, and shoulder. PMID:23351913

  8. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis

    OpenAIRE

    Goldman, Myla D.; Motl, Robert W.; Rudick, Richard A.

    2010-01-01

    Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite (MSFC). These measures each have strengths and some weakness. Two additional measures, the six-minu...

  9. Endodontic retreatment. Aspects of decision making and clinical outcome.

    Science.gov (United States)

    Kvist, T

    2001-01-01

    Epidemiological surveys have reported that 25%-35% of root filled teeth are associated with periapical radiolucencies. Descriptive studies have demonstrated that clinicians' decision making regarding such teeth are subject to substantial variation. A coherent model to explain the observed variation has not been produced. In the present thesis a "Praxis Concept theory" was proposed. The theory suggests that dentists perceive periapical lesions of varying sizes as different stages on a continuous health scale. Interindividual variations can then be regarded as the result of the choice of different cut-off points on the continuum for prescribing retreatment. In the present study experiments among novice and expert decision makers gave evidence in favour of the theory. Data also suggested that the choice of retreatment criterion is affected by values, costs of retreatment and technical quality of original treatment. From a prescriptive point of view, the presence of a persistent periapical radiolucency has often been used as a criterion of endodontic "failure" and as an indication for endodontic retreatment. As an alternative decision strategy, the use of decision analysis has been proposed. Logical display of decision alternatives, values of probabilities, utility values (U-values) of the different outcomes and calculation of optimal decision strategy are features of this theory. The implementation of this approach is impeded by the uncertainty of outcome probabilities and lack of investigations concerning U-values. U-values of two periapical health states in root filled teeth (with and without a periapical lesion respectively) were investigated in a group of 82 dental students and among 16 Swedish endodontists. Two methods were used to elicit U-values: Standard gamble and Visual Analogue Scale. Large interindividual variation for both health states were recorded. The difference in U-values between the two health states was found to be statistically significant

  10. Good clinical practice in clinical interventional studies

    OpenAIRE

    Pieterse, Herman; Diamant, Zuzana

    2014-01-01

    Good clinical practice (GCP) guidelines should always be implemented and obeyed in clinical interventional studies. In this mini-review, we will address several burning questions relating to GCP in a concise ‘frequently asked questions’ format.While compliance to current rules and regulations is our mission, we also wish to play devil’s advocate attempting to translate the rules into sizeable chunks using a high dose of common sense.Keywords: clinical interventional studies; quality; safety; ...

  11. Evaluation of multi-outcome longitudinal studies

    DEFF Research Database (Denmark)

    Jensen, Signe Marie; Pipper, Christian Bressen; Ritz, Christian

    Evaluation of intervention effects on multiple outcomes is a common scenario in clinical studies. In longitudinal studies, such evaluation is a challenge if one wishes to adequately capture simultaneous data behavior. In this situation, a common approach is to analyze each outcome separately. As a...... result, multiple statistical statements describing the intervention effect need to be reported and an adjustment for multiple testing is necessary. This is typically done by means of the Bonferroni procedure, which does not take into account the correlation between outcomes, thus resulting in overly...

  12. Mature Results of the Ottawa Phase II Study of Intermittent Androgen-Suppression Therapy in Prostate Cancer: Clinical Predictors of Outcome

    International Nuclear Information System (INIS)

    Purpose: To present the mature experience of a phase II trial of intermittent androgen suppression (IAS). Methods and Materials: Intermittent androgen-suppression therapy was initiated in prostate-cancer patients to delay hormone resistance and minimize potential side effects of androgen-deprivation therapy (ADT). Patients received cyclical periods of ADT and observation (off-treatment interval [OTI]). Androgen-deprivation therapy was reinitiated when the level of prostate-specific antigen (PSA) rose above 10 ng/ml, or for disease progression. Associations between clinical factors and eligibility for OTI were measured. Kaplan-Meier and Cox regression analyses were used to determine factors predicting the duration of OTIs. Results: Ninety-five patients completed 187 cycles of treatment. The median duration of OTIs was 8.5 months. Patients with higher PSA and metastatic disease were less likely to be eligible for the first OTI (p < 0.01). In multivariate analysis, patients with higher PSA and local relapse had significantly longer OTIs (p < 0.01) compared with metastatic patients. The median time to withdrawal from the study was 37 months. Conclusions: Intermittent androgen suppression appears to be a favorable treatment option for patients with biochemically (according to level of PSA) or locally recurrent prostate cancer with favorable long-term survival, a high probability of eligibility for OTIs, and durable OTIs

  13. Atypical teratoid rhabdoid tumors: a population-based clinical outcomes study involving 174 patients from the Surveillance, Epidemiology, and End Results database (1973–2010)

    International Nuclear Information System (INIS)

    Atypical teratoid rhabdoid tumors (ATRTs) are rare, highly malignant embryonal tumors of the central nervous system (CNS) accounting for 20% of CNS tumors in children under the age of 3. This study examines a large cohort of ATRT patients to determine demographic, clinical, and pathologic factors which impact prognosis and survival. Demographic and clinical data were abstracted on 174 ATRT patients (171 pediatric patients age <20 and 3 adult patients age ≥20) from the Surveillance, Epidemiology, and End Results database (1973–2010). Standard statistical methodology was used. A total of 174 ATRT cases (mean age of 2.84 years) were identified. ATRT had a higher incidence in males (56.3%), Caucasians (59.1%), and children <3 years of age (80.5%), P<0.001. The most common primary sites were the cerebellum (17.8%), ventricles (16.1%), and frontal lobe (12.6%). Mean overall survival was 3.2±0.4 years, while overall and cancer-specific mortality were 63.2% and 56.3%, respectively, P=0.005. Most ATRT cases were treated with surgery alone (58.0%), followed by a combination of surgery and radiation (34.3%), no treatment (6.5%), and radiation alone (1.2%). The use of combination therapy has increased significantly (16.1%) since 2005 (P<0.001), while primary surgical resection and radiation therapy rates remain relatively unchanged. The longest survival was observed among ATRT patients receiving combination therapy (5.9±0.7 years), followed by radiation alone (2.8±1.2 years), and surgery alone (1.9±0.4 years), P<0.001. Multivariable analysis identified only distant metastases (OR =4.6) as independently associated with increased mortality, whereas combination therapy (OR =0.4) was associated with reduced mortality, P<0.005. ATRT is a rare and highly aggressive embryonal malignancy of the CNS that presents more often as locoregional tumors >4 cm in male Caucasian children of age <3 years, involving the cerebellum, ventricles, or frontal lobe. Combination therapy

  14. Early seizures in patients with acute stroke: Frequency, predictive factors, and effect on clinical outcome

    OpenAIRE

    Andrea Alberti; Maurizio Paciaroni; Valeria Caso; Michele Venti; Francesco Palmerini; Giancarlo Agnelli

    2008-01-01

    Andrea Alberti, Maurizio Paciaroni, Valeria Caso, Michele Venti, Francesco Palmerini, Giancarlo AgnelliStroke Unit and Division of Internal and Cardiovascular Medicine, University of Perugia, Perugia, ItalyBackground: Early seizure (ES) may complicate the clinical course of patients with acute stroke. The aim of this study was to assess the rate of and the predictive factors for ES as well the effects of ES on the clinical outcome at hospital discharge in patients with first-ever stroke.Patie...

  15. Epidemiology and Clinical Outcomes of Patients with Carbapenem-Resistant Klebsiella pneumoniae Bacteriuria

    OpenAIRE

    Qureshi, Zubair A.; Syed, Alveena; Clarke, Lloyd G.; Doi, Yohei; Shields, Ryan K.

    2014-01-01

    Carbapenem-resistant Klebsiella pneumoniae (CRKP) bacteriuria is a frequently encountered clinical condition, but its clinical impact is unknown. We conducted a retrospective cohort study to define the epidemiology and outcomes for patients with CRKP bacteriuria. Patients with positive urine cultures for CRKP were classified as having asymptomatic bacteriuria (ASB) or symptomatic urinary tract infection (UTI). Among 105 patients with CRKP bacteriuria, 80% (84/105 patients) and 20% (21/105 pat...

  16. Clinical features and outcomes of autoimmune hemolytic anemia: a retrospective analysis of 32 cases

    OpenAIRE

    Baek, Seung-Woo; Lee, Myung-Won; Ryu, Hae-Won; Lee, Kyu-Seop; SONG, IK-CHAN; Lee, Hyo-Jin; Yun, Hwan-Jung; Kim, Samyong; Jo, Deog-Yeon

    2011-01-01

    Background There has been no report on the clinical features or natural history of autoimmune hemolytic anemia (AIHA) in the Korean adult population. This study retrospectively analyzed the clinical characteristics and long-term outcomes of AIHA in the Korean adults. Methods Patients newly diagnosed with AIHA between January 1994 and December 2010 at Chungnam National University Hospital were enrolled. Patient characteristics at diagnosis, response to treatment, and the natural course of the ...

  17. The functional and clinical outcomes of exercise training following a very low energy diet for severely obese women: study protocol for a randomised controlled trial

    OpenAIRE

    Miller, Clint T.; Fraser, Steve F; Selig, Steve E; Rice, Toni; Grima, Mariee; Straznicky, Nora E.; Levinger, Itamar; Lambert, Elisabeth A.; van den Hoek, Daniel J.; Dixon, John B.

    2016-01-01

    Background Clinical practice guidelines globally recommend lifestyle modification including diet and exercise training as first-line treatment for obesity. The clinical benefits of exercise training in adults with obesity is well-documented; however, there is no strong evidence for the effectiveness of exercise training for weight loss in class II and class III obesity. The purpose of the randomised controlled trial described in this protocol article is to examine the effect of exercise train...

  18. Spontaneous reduction of intussusception: clinical spectrum, management and outcome

    Energy Technology Data Exchange (ETDEWEB)

    Kornecki, A.; Daneman, A.; Navarro, O.; Connolly, B.; Manson, D.; Alton, D.J. [Toronto Univ., ON (Canada); Department of Diagnostic Imaging, Hospital for Sick Children, Toronto, ON (Canada)

    2000-01-01

    Background. To analyze the spectrum of clinical features, management and outcome of children with documented spontaneous reduction of intussusception (SROI). Materials and methods. Review of records of 50 children (33 boys, 17 girls; age range 11 days-15 years; mean age 4 years) with documented SROI, in whom intussusception was initially diagnosed by sonography (US) in 44, air enema in 2, and computed tomography in 4, in the 6-year period 1992-1998. Results. Symptoms suggestive of intussusception were present in 21 (3 of whom had Henoch-Schoenlein purpura and 4 had previous ileocolic intussusception reduced by air enema). Intussusception was an incidental finding in the other 29, in 28 of whom the finding was in the small bowel. Intussusception was limited to the small bowel in 43 and was ileocolic in 7. SROI was usually documented on US. Laparotomy performed in only 4 showed no evidence of intussusception or pathologic lead point. Outcome in all patients was favorable. Conclusions. SROI may present in symptomatic or asymptomatic children and occurs more commonly than previously reported. These intussusceptions are usually short-segment, small-bowel intussusceptions with no recognizable lead point. In asymptomatic patients, conservative observation is warranted. Intervention should be dictated by the clinical findings in symptomatic patients. (orig.)

  19. Low Plasma alpha-Tocopherol Concentrations and Adverse Clinical Outcomes in Diabetic Hemodialysis Patients

    NARCIS (Netherlands)

    Espe, Katharina M.; Raila, Jens; Henze, Andrea; Blouin, Katja; Schneider, Andreas; Schmiedeke, Daniel; Krane, Vera; Pilz, Stefan; Schweigert, Florian J.; Hocher, Berthold; Wanner, Christoph; Drechsler, Christiane

    2013-01-01

    Background and objectives Trials with the antioxidant vitamin E have failed to show benefit in the general population. Considering the different causes of death in ESRD, this study investigated the association between plasma concentrations of alpha-tocopherol and specific clinical outcomes in diabet

  20. ST-Segment resolution and clinical outcome with ischemic postconditioning and comparison to magnetic resonance

    DEFF Research Database (Denmark)

    Lønborg, Jacob; Holmvang, Lene; Kelbæk, Henning;

    2010-01-01

    Ischemic postconditioning (IPost) during primary percutaneous coronary intervention (PPCI) is suggested to reduce myocardial damage. However, the association with ST-segment resolution (STR) and clinical outcome is not determined. The primary aim of this study was to evaluate the association of I...

  1. Poststroke Shoulder Pain in Turkish Stroke Patients: Relationship with Clinical Factors and Functional Outcomes

    Science.gov (United States)

    Barlak, Aysegul; Unsal, Sibel; Kaya, Kurtulus; Sahin-Onat, Sule; Ozel, Sumru

    2009-01-01

    The objective of this study was to assess the possible causes of hemiplegic shoulder pain (HSP) in Turkish patients with stroke, to identify the correlation between HSP and clinical factors, and to review the effects of HSP on functional outcomes. A total of 187 consecutive patients with stroke were evaluated for the presence of HSP and for the…

  2. Establishing a new falls clinic - conflicting attitudes and inter-sectoral competition affecting the outcome

    DEFF Research Database (Denmark)

    Evron, Lotte; Schultz-Larsen, Kirsten; Egerod, Ingrid

    2008-01-01

    Scand J Caring Sci; 2008 Establishing a new falls clinic - conflicting attitudes and inter-sectoral competition affecting the outcomeFalls clinics are a newer model for falls management among the elderly. Few studies have addressed the impact of the strategy on falls prevention in the healthcare...... system. The aim of the present study was to describe the social processes that affect the implementation of new strategies in falls management. A newly established falls clinic was chosen as an instrumental case to describe the systematic and comprehensive approach to falls prevention among the elderly...

  3. Clinical Outcomes and Complications of Cortical Button Distal Biceps Repair: A Systematic Review of the Literature

    Directory of Open Access Journals (Sweden)

    Andreas Panagopoulos

    2016-01-01

    Full Text Available Objectives. The purpose of the present study was to investigate the clinical outcomes and complications of the cortical button distal biceps fixation method. Material and Methods. All methods followed the PRISMA guidelines. Included studies had to describe clinical outcomes and complications after acute distal biceps repair with cortical button fixation. Eligibility criteria also included English language, more than 5 cases with minimum follow-up of 6 months, and preferably usage of at least one relevant clinical score (MEPS, ASES, and/or DASH for final outcome. A loss of at least 30° in motion—flexion, extension, pronation, or supination—and a loss of at least 30% of strength were considered an unsatisfactory result. Results. The review identified 7 articles including 105 patients (mean age 43.6 years with 106 acute distal biceps ruptures. Mean follow-up was 26.3 months. Functional outcome of ROM regarding flexion/extension and pronation/supination was satisfactory in 94 (89.5% and 86 (82% patients in respect. Averaged flexion and supination strength had been reported in 6/7 studies (97 patients and were satisfactory in 82.4% of them. The most common complication was transient nerve palsy (14.2%. The overall reoperation rate was 4.8% (5/105 cases. Conclusion. Cortical button fixation for acute distal biceps repair is a reproducible operation with good clinical results. Most of the complications can be avoided with appropriate surgical technique.

  4. CLINICAL HISTORY AND OUTCOME OF 59 PATIENTS WITH IDIOPATHIC HYPERPROLACTINEMIA

    NARCIS (Netherlands)

    SLUIJMER, AV; LAPPOHN, RE

    1992-01-01

    Objective: To investigate the clinical course of hyperprolactinemia without demonstrable cause. Design: Prospective study of all patients with idiopathic hyperprolactinemia first seen between 1974 and 1985. Setting: Outpatient Department of University Hospital. Patients: Fifty-nine patients followed

  5. Prediction of labor induction outcome using different clinical parameters

    OpenAIRE

    Tatić-Stupar Žaklina; Novakov-Mikić Aleksandra; Bogavac Mirjana; Milatović Stevan; Sekulić Slobodan

    2013-01-01

    Introduction. Induction of labor is one of the most common obstetric interventions in contemporary obstetrics. Objective. The aim of the study was to evaluate the clinical and sonographic parameters in prediction of success of labor induction. Methods. The prospective study included 422 women in whom induction of labor was carried out at the Department of Obstetrics and Gynecology of Clinical Centre of Vojvodina. The role of body mass index and age of women...

  6. Clinical audit of foetomaternal outcome in pregnancies with fibroid uterus

    International Nuclear Information System (INIS)

    Background: Leiomyoma, myoma, leiomyoma or fibroids are synonymous terms. They may be present in as many as 1 in 5 women over age 35 years. If pregnancy is associated with fibroids, it leads to multiple complications. Objectives of this study were to evaluate the maternal and foetal outcome in women having pregnancy with fibroids in uterus and the complications associated with fibroids during the pregnancy. Methods: This descriptive study was conducted in the Department of Obstetrics and Gynaecology, Ayub Teaching Hospital Abbottabad from March 2009 to March 2010. Data were collected on proforma regarding demographic variables, obstetrical history, mode of delivery, maternal outcome, maternal complications, and foetal outcome. Mean and standard deviation was calculated for age, period of gestation, and obstetrical history. Frequency and percentages was calculated for booking status, maternal outcome, maternal complications and foetal outcome. Results: Thirty patients were included in this study who had pregnancy with fibroid. Normal delivery was achieved in 14 (46.66%) patients. Eight (26.67%) patients had caesarean section and eight (26.67%) had miscarriages. Seven (23.33%) patients had no complications while 8 (26.67%) had miscarriages, 8 (26.67%) had postpartum haemorrhage, 10 (33.33%) had preterm delivery, and 3 patients had ante-partum haemorrhage. Two (10%) patients had premature rupture off membranes and 1 patient (3.33%) had pain abdomen and technical difficulty during caesarean section. There were 12 (40%) healthy babies. Five (16.67%) babies delivered with morbidity but recovered. There were 4 (13.33%) intrauterine deaths and one early neonatal death. Conclusion: Fibroid in pregnancy, especially multiple intramural fibroids and fibroids larger than 10 Cm, cause miscarriage and preterm labour. (author)

  7. PPB | What is a Clinical Study

    Science.gov (United States)

    The Pleuropulmonary blastoma (PPB) DICER1 Syndrome Study ‹an observational clinical research study‹is enrolling children with PPB and their families. In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.

  8. Outcome Measures for Clinical Trials in Interstitial Lung Diseases

    Science.gov (United States)

    Lammi, Matthew R.; Baughman, Robert P.; Birring, Surinder S.; Russell, Anne-Marie; Ryu, Jay H.; Scholand, Marybeth; Distler, Oliver; LeSage, Daphne; Sarver, Catherine; Antoniou, Katerina; Highland, Kristin B.; Kowal-Bielecka, Otylia; Lasky, Joseph A.; Wells, Athol U.; Saketkoo, Lesley Ann

    2015-01-01

    The chronic fibrosing idiopathic interstitial pneumonias (IIPs) are a group of heterogeneous pulmonary parenchymal disorders described by radiologic and histological patterns termed usual interstitial pneumonia (UIP) and non-specific interstitial pneumonia (NSIP). These include idiopathic pulmonary fibrosis (IPF) and those related to connective tissue disease (CTD) and are associated with substantial morbidity and mortality. Beyond the importance of establishing an appropriate diagnosis, designing optimal clinical trials for IIPs has been fraught with difficulties in consistency of clinical endpoints making power analyses, and the establishment of efficacy and interpretation of results across trials challenging. Preliminary recommendations, developed by rigorous consensus methods, proposed a minimum set of outcome measures, a ‘core set’, to be incorporated into future clinical trials (Saketkoo et al, THORAX. 2014.). This paper sets out to examine the candidate instruments for each domain (Dyspnea, Cough, Health Related Quality of Life, Imaging, Lung Physiology and Function, Mortality). Candidate measures that were not selected as well as measures that were not available for examination at the time of the consensus process will also be discussed. PMID:27019654

  9. Clinical Outcomes of Extreme Lateral Interbody Fusion in the Treatment of Adult Degenerative Scoliosis

    Directory of Open Access Journals (Sweden)

    Adam M. Caputo

    2012-01-01

    Full Text Available Introduction. The use of extreme lateral interbody fusion (XLIF and other lateral access surgery is rapidly increasing in popularity. However, limited data is available regarding its use in scoliosis surgery. The objective of this study was to evaluate the clinical outcomes of adults with degenerative lumbar scoliosis treated with XLIF. Methods. Thirty consecutive patients with adult degenerative scoliosis treated by a single surgeon at a major academic institution were followed for an average of 14.3 months. Interbody fusion was completed using the XLIF technique with supplemental posterior instrumentation. Validated clinical outcome scores were obtained on patients preoperatively and at most recent follow-up. Complications were recorded. Results. The study group demonstrated improvement in multiple clinical outcome scores. Oswestry Disability Index scores improved from 24.8 to 19.0 (P < 0.001. Short Form-12 scores improved, although the change was not significant. Visual analog scores for back pain decreased from 6.8 to 4.6 (P < 0.001 while scores for leg pain decreased from 5.4 to 2.8 (P < 0.001. A total of six minor complications (20% were recorded, and two patients (6.7% required additional surgery. Conclusions. Based on the significant improvement in validated clinical outcome scores, XLIF is effective in the treatment of adult degenerative scoliosis.

  10. Treatment Outcomes in Patients with Internet Addiction: A Clinical Pilot Study on the Effects of a Cognitive-Behavioral Therapy Program

    OpenAIRE

    2014-01-01

    Internet addiction is regarded as a growing health concern in many parts of the world with prevalence rates of 1-2% in Europe and up to 7% in some Asian countries. Clinical research has demonstrated that Internet addiction is accompanied with loss of interests, decreased psychosocial functioning, social retreat, and heightened psychosocial distress. Specialized treatment programs are needed to face this problem that has recently been added to the appendix of the DSM-5. While there are numerou...

  11. Testing for heterogeneity among the components of a binary composite outcome in a clinical trial

    Directory of Open Access Journals (Sweden)

    Devereaux PJ

    2010-06-01

    Full Text Available Abstract Background Investigators designing clinical trials often use composite outcomes to overcome many statistical issues. Trialists want to maximize power to show a statistically significant treatment effect and avoid inflation of Type I error rate due to evaluation of multiple individual clinical outcomes. However, if the treatment effect is not similar among the components of this composite outcome, we are left not knowing how to interpret the treatment effect on the composite itself. Given significant heterogeneity among these components, a composite outcome may be judged as being invalid or un-interpretable for estimation of the treatment effect. This paper compares the power of different tests to detect heterogeneity of treatment effect across components of a composite binary outcome. Methods Simulations were done comparing four different models commonly used to analyze correlated binary data. These models included: logistic regression for ignoring correlation, logistic regression weighted by the intra cluster correlation coefficient, population average logistic regression using generalized estimating equations (GEE, and random effects logistic regression. Results We found that the population average model based on generalized estimating equations (GEE had the greatest power across most scenarios. Adequate power to detect possible composite heterogeneity or variation between treatment effects of individual components of a composite outcome was seen when the power for detecting the main study treatment effect for the composite outcome was also reasonably high. Conclusions It is recommended that authors report tests of composite heterogeneity for composite outcomes and that this accompany the publication of the statistically significant results of the main effect on the composite along with individual components of composite outcomes.

  12. CD19-targeted CAR T-cell therapeutics for hematologic malignancies: interpreting clinical outcomes to date.

    Science.gov (United States)

    Park, Jae H; Geyer, Mark B; Brentjens, Renier J

    2016-06-30

    Adoptive transfer of T cells genetically modified to express chimeric antigen receptors (CARs) targeting CD19 has produced impressive results in treating patients with B-cell malignancies. Although these CAR-modified T cells target the same antigen, the designs of CARs vary as well as several key aspects of the clinical trials in which these CARs have been studied. It is unclear whether these differences have any impact on clinical outcome and treatment-related toxicities. Herein, we review clinical results reflecting the investigational use of CD19-targeted CAR T-cell therapeutics in patients with B-cell hematologic malignancies, in light of differences in CAR design and production, and outline the limitations inherent in comparing outcomes between studies. PMID:27207800

  13. Clinical outcomes of enjoying sexualization among lesbian women.

    Science.gov (United States)

    Erchull, Mindy J; Liss, Miriam

    2015-01-01

    The Enjoyment of Sexualization Scale (ESS) was given to 150 lesbians in addition to measures of self-objectification, negative eating attitudes, and depression. The ESS was found to have acceptable levels of internal consistency reliability with a lesbian sample. Scores on the ESS were lower in this sample than in previously reported research with heterosexual women. Enjoying sexualization was found to moderate the relationship between body shame and both depressive symptomatology and negative eating attitudes. In contrast to findings from a heterosexual sample, lesbians who enjoyed sexualization had smaller relationships between these negative clinical outcomes and body shame than lesbians who did not. For lesbians, enjoying sexualization may serve a protective function against the negative effects of self-objectification. Findings are discussed in terms of body image and perceptions of ideal beauty among lesbians. PMID:25287134

  14. Clinical outcomes following salvage Gamma Knife radiosurgery for recurrent glioblastoma

    OpenAIRE

    Larson, Erik W.; Peterson, Halloran E.; Lamoreaux, Wayne T.; Mackay, Alexander R.; Fairbanks, Robert K; Call, Jason A.; Carlson, Jonathan D.; Ling, Benjamin C; Demakas, John J.; Cooke, Barton S; Lee, Christopher M

    2014-01-01

    Glioblastoma multiforme (GBM) is the most common malignant primary brain tumor with a survival prognosis of 14-16 mo for the highest functioning patients. Despite aggressive, multimodal upfront therapies, the majority of GBMs will recur in approximately six months. Salvage therapy options for recurrent GBM (rGBM) are an area of intense research. This study compares recent survival and quality of life outcomes following Gamma Knife radiosurgery (GKRS) salvage therapy. Following a PubMed search...

  15. Atrial Fibrillation Ablation in Systolic Dysfunction: Clinical and Echocardiographic Outcomes

    Directory of Open Access Journals (Sweden)

    Tasso Julio Lobo

    2015-01-01

    Full Text Available Background: Heart failure and atrial fibrillation (AF often coexist in a deleterious cycle. Objective: To evaluate the clinical and echocardiographic outcomes of patients with ventricular systolic dysfunction and AF treated with radiofrequency (RF ablation. Methods: Patients with ventricular systolic dysfunction [ejection fraction (EF <50%] and AF refractory to drug therapy underwent stepwise RF ablation in the same session with pulmonary vein isolation, ablation of AF nests and of residual atrial tachycardia, named "background tachycardia". Clinical (NYHA functional class and echocardiographic (EF, left atrial diameter data were compared (McNemar test and t test before and after ablation. Results: 31 patients (6 women, 25 men, aged 37 to 77 years (mean, 59.8±10.6, underwent RF ablation. The etiology was mainly idiopathic (19 p, 61%. During a mean follow-up of 20.3±17 months, 24 patients (77% were in sinus rhythm, 11 (35% being on amiodarone. Eight patients (26% underwent more than one procedure (6 underwent 2 procedures, and 2 underwent 3 procedures. Significant NYHA functional class improvement was observed (pre-ablation: 2.23±0.56; postablation: 1.13±0.35; p<0.0001. The echocardiographic outcome also showed significant ventricular function improvement (EF pre: 44.68%±6.02%, post: 59%±13.2%, p=0.0005 and a significant left atrial diameter reduction (pre: 46.61±7.3 mm; post: 43.59±6.6 mm; p=0.026. No major complications occurred. Conclusion: Our findings suggest that AF ablation in patients with ventricular systolic dysfunction is a safe and highly effective procedure. Arrhythmia control has a great impact on ventricular function recovery and functional class improvement.

  16. Clinical decision making and outcome in the routine care of people with severe mental illness across Europe (CEDAR)

    OpenAIRE

    Puschner, B; Becker, T.; Mayer, B; Jordan, H.; Maj, M.; Fiorillo, A; Égerházi, A.; Ivánka, T.; Munk-Jørgensen, P; Krogsgaard Bording, M.; Rössler, W.; Kawohl, W; Slade, Mike

    2016-01-01

    Aims. There is a lack of knowledge on clinical decision making and its relation to outcome in the routine treatment of people with severe mental illness. This study examined preferred and experienced clinical decision making from the perspectives of patients and staff, and how these affect treatment outcome. Methods. CEDAR (ISRCTN75841675) is a naturalistic prospective observational study with bimonthly assessments during a 12-month observation period. 588 adults with severe mental illnes...

  17. A CLINICAL STUDY OF EFFECTS OF POLY AND OLIGOHY DROMNIOS ON OBSTETRIC OUTCOME WITH A SP E C I AL REF ERENCE TO PERINATAL MORTALITY AND MORBI D ITY

    Directory of Open Access Journals (Sweden)

    Sunanda Bai

    2015-08-01

    Full Text Available OBJECTIVES: To study the obstetric outcome in pregnancies with oligohydramnios and polyhydramnios. To determine the perinatal outcome in pregnancies complicated with oligohydramnios and polyhydramnios. METHODS: This study is conducted on pregnant woman with abnormal liquor volume who attended the antenatal clinic at Institute of obstetrics and gynecology , Bowring and Lady curzon Hospital attached to BMCRI Bengaluru January 2013 to January 2014 , 150 cases of oligohydramnios and 50 cases of polyhydramnios were selected for the study. A detailed history was taken. Detailed examination was done. Routine investigation was done. USG was done. Patient was followed up for timely and post - natal period. T he values obtained so far was tabulated, analyzed, compared with other studies and concluded. RESULTS: Majority of the oligohydramnios cases were primigavida and polyhydramnios cases were multigravida. Mild polyhydramnios was the most common type. Isolated oligohydramnios (37.33% was the most common cause followed by postdated pregnancy (28.67% and third being the hypertensive diseases of pregnancy (17.34% in oligohydramnios group. Incidence of congenital anomalies was high in polyhydramnios (22% than i n oligohydramnios (4%. Induction of labour was high in oligohydramnios group (65.33% than in polyhydramios (20% group. 59.33% were underwent cesarean section in oligohydramnios group compared to 18% in polyhydramnios group. Fetal distress (76.4% was th e leading cause of cesarean in oligohydramnios, CPD (33.33% was the common cause in polyhydramnios group. In oligohydramnios group, the alive babies’ rate was 92.7% and perinatal death was 7.3%. In polyhydramnios group, the alive and perinatal death rate was 72%, and 28% respectively. In the oligohydramnios group, congenital anomaly was not the cause of any perinatal death but in polyhydramnios group majority of the death was due to lethal congenital anomalies. Birth weight <2.5kg were high in

  18. Ebola in children: epidemiology, clinical features, diagnosis and outcomes.

    Science.gov (United States)

    Olupot-Olupot, Peter

    2015-03-01

    Ebola virus disease is caused by a highly contagious and pathogenic threadlike RNA virus of the Filoviridae family. The index human case is usually a zoonosis that launches human-to-human transmission interface with varying levels of sustainability of the epidemic depending on the level of public health preparedness of the affected country and the Ebola virus strain. The disease affects all age groups in the population. Clinical diagnosis is challenging in index cases especially in the early stages of the disease when the presenting features are usually nonspecific and only similar to a flu-like illness. However, in the agonal stages, hemorrhage frequently occurs in a high proportion of cases. The diagnostic gold standard is by detecting the antigen using reverse transcription-polymerase chain reaction. Mortality rates in the past 28 outbreaks since 1976 have ranged from 30% to 100% in different settings among adults, but lower mortality rates have been documented in children. This review aims to describe Ebola virus infection, clinical presentation, diagnosis and outcomes in children. PMID:25522340

  19. Clinical outcomes in patients with ICU-related pancreatitis

    Institute of Scientific and Technical Information of China (English)

    Chia-Cheng Tseng; Wen-Feng Fang; Yu-Hsiu Chung; Yi-Hsi Wang; Ivor S Douglas; Meng-Chih Lin

    2009-01-01

    AIM: To identify risk factors predictive of intensive care unit (ICU) mortality in patients with ventilatorrelated pancreatitis. The clinical outcomes of patients with ventilator-related pancreatitis were compared with those of patients with pancreatitis-related respiratory failure as well as controls.METHODS: One hundred and forty-eight patients with respiratory failure requiring mechanical ventilation and concomitant acute pancreatitis were identified from a prospectively collected dataset of 9108 consecutive patients admitted with respiratory failure over a period of five years. Sixty patients met the criteria for ventilator-related pancreatitis, and 88 (control patients), for pancreatitis-related respiratory failure.RESULTS: Mortality rate in ventilator-related pancreatitis was comparable to that in ICU patients without pancreatitis by case-control methodology ( P = 0.544). Multivariate logistic regression analysis identified low PaO_2/FiO_2 (OR: 1.032, 95% CI: 1.006-1.059, P = 0.016) as an independent risk factor for mortality in patients with ventilator-related pancreatitis. The mortality rate in patients with ventilator-related pancreatitis was lower than that in patients with acute pancreatitis-related respiratory failure ( P < 0.001).CONCLUSION: We found that low PaO_2/FiO_2 was an independent clinical parameter predictive of ICU mortality in patients with ventilator-related pancreatitis.

  20. Molecular remission is an independent predictor of clinical outcome in patients with mantle cell lymphoma after combined immunochemotherapy: a European MCL intergroup study

    DEFF Research Database (Denmark)

    Pott, Christiane; Hoster, Eva; Delfau-Larue, Marie-Helene;

    2010-01-01

    %) achieved a molecular remission (MR) based on blood and/or bone marrow (BM) analysis. MR resulted in a significantly improved response duration (RD; 87% vs 61% patients in remission at 2 years, P = .004) and emerged to be an independent prognostic factor for RD (hazard ratio = 0.4, 95% confidence interval......The prognostic impact of minimal residual disease (MRD) was analyzed in 259 patients with mantle cell lymphoma (MCL) treated within 2 randomized trials of the European MCL Network (MCL Younger and MCL Elderly trial). After rituximab-based induction treatment, 106 of 190 evaluable patients (56......, 0.1-0.9, P = .028). MR was highly predictive for prolonged RD independent of clinical response (complete response [CR], complete response unconfirmed [CRu], partial response [PR]; RD at 2 years: 94% in BM MRD-negative CR/CRu and 100% in BM MRD-negative PR, compared with 71% in BM MRD-positive CR...

  1. Clinical study of radioprotective effects of amifostine (YM-08310, WR-2721) on long-term outcome for patients with cervical cancer

    Energy Technology Data Exchange (ETDEWEB)

    Mitsuhashi, Norio; Takahashi, Iku; Takahashi, Mitsuhiro; Hayakawa, Kazushige; Niibe, Hideo (Gumma Univ. School of Medicine (Japan))

    1993-06-15

    A retrospective analysis was performed to investigate the radioprotective effects of amifostine on the long-term outcome of radiation therapy for patients with carcinoma of the uterine cervix. Eighty-three patients with histologically proven epidermoid carcinoma (Stage II-IVA disease) of the uterine cervix were treated with definite radiation therapy between January 1978 and December 1984. Forty-six patients were treated with radiation alone, whereas 37 patients were treated with radiation plus amifostine daily from the initiation of the course of radiation therapy. The median total dose of amifostine given was 1300 mg/m[sub 2], with a range of 280 mg/m[sup 2] to 3700 mg/m[sup 2]. The 5-year overall actuarial survival for the patients treated with radiation along and with radiation plus amifostine were: 72% and 88% in Stage II disease (p = 0.45); 52% and 50% in Stage III disease (p = 0.68); and 40% and 43% in Stage IVA disease (p = 0.51), respectively. The 5-year intra-pelvic recurrence rates in the patients treated with amifostine were almost the same as those observed in the patients treated without amifostine (0% vs. 6% in Stage II disease; 15% vs. 10% in Stage III disease; 25% vs. 40% in Stage IVA disease). There was also no statistically significant difference of the chronic rectal or bladder complication rate between the groups treated by each regimen. The authors concluded that any radioprotective effects of amifostine on tumor tissue and any beneficial effects of amifostine against chronic radiation injury were not observed in the patients with cervical cancer followed up for more than 5 years after radiation therapy. 17 refs., 3 figs., 3 tabs.

  2. The Utility of Outcome Studies in Plastic Surgery

    Directory of Open Access Journals (Sweden)

    Hani Sinno, MD, MEng

    2014-07-01

    Full Text Available Summary: Outcome studies help provide the evidence-based science rationalizing treatment end results that factor the experience of patients and the impact on society. They improve the recognition of the shortcoming in clinical practice and provide the foundation for the development of gold standard care. With such evidence, health care practitioners can develop evidence-based justification for treatments and offer patients with superior informed consent for their treatment options. Furthermore, health care and insurance agencies can recognize improved cost-benefit options in the purpose of disease prevention and alleviation of its impact on the patient and society. Health care outcomes are ultimately measured by the treatment of disease, the reduction of symptoms, the normalization of laboratory results and physical measures, saving a life, and patient satisfaction. In this review, we outline the tools available to measure outcomes in plastic surgery and subsequently allow the objective measurements of plastic surgical conditions. Six major outcome categories are discussed: (1 functional measures; (2 preference-based measures and utility outcome scores; (3 patient satisfaction; (4 health outcomes and time; (5 other tools: patient-reported outcome measurement information system, BREAST-Q, and Tracking Operations and Outcomes for Plastic Surgeons; and (6 cost-effectiveness analysis. We use breast hypertrophy requiring breast reduction as an example throughout this review as a representative plastic surgical condition with multiple treatments available.

  3. Describing the characteristics, treatment pathways, outcomes, and costs of people with persistent noncancer pain managed by community pain clinics and generating an indicative estimate of cost-effectiveness: feasibility study protocol

    Directory of Open Access Journals (Sweden)

    AlAujan S

    2016-05-01

    Full Text Available Shiekha AlAujan,1 Saja AlMazrou,1 Roger D Knaggs,1,2 Rachel A Elliott11Division for Social Research in Medicines and Health, The School of Pharmacy, University of Nottingham, Nottingham, UK; 2Pharmacy Department and Pain Management Service, Nottingham University Hospitals NHS Trust, Nottingham, UKBackground: Low back pain (LBP and fibromyalgia (FM, also known as chronic widespread pain (CWP, are highly prevalent chronic painful conditions that have substantial impact on patients, health care systems, and society. Diagnosis is complex and management strategies are associated with various levels of evidence for effectiveness and cost-effectiveness. Multidisciplinary pain services have been shown to be effective in some settings and therefore are recommended by clinical practice guidelines as a rational treatment option to manage these patients. Knowing that these services are resource intensive, evidence is needed to demonstrate their cost-effectiveness. This study aims to describe the management of patients with LBP and FM in two community pain clinics to derive an indicative estimate of cost-effectiveness compared with standard practice.Methods: This is a prospective observational multicenter study, using patient-level data. The data from this study will be combined with modelling of the long-term economic impact of community pain clinics in treating people with LBP and FM. Newly referred patients with LBP and FM who provide written consent will be included. We will collect data on functional disability, pain intensity, quality of life, and health resource utilization. Follow-up data at the 3- and 6-month points will be collected by patient-completed questionnaires and health care contact diaries. Health care resource use from diaries will be compared with patient electronic records to assess the agreement between these recording methods. Patient cohort characteristics, treatment pathways, resource use, and outcomes derived from this study will

  4. Clinical outcomes of pars plicata anterior vitrectomy: 2-year results

    Directory of Open Access Journals (Sweden)

    Priya Narang

    2015-01-01

    Full Text Available Purpose: To demonstrate the safety and outcome of a surgical approach that uses pars plicata site for anterior vitrectomy during phacoemulsification procedure complicated by posterior capsule rupture and residual cortical matter. Design: Single center, retrospective, interventional, noncomparative study. Materials and Methods: Medical records of a consecutive series of 35 eyes of 35 patients who underwent pars plicata anterior vitrectomy (PPAV were reviewed. The main outcome measures were corrected and uncorrected distance visual acuity (CDVA, UDVA, early and late postoperative complications and intraocular pressure (IOP. Ultrasound biomicroscopic (UBM evaluation of sclerotomy site and spectral domain optical coherence tomography analysis for central macular thickness (CMT was performed. The final visual outcome at 2 years was evaluated. Results: At 2 years follow-up, the mean postoperative UDVA (logarithm of the minimum angle of resolution [logMAR] and CDVA (logMAR was 0.49 ± 0.26 and 0.19 ± 0.14, respectively. There was no significant change in the IOP (P = 0.061 and the mean CMT at 2 years was 192.5 ± 5.54 mm. The postoperative UBM image of the sclerotomy site at 8 weeks demonstrated a clear wound without any vitreous adhesion or incarceration. Intraoperative hyphema was seen in 1 (2.8% case and postoperative uveitis was seen in 2 (5.7% cases, which resolved with medications. No case of an iatrogenic retinal break or retinal detachment was reported. Conclusions: PPAV enables a closed chamber approach, allows thorough cleanup of vitreous in the pupillary plane and anterior chamber and affords better access to the subincisional and retropupillary cortical remnant with a significant visual outcome and an acceptable complication rate.

  5. 42 CFR 482.80 - Condition of participation: Data submission, clinical experience, and outcome requirements for...

    Science.gov (United States)

    2010-10-01

    ...) Standard: Clinical experience. To be considered for initial approval, an organ-specific transplant center..., clinical experience, and outcome requirements for initial approval of transplant centers. 482.80 Section... Hospitals Transplant Center Data Submission, Clinical Experience, and Outcome Requirements §...

  6. GWAS-identified colorectal cancer susceptibility loci associated with clinical outcomes

    OpenAIRE

    Dai, Jingyao; Gu, Jian; Huang, Maosheng; Eng, Cathy; Kopetz, E. Scott; Ellis, Lee M.; Hawk, Ernest; Wu, Xifeng

    2012-01-01

    Recent genome-wide association studies (GWAS) have identified several common susceptibility loci associated with the risk of colorectal cancer (CRC). However, whether these loci affect clinical outcomes of CRC is not clear. In this study, we genotyped 26 single nucleotide polymorphisms (SNPs) in 10 GWAS-identified CRC susceptibility regions and evaluated their associations with survival and recurrence in 285 stage II and III patients receiving fluorouracil-based adjuvant chemotherapy. Only on...

  7. Clinical Outcome of Magnetic Resonance Imaging-Detected Additional Lesions in Breast Cancer Patients

    OpenAIRE

    Ha, Gi-Won; Yi, Mi Suk; Lee, Byoung Kil; Youn, Hyun Jo; Jung, Sung Hoo

    2011-01-01

    Purpose The aim of this study was to investigate the clinical outcome of additional breast lesions identified with breast magnetic resonance imaging (MRI) in breast cancer patients. Methods A total of 153 patients who underwent breast MRI between July 2006 and March 2008 were retrospectively reviewed. Thirty-three patients (21.6&) were recommended for second-look ultrasound (US) for further characterization of additional lesions detected on breast MRI and these patients constituted our study ...

  8. Clinical Outcomes of Myasthenia Gravis with Thymoma and Thymic Hyperplasia Undergoing Extended Transsternal Thymectomy: A Single-Center Experience

    OpenAIRE

    Surena Nazarbaghi; Mohammad Reza Amiri-Nikpour; Rahim Mahmodlou; Nasim Arjmand; Yousef Rezaei

    2015-01-01

    Background: Despite the widespread use of thymectomy in myasthenia gravis (MG) patients, it has remained controversial as to whether this procedure is of a similar efficacy and clinical outcome among MG patients with thymoma and thymic hyperplasia. Aim: We sought to determine the long-term clinical outcomes of MG patients who received extended transsternal thymectomy associated with pyridostigmine and prednisolone postoperatively. Materials and Methods: In a retrospective study from January 1...

  9. Preoperative neutrophil response as a predictive marker of clinical outcome following open heart surgery and the impact of leukocyte filtration.

    LENUS (Irish Health Repository)

    Soo, Alan W

    2010-11-01

    Open heart surgery is associated with a massive systemic inflammatory response. Neutrophils, are the main mediator of this response. We hypothesised that the degree of neutrophil activation and inflammatory response to open heart surgery varies individually and correlates with clinical outcome. The aim of this study was to determine if individual clinical outcome can be predicted preoperatively through assessment of in-vitro stimulated neutrophil responses. Following that, the effects of neutrophil depletion through leukocyte filters are examined.

  10. Omega-3 fatty acid improves the clinical outcome of hepatectomized patients with hepatitis B virus (HBV)-associated hepatocellular carcinoma

    OpenAIRE

    Wu, Zhengshan; Qin, Jianjie; Pu, Liyong

    2012-01-01

    Omega-3 fatty acid supplemented total parenteral nutrition improves the clinical outcome of patients undergoing certain operations; however, its benefits for patients with hepatitis type B virus (HBV)-associated hepatocellular carcinoma (HCC) who have undergone hepatectomy are still not clear. The aim of this study was to evaluate the effect of omega-3 fatty acid supplemented total parenteral nutrition on the clinical outcome of patients with HBV-associated HCC who underwent hepatectomy at ou...

  11. Clinical effectiveness and safety outcomes associated with prothrombin complex concentrates.

    Science.gov (United States)

    Hedges, Ashley; Coons, James C; Saul, Melissa; Smith, Roy E

    2016-07-01

    Prothrombin complex concentrates (PCCs) are indicated for urgent reversal of warfarin and used for reversal of novel oral anticoagulants, in patients with acute major bleeding or need for an urgent procedure. The research goal was to evaluate effectiveness and safety outcomes with PCC usage at our institution. A retrospective review of electronic medical records identified patients that received a PCC commercially available in the United States (KCentra(®) or Profilnine(®)) at twelve hospitals in a tertiary care health system from July 1, 2013 to April 30, 2014. A total of 193 patients received PCC, of which 184 patients received four-factor PCC. The patient population was 48 % male and 75 % Caucasian, with a mean age of 73 years old. Clinical outcomes of interest included time to achieve a target INR ≤1.3, time to Hgb >7 g/dL, and incidence of thromboembolism. A total of 143 patients were on warfarin (74.1 %) at baseline, whereas 18 patients (9.3 %) were taking a novel anticoagulant. Target INR of ≤1.3 was achieved in 125 patients (65.8 %), within a median time of 8.03 h (IQR 3.38-34.07). Among patients with a baseline Hgb 7 g/dL was 8.48 h (IQR 6.95-13.00). Eight patients (4.1 %) developed an acute venous thromboembolism following PCC administration. INR reversal was achieved in approximately two-thirds of patients, with a low incidence of venous thromboembolism. Four-factor PCC is a viable alternative to plasma. PMID:26685667

  12. Clinical Supervision in Treatment Transport: Effects on Adherence and Outcomes

    Science.gov (United States)

    Schoenwald, Sonja K.; Sheidow, Ashli J.; Chapman, Jason E.

    2009-01-01

    This nonexperimental study used mixed-effects regression models to examine relations among supervisor adherence to a clinical supervision protocol, therapist adherence, and changes in the behavior and functioning of youths with serious antisocial behavior treated with an empirically supported treatment (i.e., multisystemic therapy [MST]) 1 year…

  13. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... E-Newsletters About NHLBI Organization NHLBI Director Budget, Planning, & Legislative Advisory ... Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ...

  14. Predictors of treatment outcome among Asian pathological gamblers (PGs): clinical, behavioural, demographic, and treatment process factors.

    Science.gov (United States)

    Guo, Song; Manning, Victoria; Thane, Kyaw Kyaw Wai; Ng, Andrew; Abdin, Edimansyah; Wong, Kim Eng

    2014-03-01

    Research on predictors of treatment outcome among pathological gamblers (PGs) is inconclusive and dominated by studies from Western countries. Using a prospective longitudinal design, the current study examined demographic, clinical, behavioural and treatment programme predictors of gambling frequency at 3, 6 and 12-months, among PGs treated at an addiction clinic in Singapore. Measures included the Hospital anxiety and depression scale, gambling symptom assessment scale (GSAS), personal well-being index (PWI), treatment perception questionnaire and gambling readiness to change scale. Treatment response in relation to changes in symptom severity, personal wellbeing and abstinence were also assessed. Abstinence rates were 38.6, 46.0 and 44.4 % at 3, 6 and 12-months respectively. Significant reductions in gambling frequency, GSAS, and improvement in PWI were reported between baseline and subsequent outcome assessments, with the greatest change occurring in the initial three months. No demographic, clinical, behavioural or treatment programme variable consistently predicted outcome at all three assessments, though treatment satisfaction was the most frequent significant predictor. However, being unemployed, having larger than average debts, poor treatment satisfaction and attending fewer sessions at the later stages of treatment were associated with significantly poorer outcomes, up to 1-year after initiating treatment. These findings show promise for the effectiveness of a CBT-based treatment approach for the treatment of predominantly Chinese PGs. Clinical implications and suggestions for future research are discussed. Taken together, the findings suggest early treatment satisfaction is paramount in improving short-term outcomes, with baseline gambling behaviour and treatment intensity playing a more significant role in the longer term. PMID:22945784

  15. The Relationship Between Thyroxine Level and Short Term Clinical Outcome Among Sick Newborn Infants

    Directory of Open Access Journals (Sweden)

    Maliheh Kadivar

    2011-02-01

    Full Text Available Premature and critically sick infants frequently experience several interventions, including blood transfusions, parentral nutrition, and prescriptions during hospitalization that could affect the result of thyroid function test. This study aims to investigate the correlation between thyroxine level and clinical short term outcome among the newborn infants in the neonatal intensive care unit (NICU. We assessed serum levels of thyroxine and thyroid stimulating hormone of 99 neonates who were admitted in the NICU from September 1st 2004 to March 30th 2005. Number of patients with low thyroxin level (less than 6.5 µg/dl was determined and the relation between serum total thyroxine level and birth weight, gestational age, duration of hospitalization, clinical diagnosis, and final outcome was investigated. Short term outcome was considered as duration of hospitalization and discharge alive from hospital. Prevalence of hypothyroxinemia was 26 percent. Later assessment of thyroxine level within 3 weeks revealed normal level of this parameter (8.12 µg/dl ±1.36. Patients with lower gestational age and lower birth weight had lower thyroxine level (7.15 µg/dl ±2.56, and P=0.03, 6.72 µg/dl ±3.03, and P=0.08. Low thyroxine level was not associated with adverse short-term clinical outcome (mortality rates; 3(11% and 9(12%, and duration of hospitalization among 17.7±9.8 vs 16.7± 13.0 in patients with hypothyroxinemia and low thyroxine level respectively. Hypothyroxinemia has considerable prevalence in neonatal intensive care setting and is related with lower birth weight and gestational age. Whether thyroxin levels are a marker or mediator of short term clinical outcome remains to be determined by further studies.

  16. Interpretation of lung cancer study outcomes.

    Science.gov (United States)

    Cortinovis, Diego; Abbate, Marida; Bidoli, Paolo; Pelizzoni, Davide; Canova, Stefania

    2015-11-01

    Lung cancer is the leading cause of cancer death in developed countries. However, in the last few years we observed an important acceleration in drug development due to oncogenic driver tumors discovery. Sharing and putting together preclinical data from benchmark and data from clinical research is the scientific paradigm that allows real breakthrough in clinical practice in this field, but only a few targeted agents are worthy and practice changing. The clinical research and proper use of statistical methodology are the pillars to continue to achieve important goals like improvement of overall survival. A good medical oncologist should be able to critically read a scientific paper and move from the observed outcomes into clinical perspective. Despite clinical improvements, sometimes the union of promising targeted agents and optimistic expectations misrepresent the reality and the value of clinical research. In this article, we try to analyze the meaning of statistical assumptions from clinical trials, especially in lung cancer, through a critical review of the concept of value-based medicine. We also attempt to give the reader some practical tools to weigh scientific value of literature reports. PMID:26716052

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

    Science.gov (United States)

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin; Pirmoazen, Salma

    2015-06-01

    Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA) and Biodentine(TM) as coronal barriers and different irrigants, which led to different clinical outcomes. PMID:26884781

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

    Directory of Open Access Journals (Sweden)

    Mehrfam Khoshkhounejad

    2015-11-01

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

  19. Outcome research in palliative care: could it represent a new dimension of clinical research or clinical practice?

    Science.gov (United States)

    Tassinari, Davide; Maltoni, Marco; Sartori, Sergio; Fantini, Manuela; Poggi, Barbara; Ravaioli, Alberto

    2005-03-01

    Outcome research is a new dimension of clinical research, and all fields of clinical medicine are involved in this kind of analysis. Overall survival and quality of life are the main outcomes identified in clinical oncology. The former must be the main outcome whenever possible; the latter has to be the main outcome when an improvement of overall survival cannot be expected. It follows that quality of life is the main outcome of palliative care, in which the patient instead of the disease represents the target of the clinical approach. In our critical paper, we review the meaning of clinical outcomes in palliative care, classifying the outcomes as main and surrogate outcomes, and the results of the trials as indexes of activity and efficacy of a treatment. We also review the main randomized clinical trials on the treatment of cancer cachexia, trying to define the role of the treatments in cachexia-related symptom control and quality of life improvement. Strictly related to outcome analysis is the dimension of pharmacoeconomic evaluation. The models of the different designs of pharmacoeconomic analysis are revisited in an attempt to conjugate the pharmacoeconomic evaluation with the particular dimension of palliative care. PMID:15580363

  20. Clinical Outcomes and Quality of Life in Recipients of Livers Donated after Cardiac Death

    Directory of Open Access Journals (Sweden)

    Neehar D. Parikh

    2015-01-01

    Full Text Available Donation after cardiac death (DCD has expanded in the last decade in the US; however, DCD liver utilization has flattened in recent years due to poor outcomes. We examined clinical and quality of life (QOL outcomes of DCD recipients by conducting a retrospective and cross-sectional review of patients from 2003 to 2010. We compared clinical outcomes of DCD recipients (n=60 to those of donation after brain death (DBD liver recipients (n=669 during the same time period. DCD recipients had significantly lower rates of 5-year graft survival (P<0.001 and a trend toward lower rates of 5-year patient survival (P=0.064 when compared to the DBD cohort. In order to examine QOL outcomes in our cohorts, we administered the Short Form Liver Disease Quality of Life questionnaire to 30 DCD and 60 DBD recipients. The DCD recipients reported lower generic and liver-specific QOL. We further stratified the DCD cohort by the presence of ischemic cholangiopathy (IC. Patients with IC reported lower QOL when compared to DBD recipients and those DCD recipients without IC (P<0.05. While the results are consistent with clinical experience, this is the first report of QOL in DCD recipients using standardized measures. These data can be used to guide future comparative effectiveness studies.

  1. Very poor outcome schizophrenia: Clinical and neuroimaging aspects

    Science.gov (United States)

    Mitelman, Serge A.; Buchsbaum, Monte S.

    2009-01-01

    In spite of significant advances in treatment of patients with schizophrenia and continued efforts towards their deinstitutionalization, a considerable group of patients remain chronically hospitalized or otherwise dependent on others for basic necessities of life. It has been proposed that these patients belong to a distinct etiopathological subgroup, termed Kraepelinian, whose course of illness may be progressive and resistant to treatment. Indeed, longitudinal studies appear to show that elderly Kraepelinian patients follow a course of rapid cognitive and functional deterioration, commensurate with a dementing process, and that their poor functional status is closely correlated with the cognitive deterioration. Recent neuroimaging studies described a pattern of posteriorization of grey and white matter deficits with poor outcome in schizophrenia, and produced a constellation of findings implicating primary processing of visual and auditory information as central to the impaired functional status in this patient group. These studies are summarized in detail in this review and future directions for neuroimaging assessment of very poor outcome patients with schizophrenia are suggested. PMID:17671868

  2. Clinical and functional outcomes of the saddle prosthesis

    OpenAIRE

    Donati, D.; D’Apote, G.; M. Boschi; Cevolani, L.; M.G. Benedetti

    2012-01-01

    Background The implantation of a saddle prosthesis after resection of a pelvic tumor has been proposed as a simple method of reconstruction that provides good stability and reduces the surgical time, thus limits the onset of intraoperative complications. There are no studies in the literature of patients evaluated using gait analysis after being implanted with a saddle prosthesis. The present study is a retrospective case review aimed at illustrating long-term clinical and functional findings...

  3. Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study

    DEFF Research Database (Denmark)

    Lundgren, Jens; Emery, Sean; Neuhaus, Jacqueline A;

    2008-01-01

    BACKGROUND: The SMART study randomized 5,472 human immunodeficiency virus (HIV)-infected patients with CD4+ cell counts >350 cells/microL to intermittent antiretroviral therapy (ART; the drug conservation [DC] group) versus continuous ART (the viral suppression [VS] group). In the DC group...

  4. Effect of ACE insertion/deletion and 12 other polymorphisms on clinical outcomes and response to treatment in the life study

    DEFF Research Database (Denmark)

    Nordestgaard, Børge G; Kontula, Kimmo; Benn, Marianne;

    2010-01-01

    OBJECTIVE: This pharmacogenetics substudy from the Losartan Intervention for Endpoint reduction in Hypertension study in patients with hypertension and left ventricular hypertrophy (LVH) treated with the angiotensin receptor blocker losartan versus the beta-blocker atenolol for 4.8 years tested...

  5. Survival, clinical and radiological outcome of the Zweymuller SL/Bicon-Plus total hip arthroplasty : a 15-year follow-up study

    NARCIS (Netherlands)

    Ottink, Karsten; Barnaart, Lex; Westerbeek, Robin; van Kampen, Karin; Bulstra, Sjoerd; van Jonbergen, Hans-Peter

    2015-01-01

    Aim: The primary aim of this study is to analyse the long-term results of the third generation of the " Zweymuller" total hip arthroplasty (THA) comprising the SL-Plus Stem and the Bicon-Plus cup. Methods: We evaluated 208 patients with a SL/Bicon-Plus primary THA (218 hips). Survival analysis was p

  6. Results and outcome reporting In ClinicalTrials.gov, what makes it happen?

    Directory of Open Access Journals (Sweden)

    Olga Kirillova

    Full Text Available BACKGROUND: At the end of the past century there were multiple concerns regarding lack of transparency in the conduct of clinical trials as well as some ethical and scientific issues affecting the trials' design and reporting. In 2000 ClinicalTrials.gov data repository was developed and deployed to serve public and scientific communities with valid data on clinical trials. Later in order to increase deposited data completeness and transparency of medical research a set of restrains had been imposed making the results deposition compulsory for multiple cases. METHODS: We investigated efficiency of the results deposition and outcome reporting as well as what factors make positive impact on providing information of interest and what makes it more difficult, whether efficiency depends on what kind of institution was a trial sponsor. Data from the ClinicalTrials.gov repository has been classified based on what kind of institution a trial sponsor was. The odds ratio was calculated for results and outcome reporting by different sponsors' class. RESULTS: As of 01/01/2012 118,602 clinical trials data deposits were made to the depository. They came from 9068 different sources. 35344 (29.8% of them are assigned as FDA regulated and 25151 (21.2% as Section 801 controlled substances. Despite multiple regulatory requirements, only about 35% of trials had clinical study results deposited, the maximum 55.56% of trials with the results, was observed for trials completed in 2008. CONCLUSIONS: The most positive impact on depositing results, the imposed restrains made for hospitals and clinics. Health care companies showed much higher efficiency than other investigated classes both in higher fraction of trials with results and in providing at least one outcome for their trials. They also more often than others deposit results when it is not strictly required, particularly, in the case of non-interventional studies.

  7. Below knee angioplasty in elderly patients: Predictors of major adverse clinical outcomes.

    LENUS (Irish Health Repository)

    Keeling, Aoife N

    2011-03-01

    To determine predictors of clinical outcome following percutaneous transluminal angioplasty (PTA) in elderly patients with below knee atherosclerotic lesions causing intermittent claudication (IC) or critical limb ischaemia (CLI).

  8. Clinical outcomes and costs for people with complex psychosis; a naturalistic prospective cohort study of mental health rehabilitation service users in England

    OpenAIRE

    Killaspy, Helen; Marston, Louise; Green, Nicholas; Harrison, Isobel; Lean, Melanie; Holloway, F.; Jamieson-Craig, Thomas Kern; Leavey, G.; Arbuthnott, Maurice; Koeser, Leonardo Alberto; McCrone, Paul Richard; Omar, Rumana; King, Michael

    2016-01-01

    BackgroundMental health rehabilitation services in England focus on people with complex psychosis. This group tend to have lengthy hospital admissions due to the severity of their problems and, despite representing only 10–20 % of all those with psychosis, they absorb 25–50 % of the total mental health budget. Few studies have investigated the effectiveness of these services and there is little evidence available to guide clinicians working in this area. As part of a programme of research int...

  9. A multilevel investigation of inequalities in clinical and psychosocial outcomes for women after breast cancer

    Directory of Open Access Journals (Sweden)

    Aitken Joanne F

    2011-09-01

    Full Text Available Abstract Background In Australia, breast cancer is the most common cancer affecting Australian women. Inequalities in clinical and psychosocial outcomes have existed for some time, affecting particularly women from rural areas and from areas of disadvantage. We have a limited understanding of how individual and area-level factors are related to each other, and their associations with survival and other clinical and psychosocial outcomes. Methods/Design This study will examine associations between breast cancer recurrence, survival and psychosocial outcomes (e.g. distress, unmet supportive care needs, quality of life. The study will use an innovative multilevel approach using area-level factors simultaneously with detailed individual-level factors to assess the relative importance of remoteness, socioeconomic and demographic factors, diagnostic and treatment pathways and processes, and supportive care utilization to clinical and psychosocial outcomes. The study will use telephone and self-administered questionnaires to collect individual-level data from approximately 3, 300 women ascertained from the Queensland Cancer Registry diagnosed with invasive breast cancer residing in 478 Statistical Local Areas Queensland in 2011 and 2012. Area-level data will be sourced from the Australian Bureau of Statistics census data. Geo-coding and spatial technology will be used to calculate road travel distances from patients' residence to diagnostic and treatment centres. Data analysis will include a combination of standard empirical procedures and multilevel modelling. Discussion The study will address the critical question of: what are the individual- or area-level factors associated with inequalities in outcomes from breast cancer? The findings will provide health care providers and policy makers with targeted information to improve the management of women with breast cancer, and inform the development of strategies to improve psychosocial care for women

  10. Core Outcomes for Colorectal Cancer Surgery: A Consensus Study

    Science.gov (United States)

    Whistance, Robert N.; Forsythe, Rachael O.; Macefield, Rhiannon; Pullyblank, Anne M.; Avery, Kerry N. L.; Brookes, Sara T.; Thomas, Michael G.; Sylvester, Paul A.; Russell, Ann; Oliver, Alfred; Morton, Dion; Kennedy, Robin; Jayne, David G.; Huxtable, Richard; Hackett, Roland; Card, Mia; Brown, Julia; Blazeby, Jane M.

    2016-01-01

    Background Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard “core” set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery. Methods and Findings The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained

  11. Crossover studies with survival outcomes.

    Science.gov (United States)

    Buyze, Jozefien; Goetghebeur, Els

    2013-12-01

    Crossover designs are well known to have major advantages when comparing the effect of two treatments which do not interact. With a right-censored survival endpoint, however, this design is quickly abandoned in favour of the more costly parallel design. Motivated by human immunodeficiency virus (HIV) prevention studies which lacked power, we evaluate what may be gained in this setting and compare parallel with crossover designs. In a heterogeneous population, we find and explain a substantial increase in power for the crossover study using a non-parametric logrank test. With frailties in a proportional hazards model, crossover designs equally lead to substantially smaller variance for the subject-specific hazard ratio (HR), while the population-averaged HR sees negligible gain. Its efficiency benefit is recovered when the population-averaged HR is reconstructed from estimated subject-specific hazard rates. We derive the time point for treatment crossover that optimizes efficiency and end with the analysis of two recent HIV prevention trials. We find that a Cellulose sulphate trial could have hardly gained efficiency from a crossover design, while a Nonoxynol-9 trial stood to gain substantial power. We conclude that there is a role for effective crossover designs in important classes of survival problems. PMID:21715438

  12. Total Laparoscopic Hysterectomy Compared with Abdominal Hysterectomy; Clinical Outcomes

    Directory of Open Access Journals (Sweden)

    Cem Celik

    2013-10-01

    Full Text Available Aim: The purpose of this study was to confirm the positive intraoperative and postoperative outcomes of total laparoscopic hysterectomy (TLH and total abdominal hysterectomy (TAH. Material and Method: We presented surgical procedures performed at Namik Kemal University Faculty of Medicine, Department of Obstetrics and Gynecology between September 2010 and December 2012, 47 patients who underwent TLH and 30 patients who underwent TAH  were included in the present study. Results: Operating time in TLH group was significantly longer than in the TAH group (202.56±61.53 vs 138.06±40.52 min. There were no significant differences between the two groups regarding complications, conversion to laparotomy, intraoperative bleeding. We observed no differences in reoperation and transfusion rates between the two groups. Duration of hospital stay was statistically shorter in TLH group compared to the TAH group (3.93±0.70 vs 5.26±1.63 day. Discussion: Laparoscopic hysterectomy, compared to laparotomy regarding equal outcomes and lower perioperative morbidity, improvement of quality of life, shorter hospital stay and faster return to activity.

  13. Arterial Stiffening and Clinical Outcomes in Dialysis Patients.

    Science.gov (United States)

    Kato, Akihiko

    2015-09-01

    Cardiovascular disease (CVD) is an important cause of morbidity and mortality in dialysis patients. Brachial-ankle pulse wave velocity (baPWV) is more efficient to handily assess arteriosclerosis than aortic PWV. The cardio-ankle vascular index (CAVI) is also a novel blood pressure-independent arterial stiffness parameter. In dialysis patients, both baPWV and CAVI are increased compared to general subjects. Several studies have demonstrated that increased baPWV is associated with carotid atherosclerosis and diastolic left ventricular dysfunction in hemodialysis (HD) patients. In addition, higher baPWV is related to all-cause and cardiovascular (CV) mortality. CAVI is similarly associated with CVD. However, baPWV is superior to CAVI as a predictor of CV outcomes in HD patients. Besides these outcomes, a close relationship exists between sarcopenia, abdominal visceral obesity and arterial stiffening. Reduction of thigh muscle mass is inversely correlated with baPWV and CAVI in males. Abdominal fatness is also associated with increased arterial stiffness in females. These observations provide further evidence of higher risk of CV events in HD patients with sarcopenic obesity. In addition, arterial stiffness is associated with cerebral small vessel disease and decreased cognitive function in the elderly. However, it is unknown whether arterial stiffness may be useful as an early indicator of cognitive decline in dialysis patients. Because dialysis patients are at risk of developing dementia, more studies are needed to elucidate the causal link between arterial stiffness and cognitive impairment. PMID:26587457

  14. Uterine arterial embolization for uterine leiomyoma: efficacy and clinical outcome

    International Nuclear Information System (INIS)

    To determine the efficacy and clinical outcome of uterine arterial embolization as a new approach to the management of uterine leiomyomas. Uterine arterial embolization was performed in 21 patients aged 26-62(mean, 42) years. Twenty of these had menorrhagia, dysmenorrhea, and mass-related symptoms (low abdominal discomfort, backache, urinary frequency, etc.) and one was diagnosed incidentally. Bilateral uterine arteries were selected individually and polyvinyl alcohol and/or gelfoam was used as an embolic material. Nineteen patients were followed up after embolization. Seventeen (89.5 %)reported satisfactory improvement of symptoms and follow-up sonography three months later showed a 58.5 % reduction in mean myoma volume. In 17 patients (89.5 %), the menstrual cycle returned to normal. All patients experienced pain after the procedure and other complications were vaginal bleeding (26.3 %) and fever (23.8 %). Uterine arterial embolization represents a new approach to the management of uterine leiomyoma-related symptoms. Further investigations and long-term follow-up are, however, enquired

  15. Uterine arterial embolization for uterine leiomyoma: efficacy and clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jeong Seon; Lee, Do Yon; Kim, Yong Tae; Park, Ki Hyun; Park, Yong Won; Cho, Jae Sung; Kim, Myung Jun [Yonsei Univ. College of Medicine, Seoul (Korea, Republic of); Won, Je Hwan [Ajou Univ. College of Medicine, Suwon (Korea, Republic of); Kang, Byung Chul [Ewha Womans Univ. College of Medicine, Seoul (Korea, Republic of)

    1999-09-01

    To determine the efficacy and clinical outcome of uterine arterial embolization as a new approach to the management of uterine leiomyomas. Uterine arterial embolization was performed in 21 patients aged 26-62(mean, 42) years. Twenty of these had menorrhagia, dysmenorrhea, and mass-related symptoms (low abdominal discomfort, backache, urinary frequency, etc.) and one was diagnosed incidentally. Bilateral uterine arteries were selected individually and polyvinyl alcohol and/or gelfoam was used as an embolic material. Nineteen patients were followed up after embolization. Seventeen (89.5 %)reported satisfactory improvement of symptoms and follow-up sonography three months later showed a 58.5 % reduction in mean myoma volume. In 17 patients (89.5 %), the menstrual cycle returned to normal. All patients experienced pain after the procedure and other complications were vaginal bleeding (26.3 %) and fever (23.8 %). Uterine arterial embolization represents a new approach to the management of uterine leiomyoma-related symptoms. Further investigations and long-term follow-up are, however, enquired.

  16. Magnetic resonance imaging findings of postresuscitation encephalopathy. Sequential change and correlation with clinical outcome

    International Nuclear Information System (INIS)

    The purpose of this study was to describe the findings of sequential magnetic resonance imaging (MRI) in postresuscitation encephalopathy. Although its outcome is known to be overwhelming, but its acute findings by variable imaging methods are subtle and show only limited values. The correlation of the findings of MRI with clinical outcome were also analyzed. Twelve patients with global cerebral anoxia who underwent MRI with conventional and diffusion-weighted imaging were enrolled in this study. Compared with normal MRI images, abnormal signal regions were checked and described in cortex, basal ganglia and white matter. Also medical records were carefully reviewed to study the cause, the time necessary for resuscitation and long term clinical outcome. The earliest finding was obtained by diffusion-weighted image less than 24 hours (acute period) in bilateral cerebral cortex as bright high signal intensity regions. Similar abnormality of bright high signal area in FLAIR and T2 was followed according to the time elapsed in early subacute period (1-13 days). Succeedingly, white matter was involved and laminar necrosis in cortical area was observed in late subacute period (14-20 days). Finally, diffuse brain atrophy and obtundation of gray-white matter junction were seen in chronic stage (after 21 days). These MR findings were coincided well with histopathological findings reported in literatures. The poor outcome was closely and significantly correlated with abnormality in MR images. MRI was a useful diagnostic modality to diagnose the whole brain ischemic encephalopathy and to predict the prognosis. (author)

  17. Effect of ACE insertion/deletion and 12 other polymorphisms on clinical outcomes and response to treatment in the life study

    DEFF Research Database (Denmark)

    2010-01-01

    OBJECTIVE: This pharmacogenetics substudy from the Losartan Intervention for Endpoint reduction in Hypertension study in patients with hypertension and left ventricular hypertrophy (LVH) treated with the angiotensin receptor blocker losartan versus the beta-blocker atenolol for 4.8 years tested....... These polymorphisms were chosen because they could affect blood pressure control or the pharmacological action of losartan or atenolol. METHODS: We genotyped 3503 patients, 1774 on losartan and 1729 on atenolol. RESULTS: ACE and the 12 other genotypes did not affect the reduction in systolic blood...... pressure, diastolic blood pressure, pulse pressure, mean arterial pressure, or heart rate, or treatment differences between losartan and atenolol on these endpoints, as assessed by general linear models. Also, ACE and the 12 other genotypes did not affect risk of the primary composite endpoint or its...

  18. Association of TMPRSS2-ERG gene fusion with clinical characteristics and outcomes: results from a population-based study of prostate cancer

    International Nuclear Information System (INIS)

    The presence of the TMPRSS2-ERG fusion gene in prostate tumors has recently been associated with an aggressive phenotype, as well as recurrence and death from prostate cancer. These associations suggest the hypothesis that the gene fusion may be used as a prognostic indicator for prostate cancer. In this study, fluorescent in situ hybridization (FISH) assays were used to assess TMPRSS2-ERG fusion status in a group of 214 prostate cancer cases from two population-based studies. The FISH assays were designed to detect both fusion type (deletion vs. translocation) and the number of fusion copies (single vs. multiple). Genotyping of four ERG and one TMPRSS2 SNPs using germline DNA was also performed in a sample of the cases (n = 127). Of the 214 tumors scored for the TMPRSS2-ERG fusion, 64.5% were negative and 35.5% were positive for the fusion. Cases with the TMPRSS2-ERG fusion did not exhibit reduced prostate cancer survival (HR = 0.92, 95% CI = 0.22–3.93), nor was there a significant difference in cause-specific survival when stratifying by translocation or deletion (HR = 0.84, 95% CI = 0.23–3.12) or by the number of retained fusion copies (HR = 1.22, 95% CI = 0.45–3.34). However, evidence for reduced prostate cancer-specific survival was apparent in those cases whose tumor had multiple copies of the fusion. The variant T allele of the TMPRSS2 SNP, rs12329760, was positively associated with TMPRSS2-ERG fusion by translocation (p = 0.05) and with multiple copies of the gene fusion (p = 0.03). If replicated, the results presented here may provide insight into the mechanism by which the TMPRSS2-ERG gene fusion arises and also contribute to diagnostic evaluations for determining the subset of men who will go on to develop metastatic prostate cancer

  19. Healthcare Utilization and Clinical Outcomes after Catheter Ablation of Atrial Flutter

    OpenAIRE

    Dewland, Thomas A.; Glidden, David V.; Marcus, Gregory M

    2014-01-01

    Atrial flutter ablation is associated with a high rate of acute procedural success and symptom improvement. The relationship between ablation and other clinical outcomes has been limited to small studies primarily conducted at academic centers. We sought to determine if catheter ablation of atrial flutter is associated with reductions in healthcare utilization, atrial fibrillation, or stroke in a large, real world population. California Healthcare Cost and Utilization Project databases were u...

  20. Clinical Outcomes of Heart-Lung Transplantation: Review of 10 Single-Center Consecutive Patients

    OpenAIRE

    Yun, Jae Kwang; Choi, Se Hoon; Park, Seung-Il; [...

    2016-01-01

    Background Heart-lung transplantation (HLT) has provided hope to patients with end-stage lung disease and irreversible heart dysfunction. We reviewed the clinical outcomes of 10 patients who underwent heart-lung transplantation at Asan Medical Center. Methods Between July 2010 and August 2014, a total of 11 patients underwent HLT at Asan Medical Center. After excluding one patient who underwent concomitant liver transplantation, 10 patients were enrolled in our study. We reviewed the demograp...

  1. Clinical and surgical outcomes after lumbar laminectomy: An analysis of 500 patients

    OpenAIRE

    Mohamad Bydon; Mohamed Macki; Abt, Nicholas B.; Sciubba, Daniel M.; Jean-Paul Wolinsky; Timothy F Witham; Gokaslan, Ziya L.; Ali Bydon

    2015-01-01

    Background: The objective of this study is to determine the clinical and surgical outcomes following lumbar laminectomy. Methods: We retrospectively reviewed medical records of neurosurgical patients who underwent first-time, bilateral, 1-3 level laminectomies for degenerative lumbar disease. Patients with discectomy, complete facetectomy, and fusion were excluded. Results: Five hundred patients were followed for an average of 46.79 months. Following lumbar laminectomy, patients exper...

  2. Prime Time: 18-Month Violence Outcomes of a Clinic-Linked Intervention

    OpenAIRE

    Sieving, Renee E.; McMorris, Barbara J.; Secor-Turner, Molly; Garwick, Ann W.; Shlafer, Rebecca; Beckman, Kara J.; Pettingell, Sandra L.; Oliphant, Jennifer A.; Seppelt, Ann M.

    2014-01-01

    Prime Time, a youth development intervention, aims to reduce multiple risk behaviors among adolescent girls seeking clinic services who are at high risk for pregnancy. The purpose of the current study was to examine whether Prime Time involvement produced changes in relational aggression, physical violence and related psychosocial and behavioral outcomes. Qualitative case exemplars illustrated social contexts of intervention participants with differing longitudinal patterns of relational aggr...

  3. Clinical outcome of protein-energy malnourished patients in a Brazilian university hospital

    OpenAIRE

    Pasquini, T.A.S.; H.D. Neder; Araújo-Junqueira, L.; De-Souza, D.A.

    2012-01-01

    Protein-energy malnutrition (PEM) is a treatable disease with high prevalence among hospitalized patients. It can cause significant increases in the duration of hospitalization and costs. PEM is especially important for health systems since malnourished patients present higher morbidity and mortality. The objective of the present study was to assess the evolution of nutritional status (NS) and the effect of malnutrition on clinical outcome of patients at a public university hospital of high c...

  4. Variation in lung function is associated with worse clinical outcomes in cystic fibrosis

    OpenAIRE

    João Paulo Heinzmann-Filho; Leonardo Araujo Pinto; Paulo José Cauduro Marostica; Márcio Vinícius Fagundes Donadio

    2015-01-01

    ABSTRACT OBJECTIVE: To determine whether the variation in lung function over one year is associated with worse clinical outcomes, as well as with a decline in lung function in the following years, in patients with cystic fibrosis (CF). METHODS: This was a retrospective study involving CF patients (4-19 years of age), evaluated over a three-year period. We evaluated demographic characteristics, chronic Pseudomonas aeruginosa infection, antibiotic use, hospitalization, six-minute walk dista...

  5. Variation in lung function is associated with worse clinical outcomes in cystic fibrosis

    OpenAIRE

    Heinzmann-Filho, João Paulo; Pinto, Leonardo Araujo; Marostica, Paulo José Cauduro; Donadio, Márcio Vinícius Fagundes

    2015-01-01

    ABSTRACT OBJECTIVE: To determine whether the variation in lung function over one year is associated with worse clinical outcomes, as well as with a decline in lung function in the following years, in patients with cystic fibrosis (CF). METHODS: This was a retrospective study involving CF patients (4-19 years of age), evaluated over a three-year period. We evaluated demographic characteristics, chronic Pseudomonas aeruginosa infection, antibiotic use, hospitalization, six-minute walk distance ...

  6. Nutritional Care of Gastric Cancer Patients with Clinical Outcomes and Complications: A Review

    OpenAIRE

    Choi, Wook Jin; Kim, Jeongseon

    2016-01-01

    The incidence and mortality of gastric cancer have been steadily decreased over the past few decades. However, gastric cancer is still one of the leading causes of cancer deaths across many regions of the world, particularly in Asian countries. In previous studies, nutrition has been considered one of significant risk factors in gastric cancer patients. Especially, malnourished patients are at greater risk of adverse clinical outcomes (e.g., longer hospital stay) and higher incidence of compl...

  7. Erythrocyte membrane protein destabilization versus clinical outcome in 160 Portuguese Hereditary Spherocytosis patients

    OpenAIRE

    Rocha, Susana; Costa, Elísio; Rocha-Pereira, Petronila; Ferreira, Fátima; Cleto, Esmeralda; Barbot, José; Quintanilha, Alexandre; Belo, Luís; Santos-Silva, Alice

    2010-01-01

    Abstract Hereditary Spherocytosis (HS) is a haemolytic anaemia caused by erythrocyte protein membrane defects ? spectrin, ankyrin, band 3 or protein 4.2 ? that lead to membrane destabilization. Ours aims were to evaluate the prevalence of protein deficiencies and the role of membrane proteins or of membrane linked proteins in membrane disturbance and in HS clinical outcome. We studied 215 Portuguese individuals ? 203 from 71 families plus 12 individual unrelated subjects, and found...

  8. The effects of endometrial injury on intrauterine insemination outcome: A randomized clinical trial

    OpenAIRE

    Afsoon Zarei; Saeed Alborzi; Nasrin Dadras; Ghazal Azadi

    2014-01-01

    Background: Implantation is considered as the rate-limiting step in success of assisted reproduction techniques, and intrauterine insemination cycles. It might be affected by ovarian superovulation and endometrial local scratching. Objective: This study aims to investigate the effect of local endometrial injury on the outcome of IUI cycles. Materials and Methods: In this randomized clinical trial 144 women with unexplained infertility, mild male factor, and mild endometriosis randomly d...

  9. Clinical outcome and bowel function after surgical treatment in Hirschsprung′s disease

    OpenAIRE

    Maryam Khazdouz; Majid Sezavar; Bahareh Imani; Hossein Akhavan; Alireza Babapour; Gholamreza Khademi

    2015-01-01

    Background: Bowel function has been reported to be adversely affected following surgery in cases of Hirschsprung. We retrospectively studied both the clinical outcome and bowel function status following surgery in patients diagnosed with Hirschprung′s disease (HD). 161 cases, who underwent pull-through operations for HD in Sheikh Pediatric Tertiary Centre, Mashhad, Iran. The specified time bracket spanned between 2006 and 2011. Materials and Methods: Data was extracted from Health Information...

  10. Different clinical outcomes of Entamoeba histolytica in Malaysia: does genetic diversity exist?

    OpenAIRE

    Anuar, Tengku Shahrul; Al-Mekhlafi, Hesham M.; Abdul Ghani, Mohamed Kamel; Azreen, Siti Nor; Salleh, Fatmah Md; Ghazali, Nuraffini; Bernadus, Mekadina; Moktar, Norhayati

    2013-01-01

    International audience The present study was conducted to investigate the clinical outcomes of Entamoeba histolytica infection in symptomatic and asymptomatic Orang Asli (aborigine) communities in Malaysia. Examination was performed on 500 stool samples obtained from Orang Asli communities in 3 different states using formalin-ether concentration, trichrome staining, and single-round PCR techniques. Out of 500 stool samples, single infection of E. histolytica, Entamoeba dispar, and Entamoeb...

  11. The impact of patient support programs on adherence, clinical, humanistic, and economic patient outcomes: a targeted systematic review

    Directory of Open Access Journals (Sweden)

    Ganguli A

    2016-04-01

    Full Text Available Arijit Ganguli,1 Jerry Clewell,2 Alicia C Shillington3 1Department of Health Economics and Outcomes Research, 2Department of Medical Affairs, AbbVie, North Chicago, IL, USA; 3EPI-Q Inc., Oak Brook, IL, USA Background: Patient support programs (PSPs, including medication management and counseling, have the potential to improve care in chronic disease states with complex therapies. Little is known about the program’s effects on improving clinical, adherence, humanistic, and cost outcomes. Purpose: To conduct a targeted review describing medical conditions in which PSPs have been implemented; support delivery components (eg, face-to-face, phone, mail, and internet; and outcomes associated with implementation. Data sources: MEDLINE – 10 years through March 2015 with supplemental handsearching of reference lists. Study selection: English-language trials and observational studies of PSPs providing at minimum, counseling for medication management, measurement of ≥1 clinical outcome, and a 3-month follow-up period during which outcomes were measured. Data extraction: Program characteristics and related clinical, adherence, humanistic, and cost outcomes were abstracted. Study quality and the overall strength of evidence were reviewed using standard criteria. Data synthesis: Of 2,239 citations, 64 studies met inclusion criteria. All targeted chronic disease processes and the majority (48 [75%] of programs offered in-clinic, face-to-face support. All but 9 (14.1% were overseen by allied health care professionals (eg, nurses, pharmacists, paraprofessionals. Forty-one (64.1% reported at least one significantly positive clinical outcome. The most frequent clinical outcome impacted was adherence, where 27 of 41 (66% reported a positive outcome. Of 42 studies measuring humanistic outcomes (eg, quality of life, functional status, 27 (64% reported significantly positive outcomes. Only 15 (23.4% programs reported cost or utilization-related outcomes, and, of

  12. Comparison of statistical and clinical predictions of functional outcome after ischemic stroke.

    Directory of Open Access Journals (Sweden)

    Douglas D Thompson

    Full Text Available To determine whether the predictions of functional outcome after ischemic stroke made at the bedside using a doctor's clinical experience were more or less accurate than the predictions made by clinical prediction models (CPMs.A prospective cohort study of nine hundred and thirty one ischemic stroke patients recruited consecutively at the outpatient, inpatient and emergency departments of the Western General Hospital, Edinburgh between 2002 and 2005. Doctors made informal predictions of six month functional outcome on the Oxford Handicap Scale (OHS. Patients were followed up at six months with a validated postal questionnaire. For each patient we calculated the absolute predicted risk of death or dependence (OHS≥3 using five previously described CPMs. The specificity of a doctor's informal predictions of OHS≥3 at six months was good 0.96 (95% CI: 0.94 to 0.97 and similar to CPMs (range 0.94 to 0.96; however the sensitivity of both informal clinical predictions 0.44 (95% CI: 0.39 to 0.49 and clinical prediction models (range 0.38 to 0.45 was poor. The prediction of the level of disability after stroke was similar for informal clinical predictions (ordinal c-statistic 0.74 with 95% CI 0.72 to 0.76 and CPMs (range 0.69 to 0.75. No patient or clinician characteristic affected the accuracy of informal predictions, though predictions were more accurate in outpatients.CPMs are at least as good as informal clinical predictions in discriminating between good and bad functional outcome after ischemic stroke. The place of these models in clinical practice has yet to be determined.

  13. Retrospective observational study to assess the clinical management and outcomes of hospitalised patients with complicated urinary tract infection in countries with high prevalence of multidrug resistant Gram-negative bacteria (RESCUING)

    Science.gov (United States)

    Shaw, Evelyn; Addy, Ibironke; Stoddart, Margaret; Vank, Christiane; Grier, Sally; Wiegand, Irith; Leibovici, Leonard; Eliakim-Raz, Noa; Vallejo-Torres, Laura; Morris, Stephen; MacGowan, Alasdair; Carratalà, Jordi; Pujol, Miquel

    2016-01-01

    Introduction The emergence of multidrug resistant (MDR) Gram-negative bacteria (GNB), including carbapenemase-producing strains, has become a major therapeutic challenge. These MDR isolates are often involved in complicated urinary tract infection (cUTI), and are associated with poor clinical outcomes. The study has been designed to gain insight into the epidemiology, clinical management, outcome and healthcare cost of patients with cUTI, especially in countries with high prevalence of MDR GNB. Methods and analysis This multinational and multicentre observational, retrospective study will identify cases from 1 January 2013 to 31 December 2014 in order to collect data on patients with cUTI as a cause of hospital admission, and patients who develop cUTI during their hospital stay. The primary end point will be treatment failure defined as the presence of any of the following criteria: (1) signs or symptoms of cUTI present at diagnosis that have not improved by days 5–7 with appropriate antibiotic therapy, (2) new cUTI-related symptoms that have developed within 30 days of diagnosis, (3) urine culture taken within 30 days of diagnosis, either during or after completion of therapy, that grows ≥104 colony-forming unit/mL of the original pathogen and (4) death irrespective of cause within 30 days of the cUTI diagnosis. Sample size 1000 patients afford a power of 0.83 (α=0.05) to detect an absolute difference of 10% in the treatment failure rate between MDR bacteria and other pathogens. This should allow for the introduction of about 20 independent risk factors (or their interaction) in a logistic regression model looking at risk factors for failure. Ethics and dissemination Approval will be sought from all relevant Research Ethics Committees. Publication of this study will be considered as a joint publication by the participating investigator leads, and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE). Trial

  14. Cardiac asthma in elderly patients: incidence, clinical presentation and outcome

    Directory of Open Access Journals (Sweden)

    Ray Patrick

    2007-05-01

    Full Text Available Abstract Background Cardiac asthma is common, but has been poorly investigated. The objective was to compare the characteristics and outcome of cardiac asthma with that of classical congestive heart failure (CHF in elderly patients. Methods Prospective study in an 1,800-bed teaching hospital. Results Two hundred and twelve consecutive patients aged ≥ 65 years presenting with dyspnea due to CHF (mean age of 82 ± 8 years were included. Findings of cardiac echocardiography and natriuretic peptides levels were used to confirm CHF. Cardiac asthma patients were defined as a patient with CHF and wheezing reported by attending physician upon admission to the emergency department. The CHF group (n = 137 and the cardiac asthma group (n = 75, differed for tobacco use (34% vs. 59%, p 2 (47 ± 15 vs. 41 ± 11 mmHg, p Conclusion Patients with cardiac asthma represented one third of CHF in elderly patients. They were more hypercapnic and experienced more distal airway obstruction. However, outcomes were similar.

  15. Clinical features and outcomes of ANCA-associated renal vasculitis

    Directory of Open Access Journals (Sweden)

    Sidy Mohamed Seck

    2012-01-01

    Full Text Available To determine the patterns and outcomes of the pauci-immune vasculitis in the nephrology department at hospital La Conception in Marseille, we conducted a retrospective study including all patients with diagnosis of pauci-immune renal vasculitis between January 1, 2000 and December 31, 2007. Among 33 cases, 25 were diagnosed as Wegener granulomatosis (WG, seven as microscopic polyangitis (MPA and one as Churg-Strauss syndrome (SCS. The median age of the patients was 57.7 years and the sex-ratio (M/F was 1.6. The visceral mani-festations included kidneys (100% of patients, lungs (75%, ENT (52% of WG, and nervous system (57% of MPA. The mean serum creatinine at admission was 3.3 mg/dL. Renal biopsies revealed a pauci-immune crescentic gromerulonephritis in 96% of the cases. Two patients with WG received plasmapheresis and seven patients required emergency hemodialysis. Induction therapy comprised cyclophosphamide IV and corticosteroids, while maintenance therapy included azathioprine for the majority of patients. Eighty four percent of the patients experienced complete remission after induction therapy. During maintenance therapy relapses were more frequent among patients with MPA (28% compared to WG cases (12%. After 35 months of follow-up, eight patients ended on chronic hemodialysis, and five patients died. ANCA associated vasculitis are frequent in our patients. Long-term outcomes are relatively good despite a mortality rate of 15% and 25% of the patients entering dialysis after three years of follow-up.

  16. Clinical Supervision in Treatment Transport: Effects on Adherence and Outcomes

    OpenAIRE

    Schoenwald, Sonja K.; Sheidow, Ashli J.; Chapman, Jason E.

    2009-01-01

    This non-experimental study used Mixed-Effects Regression Models (MRMs) to examine relations among supervisor adherence to a clinical supervision protocol, therapist adherence, and changes in the behavior and functioning of youth with serious antisocial behavior treated with an empirically supported treatment (i.e., Multisystemic Therapy), one-year post treatment. Participants were 1979 youth and families treated by 429 clinicians across 45 provider organizations in North America. Four dimens...

  17. The Vermont Model for Rural HIV Care Delivery: Eleven Years of Outcome Data Comparing Urban and Rural Clinics

    Science.gov (United States)

    Grace, Christopher; Kutzko, Deborah; Alston, W. Kemper; Ramundo, Mary; Polish, Louis; Osler, Turner

    2010-01-01

    Context: Provision of human immunodeficiency virus (HIV) care in rural areas has encountered unique barriers. Purpose: To compare medical outcomes of care provided at 3 HIV specialty clinics in rural Vermont with that provided at an urban HIV specialty clinic. Methods: This was a retrospective cohort study. Findings: Over an 11-year period 363 new…

  18. Clinical management and survival outcomes of gliosarcomas in the era of multimodality therapy.

    Science.gov (United States)

    Damodaran, Omprakash; van Heerden, Jolandi; Nowak, Anna K; Bynevelt, Michael; McDonald, Kerrie; Marsh, Julie; Lee, Gabriel

    2014-03-01

    Gliosarcoma (GSM) is a rare primary malignant brain tumour accounting for less than 0.5% of all intracranial tumours. It has a biphasic histological composition, demonstrating both gliomatous and sarcomatous elements. In clinical practice GSM are generally managed similarly to glioblastoma multiforme (GBM). However, unique features including its clinical propensity for extra-cranial metastasis, distinct radiological features and possible worse prognosis than GBM suggest that GSM may be a distinct clinico-pathological entity. Hence we reviewed patterns of care and outcomes for a series of Australian patients diagnosed with GSM in the era of combined chemo-radiotherapy. Patients were identified by searching the Australian Genomics and Clinical Outcomes of Glioma (AGOG) database and the Western Australian Interhospital Neurosurgical database. Nineteen patients with GSM were identified. Of these, 15 patients were diagnosed with primary GSM and four patients developed secondary GSM after radiation therapy for primary GBM. For comparative purposes, 408 primary GBM patients were identified from the AGOG database during the same study period. The overall median survival for all primary GSM patients was 9.7 months. In comparison the overall median survival for GBM patients recruited to the AGOG database over the same period was 12.2 months. The median survival for secondary GSM patients from the time of diagnosis was 5 months. Primary and secondary GSM pose a great clinical challenge due to their rarity. Our study adds further evidence to support GSM as a unique clinical entity with a likely worse prognosis than GBM. PMID:24332268

  19. Perceived Benefits of Pre-Clinical Simulation-based Training on Clinical Learning Outcomes among Omani Undergraduate Nursing Students

    Directory of Open Access Journals (Sweden)

    Girija Madhavanprabhakaran

    2015-01-01

    Full Text Available Objectives: This study aimed to explore the benefits perceived by Omani undergraduate maternity nursing students regarding the effect of pre-clinical simulation-based training (PSBT on clinical learning outcomes. Methods: This non-experimental quantitative survey was conducted between August and December 2012 among third-year baccalaureate nursing students at Sultan Qaboos University in Muscat, Oman. Voluntary participants were exposed to faculty-guided PSBT sessions using low- and medium-fidelity manikins, standardised scenarios and skill checklists on antenatal, intranatal, postnatal and newborn care and assessment. Participants answered a purposely designed self-administered questionnaire on the benefits of PSBT in enhancing learning outcomes. Items were categorised into six subscales: knowledge, skills, patient safety, academic safety, confidence and satisfaction. Scores were rated on a four-point Likert scale. Results: Of the 57 participants, the majority (95.2% agreed that PSBT enhanced their knowledge. Most students (94.3% felt that their patient safety practices improved and 86.5% rated PSBT as beneficial for enhancing skill competencies. All male students and 97% of the female students agreed that PSBT enhanced their confidence in the safe holding of newborns. Moreover, 93% of participants were satisfied with PSBT. Conclusion: Omani undergraduate nursing students perceived that PSBT enhanced their knowledge, skills, patient safety practices and confidence levels in providing maternity care. These findings support the use of simulation training as a strategy to facilitate clinical learning outcomes in future nursing courses in Oman, although further research is needed to explore the objective impact of PSBT on learning outcomes.

  20. Outcomes for depression and anxiety in primary care and details of treatment : a naturalistic longitudinal study

    NARCIS (Netherlands)

    Prins, Marijn A.; Verhaak, Peter F. M.; Hilbink-Smolders, Mirrian; Spreeuwenberg, Peter; Laurant, Miranda G. H.; van der Meer, Klaas; van Marwijk, Harm W. J.; Penninx, Brenda W. J. H.; Bensing, Jozien M.

    2011-01-01

    Background: There is little evidence as to whether or not guideline concordant care in general practice results in better clinical outcomes for people with anxiety and depression. This study aims to determine possible associations between guideline concordant care and clinical outcomes in general pr

  1. Outcomes for depression and anxiety in primary care and details of treatment: a naturalistic longitudinal study.

    NARCIS (Netherlands)

    Prins, M.A.; Verhaak, P.F.M.; Hilbink-Smolders, M.; Spreeuwenberg, P.; Laurant, M.G.H.; Meer, K. van der; Marwijk, H.W.J. van; Penninx, B.W.J.H.; Bensing, J.M.

    2011-01-01

    Background: There is little evidence as to whether or not guideline concordant care in general practice results in better clinical outcomes for people with anxiety and depression. This study aims to determine possible associations between guideline concordant care and clinical outcomes in general pr

  2. Clinical outcome in 20 cases of lingual hemangiosarcoma in dogs: 1996-2011.

    Science.gov (United States)

    Burton, J H; Powers, B E; Biller, B J

    2014-09-01

    With the exception of solar-induced dermal hemangiosarcoma (HSA), the biologic behaviour of canine HSA is characterised by rapid tumour growth, a high metastatic rate and short survival times. Outcome of dogs with HSA of the tongue has not been previously reported. The purpose of this study was to assess outcome and prognostic factors in dogs with lingual HSA. Clinical data was collected retrospectively and histopathology was reviewed for 20 dogs. Median progression free survival was 524 days and the median overall survival time was 553 days. All dogs had low or intermediate grade tumours; most tumours were small and located on the ventral surface of the tongue. Prognostic factors significantly associated with increased survival included small tumour size and absence of clinical signs of an oral mass at the time of diagnosis. Dogs with HSA confined to the tongue may have a better prognosis compared with HSA in other organs. PMID:22905712

  3. Skin Disease in the Uninsured: Diagnoses, Management Decisions, and Referral Outcomes of an Urban Free Clinic.

    Science.gov (United States)

    Rosenbaum, Brooke E; Freitas, Derek; Nosal, Sarah C; Meydani, Ahou

    2016-01-01

    An understanding of the burden of skin disease in the uninsured population is needed to address the unique barriers they face to access dermatologic care. We conducted a retrospective chart review of patients seen for skin conditions over three years at the New York City (NYC) Free Clinic, a weekly primary care clinic operated by the NYU School of Medicine and the Institute for Family Health. Main outcomes of this study were descriptive analyses of demographic characteristics, diagnoses, management strategies, and referral outcomes, as well as key factors influencing referral to a dermatologist and referral attendance. Diagnosis was a significant predictor of referral (ptravel distance had no significant association with non-attendance. While demand for dermatologic care by uninsured patients in NYC is high, referral non-attendance remains a substantial barrier to care. PMID:27180711

  4. The influence of job characteristics on job outcomes of pharmacists in hospital, clinic, and community pharmacies.

    Science.gov (United States)

    Lin, Blossom Yen-Ju; Yeh, Ying-Chen; Lin, Wen-Hung

    2007-06-01

    This study examines the relationship between job characteristics and job outcomes of pharmacists in hospital, clinic, and community pharmacies in Taiwan. The structured questionnaires covered the items of job characteristics, job outcomes, and demographics of pharmacists, and were distributed between Feb 2004 and April 2004. Two hundred and ninety-eight pharmacists responded. Data were analyzed descriptively, and univariate analyses, factor analysis, and multiple regression analyses were used. It found the more enriched the job, the greater the job satisfaction and less intention to leave. And community pharmacists reported greater job enrichment and job satisfaction and less intention to leave than did hospital and clinic pharmacists. It suggests pharmacy managers could recognize the needs of pharmacists to redesign and enrich their work arrangements. PMID:17622026

  5. Clinical Characteristics and Outcome of Cardiovascular Implantable Electronic Device Infections in Turkey.

    Science.gov (United States)

    Aydin, Mesut; Yildiz, Abdulkadir; Kaya, Zeynettin; Kaya, Zekeriya; Basarir, Ahmet Ozgur; Cakmak, Nazmiye; Donmez, Ibrahim; Morrad, Baktash; Avci, Ahmet; Demir, Kenan; Cagliyan, Emre Caglar; Yuksel, Murat; Elbey, Mehmet Ali; Kayan, Fethullah; Ozaydogdu, Necdet; Islamoglu, Yahya; Cayli, Murat; Alan, Said; Ulgen, Mehmet Siddik; Ozhan, Hakan

    2016-07-01

    Infection is one of the most devastating outcomes of cardiovascular implantable electronic device (CIED) implantation and is related to significant morbidity and mortality. In our country, there is no evaluation about CIED infection. Therefore, our aim was to investigate clinical characteristics and outcome of patients who had infection related to CIED implantation or replacement. The study included 144 consecutive patients with CIED infection treated at 11 major hospitals in Turkey from 2005 to 2014 retrospectively. We analyzed the medical files of all patients hospitalized with the diagnosis of CIED infection. Inclusion criteria were definite infection related to CIED implantation, replacement, or revision. Generator pocket infection, with or without bacteremia, was the most common clinical presentation, followed by CIED-related endocarditis. Coagulase-negative staphylococci and Staphylococcus aureus were the leading causative agents of CIED infection. Multivariate analysis showed that infective endocarditis and ejection fraction were the strongest predictors of in-hospital mortality. PMID:25589093

  6. Clinical Impact of Rapid Reduction of Low-Density Lipoprotein Cholesterol Level on Long-Term Outcome of Acute Myocardial Infarction in the Statin Era: Subanalysis of the ALPS-AMI Study.

    Directory of Open Access Journals (Sweden)

    Takashi Miura

    Full Text Available The optimal period to achieve target percent reduction of low-density lipoprotein cholesterol (LDL-C level for secondary prevention of acute myocardial infarction (AMI is not well established.The Assessment of Lipophilic vs. Hydrophilic Statin Therapy in AMI (ALPS-AMI study enrolled 508 patients (mean age, 66.0± 11.6 years; 80.6% male who were hospitalized for AMI and underwent percutaneous coronary intervention (PCI. Of these patients, 81 were excluded because of the absence of LDL-C measurements at 4 weeks after randomization. In the remaining 427 patients, the target LDL-C level reduction of ≥30% was achieved and not reached within 4 weeks after randomization in 204 cases (early reduction group and 223 cases (late reduction group. The groups were formed prospectively and analyzed with regard to the composite end point (major adverse cardiovascular event [MACE]: all-cause death, myocardial infarction, and stroke and clinical outcomes.MACE were significantly more frequent in the late reduction group compared to the early reduction group (9.4% vs. 3.4%, P = 0.013. The incidence of cardiac deaths was also significantly higher in the late reduction group (3.1% vs. 0.5%, P = 0.044. On age-adjusted Cox proportional hazards analysis in statin-naïve patients, percent reduction of LDL-C level during the initial 4 weeks (HR, 0.98; 95% CI: 0.97-0.99, P = 0.042 and baseline LDL-C level (HR, 0.98; 95% CI: 0.97-0.99, P = 0.033 predicted adverse events.Rapid reduction of LDL-C level is strongly associated with favorable outcome in patients with AMI.

  7. Clinical studies on cerebral infarction

    International Nuclear Information System (INIS)

    Hemorrhagic infarction (HI) is termed as the infarction in which a large part of the necrotic tissue is stippled with small hemorrhage. The pathogenetic mechanism of this disease still remains controversial. Cerebral infarction has long been divided into two subtypes-thrombosis and embolism-according to the pathogenetic mechanisms. Clinical studies were carried out in 31 cases of HI with cerebral thrombosis. CT findings of these cases were classified into five groups according to both size of low density area which indicates regions of infarction and distribution of arterial supply. The low density area of Type I-Type III were observed in the area of the middle cerebral artery. That of Type IV was observed in the area of the internal capsule and basal ganglia. That of Type V was observed in the area of the posterior cerebral artery. CT reveals two patterns of HI -pattern A and pattern B-. The CT finding of pattern A is appearance of high density area in the low density area. The CT finding of pattern B is appearance of iso density area in the low density area. rCBF was measured by 133Xe inhalation technique in 21 patients with CT type I, II and III. Thereafter, with regard to the various findings in CT, the clinical findings and CBF findings, a comparative study was carried out on these ten groups. From the results of present studies, it is concluded that sequential changes of CBF in cases with pattern A are different from those with pattern B, and that CBF measurement does not permit an estimation of a patient's chance for functionary recovery after a stroke in acute and subacute stage but permits estimation of functional outcome in chronic stage. (J.P.N.)

  8. CLINICAL STUDY OF ANORECTAL MALFORMATIONS

    Directory of Open Access Journals (Sweden)

    Umesh

    2015-01-01

    Full Text Available BACKGROUND: A norectal malformations are relatively encountered anomalies. Presentations may vary from mild to severe and bowel control is t he main concern. AIM: To study the modes of presentation , types of anomalies , associated anomalies , reliability of clinical signs and radiological investigations in the diagnosis and the prognosis and continence in the post - operative in relation to type of anomaly and associated anomaly (s. MATERIAL AND METHODS: 50 cases of anorectal malformations admit ted to Department of Paediatric Surgery , in Medical Coll ege and Research Institute , were included in the study. Data related to the objectives of the study were collected. RESULTS: Commonest mode of presentation was failure to pass meconium 50%. 59% of mal es had high anomalies , while 53% females had intermediate anomalies. The diagnosis of low anomaly was made clinically , while high and intermediate anomalies needed further investigations. Associated anomalies were noted in 46.6% of the cases. 71.42% of the se patients had either a high or intermediate ARM. All patients with high anomalies underwent a 3 stage procedure , while low anomalies underwent a single stage procedure followed by anal dilatations. Rectal mucosal prolapse (2 cases , wound infection (4 ca ses , stenosis (3 cases , retraction of neo anus (1 case was seen. All the patients with low anomalies had a good functional result post operatively , while 57% and 28% of patients with intermediate and high anomalies had good results. CONCLUSION : Anorectal malformations are common congenital anomalies. Males are more commonly affected (1.3:1. Low anomalies are the commonest lesions noted in both the sexes (36.67%. High anomalies are more frequent in males. Invertogram offer an accurate diagnosis for planning management in patients with anorectal malformations. Low anomalies have a better outcome following surgery. For intermediate and high anomalies a staged repair offers better results

  9. Improving Treatment Trial Outcomes for Rett Syndrome: The Development of Rett-specific Anchors for the Clinical Global Impression Scale.

    Science.gov (United States)

    Neul, Jeffrey L; Glaze, Daniel G; Percy, Alan K; Feyma, Tim; Beisang, Arthur; Dinh, Thuy; Suter, Bernhard; Anagnostou, Evdokia; Snape, Mike; Horrigan, Joseph; Jones, Nancy E

    2015-11-01

    Rett syndrome is a genetically based neurodevelopmental disorder. Although the clinical consequences of Rett syndrome are profound and lifelong, currently no approved drug treatments are available specifically targeted to Rett symptoms. High quality outcome measures, specific to the core symptoms of a disorder are a critical component of well-designed clinical trials for individuals with neurodevelopmental disorders. The Clinical Global Impression Scale is a measure of global clinical change with strong face validity that has been widely used as an outcome measure in clinical trials of central nervous system disorders. Despite its favorable assay sensitivity in clinical trials, as a global measure, the Clinical Global Impression Scale is not specific to the signs and symptoms of the disorder under study. Development of key anchors for the scale, specific to the disorder being assessed, holds promise for enhancing the validity and reliability of the measure for disorders such as Rett syndrome. PMID:25895911

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

    International Nuclear Information System (INIS)

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2012-02-01

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

  12. A Comparison of Medical Birth Register Outcomes between Maternity Health Clinics and Integrated Maternity and Child Health Clinics in Southwest Finland

    OpenAIRE

    Tuominen, Miia; Kaljonen, Anne; Ahonen, Pia; Mäkinen, Juha; Rautava, Päivi

    2016-01-01

    Introduction: Primary maternity care services are globally provided according to various organisational models. Two models are common in Finland: a maternity health clinic and an integrated maternity and child health clinic. The aim of this study was to clarify whether there is a relation between the organisational model of the maternity health clinics and the utilisation of maternity care services, and certain maternal and perinatal health outcomes.Methods: A comparative, register-based cros...

  13. Analytical comparison study of the clinical and radiological outcome of spine fixation using posterolateral, posterior lumber interbody and transforaminal lumber interbody spinal fixation techniques to treat lumber spine degenerative disc disease

    OpenAIRE

    Al Barbarawi, Moh’d M; Audat, Ziad M; Mohammed Z. Allouh

    2015-01-01

    Background Degenerative disc disease is a common cause of chronic and disabling back pain that requires surgical intervention, posterolateral and posterior instrumental fixation (PLF), posterior lumber interbody fusion (PLIF) and transforaminal lumber interbody fusion (TLIF) are the techniques used to deal with such a problem. Objective To compare the clinical and radiological outcome of the variable surgical techniques used to deal with Lumber degenerative disc disease and to recommend the t...

  14. Beta-blocker use and clinical outcomes after primary vascular surgery

    DEFF Research Database (Denmark)

    Høgh, A; Lindholt, J S; Nielsen, H;

    2013-01-01

    To explore the associations between beta-blocker use and clinical outcomes (death, hospitalisation with myocardial infarction (MI) or stroke, major amputation and recurrent vascular surgery) after primary vascular reconstruction.......To explore the associations between beta-blocker use and clinical outcomes (death, hospitalisation with myocardial infarction (MI) or stroke, major amputation and recurrent vascular surgery) after primary vascular reconstruction....

  15. Integrating Interactive Web-Based Technology to Assess Adherence and Clinical Outcomes in Pediatric Sickle Cell Disease

    Directory of Open Access Journals (Sweden)

    Lori E. Crosby

    2012-01-01

    Full Text Available Research indicates that the quality of the adherence assessment is one of the best predictors for improving clinical outcomes. Newer technologies represent an opportunity for developing high quality standardized assessments to assess clinical outcomes such as patient experience of care but have not been tested systematically in pediatric sickle cell disease (SCD. The goal of the current study was to pilot an interactive web-based tool, the Take-Charge Program, to assess adherence to clinic visits and hydroxyurea (HU, barriers to adherence, solutions to overcome these barriers, and clinical outcomes in 43 patients with SCD age 6–21 years. Results indicate that the web-based tool was successfully integrated into the clinical setting while maintaining high patient satisfaction (>90%. The tool provided data consistent with the medical record, staff report, and/or clinical lab data. Participants reported that forgetting and transportation were major barriers for adherence to both clinic attendance and HU. A greater number of self-reported barriers (P<.01 and older age (P<.05 were associated with poorer clinic attendance and HU adherence. In summary, the tool represents an innovative approach to integrate newer technology to assess adherence and clinical outcomes for pediatric patients with SCD.

  16. Acute pyelonephritis: role of enhanced CT scan in the prediction of clinical outcome

    International Nuclear Information System (INIS)

    To correlate the CT findings of acute pyelonephritis with its outcome and with clinical data. Thirty five contrast enhanced CT scans in patients diagnosed as suffering from acute pyelonephritis were retrospectively analyzed. Findings based on the morphology of perfusion defect in the renal parenchyma were classified as normal, focal wedge, multifocal wedge, focal mass, or mixed form composed of wedge and mass. These findings were correlated with clinical data such as degree of fever, leukocytosis, the period after antibiotic treatment during which fever was reduced, and the presence of pyuria in each group Analysis was then performed. Perfusion defects were seen in 23 of 35 cases, and their morphology was classified as follow; focal wedge (n=2), multifocal wedge (n=8), focal mass (n=4), and mixed form (n=9). Twelve cases (34.3%) showed no perfusion defect. The duration of fever was significantly prolonged in patients with focal mass form (p < .05). There was no significant correlation between the morphology of perfusion defect, bilaterality, and other clinical factors. The present study shows that the clinical course of the focal mass form of perfusion defect, as seen on CT, is different from that of other types. CT could be effective in predicting clinical progress and the outcome of treatment in cases of acute pyelonephritis

  17. Acute pyelonephritis: role of enhanced CT scan in the prediction of clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Jo, Byung June; Kim, Ki Whang; Yu, Jeong Sik; Kim, Jai Keun; Yoon, Sang Wook; Ha, Sung Kyu; Park, Chong Hoon [Yonsei Univ. College of Medicine, Seoul (Korea, Republic of)

    1997-04-01

    To correlate the CT findings of acute pyelonephritis with its outcome and with clinical data. Thirty five contrast enhanced CT scans in patients diagnosed as suffering from acute pyelonephritis were retrospectively analyzed. Findings based on the morphology of perfusion defect in the renal parenchyma were classified as normal, focal wedge, multifocal wedge, focal mass, or mixed form composed of wedge and mass. These findings were correlated with clinical data such as degree of fever, leukocytosis, the period after antibiotic treatment during which fever was reduced, and the presence of pyuria in each group Analysis was then performed. Perfusion defects were seen in 23 of 35 cases, and their morphology was classified as follow; focal wedge (n=2), multifocal wedge (n=8), focal mass (n=4), and mixed form (n=9). Twelve cases (34.3%) showed no perfusion defect. The duration of fever was significantly prolonged in patients with focal mass form (p < .05). There was no significant correlation between the morphology of perfusion defect, bilaterality, and other clinical factors. The present study shows that the clinical course of the focal mass form of perfusion defect, as seen on CT, is different from that of other types. CT could be effective in predicting clinical progress and the outcome of treatment in cases of acute pyelonephritis.

  18. Clinical Studies with Epothilones

    Science.gov (United States)

    Altmann, Karl-Heinz

    As indicated in previous chapters, epothilone research so far has delivered seven new chemical entities that have been advanced to clinical trials in humans (Fig. 1). However, the amount of clinical data publicly available at this time strongly varies between individual compounds, depending on their development stage, but also on the general publication policy of the developing company. The compound that has been most comprehensively characterized in the clinical literature is ixabepilone (BMS-247550), for which trial results have been described in a number of articles in peer-reviewed journals and which has been granted FDA approval for two clinical indications on Oct. 16, 2007. For all other compounds, most of the information on clinical trials is available only in abstract form. In all these cases it remains uncertain, whether the content of these abstracts fully reflects the content of the subsequent (poster or oral) presentations at the corresponding meeting; in fact, it seems likely that additional data will have been included in the actual meeting presentations that may not have been available at the time of abstract submission. As this is unknown to the author, such additional information cannot be considered in this chapter, which is solely based on information documented in accessible abstracts or journal publications. It should also be kept in mind that the interpretation of data from ongoing clinical trials or forward looking statements based on data from completed trials are always preliminary in character.

  19. Prime time: 18-month violence outcomes of a clinic-linked intervention.

    Science.gov (United States)

    Sieving, Renee E; McMorris, Barbara J; Secor-Turner, Molly; Garwick, Ann W; Shlafer, Rebecca; Beckman, Kara J; Pettingell, Sandra L; Oliphant, Jennifer A; Seppelt, Ann M

    2014-08-01

    Prime Time, a youth development intervention, aims to reduce multiple risk behaviors among adolescent girls seeking clinic services who are at high risk for pregnancy. The purpose of the current study was to examine whether Prime Time involvement produced changes in relational aggression, physical violence, and related psychosocial and behavioral outcomes. Qualitative case exemplars illustrated social contexts of intervention participants with differing longitudinal patterns of relational aggression and physical violence. Data were from a randomized efficacy trial with 13-17 year-old girls (n = 253) meeting specified risk criteria. Intervention participants were involved in Prime Time and usual clinic services for 18 months, control participants received usual clinic services. Participants in the current study completed self-report surveys at baseline and 18 months following enrollment. Outcomes analyses revealed significantly lower levels of relational aggression perpetration in the intervention group versus controls. In contrast, Prime Time involvement did not result in significant reductions in physical violence. Exploratory dose-response analyses indicated that reductions in relational aggression may have been most pronounced among girls actively involved in Prime Time case management and peer leadership activities. Qualitative findings suggested that the intervention's emphasis on modeling and building supportive relationships contributed to reductions in relational aggression. This study contributes to what has been a very limited evidence base regarding effective approaches to preventing violence among high-risk adolescent girls. Findings suggest that offering youth development interventions through clinic settings hold promise in reducing violence risk among vulnerable youth. PMID:23543359

  20. Maternal characteristics and clinical diagnoses influence obstetrical outcomes in Indonesia.

    Science.gov (United States)

    Adisasmita, Asri; Smith, Carl V; El-Mohandes, Ayman A E; Deviany, Poppy Elvira; Ryon, Judith J; Kiely, Michele; Rogers-Bloch, Quail; Gipson, Reginald F

    2015-07-01

    This Indonesian study evaluates associations between near-miss status/death with maternal demographic, health care characteristics, and obstetrical complications, comparing results using retrospective and prospective data. The main outcome measures were obstetric conditions and socio-economic factors to predict near-miss/death. We abstracted all obstetric admissions (1,358 retrospective and 1,240 prospective) from two district hospitals in East Java, Indonesia between 4/1/2009 and 5/15/2010. Prospective data added socio-economic status, access to care and referral patterns. Reduced logistic models were constructed, and multivariate analyses used to assess association of risk variables to outcome. Using multivariate analysis, variables associated with risk of near-miss/death include postpartum hemorrhage (retrospective AOR 5.41, 95 % CI 2.64-11.08; prospective AOR 10.45, 95 % CI 5.59-19.52) and severe preeclampsia/eclampsia (retrospective AOR 1.94, 95 % CI 1.05-3.57; prospective AOR 3.26, 95 % CI 1.79-5.94). Associations with near-miss/death were seen for antepartum hemorrhage in retrospective data (AOR 9.34, 95 % CI 4.34-20.13), and prospectively for poverty (AOR 2.17, 95 % CI 1.33-3.54) and delivering outside the hospital (AOR 2.04, 95 % CI 1.08-3.82). Postpartum hemorrhage and severe preeclampsia/eclampsia are leading causes of near-miss/death in Indonesia. Poverty and delivery outside the hospital are significant risk factors. Prompt recognition of complications, timely referrals, standardized care protocols, prompt hospital triage, and structured provider education may reduce obstetric mortality and morbidity. Retrospective data were reliable, but prospective data provided valuable information about barriers to care and referral patterns. PMID:25656716

  1. Testing for heterogeneity among the components of a binary composite outcome in a clinical trial

    OpenAIRE

    Devereaux PJ; Thabane Lehana; Pogue Janice; Yusuf Salim

    2010-01-01

    Abstract Background Investigators designing clinical trials often use composite outcomes to overcome many statistical issues. Trialists want to maximize power to show a statistically significant treatment effect and avoid inflation of Type I error rate due to evaluation of multiple individual clinical outcomes. However, if the treatment effect is not similar among the components of this composite outcome, we are left not knowing how to interpret the treatment effect on the composite itself. G...

  2. Brucellosis in pregnancy: clinical aspects and obstetric outcomes

    Directory of Open Access Journals (Sweden)

    Gustavo Vilchez

    2015-09-01

    Conclusions: This is the largest series of brucellosis in pregnancy reported in the literature. Brucella presents adverse obstetric outcomes including fetal and maternal/neonatal death. Cases with unexplained spontaneous abortion should be investigated for brucellosis. Prompt treatment is paramount to decrease the devastating outcomes.

  3. Clinical profile and outcomes of atrial fibrillation in elderly patients with acute myocardial infarction

    Institute of Scientific and Technical Information of China (English)

    LI Kang; HUO Yong; DING Yan-sheng

    2008-01-01

    Background Atrial fibrillation (AF) occurs commonly in patients with acute myocardial infarction (MI) and is associated with an increased long-term mortality.This study aimed to investigate the clinical characteristics and outcomes of AF in in-hospital elderly Chinese patients with acute MI.Methods A total of 967 patients with acute MI,aged≥65 years,were categorized on the basis of the absence or presence of AF.Patients with documented AF were classified into two subgroups: the ongoing AF group and the new-onset AF group.We retrospectively evaluated the clinical profile,in-hospital outcomes,and effects of revascularization on the incidence of AF in elderly patients with acute MI.Results AF was documented in 100 (11.53%) patients and the incidence of new-onset AF was 6.51% during hospitalization.History of old MI and cerebrovascular events were more common in patients with AF than in those without AF (P<0.001,P<0.01,respectively).The incidence of AF was higher in patients with non-ST elevated MI (P=0.014),inferior wall MI (P=0.004) and cardiac function of Killip class III or IV (P=0.008).Patients with AF had more complication of pneumonia (P=0.003) and longer hospital stay.Left circumflex coronary artery involvement was more common in patients with AF (compared with patients without AF,P <0.001).Percutaneous coronary intervention or coronary artery bypass grafting significantly decreased the incidence of new-onset AF from 7.97% to 3.82% (P=0.017).AF depended to heart failure,increased the in-hospital mortality.Conclusions AF is common in elderly patients with acute MI and is associated with poorer clinical outcomes.Revascularization reduces the incidence of AF and thus improves the clinical outcomes in these patients.

  4. Percutaneous coronary intervention in asians- are there differences in clinical outcome?

    Directory of Open Access Journals (Sweden)

    Chua Terrance S

    2011-05-01

    Full Text Available Abstract Background Ethnic differences in clinical outcome after percutaneous coronary intervention (PCI have been reported. Data within different Asian subpopulations is scarce. We aim to explore the differences in clinical profile and outcome between Chinese, Malay and Indian Asian patients who undergo PCI for coronary artery disease (CAD. Methods A prospective registry of consecutive patients undergoing PCI from January 2002 to December 2007 at a tertiary care center was analyzed. Primary endpoint was major adverse cardiovascular events (MACE of myocardial infarction (MI, repeat revascularization and all-cause death at six months. Results 7889 patients underwent PCI; 7544 (96% patients completed follow-up and were included in the analysis (79% males with mean age of 59 years ± 11. There were 5130 (68% Chinese, 1056 (14% Malays and 1001 (13.3% Indian patients. The remaining 357 (4.7% patients from other minority ethnic groups were excluded from the analysis. The primary end-point occurred in 684 (9.1% patients at six months. Indians had the highest rates of six month MACE compared to Chinese and Malays (Indians 12% vs. Chinese 8.2% vs. Malays 10.7%; OR 1.55 95%CI 1.24-1.93, p Conclusion These data indicate that ethnic variations in clinical outcome exist following PCI. In particular, Indian patients have higher six month event rates compared to Chinese and Malays. Future studies are warranted to elucidate the underlying mechanisms behind these variations.

  5. Caspofungin: Pharmacodynamics, pharmacokinetics, clinical uses and treatment outcomes.

    Science.gov (United States)

    Song, Jessica C; Stevens, David A

    2016-09-01

    Over the past decade, echinocandins have emerged as first-line antifungal agents for many Candida infections. The echinocandins have a unique mechanism of action, inhibiting the synthesis of β-1,3-d-glucan polymers, key components of the cell wall in pathogenic fungi. Caspofungin was the first echinocandin antifungal agent to become licensed for use. The objectives of this review are to summarize the existing published data on caspofungin, under the subject headings of chemistry and mechanism of action, spectrum of activity, pharmacodynamics, pharmacokinetics, clinical studies, safety, drug interactions, dosing, and an overview of the drug's current place in therapy. PMID:26369708

  6. Influence of advancing age on clinical presentation, treatment efficacy and safety, and long-term outcome of pre-excitation syndromes: a retrospective cohort study of 961 patients included over a 25-year period

    Science.gov (United States)

    Brembilla-Perrot, Béatrice; Olivier, Arnaud; Sellal, Jean-Marc; Manenti, Vladimir; Brembilla, Alice; Villemin, Thibaut; Admant, Philippe; Beurrier, Daniel; Bozec, Erwan; Girerd, Nicolas

    2016-01-01

    Objectives There are very little data on pre-excitation syndrome (PS) in the elderly. We investigated the influence of advancing age on clinical presentation, treatment and long-term outcome of PS. Setting Single-centre retrospective study of patient files. Participants In all, 961 patients (72 patients ≥60 years (mean 68.5±6), 889 patients <60 years (mean 30.5±14)) referred for overt pre-excitation and indication for electrophysiological study (EPS) were followed for 5.3±5 years. Usual care included 24 h Holter monitoring, echocardiography and EPS. Patients underwent accessory pathway (AP) ablation if necessary. Primary and secondary outcome measures Occurrence of atrial fibrillation (AF) or procedure-induced adverse event. Results Electrophysiological data and recourse to AP ablation (43% vs 48.5%, p=0.375) did not significantly differ between the groups. Older patients more often had symptomatic forms (81% vs 63%, p=0.003), history of spontaneous AF (8% vs 3%, p=0.01) or adverse presentation (poorly tolerated arrhythmias: 18% vs 7%, p=0.0009). In multivariable analysis, patients ≥60 years had a significantly higher risk of history of AF (OR=4.2, 2.1 to 8.3, p=0.001) and poorly tolerated arrhythmias (OR=3.8, 1.8 to 8.1, p=0.001). Age ≥60 years was associated with an increased major AP ablation complication risk (10% vs 1.9%, p=0.006). During follow-up, occurrence of AF (13.9% vs 3.6%, p<0.001) and incidence of poorly tolerated tachycardia (4.2% vs 0.6%, p=0.001) were more frequent in patients ≥60 years, although frequency of ablation failure or recurrence was similar (20% vs 15.5%, p=0.52). In multivariable analysis, patients ≥60 years had a significantly higher risk of AF (OR=2.9, 1.2 to 6.8, p≤0.01). Conclusions In this retrospective monocentre study, patients ≥60 years referred for PS work up appeared at higher risk of AF and adverse presentation, both prior and after the work up. These results suggest that, in elderly

  7. Nutritional Care of Gastric Cancer Patients with Clinical Outcomes and Complications: A Review.

    Science.gov (United States)

    Choi, Wook Jin; Kim, Jeongseon

    2016-04-01

    The incidence and mortality of gastric cancer have been steadily decreased over the past few decades. However, gastric cancer is still one of the leading causes of cancer deaths across many regions of the world, particularly in Asian countries. In previous studies, nutrition has been considered one of significant risk factors in gastric cancer patients. Especially, malnourished patients are at greater risk of adverse clinical outcomes (e.g., longer hospital stay) and higher incidence of complications (e.g., wound/infectious complications) compared to well-nourished patients. Malnutrition is commonly found in advanced gastric cancer patients due to poor absorption of essential nutrients after surgery. Therefore, nutritional support protocols, such as early oral and enternal feeding, have been proposed in many studies, to improve unfavorable clinical outcomes and to reduce complications due to delayed application of oral nutritional support or parental feeding. Also, the supplied with enternal immune-enriched diet had more benefits in improving clinical outcomes and fewer complications compared to a group supplied with control formula. Using nutritional screening tools, such as nutritional risk index (NRI) and nutritional risk screening (NRS 2002), malnourished patients showed higher incidence of complications and lower survival rates than non-malnourished patients. However, a long-term nutritional intervention, such as nutritional counseling, was not effective in the patients. Therefore, early assessment of nutritional status in patients using a proper nutritional screening tool is suggested to prevent malnutrition and adverse health outcomes. Further studies with numerous ethnic groups may provide stronger scientific evidences in association between nutritional care and recovery from surgery in patients with gastric cancer. PMID:27152296

  8. Nutritional Care of Gastric Cancer Patients with Clinical Outcomes and Complications: A Review

    Science.gov (United States)

    Choi, Wook Jin

    2016-01-01

    The incidence and mortality of gastric cancer have been steadily decreased over the past few decades. However, gastric cancer is still one of the leading causes of cancer deaths across many regions of the world, particularly in Asian countries. In previous studies, nutrition has been considered one of significant risk factors in gastric cancer patients. Especially, malnourished patients are at greater risk of adverse clinical outcomes (e.g., longer hospital stay) and higher incidence of complications (e.g., wound/infectious complications) compared to well-nourished patients. Malnutrition is commonly found in advanced gastric cancer patients due to poor absorption of essential nutrients after surgery. Therefore, nutritional support protocols, such as early oral and enternal feeding, have been proposed in many studies, to improve unfavorable clinical outcomes and to reduce complications due to delayed application of oral nutritional support or parental feeding. Also, the supplied with enternal immune-enriched diet had more benefits in improving clinical outcomes and fewer complications compared to a group supplied with control formula. Using nutritional screening tools, such as nutritional risk index (NRI) and nutritional risk screening (NRS 2002), malnourished patients showed higher incidence of complications and lower survival rates than non-malnourished patients. However, a long-term nutritional intervention, such as nutritional counseling, was not effective in the patients. Therefore, early assessment of nutritional status in patients using a proper nutritional screening tool is suggested to prevent malnutrition and adverse health outcomes. Further studies with numerous ethnic groups may provide stronger scientific evidences in association between nutritional care and recovery from surgery in patients with gastric cancer. PMID:27152296

  9. Analysis of repeated outcome measures from longitudinal studies

    Institute of Scientific and Technical Information of China (English)

    Yuanjia WANG; Naihua DUAN

    2011-01-01

    @@ In many clinical studies repeated measurements of an outcome are collected over time.For example,in an 8-week study of treatment for obsessive compulsive disorder,the severity of the disorder may be measured weekly using the Yale-Brown-Obsessive-Compulsive-Disorder-Scale (YBOCS).For each study participant who completes the study,there will be nine repeated measures of YBOCS (a baseline assessment plus eight assessments during the course of treatment).Such a study in which participants are followed and measured repeatedly over time is called a longitudinal study and the resulting data are called longitudinal data.

  10. Clinical outcomes of locked plating of distal femoral fractures in a retrospective cohort

    Science.gov (United States)

    2013-01-01

    Purpose Locked plating (LP) of distal femoral fractures has become very popular. Despite technique suggestions from anecdotal and some early reports, knowledge about risk factors for failure, nonunion (NU), and revision is limited. The purpose of this study was to analyze the complications and clinical outcomes of LP treatment for distal femoral fractures. Materials and methods From two trauma centers, 243 consecutive surgically treated distal femoral fractures (AO/OTA 33) were retrospectively identified. Of these, 111 fractures in 106 patients (53.8% female) underwent locked plate fixation. They had an average age of 54 years (range 18 to 95 years): 34.2% were obese, 18.9% were smokers, and 18.9% were diabetic. Open fractures were present in 40.5% with 79.5% Gustilo type III. Fixation constructs for plate length, working length, and screw concentration were delineated. Nonunion and/or infection, and implant failure were used as outcome complication variables. Outcome was based on surgical method and addressed according to Pritchett for reduction, range of motion, and pain. Results Eighty-three (74.8%) of the fractures healed after the index procedure. Twenty (18.0%) of the patients developed a NU. Four of 20 (20%) resulted in a recalcitrant NU. Length of comminution did not correlate to NU (p = 0.180). Closed injuries had a higher tendency to heal after the index procedure than open injuries (p = 0.057). Closed and minimally open (Gustilo/Anderson types I and II) fractures healed at a significantly higher rate after the index procedure compared to type III open fractures (80.0% versus 61.3%, p = 0.041). Eleven fractures (9.9%) developed hardware failure. Fewer nonunions were found in the submuscular group (10.7%) compared to open reduction (32.0%) (p = 0.023). Fractures above total knee arthroplasties had a significantly greater rate of failed hardware (p = 0.040) and worse clinical outcome according to Pritchett (p = 0.040). Loss of

  11. Prediction of labor induction outcome using different clinical parameters

    Directory of Open Access Journals (Sweden)

    Tatić-Stupar Žaklina

    2013-01-01

    Full Text Available Introduction. Induction of labor is one of the most common obstetric interventions in contemporary obstetrics. Objective. The aim of the study was to evaluate the clinical and sonographic parameters in prediction of success of labor induction. Methods. The prospective study included 422 women in whom induction of labor was carried out at the Department of Obstetrics and Gynecology of Clinical Centre of Vojvodina. The role of body mass index and age of women, parity Bishop score, cervical length measured by transvaginal ultrasound was evaluated in regard of the success of induction, which was considered successful if a vaginal delivery occurred within 24 hours after the onset of induction. Data were statistically analyzed by univariate statistical analysis and Pearson’s χ2 test. Results. Out of 422 women, induction of labor was successful in 356 (84.4%, and it failed in 66 (15.6% cases. The values of Bishop score and cervical length had positive correlation with the success of induction. Conclusion. Bishop score and transvaginal cervical length were both reliable predictors in determining the success of labor induction, as well as parity and BMI. These parameters are mostly complementary, not competitive in prediction of labor induction success.

  12. Improving periodontal outcomes: merging clinical and behavioral science.

    Science.gov (United States)

    Wilder, Rebecca S; Bray, Kimberly S

    2016-06-01

    New data indicate that periodontal diseases are much more prevalent than previously thought, which means that there are large numbers of patients who will need to be diagnosed and treated for periodontal disease in a general dental practice. Oral hygiene procedures performed by patients between office visits are important for gingival health. No particular type of toothbrush has consistently been shown to have superior plaque-removal ability over another. Although studies on powered brushes have shown evidence for efficacy of biofilm removal and increased patient compliance, they are of short duration, making evaluation of long-term effects difficult to achieve. Interdental cleaning with dental floss can be effective but it is technique-sensitive. Interdental brushes have been shown to be superior to floss in plaque index scores, but not in gingival inflammation reduction. A systematic review of oral irrigation reported a beneficial adjunctive effect on bleeding and gingival indices and pocket depth. Antimicrobials in mouthrinses and toothpastes have shown significant reductions in plaque and gingivitis when used correctly. Even though it is considered essential for patients to utilize biofilm-removal techniques on a frequent basis, studies on adherence show that approximately 30-60% of health information is forgotten within 1 h, and 50% of health recommendations are not followed. Incorporating psychosocial aspects of behavioral change, including well-established counseling strategies, such as motivational interviewing, may elicit improved patient outcomes. PMID:27045431

  13. Clinical outcome and follow-up of prenatal hydronephrosis

    Directory of Open Access Journals (Sweden)

    Afshin Safaei Asl

    2012-01-01

    Full Text Available Hydronephrosis is probably the most common congenital abnormality detected prenatally by ultrasonography This study was performed to determine the cause and outcome of prenatal hydronephrosis in our hospital. A total of 45 infants, with 57 prenatally hydronephrotic renal units, were enrolled into this study. For the purpose of this study, the degree of hydronephrosis was defined as mild, moderate or severe. Postnatal ultrasonography was performed as soon as possible in those with bilateral hyronephrosis and 3-7 days after birth in those with unilateral hydronephrosis. Voiding cystourethrogram was performed in 6-8 weeks time. In the absence of vesicoureteral reflux (VUR, Diethylenetriamene penta acetate scan was performed to exclude obstructive uropathy. There were 29 males and 16 females (male:female ratio 1.8:1, and unilateral and bilateral hydronephrosis were seen in 33 (73% and 12 (27% of the cases, res-pectively. Hydronephrosis was caused by ureteropelvic junction obstruction (UPJO in 20 (44.5%, VUR in 10 (22.2%, ureterovesical junction obstruction in four (8.9 %, posteriorurethral valves in four (8.9 %, UPJO with VUR in two (4.4% and non-VUR non-obstructive in one (2.2%. During follow-up, 16 patients (35.5% required operative intervention while seven (15.5% improved spontaneously. Fetal hydronephrosis needs close follow-up during both ante-natal and postnatal periods. In this study, the most common cause for hydronephrosis were UPJO and VUR. Also seen in this study is the noteworthy point that mild fetal hydronephrosis is relatively benign and does not require surgical intervention in most cases and surgery should be performed only if there is renal function compromise. Prenatal consultation with a pediatric nephrologist and urologist is useful in decreasing parental anxiety and facilitating postnatal management.

  14. Thrombolytic-Related Asymptomatic Hemorrhagic Transformation Does Not Deteriorate Clinical Outcome: Data from TIMS in China.

    Directory of Open Access Journals (Sweden)

    Weihua Jia

    Full Text Available It has been unclear whether thrombolytic-related asymptomatic hemorrhagic transformation (AHT affects the clinical outcome. To answer this question, we examined whether thrombolytic-related AHT affect short-term and long-term clinical outcome.All data were collected from the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China (TIMS-China registry. The patients were diagnosed as having AHT group and non- hemorrhagic transformation (HT group based on clinical and imaging data. The patients with symptomatic hemorrhagic transformation were excluded from this study. Thrombolytic-related AHT was defined according to European-Australasian Acute Stroke Study (ECASS II criteria. 90-day functional outcome, 7-day National Institutes of Health Stroke Scale (NIHSS score, 7-day and 90-day mortalities were compared between two groups. Logistic regression analysis was used to evaluate the effects of AHT on a short-term and long-term clinical outcome.904 of all 1440 patients in TIMS-China registry were enrolled. 89 (9.6% patients presented with AHT after thrombolysis within 24-36 h. These patients with AHT were more likely to be elder age, cardioembolic subtype, and to have higher National Institutes of Health Stroke Scale score before thrombolysis than patients without AHT. No significant difference was found on the odds of 7-day (95% CI:0.692 (0.218-2.195, (P = 0.532 or 90-day mortalities (95% CI:0.548 (0.237-1.268, P = 0.160 and modified Rankin Score(0-1 at 90-day (95% CI:0.798 (0.460-1.386, P = 0.423 or modified Rankin Score(0-2 at 90-day (95% CI:0.732 (0.429-1.253, P = 0.116 or modified Rankin Score(5-6 at 90-day (95% CI:0.375 (0.169-1.830, P = 0.116 between two groups.Thrombolytic-related AHT does not deteriorate short-term and long-term clinical outcome.

  15. Cerebral amyloid angiopathy-related inflammation: imaging findings and clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Martucci, Matia [Vall d' Hebron University Hospital, Neuroradiology Unit, Radiology Department (IDI), Barcelona (Spain); Catholic University of Sacred Heart, ' ' A. Gemelli' ' University Hospital, Department of Radiological Sciences, Rome (Italy); Sarria, Silvana; Coscojuela, Pilar; Vert, Carla; Siurana, Sahyly; Auger, Cristina; Rovira, Alex [Vall d' Hebron University Hospital, Neuroradiology Unit, Radiology Department (IDI), Barcelona (Spain); Toledo, Manuel [Vall d' Hebron University Hospital, Epilepsy Unit, Neurology Department, Barcelona (Spain)

    2014-04-15

    We aim to investigate the clinical onset, computed tomography (CT) and magnetic resonance (MR) imaging findings, and follow-up of patients with cerebral amyloid angiopathy (CAA)-related inflammation, an uncommon but clinically striking presentation of CAA. We retrospectively reviewed the clinical manifestations, CT/MR imaging findings, and outcome of ten consecutive patients with CAA-related inflammation. In each patient, a brain CT study was performed at hospital admission, and brain MR imaging was carried out 2 to 4 days later. Clinical and radiologic follow-up findings were evaluated in all patients. The most common clinical onset was rapidly progressive cognitive decline, followed by focal neurological signs. Brain CT/MR showed unenhanced expansive subcortical lesions, corresponding to areas of vasogenic edema, associated with chronic lobar, cortical, or cortical-subcortical micro/macrohemorrhages. Clinical symptoms recovered in a few weeks under treatment in eight patients and spontaneously in the remaining two. MRI follow-up at 2 to 12 months after treatment showed resolution of the lesions. Three patients experienced symptomatic disease recurrence, with new lesions on CT/MR. In the absence of histological data, early recognition of the clinical symptoms and typical radiologic features of CAA-related inflammation is essential to enable timely establishment of proper treatment. (orig.)

  16. Impact of clinical severity on outcomes of mentalisation-based treatment for borderline personality disorder

    OpenAIRE

    Bateman, A; Fonagy, P.

    2013-01-01

    Objective – Evidence of remission without specialized treatment for BPD is accumulating. The authors investigated whether specialized treatments are particularly indicated for patients at high levels of clinical severity. They examined the impact of clinical severity on outcomes of a randomized controlled trial of mentalization-based treatment (MBT) contrasted with supportive clinical management (SCM). Method – 134 patients were randomly allocated to MBT or SCM. The primary outcome was the ab...

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

    Science.gov (United States)

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

    2016-01-01

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

  18. Stakeholder views regarding cultural diversity teaching outcomes: a qualitative study

    Directory of Open Access Journals (Sweden)

    Carter-Pokras Olivia

    2005-11-01

    Full Text Available Abstract Background Cultural diversity teaching is increasingly present in both undergraduate and postgraduate training programmes. This study explored the views of stakeholders in medical education about the potential outcomes of cultural diversity teaching and how they thought cultural diversity programmes might be effectively evaluated. Methods A semi-structured interview was undertaken with 61 stakeholders (including policymakers, diversity teachers, students and users. The data were analysed and themes identified. Results Many participants felt that clinical practice was improved through 'cultural diversity teaching' and this was mostly as a result of improved doctor-patient communication. There was a strong view that service users need to participate in the evaluation of outcomes of cultural diversity teaching. Conclusion There is a general perception, rather than clear evidence, that cultural diversity teaching can have a positive effect on clinical practice. Cultural diversity teaching needs to be reviewed in undergraduate and postgraduate medicine and better evaluation tools need to be established.

  19. Pain relief and clinical outcome: from opioids to balanced analgesia

    DEFF Research Database (Denmark)

    Kehlet, H

    1996-01-01

    If it is generally accepted that adequate postoperative pain relief will improve outcome from surgery, several controlled trials demonstrated this only for lower body surgical procedures with epidural and spinal anesthetics. Important effects on outcome were not shown when postoperative opioids...... were administered with patient controlled (PCA) or epidural techniques. However, the most optimal pain relief seems to be best achieved with balanced analgesia techniques using combinations of epidural opioids and local anesthetics and systemic non-steroidal antiinflammatory drugs. Future efforts...

  20. Propionic acidemia: clinical course and outcome in 55 pediatric and adolescent patients

    Directory of Open Access Journals (Sweden)

    Grünert Sarah C

    2013-01-01

    Full Text Available Abstract Background Propionic acidemia is an inherited disorder caused by deficiency of propionyl-CoA carboxylase. Although it is one of the most frequent organic acidurias, information on the outcome of affected individuals is still limited. Study design/methods Clinical and outcome data of 55 patients with propionic acidemia from 16 European metabolic centers were evaluated retrospectively. 35 patients were diagnosed by selective metabolic screening while 20 patients were identified by newborn screening. Endocrine parameters and bone age were evaluated. In addition, IQ testing was performed and the patients’ and their families’ quality of life was assessed. Results The vast majority of patients (>85% presented with metabolic decompensation in the neonatal period. Asymptomatic individuals were the exception. About three quarters of the study population was mentally retarded, median IQ was 55. Apart from neurologic symptoms, complications comprised hematologic abnormalities, cardiac diseases, feeding problems and impaired growth. Most patients considered their quality of life high. However, according to the parents’ point of view psychic problems were four times more common in propionic acidemia patients than in healthy controls. Conclusion Our data show that the outcome of propionic acidemia is still unfavourable, in spite of improved clinical management. Many patients develop long-term complications affecting different organ systems. Impairment of neurocognitive development is of special concern. Nevertheless, self-assessment of quality of life of the patients and their parents yielded rather positive results.

  1. Early seizures in patients with acute stroke: Frequency, predictive factors, and effect on clinical outcome

    Directory of Open Access Journals (Sweden)

    Andrea Alberti

    2008-06-01

    Full Text Available Andrea Alberti, Maurizio Paciaroni, Valeria Caso, Michele Venti, Francesco Palmerini, Giancarlo AgnelliStroke Unit and Division of Internal and Cardiovascular Medicine, University of Perugia, Perugia, ItalyBackground: Early seizure (ES may complicate the clinical course of patients with acute stroke. The aim of this study was to assess the rate of and the predictive factors for ES as well the effects of ES on the clinical outcome at hospital discharge in patients with first-ever stroke.Patients and methods: A total of 638 consecutive patients with first-ever stroke (543 ischemic, 95 hemorrhagic, admitted to our Stroke Unit, were included in this prospective study. ES were defined as seizures occurring within 7 days from acute stroke. Patients with history of epilepsy were excluded.Results: Thirty-one patients (4.8% had ES. Seizures were significantly more common in patients with cortical involvement, severe and large stroke, and in patient with cortical hemorrhagic transformation of ischemic stroke. ES was not associated with an increase in adverse outcome (mortality and disability. After multivariate analysis, hemorrhagic transformation resulted as an independent predictive factor for ES (OR = 6.5; 95% CI: 1.95–22.61; p = 0.003.Conclusion: ES occur in about 5% of patients with acute stroke. In these patients hemorrhagic transformation is a predictive factor for ES. ES does not seem to be associated with an adverse outcome at hospital discharge after acute stroke.Keywords: seizures, stroke, cortical involvement, hemorrhagic transformation

  2. Early seizures in patients with acute stroke: Frequency, predictive factors, and effect on clinical outcome

    Science.gov (United States)

    Alberti, Andrea; Paciaroni, Maurizio; Caso, Valeria; Venti, Michele; Palmerini, Francesco; Agnelli, Giancarlo

    2008-01-01

    Background Early seizure (ES) may complicate the clinical course of patients with acute stroke. The aim of this study was to assess the rate of and the predictive factors for ES as well the effects of ES on the clinical outcome at hospital discharge in patients with first-ever stroke. Patients and methods A total of 638 consecutive patients with first-ever stroke (543 ischemic, 95 hemorrhagic), admitted to our Stroke Unit, were included in this prospective study. ES were defined as seizures occurring within 7 days from acute stroke. Patients with history of epilepsy were excluded. Results Thirty-one patients (4.8%) had ES. Seizures were significantly more common in patients with cortical involvement, severe and large stroke, and in patient with cortical hemorrhagic transformation of ischemic stroke. ES was not associated with an increase in adverse outcome (mortality and disability). After multivariate analysis, hemorrhagic transformation resulted as an independent predictive factor for ES (OR = 6.5; 95% CI: 1.95–22.61; p = 0.003). Conclusion ES occur in about 5% of patients with acute stroke. In these patients hemorrhagic transformation is a predictive factor for ES. ES does not seem to be associated with an adverse outcome at hospital discharge after acute stroke. PMID:18827922

  3. A Comparison of Medical Birth Register Outcomes between Maternity Health Clinics and Integrated Maternity and Child Health Clinics in Southwest Finland

    Directory of Open Access Journals (Sweden)

    Miia Tuominen

    2016-07-01

    Full Text Available Introduction: Primary maternity care services are globally provided according to various organisational models. Two models are common in Finland: a maternity health clinic and an integrated maternity and child health clinic. The aim of this study was to clarify whether there is a relation between the organisational model of the maternity health clinics and the utilisation of maternity care services, and certain maternal and perinatal health outcomes. Methods: A comparative, register-based cross-sectional design was used. The data of women (N = 2741 who had given birth in the Turku University Hospital area between 1 January 2009 and 31 December 2009 were collected from the Finnish Medical Birth Register. Comparisons were made between the women who were clients of the maternity health clinics and integrated maternity and child health clinics. Results: There were no clinically significant differences between the clients of maternity health clinics and integrated maternity and child health clinics regarding the utilisation of maternity care services or the explored health outcomes. Conclusions: The organisational model of the maternity health clinic does not impact the utilisation of maternity care services or maternal and perinatal health outcomes. Primary maternity care could be provided effectively when integrated with child health services.

  4. Impact of cardiology referral: clinical outcomes and factors associated with physicians' adherence to recommendations

    Directory of Open Access Journals (Sweden)

    André C. Marques

    2014-12-01

    Full Text Available OBJECTIVES: Cardiology referral is common for patients admitted for non-cardiac diseases. Recommendations from cardiologists may involve complex and aggressive treatments that could be ignored or denied by other physicians. The purpose of this study was to compare the outcomes of patients who were given recommendations during cardiology referrals and to examine the clinical outcomes of patients who did not follow the recommendations. METHODS: We enrolled 589 consecutive patients who received in-hospital cardiology consultations. Data on recommendations, implementation of suggestions and outcomes were collected. RESULTS: Regarding adherence of the referring service to the recommendations, 77% of patients were classified in the adherence group and 23% were classified in the non-adherence group. Membership in the non-adherence group (p<0.001; odds ratio: 10.25; 95% CI: 4.45-23.62 and advanced age (p = 0.017; OR: 1.04; 95% CI: 1.01-1.07 were associated with unfavorable outcomes. Multivariate analysis identified four independent predictors of adherence to recommendations: follow-up notes in the medical chart (p<0.001; OR: 2.43; 95% CI: 1.48-4.01; verbal reinforcement (p = 0.001; OR: 1.86; 95% CI: 1.23-2.81; a small number of recommendation (p = 0.001; OR: 0.87; 95% CI: 0.80-0.94; and a younger patient age (p = 0.002; OR: 0.98; 95% CI: 0.96-0.99. CONCLUSIONS: Poor adherence to cardiology referral recommendations was associated with unfavorable clinical outcomes. Follow-up notes in the medical chart, verbal reinforcement, a limited number of recommendations and a patient age were associated with greater adherence to recommendations.

  5. Impact of clinical pharmacy services on renal transplant recipients’ adherence and outcomes

    OpenAIRE

    Chisholm-Burns, Marie A.; Spivey, Christina A.; Garrett, Charlene; McGinty, Herbert; Mulloy, Laura L

    2008-01-01

    The purpose of this article is to provide a description of a clinical pharmacy services program implemented in a renal transplant clinic to improve medication access and adherence as well as health and economic outcomes among renal transplant recipients (RTRs). Following a team-based planning process and an informal survey of RTRs, a clinical pharmacy service intervention was implemented in the Medical College of Georgia renal transplant clinic. As part of the intervention, a clinical pharmac...

  6. Clinical outcomes in pediatric hemodialysis patients in the USA: lessons from CMS' ESRD CPM Project.

    Science.gov (United States)

    Neu, Alicia M; Frankenfield, Diane L

    2009-07-01

    Although prospective randomized trials have provided important information and allowed the development of evidence-based guidelines in adult hemodialysis (HD) patients, with approximately 800 prevalent pediatric HD patients in the United States, such studies are difficult to perform in this population. Observational data obtained through the Center for Medicare & Medicaid Services' (CMS') End Stage Renal Disease (ESRD) Clinical Performance Measures (CPM) Project have allowed description of the clinical care provided to pediatric HD patients as well as identification of risk factors for failure to reach adult targets for clinical parameters such as hemoglobin, single-pool Kt/V (spKt/V) and serum albumin. In addition, studies linking data from the ESRD CPM Project and the United States Renal Data System have allowed evaluation of associations between achievement of those targets and the outcomes of hospitalization and death. The results of those studies, while unable to prove cause and effect, suggest that the adult ESRD CPM targets may assist in identifying pediatric HD patients at risk for poor outcomes. PMID:18509683

  7. Randomized Clinical Investigation of Titanium Implants with and without Platform Switching: Six Months’ Radiographic and Clinical Outcome

    Directory of Open Access Journals (Sweden)

    Roberto Rossi

    2015-04-01

    Full Text Available The aim of this study was to obtain a randomized, clinical and radiological comparison of implants with and without platform switching (PFS. The two compared titanium implant types differed only in the microgap position: test (PFS or control (StE, no PFS. All implants were inserted in posterior regions and followed up for six months after abutment connection (AC. Twenty one patients with 21 PFS and 18 StE implants completed the six-month evaluation. No implant failed. One complication (exposed cap screw was reported at AC. No statistically significant difference was observed between the marginal bone level of PFS and StE implants. Their bone level stabilized approximately 1 mm below the microgap. Based on the outcome of this short-term study with a limited number of patients, it seems unlikely that the optimal clinical and radiological outcome obtained with the tested standard implant (no PFS can be improved by introducing an inward microgap shift (PFS.

  8. Clinical outcomes and efficacy of transforaminal lumbar endoscopic discectomy

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    Cezmi Çagri Türk

    2015-01-01

    Full Text Available Background: Transforaminal lumbar endoscopic discectomy (TLED is a minimally invasive procedure for removing lumbar disc herniations. This technique was initially reserved for herniations in the foraminal or extraforaminal region. This study concentrated on our experience regarding the outcomes and efficacy of TLED. Materials and Methods: A total of 105 patients were included in the study. The patients were retrospectively evaluated for demographic features, lesion levels, numbers of affected levels, visual analog scores (VASs, Oswestry disability questionnaire scale scores and MacNab pain relief scores. Results: A total of 48 female and 57 male patients aged between 25 and 64 years (mean: 41.8 years underwent TLED procedures. The majority (83% of the cases were operated on at the levels of L4-5 and L5-S1. Five patients had herniations at two levels. There were significant decreases between the preoperative VAS scores collected postoperatively at 6 months (2.3 and those collected after 1-year (2.5. Two patients were referred for microdiscectomy after TLED due to unsatisfactory pain relief on the 1 st postoperative day. The overall success rate with respect to pain relief was 90.4% (95/105. Seven patients with previous histories of open discectomy at the same level reported fair pain relief after TLED. Conclusions: Transforaminal lumbar endoscopic discectomy is a safe and effective alternative to microdiscectomy that is associated with minor tissue trauma. Herniations that involved single levels and foraminal/extraforaminal localizations were associated with better responses to TLED.

  9. Clinical study of glycemic control analysis and pregnancy outcomes of patients with gestational diabetes%妊娠期糖尿病血糖控制分析与妊娠结局的临床研究

    Institute of Scientific and Technical Information of China (English)

    黄莉莉; 黄惠莹

    2014-01-01

    目的:研究妊娠期糖尿病血糖控制对妊娠结局的影响。方法2011年1月~2013年6月期间,选取75例经相关治疗血糖控制在正常范围内的妊娠期糖尿病孕妇作为研究组,选取未进行血糖控制或血糖控制不理想的75例孕妇作为对照组,同时选取健康孕妇75例,回顾性分析3组孕妇的临床资料,比较妊娠结局。结果研究组75例孕妇中,8例出现妊娠期高血压症、3例出现酮症、5例出现羊水过多、7例出现胎膜早破、3例出现产后出血、7例出现感染,并发症发生情况与健康组相比无显著差异,但明显低于对照组。结论妊娠期糖尿病可导致妊娠期高血压、羊水过多、胎儿窘迫、新生儿窒息等多种并发症,通过加强对妊娠期糖尿病血糖控制,可以明显降低母婴并发症的发生,对于改善妊娠结局具有重要意义。%Objective To investigate the impact of glycemic control on the pregnancy outcomes of patients with gestational diabetes. Methods Seventy-five pregnant women with gestational diabetes whose blood sugar was controlled in the normal range after receiving relevant treatment were selected as the study group; Seventy-five pregnant women who did not receive glycemic control or did not have ideal glycemic control were selected as the control group; Seventy-five healthy pregnant women were selected also. Clinical information of the 3 groups of pregnant women was analyzed retrospectively and their pregnancy outcomes were compared. Results Of the 75 pregnant women in the study group, 8 women had gestational hypertension, 3 women had ketosis, 5 patients had polyhydramnios, 7 patients had premature rupture of membrane, 3 patients had postpartum hemorrhage and 7 patients had infection. The occurrence of complications in the study group was not significantly different from that in the healthy group, but was significantly lower than that in the control group. Conclusion Gestational

  10. A Pilot Evaluation of Therapist Training in Cognitive Therapy for Psychosis:Therapy Quality and Clinical Outcomes

    OpenAIRE

    Jolley, Suzanne; Onwumere, Juliana; Bissoli, Sarah; Bhayani, Pooja; Singh, Gurpreet; Kuipers, Elizabeth; Craig, Tom; Garety, Philippa

    2015-01-01

    Background: Historically, it has been difficult to demonstrate an impact of training in psychological interventions for people with psychosis on routine practice and on patient outcomes. A recent pilot evaluation suggested that postgraduate training in Cognitive Behavioural Therapy for Psychosis (CBTp) increased the delivery of competent therapy in routine services. In this study, we evaluated clinical outcomes for patients receiving therapy from therapists who successfully completed training...

  11. [Clinical outcomes in the first year of life of premature infants].

    Science.gov (United States)

    Nunes, Cristiane Raupp; Abdala, Leticia Gabriel; Beghetto, Mariur Gomes

    2013-12-01

    The aim of this retrospective cohort study was to investigate clinical outcomes of the first year of life of premature infants discharged from the Neonatal Intensive Care Unit (NICU) based on mortality and readmission data, and the motor development of the children. The sample consisted of 170 children with gestational age under 37 weeks and who survived hospitalization in neonatal intensive care unit (NICU). Data were collected from medical records, the hospital IT system and telephone interview with the caregiver. The authors found 100% survival during the study period and that 39.4% of the infants were often readmitted (26.5%) due to respiratory conditions. Their development was considered as expected, when using the corrected age. In conclusion, the premature infants from this study showed good clinical evolution of the proposed observation. PMID:25080696

  12. Cerebral atrophy as outcome measure in short-term phase 2 clinical trials in multiple sclerosis

    International Nuclear Information System (INIS)

    Cerebral atrophy is a compound measure of the neurodegenerative component of multiple sclerosis (MS) and a conceivable outcome measure for clinical trials monitoring the effect of neuroprotective agents. In this study, we evaluate the rate of cerebral atrophy in a 6-month period, investigate the predictive and explanatory value of other magnetic resonance imaging (MRI) measures in relation to cerebral atrophy, and determine sample sizes for future short-term clinical trials using cerebral atrophy as primary outcome measure. One hundred thirty-five relapsing-remitting multiple sclerosis patients underwent six monthly MRI scans from which the percentage brain volume change (PBVC) and the number and volume of gadolinium (Gd)-enhancing lesions, T2 lesions, and persistent black holes (PBH) were determined. By means of multiple linear regression analysis, the relationship between focal MRI variables and PBVC was assessed. Sample size calculations were performed for all patients and subgroups selected for enhancement or a high T2 lesion load at baseline. A significant atrophy occurred over 6 months (PBVC = -0.33%, SE = 0.061, p < 0.0001). The number of baseline T2 lesions (p = 0.024), the on-study Gd-enhancing lesion volume (p = 0.044), and the number of on-study PBHs (p = 0.003) were associated with an increased rate of atrophy. For a 50% decrease in rate of atrophy, the sample size calculations showed that approximately 283 patients per arm are required in an unselected sampled population and 185 patients per arm are required in a selected population. Within a 6-month period, significant atrophy can be detected and on-study associations of PBVC and PBHs emphasizes axonal loss to be a driving mechanism. Application as primary outcome measure in short-term clinical trials with feasible sample size requires a potent drug to obtain sufficient power. (orig.)

  13. Bacterial meningitis in newborn and infant: correlation between organism, CT findings and clinical outcome

    International Nuclear Information System (INIS)

    Acute bacterial meningitis often results in significant neurologic complications regardless of the antibiotics treatment Computed tomographic (CT) finding of tuberculous meningitis is fairly well known but not the findings of bacterial meningitis. This study was performed to determine the incidence of causative organisms and to correlate between the organisms and computed tomographic (CT) findings with clinical outcome of bacterial meningitis in newborns and infants. We analyzed the brain CT and clinical records of 15 infants who had been diagnosed as bacterial meningitis by CSF culture. We found that the most common organisms were Group B streptococcus in neonates without no neurologic complications in all but one and Hemophilus influenza in infants whose clinical outcomes were poor in all except one. CT findings related with poor prognosis in this study were cerebral edema, basal cisternal obliteration and enhancement, and cerebral infarction on initial CT and ventriculomegaly on follow-up CT. We concluded that CT diagnosed intracranial complications of bacterial meningitis well and could contributed to better treatment of bacterial meningitis

  14. Clinical factors affecting the outcome in postradioactive iodine (RAI) therapy patients - Philippine Heart Center experience

    International Nuclear Information System (INIS)

    Full text: Clinical factors such as patient's age, duration of the underlying autoimmune thyroid stimulus and anti-thyroid drug therapy may affect the outcome of patients who underwent RAI therapy. Objective: To evaluate the clinical factors affecting the outcome of RAI therapy. Methodology: Patients (n=41) with Graves' disease treated with anti-thyroid drugs were followed up after Radioactive Iodine therapy treatment. Thyroid scan, 2 and 24 hours radioactive iodine uptake were taken to compute for the therapy dose (120 uci) (computed thyroid weight in gms) (24-hour I 131 uptake). Patients were then divided into groups (Group 1= hypothyroid, Group 2= euthyroid, Group 3 hyperthyroid) based on their thyroid function results (FT3, FT4, TSH) after 2, 4, 6, 12 months post-therapy. Clinical and physiologic factors were then correlated with the outcome. Results: The population consisted of 41 patients (male=8, female=33) with an overall incidence of Group 1= 17%, Group 2= 54% and Group 3= 29% posttherapy. Factors such as age, with their means (Groups 134, 2= 39, 3=39 p= 0.42) and gland uptake (24-hour Groups 1= 53, 2= 61 358, p= 0.41) were not associated with the remission rate. Other factors that were related to the length of the disease such as duration of symptoms (Groups 121, 2=24, 3= 29 months p0.68), duration of medicine prior to RAI therapy (Group 1= 10, 2= 15, 3= 18 months p=0.306) and gland weight (Groups 1=40 2=42 3=46 grams p=0.78) tends to have a higher mean values in therapy failure patients. Conclusion: Clinical factors studied showed no significant differences among patients developing hypothyroid, euthyroid or hyperthyroid state. The data suggested that treatment failures in patients with Graves' disease could be improved by lessening the time interval between the diagnosis and radioactive iodine therapy. (author)

  15. Femoral condyle insufficiency fractures: associated clinical and morphological findings and impact on outcome

    International Nuclear Information System (INIS)

    To determine the characteristics of femoral condyle insufficiency fracture (FCIF) lesions and their relative associations with the risk of clinical progression. This HIPAA-compliant retrospective study was approved by our Institutional Review Board. Seventy-three patients (age range, 19-95) were included after excluding patients with post-traumatic fractures, bone marrow infarct, osteochondritis dissecans, or underlying tumor. Two board-certified musculoskeletal radiologists classified morphologic findings including lesion diameter, associated bone marrow edema pattern, and associated cartilage/meniscus damage. Electronic medical charts were evaluated for symptoms, risk factors, and longitudinal outcomes, including total knee arthroplasty (TKA). Imaging characteristics were correlated with clinical findings, and comparison of outcome groups was performed using a regression model adjusted for age. The majority of patients with FCIF were women (64.4 %, 47/73), on average 10 years older than men (66.28 ± 15.86 years vs. 56.54 ± 10.39 years, p = 0.005). The most common location for FCIF was the central weight-bearing surface of the medial femoral condyle; overlying full thickness cartilage loss (75.7 %, 53/70) and ipsilateral meniscal injury (94.1 %, 64/68) were frequently associated. Clinical outcomes were variable, with 23.9 % (11/46) requiring TKA. Cartilage WORMS score, adjacent cartilage loss, and contralateral meniscal injury, in addition to decreased knee range of motion at presentation, were significantly associated with progression to TKA (p < 0.05). FCIF are frequently associated with overlying cartilage loss and ipsilateral meniscal injury. The extent of cartilage loss and meniscal damage, in addition to loss of knee range of motion at the time of presentation, are significantly associated with clinical progression. (orig.)

  16. Dissecting the determinants of depressive disorders outcome: an in depth analysis of two clinical cases

    Directory of Open Access Journals (Sweden)

    Oasi Osmano

    2007-02-01

    Full Text Available Abstract Clinicians face everyday the complexity of depression. Available pharmacotherapies and psychotherapies improve patients suffering in a large part of subjects, however up to half of patients do not respond to treatment. Clinicians may forecast to a good extent if a given patient will respond or not, based on a number of data and sensations that emerge from face to face assessment. Conversely, clinical predictors of non response emerging from literature are largely unsatisfactory. Here we try to fill this gap, suggesting a comprehensive assessment of patients that may overcome the limitation of standardized assessments and detecting the factors that plausibly contribute to so marked differences in depressive disorders outcome. For this aim we present and discuss two clinical cases. Mr. A was an industrial manager who came to psychiatric evaluation with a severe depressive episode. His employment was demanding and the depressive episode undermined his capacity to manage it. Based on standardized assessment, Mr. A condition appeared severe and potentially dramatic. Mrs. B was a housewife who came to psychiatric evaluation with a moderate depressive episode. Literature predictors would suggest Mrs. B state as associated with a more favourable outcome. However the clinician impression was not converging with the standardized assessment and in fact the outcome will reverse the prediction based on the initial formal standard evaluation. Although the present report is based on two clinical cases and no generalizability is possible, a more detailed analysis of personality, temperament, defense mechanisms, self esteem, intelligence and social adjustment may allow to formalize the clinical impressions used by clinicians for biologic and pharmacologic studies.

  17. Femoral condyle insufficiency fractures: associated clinical and morphological findings and impact on outcome

    Energy Technology Data Exchange (ETDEWEB)

    Plett, Sara K.; Hackney, Lauren A.; Heilmeier, Ursula; Nardo, Lorenzo; Zhang, Chiyuan A.; Link, Thomas M. [Department of Radiology and Biomedical Imaging, University of California, San Francisco, CA (United States); Yu, Aihong [Department of Radiology and Biomedical Imaging, University of California, San Francisco, CA (United States); 4th Medical College of Peking University, Department of Radiology, Beijing Jishuitan Hospital, Beijing (China)

    2015-12-15

    To determine the characteristics of femoral condyle insufficiency fracture (FCIF) lesions and their relative associations with the risk of clinical progression. This HIPAA-compliant retrospective study was approved by our Institutional Review Board. Seventy-three patients (age range, 19-95) were included after excluding patients with post-traumatic fractures, bone marrow infarct, osteochondritis dissecans, or underlying tumor. Two board-certified musculoskeletal radiologists classified morphologic findings including lesion diameter, associated bone marrow edema pattern, and associated cartilage/meniscus damage. Electronic medical charts were evaluated for symptoms, risk factors, and longitudinal outcomes, including total knee arthroplasty (TKA). Imaging characteristics were correlated with clinical findings, and comparison of outcome groups was performed using a regression model adjusted for age. The majority of patients with FCIF were women (64.4 %, 47/73), on average 10 years older than men (66.28 ± 15.86 years vs. 56.54 ± 10.39 years, p = 0.005). The most common location for FCIF was the central weight-bearing surface of the medial femoral condyle; overlying full thickness cartilage loss (75.7 %, 53/70) and ipsilateral meniscal injury (94.1 %, 64/68) were frequently associated. Clinical outcomes were variable, with 23.9 % (11/46) requiring TKA. Cartilage WORMS score, adjacent cartilage loss, and contralateral meniscal injury, in addition to decreased knee range of motion at presentation, were significantly associated with progression to TKA (p < 0.05). FCIF are frequently associated with overlying cartilage loss and ipsilateral meniscal injury. The extent of cartilage loss and meniscal damage, in addition to loss of knee range of motion at the time of presentation, are significantly associated with clinical progression. (orig.)

  18. The Impacts of Inclusion in Clinical Trials on Outcomes among Patients with Metastatic Breast Cancer (MBC.

    Directory of Open Access Journals (Sweden)

    Ji Yun Lee

    Full Text Available Metastatic breast cancer (MBC remains a devastating and incurable disease. Over the past decade, the implementation of clinical trials both with and without molecular targeted therapeutics has impacted the daily clinical treatment of patients with MBC. In this study, we determine whether including MBC patients in clinical trials affects clinical outcomes.We retrospectively reviewed data for a total of 863 patients diagnosed with initial or recurrent (after receiving adjuvant systemic treatments following surgery metastatic disease between January 2000 and December 2013. Data were obtained from the breast cancer database of Samsung Medical Center.Among the 806 patients selected for inclusion, 188 (23% had participated in clinical trials. A total of 185 clinical trials were conducted from 2000 to 2014. When compared with earlier periods (n = 10 for 2000-2004, clinical trial enrollment significantly increased over time (n = 103 for 2005-2009, P = 0.024; n = 110 for 2010-2014, P = 0.046. Multivariate analyses revealed that biologic subtype, distant recurrence free interval (DRFI, and clinical trial enrollment were independent predictors of overall survival. Patients who participated in clinical trials showed improved survival, with a hazard ratio of 0.75 (95% CI, 0.59-0.95, which was associated with a 25% reduction in the risk of death. However, subgroup analysis showed that this improved survival benefit was not maintained in patients with triple negative breast cancer (TNBC.Although not conclusive, we could speculate that there were differences in the use of newer agents or regimens over time, and these differences appear to be associated with improved survival.

  19. Shared Medical Appointments: Impact on Clinical and Quality Outcomes in Veterans With Diabetes.

    Science.gov (United States)

    Harris, Marianne D; Kirsh, Susan; Higgins, Patricia A

    2016-01-01

    Managing diabetes poses substantial challenges to the over 29.1 million Americans afflicted, and is financially overwhelming to the US health care system. One potential strategy is utilizing a group approach to care delivery or shared medical appointment (SMA). The purpose of this 3-year retrospective VA study was to investigate differences in clinical and quality outcome measures in veterans with type 2 diabetes who used SMAs and those who received only usual care (UC) one-on-one with their doctor. This observational, 2-group cohort study used abstracted medical records from a large Midwestern Veterans Administration hospital. Clinical outcome metrics included hemoglobin A1c (hbA1c), systolic blood pressure, low-density lipoprotein cholesterol, and emergency department (ED) visits. Quality outcomes included Veterans' Administration (VA) Department of Defense clinical practice guidelines for the management of diabetes. A total of 988 total VA cases were examined retrospectively over 3 years: 371 cases had used SMAs and 617 were in the UC cohort, and had never attended a diabetes SMA. The study period used abstracted VA medical records from 2008 to 2010. There were no statistically significant differences in HbA1c, systolic blood pressure, and ED visits between groups; however, hbA1c for individuals who attended SMAs was 8.55 (standard deviation [SD] = 1.72) and UC was 7.49 (SD = 1.28) (P inhibitors (ACE-I). SMAs may provide a venue for assessing and delivering quality care for patients with type 2 diabetes. More research is needed to ascertain effective strategies for diabetes disease management in high-risk patients. PMID:27367218

  20. Clinical outcome of