WorldWideScience

Sample records for clinical outcomes study

  1. Korean Clinic Based Outcome Measure Studies

    OpenAIRE

    Jongbae Park

    2003-01-01

    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...

  2. Korean Clinic Based Outcome Measure Studies

    Directory of Open Access Journals (Sweden)

    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

  3. Controlled outcome studies of child clinical hypnosis.

    Science.gov (United States)

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

    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.

  4. Clinical Outcomes Used in Clinical Pharmacy Intervention Studies in Secondary Care

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    Lene Juel Kjeldsen

    2017-05-01

    Full Text Available The objective was to investigate type, frequency and result of clinical outcomes used in studies to assess the effect of clinical pharmacy interventions in inpatient care. The literature search using Pubmed.gov was performed for the period up to 2013 using the search phrases: “Intervention(s” and “pharmacist(s” and “controlled” and “outcome(s” or “effect(s”. Primary research studies in English of controlled, clinical pharmacy intervention studies, including outcome evaluation, were selected. Titles, abstracts and full-text papers were assessed individually by two reviewers, and inclusion was determined by consensus. In total, 37 publications were included in the review. The publications presented similar intervention elements but differed in study design. A large variety of outcome measures (135 had been used to evaluate the effect of the interventions; most frequently clinical measures/assessments by physician and health care service use. No apparent pattern was established among primary outcome measures with significant effect in favour of the intervention, but positive effect was most frequently related to studies that included power calculations and sufficient inclusion of patients (73% vs. 25%. This review emphasizes the importance of considering the relevance of outcomes selected to assess clinical pharmacy interventions and the importance of conducting a proper power calculation.

  5. Autogenic training: a meta-analysis of clinical outcome studies.

    Science.gov (United States)

    Stetter, Friedhelm; Kupper, Sirko

    2002-03-01

    Autogenic training (AT) is a self-relaxation procedure by which a psychophysiological determined relaxation response is elicited. A meta-analysis was performed to evaluate the clinical effectiveness of AT. Seventy-three controlled outcome studies were found (published 1952-99). Sixty studies (35 randomized controlled trials [RCT]) qualified for inclusion in the meta-analysis. Medium-to-large effect sizes (ES) occurred for pre-post comparisons of disease-specific AT-effects, with the RCTs showing larger ES. When AT was compared to real control conditions, medium ES were found. Comparisons of AT versus other psychological treatment mostly resulted in no effects or small negative ES. This pattern of results was stable at follow-up. Unspecific AT-effects (i.e., effects on mood, cognitive performance, quality of life, and physiological variables) tended to be even larger than main effects. Separate meta-analyses for different disorders revealed a significant reduction of the heterogeneity of ES. Positive effects (medium range) of AT and of AT versus control in the meta-analysis of at least 3 studies were found for tension headache/migraine, mild-to-moderate essential hypertension, coronary heart disease, asthma bronchiale, somatoform pain disorder (unspecified type), Raynaud's disease, anxiety disorders, mild-to-moderate depression/dysthymia, and functional sleep disorders.

  6. 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.

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

    Science.gov (United States)

    2010-01-01

    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. PMID:20205867

  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. Disorganization at the stage of schizophrenia clinical outcome: Clinical-biological study.

    Science.gov (United States)

    Nestsiarovich, A; Obyedkov, V; Kandratsenka, H; Siniauskaya, M; Goloenko, I; Waszkiewicz, N

    2017-05-01

    According to the multidimensional model of schizophrenia, three basic psychopathological dimensions constitute its clinical structure: positive symptoms, negative symptoms and disorganization. The latter one is the newest and the least studied. Our aim was to discriminate disorganization in schizophrenia clinical picture and to identify its distinctive biological and socio-psychological particularities and associated genetic and environmental factors. We used SAPS/SANS psychometrical scales, scales for the assessment of patient's compliance, insight, social functioning, life quality. Neuropsychological tests included Wisconsin Card Sorting Test (WCST), Stroop Color-Word test. Neurophysiological examination included registration of P300 wave of the evoked cognitive auditory potentials. Environmental factors related to patient's education, family, surrounding and nicotine use, as well as subjectively significant traumatic events in childhood and adolescence were assessed. Using PCR we detected SNP of genes related to the systems of neurotransmission (COMT, SLC6A4 and DRD2), inflammatory response (IL6, TNF), cellular detoxification (GSTM1, GSTT1), DNA methylation (MTHFR, DNMT3b, DNMT1). Disorganization is associated with early schizophrenia onset and history of psychosis in family, low level of insight and compliance, high risk of committing delicts, distraction errors in WCST, lengthened P300 latency of evoked cognitive auditory potentials, low-functional alleles of genes MTHFR (rs1801133) and DNMT3b (rs2424913), high level of urbanicity and psychotraumatic events at early age. Severe disorganization at the stage of schizophrenia clinical outcome is associated with the set of specific biological and social-psychological characteristics that indicate its epigenetic nature and maladaptive social significance. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  10. CLINICAL OUTCOME OF PENETRATING KERATOPLASTY IN CORNEAL OPACITIES OF DIFFERENT AETIOLOGY- A CLINICAL STUDY

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    Dipak Bhuyan

    2017-01-01

    Full Text Available BACKGROUND Corneal transplantation or grafting is an operation in which abnormal corneal host tissue is replaced by healthy donor cornea. According to the World Health Organization (WHO, corneal diseases are among the major causes of vision loss and blindness in the world today after cataract and glaucoma. The aim of the study is to- 1. Evaluate the different aetiology of corneal opacity including active infective aetiology as indicated for penetrating keratoplasty. 2. Determine the clinical outcome of penetrating keratoplasty in relation to graft survival, graft rejection and peri-operative complications in different aetiology groups. 3. Determine the final visual outcome. MATERIALS AND METHODS Candidates for keratoplasty were selected from- 1. Eye Bank of Regional Institute of Ophthalmology (R.I.O. 2. R.I.O OPD. The study period was from September 2014 to August 2015. 30 cases were taken in the study. Descriptive statistics were applied to analyse the data wherever necessary. RESULTS 34.6±19.73 yrs. (mean±SD was the mean age at which transplants were done in the study. Out of total 30 cases, 13 (43.33% and 17 (56.66% were male and female, respectively. The different indications for penetrating keratoplasty are- Post ulcer corneal opacity in 14 cases (46.66%, posttraumatic corneal opacity 9 cases (30%, pseudophakic bullous keratopathy 4 cases (13.33%, corneal dystrophy in 2 cases (6.66% and non-healing corneal ulcer in 1 case (3.33%. 16 cases (53.33% showed clear graft till the last follow up while 11 (33.33% cases showed partially clear graft resulting in improved visual outcome while 3 cases (10.00% of the grafts were opaque due to graft failure. CONCLUSION The major indications for penetrating keratoplasty in this part of the world are post ulcer and posttraumatic corneal opacity and majority of them are illiterate agricultural workers who failed to get adequate treatment on time. Graft survival rate is high, which can be attributed to the

  11. A clinical study on etiology, prognosis, outcome and role of ...

    African Journals Online (AJOL)

    Upper gastrointestinal bleed is defined as bleeding proximal to the ligament of Treitz. The aim of this study was to know the cause of upper GI bleed, prognosis of the patients and role of upper gastrointestinal endoscopy (UGIE) in the management of upper gastrointestinal bleed (UGIB). A study of 140 cases was carried out ...

  12. A clinical study on etiology, prognosis, outcome and role of ...

    African Journals Online (AJOL)

    Arun Kumar Agnihotri

    In our study, the Rockall scoring system was seen to predict the mortality in patients with upper GI .... 100 bpm. SBP < 100. mmHg; Pulse ≥. 100 bpm. Comorbid illness. No major. CHF, IHD, .... This study provides new information in that the.

  13. 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

    2008-01-01

    CONTEXT: The impact of clinical experience on learning outcome from a resuscitation course has not been systematically investigated. AIM: To determine whether half a year of clinical experience before participation in an Advanced Life Support (ALS) course increases the immediate learning outcome...... and 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 immediate learning outcome. The intervention group had significantly higher...

  14. 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.

  15. A Qualitative Study of US Clinical Ethics Services: Objectives and Outcomes.

    Science.gov (United States)

    McClimans, Leah; Pressgrove, Geah; Rhea, James

    2016-01-01

    The quality of clinical ethics services in health care organizations is increasingly seen as an important aspect of the overall quality of care. But measuring this quality is difficult because there is a lack of clarity and consensus regarding the objectives of clinical ethics and the best outcome domains to measure. The aim of this qualitative study is to explore the views of experts about the objectives and outcomes of clinical ethics services in the US. We interviewed 19 experts in clinical ethics, focusing on the appropriate objectives and outcomes of a clinical ethics service (CES). Participants were selected using a purposive snowball sampling strategy. The development of the interview protocol was informed by the clinical ethics literature as well as by research and theories that inform clinical ethics practice. Interviews were conducted by phone, recorded, and transcribed for individual analysis. Analysis proceeded through the development of a codebook of categories using QDA Miner software. Our experts identified 12 objectives and nine outcomes. Some of these identifications were familiar (e.g., mediation and satisfaction) and some were novel (e.g., be of service and transformation). We found that experts are divided in their emphasis on the kinds of objectives that are most important. In terms of outcomes, our experts were concerned with the appropriateness of different proxy and direct measures. This study provides the perspectives of a select group of experts on the objectives and outcomes appropriate for a CES in the United States. The themes identified will be used in future research to inform a Delphi study to refine and obtain expert consensus.

  16. Dietary patterns and clinical outcomes in hemodialysis patients in Japan: a cohort study.

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    Kazuhiko Tsuruya

    Full Text Available Little is known about actual dietary patterns and their associations with clinical outcomes in hemodialysis patients. We identified dietary patterns in hemodialysis patients in Japan and examined associations between dietary patterns and clinical outcomes.We used data from 3,080 general-population participants in the Hisayama study (year 2007, and data from 1,355 hemodialysis patients in the Japan Dialysis Outcomes and Practice Patterns Study (JDOPPS: years 2005-2007. Food intake was measured using a brief self-administered diet-history questionnaire (BDHQ. To identify food groups with the Hisayama population data, we used principal components analysis with Promax rotation. We adjusted the resulting food groups for total daily energy intake, and then we used those adjusted food-group scores to identify dietary patterns in the JDOPPS patients by cluster analysis (Ward's method. We then used Cox regression to examine the association between dietary patterns and a composite of adverse clinical outcomes: hospitalization due to cardiovascular disease or death due to any cause.We identified three food groups: meat, fish, and vegetables. Using those groups we then identified three dietary patterns: well-balanced, unbalanced, and other. After adjusting for potential confounders, we found an association between an unbalanced diet and important clinical events (hazard ratio 1.90, 95% C.I. 1.19-3.04.Hemodialysis patients whose diet was unbalanced were more likely to have adverse clinical outcomes. Thus hemodialysis patients might benefit not only from portion control, but also from a diet that is well-balanced diet with regard to the food groups identified here as meat, fish, and vegetables.

  17. 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

  18. Clinical characteristics and outcome of heart failure and captagon amphetamine use: An observational prospective study

    OpenAIRE

    Abdelfatah A. Elasfar; Kamal Eldein Ahmad; Waleed AlShaghaa

    2014-01-01

    The fenetylline (captagon) tablets (an amphetamine like substance) are a stimulant drugs which are widely used in the Arabian Peninsula. Objectives: The aim of this study was to evaluate the clinical characteristics and outcome of acute heart failure in patients using captagon tablets. Methods: From September, 2009, through December, 2011, 280 consecutive patients with acute dilated cardiomyopathy and acute heart failure syndrome presented to emergency department in one tertiary care ce...

  19. Impact of Site Selection and Study Conduct on Outcomes in Global Clinical Trials.

    Science.gov (United States)

    Sarwar, Chaudhry M S; Vaduganathan, Muthiah; Butler, Javed

    2017-08-01

    There are over 25 million patients living with heart failure globally. Overall, and especially post-discharge, clinical outcomes have remained poor in heart failure despite multiple trials, with both successes and failures over the last two decades. Matching therapies to the right patient population, identifying high-quality sites, and ensuring optimal trial design and execution represent important considerations in the development of novel therapeutics in this space. While clinical trials have undergone rapid globalization, this has come with regional variation in comorbidities, clinical parameters, and even clinical outcomes and treatment effects across international sites. These issues have now highlighted knowledge gaps about the conduct of trials, selection of study sites, and an unmet need to develop and identify "ideal" sites. There is a need for all stakeholders, including academia, investigators, healthcare organizations, patient advocacy groups, industry sponsors, research organizations, and regulatory authorities, to work as a multidisciplinary group to address these problems and develop practical solutions to improve trial conduct, efficiency, and execution. We review these trial-level issues using examples from contemporary studies to inform and optimize the design of future global clinical trials in heart failure.

  20. Clinical profile and outcome of myasthenic crisis in a tertiary care hospital: A prospective study.

    Science.gov (United States)

    Sharma, Sudhir; Lal, Vivek; Prabhakar, Sudesh; Agarwal, Ritesh

    2013-04-01

    The present understanding of the clinical course, complications, and outcome of myasthenic crisis (MC) is based chiefly on observational studies and retrospective case series. To study the baseline demographic and clinical variables, risk factors, complications, outcome, and mortality in patients of MC. All patients of myasthenia gravis (MG) who presented with myasthenic crisis between July 2009 and December 2010 were included. Ten patients of MC were included in this study. The median age of the patients was 40.5 years (range 14-71 years). Seven were females and three were males. Nine had generalized MG and one patient had oculobulbar involvement only. Median duration of disease was 3 years (range 1 month to17 years). Two patients had thymoma. Two patients had history of thymectomy in the past. Infection was the most common triggering factor accounting for five cases (50%) followed by inadequate treatment/drug withdrawal in three (30%) and steroid initiation and hypokalemia in the remaining two patients (20%). Median duration of MC was 12 days (range 3-28 days). Mortality was in 3 out of 10 (30%) during MC. Management in the intensive care unit (ICU) and treatment with plasma exchange/intravenous immunoglobulins were associated with good outcome. Ventilator support and management in intensive care unit are the most important components in the management of MC. The high mortality rate seen in present study may be more reflective of the actual ground reality in resource constrained developing countries, however, larger prospective studies are needed to confirm these findings.

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

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    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

  2. Depression, social support, and clinical outcomes following lung transplantation: a single-center cohort study.

    Science.gov (United States)

    Smith, Patrick J; Snyder, Laurie D; Palmer, Scott M; Hoffman, Benson M; Stonerock, Gregory L; Ingle, Krista K; Saulino, Caroline K; Blumenthal, James A

    2018-05-01

    Depressive symptoms are common among lung transplant candidates and have been associated with poorer clinical outcomes in some studies. Previous studies have been plagued by methodologic problems, including small sample sizes, few clinical events, and uncontrolled confounders, particularly perioperative complications. In addition, few studies have examined social support as a potential protective factor. We therefore examined the association between pretransplant depressive symptoms, social support, and mortality in a large sample of lung transplant recipients. As a secondary aim, we also examined the associations between psychosocial factors, perioperative outcomes [indexed by hospital length of stay (LOS)], and mortality. We hypothesized that depression would be associated with longer LOS and that the association between depression, social support, and mortality would be moderated by LOS. Participants included lung transplant recipients, transplanted at Duke University Medical Center from January 2009 to December 2014. Depressive symptoms were evaluated using the Beck Depression Inventory (BDI-II) and social support using the Perceived Social Support Scale (PSSS). Medical risk factors included forced vital capacity (FVC), partial pressure of carbon dioxide (PCO 2 ), donor age, acute rejection, and transplant type. Functional status was assessed using six-minute walk distance (6MWD). We also controlled for demographic factors, including age, gender, and native disease. Transplant hospitalization LOS was examined as a marker of perioperative clinical outcomes. Participants included 273 lung recipients (174 restrictive, 67 obstructive, 26 cystic fibrosis, and six "other"). Pretransplant depressive symptoms were common, with 56 participants (21%) exhibiting clinically elevated levels (BDI-II ≥ 14). Greater depressive symptoms were associated with longer LOS [adjusted b = 0.20 (2 days per 7-point higher BDI-II score), P social support (P social support were

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

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    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.

  4. Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

    Science.gov (United States)

    Sennerby, L; Gottlow, J

    2008-06-01

    Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3).

  5. Automation of CT-based haemorrhagic stroke assessment for improved clinical outcomes: study protocol and design.

    Science.gov (United States)

    Chinda, Betty; Medvedev, George; Siu, William; Ester, Martin; Arab, Ali; Gu, Tao; Moreno, Sylvain; D'Arcy, Ryan C N; Song, Xiaowei

    2018-04-19

    Haemorrhagic stroke is of significant healthcare concern due to its association with high mortality and lasting impact on the survivors' quality of life. Treatment decisions and clinical outcomes depend strongly on the size, spread and location of the haematoma. Non-contrast CT (NCCT) is the primary neuroimaging modality for haematoma assessment in haemorrhagic stroke diagnosis. Current procedures do not allow convenient NCCT-based haemorrhage volume calculation in clinical settings, while research-based approaches are yet to be tested for clinical utility; there is a demonstrated need for developing effective solutions. The project under review investigates the development of an automatic NCCT-based haematoma computation tool in support of accurate quantification of haematoma volumes. Several existing research methods for haematoma volume estimation are studied. Selected methods are tested using NCCT images of patients diagnosed with acute haemorrhagic stroke. For inter-rater and intrarater reliability evaluation, different raters will analyse haemorrhage volumes independently. The efficiency with respect to time of haematoma volume assessments will be examined to compare with the results from routine clinical evaluations and planimetry assessment that are known to be more accurate. The project will target the development of an enhanced solution by adapting existing methods and integrating machine learning algorithms. NCCT-based information of brain haemorrhage (eg, size, volume, location) and other relevant information (eg, age, sex, risk factor, comorbidities) will be used in relation to clinical outcomes with future project development. Validity and reliability of the solution will be examined for potential clinical utility. The project including procedures for deidentification of NCCT data has been ethically approved. The study involves secondary use of existing data and does not require new consent of participation. The team consists of clinical neuroimaging

  6. CLINICAL OUTCOME AFTER OPERATIVE TREATMENT IN FLOATING SHOULDER- A PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Nabarun Saha

    2017-06-01

    Full Text Available BACKGROUND The ‘floating shoulder’ is a rare injury consisting of ipsilateral fractures of the clavicle and glenoid neck. Although it may appear to be bony injury, studies suggest that ligamentous disruption associated with ipsilateral clavicle fracture and scapular neck fracture contributes to such entity. More commonly floating shoulder is defined as double disruption of the superior shoulder suspensory complex. Open reduction and internal fixation of both the fractures is the treatment of choice. We have made this study to assess clinical outcome after operative treatment of floating shoulder by DASH score. MATERIALS AND METHODS This is a study of 10 cases of floating shoulder injury operated in the same sitting by anterior approach for fracture clavicle and Judet’s posterior approach for scapula fracture from Jan 2014 to Oct 2016. All cases were assessed with DASH score at the end of six months. RESULTS Results of our study shows that majority of patients had excellent to good results with improvement in DASH score from 92.8 to 16.8 at final follow up. No major complications. All patients had radiological signs of union at the end of 1 year. CONCLUSION Surgical intervention should be considered for all floating shoulder injuries. open reduction and internal fixation not only increases stability but also to improves functional outcome of the patient. DASH score is an effective method to assess clinicofunctional outcome in post-operative cases of floating shoulder.

  7. A systematic literature search to identify performance measure outcomes used in clinical studies of racehorses.

    Science.gov (United States)

    Wylie, C E; Newton, J R

    2018-05-01

    Racing performance is often used as a measurable outcome variable in research studies investigating clinical diagnoses or interventions. However, the use of many different performance measures largely precludes conduct of meaningful comparative studies and, to date, those being used have not been collated. To systematically review the veterinary scientific literature for the use of racing performance as a measurable outcome variable in clinical studies of racehorses, collate and identify those most popular, and identify their advantages and disadvantages. Systematic literature search. The search criteria "((racing AND performance) AND (horses OR equidae))" were adapted for both MEDLINE and CAB Abstracts databases. Data were collected in standardised recording forms for binary, categorical and quantitative measures, and the use of performance indices. In total, 217 studies that described racing performance were identified, contributing 117 different performance measures. No one performance measure was used in all studies, despite 90.3% using more than one variable. Data regarding race starts and earnings were used most commonly, with 88.0% and 54.4% of studies including at least one measure of starts and earnings, respectively. Seventeen variables were used 10 times or more, with the top five comprising: 'return to racing', 'number of starts', 'days to first start', 'earnings per period of time' and 'earnings per start'. The search strategies may not have identified all relevant papers, introducing bias to the review. Performance indices have been developed to improve assessment of interventions; however, they are not widely adopted in the scientific literature. Use of the two most commonly identified measures, whether the horse returned to racing and number of starts over a defined period of time, would best facilitate future systematic reviews and meta-analyses in advance of the development of a gold-standard measure of race performance outcome. © 2017 EVJ Ltd.

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

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    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

  9. Measurement-based Treatment of Residual Symptoms Using Clinically Useful Depression Outcome Scale: Korean Validation Study

    Science.gov (United States)

    Jeon, Sang Won; Han, Changsu; Ko, Young-Hoon; Yoon, Seo Young; Pae, Chi-Un; Choi, Joonho; Park, Yong Chon; Kim, Jong-Woo; Yoon, Ho-Kyoung; Ko, Seung-Duk; Patkar, Ashwin A.; Zimmerman, Mark

    2017-01-01

    Objective This study was aimed at evaluating the diagnostic validity of the Korean version of the Clinically Useful Depression Outcome Scale (CUDOS) with varying follow-up in a typical clinical setting in multiple centers. Methods In total, 891 psychiatric outpatients were enrolled at the time of their intake appointment. Current diagnostic characteristics were examined using the Structured Clinical Interview for DSM-IV (41% major depressive disorder). The CUDOS was measured and compared with three clinician rating scales and four self-report scales. Results The CUDOS showed excellent results for internal consistency (Cronbach’s α, 0.91), test-retest reliability (patients at intake, r=0.81; depressed patients in ongoing treatment, r=0.89), and convergent and discriminant validity (measures of depression, r=0.80; measures of anxiety and somatization, r=0.42). The CUDOS had a high ability to discriminate between different levels of depression severity based on the rating of Clinical Global Impression for depression severity and the diagnostic classification of major depression, minor depression, and non-depression. The ability of the CUDOS to identify patients with major depression was high (area under the receiver operating characteristic curve=0.867). A score of 20 as the optimal cutoff point was suggested when screening for major depression using the CUDOS (sensitivity=89.9%, specificity=69.5%). The CUDOS was sensitive to change after antidepressant treatment: patients with greater improvement showed a greater decrease in CUDOS scores (p<0.001). Conclusion The results of this multi-site outpatient study found that the Korean version of the CUDOS is a very useful measurement for research and for clinical practice. PMID:28138107

  10. Clinical outcomes and costs of reusable and single-use flexible ureterorenoscopes: a prospective cohort study.

    Science.gov (United States)

    Mager, R; Kurosch, M; Höfner, T; Frees, S; Haferkamp, A; Neisius, A

    2018-01-22

    The purpose of this study is to analyze clinical outcomes and costs of single-use flexible ureterorenoscopes in comparison with reusable flexible ureterorenoscopes in a tertiary referral center. Prospectively, 68 flexible ureterorenoscopies utilizing reusable (Flex-X2S, Flex-X C , Karl Storz) and 68 applying single-use flexible ureterorenoscopes (LithoVue, Boston Scientific) were collected. Clinical outcome parameters such as overall success rate, complication rates according to Clavien-Dindo, operation time and radiation exposure time were measured. Cost analysis was based on purchase costs and recurrent costs for repair and reprocessing divided by number of procedures. In each group 68 procedures were available for evaluation. In 91% of reusable and 88% of single-use ureterorenoscopies stone disease was treated with a mean stone burden of 101 ± 226 and 90 ± 244 mm 2 and lower pole involvement in 47 and 41%, respectively (p > 0.05). Comparing clinical outcomes of reusable vs. single-use instruments revealed no significant difference for overall success rates (81 vs. 87%), stone-free rates (82 vs. 85%), operation time (76.2 ± 46.8 vs. 76.8 ± 40.2 min), radiation exposure time (3.83 ± 3.15 vs. 3.93 ± 4.43 min) and complication rates (7 vs. 17%) (p > 0.05). A wide range of repair and purchase costs resulted in total to $1212-$1743 per procedure for reusable ureterorenoscopy whereas price of single-use ureterorenoscopy was $1300-$3180 per procedure. The current work provided evidence for equal clinical effectiveness of reusable and single-use flexible ureterorenoscopes. Partially overlapping ranges of costs for single-use and reusable scopes stress the importance to precisely know the expenses and caseload when negotiating purchase prices, repair prices and warranty conditions.

  11. Correlating nerve conduction studies and clinical outcome measures on carpal tunnel syndrome: lessons from a randomized controlled trial

    NARCIS (Netherlands)

    Schrijver, H.M.; Gerritsen, A.A.M.; Strijers, R.L.; Uitdehaag, B.M.J.; Scholten, R.J.P.M.; Vet, de H.C.W.; Bouter, L.M.

    2005-01-01

    0.4) were found between the neurophysiologic and clinical outcome measures after 12 months, and between the changes in these different categories of outcome measures. This study confirms that the parameters of NCS improve significantly after treatment for CTS, but the modest correlations between

  12. Clinical features and outcomes in patients with disseminated toxoplasmosis admitted to intensive care: a multicenter study.

    Science.gov (United States)

    Schmidt, Matthieu; Sonneville, Romain; Schnell, David; Bigé, Naike; Hamidfar, Rebecca; Mongardon, Nicolas; Castelain, Vincent; Razazi, Keyvan; Marty, Antoine; Vincent, François; Dres, Martin; Gaudry, Stephane; Luyt, Charles Edouard; Das, Vincent; Micol, Jean-Baptiste; Demoule, Alexandre; Mayaux, Julien

    2013-12-01

    Characteristics and outcomes of adult patients with disseminated toxoplasmosis admitted to the intensive care unit (ICU) have rarely been described. We performed a retrospective study on consecutive adult patients with disseminated toxoplasmosis who were admitted from January 2002 through December 2012 to the ICUs of 14 university-affiliated hospitals in France. Disseminated toxoplasmosis was defined as microbiological or histological evidence of disease affecting >1 organ in immunosuppressed patients. Isolated cases of cerebral toxoplasmosis were excluded. Clinical data on admission and risk factors for 60-day mortality were collected. Thirty-eight patients were identified during the study period. Twenty-two (58%) had received an allogeneic hematopoietic stem cell transplant (median, 61 [interquartile range {IQR}, 43-175] days before ICU admission), 4 (10%) were solid organ transplant recipients, and 10 (27%) were infected with human immunodeficiency virus (median CD4 cell count, 14 [IQR, 6-33] cells/µL). The main indications for ICU admission were acute respiratory failure (89%) and shock (53%). The 60-day mortality rate was 82%. Allogeneic hematopoietic stem cell transplant (hazard ratio [HR] = 2.28; 95% confidence interval [CI], 1.05-5.35; P = .04) and systolic cardiac dysfunction (HR = 3.54; 95% CI, 1.60-8.10; P toxoplasmosis leading to ICU admission has a poor prognosis. Recipients of allogeneic hematopoietic stem cell transplant appear to have the highest risk of mortality. We identified systolic cardiac dysfunction as a major determinant of outcome. Strategies aimed at preventing this fatal opportunistic infection may improve outcomes.

  13. Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum: A prospective cohort study.

    Science.gov (United States)

    Thomas, Kim S; Ormerod, Anthony D; Craig, Fiona E; Greenlaw, Nicola; Norrie, John; Mitchell, Eleanor; Mason, James M; Johnston, Graham A; Wahie, Shyamal; Williams, Hywel C

    2016-11-01

    Pyoderma gangrenosum (PG) is an uncommon dermatosis with a limited evidence base for treatment. We sought to estimate the effectiveness of topical therapies in the treatment of patients with PG. This was a prospective cohort study of UK secondary care patients with a clinical diagnosis of PG that was suitable for topical treatment (recruited between July 2009 and June 2012). Participants received topical therapy after normal clinical practice (primarily topical corticosteroids [classes I-III] and tacrolimus 0.03% or 0.1%). The primary outcome was speed of healing at 6 weeks. Secondary outcomes included the following: proportion healed by 6 months; time to healing; global assessment; inflammation; pain; quality of life; treatment failure; and recurrence. Sixty-six patients (22-85 years of age) were enrolled. Clobetasol propionate 0.05% was the most commonly prescribed therapy. Overall, 28 of 66 (43.8%) ulcers healed by 6 months. The median time to healing was 145 days (95% confidence interval, 96 days to ∞). Initial ulcer size was a significant predictor of time to healing (hazard ratio, 0.94 [95% confidence interval, 0.88-1.00); P = .043). Four patients (15%) had a recurrence. Our study did not include a randomized comparator. Topical therapy is potentially an effective first-line treatment for PG that avoids the possible side effects associated with systemic therapy. It remains unclear whether more severe disease will respond adequately to topical therapy alone. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

  14. 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 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.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.Very few studies address the appropriate choice of outcomes for clinical research

  15. Clinical Outcomes With Dose-Escalated Adaptive Radiation Therapy for Urinary Bladder Cancer: A Prospective Study

    Energy Technology Data Exchange (ETDEWEB)

    Murthy, Vedang, E-mail: vmurthy@actrec.gov.in [Department of Radiation Oncology, Tata Memorial Centre, Parel, Mumbai (India); Masodkar, Renuka; Kalyani, Nikhil; Mahantshetty, Umesh [Department of Radiation Oncology, Tata Memorial Centre, Parel, Mumbai (India); Bakshi, Ganesh; Prakash, Gagan [Department of Surgical Oncology, Tata Memorial Centre, Parel, Mumbai (India); Joshi, Amit; Prabhash, Kumar [Department of Medical Oncology, Tata Memorial Centre, Parel, Mumbai (India); Ghonge, Sujata; Shrivastava, Shyamkishore [Department of Radiation Oncology, Tata Memorial Centre, Parel, Mumbai (India)

    2016-01-01

    Purpose: The purpose of this study was to assess feasibility, clinical outcomes, and toxicity in patients with bladder cancer treated with adaptive, image guided radiation therapy (IGRT) for bladder preservation as a part of trimodality treatment. The role of dose escalation was also studied. Methods and Materials: Forty-four patients with localized bladder cancer were enrolled in a prospective study. They underwent maximal safe resection of bladder tumor and concurrent platinum-based chemotherapy. Patients with large tumors were offered induction chemotherapy. Radiation therapy planning was done using either 3 (n=34) or 6 (n=10) concentrically grown planning target volumes (PTV). Patients received 64 Gy in 32 fractions to the whole bladder and 55 Gy to the pelvic nodes and, if appropriate, a simultaneous integrated boost to the tumor bed to 68 Gy (equivalent dose for 2-Gy fractions assuming α/β of 10 [EQD2]{sub 10} = 68.7 Gy). Daily megavoltage (MV) imaging helped to choose the most appropriate PTV encompassing bladder for the particular day (using plan-of-the-day approach). Results: Most patients (88%) had T2 disease. Sixteen patients (36%) received neoadjuvant chemotherapy. A majority of the patients (73%) received prophylactic nodal irradiation, whereas 55% of the patients received escalated dose to the tumor bed. With a median follow-up of 30 months, the 3-year locoregional control (LRC), disease-free survival, and overall survival (OS) were 78%, 66%, and 67%, respectively. The bladder preservation rate was 83%. LRC (87% vs 68%, respectively, P=.748) and OS (74% vs 60%, respectively, P=.36) rates were better in patients receiving dose escalation. Instances of acute and late Radiation Therapy Oncology Group (RTOG) grade 3 genitourinary toxicity was seen in 5 (11%) and 2 (4%) patients, respectively. There was no acute or late RTOG grade 3 or higher gastrointestinal toxicity. Conclusions: Adaptive IGRT using plan-of-the-day approach for bladder

  16. Clinical Outcomes With Dose-Escalated Adaptive Radiation Therapy for Urinary Bladder Cancer: A Prospective Study

    International Nuclear Information System (INIS)

    Murthy, Vedang; Masodkar, Renuka; Kalyani, Nikhil; Mahantshetty, Umesh; Bakshi, Ganesh; Prakash, Gagan; Joshi, Amit; Prabhash, Kumar; Ghonge, Sujata; Shrivastava, Shyamkishore

    2016-01-01

    Purpose: The purpose of this study was to assess feasibility, clinical outcomes, and toxicity in patients with bladder cancer treated with adaptive, image guided radiation therapy (IGRT) for bladder preservation as a part of trimodality treatment. The role of dose escalation was also studied. Methods and Materials: Forty-four patients with localized bladder cancer were enrolled in a prospective study. They underwent maximal safe resection of bladder tumor and concurrent platinum-based chemotherapy. Patients with large tumors were offered induction chemotherapy. Radiation therapy planning was done using either 3 (n=34) or 6 (n=10) concentrically grown planning target volumes (PTV). Patients received 64 Gy in 32 fractions to the whole bladder and 55 Gy to the pelvic nodes and, if appropriate, a simultaneous integrated boost to the tumor bed to 68 Gy (equivalent dose for 2-Gy fractions assuming α/β of 10 [EQD2] 10  = 68.7 Gy). Daily megavoltage (MV) imaging helped to choose the most appropriate PTV encompassing bladder for the particular day (using plan-of-the-day approach). Results: Most patients (88%) had T2 disease. Sixteen patients (36%) received neoadjuvant chemotherapy. A majority of the patients (73%) received prophylactic nodal irradiation, whereas 55% of the patients received escalated dose to the tumor bed. With a median follow-up of 30 months, the 3-year locoregional control (LRC), disease-free survival, and overall survival (OS) were 78%, 66%, and 67%, respectively. The bladder preservation rate was 83%. LRC (87% vs 68%, respectively, P=.748) and OS (74% vs 60%, respectively, P=.36) rates were better in patients receiving dose escalation. Instances of acute and late Radiation Therapy Oncology Group (RTOG) grade 3 genitourinary toxicity was seen in 5 (11%) and 2 (4%) patients, respectively. There was no acute or late RTOG grade 3 or higher gastrointestinal toxicity. Conclusions: Adaptive IGRT using plan-of-the-day approach for bladder preservation

  17. Clinical and entomological factors influence the outcome of sting challenge studies.

    Science.gov (United States)

    Golden, David B K; Breisch, Nancy L; Hamilton, Robert G; Guralnick, Miles W; Greene, Albert; Craig, Timothy J; Kagey-Sobotka, Anne

    2006-03-01

    The reported frequency of systemic reactions to challenge sting varies greatly. To evaluate the interaction of clinical and entomological factors that determine the outcome of a challenge sting. Patients allergic to yellow jacket were stung and monitored for systemic reaction. The frequency and severity of sting reactions were analyzed in relation to the species of insect used and patient characteristics. Objective systemic reactions occurred in 21 of 69 patients (30%) stung with Vespula maculifrons and in 8 of 71 patients (11%) with Vespula germanica (P=.005). Systemic reactions were more frequent in patients with a severe history (9/30; 30%) than in those with a mild or moderate history (21/145; 14%; P=.04). In only 1 of 111 patients (0.9%) was the reaction to sting challenge more severe than previous reactions. The reaction rate was higher when venom skin tests were positive at <1.0 microg/mL (17/75=23%) than when sensitivity was milder (9/100=9%; P=.012). We compared sting outcome and venom-induced histamine release in relation to insects collected in July or in October, and found no difference. Allergic reactions to sting challenge are determined by the species of yellow jacket used, the severity of previous sting reactions, and the degree of skin test sensitivity, but not by the time of year. These factors are important to clinicians when they evaluate the chance of reaction to a future sting and to researchers when they design and report sting challenge studies.

  18. A study of the clinical profile and outcome of spina bifida

    Directory of Open Access Journals (Sweden)

    Theophilus Nikita Kumar

    2016-02-01

    Full Text Available Neural tube defects (NTDs are a group of congenital anomalies characterized by defects in dorsal midline structures, including neural tissue, dura, muscle, bone and/or skin. The clinical presentations and the follow-up of these patients requires attention to various end organs besides the nervous system. To evaluate the clinical profile and surgical outcome of children with spina bifida. Out of a total of 74 patients treated at our institute for spina bifida between June 2013 to august 2015, 74 cases of spina bifida were analyzed retrospectively and prospectively. The clinical profile, radiological findings and urodynamic studies were recorded. Craniospinal MRI was done in patients to screen for Arnold Chiari malformations and monitoring of hydrocephalus was done as a management protocol at our institute for these children. All these patients except two underwent surgery for correction and closure of the spinal defect. Associated anomalies were treated accordingly. They were clinically assessed over a mean follow up period of 1.3years, ranging from 2months to 2½ years. 73% of the patients presented in the neonatal age group. Of which, 72% presented with a visible sac over the back.72% of the cases were Myelomeningocoeles. 79% of the defects were in the lumbosacral region.30% presented with sensorimotor loss or bladder bowel incontinence. Sensorimotor improvement was seen in 12.5% after repairing the defect with the help of physiotherapy and braces. 30% of the patients were diagnosed to have hydrocephalus, of which 33% required a CSF diversion procedure. The postoperative course of spina bifida repair was found to be uneventful in 90% of the patients

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

    Science.gov (United States)

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

    2016-02-01

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

  20. A PROSPECTIVE STUDY OF CLINICAL OUTCOME AFTER USING LIGAMENTOTAXIS IN MANAGEMENT OF DISTAL RADIUS FRACTURES

    Directory of Open Access Journals (Sweden)

    Chandrashekhar V. Mudgal

    2017-04-01

    Full Text Available BACKGROUND A study was done to evaluate the effect of the ligamentotaxis in the management of intraarticular fractures of the distal radius. MATERIALS AND METHODS 34 patients were studied prospectively between March 2014 and February 2016. All patients had intraarticular fracture of distal end of radius and all were treated with ligamentotaxis after closed reduction with fluoroscopic guidance. The follow-up period was 12 months. At the time of surgery, the mean age was 45.29 years. RESULTS In all fracture cases, the mean of fracture union was 5.8 weeks. During the final follow-up, the mean range of motion was 55.30 in flexion, 56.60 in extension, 21.0 in ulnar deviation, 9.00 in radial deviation, 70.30 in pronation and 67.10 in supination. According to the scoring system of Gartland and Werley, the clinical and functional outcomes showed that 15 patients (44.1% had excellent results, 14 (41.1% had good results, 3 (8.8% had fair results and 2 (5.8% had poor results. CONCLUSION Closed reduction under fluoroscopic image guidance and the ligamentotaxis is useful and effective in the treatment of intraarticular fractures of the distal radius.

  1. Six-year clinical outcome of single implant-retained mandibular overdentures--a pilot study.

    Science.gov (United States)

    Passia, Nicole; Wolfart, Stefan; Kern, Matthias

    2015-10-01

    The aim of this prospective pilot study was to evaluate the prosthodontic maintenance as well as the implant outcome of single implant-retained mandibular overdentures over an observation period of 6 years. Eleven edentulous patients received one single implant in the midline of the mandible. Denture bases were temporarily relined and 2 months later provided with a ball attachment for implant retention. Implant related parameters and prosthodontic maintenance interventions were assessed 4 weeks after implant loading and then once a year. Over a mean observation period of 75.9 months, no implant was lost. The most frequent prosthetic maintenance intervention was activation of the matrix due to loss of retention, followed by exchange of the female part. Eight denture bases had to be repaired after a fracture in the midline area. Within the limitations of this preliminary clinical study, the concept of a single midline implant to retain a mandibular complete denture was a successful treatment option for elderly edentulous patients. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. Training Load, Immune Status, and Clinical Outcomes in Young Athletes: A Controlled, Prospective, Longitudinal Study

    Science.gov (United States)

    Blume, Katharina; Körber, Nina; Hoffmann, Dieter; Wolfarth, Bernd

    2018-01-01

    Introduction: Beside positive effects on athlete's health, competitive sport can be linked with an increased risk of illness and injury. Because of high relative increases in training, additional physical and psychological strains, and an earlier specialization and professionalization, adolescent athletes needs an increased attention. Training can alter the immune system by inducing a temporary immunosuppression, finally developing infection symptoms. Previous studies identified Epstein Barr Virus (EBV) as potential indicator for the immune status. In addition to the identification of triggering risk factors for recurrent infections, the aim was to determine the interaction between training load, stress sense, immunological parameters, and clinical symptoms. Methods: A controlled, prospective, longitudinal study on young athletes (n = 274, mean age: 13.8 ± 1.5 yrs) was conducted between 2010 and 2014. Also 285 controls (students, who did not perform competitive sports, mean age: 14.5 ± 1.9 yrs) were recruited. Athletes were examined 3 times each year to determine the effects of stress factors (training load: training hours per week [Th/w]) on selected outcome parameters (clinical [susceptibility to infection, WURSS-21: 21-item Wisconsin Upper Respiratory Symptom Survey], immunological, psychological end points). As part of each visit, EBV serostatus and EBV-specific IgG tiers were studied longitudinally as potential immune markers. Results: Athletes (A) trained 14.9 ± 5.6 h weekly. Controls (C) showed no lower stress levels compared to athletes (p = 0.387). Twelve percent of athletes reported recurrent infections (C: 8.5%, p = 0.153), the presence of an upper respiratory tract infection (URTI) was achieved in 30.7%. EBV seroprevalence of athletes was 60.3% (C: 56.6%, p = 0.339). Mean EBV-specific IgG titer of athletes was 166 ± 115 U/ml (C: 137 ± 112 U/ml, p = 0.030). With increasing Th/w, higher stress levels were observed (p athletes showed no increased

  3. Bariatric Surgery in the United Kingdom: A Cohort Study of Weight Loss and Clinical Outcomes in Routine Clinical Care

    Science.gov (United States)

    Douglas, Ian J.; Bhaskaran, Krishnan; Batterham, Rachel L.; Smeeth, Liam

    2015-01-01

    Background Bariatric surgery is becoming a more widespread treatment for obesity. Comprehensive evidence of the long-term effects of contemporary surgery on a broad range of clinical outcomes in large populations treated in routine clinical practice is lacking. The objective of this study was to measure the association between bariatric surgery, weight, body mass index, and obesity-related co-morbidities. Methods and Findings This was an observational retrospective cohort study using data from the United Kingdom Clinical Practice Research Datalink. All 3,882 patients registered in the database and with bariatric surgery on or before 31 December 2014 were included and matched by propensity score to 3,882 obese patients without surgery. The main outcome measures were change in weight and body mass index over 4 y; incident diagnoses of type 2 diabetes mellitus (T2DM), hypertension, angina, myocardial infarction (MI), stroke, fractures, obstructive sleep apnoea, and cancer; mortality; and resolution of hypertension and T2DM. Weight measures were available for 3,847 patients between 1 and 4 mo, 2,884 patients between 5 and 12 mo, and 2,258 patients between 13 and 48 mo post-procedure. Bariatric surgery patients exhibited rapid weight loss for the first four postoperative months, at a rate of 4.98 kg/mo (95% CI 4.88–5.08). Slower weight loss was sustained to the end of 4 y. Gastric bypass (6.56 kg/mo) and sleeve gastrectomy (6.29 kg/mo) were associated with greater initial weight reduction than gastric banding (2.77 kg/mo). Protective hazard ratios (HRs) were detected for bariatric surgery for incident T2DM, 0.68 (95% CI 0.55–0.83); hypertension, 0.35 (95% CI 0.27–0.45); angina, 0.59 (95% CI 0.40–0.87);MI, 0.28 (95% CI 0.10–0.74); and obstructive sleep apnoea, 0.55 (95% CI 0.40–0.87). Strong associations were found between bariatric surgery and the resolution of T2DM, with a HR of 9.29 (95% CI 6.84–12.62), and between bariatric surgery and the resolution of

  4. Clinical outcomes of ABO- and HLA-incompatible kidney transplantation: a nationwide cohort study.

    Science.gov (United States)

    Ko, Eun Jeong; Yu, Ji Hyun; Yang, Chul Woo; Chung, Byung Ha

    2017-12-01

    This was a nationwide cohort study to investigate the impact of anti-A/B and donor-specific anti-HLA (HLA-DSA) antibodies on the clinical outcomes in kidney transplant recipients (KTRs). We classified a total of 1964 KTRs into four groups: transplants from ABO-incompatible donors (ABOi, n = 248); transplants in recipients with HLA-DSA (HLAi, n = 144); transplants from combined ABOi and HLAi donors (ABOi + HLAi, n = 31); and a control group for whom neither ABOi nor HLAi was applicable (CONT, n = 1541). We compared the incidence of biopsy-proven acute rejection (BPAR), allograft and patient survival rates. The incidence of BPAR was higher in the HLAi and ABOi + HLAi groups relative to the CONT group; in contrast, it was not higher in the ABOi group. Death-censored graft survival rates did not differ across the four groups. However, relative to the CONT group, patient survival rate was reduced in the ABOi and ABOi + HLAi groups, and with infection being the most common cause of death. Further, multivariable analysis revealed that desensitization therapy because of ABOi or HLAi was independent risk factors for patient mortality. HLAi was a more important risk factor for BPAR compared with ABOi. However, pretransplant desensitization therapy for either ABOi or HLAi significantly increased the risk of infection-related mortality. © 2017 Steunstichting ESOT.

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

    International Nuclear Information System (INIS)

    Costalat, V.; Lobotesis, K.; Machi, P.; Mourand, I.; Maldonado, I.; Heroum, C.; Vendrell, J.F.; Milhaud, D.; Riquelme, C.; Bonafé, A.; Arquizan, C.

    2012-01-01

    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

  6. 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

  7. The Clinical Research Office of the Endourological Society Ureteroscopy Global Study: Indications, Complications, and Outcomes in 11885 Patients

    DEFF Research Database (Denmark)

    De La Rosette, Jean; Denstedt, John D; Geavlete, Petrisor A

    2013-01-01

    Purpose: To assess the current indications for ureteroscopy (URS) treatment, outcome in terms of stone-free rate, and intra- and postoperative complications using the modified Clavien grading system. Patients and Methods: The Clinical Research Office of the Endourological Society (CROES) collected...... prospective data as part of the URS Global Study for consecutive patients treated with URS at centers around the world for 1 year. URS was performed according to study protocol and local clinical practice guidelines. Stone size and location were recorded and postoperative outcome and complications, graded...

  8. Shunting outcomes in posthemorrhagic hydrocephalus: results of a Hydrocephalus Clinical Research Network prospective cohort study.

    Science.gov (United States)

    Wellons, John C; Shannon, Chevis N; Holubkov, Richard; Riva-Cambrin, Jay; Kulkarni, Abhaya V; Limbrick, David D; Whitehead, William; Browd, Samuel; Rozzelle, Curtis; Simon, Tamara D; Tamber, Mandeep S; Oakes, W Jerry; Drake, James; Luerssen, Thomas G; Kestle, John

    2017-07-01

    OBJECTIVE Previous Hydrocephalus Clinical Research Network (HCRN) retrospective studies have shown a 15% difference in rates of conversion to permanent shunts with the use of ventriculosubgaleal shunts (VSGSs) versus ventricular reservoirs (VRs) as temporization procedures in the treatment of hydrocephalus due to high-grade intraventricular hemorrhage (IVH) of prematurity. Further research in the same study line revealed a strong influence of center-specific decision-making on shunt outcomes. The primary goal of this prospective study was to standardize decision-making across centers to determine true procedural superiority, if any, of VSGS versus VR as a temporization procedure in high-grade IVH of prematurity. METHODS The HCRN conducted a prospective cohort study across 6 centers with an approximate 1.5- to 3-year accrual period (depending on center) followed by 6 months of follow-up. Infants with premature birth, who weighed less than 1500 g, had Grade 3 or 4 IVH of prematurity, and had more than 72 hours of life expectancy were included in the study. Based on a priori consensus, decisions were standardized regarding the timing of initial surgical treatment, upfront shunt versus temporization procedure (VR or VSGS), and when to convert a VR or VSGS to a permanent shunt. Physical examination assessment and surgical technique were also standardized. The primary outcome was the proportion of infants who underwent conversion to a permanent shunt. The major secondary outcomes of interest included infection and other complication rates. RESULTS One hundred forty-five premature infants were enrolled and met criteria for analysis. Using the standardized decision rubrics, 28 infants never reached the threshold for treatment, 11 initially received permanent shunts, 4 were initially treated with endoscopic third ventriculostomy (ETV), and 102 underwent a temporization procedure (36 with VSGSs and 66 with VRs). The 2 temporization cohorts were similar in terms of sex, race

  9. Clinical outcome after standardized versus dosimetric radioiodine treatment of hyperthyroidism: an equivalence study

    NARCIS (Netherlands)

    Kok, S. W.; Smit, J. W.; de Craen, A. J.; Goslings, B. M.; van Eck-Smit, B. L.; Romijn, J. A.

    2000-01-01

    The aim of this study was to investigate the equivalence in outcome of standardized versus uptake-adjusted dosing of radioactive iodine (131I) for hyperthyroidism. We performed a 1-year follow-up study of two patient cohorts: 326 patients referred for 131I treatment of hyperthyroidism in Graves'

  10. 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

  11. Training Load, Immune Status, and Clinical Outcomes in Young Athletes: A Controlled, Prospective, Longitudinal Study

    Directory of Open Access Journals (Sweden)

    Katharina Blume

    2018-03-01

    Full Text Available Introduction: Beside positive effects on athlete's health, competitive sport can be linked with an increased risk of illness and injury. Because of high relative increases in training, additional physical and psychological strains, and an earlier specialization and professionalization, adolescent athletes needs an increased attention. Training can alter the immune system by inducing a temporary immunosuppression, finally developing infection symptoms. Previous studies identified Epstein Barr Virus (EBV as potential indicator for the immune status. In addition to the identification of triggering risk factors for recurrent infections, the aim was to determine the interaction between training load, stress sense, immunological parameters, and clinical symptoms.Methods: A controlled, prospective, longitudinal study on young athletes (n = 274, mean age: 13.8 ± 1.5 yrs was conducted between 2010 and 2014. Also 285 controls (students, who did not perform competitive sports, mean age: 14.5 ± 1.9 yrs were recruited. Athletes were examined 3 times each year to determine the effects of stress factors (training load: training hours per week [Th/w] on selected outcome parameters (clinical [susceptibility to infection, WURSS-21: 21-item Wisconsin Upper Respiratory Symptom Survey], immunological, psychological end points. As part of each visit, EBV serostatus and EBV-specific IgG tiers were studied longitudinally as potential immune markers.Results: Athletes (A trained 14.9 ± 5.6 h weekly. Controls (C showed no lower stress levels compared to athletes (p = 0.387. Twelve percent of athletes reported recurrent infections (C: 8.5%, p = 0.153, the presence of an upper respiratory tract infection (URTI was achieved in 30.7%. EBV seroprevalence of athletes was 60.3% (C: 56.6%, p = 0.339. Mean EBV-specific IgG titer of athletes was 166 ± 115 U/ml (C: 137 ± 112 U/ml, p = 0.030. With increasing Th/w, higher stress levels were observed (p < 0.001. Analyzes of WURSS

  12. Factors associated with outcomes in ruptured aneurysmal patients: Clinical Study of 80 Patients

    Directory of Open Access Journals (Sweden)

    Alfotih Gobran Taha Ahmed

    2015-03-01

    Full Text Available Background: Due to insufficient data in the literature, the optimal timing for surgical intervention for ruptured intracranial aneurysms is still controversial. Some practitioners advocate early surgery, but others not. It is important to identify other factors that can be used to predict poor prognosis in ruptured intracranial aneurysm patients. Objective: To determine the influence of timing of clipping surgery, and other factors on the outcomes of ruptured intracranial aneurysms in Hunt & Hess I~III grade patients. Method: We have performed a retrospective study involving 80 patients who were surgically treated for ruptured intracranial aneurysm between 2007 and 2012. The patient population consisted of 50(62.5% females and 30(37.5% males, with an age range of 12 to 75 years old, mean age 52.33 ± 10.63 years. We measured association between the Glasgow Outcome Scores and Sex, timing of clipping surgery, aneurysm location and pre-operative patient's neurological condition using famous Hunt and Hess grade system. Results: We did not find any correlation between the outcomes of ruptured intracranial aneurysm patients and timing (early, intermediate, late stage of clipping, sex, aneurysm location. Whereas there is a significant correlation between patients outcomes and pre-operative patient neurological condition (Hunt & Hess grade. Conclusion: Timing of Surgery (early, intermediate, late does not affect outcomes in low Hunt and Hess grade patients I~III. Whereas neurological condition (Hunt & Hess has strong impact on postoperative outcomes. Others factors like sex, Age, Aneurysm location have no effect on outcomes in ruptured intracranial aneurysms.

  13. A STUDY OF CLINICAL AND SURGICAL OUTCOME OF FRACTURE NECK OF FEMUR

    Directory of Open Access Journals (Sweden)

    Anish G. Cherian

    2016-09-01

    Full Text Available BACKGROUND Fracture neck of femur has high incidence of complications even with treatment, hence it is also termed as unsolved fracture. Factors making treatment difficult are the blood supply to head, which gets cut off and difficulty in achieving reduction. Impacted fractures can be treated conservatively. If the fracture is undisplaced, a conservative approach may be done or multiple cancellous screws can be used. If the patient’s age is less than 60 years, a closed reduction under C-arm control can be tried. If the reduction is possible, then multiple screw fixations can be done. If reduction is not achieved, then open screw reduction and screw fixation can be done. If the patient is above 60 years of age, then it is preferable to excise the head off and replace it with prosthesis. If the hip is normal, then hemiarthroplasty with a unipolar or bipolar prosthesis can be done. If the hip has pre-existing arthritis, then total hip replacement surgery is advisable. A sincere effort has been put to understand the clinical and surgical outcome of fracture neck of femur in elderly. This paper is intended to help the practicing orthopaedicians to understand the various treatment modalities which is commonly used in practice and also the complications which are associated with the pathology. METHODS  The study was done in the Department of Orthopaedics, Travancore Medical College at Kollam.  The study was done from August 2014 to June 2016.  Eighty cases who attended in the Department of Orthopaedics were taken for the study.  Detailed History and Clinical Examination was conducted. INCLUSION CRITERIA  Both traumatic and pathological fractures were taken up for the study.  Individuals who were aged more than 55 years were taken up for the study. EXCLUSION CRITERIA  Aged less than 55 years were not considered.  All the statistical analysis was done using the latest SPSS software 2015 (California. RESULT Fracture neck of femur

  14. The Influence of Preoperative and Postoperative Psychological Symptoms on Clinical Outcome after Shoulder Surgery : A Prospective Longitudinal Cohort Study

    NARCIS (Netherlands)

    Koorevaar, Rinco C T; van 't Riet, Esther; Gerritsen, Marleen J J; Madden, Kim; Bulstra, Sjoerd K.

    2016-01-01

    BACKGROUND: Psychological symptoms are highly prevalent in patients with shoulder complaints. Psychological symptoms in patients with shoulder complaints might play a role in the aetiology, perceived disability and pain and clinical outcome of treatment. The aim of this study was to assess whether

  15. The Influence of Preoperative and Postoperative Psychological Symptoms on Clinical Outcome after Shoulder Surgery: A Prospective Longitudinal Cohort Study

    NARCIS (Netherlands)

    Koorevaar, R.C.; Riet, E. van 't; Gerritsen, M.J.P.; Madden, K.; Bulstra, S.K.

    2016-01-01

    BACKGROUND: Psychological symptoms are highly prevalent in patients with shoulder complaints. Psychological symptoms in patients with shoulder complaints might play a role in the aetiology, perceived disability and pain and clinical outcome of treatment. The aim of this study was to assess whether

  16. Does sensory stimulation threshold affect lumbar facet radiofrequency denervation outcomes? A prospective clinical correlational study.

    Science.gov (United States)

    Cohen, Steven P; Strassels, Scott A; Kurihara, Connie; Lesnick, Ivan K; Hanling, Steven R; Griffith, Scott R; Buckenmaier, Chester C; Nguyen, Conner

    2011-11-01

    Radiofrequency facet denervation is one of the most frequently performed procedures for chronic low back pain. Although sensory stimulation is generally used as a surrogate measure to denote sufficient proximity of the electrode to the nerve, no study has examined whether stimulation threshold influences outcome. We prospectively recorded data in 61 consecutive patients undergoing lumbar facet radiofrequency denervation who experienced significant pain relief after medial branch blocks. For each nerve lesioned, multiple attempts were made to maximize sensory stimulation threshold (SST). Mean SST was calculated on the basis of the lowest stimulation perceived at 0.1-V increments for each medial branch. A positive outcome was defined as a ≥50% reduction in back pain coupled with a positive satisfaction score lasting ≥3 months. The relationship between mean SST and denervation outcomes was evaluated via a receiver's operating characteristic (ROC) curve, and stratifying outcomes on the basis of various cutoff values. No correlation was noted between mean SST and pain relief at rest (Pearson's r=-0.01, 95% confidence interval [CI]: -0.24 to 0.23, P=0.97), with activity (r=-0.17, 95% CI: -0.40 to 0.07, P=0.20), or a successful outcome. No optimal SST could be identified. There is no significant relationship between mean SST during lumbar facet radiofrequency denervation and treatment outcome, which may be due to differences in general sensory perception. Because stimulation threshold was optimized for each patient, these data cannot be interpreted to suggest that sensory testing should not be performed, or that high sensory stimulation thresholds obtained on the first attempt should be deemed acceptable.

  17. Clinical manifestations of nocardiosis: Study of risk factors and outcomes in a tertiary care hospital

    Directory of Open Access Journals (Sweden)

    Teena Wadhwa

    2017-01-01

    Conclusions: The study indicates that Nocardial infections are re-emerging on account of an increase in numbers of immunocompromised patients due to increased organ transplants, autoimmune diseases, malignancies, and use of immunosuppressive drugs and steroids. The diagnosis is often missed/not suspected and delayed because of the clinical resemblance to many other infections. Nocardial infection should be suspected and assessed particularly in immunocompromised patients not responding to treatment/improving clinically.

  18. Integrating patient reported outcomes with clinical cancer registry data: a feasibility study of the electronic Patient-Reported Outcomes From Cancer Survivors (ePOCS) system.

    Science.gov (United States)

    Ashley, Laura; Jones, Helen; Thomas, James; Newsham, Alex; Downing, Amy; Morris, Eva; Brown, Julia; Velikova, Galina; Forman, David; Wright, Penny

    2013-10-25

    Routine measurement of Patient Reported Outcomes (PROs) linked with clinical data across the patient pathway is increasingly important for informing future care planning. The innovative electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system was developed to integrate PROs, collected online at specified post-diagnostic time-points, with clinical and treatment data in cancer registries. This study tested the technical and clinical feasibility of ePOCS by running the system with a sample of potentially curable breast, colorectal, and prostate cancer patients in their first 15 months post diagnosis. Patients completed questionnaires comprising multiple Patient Reported Outcome Measures (PROMs) via ePOCS within 6 months (T1), and at 9 (T2) and 15 (T3) months, post diagnosis. Feasibility outcomes included system informatics performance, patient recruitment, retention, representativeness and questionnaire completion (response rate), patient feedback, and administration burden involved in running the system. ePOCS ran efficiently with few technical problems. Patient participation was 55.21% (636/1152) overall, although varied by approach mode, and was considerably higher among patients approached face-to-face (61.4%, 490/798) than by telephone (48.8%, 21/43) or letter (41.0%, 125/305). Older and less affluent patients were less likely to join (both Pplanning and for targeting service provision.

  19. Volume overload and adverse outcomes in chronic kidney disease: clinical observational and animal studies.

    Science.gov (United States)

    Hung, Szu-Chun; Lai, Yi-Shin; Kuo, Ko-Lin; Tarng, Der-Cherng

    2015-05-05

    Volume overload is frequently encountered and is associated with cardiovascular risk factors in patients with chronic kidney disease (CKD). However, the relationship between volume overload and adverse outcomes in CKD is not fully understood. A prospective cohort of 338 patients with stage 3 to 5 CKD was followed for a median of 2.1 years. The study participants were stratified by the presence or absence of volume overload, defined as an overhydration index assessed by bioimpedance spectroscopy exceeding 7%, the 90th percentile for the healthy population. The primary outcome was the composite of estimated glomerular filtration rate decline ≥50% or end-stage renal disease. The secondary outcome included a composite of morbidity and mortality from cardiovascular causes. Animal models were used to simulate fluid retention observed in human CKD. We found that patients with volume overload were at a higher risk of the primary and secondary end points in the adjusted Cox models. Furthermore, overhydration appears to be more important than hypertension in predicting an elevated risk. In rats subjected to unilateral nephrectomy and a high-salt diet, the extracellular water significantly increased. This fluid retention was associated with an increase in blood pressure, proteinuria, renal inflammation with macrophage infiltration and tumor necrosis factor-α overexpression, glomerular sclerosis, and cardiac fibrosis. Diuretic treatment with indapamide attenuated these changes, suggesting that fluid retention might play a role in the development of adverse outcomes. Volume overload contributes to CKD progression and cardiovascular diseases. Further research is warranted to clarify whether the correction of volume overload would improve outcomes for CKD patients. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  20. 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.

  1. Prospective clinical study of prosthetic treatment outcome of implantretained-removable-partial-denture during 5 year-follow-ups

    OpenAIRE

    Mehran Bahrami; Mohammed Hussein Mahmood Alsharbaty

    2017-01-01

    Background IRRPD offers patients the ability to upgrade their treatment planning to implant-supported-overdentures (ISOs) or implant-supported-fixed-prostheses (ISFPs) through insertion of more implants in the future after the loss of the remaining natural teeth. Aims The purpose of this prospective-clinical-study was to evaluate the success rate and treatment outcome of IRRPD for 15 patients, during at least 5-year-follow-ups after prosthetic rehabilitation with respect to implant ...

  2. Characterization of neurophysiologic and neurocognitive biomarkers for use in genomic and clinical outcome studies of schizophrenia.

    Directory of Open Access Journals (Sweden)

    Gregory A Light

    Full Text Available Endophenotypes are quantitative, laboratory-based measures representing intermediate links in the pathways between genetic variation and the clinical expression of a disorder. Ideal endophenotypes exhibit deficits in patients, are stable over time and across shifts in psychopathology, and are suitable for repeat testing. Unfortunately, many leading candidate endophenotypes in schizophrenia have not been fully characterized simultaneously in large cohorts of patients and controls across these properties. The objectives of this study were to characterize the extent to which widely-used neurophysiological and neurocognitive endophenotypes are: 1 associated with schizophrenia, 2 stable over time, independent of state-related changes, and 3 free of potential practice/maturation or differential attrition effects in schizophrenia patients (SZ and nonpsychiatric comparison subjects (NCS. Stability of clinical and functional measures was also assessed.Participants (SZ n = 341; NCS n = 205 completed a battery of neurophysiological (MMN, P3a, P50 and N100 indices, PPI, startle habituation, antisaccade, neurocognitive (WRAT-3 Reading, LNS-forward, LNS-reorder, WCST-64, CVLT-II. In addition, patients were rated on clinical symptom severity as well as functional capacity and status measures (GAF, UPSA, SOF. 223 subjects (SZ n = 163; NCS n = 58 returned for retesting after 1 year.Most neurophysiological and neurocognitive measures exhibited medium-to-large deficits in schizophrenia, moderate-to-substantial stability across the retest interval, and were independent of fluctuations in clinical status. Clinical symptoms and functional measures also exhibited substantial stability. A Longitudinal Endophenotype Ranking System (LERS was created to rank neurophysiological and neurocognitive biomarkers according to their effect sizes across endophenotype criteria.The majority of neurophysiological and neurocognitive measures exhibited deficits in

  3. Characterization of neurophysiologic and neurocognitive biomarkers for use in genomic and clinical outcome studies of schizophrenia.

    Science.gov (United States)

    Light, Gregory A; Swerdlow, Neal R; Rissling, Anthony J; Radant, Allen; Sugar, Catherine A; Sprock, Joyce; Pela, Marlena; Geyer, Mark A; Braff, David L

    2012-01-01

    Endophenotypes are quantitative, laboratory-based measures representing intermediate links in the pathways between genetic variation and the clinical expression of a disorder. Ideal endophenotypes exhibit deficits in patients, are stable over time and across shifts in psychopathology, and are suitable for repeat testing. Unfortunately, many leading candidate endophenotypes in schizophrenia have not been fully characterized simultaneously in large cohorts of patients and controls across these properties. The objectives of this study were to characterize the extent to which widely-used neurophysiological and neurocognitive endophenotypes are: 1) associated with schizophrenia, 2) stable over time, independent of state-related changes, and 3) free of potential practice/maturation or differential attrition effects in schizophrenia patients (SZ) and nonpsychiatric comparison subjects (NCS). Stability of clinical and functional measures was also assessed. Participants (SZ n = 341; NCS n = 205) completed a battery of neurophysiological (MMN, P3a, P50 and N100 indices, PPI, startle habituation, antisaccade), neurocognitive (WRAT-3 Reading, LNS-forward, LNS-reorder, WCST-64, CVLT-II). In addition, patients were rated on clinical symptom severity as well as functional capacity and status measures (GAF, UPSA, SOF). 223 subjects (SZ n = 163; NCS n = 58) returned for retesting after 1 year. Most neurophysiological and neurocognitive measures exhibited medium-to-large deficits in schizophrenia, moderate-to-substantial stability across the retest interval, and were independent of fluctuations in clinical status. Clinical symptoms and functional measures also exhibited substantial stability. A Longitudinal Endophenotype Ranking System (LERS) was created to rank neurophysiological and neurocognitive biomarkers according to their effect sizes across endophenotype criteria. The majority of neurophysiological and neurocognitive measures exhibited deficits in patients

  4. Longterm clinical outcomes of omalizumab therapy in severe allergic asthma: Study of efficacy and safety.

    Science.gov (United States)

    Mansur, Adel H; Srivastava, Sapna; Mitchell, Verity; Sullivan, Julie; Kasujee, Ismail

    2017-03-01

    Omalizumab has been shown to be an effective add-on therapy for patients with uncontrolled severe persistent allergic asthma. There has been a steady accumulation of evidence on the long-term effectiveness of omalizumab; however, data on real-life outcomes beyond one year of treatment is limited. In this study, we report on long-term outcomes of omalizumab treatment. We collected data from our severe asthma registry on hospitalisations, exacerbations, corticosteroid sparing, asthma control, lung function, biomarkers and side effects, to determine if the benefit was sustained and treatment was safe on the long term. Forty-five patients [mean age 44.9 years (range 19-69), females 37/45 (82%), mean duration of omalizumab treatment = 60.7 ± 30.9 months (range 23-121) were included in the analysis. We observed a reduction in the annual acute asthma related hospital admissions for the total population from 207 at baseline to 40 on treatment (80.7% reduction), whilst the per patient annual hospitalisations were reduced from a mean of 4.8 to 0.89 post-omalizumab treatment (p omalizumab therapy. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. Cognitive Impairment after Severe Traumatic Brain Injury, Clinical Course and Impact on Outcome: A Swedish-Icelandic Study

    Science.gov (United States)

    Stenberg, Maud; Godbolt, Alison K.; Nygren De Boussard, Catharina; Levi, Richard; Stålnacke, Britt-Marie

    2015-01-01

    Objective. To assess the clinical course of cognitive and emotional impairments in patients with severe TBI (sTBI) from 3 weeks to 1 year after trauma and to study associations with outcomes at 1 year. Methods. Prospective, multicenter, observational study of sTBI in Sweden and Iceland. Patients aged 18–65 years with acute Glasgow Coma Scale 3–8 were assessed with the Barrow Neurological Institute Screen for Higher Cerebral Functions (BNIS) and the Hospital Anxiety and Depression Scale (HADS). Outcome measures were Glasgow Outcome Scale Extended (GOSE) and Rancho Los Amigos Cognitive Scale-Revised (RLAS-R). Results. Cognition was assessed with the BNIS assessed for 42 patients out of 100 at 3 weeks, 75 patients at 3 months, and 78 patients at 1 year. Cognition improved over time, especially from 3 weeks to 3 months. The BNIS subscales “orientation” and “visuospatial and visual problem solving” were associated with the GOSE and RLAS-R at 1 year. Conclusion. Cognition seemed to improve over time after sTBI and appeared to be rather stable from 3 months to 1 year. Since cognitive function was associated with outcomes, these results indicate that early screening of cognitive function could be of importance for rehabilitation planning in a clinical setting. PMID:26783381

  6. Cognitive Impairment after Severe Traumatic Brain Injury, Clinical Course and Impact on Outcome: A Swedish-Icelandic Study

    Directory of Open Access Journals (Sweden)

    Maud Stenberg

    2015-01-01

    Full Text Available Objective. To assess the clinical course of cognitive and emotional impairments in patients with severe TBI (sTBI from 3 weeks to 1 year after trauma and to study associations with outcomes at 1 year. Methods. Prospective, multicenter, observational study of sTBI in Sweden and Iceland. Patients aged 18–65 years with acute Glasgow Coma Scale 3–8 were assessed with the Barrow Neurological Institute Screen for Higher Cerebral Functions (BNIS and the Hospital Anxiety and Depression Scale (HADS. Outcome measures were Glasgow Outcome Scale Extended (GOSE and Rancho Los Amigos Cognitive Scale-Revised (RLAS-R. Results. Cognition was assessed with the BNIS assessed for 42 patients out of 100 at 3 weeks, 75 patients at 3 months, and 78 patients at 1 year. Cognition improved over time, especially from 3 weeks to 3 months. The BNIS subscales “orientation” and “visuospatial and visual problem solving” were associated with the GOSE and RLAS-R at 1 year. Conclusion. Cognition seemed to improve over time after sTBI and appeared to be rather stable from 3 months to 1 year. Since cognitive function was associated with outcomes, these results indicate that early screening of cognitive function could be of importance for rehabilitation planning in a clinical setting.

  7. Clinical outcomes research in gynecologic oncology.

    Science.gov (United States)

    Melamed, Alexander; Rauh-Hain, J Alejandro; Schorge, John O

    2017-09-01

    Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology. Copyright © 2017. Published by Elsevier Inc.

  8. Educational Level, Anticoagulation Quality, and Clinical Outcomes in Elderly Patients with Acute Venous Thromboembolism: A Prospective Cohort Study.

    Science.gov (United States)

    Hofmann, Eveline; Faller, Nicolas; Limacher, Andreas; Méan, Marie; Tritschler, Tobias; Rodondi, Nicolas; Aujesky, Drahomir

    2016-01-01

    Whether the level of education is associated with anticoagulation quality and clinical outcomes in patients with acute venous thromboembolism (VTE) is uncertain. We thus aimed to investigate the association between educational level and anticoagulation quality and clinical outcomes in elderly patients with acute VTE. We studied 817 patients aged ≥65 years with acute VTE from a Swiss prospective multicenter cohort study (09/2009-12/2013). We defined three educational levels: 1) less than high school, 2) high school, and 3) post-secondary degree. The primary outcome was the anticoagulation quality, expressed as the percentage of time spent in the therapeutic INR range (TTR). Secondary outcomes were the time to a first recurrent VTE and major bleeding. We adjusted for potential confounders and periods of anticoagulation. Overall, 56% of patients had less than high school, 25% a high school degree, and 18% a post-secondary degree. The mean percentage of TTR was similar across educational levels (less than high school, 61%; high school, 64%; and post-secondary, 63%; P = 0.36). Within three years of follow-up, patients with less than high school, high school, and a post-secondary degree had a cumulative incidence of recurrent VTE of 14.2%, 12.9%, and 16.4%, and a cumulative incidence of major bleeding of 13.3%, 15.1%, and 15.4%, respectively. After adjustment, educational level was neither associated with anticoagulation quality nor with recurrent VTE or major bleeding. In elderly patients with VTE, we did not find an association between educational level and anticoagulation quality or clinical outcomes.

  9. Clinical Outcomes Following the Ross Procedure in Adults: A 25-Year Longitudinal Study.

    Science.gov (United States)

    Martin, Elisabeth; Mohammadi, Siamak; Jacques, Frederic; Kalavrouziotis, Dimitri; Voisine, Pierre; Doyle, Daniel; Perron, Jean

    2017-10-10

    Very few reports of long-term outcomes of patients who underwent the Ross procedure have been published. The authors reviewed their 25-year experience with the Ross procedure with the aim of defining very-long-term survival and factors associated with Ross-related failure. Between January 1990 and December 2014, the Ross procedure was performed in 310 adults (mean age 40.8 years) at a single institution. All patients were prospectively added to a dedicated cardiac surgery registry. Complete post-operative clinical examination and history were obtained, and transthoracic echocardiography was performed according to a standardized protocol. There was no loss to follow-up. Median follow-up was 15.1 years and up to 25 years. Bicuspid aortic valve was diagnosed in 227 patients (73.2%), and the most common indication for surgery was aortic stenosis (n = 225 [72.6%]). Freedom from any Ross-related reintervention was 92.9% and 70.1% at 10 and 20 years, respectively. Independent risk factors for pulmonary autograft degeneration were pre-operative large aortic annulus (hazard ratio: 1.1; p = 0.01), pre-operative aortic insufficiency (hazard ratio: 2.7; p = 0.002), and concomitant replacement of the ascending aorta (hazard ratio: 7.7; p = 0.0003). There were 4 hospital deaths (1.3%), and overall survival at 10 and 20 years was 94.1% and 83.6%, respectively. Long-term survival was not significantly different in patients who required Ross-related reintervention (log-rank p = 0.70). However, compared with the general population, survival was significantly lower in patients following the Ross procedure when matched on age and sex (p Ross procedure was associated with excellent long-term valvular outcomes and survival, regardless of the need for reintervention. Adults presenting with aortic insufficiency or a dilated aortic annulus or ascending aorta were at greater risk for reintervention. Unlike previous reports, long-term survival was lower in Ross

  10. STUDY OF CLINICAL OUTCOMES OF SUBFASCIAL PERFORATOR LIGATION SURGERY IN PERFORATOR INCOMPETENCE

    Directory of Open Access Journals (Sweden)

    Vasuki Rajam

    2017-02-01

    Full Text Available BACKGROUND Chronic venous insufficiency presents with a spectrum of clinical features ranging from pain or heaviness of affected limbs to non-healing ulcers over the lower limbs and usually require some form of surgical intervention, performing direct perforator vein division preferably by subfascial endoscopic perforator ligation surgery for perforator incompetence, as despite aggressive conservative therapy including compression, lifestyle modification and venotonic medications which are of high cost treatment with increased risk of increasing symptoms. MATERIALS AND METHODS A prospective longitudinal clinical study of 30 patients selected by systematic sampling method from November 2014 to September 2015 at our institution was conducted to determine the results of subfascial endoscopic perforator vein surgery (SEPS in perforator incompetence. RESULTS For venous clinical severity scoring pre operatively and after 3 weeks post-surgery, the mean for VCSS pre-operatively was 6.66 and a standard deviation of 2.399. The T value was calculated and was found to be 4.9321 and p value of 0.00001(p value less than 0.05 is significant. Similarly for the cases with active ulcer, the size assessment pre-operatively and post-SEPS was again analysed using student t test and the mean ulcer size prior to surgery was found to be 3.3 and standard deviation of 1.984. The T value was calculated and was found to be 1.789009 and a p value of 0.04 (p value less than 0.05 is significant. CONCLUSION Our study concluded that favourable and significant ulcer healing rate with improvement and reduction in clinical severity suggests that SEPS plays an important role in surgical management of advanced stages of venous insufficiency.

  11. Clinical outcomes of first-line antiretroviral therapy in Latin America: analysis from the LATINA retrospective cohort study.

    Science.gov (United States)

    Angriman, Federico; Belloso, Waldo H; Sierra-Madero, Juan; Sánchez, Jorge; Moreira, Ronaldo Ismerio; Kovalevski, Leandro O; Orellana, Liliana C; Cardoso, Sandra Wagner; Crabtree-Ramirez, Brenda; La Rosa, Alberto; Losso, Marcelo H

    2016-02-01

    Nearly 2 million people are infected with human immunodeficiency virus (HIV) in Latin America. However, information regarding population-scale outcomes from a regional perspective is scarce. We aimed to describe the baseline characteristics and therapeutic outcomes of newly-treated individuals with HIV infection in Latin America. A Retrospective cohort study was undertaken. The primary explanatory variable was combination antiretroviral therapy based on either a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI). The main outcome was defined as the composite of all-cause mortality and the occurrence of an AIDS-defining clinical event or a serious non-AIDS-defining event during the first year of therapy. The secondary outcomes included the time to a change in treatment strategy. All analyses were performed according to the intention to treat principle. A total of 937 treatment-naive patients from four participating countries were included (228 patients with PI therapy and 709 with NNRTI-based treatment). At the time of treatment initiation, the patients had a mean age of 37 (SD: 10) years and a median CD4 + T-cell count of 133 cells/mm(3) (interquartile range: 47.5-216.0). Patients receiving PI-based regimens had a significantly lower CD4 + count, a higher AIDS prevalence at baseline and a shorter time from HIV diagnosis until the initiation of treatment. There was no difference in the hazard ratio for the primary outcome between groups. The only covariates associated with the latter were CD4 + cell count at baseline, study site and age. The estimated hazard ratio for the time to a change in treatment (NNRTI vs PI) was 0.61 (95% CI 0.47-0.80, p America present with similar clinical outcomes regardless of the choice of initial therapy. Patients treated with PIs are more likely to require a treatment change during the first year of follow up. © The Author(s) 2015.

  12. Clinical Manifestations and Outcomes of Rickettsia australis Infection: A 15-Year Retrospective Study of Hospitalized Patients

    Directory of Open Access Journals (Sweden)

    Adam Stewart

    2017-06-01

    Full Text Available Queensland tick typhus (QTT; Rickettsia australis is an important cause of community-acquired acute febrile illness in eastern Australia. Cases of QTT were identified retrospectively from 2000 to 2015 at five sites in Northern Brisbane through a pathology database. Those included had a fourfold rise in spotted fever group (SFG-specific serology, a single SFG-specific serology ≥ 256 or SFG-specific serology ≥ 128 with a clinically consistent illness. Cases were excluded on the basis of clinical unlikelihood of QTT infection. Thirty-six cases were included. Fever was found in 34/36 (94% patients. Rash occurred in 83% of patients with maculopapular being the dominant morphology (70%. Thrombocytopenia, lymphopenia, and raised transaminases were common and occurred in 58%, 69%, and 89% of patients, respectively. Thirty-one of 36 (86% patients received antibiotic therapy (usually doxycycline and the time to correct antibiotic (from admission ranged from 3 to 120 h (mean 45.5 h. Four of 36 (11% required intensive care unit (ICU admission for severe sepsis and end-organ support. There were no deaths. QTT has a wide range of clinical and laboratory features. Early and appropriate antimicrobial therapy is important and may prevent severe disease. Further prospective studies are required to identify factors associated with severe infection and sepsis.

  13. Clinical outcome of nonculprit plaque ruptures in patients with acute coronary syndrome in the PROSPECT study.

    Science.gov (United States)

    Xie, Yong; Mintz, Gary S; Yang, Junqing; Doi, Hiroshi; Iñiguez, Andrés; Dangas, George D; Serruys, Patrick W; McPherson, John A; Wennerblom, Bertil; Xu, Ke; Weisz, Giora; Stone, Gregg W; Maehara, Akiko

    2014-04-01

    The aim of this study was to report the frequency, patient and lesion-related characteristics, and outcomes of subclinical, nonculprit plaque ruptures in the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study. Plaque rupture and subsequent thrombosis is the most common cause of acute coronary syndrome (ACS). Secondary, subclinical, nonculprit plaque ruptures have been seen in both stable patients and patients with ACS; however, reports of the natural history of these secondary plaque ruptures are limited. After successful stenting in 697 patients with ACS, 3-vessel grayscale and intravascular ultrasound virtual histology (IVUS-VH) was performed in the proximal-mid segments of all 3 coronary arteries as part of a prospective multicenter study. Among 660 patients with complete IVUS data, 128 plaque ruptures were identified in 105 nonculprit lesions in 100 arteries from 93 patients (14.1%). Although the minimum lumen area (MLA) was similar, the plaque burden was significantly greater in nonculprit lesions with a plaque rupture compared with nonculprit lesions without a plaque rupture (66.0% [95% confidence interval: 64.5% to 67.4%] vs. 56.0% [95% confidence interval: 55.6% to 56.4%]; p PROSPECT]; NCT00180466). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  14. Histological outcome of duodenal biopsies in patients with clinically suspected celiac disease - a study of 100 cases

    International Nuclear Information System (INIS)

    Sarfraz, T.; Khan, S.A.; Tariq, H.

    2018-01-01

    To see the histological outcome of duodenal biopsies done in patients clinically suspected of celiac disease. Study Design: Prospective descriptive study. Place and Duration of Study: Histopathology Department, Army Medical College Rawalpindi, from 1 Jan 2017 to 30 Jun 2017. Material and Methods: One hundred (100) cases were included in the study. Duodenal biopsies done in patients clinically suspected of celiac disease were included in the study. Inadequate biopsies were excluded from the study. All the normal and abnormal histological features were noted to make the diagnosis. Data was entered and analyzed by using SPSS version 17. Results: Duodenal biopsies of 100 patients, done in clinically suspected cases of celiac disease were analyzed histologically. Out of these 100 cases, 46 cases (46%) showed histological features consistent with celiac disease, while 38 cases (38%) revealed chronic non specific duodenitis, 2 cases (2%) were of giardiasis, while 14 biopsies (14%) were unremarkable with no significant pathology. Conclusion: A significant number of cases clinically suspected of celiac disease may not be showing histological features consistent with celiac disease on duodenal biopsies. Due to the changing presentation of disease, as well as the recognition of a number of potential clinical and histopathological mimics, communication between pathologists and gastroenterologists is essential for appropriate interpretation of duodenal biopsy specimens. (author)

  15. Clinical outcome of pneumatic dilatation in patients with achalasia cardia: A single-center prospective study

    Directory of Open Access Journals (Sweden)

    Amit Hanmant Shejal

    2017-01-01

    Full Text Available Background and Aim: Pneumatic balloon dilation is one of the most commonly used and effective methods for treating patients with achalasia cardia. This study was performed to assess immediate and long-term response of pneumatic dilatation (PD in these patients. Materials and Methods: Forty-four achalasia cardia patients, who underwent PD in our center from January 2013 to December 2015, were prospectively studied. Data from these patients were analyzed for clinical improvement in symptoms after dilatation procedure over this period as per Eckardt score. Patients who required repeated procedure and factors influencing remission of symptoms were analyzed. Results: A total of 44 patients underwent PD, among which three lost to follow up. Of the 41 patients, 21 were male (51.22% and 20 were females (48.78%. Mean age was 38.68 (13–64 years. Median symptom duration before first dilatation was 18 months (2–240. Major symptoms at presentation were dysphagia (n = 41, 100%, regurgitation (n = 38 92.68%, chest pain (n = 31, 75.6%, and weight loss (n = 20, 48.78%. Mean follow-up period was 22.22 months (9–38. Forty (97.56% patients had immediate clinical improvement after 1 dilatation, of which 38 (92.68% patients did not require any further treatment. Mean Eckardt score was 6.82 (4–11 at the time of first dilatation which improved to 0.66 during follow-up. Two patients required second dilatation (one 5 months and other 18 months after the first procedure. Conclusion: PD is a safe and effective long-term therapy for achalasia cardia and has a good long-term clinical remission.

  16. Benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study: protocol, tools, and population.

    Science.gov (United States)

    Nicolucci, Antonio; Rossi, Maria C; Pellegrini, Fabio; Lucisano, Giuseppe; Pintaudi, Basilio; Gentile, Sandro; Marra, Giampiero; Skovlund, Soren E; Vespasiani, Giacomo

    2014-01-01

    In the context of the DAWN-2 initiatives, the BENCH-D Study aims to test a model of regional benchmarking to improve not only the quality of diabetes care, but also patient-centred outcomes. As part of the AMD-Annals quality improvement program, 32 diabetes clinics in 4 Italian regions extracted clinical data from electronic databases for measuring process and outcome quality indicators. A random sample of patients with type 2 diabetes filled in a questionnaire including validated instruments to assess patient-centred indicators: SF-12 Health Survey, WHO-5 Well-Being Index, Diabetes Empowerment Scale, Problem Areas in Diabetes, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Barriers to Medications, Patient Support, Diabetes Self-care Activities, and Global Satisfaction for Diabetes Treatment. Data were discussed with participants in regional meetings. Main problems, obstacles and solutions were identified through a standardized process, and a regional mandate was produced to drive the priority actions. Overall, clinical indicators on 78,854 patients have been measured; additionally, 2,390 patients filled-in the questionnaire. The regional mandates were officially launched in March 2012. Clinical and patient-centred indicators will be evaluated again after 18 months. A final assessment of clinical indicators will take place after 30 months. In the context of the BENCH-D study, a set of instruments has been validated to measure patient well-being and satisfaction with the care. In the four regional meetings, different priorities were identified, reflecting different organizational resources of the different areas. In all the regions, a major challenge was represented by the need of skills and instruments to address psychosocial issues of people with diabetes. The BENCH-D study allows a field testing of benchmarking activities focused on clinical and patient-centred indicators.

  17. Symptom profile and short term outcome of catatonia: an exploratory clinical study.

    Science.gov (United States)

    Worku, Benyam; Fekadu, Abebaw

    2015-07-22

    Catatonia is a potentially life-threatening but treatable neuropsychiatric condition. Although considered more common in low income countries, data is particularly sparse in these settings. In this study we explore the symptomatology, treatment, and short-term outcome of catatonia in Ethiopia, a low income country. The study was a prospective evaluation of patients admitted with a DSM-IV diagnosis of catatonia. Diagnosis of Catatonia and its severity were further assessed with the Bush-Francis Catatonia Rating Scale (BFCRS). Twenty participants, 5 male and 15 female, were included in the study: 15 patients (75 %) had underlying mood disorders, 4 patients (20 %) had schizophrenia and 1 patient (5 %) had general medical condition. The most common catatonic symptoms, occurring in over two-thirds of participants, were mutism, negativism, staring and immobility (stupor). Eighteen (90 %) of the twenty patients were on multiple medications. Antipsychotics were the most commonly prescribed medications. ECT was required in seven patients (35.0 %). Dehydration, requiring IV rehydration, and infections were the most important complications ascribed to the catatonia. These occurred in seven patients (25 %). Almost all patients (n = 19/20) were discharged with significant improvement. This study supports the growing consensus that catatonia is most often associated with mood disorders. Overall prognosis appears very good although the occurrence of life-threatening complications underlines the serious nature of catatonia. This has implication for "task-shifted" service scale up plans, which aim to improve treatment coverage by training non-specialist health workers to provide mental health care in low income countries. Further larger scale studies are required to clarify the nature and management, as well as, service requirements for catatonia.

  18. The Influence of Preoperative and Postoperative Psychological Symptoms on Clinical Outcome after Shoulder Surgery: A Prospective Longitudinal Cohort Study.

    Science.gov (United States)

    Koorevaar, Rinco C T; van 't Riet, Esther; Gerritsen, Marleen J J; Madden, Kim; Bulstra, Sjoerd K

    2016-01-01

    Psychological symptoms are highly prevalent in patients with shoulder complaints. Psychological symptoms in patients with shoulder complaints might play a role in the aetiology, perceived disability and pain and clinical outcome of treatment. The aim of this study was to assess whether preoperative symptoms of distress, depression, anxiety and somatisation were associated with a change in function after shoulder surgery and postoperative patient perceived improvement of pain and function. In addition, the change of psychological symptoms after shoulder surgery was analyzed and the influence of postoperative symptoms of psychological disorders after surgery on the change in function after shoulder surgery and perceived postoperative improvement of pain and function. A prospective longitudinal cohort study was performed in a general teaching hospital. 315 consecutive patients planned for elective shoulder surgery were included. Outcome measures included change of Disabilities of the Arm, Shoulder and Hand (DASH) score and anchor questions about improvement in pain and function after surgery. Psychological symptoms were identified before and 12 months after surgery with the validated Four-Dimensional Symptom Questionnaire (4DSQ). Psychological symptoms were encountered in all the various shoulder diagnoses. Preoperative symptoms of psychological disorders persisted after surgery in 56% of patients, 10% of patients with no symptoms of psychological disorders before surgery developed new psychological symptoms. Preoperative symptoms of psychological disorders were not associated with the change of DASH score and perceived improvement of pain and function after shoulder surgery. Patients with symptoms of psychological disorders after surgery were less likely to improve on the DASH score. Postoperative symptoms of distress and depression were associated with worse perceived improvement of pain. Postoperative symptoms of distress, depression and somatisation were

  19. Temporal Bone Fractures and its Classification: Retrospective Study of Incidence, Causes, Clinical Features, Complications and Outcome

    Directory of Open Access Journals (Sweden)

    Umamaheshwari Basavaraju

    2017-10-01

    Full Text Available Introduction: Temporal bone fracture is usually associated with high energy head injury and can cause potentially severe complications. Immediate detection of temporal bone fracture and its complications helps in providing early and effective treatment, which if left untreated can have drastic consequences. Aim: The main objective of the study is to document the frequency and most prevalent type of temporal bone fracture, co-existing complications and to establish association between them. Materials and Methods: One year (2015-2016 retrospective study of head injured patients presented to the Emergency Department, Mysore Medical College And Research Institute was conducted. Age and gender distribution, cause of injury, radiological findings, otorhinolaryngological clinical presentations and treatment given were analyzed. The results were tabulated and were evaluated by Microsoft Excel 2013. Results: Out of 1450 patients evaluated for head injury 154 patients were positive for temporal bone fracture. Incidence of the study was 10.6%. Majority of the patients were male (66.2% and were between 30 to 40 years (50.1%. The major cause of injury was motor vehicle accidents (84.48%. Right side was involved (58.4% more than the left side (41.5%. Most common clinical presentation was otorrhea 68.8%, followed by otalgia (35.04% and otorhinorrhea (24.67%. Longitudinal type fracture was most frequent 56.25%. Otic capsule involvement was present in 35.93%. Most of the fractures were managed conservatively whereas surgery was required in 12 patients (7.7%. Conclusion: Temporal bone fractures were frequently associated with severe traumatic brain injury leading to serious long term morbidity and sequelae. CT-scan is of utmost importance in detection of fractures and its complications.

  20. Central nervous system histoplasmosis: Multicenter retrospective study on clinical features, diagnostic approach and outcome of treatment.

    Science.gov (United States)

    Wheat, Joseph; Myint, Thein; Guo, Ying; Kemmer, Phebe; Hage, Chadi; Terry, Colin; Azar, Marwan M; Riddell, James; Ender, Peter; Chen, Sharon; Shehab, Kareem; Cleveland, Kerry; Esguerra, Eden; Johnson, James; Wright, Patty; Douglas, Vanja; Vergidis, Pascalis; Ooi, Winnie; Baddley, John; Bamberger, David; Khairy, Raed; Vikram, Holenarasipur R; Jenny-Avital, Elizabeth; Sivasubramanian, Geetha; Bowlware, Karen; Pahud, Barbara; Sarria, Juan; Tsai, Townson; Assi, Maha; Mocherla, Satish; Prakash, Vidhya; Allen, David; Passaretti, Catherine; Huprikar, Shirish; Anderson, Albert

    2018-03-01

    Central nervous system (CNS) involvement occurs in 5 to 10% of individuals with disseminated histoplasmosis. Most experience has been derived from small single center case series, or case report literature reviews. Therefore, a larger study of central nervous system (CNS) histoplasmosis is needed in order to guide the approach to diagnosis, and treatment.A convenience sample of 77 patients with histoplasmosis infection of the CNS was evaluated. Data was collected that focused on recognition of infection, diagnostic techniques, and outcomes of treatment.Twenty nine percent of patients were not immunosuppressed. Histoplasma antigen, or anti-Histoplasma antibodies were detected in the cerebrospinal fluid (CSF) in 75% of patients. One year survival was 75% among patients treated initially with amphotericin B, and was highest with liposomal, or deoxycholate formulations. Mortality was higher in immunocompromised patients, and patients 54 years of age, or older. Six percent of patients relapsed, all of whom had the acquired immunodeficiency syndrome (AIDS), and were poorly adherent with treatment.While CNS histoplasmosis occurred most often in immunocompromised individuals, a significant proportion of patients were previously, healthy. The diagnosis can be established by antigen, and antibody testing of the CSF, and serum, and antigen testing of the urine in most patients. Treatment with liposomal amphotericin B (AMB-L) for at least 1 month; followed by itraconazole for at least 1 year, results in survival among the majority of individuals. Patients should be followed for relapse for at least 1 year, after stopping therapy.

  1. Clinical and histologic studies of olfactory outcomes after nasoseptal flap harvesting.

    Science.gov (United States)

    Kim, Sang-Wook; Park, Kyung Bum; Khalmuratova, Roza; Lee, Hong-Kyoung; Jeon, Sea-Yuong; Kim, Dae Woo

    2013-07-01

    Since the introduction of an endonasal endoscopic approach in transsphenoidal pituitary surgery, reports of perioperative olfactory changes have presented conflicting results. We examined the incidence of olfactory loss in cases of endoscopic transsphenoidal pituitary surgery with skull base repair using the nasoseptal flap (NSF) and the effects of monopolar electrocautery commonly used in designing the NSF. Case-control study. Fifteen patients who underwent endoscopic transsphenoidal pituitary surgery with skull base reconstruction using the NSF were divided into cold knife (n = 8) and electrocautery (n = 7) groups according to the device used in the superior incision of the NSF. Patients were followed regularly to monitor the need for dressing or adhesiolysis around the olfactory cleft. All subjects received olfactory tests before and 6 months after surgery. Septal mucosa specimens obtained during posterior septectomy were incised with different devices, and the degree of mucosal damage was evaluated. One patient in the electrocautery group demonstrated olfactory dysfunction postoperatively, but the other 14 patients showed no decrease in olfaction. In histologic analyses, 55.8% and 76.9% of the mucosal surface showed total epithelial loss when the mucosa was cut with cutting- and coagulation-mode electrocautery, respectively. In contrast, only 20% of the mucosal surface exhibited total epithelial loss when the mucosa was cut with a cold knife (P knife in making superior incision may reduce tissue damage with better olfactory outcomes. Copyright © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

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

    Science.gov (United States)

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

    2017-03-01

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

  3. 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...... 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?...

  4. Tricuspid valve dysplasia: A retrospective study of clinical features and outcome in dogs in the UK

    Directory of Open Access Journals (Sweden)

    Xavier Navarro-Cubas

    2017-12-01

    Full Text Available The objective of this study was to determine the demographic, clinical and survival characteristics and to identify risk factors for mortality due to tricuspid valve dysplasia in UK dogs. Records of client-owned dogs diagnosed with tricuspid valve dysplasia at a referral centre were retrospectively reviewed. Only dogs diagnosed with tricuspid valve dysplasia based on the presence of a right-sided heart murmur identified prior to one year of age, and confirmed with Doppler echocardiography, were included. Dogs with concomitant cardiac diseases, pulmonary hypertension and/or trivial tricuspid regurgitation were excluded. Analysed data included signalment, reason for presentation, clinical signs, electrocardiographic and echocardiographic features, survival status and cause of death. Survival times and risk factors for mortality were evaluated using Kaplan-Meier curves and Cox regression. Eighteen dogs met inclusion criteria. Border collies were over-represented (p= 0.014. Dogs were most frequently referred for investigation of heart murmur. The most common arrhythmia was atrial fibrillation (n=3. Median survival time from diagnosis of tricuspid valve dysplasia was 2775 days (range 1-3696 days; 95% CI 1542.41-4007.59 and from onset of right-sided congestive heart failure was 181 days (range 1-2130 days; 95% CI 0-455.59. Syncope was the sole risk factor for cardiac death. In this population of UK dogs, tricuspid valve dysplasia was uncommon but, when severe, frequently led to right-sided congestive heart failure. Prognosis was favourable for mild and moderate tricuspid dysplasia. Survival time was reduced with right-sided congestive heart failure but varied widely. Risk of cardiac death was significantly increased if syncope had occurred.

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

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    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

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

    International Nuclear Information System (INIS)

    Wu, Fang; Wang, Rensheng; Lu, Heming; Wei, Bo; Feng, Guosheng; Li, Guisheng; Liu, Meilian; Yan, Haolin; Zhu, Jinxian; Zhang, Yong; Hu, Kai

    2014-01-01

    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

  7. Anxiety, Depression, and Adverse Clinical Outcomes in Patients With Atrial Fibrillation Starting Warfarin: Cardiovascular Research Network WAVE Study.

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    Baumgartner, Christine; Fan, Dongjie; Fang, Margaret C; Singer, Daniel E; Witt, Daniel M; Schmelzer, John R; Williams, Marc S; Gurwitz, Jerry H; Sung, Sue Hee; Go, Alan S

    2018-04-14

    Anxiety and depression are associated with worse outcomes in several cardiovascular conditions, but it is unclear whether they affect outcomes in atrial fibrillation (AF). In a large diverse population of adults with AF, we evaluated the association of diagnosed anxiety and/or depression with stroke and bleeding outcomes. The Cardiovascular Research Network WAVE (Community-Based Control and Persistence of Warfarin Therapy and Associated Rates and Predictors of Adverse Clinical Events in Atrial Fibrillation and Venous Thromboembolism) Study included adults with AF newly starting warfarin between 2004 and 2007 within 5 health delivery systems in the United States. Diagnosed anxiety and depression and other patient characteristics were identified from electronic health records. We identified stroke and bleeding outcomes from hospitalization databases using validated International Classification of Diseases, Ninth Revision ( ICD-9 ), codes. We used multivariable Cox regression to assess the relation between anxiety and/or depression with outcomes after adjustment for stroke and bleeding risk factors. In 25 570 adults with AF initiating warfarin, 490 had an ischemic stroke or intracranial hemorrhage (1.52 events per 100 person-years). In multivariable analyses, diagnosed anxiety was associated with a higher adjusted rate of combined ischemic stroke and intracranial hemorrhage (hazard ratio, 1.52; 95% confidence interval, 1.01-2.28). Results were not materially changed after additional adjustment for patient-level percentage of time in therapeutic anticoagulation range on warfarin (hazard ratio, 1.56; 95% confidence interval, 1.03-2.36). In contrast, neither isolated depression nor combined depression and anxiety were significantly associated with outcomes. Diagnosed anxiety was independently associated with increased risk of combined ischemic stroke and intracranial hemorrhage in adults with AF initiating warfarin that was not explained by differences in risk factors

  8. STUDY OF CLINICAL PROFILE AND OUTCOME OF ORGANOPHOSPHORUS POISONING IN RELATION TO PSEUDOCHOLINESTERASE LEVEL

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    Rajyalakshmi

    2017-11-01

    Full Text Available BACKGROUND The state of Andhra Pradesh, particularly the coastal districts are an area of intensive agricultural production. Pesticide use is high, and the state has one of the highest reported rates of pesticide poisoning in India. The resources for treating this number of cases in government hospitals are limited and likely to have an impact on patient outcome. The present study was carried out in one such hospital of the state. Amongst these pesticides, insecticides constitute an important group, and organophosphorus compounds are possibly the insecticides widely used, all over the world. MATERIALS AND METHODS Hundred patients of pesticide poisoning admitted into the medical ward of Government General Hospital, Kakinada during the period of August 2010 to July 2014 were studied. Detailed history was taken in each case from patient and attendants. A meticulous physical examination was done on each of them at the time of admission. The diagnosis of poisoning was suspected from the characteristic garlic and kerosene like odour, characteristic signs and symptoms of poisoning and corroborative evidence collected in the form of packets or containers obtained from the site by family members or bystanders. RESULTS Out of the 14 patients who died, 11 died due to organophosphate poisoning, 2 patients died due to organochlorine poisoning and 1 patient died due to herbicide poisoning. Out of the 11 patients who expired due to organophosphate poisoning, 10 patients had pseudocholinesterase value ≤1 unit/mL. The remaining one (1 patient who died, had a pseudocholinesterase value of 2.2 units/mL. Of the 11 patients who died due to organophosphate poisoning, Monocrotophos recorded highest number of deaths (6 cases, followed by dimethoate, which was responsible for 2 deaths. Methyl parathion, Profenophos and Chlorpyriphos caused 1 death each. An organochlorine compound, Endosulfan caused 2 deaths. Paraquat, a herbicide was responsible for 1 death

  9. Remote monitoring improves outcome after ICD implantation: the clinical efficacy in the management of heart failure (EFFECT) study.

    Science.gov (United States)

    De Simone, Antonio; Leoni, Loira; Luzi, Mario; Amellone, Claudia; Stabile, Giuseppe; La Rocca, Vincenzo; Capucci, Alessandro; D'onofrio, Antonio; Ammendola, Ernesto; Accardi, Francesco; Valsecchi, Sergio; Buja, Gianfranco

    2015-08-01

    Internet-based remote interrogation systems have been shown to reduce emergency department and in-office visits in patients with implantable cardioverter defibrillators (ICDs), resulting in increased efficiency for healthcare providers. Nonetheless, studies sized to demonstrate the impact of remote monitoring on patients' outcome have been lacking. The EFFECT study was a multicentre clinical trial aimed at measuring and comparing the outcome of ICD patients conventionally followed-up by means of in-clinic visits (Standard arm) or by remote monitoring (Remote arm) in the clinical practice of 25 Italian centres. From 2011 to 2013, 987 consecutive patients were enrolled and followed up for at least 12 months. The primary endpoint was the rate of death and cardiovascular hospitalizations. Remote monitoring was adopted by 499 patients. Patients in the Standard and Remote arms did not differ significantly in terms of baseline clinical characteristics, except for a more frequent use of ICD with cardiac resynchronization therapy (CRT-D) in the Remote arm (48 vs. 36%, P Remote arm (incident rate ratio, 0.55; 95% CI, 0.41-0.73; P Remote arms were 0.27 and 0.08 events/year, respectively, among CRT-D recipients (P Remote arm. Compared with the standard follow-up through in-office visits, remote monitoring is associated with reduced death and cardiovascular hospitalizations in patients with ICD in clinical practice. URL: http://clinicaltrials.gov/ Identifier: NCT01723865. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  10. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

    Science.gov (United States)

    Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F; Muizelaar, J Paul; Mendelow, A David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G; Macdonald, R Loch; Diringer, Michael N; Broderick, Joseph P; Dreier, Jens P; Roos, Yvo B W E M

    2010-10-01

    In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies.

  11. Prospective study to evaluate the clinical and radiological outcome of patients with scleroderma of the face.

    Science.gov (United States)

    Careta, Mariana Figueiroa; Leite, Claudia da Costa; Cresta, Fernando; Albino, Jose; Tsunami, Mirian; Romiti, Ricardo

    2013-09-01

    Scleroderma featuring rare connective tissue disease that manifests as skin sclerosis and variable systemic involvement. Two categories of scleroderma are known: systemic sclerosis, characterized by cutaneous sclerosis and visceral involvement and localized scleroderma or morphea which classically presents benign evolution and self-limited, confined to the skin and/or underlying tissue. Recent studies show that the localized form may possibly course with involvement of internal organs and variable morbidity. This study aimed to determine the demographic characteristics, the prevalence of systemic manifestations and laboratory findings, as well as the association with autoimmune diseases, and the evolution of neurological findings, both clinical as brain MRI in patients with scleroderma of the face and its relation with the activity skin. Patients with localized scleroderma with facial involvement were evaluated and underwent neurological examination, magnetic resonance imaging and ophthalmology evaluation. After 3years, the patients were subjected again to MRI. We studied 12 patients with localized scleroderma of the face. Of this total, headache being the most frequent complaint found in 66.7% of patients, 33.3% had neurological changes possibly associated with scleroderma. As for ophthalmologic evaluation, 25% of patients showed abnormalities. The most frequent parenchymal finding was the presence of lesions with hyperintense or hypointense signal in 75% of patients, followed by ventricular asymmetry at 16.7%. Of the patients who had neurological deficits, 75% also had a change to MRI. In all patients, imaging findings after 3years were unchanged. During this interval of 3years, 25% of patients showed signs of activity of scleroderma. Patients with localized scleroderma of the face have a high prevalence of neurological and ophthalmological changes. Based on these findings, we suggest that all cases of localized scleroderma of the face should be thoroughly

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

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    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.

  13. The Pancreatitis Activity Scoring System predicts clinical outcomes in acute pancreatitis: findings from a prospective cohort study.

    Science.gov (United States)

    Buxbaum, James; Quezada, Michael; Chong, Bradford; Gupta, Nikhil; Yu, Chung Yao; Lane, Christianne; Da, Ben; Leung, Kenneth; Shulman, Ira; Pandol, Stephen; Wu, Bechien

    2018-03-15

    The Pancreatitis Activity Scoring System (PASS) has been derived by an international group of experts via a modified Delphi process. Our aim was to perform an external validation study to assess for concordance of the PASS score with high face validity clinical outcomes and determine specific meaningful thresholds to assist in application of this scoring system in a large prospectively ascertained cohort. We analyzed data from a prospective cohort study of consecutive patients admitted to the Los Angeles County Hospital between March 2015 and March 2017. Patients were identified using an emergency department paging system and electronic alert system. Comprehensive characterization included substance use history, pancreatitis etiology, biochemical profile, and detailed clinical course. We calculated the PASS score at admission, discharge, and at 12 h increments during the hospitalization. We performed several analyses to assess the relationship between the PASS score and outcomes at various points during hospitalization as well as following discharge. Using multivariable logistic regression analysis, we assessed the relationship between admission PASS score and risk of severe pancreatitis. PASS score performance was compared to established systems used to predict severe pancreatitis. Additional inpatient outcomes assessed included local complications, length of stay, development of systemic inflammatory response syndrome (SIRS), and intensive care unit (ICU) admission. We also assessed whether the PASS score at discharge was associated with early readmission (re-hospitalization for pancreatitis symptoms and complications within 30 days of discharge). A total of 439 patients were enrolled, their mean age was 42 (±15) years, and 53% were male. Admission PASS score >140 was associated with moderately severe and severe pancreatitis (OR 3.5 [95% CI 2.0, 6.3]), ICU admission (OR 4.9 [2.5, 9.4]), local complications (3.0 [1.6, 5.7]), and development of SIRS (OR 2.9 [1

  14. Clinical Manifestations, Treatment, and Outcome of Hospitalized Patients with Plasmodium vivax Malaria in Two Indian States: A Retrospective Study

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    Jagjit Singh

    2013-01-01

    Full Text Available This was a retrospective study done on 110 patients hospitalized with P. vivax malaria in three medical college hospitals, one in the union territory of Chandigarh and the other two in Gujarat, that is, Ahmedabad and Surat. The clinical presentation, treatment, and outcome were recorded. As per WHO criteria for severity, 19 of 110 patients had severe disease—six patients had clinical jaundice with hepatic dysfunction, three patients had severe anemia, three had spontaneous bleeding, two had acute respiratory distress syndrome, and one had cerebral malaria, hyperparasitemia, renal failure, circulatory collapse, and metabolic acidosis. All patients with severe P. vivax malaria survived, but one child with cerebral malaria had neurological sequelae. There was wide variation in the antimalarial treatment received at the three centres. Plasmodium vivax malaria can no longer be considered a benign condition. WHO guidelines for treatment of P. vivax malaria need to be reinforced.

  15. Percutaneous nephrolithotomy among patients with renal anomalies: patient characteristics and outcomes; a subgroup analysis of the clinical research office of the endourological society global percutaneous nephrolithotomy study

    DEFF Research Database (Denmark)

    Osther, Palle Jörn; Razvi, Hassan; Liatsikos, Evangelos

    2011-01-01

    This study compared the characteristics and outcomes of percutaneous nephrolithotomy (PCNL) in patients with and without renal malformations using the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study database.......This study compared the characteristics and outcomes of percutaneous nephrolithotomy (PCNL) in patients with and without renal malformations using the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study database....

  16. Clinical profile and outcomes of acute cardiorenal syndrome type-5 in sepsis: An eight-year cohort study.

    Science.gov (United States)

    Vallabhajosyula, Saraschandra; Sakhuja, Ankit; Geske, Jeffrey B; Kumar, Mukesh; Kashyap, Rahul; Kashani, Kianoush; Jentzer, Jacob C

    2018-01-01

    To evaluate the clinical features and outcomes of acute cardiorenal syndrome type-5 in patients with severe sepsis and septic shock. Historical cohort study of all adult patients with severe sepsis and septic shock admitted to the intensive care units (ICU) at Mayo Clinic Rochester from January 1, 2007 through December 31, 2014. Patients with prior renal or cardiac dysfunction were excluded. Patients were divided into groups with and without cardiorenal syndrome type-5. Acute Kidney Injury (AKI) was defined by both serum creatinine and urine output criteria of the AKI Network and the cardiac injury was determined by troponin-T levels. Outcomes included in-hospital mortality, ICU and hospital length of stay, and one-year survival. Of 602 patients meeting the study inclusion criteria, 430 (71.4%) met criteria for acute cardiorenal syndrome type-5. Patients with cardiorenal syndrome type-5 had higher severity of illness, greater vasopressor and mechanical ventilation use. Cardiorenal syndrome type-5 was associated higher unadjusted in-hospital mortality, ICU and hospital lengths of stay, and lower one-year survival. When adjusted for age, gender, severity of illness and mechanical ventilation, cardiorenal syndrome type-5 was independently associated with 1.7-times greater odds of in-hospital mortality (p = .03), but did not predict one-year survival (p = .06) compared to patients without cardiorenal syndrome. In sepsis, acute cardiorenal syndrome type-5 is associated with worse in-hospital mortality compared to patients without cardiorenal syndrome.

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

    Science.gov (United States)

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

    2016-12-01

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

  18. 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 effect size were observed on all rating scales (p-value

  19. 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 knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates...... 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?...

  20. Using case study within a sequential explanatory design to evaluate the impact of specialist and advanced practice roles on clinical outcomes: the SCAPE study.

    Science.gov (United States)

    Lalor, Joan G; Casey, Dympna; Elliott, Naomi; Coyne, Imelda; Comiskey, Catherine; Higgins, Agnes; Murphy, Kathy; Devane, Declan; Begley, Cecily

    2013-04-08

    The role of the clinical nurse/midwife specialist and advanced nurse/midwife practitioner is complex not least because of the diversity in how the roles are operationalised across health settings and within multidisciplinary teams. This aim of this paper is to use The SCAPE Study: Specialist Clinical and Advanced Practitioner Evaluation in Ireland to illustrate how case study was used to strengthen a Sequential Explanatory Design. In Phase 1, clinicians identified indicators of specialist and advanced practice which were then used to guide the instrumental case study design which formed the second phase of the larger study. Phase 2 used matched case studies to evaluate the effectiveness of specialist and advanced practitioners on clinical outcomes for service users. Data were collected through observation, documentary analysis, and interviews. Observations were made of 23 Clinical Specialists or Advanced Practitioners, and 23 matched clinicians in similar matched non-postholding sites, while they delivered care. Forty-one service users, 41 clinicians, and 23 Directors of Nursing or Midwifery were interviewed, and 279 service users completed a survey based on the components of CS and AP practice identified in Phase 1. A coding framework, and the generation of cross tabulation matrices in NVivo, was used to make explicit how the outcome measures were confirmed and validated from multiple sources. This strengthened the potential to examine single cases that seemed 'different', and allowed for cases to be redefined. Phase 3 involved interviews with policy-makers to set the findings in context. Case study is a powerful research strategy to use within sequential explanatory mixed method designs, and adds completeness to the exploration of complex issues in clinical practice. The design is flexible, allowing the use of multiple data collection methods from both qualitative and quantitative paradigms. Multiple approaches to data collection are needed to evaluate the impact

  1. 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

    of longitudinal studies on TBI that follow DTI changes over time and correlate findings with long-term clinical outcome. We performed a prospective longitudinal study of 30 adult patients admitted for subacute rehabilitation following severe traumatic brain injury. DTI and conventional MRI were acquired at mean 8......Diffusion tensor imaging (DTI) has been proposed as a sensitive biomarker of traumatic white matter injury, which could potentially serve as a tool for prognostic assessment and for studying microstructural changes during recovery from traumatic brain injury (TBI). However, there is a lack...... weeks (5-11 weeks), and repeated in 23 of the patients at mean 12 months (9-15 months) post-trauma. Using a region-of-interest-based approach, DTI parameters were compared to those of healthy matched controls, scanned during the same time period and rescanned with a similar interval as that of patients...

  2. Clinical Studies

    DEFF Research Database (Denmark)

    Pallesen, Ulla

    universities and practicing dentists restore millions of teeth throughout the World with composite resin materials. Do we know enough about the clinical performance of these restorations over time? Numerous in vitro studies are being published on resin materials and adhesion, some of them attempting to imitate...... in vivo conditions. But real life is different and in vitro studies cannot include all variables. Only clinical studies can provide valid information on the clinical performance of restorations over time. What do we know about longevity of posterior resin restorations? What are the reasons for replacement...... and results from own up to 30-year prospective clinical university studies and practice based studies from Public Dental Health Service on the clinical performance of posterior composite resin restorations....

  3. Clinical Study of Nasopharyngeal Carcinoma Treated by Helical Tomotherapy in China: 5-Year Outcomes

    Directory of Open Access Journals (Sweden)

    Lei Du

    2014-01-01

    Full Text Available Background. To evaluate the outcomes of nasopharyngeal carcinoma (NPC patients treated with helical tomotherapy (HT. Methods. Between September 2007 and August 2012, 190 newly diagnosed NPC patients were treated with HT. Thirty-one patients were treated with radiation therapy as single modality, 129 with additional cisplatin-based chemotherapy with or without anti-EGFR monoclonal antibody therapy, and 30 with concurrent anti-EGFR monoclonal antibody therapy. Results. Acute radiation related side effects were mainly grade 1 or 2. Grade 3 and greater toxicities were rarely noted. The median followup was 32 (3–38 months. The local relapse-free survival (LRFS, nodal relapse-free survival (NRFS, distant metastasis-free survival (DMFS, and overall survival (OS were 96.1%, 98.2%, 92.0%, and 86.3%, respectively, at 3 years. Cox multivariate regression analysis showed that age and T stage were independent predictors for 3-year OS. Conclusions. Helical tomotherapy for NPC patients achieved excellent 3-year locoregional control, distant metastasis-free survival, and overall survival, with relatively minor acute and late toxicities. Age and T stage were the main prognosis factors.

  4. Patient-reported outcomes and socioeconomic status as predictors of clinical outcomes following hematopoietic stem cell transplantation: A study from the BMT CTN 0902 trial

    Science.gov (United States)

    Knight, Jennifer M; Syrjala, Karen L; Majhail, Navneet S; Martens, Michael; Le-Rademacher, Jennifer; Logan, Brent R; Lee, Stephanie J; Jacobsen, Paul B; Wood, William A; Jim, Heather SL; Wingard, John R; Horowitz, Mary M; Abidi, Muneer H; Fei, Mingwei; Rawls, Laura; Rizzo, J Douglas

    2016-01-01

    This secondary analysis of a large, multi-center Blood and Marrow Transplant Clinical Trials Network (BMT CTN) randomized trial assessed whether patient-reported outcomes (PROs) and socioeconomic status (SES) before hematopoietic stem cell transplantation (HCT) are associated with each other and predictive of clinical outcomes including time to hematopoietic recovery, acute graft-versus-host disease, hospitalization days, and overall survival (OS) among 646 allogeneic and autologous HCT recipients. Pre-transplant Cancer and Treatment Distress (CTXD), Pittsburgh Sleep Quality Index (PSQI), and mental and physical component scores (MCS and PCS) of the SF-36 were correlated with each other and with SES variables. PROs and SES variables were further evaluated as predictors of clinical outcomes, with the PSQI and CTXD evaluated as OS predictors (pincome was related to worse physical functioning (p=.005) and increased distress (p=.008); lack of employment pre-transplant was associated with worse physical functioning (p<.01); unmarried status was associated with worse sleep (p=.003). In this large heterogeneous cohort of HCT recipients, while PROs and SES variables were correlated at baseline, they were not associated with any clinical outcomes. Future research should focus on HCT recipients at greater psychosocial disadvantage. PMID:27565521

  5. Cigarette Smoking During Substance Use Disorder Treatment: Secondary Outcomes from a National Drug Abuse Treatment Clinical Trials Network study.

    Science.gov (United States)

    McClure, Erin A; Campbell, Aimee N C; Pavlicova, Martina; Hu, Meichen; Winhusen, Theresa; Vandrey, Ryan G; Ruglass, Lesia M; Covey, Lirio S; Stitzer, Maxine L; Kyle, Tiffany L; Nunes, Edward V

    2015-06-01

    The majority of patients enrolled in treatment for substance use disorders (SUDs) also use tobacco. Many will continue to use tobacco even during abstinence from other drugs and alcohol, often leading to smoking-related illnesses. Despite this, little research has been conducted to assess the influence of being a smoker on SUD treatment outcomes and changes in smoking during a treatment episode. In this secondary analysis, cigarette smoking was evaluated in participants completing outpatient SUD treatment as part of a multi-site study conducted by the National Drug Abuse Treatment Clinical Trials Network. Analyses included the assessment of changes in smoking and nicotine dependence via the Fagerström Test for Nicotine Dependence during the 12-week study among all smokers (aim #1), specifically among those in the experimental treatment group (aim #2), and the moderating effect of being a smoker on treatment outcomes (aim #3). Participants generally did not reduce or quit smoking throughout the course of the study. Among a sub-set of participants with higher baseline nicotine dependence scores randomized to the control arm, scores at the end of treatment were lower compared to the experimental arm, though measures of smoking quantity did not appear to decrease. Further, being a smoker was associated with poorer treatment outcomes compared to non-smokers enrolled in the trial. This study provides evidence that patients enrolled in community-based SUD treatment continue to smoke, even when abstaining from drugs and alcohol. These results add to the growing literature encouraging the implementation of targeted, evidence-based interventions to promote abstinence from tobacco among SUD treatment patients. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Development and validation of clinical prediction models for mortality, functional outcome and cognitive impairment after stroke: a study protocol.

    Science.gov (United States)

    Fahey, Marion; Rudd, Anthony; Béjot, Yannick; Wolfe, Charles; Douiri, Abdel

    2017-08-18

    Stroke is a leading cause of adult disability and death worldwide. The neurological impairments associated with stroke prevent patients from performing basic daily activities and have enormous impact on families and caregivers. Practical and accurate tools to assist in predicting outcome after stroke at patient level can provide significant aid for patient management. Furthermore, prediction models of this kind can be useful for clinical research, health economics, policymaking and clinical decision support. 2869 patients with first-ever stroke from South London Stroke Register (SLSR) (1995-2004) will be included in the development cohort. We will use information captured after baseline to construct multilevel models and a Cox proportional hazard model to predict cognitive impairment, functional outcome and mortality up to 5 years after stroke. Repeated random subsampling validation (Monte Carlo cross-validation) will be evaluated in model development. Data from participants recruited to the stroke register (2005-2014) will be used for temporal validation of the models. Data from participants recruited to the Dijon Stroke Register (1985-2015) will be used for external validation. Discrimination, calibration and clinical utility of the models will be presented. Patients, or for patients who cannot consent their relatives, gave written informed consent to participate in stroke-related studies within the SLSR. The SLSR design was approved by the ethics committees of Guy's and St Thomas' NHS Foundation Trust, Kings College Hospital, Queens Square and Westminster Hospitals (London). The Dijon Stroke Registry was approved by the Comité National des Registres and the InVS and has authorisation of the Commission Nationale de l'Informatique et des Libertés. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  7. Clinical features, microbiology and surgical outcomes of infective endocarditis: a 13-year study from a UK tertiary cardiothoracic referral centre.

    Science.gov (United States)

    Marks, D J B; Hyams, C; Koo, C Y; Pavlou, M; Robbins, J; Koo, C S; Rodger, G; Huggett, J F; Yap, J; Macrae, M B; Swanton, R H; Zumla, A I; Miller, R F

    2015-03-01

    Infective endocarditis (IE) causes substantial morbidity and mortality. Patient and pathogen profiles, as well as microbiological and operative strategies, continue to evolve. The impact of these changes requires evaluation to inform optimum management and identify individuals at high risk of early mortality. Identification of clinical and microbiological features, and surgical outcomes, among patients presenting to a UK tertiary cardiothoracic centre for surgical management of IE between 1998 and 2010. Retrospective observational cohort study. Clinical, biochemical, microbiological and echocardiographic data were identified from clinical records. Principal outcomes were all-cause 28-day mortality and duration of post-operative admission. Patients (n = 336) were predominantly male (75.0%); median age 52 years (IQR = 41-67). Most cases involved the aortic (56.0%) or mitral (53.9%) valves. Microbiological diagnoses, obtained in 288 (85.7%) patients, included streptococci (45.2%); staphylococci (34.5%); Haemophilus, Actinobacillus, Cardiobacterium, Eikenella, Kingella (HACEK) organisms (3.0%); and fungi (1.8%); 11.3% had polymicrobial infection. Valve replacement in 308 (91.7%) patients included mechanical prostheses (69.8%), xenografts (24.0%) and homografts (6.2%). Early mortality was 12.2%, but fell progressively during the study (P = 0.02), as did median duration of post-operative admission (33.5 to 10.5 days; P = 0.0003). Multivariable analysis showed previous cardiothoracic surgery (OR = 3.85, P = 0.03), neutrophil count (OR = 2.27, P = 0.05), albumin (OR = 0.94, P = 0.04) and urea (OR = 2.63, P < 0.001) predicted early mortality. This study demonstrates reduced post-operative early mortality and duration of hospital admission for IE patients over the past 13 years. Biomarkers (previous cardiothoracic surgery, neutrophil count, albumin and urea), predictive of early post-operative mortality, require prospective evaluation to refine algorithms, further improve

  8. Clinical Characteristics, Risk Factors, and Outcomes Associated With Neonatal Hemorrhagic Stroke: A Population-Based Case-Control Study.

    Science.gov (United States)

    Cole, Lauran; Dewey, Deborah; Letourneau, Nicole; Kaplan, Bonnie J; Chaput, Kathleen; Gallagher, Clare; Hodge, Jacquie; Floer, Amalia; Kirton, Adam

    2017-03-01

    Hemorrhage into the brain of term newborns often results in major injury and lifelong disability. The clinical epidemiology of neonatal hemorrhagic stroke (NHS) remains undefined, hindering the development of strategies to improve outcomes. To characterize the incidence, types, presentations, associated factors, and outcomes of neonatal hemorrhagic stroke. Population-based, nested case-control study. The Alberta Perinatal Stroke Project, a provincial registry, ascertained NHS cases using exhaustive diagnostic code searching (1992-2010, >2500 medical record reviews). Prospective cases were captured through the Calgary Pediatric Stroke Program (2007-2014). Participants included term neonates with magnetic resonance imaging-confirmed NHS including primary and secondary intracerebral hemorrhage, hemorrhagic transformation of ischemic injury, and presumed perinatal hemorrhagic stroke. Control infants with common data were recruited from a population-based study (4 to 1 ratio). Infants with NHS underwent structured medical record review using data-capture forms and blinded scoring of neuroimaging. Clinical risk factor common data elements were explored using logistic regression. Provincial live births were obtained from Statistics Canada. Outcomes were extrapolated to the Pediatric Stroke Outcome Measure. We identified 86 cases: 51 infants (59%) with NHS, of which 32 (67%) were idiopathic, 30 (35%) were hemorrhagic transformation of primary ischemic injuries (14 with neonatal cerebral sinovenous thrombosis, 11 with hypoxic ischemic encephalopathy, and 5 with neonatal arterial ischemic stroke), and 5 were presumed perinatal hemorrhagic stroke. Sixty-two percent were male. Incidence of pure NHS was 1 in 9500 live births and 1 in 6300 for all forms. Most presented in the first week of life with seizures and encephalopathy. Acute neurosurgical intervention was rare (3 of 86 total cases; 3.5%). Temporal lobe was the most common NHS location (16 of 51 pure NHS cases; 31%). A

  9. Clinical patterns and outcomes of ischaemic colitis: results of the Working Group for the Study of Ischaemic Colitis in Spain (CIE study).

    Science.gov (United States)

    Montoro, Miguel A; Brandt, Lawrence J; Santolaria, Santos; Gomollon, Fernando; Sánchez Puértolas, Belén; Vera, Jesús; Bujanda, Luis; Cosme, Angel; Cabriada, José Luis; Durán, Margarita; Mata, Laura; Santamaría, Ana; Ceña, Gloria; Blas, Jose Manuel; Ponce, Julio; Ponce, Marta; Rodrigo, Luis; Ortiz, Jacobo; Muñoz, Carmen; Arozena, Gloria; Ginard, Daniel; López-Serrano, Antonio; Castro, Manuel; Sans, Miquel; Campo, Rafael; Casalots, Alex; Orive, Víctor; Loizate, Alberto; Titó, Lluçia; Portabella, Eva; Otazua, Pedro; Calvo, M; Botella, Maria Teresa; Thomson, Concepción; Mundi, Jose Luis; Quintero, Enrique; Nicolás, David; Borda, Fernando; Martinez, Benito; Gisbert, Javier P; Chaparro, María; Jimenez Bernadó, Alfredo; Gómez-Camacho, Federico; Cerezo, Antonio; Casal Nuñez, Enrique

    2011-02-01

    There is a lack of prospective studies evaluating the natural history of colonic ischaemia (CI). We performed such a study to evaluate the clinical presentation, outcome, and mortality as well as clinical variables associated with poor prognosis. An open, prospective, and multicentre study was conducted in 24 Spanish hospitals serving a population of 3.5 million people. The study included only patients who met criteria for definitive or probable CI. A website (www.colitisisquemica.org) provided logistical support. A total of 364 patients met criteria for inclusion. CI was suspected clinically in only 24.2% of cases. The distribution of clinical patterns was as follows: reversible colopathy (26.1%), transient colitis (43.7%), gangrenous colitis (9.9%), fulminant pancolitis (2.5%), and chronic segmental colitis (17.9%). A total of 47 patients (12.9%) had an unfavorable outcome as defined by mortality and/or the need for surgery. Multivariate analysis identified the following signs as independent risk factors for an unfavorable outcome: abdominal pain without rectal bleeding [odds ratio (OR) 3.9; 95% confidence interval (CI) = 1.6-9.3], non-bloody diarrhoea (OR 10; 95% CI = 3.7-27.4), and peritoneal signs (OR 7.3; 95% CI = 2.7-19.6). Unfavorable outcomes also were more frequent in isolated right colon ischaemia (IRCI) compared with non-IRCI (40.9 vs. 10.3%, respectively; p < 0.0001). The overall mortality rate was 7.7%. The clinical presentation of CI is very heterogeneous, perhaps explaining why clinical suspicion of this disease is so low. The presence of IRCI, and occurrence of peritoneal signs or onset of CI as severe abdominal pain without bleeding, should alert the physician to a potentially unfavorable course.

  10. Outcome measures used in clinical studies on neonatal brachial plexus palsy: A systematic literature review using the International Classification of Functioning, Disability and Health.

    Science.gov (United States)

    Sarac, Cigdem; Duijnisveld, Bouke J; van der Weide, Amber; Schoones, Jan W; Malessy, Martijn J A; Nelissen, Rob G H H; Vlieland, Thea P M Vliet

    2015-01-01

    Symptoms of a neonatal brachial plexus palsy (NBPP) can vary widely among individuals and numerous clinical studies have been performed to identify the natural history and to improve treatment. The aim of this study was to identify and describe all outcome measures used in clinical studies on patients with an NBPP and categorize these outcome measures according to the International Classification of Functioning, Disability and Health (ICF). Electronic searches of different databases were carried out. All clinical studies describing one or more outcomes of NBPP were selected. Data on outcome measures was systematically extracted and the contents were analyzed and linked to the ICF. A total of 217 full texts were selected and 59 different outcome measures were identified. The 5 most frequently used outcome measures included range of motion of the shoulder (n= 166 studies, 76%), range of motion of the elbow (n= 87 studies, 40%), the Mallet scale (n= 66 studies, 30%), Magnetic Resonance Imaging (n= 37 studies, 17%) and the Medical Research Council motor grading scale (n= 31 studies, 14%). Assessments related to Body functions and Structures were most frequent, whereas assessments associated with Activities and Participation and Environmental Factors were relatively uncommon. There was a high variability among the outcome measures used, with measures within the ICF component Body Functions being most common. These results underscore the need for the development and usage of outcome measures representing all domains of health status in patients with NBPP.

  11. Management, clinical outcomes, and complications of acute cannula-related peripheral vein phlebitis of the upper extremity: A retrospective study.

    Science.gov (United States)

    Dunda, S E; Demir, E; Mefful, O J; Grieb, G; Bozkurt, A; Pallua, N

    2015-07-01

    Acute phlebitis due to peripheral vein catheter use is frequently observed in clinical practice, and requires surgical therapy in severe cases. In this retrospective study, we aimed to increase awareness, evaluate current treatment options, and develop recommendations to optimize treatment outcomes. A total of 240 hospitalized patients with a diagnosis of upper extremity phlebitis from 2006 to 2011 were evaluated in terms of initial clinical features, parameters, co-morbidities and treatment regimes. Severity of phlebitis was graded according to the Baxter scale by assessing clinical symptoms such as pain, erythema, induration, swelling, or palpable venous cord (grade 0-5). Patients were divided in two subgroups: conservative (n = 132) and operative (n = 108) treatment. Surgical intervention rates and severity were higher for cannula insertion in the cubital fossa region than for cannula insertion in the forearm and hand region (p phlebitis and is not recommended as the first site of choice for cannulation. Phlebitis of Baxter scale grade 4 or 5 should be considered for early surgical intervention. © The Author(s) 2014.

  12. Influence of clinical mastitis and its treatment outcome on reproductive performance in crossbred cows: A retrospective study.

    Science.gov (United States)

    Kumar, Narender; Manimaran, A; Sivaram, M; Kumaresan, A; Jeyakumar, S; Sreela, L; Mooventhan, P; Rajendran, D

    2017-05-01

    Evaluation of the effect of clinical mastitis (CM) and its treatment outcome on the reproductive performance in crossbred cows retrospectively. Datasets of 835 lactating cows affected with CM during a period of 12 years (2001-2012) were considered for this study. Mastitis treatment related data and reproductive parameters such as days to first detected heat (DTFDH), days to first insemination (DTFI), days open (DO), and number of services per conception (SC) were collected from mastitis treatment and artificial insemination registers, respectively. Data were analyzed by ANOVA using SPSS 20 software. The means were compared with the Duncan's multiple comparison post-hoc test. CM affected cows had significantly (p<0.05) higher DTFDH, DTFI, DO and SC compared to clinically healthy cows. Cows diagnosed with a single episode of CM had significantly (p<0.05) delayed DTFDH while, DO and SC were significantly higher (p<0.05) in cows diagnosed by multiple episodes of CM. SC was significantly (p<0.05) higher in cows diagnosed with both relapse and recurrence. Severe CM affected cows had significantly (p<0.05) altered reproductive parameters. The reproductive parameters were altered to high extent when CM occurred during the breeding period. CM-affected cows had higher DTFDH, DTFI, DO and SC compared to clinically healthy cows. The negative effects of CM on reproduction parameters were higher when CM occurred during the breeding period.

  13. Influence of clinical mastitis and its treatment outcome on reproductive performance in crossbred cows: A retrospective study

    Directory of Open Access Journals (Sweden)

    Narender Kumar

    2017-05-01

    Full Text Available Aim: Evaluation of the effect of clinical mastitis (CM and its treatment outcome on the reproductive performance in crossbred cows retrospectively. Materials and Methods: Datasets of 835 lactating cows affected with CM during a period of 12 years (2001-2012 were considered for this study. Mastitis treatment related data and reproductive parameters such as days to first detected heat (DTFDH, days to first insemination (DTFI, days open (DO, and number of services per conception (SC were collected from mastitis treatment and artificial insemination registers, respectively. Data were analyzed by ANOVA using SPSS 20 software. The means were compared with the Duncan's multiple comparison post-hoc test. Results: CM affected cows had significantly (p<0.05 higher DTFDH, DTFI, DO and SC compared to clinically healthy cows. Cows diagnosed with a single episode of CM had significantly (p<0.05 delayed DTFDH while, DO and SC were significantly higher (p<0.05 in cows diagnosed by multiple episodes of CM. SC was significantly (p<0.05 higher in cows diagnosed with both relapse and recurrence. Severe CM affected cows had significantly (p<0.05 altered reproductive parameters. The reproductive parameters were altered to high extent when CM occurred during the breeding period. Conclusion: CM-affected cows had higher DTFDH, DTFI, DO and SC compared to clinically healthy cows. The negative effects of CM on reproduction parameters were higher when CM occurred during the breeding period.

  14. Clinical characteristics and outcome of heart failure and captagon amphetamine use: An observational prospective study

    Directory of Open Access Journals (Sweden)

    Abdelfatah A. Elasfar

    2014-03-01

    Conclusios: Captagon use was found to be an independent risk factor of death and other morbidities in patients presented with cardiomyopathy and acute heart failure. Our study underscores the importance of improving education concerning the cardiac risks of captagon use.

  15. 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.

  16. Antiphospholipid Antibody Titers and Clinical Outcomes in Patients with Recurrent Miscarriage and Antiphospholipid Antibody Syndrome: A Prospective Study

    Science.gov (United States)

    Song, Yu; Wang, Hai-Yan; Qiao, Jie; Liu, Ping; Chi, Hong-Bin

    2017-01-01

    Background: The management of patients with recurrent miscarriage (RM) and antiphospholipid antibody syndrome (APS) includes prolonged treatment with heparin and aspirin, starting from the confirmation of pregnancy and continuing until 6 weeks after birth. This study was conducted to determine the relationship between changes in antiphospholipid antibody titers and clinical outcomes. The effect of a shortened treatment regimen was also evaluated. Methods: A prospective study of 123 patients with RM and APS between March 2012 and May 2014 was conducted. Patients were pretreated with a low dose of prednisone plus aspirin before pregnancy, and heparin was added after conception. The levels of antiphospholipid antibodies and pregnancy outcomes were evaluated. Results: All patients were positive for anti-β2-glycoprotein 1 (anti-β2-GP1) IgM. After prepregnancy treatment with low-dose prednisone plus aspirin, 99 of 123 patients became pregnant, and 87 of those pregnancies resulted in successful live births, while 12 resulted in miscarriage, showing a success rate of 87.9%. In the live birth group, levels of anti-β2-GP1 were 56.8 ± 49.0 RU/ml before the pretreatment regimen, 32.1 ± 26.0 RU/ml after 2 months of pretreatment, and 24.1 ± 23.1 RU/ml during early pregnancy (P antiphospholipid antibody titers were 52.8 ± 30.7 RU/ml before pretreatment, 38.5 ± 34.2 RU/ml after pretreatment, and 33.9 ± 24.7 RU/ml during early pregnancy; the decrease in antiphospholipid antibodies was lower in the miscarriage group than in the live birth group (P antiphospholipid antibody titers correlated with better pregnancy outcomes. The shorter treatment regimen was effective and economical. PMID:28139508

  17. Smoking cessation for free: outcomes of a study of three Romanian clinics

    Directory of Open Access Journals (Sweden)

    Trofor Antigona Carmen

    2016-01-01

    Full Text Available In 2007, Romania implemented a national program for smoking cessation, providing medication and counseling, entirely for free. The present study focuses on the results of the program among participating smokers treated in three smoking cessation centers from three main cities of Romania: Iasi, Targu Mures and Cluj.

  18. Comparison between Modified Neuroendoscopy and Craniotomy Evacuation of Spontaneous Intra-Cerebral Hemorrhages: Study of Clinical Outcome and Glasgow Outcome Score

    Directory of Open Access Journals (Sweden)

    Arie Ibrahim

    2016-08-01

    Full Text Available Background and Purposes: Stroke is still one of a leading health-care problem in industrial country and in the developing country. Spontaneous Intra-cerebral Hemorrhage accounts for 30–60% of all stroke admissions into a hospital. Presence of intra-cerebral hemorrhage is considered a poor prognostic factor due to the resultant obstruction to the mass effect following the presence of blood resulting in raised intracranial pressure. While the craniotomy procedure failed to show more benefits over functional outcome, a less invasive and quicker surgical decompression might improve the outcome. Neuroendoscopy is one of promising optional  on minimal invasive  treatment  for spontaneous intra-cerebral hemorrhage. Material and Methods: We evaluated Glasgow Outcome Score and clinical outcome of patients with Spontaneous Intra-cerebral Hemorrhage who underwent modified neuroendoscopic surgery and craniotomy. Randomized control trial was performed during 27 months in 43 patients. Twenty-five patients treated with neuroendoscopy surgery and 18 patients with craniotomy. The removal of intra-cerebral hemorrhage was done by a modified neuroendoscopic transparent sheath made of silastic material, derived from pieces of thoracic tube No. 21F as a conduit working channel. Results: We analyzed statistically, clinical outcome assessment and Glasgow Outcome Scale 6 months post operative follow-up period. The mortality rate was significantly higher by Pearson chi-square methods, in craniotomy group n=12 (63.2% compared with neuroendoscopy group, n=7 (36.8% (p<.005. Patients with Glasgow Outcome Scale score 3–5 was higher in neuroendoscopy group, n=18 (75% compared with craniotomy group n=6 (25%. The survival rate analyzed by Kaplan Meier methods, found that patients in the neuroendoscopy group were a significantly longer survival rate compare with the craniotomy group during 6 months post operative follow-up period. Conclusions: Treatment of spontaneous

  19. 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

  20. USG-guided injection of corticosteroid for lateral epicondylitis does not improve clinical outcomes: a prospective randomised study.

    Science.gov (United States)

    Gulabi, Deniz; Uysal, Mehmet Ali; Akça, Ahmet; Colak, Ilker; Çeçen, Gultekin Sıtkı; Gumustas, Seyitali

    2017-05-01

    Corticosteroid injection used to be the treatment of choice for lateral epicondylitis. Most injections are performed blindly. In the blinded technique, it could be difficult to determine the exact pathological localisation. The purpose of this single-blinded, randomised controlled clinical study was to compare the clinical therapeutic effects of blinded and USG-guided corticosteroid injection therapy in lateral epicondylitis. Forty patients with chronic lateral epicondylitis were included in this clinical trial. The patients were randomly allocated to blinded group or USG-guided injection group according to a computer-generated randomisation list. All blinded injections were administered by an orthopaedic surgeon and all ultrasound-guided injections were made by a radiologist experienced in this technique. All patients were injected under aseptic conditions using 40 mg/2 mL methylprednisolone acetate. The outcomes of both treatments were assessed by an independent assessor at pre-injection, then at 6-week and 3- and 6-month follow-up assessments. The assessor evaluated the q-DASH, VAS, and grip strength scores. No statistically significant difference was determined between the groups in respect of the Q-DASH and grip strength scores preoperatively and at 6 weeks and 3 and 6 months post-injection. No statistically significant difference was determined between the groups in respect of the VAS scores preoperatively and at 6 weeks and 6 months. No systemic or local complications were reported during the treatment. There was no statistically significant difference compared to the blinded injection technique, and the mean score differences between the groups are of no clinical relevance.

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

    Directory of Open Access Journals (Sweden)

    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.

  2. Clinical characteristics and outcomes of septic bursitis.

    Science.gov (United States)

    Lieber, Sarah B; Fowler, Mary Louise; Zhu, Clara; Moore, Andrew; Shmerling, Robert H; Paz, Ziv

    2017-12-01

    Limited data guide practice in evaluation and treatment of septic bursitis. We aimed to characterize clinical characteristics, microbiology, and outcomes of patients with septic bursitis stratified by bursal involvement, presence of trauma, and management type. We conducted a retrospective cohort study of adult patients admitted to a single center from 1998 to 2015 with culture-proven olecranon and patellar septic bursitis. Baseline characteristics, clinical features, microbial profiles, operative interventions, hospitalization lengths, and 60-day readmission rates were determined. Patients were stratified by bursitis site, presence or absence of trauma, and operative or non-operative management. Of 44 cases of septic bursitis, patients with olecranon and patellar bursitis were similar with respect to age, male predominance, and frequency of bursal trauma; patients managed operatively were younger (p = 0.05). Clinical features at presentation and comorbidities were similar despite bursitis site, history of trauma, or management. The most common organism isolated from bursal fluid was Staphylococcus aureus. Patients managed operatively were discharged to rehabilitation less frequently (p = 0.04). This study of septic bursitis is among the largest reported. We were unable to identify presenting clinical features that differentiated patients treated surgically from those treated conservatively. There was no clear relationship between preceding trauma or bursitis site and clinical course, management, or outcomes. Patients with bursitis treated surgically were younger. Additional study is needed to identify patients who would benefit from early surgical intervention for septic bursitis.

  3. The effect of efavirenz versus nevirapine-containing regimens on immunologic, virologic and clinical outcomes in a prospective observational study

    NARCIS (Netherlands)

    Collaboration, H.-C.; Koopmans †, P.P.; Brouwer, A.M.; Dofferhoff, A.S.M.; Flier, M. van der; Groot, R. de; Hofstede, H.J.M. ter; Keuter, M.; Ven, A.J.A.M. van der; et al.,

    2012-01-01

    OBJECTIVE: To compare regimens consisting of either efavirenz or nevirapine and two or more nucleoside reverse transcriptase inhibitors (NRTIs) among HIV-infected, antiretroviral-naive, and AIDS-free individuals with respect to clinical, immunologic, and virologic outcomes. DESIGN: Prospective

  4. Long-term outcomes from the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study.

    Science.gov (United States)

    Weiss, Roger D; Potter, Jennifer Sharpe; Griffin, Margaret L; Provost, Scott E; Fitzmaurice, Garrett M; McDermott, Katherine A; Srisarajivakul, Emily N; Dodd, Dorian R; Dreifuss, Jessica A; McHugh, R Kathryn; Carroll, Kathleen M

    2015-05-01

    Despite the growing prevalence of prescription opioid dependence, longitudinal studies have not examined long-term treatment response. The current study examined outcomes over 42 months in the Prescription Opioid Addiction Treatment Study (POATS). POATS was a multi-site clinical trial lasting up to 9 months, examining different durations of buprenorphine-naloxone plus standard medical management for prescription opioid dependence, with participants randomized to receive or not receive additional opioid drug counseling. A subset of participants (N=375 of 653) enrolled in a follow-up study. Telephone interviews were administered approximately 18, 30, and 42 months after main-trial enrollment. Comparison of baseline characteristics by follow-up participation suggested few differences. At Month 42, much improvement was seen: 31.7% were abstinent from opioids and not on agonist therapy; 29.4% were receiving opioid agonist therapy, but met no symptom criteria for current opioid dependence; 7.5% were using illicit opioids while on agonist therapy; and the remaining 31.4% were using opioids without agonist therapy. Participants reporting a lifetime history of heroin use at baseline were more likely to meet DSM-IV criteria for opioid dependence at Month 42 (OR=4.56, 95% CI=1.29-16.04, popioid abstinence. Eight percent (n=27/338) used heroin for the first time during follow-up; 10.1% reported first-time injection heroin use. Long-term outcomes for those dependent on prescription opioids demonstrated clear improvement from baseline. However, a subset exhibited a worsening course, by initiating heroin use and/or injection opioid use. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  5. Clinical outcomes and development of children born to couples with obstructive and nonobstructive azoospermia undergoing testicular sperm extraction-intracytoplasmic sperm injection: A comparative study

    Directory of Open Access Journals (Sweden)

    Yi-Ru Tsai

    2015-04-01

    Conclusion: In our study, there were no differences in the fertility rate and clinic pregnancy rate between the OA and NOA groups using TESE-ICSI. Also, the clinical outcomes and development of children were similar between the OA and the NOA groups using TESE-ICSI.

  6. The Auckland Cataract Study: co-morbidity, surgical techniques, and clinical outcomes in a public hospital service

    Science.gov (United States)

    Riley, Andrew F; Malik, Tahira Y; Grupcheva, Christina N; Fisk, Michael J; Craig, Jennifer P; McGhee, Charles N

    2002-01-01

    Aim: To prospectively assess cataract surgery in a major New Zealand public hospital by defining presenting clinical parameters and surgical and clinical outcomes in a cohort of subjects just below threshold for treatment, based upon a points based prioritisation system. Methods: The prospective observational study comprised 488 eyes of 480 subjects undergoing consecutive cataract operations at Auckland Hospital. All subjects underwent extensive ophthalmic examination before and after surgery. Details of the surgical procedure, including any intraoperative difficulties or complications, were documented. Postoperative review was performed at 1 day and 4 weeks after surgery. Demographic data, clinical outcomes, and adverse events were correlated by an independent assessor. Results: The mean age at surgery was 74.9 (SD 9.6) years with a female predominance (62%). Significant systemic disease affected 80% of subjects, with 20% of the overall cohort exhibiting diabetes mellitus. 26% of eyes exhibited coexisting ocular disease and in 7.6% this affected best spectacle corrected visual acuity (BSCVA). A mean spherical equivalent of −0.49 (1.03) D and mean BSCVA of 0.9 (0.6) log MAR units (Snellen equivalent approximately 6/48) was noted preoperatively. Local anaesthesia was employed in 99.8% of subjects (94.9% sub-Tenon's). The majority of procedures (97.3%) were small incision phacoemulsification with foldable lens implant. Complications included: 4.9% posterior capsule tears, 3.8% cystoid macular oedema, and one case (0.2%) of endophthalmitis. Mean BSCVA after surgery was 0.1 (0.2) log MAR units (6/7.5 Snellen equivalent), with a mean spherical equivalent of −0.46 (0.89) D, and was 6/12 or better in 88% of all eyes. A drop in BSCVA, thought to be directly attributable to the surgical intervention, was recorded in a small percentage of eyes (1.5%) after surgery. Conclusion: This study provides a representative assessment of the management of cataract in the New

  7. VEGF and VEGFR genotyping in the prediction of clinical outcome for HCC patients receiving sorafenib: the ALICE-1 study.

    Science.gov (United States)

    Scartozzi, Mario; Faloppi, Luca; Svegliati Baroni, Gianluca; Loretelli, Cristian; Piscaglia, Fabio; Iavarone, Massimo; Toniutto, Pierluigi; Fava, Giammarco; De Minicis, Samuele; Mandolesi, Alessandra; Bianconi, Maristella; Giampieri, Riccardo; Granito, Alessandro; Facchetti, Floriana; Bitetto, Davide; Marinelli, Sara; Venerandi, Laura; Vavassori, Sara; Gemini, Stefano; D'Errico, Antonietta; Colombo, Massimo; Bolondi, Luigi; Bearzi, Italo; Benedetti, Antonio; Cascinu, Stefano

    2014-09-01

    Although new treatment modalities changed the global approach to hepatocellular carcinoma (HCC), this disease still represents a medical challenge. Currently, the therapeutic stronghold is sorafenib, a tyrosine kinase inhibitor (TKI) directed against the vascular endothelial growth factor (VEGF) family. Previous observations suggested that polymorphisms of VEGF and its receptor (VEGFR) genes may regulate angiogenesis and lymphangiogenesis and thus tumour growth control. The aim of our study was to evaluate the role of VEGF and VEGFR polymorphisms in determining the clinical outcome of HCC patients receiving sorafenib. From a multicentre experience 148 samples (tumour or blood samples) of HCC patients receiving sorafenib were tested for VEGF-A, VEGF-C and VEGFR-1,2,3 single nucleotide polymorphisms (SNPs). Patients' progression-free survival (PFS) and overall survival (OS) were analysed. At univariate analysis VEGF-A alleles C of rs25648, T of rs833061, C of rs699947, C of rs2010963, VEGF-C alleles T of rs4604006, G of rs664393, VEGFR-2 alleles C of rs2071559, C of rs2305948 were significant predictors of PFS and OS. At multivariate analysis rs2010963, rs4604006 and BCLC (Barcelona Clinic Liver Cancer) stage resulted to be independent factors influencing PFS and OS. Once prospectively validated, the analysis of VEGF and VEGFR SNPs may represent a clinical tool to better identify HCC patients more likely to benefit from sorafenib. On the other hand, the availability of more accurate predictive factors could help avoiding unnecessary toxicities to potentially resistant patients who may be optimal candidates for different treatments interfering with other tumour molecular pathways. © 2014 UICC.

  8. 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 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.To examine how the management that patients receive in hospital relates to subsequent outcome.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.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.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.

  9. Plasmapheresis in thrombotic microangiopathy-associated syndromes: review of outcome data derived from clinical trials and open studies.

    Science.gov (United States)

    von Baeyer, Hans

    2002-08-01

    Current reimbursement policy of health insurance for therapeutic plasmapheresis requires proof of efficacy using the concept of evidence-based medicine. The aim of this paper is to review the outcome of plasmapheresis used to treat thrombotic microangiopathy (TMA)-associated syndromes in the last decade to provide scientific evidence to back up reimbursement applications. The strength of evidence of each reviewed study was assessed using the five levels of evidence criteria as defined by the American Society of Hematology in 1996 for assessment of the treatment of immune thrombocytopenia. The level Experimental indication was added for situations where only case reports or small series supported by pathophysiological reasoning are available. The definitions of evidence used in this paper are as follows: Level I, randomized clinical trial with low rates of error (p historical control group; Level V, case series without a control group or expert opinion; and Experimental, case reports and pathophysiological reasoning. The results of this analysis based on the published data is summarized as follows: The indication of plasmapheresis is assigned to Level IV evidence for thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS); cancer/chemotherapy-associated TTP/HUS is assigned to Level V evidence; and TTP/HUS refractory to standard plasma exchange and post-bone marrow transplantation TTP/HUS are assigned to Experimental indication. For both subsets, protein A immunoadsorption is reportedly successful. The other TMA-associated syndromes, hemolysis elevated liver enzymes low platelets and HUS in early childhood, are no indication of plasmapheresis. Two randomized clinical trials were performed in order to demonstrate the superiority of plasma exchange/fresh frozen plasma (PEX/FFP) over plasma transfusion in the management of TTP/HUS. The results prove the greater clinical success of the latter type of plasma administration. Standard PEX/FFP has reduced the

  10. 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

  11. 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.

  12. Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT)

    Science.gov (United States)

    Grieve, Sharon; Perez, Roberto SGM; Birklein, Frank; Brunner, Florian; Bruehl, Stephen; Harden R, Norman; Packham, Tara; Gobeil, Francois; Haigh, Richard; Holly, Janet; Terkelsen, Astrid; Davies, Lindsay; Lewis, Jennifer; Thomassen, Ilona; Connett, Robyn; Worth, Tina; Vatine, Jean-Jacques; McCabe, Candida S

    2017-01-01

    Complex Regional Pain Syndrome (CRPS) is a persistent pain condition that remains incompletely understood and challenging to treat. Historically, a wide range of different outcome measures have been used to capture the multidimensional nature of CRPS. This has been a significant limiting factor in the advancement of our understanding of the mechanisms and management of CRPS. In 2013, an international consortium of patients, clinicians, researchers and industry representatives was established, to develop and agree on a minimum core set of standardised outcome measures for use in future CRPS clinical research, including but not limited to clinical trials within adult populations The development of a core measurement set was informed through workshops and supplementary work, using an iterative consensus process. ‘What is the clinical presentation and course of CRPS, and what factors influence it?’ was agreed as the most pertinent research question that our standardised set of patient-reported outcome measures should be selected to answer. The domains encompassing the key concepts necessary to answer the research question were agreed as: pain, disease severity, participation and physical function, emotional and psychological function, self efficacy, catastrophizing and patient's global impression of change. The final core measurement set included the optimum generic or condition-specific patient-reported questionnaire outcome measures, which captured the essence of each domain, and one clinician reported outcome measure to capture the degree of severity of CRPS. The next step is to test the feasibility and acceptability of collecting outcome measure data using the core measurement set in the CRPS population internationally. PMID:28178071

  13. Self-Reported Adverse Drug Reactions, Medication Adherence, and Clinical Outcomes among Major Depressive Disorder Patients in Ethiopia: A Prospective Hospital Based Study

    Directory of Open Access Journals (Sweden)

    Tadesse Melaku Abegaz

    2017-01-01

    Full Text Available Background. There is paucity of data on prevalence of Adverse Drug Reactions (ADRs and adherence and clinical outcomes of antidepressants. The present study determined the magnitude of ADRs of antidepressants and their impact on the level of adherence and clinical outcome. Methods. A prospective cross-sectional study was conducted among depression patients from September 2016 to January 2017 at Gondar University Hospital psychiatry clinic. The Naranjo ADR probability scale was employed to assess the ADRs. The rate of medication adherence was determined using Morisky Medication Adherence Measurement Scale-Eight. Results. Two hundred seventeen patients participated in the study, more than half of them being males (122; 56.2%. More than one-half of the subjects had low adherence to their medications (124; 57.1% and about 186 (85.7% of the patients encountered ADR. The most common ADR was weight gain (29; 13.2%. More than one-half (125; 57.6% of the respondents showed improved clinical outcome. Optimal level of medication adherence decreased the likelihood of poor clinical outcome by 56.8%. Conclusion. ADRs were more prevalent. However, adherence to medications was very poor in the setup. Long duration of depression negatively affects the rate of adherence. In addition, adherence was found to influence the clinical outcome of depression patients.

  14. Evaluation of functional outcome of pilon fractures managed with limited internal fixation and external fixation: A prospective clinical study.

    Science.gov (United States)

    Meena, Umesh Kumar; Bansal, Mahesh Chand; Behera, Prateek; Upadhyay, Rahul; Gothwal, Gyan Chand

    2017-11-01

    The management of pilon fractures is controversial primarily due to the high rate of complications irrespective of the mode of treatment. Limited internal fixation with external fixation is associated with minimal soft tissue handling. This may reduce the chances of wound dehiscence and infection. This study was designed to evaluate the functional and clinical outcomes in patients treated with limited internal fixation combined with external fixation in pilon fractures. This study was conducted as a prospective clinical study on 56 skeletally mature patients with closed fractures with poor skin condition, and with open grade 1 and grade 2 distal tibial intra-articular fractures. All patients were treated with combined limited internal fixation and ankle spanning external fixation. All fractures in this series united with an average time period of union of 18.3weeks (ranging from 13 weeks to 30 weeks). There was no non-union in any case. There was malunion in 4 cases, varus malunion (>5 degree) in 2 cases and recurvatum in another 2 cases). Excellent to good functional results were observed in 88% cases based on the modified Ovadia and Beals score. The mean ankle dorsiflexion and planter flexion movements were 10.2±5.3 degrees and 27.4±7.2 degrees respectively. infections occurred in 6 patients which included 4 pin tract infections and 2 superficial wound infection, all 6 healed after removal of pin tract and with oral antibiotics. The technique of combined external fixation with internal fixation is safe and effective management option for intra-articular distal tibial fractures.

  15. 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; Keita, S; 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.

  16. Clinical outcomes of the first midwife-led normal birth unit in China: a retrospective cohort study.

    Science.gov (United States)

    Cheung, Ngai Fen; Mander, Rosemary; Wang, Xiaoli; Fu, Wei; Zhou, Hong; Zhang, Liping

    2011-10-01

    to report the clinical outcomes of the first six months of operation of an innovative midwife-led normal birth unit (MNBU) in China in 2008, aiming to facilitate normal birth and enhance midwifery practice. an urban hospital with 2000-3000 deliveries per year. this study was part of a major action research project that led to implementation of the MNBU. A retrospective cohort and a questionnaire survey were used. The data were analysed thematically. the outcomes of the first 226 women accessing the MNBU were compared with a matched retrospective cohort of 226 women accessing standard care. In total, 128 participants completed a satisfaction questionnaire before discharge. mode of birth and model of care. the vaginal birth rate was 87.6% in the MNBU compared with 58.8% in the standard care unit. All women who accessed the MNBU were supported by both a midwife and a birth companion, referred to as 'two-to-one' care. None of the women labouring in the standard care unit were identified as having a birth companion. the concept of 'two-to-one' care emerged as fundamental to women's experiences and utilisation of midwives' skills to promote normal birth and decrease the likelihood of a caesarean section. the MNBU provides an environment where midwives can practice to the full extent of their role. The high vaginal birth rate in the MNBU indicates the potential of this model of care to reduce obstetric intervention and increase women's satisfaction with care within a context of extraordinary high caesarean section rates. midwife-led care implies a separation of obstetric care from maternity care, which has been advocated in many European countries. Copyright © 2010 Elsevier Ltd. All rights reserved.

  17. Clinical predictors of outcome in vitiligo

    Directory of Open Access Journals (Sweden)

    Dave Shriya

    2002-11-01

    Full Text Available The significant inter-patient variability in progression, and response to therapy makes it a great challenge for the physician to predict the outcome of vitiligo at the very outset. Subjective factors like stress, pregnancy, sunburn and illness have been identified as aggravating factors for vitiligo. However, a few studies have evaluated the statistical significance of objective clinical parameters in predicting the outcome of vitiligo. Our retrospective analysis of 199 consecutive patients with vitiligo who presented to our OPD was aimed at evaluation of these objective clinical parameters utilizing a standard proforma. Patients already on treatment, and those with duration of disease less than 6 months were excluded from the study. Progression was defined as an increase in size or number of lesions in the 3 months prior to presentation. In all 76. 9% patients had progression of vitiligo. The clinical parameters significantly associated with progression were a positive family history (p=0. 027, mucosal involvement (p=0. 032, Koebner′s phenomenon (p=0. 036 and nonsegmental vitiligo (p=0. 033. Thrichrome sign, leucotrichia, longer duration and higher age at onset did not correlate significantly with progression. The one significant observation that we found to have the poor prognostic implication in vitiligo is the presence of mucosal vitiligo. The clinical prediction of disease progression at the outset enables the physician to set realistic treatment goals and optimize the therapeutic regimen for the individual patient.

  18. A Korean validation study of the Clinically Useful Anxiety Outcome Scale: Comorbidity and differentiation of anxiety and depressive disorders

    Science.gov (United States)

    Jeon, Sang Won; Ko, Young-Hoon; Yoon, Seoyoung; Pae, Chi-Un; Choi, Joonho; Kim, Jae-Min; Yoon, Ho-Kyoung; Lee, Hoseon; Patkar, Ashwin A.; Zimmerman, Mark

    2017-01-01

    Background This study aimed to evaluate the psychometric properties of the Korean version of the Clinically Useful Anxiety Outcome Scale (CUXOS) and to examine the current diagnostic comorbidity and differential severity of anxiety symptoms between major depressive disorder (MDD) and anxiety disorders. Methodology In total, 838 psychiatric outpatients were analyzed at their intake appointment. Diagnostic characteristics were examined using the structured clinical interview from the DSM-IV because the DSM5 was not available at the start of the study. The CUXOS score was measured and compared with that of 3 clinician rating scales and 4 self-report scales. Principal findings The CUXOS showed excellent results for internal consistency (Cronbach’s α = 0.90), test–retest reliability (r = 0.74), and discriminant and convergent validity. The CUXOS significantly discriminated between different levels of anxiety severity, and the measure was sensitive to change after treatment. Approximately 45% of patients with MDD were additionally diagnosed with anxiety disorders while 55% of patients with anxiety disorders additionally reported an MDD. There was a significant difference in CUXOS scores between diagnostic categories (MDD only, anxiety only, both disorders, and no MDD or anxiety disorder). The CUXOS scores differed significantly between all categories of depression (major, minor, and non-depression) except for the comparison between minor depression and non-depression groups. Conclusions The Korean version of the CUXOS is a reliable and valid measure of the severity of anxiety symptoms. The use of the CUXOS could broaden the understanding of coexisting and differentiating characteristics of anxiety and depression. PMID:28604808

  19. A Korean validation study of the Clinically Useful Anxiety Outcome Scale: Comorbidity and differentiation of anxiety and depressive disorders.

    Directory of Open Access Journals (Sweden)

    Sang Won Jeon

    Full Text Available This study aimed to evaluate the psychometric properties of the Korean version of the Clinically Useful Anxiety Outcome Scale (CUXOS and to examine the current diagnostic comorbidity and differential severity of anxiety symptoms between major depressive disorder (MDD and anxiety disorders.In total, 838 psychiatric outpatients were analyzed at their intake appointment. Diagnostic characteristics were examined using the structured clinical interview from the DSM-IV because the DSM5 was not available at the start of the study. The CUXOS score was measured and compared with that of 3 clinician rating scales and 4 self-report scales.The CUXOS showed excellent results for internal consistency (Cronbach's α = 0.90, test-retest reliability (r = 0.74, and discriminant and convergent validity. The CUXOS significantly discriminated between different levels of anxiety severity, and the measure was sensitive to change after treatment. Approximately 45% of patients with MDD were additionally diagnosed with anxiety disorders while 55% of patients with anxiety disorders additionally reported an MDD. There was a significant difference in CUXOS scores between diagnostic categories (MDD only, anxiety only, both disorders, and no MDD or anxiety disorder. The CUXOS scores differed significantly between all categories of depression (major, minor, and non-depression except for the comparison between minor depression and non-depression groups.The Korean version of the CUXOS is a reliable and valid measure of the severity of anxiety symptoms. The use of the CUXOS could broaden the understanding of coexisting and differentiating characteristics of anxiety and depression.

  20. Clinical research in implant dentistry: study design, reporting and outcome measurements: consensus report of Working Group 2 of the VIII European Workshop on Periodontology.

    Science.gov (United States)

    Tonetti, Maurizio; Palmer, Richard

    2012-02-01

    The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes. Discussions were informed by three systematic reviews on quality of reporting of observational studies (case series, case-control and cohort) and experimental research (randomized clinical trials). An additional systematic review provided information on choice of outcomes and analytical methods. In addition, an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems. The Workshop attempted to clarify the characteristics and the value in dental implant research of different study designs. In most areas, measurable quality improvements over time were identified. The Workshop recognized important aspects that require continued attention by clinical researchers, funding agencies and peer reviewers to decrease potential bias. With regard to choice of outcomes, the limitations of currently used systems were recognized. Three broad outcome domains that need to be captured by future research were identified: (i) patient reported outcome measures, (ii) peri-implant tissue health and (iii) performance of implant supported restorations. Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses. The Workshop recommended that collaboration between clinicians and epidemiologists/clinical trials specialists should be encouraged. Aspects of design aimed at limitation of potential bias should receive attention by clinical researchers, funding agencies and journal editors. Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary standards. Research on outcome

  1. A Study of Clinical Coding Accuracy in Surgery: Implications for the Use of Administrative Big Data for Outcomes Management.

    Science.gov (United States)

    Nouraei, S A R; Hudovsky, A; Frampton, A E; Mufti, U; White, N B; Wathen, C G; Sandhu, G S; Darzi, A

    2015-06-01

    Clinical coding is the translation of clinical activity into a coded language. Coded data drive hospital reimbursement and are used for audit and research, and benchmarking and outcomes management purposes. We undertook a 2-center audit of coding accuracy across surgery. Clinician-auditor multidisciplinary teams reviewed the coding of 30,127 patients and assessed accuracy at primary and secondary diagnosis and procedure levels, morbidity level, complications assignment, and financial variance. Postaudit data of a randomly selected sample of 400 cases were reaudited by an independent team. At least 1 coding change occurred in 15,402 patients (51%). There were 3911 (13%) and 3620 (12%) changes to primary diagnoses and procedures, respectively. In 5183 (17%) patients, the Health Resource Grouping changed, resulting in income variance of £3,974,544 (+6.2%). The morbidity level changed in 2116 (7%) patients (P data are a key engine for knowledge-driven health care provision. They are used, increasingly at individual surgeon level, to benchmark performance. Surgical clinical coding is prone to subjectivity, variability, and error (SVE). Having a specialty-by-specialty understanding of the nature and clinical significance of informatics variability and adopting strategies to reduce it, are necessary to allow accurate assumptions and informed decisions to be made concerning the scope and clinical applicability of administrative data in surgical outcomes improvement.

  2. Clinical manifestations and treatment outcomes of syphilitic uveitis in HIV-negative patients in China: A retrospective case study.

    Science.gov (United States)

    Zhu, Jiang; Jiang, Yuan; Shi, Yewen; Zheng, Bo; Xu, Zhiguo; Jia, Wei

    2017-10-01

    Syphilitic chorioretinitis should be included in differential diagnosis of any form of ocular inflammation. A significantly higher proportion of human immunodeficiency virus (HIV)-positive patients with ocular syphilis as compared to HIV-negative cases have been reported in published studies. However, the clinical signs and symptoms are more insidious in HIV-negative patients who are easily misdiagnosed. We report a series of cases of ocular syphilis and describe the clinical manifestations and treatment outcomes of syphilitic chorioretinitis in HIV-negative patients in China.This was a retrospective case series study. The clinical records of patients with syphilis chorioretinitis were reviewed. Demographic information and findings of fundus fluorescein angiography (FFA), indocyanine green angiography (ICGA), and spectral domain optical coherence tomography (SD-OCT) were analyzed. All patients received the standard treatment. Ophthalmology examination and laboratory evaluation were repeated every 3 months. All changes were recorded. The treatment was considered successful if the patients had no inflammation in both eyes and rapid plasma reagin titer was negative after therapy.The study examined 41 eyes of 28 HIV-negative patients. The main complaints were blurry vision, floaters, and visual field defect. Twenty-seven eyes presented with panuveitis, and all had posterior involvement, including uveitis, vasculitis, chorioretinitis, and optic neuritis. The most common manifestations were uveitis and retinal vasculitis. Disc hyperfluorescence and persistent dark spots were the most common findings on FFA and ICGA. The ill-defined inner segment/outer segment junction was the most frequent manifestation on SD-OCT. Patients were diagnosed with syphilitic uveitis based on positive serological tests. Best-corrected visual acuity (BCVA) was improved in 34 eyes after treatment. Eleven patients were misdiagnosed before serological tests were performed. The delay in treatment

  3. Wound healing outcomes in a diabetic foot ulcer outpatient clinic at an acute care hospital: a retrospective study.

    Science.gov (United States)

    Lu, S H; McLaren, A-M

    2017-10-01

    Patients with diabetic foot ulcers (DFU) have an increased risk of lower extremity amputation. A retrospective chart review of patients with DFUs attending the Foot Treatment and Assessment chiropodist-led outpatient clinic at an inner-city academic hospital was conducted to determine wound healing outcomes and characteristics contributing to outcomes. We reviewed the complete clinical history of 279 patients with 332 DFUs spanning over a five-year period. The mean age of patients was 61.5±12.5 years and most patients (83.5%) had one DFU. The majority of wounds (82.5%) were in the forefoot. Overall, 267/332 (80.5%) wounds healed. A greater proportion of wounds healed in the forefoot (82.5%) and midfoot (87.1%) than hindfoot (51.9%; phealing. Our findings are the first to demonstrate the benefits of chiropodists leading an acute care outpatient clinic in the management of DFUs in Canada and delivers wound healing outcomes equivalent to or exceeding those previously published.

  4. Percutaneous nephrolithotomy among patients with renal anomalies: patient characteristics and outcomes; a subgroup analysis of the clinical research office of the endourological society global percutaneous nephrolithotomy study

    NARCIS (Netherlands)

    Osther, Palle Jörn; Razvi, Hassan; Liatsikos, Evangelos; Averch, Timothy; Crisci, Alfonso; Garcia, Juan Lòpez; Mandal, Arup; de la Rosette, Jean

    2011-01-01

    This study compared the characteristics and outcomes of percutaneous nephrolithotomy (PCNL) in patients with and without renal malformations using the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study database. The CROES PCNL Global Study collected prospective data for

  5. Development of a core outcome set for clinical trials in facial aging: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

    Science.gov (United States)

    Schlessinger, Daniel I; Iyengar, Sanjana; Yanes, Arianna F; Henley, Jill K; Ashchyan, Hovik J; Kurta, Anastasia O; Patel, Payal M; Sheikh, Umar A; Franklin, Matthew J; Hanna, Courtney C; Chen, Brian R; Chiren, Sarah G; Schmitt, Jochen; Deckert, Stefanie; Furlan, Karina C; Poon, Emily; Maher, Ian A; Cartee, Todd V; Sobanko, Joseph F; Alam, Murad

    2017-08-01

    Facial aging is a concern for many patients. Wrinkles, loss of volume, and discoloration are common physical manifestations of aging skin. Genetic heritage, prior ultraviolet light exposure, and Fitzpatrick skin type may be associated with the rate and type of facial aging. Although many clinical trials assess the correlates of skin aging, there is heterogeneity in the outcomes assessed, which limits the quality of evaluation and comparison of treatment modalities. To address the inconsistency in outcomes, in this project we will develop a core set of outcomes that are to be evaluated in all clinical trials relevant to facial aging. A long list of measureable outcomes will be created from four sources: (1) systematic medical literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Two rounds of Delphi processes with homogeneous groups of physicians and patients will be performed to prioritize and condense the list. At a consensus meeting attended by physicians, patients, and stakeholders, outcomes will be further condensed on the basis of participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. Subsequent to this, specific measures will be selected or created to assess these outcomes. The aim of this study is to develop a core outcome set and relevant measures for clinical trials relevant to facial aging. We hope to improve the reliability and consistency of outcome reporting of skin aging, thereby enabling improved evaluation of treatment efficacy and patient satisfaction. Core Outcome Measures in Effectiveness Trials (COMET) Initiative, accessible at http://www.comet-initiative.org/studies/details/737 . Core Outcomes Set Initiative, (CSG-COUSIN) accessible at https://www.uniklinikum-dresden.de/de/das-klinikum/universitaetscentren/zegv/cousin/meet-the-teams/project-groups/core-outcome-set-for-the-appearance-of-facial-aging . Protocol version date is 28

  6. Clinical outcomes of three different types of hardware for the treatment of mandibular angle fractures: a comparative retrospective study.

    Science.gov (United States)

    Elsayed, S A; Mohamed, F I; Khalifa, G A

    2015-10-01

    A retrospective study was conducted to compare the clinical outcomes of three different types of hardware that are used in mandibular angle fracture fixation. Thirty patients were selected from the hospital database. The patients were categorized into the following groups: group A, in which a single 2.0-mm locking miniplate was used; group B, in which a single rigid 2.3-mm plate was used; and group C, in which a single lag screw was inserted. All patients were followed for 6 months. With regard to intraoperative variables, significant differences were found among the groups in the duration of surgery and cost. Group C had the shortest surgical time, followed by group A and then group B. Two patients, one in group A and one in group B, suffered an occlusal discrepancy after surgery. Of the group A patients, two exhibited wound dehiscence and one had an infection. One patient in group B had an exposed plate. Sensory nerve involvement was noted in three group C patients and one group B patient. The lag screw was associated with the fewest complications and exhibited all of the advantages of plating systems in the treatment of angle fracture. The lag screw involved the least hardware and a short operating time, however the differences were not significant. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  7. Prospective clinical study of prosthetic treatment outcome of implantretained-removable-partial-denture during 5 year-follow-ups

    Directory of Open Access Journals (Sweden)

    Mehran Bahrami

    2017-11-01

    Full Text Available Background IRRPD offers patients the ability to upgrade their treatment planning to implant-supported-overdentures (ISOs or implant-supported-fixed-prostheses (ISFPs through insertion of more implants in the future after the loss of the remaining natural teeth. Aims The purpose of this prospective-clinical-study was to evaluate the success rate and treatment outcome of IRRPD for 15 patients, during at least 5-year-follow-ups after prosthetic rehabilitation with respect to implant mobility, peri-implant-marginal-bone-levels, and prosthetic complications. Methods 15 successive patients were attended the Department of Implantology and Prosthodontics in TUMS, and received Implant-Retained-Removable-Partial-Dentures (IRRPDs. Two standard-size-dental-implants (Implantium/Dentium system, internal hexagon, Seoul, South Korea were placed in distal-extension-areas for each patient. After the osseointegration period, all patients received IRRPDs using two Ball attachments. All the participated patients were followed-up at least for 5 years, and the survival rate of 30 implants was evaluated. The patients’ satisfaction of function, phonetics, and aesthetics was assessed by means of questionnaire. Results None of the studied patients reported any prosthetic complications during the follow-up-periods such as attachment loosening, metal housing loosening, or denture fracture. No implants failure was recorded, so that the cumulative-implant-survival rate was 100 per cent. The mean marginal-bone-resorption (MBR around the two implants was 0.9mm with a range of 0.5–1.4mm. Teeth aesthetics was judged as excellent or very good by 86.7 per cent of the patients, while phonetics and mastication were considered excellent or very good by 66.7 per cent and 73.3 per cent of the patients, respectively. Conclusion 15 patients received 30 implants for the fabrication of IRRPDs in the posterior-edentulous-sites. The IRRPDs were delivered to the patients by the same

  8. Scrub typhus: Clinical spectrum and outcome.

    Science.gov (United States)

    Venkategowda, Pradeep M; Rao, S Manimala; Mutkule, Dnyaneshwar P; Rao, Mallela V; Taggu, Alai N

    2015-04-01

    Scrub typhus is one of the differential diagnoses for fever with thrombocytopenia. ARDS associated with Scrub typhus has high morbidity and mortality. To evaluate clinical features, lab values, and outcome in patients with scrub typhus and comparison in patients with or without ARDS. 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. 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 (MAPscrub 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. 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.

  9. Clinical outcome of shoulder muscle transfer for shoulder deformities in obstetric brachial plexus palsy: A study of 150 cases

    Directory of Open Access Journals (Sweden)

    Mukund R Thatte

    2011-01-01

    Full Text Available Background: Residual muscle weakness, cross-innervation (caused by misdirected regenerating axons, and muscular imbalance are the main causes of internal rotation contractures leading to limitation of shoulder joint movement, glenoid dysplasia, and deformity in obstetric brachial plexus palsy. Muscle transfers and release of antagonistic muscles improve range of motion as well as halt or reverse the deterioration in the bony architecture of the shoulder joint. The aim of our study was to evaluate the clinical outcome of shoulder muscle transfer for shoulder abnormalities in obstetric brachial plexus palsy. Materials and Methods: One hundred and fifty patients of obstetric brachial plexus palsy with shoulder deformity underwent shoulder muscle transfer along with anterior shoulder release at our institutions from 1999 to 2007. Shoulder function was assessed both preoperatively and postoperatively using aggregate modified Mallet score and active and passive range of motion. The mean duration of follow-up was 4 years (2.5-8 years. Results: The mean preoperative abduction was 45° ± 7.12, mean passive external rotation was 10° ± 6.79, the mean active external rotation was 0°, and the mean aggregate modified Mallet score was 11.2 ± 1.41. At a mean follow-up of 4 years (2.5-8 years, the mean active abduction was 120° ± 18.01, the mean passive external rotation was 80° ± 10.26, while the mean active external rotation was 45° ± 3.84. The mean aggregate modified Mallet score was 19.2 ± 1.66. Conclusions: This procedure can thus be seen as a very effective tool to treat internal rotation and adduction contractures, achieve functional active abduction and external rotation, as well as possibly prevent glenohumeral dysplasia, though the long-term effects of this procedure may still have to be studied in detail clinico-radiologically to confirm this hypothesis. Level of evidence: Therapeutic level IV

  10. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

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

    2014-01-01

    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......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...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

  11. The Reliability and Validity of the Outcome Rating Scale: A Replication Study of a Brief Clinical Measure

    National Research Council Canada - National Science Library

    Bringhurst, David L; Watson, Curtis W; Miller, Scott D; Duncan, Barry L

    2004-01-01

    ... (Miller, Duncan, Brown, Sparks, AND Claud, 2003). This article reports the findings of an independent replication study evaluating the reliability and concurrent validity of the ORS as studied in a non-clinical sample...

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

    Energy Technology Data Exchange (ETDEWEB)

    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

  13. Thrombolysis and clinical outcome in patients with stroke after implementation of the Tyrol Stroke Pathway: a retrospective observational study.

    Science.gov (United States)

    Willeit, Johann; Geley, Theresa; Schöch, Johannes; Rinner, Heinrich; Tür, Andreas; Kreuzer, Hans; Thiemann, Norbert; Knoflach, Michael; Toell, Thomas; Pechlaner, Raimund; Willeit, Karin; Klingler, Natalie; Praxmarer, Silvia; Baubin, Michael; Beck, Gertrud; Berek, Klaus; Dengg, Christian; Engelhardt, Klaus; Erlacher, Thomas; Fluckinger, Thomas; Grander, Wilhelm; Grossmann, Josef; Kathrein, Hermann; Kaiser, Norbert; Matosevic, Benjamin; Matzak, Heinrich; Mayr, Markus; Perfler, Robert; Poewe, Werner; Rauter, Alexandra; Schoenherr, Gudrun; Schoenherr, Hans-Robert; Schinnerl, Adolf; Spiss, Heinrich; Thurner, Theresa; Vergeiner, Gernot; Werner, Philipp; Wöll, Ewald; Willeit, Peter; Kiechl, Stefan

    2015-01-01

    Intravenous thrombolysis for ischaemic stroke remains underused worldwide. We aimed to assess whether our statewide comprehensive stroke management programme would improve thrombolysis use and clinical outcome in patients. In 2008-09, we designed the Tyrol Stroke Pathway, which provided information campaigns for the public and standardised the entire treatment pathway from stroke onset to outpatient rehabilitation. It was commenced in Tyrol, Austria, as a long-term routine-care programme and aimed to include all patients with stroke in the survey area. We focused on thrombolysis use and outcome in the first full 4 years of implementation (2010-13). We enrolled 4947 (99%) of 4992 patients with ischaemic stroke who were admitted to hospitals in Tyrol; 675 (14%) of the enrollees were treated with alteplase. Thrombolysis administration in Tyrol increased after programme implementation, from 160 of 1238 patients (12·9%, 95% CI 11·1-14·9) in 2010 to 213 of 1266 patients (16·8%, 14·8-19·0) in 2013 (ptrend 2010-13stroke programmes, thrombolysis administration remained stable or declined between 2010 and 2013 (mean reduction 14·4%, 95% CI 10·9-17·9). Although the 3-month mortality was not affected by our programme (137 [13%] of 1060 patients in 2010 vs 143 [13%] of 1069 patients in 2013), 3-month functional outcome significantly improved (modified Rankin Scale score 0-1 in 375 [40%] of 944 patients in 2010 vs 493 [53%] of 939 in 2013; score 0-2 in 531 [56%] patients in 2010 and 615 [65%] in 2013; ptrend 2010-13stroke management programme, thrombolysis administration increased and clinical outcome significantly improved, although mortality did not change. We hope that these results will guide health authorities and stroke physicians elsewhere when implementing similar programmes for patients with stroke. Reformpool of the Tyrolean Health Care Fund. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Correlating nerve conduction studies and clinical outcome measures on carpal tunnel syndrome: lessons from a randomized controlled trial

    NARCIS (Netherlands)

    Schrijver, H.M.; Gerritsen, A.A.M.; Strijers, R.L.; Uitdehaag, B.M.J.; Scholten, R.J.P.M.; de Vet, H.C.W.; Bouter, L.M.

    2005-01-01

    The reported relationships between nerve conduction studies (NCS) and outcome measures in carpal tunnel syndrome (CTS) are weak to moderate. However, selection of patients may have confounded nonrandomized studies. NCS have potentially great value in selecting patients for a specific treatment and

  15. 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...... obtainable by a certain treatment. Chronic LBP patients seem to have a reasonable idea of an acceptable change in pain but overestimate change in functional and psychological /affective domains....

  16. Clinical outcomes of CO2-less single-port video-assisted thoracoscopic thymectomy versus open thymectomy: comparative study.

    Science.gov (United States)

    Aragón, Javier; Pérez Méndez, Itzell; Gutiérrez Pérez, Alexia

    2016-01-01

    Although video-assisted thoracoscopic surgery (VATS) for thymic disorders has been introduced, its oncological outcome and benefits over others open approaches remains unclear. Single-port VATS thymectomy using a flexible port and CO 2 has been described. However, VATS thymectomy is possible by a single incision of 3 cm without CO 2 insufflation or special port device avoiding objections related to CO 2 insufflation and allowing instruments to move more freely making procedure easier and cheaper. Our institutional experience in open and CO 2 -less VATS single-port thymectomy was retrospectively reviewed to evaluate compared to sternotomy, the clinical and oncological outcomes with this novel approach. A retrospective review consisting of 84 patients who underwent thymectomy because different thymic disorders especially thymoma was performed. Eighteen patients underwent CO 2 -less VATS single port thymectomy, while 66 underwent thymectomy through open sternotomy. Many clinical factors associated with the surgical and clinical outcomes, including tumor recurrence and clinical remission, were recorded. Non major postoperative complications were observed in any group. The median operative time and postoperative hospital stay of CO 2 -less VATS single port thymectomy were 95 min and 1 day, respectively and 120 min and 7 days for open sternotomy. The thymoma was the most common thymic disorder with 7 patients (38%) in VATS group and 28 patients (42.4%) for the open approach. The median lesion size was 2.6 cm in the VATS group and 3.2 cm in the open approach. No thymoma recurrence in patients undergoing VATS was observed during the follow-up time, while in the open surgery group 14.28% recurrence was observed, distributed as follows: loco-regional 75% and 25% at distance; free disease period of these patients was 8.3 months. Thymectomy associated with myasthenia gravis (MG) was observed in 6 (33%) patients in the VATS group and 32 (48%) patients for sternotomy; our

  17. Hepatic steatosis after islet transplantation: Can ultrasound predict the clinical outcome? A longitudinal study in 108 patients.

    Science.gov (United States)

    Venturini, Massimo; Maffi, Paola; Querques, Giulia; Agostini, Giulia; Piemonti, Lorenzo; Sironi, Sandro; De Cobelli, Francesco; Fiorina, Paolo; Secchi, Antonio; Del Maschio, Alessandro

    2015-08-01

    Percutaneous intra-portal islet transplantation (PIPIT) is a less invasive, safer, and repeatable therapeutic option for brittle type 1 diabetes, compared to surgical pancreas transplantation. Hepatic steatosis is a consequence of the islet engraftment but it is curiously present in a limited number of patients and its meaning is controversial. The aims of this study were to assess hepatic steatosis at ultrasound (US) after PIPIT investigating its relationship with graft function and its role in predicting the clinical outcome. From 1996 to 2012, 108 patients underwent PIPIT: 83 type-1 diabetic patients underwent allo-transplantation, 25 auto-transplantation. US was performed at baseline, 6, 12, and 24 months, recording steatosis prevalence, first detection, duration, and distribution. Contemporaneously, steatotic and non-steatotic patients were compared for the following parameters: infused islet mass, insulin independence rate, β-score, C-peptide, glycated hemoglobin, exogenous insulin requirement, and fasting plasma glucose. Steatosis at US was detected in 21/108 patients, 20/83 allo-transplanted and 1/25 auto-transplanted, mostly at 6 and 12 months. Infused islet mass was significantly higher in steatotic than non-steatotic patients (IE/kg: S=10.822; NS=6138; p=0.001). Metabolically, steatotic patients had worse basal conditions, but better islet function when steatosis was first detected, after which progressive islet exhaustion, along with steatosis disappearance, was observed. Conversely, in non-steatotic patients these parameters remained stable in time. Number of re-transplantations was significantly higher in steatotic than in non-steatotic patients (1.8 vs 1.1; p=0.001). Steatosis at US seems to be related to the islet mass and local overworking activity. It precedes metabolic alterations and can predict graft dysfunction addressing to therapeutic decisions before islet exhaustion. If steatosis does not appear, no conclusion can be drawn. Copyright

  18. 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.

  19. Pyogenic sacroiliitis: diagnosis, management and clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    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.)

  20. Pyogenic sacroiliitis: diagnosis, management and clinical outcome

    International Nuclear Information System (INIS)

    Kucera, Tomas; Sponer, Pavel; Brtkova, Jindra; Ryskova, Lenka; Popper, Eduard; Frank, Martin; Kucerova, Marie

    2015-01-01

    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.)

  1. Hodgkin lymphoma in children, adolescents and young adults - a comparative study of clinical presentation and treatment outcome.

    Science.gov (United States)

    Englund, Annika; Glimelius, Ingrid; Rostgaard, Klaus; Smedby, Karin E; Eloranta, Sandra; Molin, Daniel; Kuusk, Thomas; Brown, Peter de Nully; Kamper, Peter; Hjalgrim, Henrik; Ljungman, Gustaf; Hjalgrim, Lisa Lyngsie

    2018-02-01

    Hodgkin lymphoma (HL) treatment protocols for children, adolescents and young adults traditionally differ, but the biological and clinical justification for this remains uncertain. We compared age-dependent clinical presentation and treatment and outcome for 1072 classical HL patients 0-24 years diagnosed in Denmark (1990-2010) and Sweden (1992-2009) in pediatric (n = 315, Denmark clinical characteristics was assessed with Pearson's chi 2 -test and Mantel-Haenszel trend test. The Kaplan-Meier method was used for survival analyses. Hazard ratios (HR) were used to compare the different treatment groups and calculated using Cox regression. Children (0-9 years) less often presented with advanced disease than adolescents (10-17 years) and young adults (18-24 years) (stage IIB-IV: children 32% vs. adolescents 50%, and adults 55%; p clinical presentation suggesting a rationale of harmonized treatment for these groups. Both adult and pediatric protocols provided high OS with no significant difference between the departments. The less frequent use of radiotherapy in Danish pediatric patients corresponded to a lower EFS, but comparable OS in all groups confirmed effective rescue strategies for the relapsing patients.

  2. Prospective cohort pilot study of 2-visit CAD/CAM monolithic complete dentures and implant-retained overdentures: Clinical and patient-centered outcomes.

    Science.gov (United States)

    Bidra, Avinash S; Farrell, Kimberly; Burnham, David; Dhingra, Ajay; Taylor, Thomas D; Kuo, Chia-Ling

    2016-05-01

    Presently, no studies have evaluated clinical outcomes or patient-centered outcomes for complete dentures fabricated with computer-aided design and computer aided manufacturing (CAD/CAM) technology. The purpose of this prospective cohort pilot study was to evaluate the clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated in 2 visits. Twenty participants with an existing set of maxillary complete dentures opposing either mandibular complete dentures or implant-retained overdentures that required replacement were recruited in this study. A 2-visit duplicate denture protocol was used to fabricate 40 arches of monolithic dentures with CAD/CAM technology. A 100-mm visual analog scale (VAS) instrument was then used to record 12 outcomes at baseline and at 1-year follow-up. Predetermined values were assigned to grade the VAS rating of each outcome as favorable (70.1-100) and unfavorable (≤70). Favorable ratings were sub-divided as excellent (90.1-100), good (80.1-90), and fair (70.1-80). The clinical outcomes were evaluated independently by 2 experienced prosthodontists at baseline and at 1-year follow-up. Patients evaluated the corresponding patient-centered outcomes during the same time intervals. Additional descriptive variables were also recorded. Each clinical and patient-centered outcome was summarized by medians and ranges. Differences in all ratings recorded at baseline and at 1 year were tested by 1-sided sign test (α=.05). Of 20 participants, 3 were lost to follow-up, and 3 were unsatisfied with the digital dentures and withdrew from the study. These 3 participants were considered treatment failures. Of the 14 remaining participants, 9 had implant-retained mandibular overdentures, and 5 had conventional mandibular complete dentures. For clinical outcomes, the 12 studied outcomes were favorably evaluated by the 2 prosthodontist judges at the 1-year follow-up. Evaluations showed minimal differences between baseline and 1 year. An

  3. Clinical presentation, demographics and outcome of Tuberculosis (TB in a low incidence area: a 4-year study in Geneva, Switzerland

    Directory of Open Access Journals (Sweden)

    Rochat Thierry

    2009-12-01

    Full Text Available Abstract Background The incidence of tuberculosis (TB in developed countries has decreased since the 1990s, reflecting worldwide efforts to identify and treat TB according to WHO recommendations. However TB remains an important public health problem in industrialized countries with a high proportion of cases occurring among subjects originating from high prevalence countries. The aim of this study was to describe clinical and social characteristics of patients with TB and their outcome in a low incidence area with a high immigration rate. Methods Four-year retrospective study based on a computerized database and subsequent review of medical records of all patients with TB followed at the outpatient section of the Division of Pulmonary Diseases, Geneva University Hospital, Switzerland. Results 252 patients (84% foreigners, 25% asylum seekers aged 38 ± 19 yrs were studied (11% co-infected with HIV. TB was intrapulmonary (TBP in 158 cases (63%, extrapulmonary (TBE in 137 (54%, and both in 43 cases (17%. TBP was smear (S+/culture (C+ in 59%, S-/C+ in 37%, S-/C- in 4%. Smoking was significantly associated with cavitary disease. Time from onset of symptoms to diagnosis was 2.1 ± 3.1 months. Initially, 10% were asymptomatic; 35% had no general symptoms. Despite systematic sputum analysis (induced or spontaneous, TBP was confirmed only by bronchoscopy in 38 subjects (24% of TBP. Side effects requiring changes in treatment occurred in 38 cases (11%. Treatment was completed in 210 (83% patients. In 42 cases, follow up was unsuccessful; causes were: failure (n = 2; 0.8%, defaulters (n = 8; 3%, transfer out (n = 28; 11% and death (n = 4; 1.6%. Relapse rate was 0.24 per 100 patient-years. Considering S+ TBP only, success rate was 87%. Conclusion TB in our area is predominantly a disease of young foreign-born subjects. Smoking appears as a possible risk factor for cavitary TBP. Time to diagnosis remains long. Compliance to treatment is satisfactory. Success

  4. The Effect of Anxiety, Depression, and Optimism on Postoperative Satisfaction and Clinical Outcomes in Lumbar Spinal Stenosis and Degenerative Spondylolisthesis Patients: Cohort Study.

    Science.gov (United States)

    Lee, Jaewon; Kim, Hong-Sik; Shim, Kyu-Dong; Park, Ye-Soo

    2017-06-01

    The aim of this study is to evaluate the effect of depression, anxiety, and optimism on postoperative satisfaction and clinical outcomes in patients who underwent less than two-level posterior instrumented fusions for lumbar spinal stenosis and degenerative spondylolisthesis. Preoperative psychological status of subjects, such as depression, anxiety, and optimism, was evaluated using the Hospital Anxiety and Depression Scale (HADS) and the Revised Life Orientation Test (LOT-R). Clinical evaluation was determined by measuring changes in a visual analogue scale (VAS) and the Oswestry Disability Index (ODI) before and after surgery. Postoperative satisfaction of subjects assessed using the North American Spine Society lumbar spine questionnaire was comparatively analyzed against the preoperative psychological status. The correlation between patient's preoperative psychological status (depression, anxiety, and optimism) and clinical outcomes (VAS and ODI) was evaluated. VAS and ODI scores significantly decreased after surgery ( p optimism) was not related to the degree of improvement in clinical outcomes (VAS and ODI) after surgery. However, postoperative satisfaction was moderately correlated with optimism. Anxiety and optimism were more correlated with patient satisfaction than clinical outcomes. Accordingly, the surgeon can predict postoperative satisfaction of patients based on careful evaluation of psychological status before surgery.

  5. Using clinical symptoms to predict adverse maternal and perinatal outcomes in women with preeclampsia: data from the PIERS (Pre-eclampsia Integrated Estimate of RiSk) study.

    Science.gov (United States)

    Yen, Tin-Wing; Payne, Beth; Qu, Ziguang; Hutcheon, Jennifer A; Lee, Tang; Magee, Laura A; Walters, Barry N; von Dadelszen, Peter

    2011-08-01

    Preeclampsia is a leading cause of maternal morbidity. The clinical challenge lies in predicting which women with preeclampsia will suffer adverse outcomes and would benefit from treatment, while minimizing potentially harmful interventions. Our aim was to determine the ability of maternal symptoms (i.e., severe nausea or vomiting, headache, visual disturbance, right upper quadrant pain or epigastric pain, abdominal pain or vaginal bleeding, and chest pain or dyspnea) to predict adverse maternal or perinatal outcomes. We used data from the PIERS (Pre-eclampsia Integrated Estimate of RiSk) study, a multicentre, prospective cohort study designed to investigate the maternal risks associated with preeclampsia. Relative risks and receiver operating characteristic (ROC) curves were assessed for each preeclampsia symptom and outcome pair. Of 2023 women who underwent assessment, 52% experienced at least one preeclampsia symptom, with 5.2% and 5.3% respectively experiencing an adverse maternal or perinatal outcome. No symptom and outcome pair, in either of the maternal or perinatal groups, achieved an area under the ROC curve value > 0.7, which would be necessary to demonstrate a discriminatory predictive value. Maternal symptoms of preeclampsia are not independently valid predictors of maternal adverse outcome. Caution should be used when making clinical decisions on the basis of symptoms alone in the preeclamptic patient.

  6. A systematic review assessing non-pharmacological conservative treatment studies for people with non-inflammatory multi-joint pain: clinical outcomes and research design considerations.

    Science.gov (United States)

    Comer, C; Smith, T O; Drew, B; Raja, R; Kingsbury, S R; Conaghan, Philip G

    2018-03-01

    To systematically review the evidence to determine the clinical outcomes and the important methodological quality features of interventional studies on adults with non-inflammatory multi-joint pain (MJP). Systematic search of published and unpublished literature using the databases: AMED, CINAHL, MEDLINE, EMBASE, psycINFO, SPORTDiscus, PEDro, OpenGrey, the EU Clinical Trials Register, World Health Organization International Clinical Trial Registry Platform, ClinicalTrials.gov and the ISRCTN registry (search: inception to 19th October 2017). All papers reporting the clinical outcomes of non-pharmacological interventions for people with non-inflammatory MJP were included. Studies were critically appraised using the Downs and Black Critical Appraisal and the TIDieR reporting checklists. Data were analysed using a Best Evidence Synthesis approach. From 3824 citations, four papers satisfied the eligibility criteria. Three studies reported outcomes from multidisciplinary rehabilitation programmes and one study reported the findings of a spa therapy intervention. All interventions significantly improved pain, function and quality of life in the short-term. There was limited reporting of measures for absenteeism, presenteeism and psychosocial outcomes. The evidence was 'weak', and due to a lack of controlled trials, there is limited evidence to ascertain treatment effectiveness. Design consideration for future trials surround improved reporting of participant characteristics, interventions and the standardisation of core outcome measures. There is insufficient high-quality trial data to determine the effectiveness of treatments for non-inflammatory MJP. Given the significant health burden which this condition presents on both individuals and wider society, developing and testing interventions and accurately reporting these, should be a research priority. Registration PROSPERO (CRD42013005888).

  7. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of quality of life outcome measures in clinical practice.

    Science.gov (United States)

    Janicak, Philip G; Dunner, David L; Aaronson, Scott T; Carpenter, Linda L; Boyadjis, Terrence A; Brock, David G; Cook, Ian A; Lanocha, Karl; Solvason, Hugh B; Bonneh-Barkay, Dafna; Demitrack, Mark A

    2013-12-01

    Transcranial magnetic stimulation (TMS) is an effective and safe therapy for major depressive disorder (MDD). This study assessed quality of life (QOL) and functional status outcomes for depressed patients after an acute course of TMS. Forty-two, U.S.-based, clinical TMS practice sites treated 307 outpatients with a primary diagnosis of MDD and persistent symptoms despite prior adequate antidepressant pharmacotherapy. Treatment parameters were based on individual clinical considerations and followed the labeled procedures for use of the approved TMS device. Patient self-reported QOL outcomes included change in the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the EuroQol 5-Dimensions (EQ-5D) ratings from baseline to end of the acute treatment phase. Statistically significant improvement in functional status on a broad range of mental health and physical health domains was observed on the SF-36 following acute TMS treatment. Similarly, statistically significant improvement in patient-reported QOL was observed on all domains of the EQ-5D and on the General Health Perception and Health Index scores. Improvement on these measures was observed across the entire range of baseline depression symptom severity. These data confirm that TMS is effective in the acute treatment of MDD in routine clinical practice settings. This symptom benefit is accompanied by statistically and clinically meaningful improvements in patient-reported QOL and functional status outcomes.

  8. Moderate efficiency of clinicians' predictions decreased for blurred clinical conditions and benefits from the use of BRASS index. A longitudinal study on geriatric patients' outcomes.

    Science.gov (United States)

    Signorini, Giulia; Dagani, Jessica; Bulgari, Viola; Ferrari, Clarissa; de Girolamo, Giovanni

    2016-01-01

    Accurate prognosis is an essential aspect of good clinical practice and efficient health services, particularly for chronic and disabling diseases, as in geriatric populations. This study aims to examine the accuracy of clinical prognostic predictions and to devise prediction models combining clinical variables and clinicians' prognosis for a geriatric patient sample. In a sample of 329 consecutive older patients admitted to 10 geriatric units, we evaluated the accuracy of clinicians' prognosis regarding three outcomes at discharge: global functioning, length of stay (LoS) in hospital, and destination at discharge (DD). A comprehensive set of sociodemographic, clinical, and treatment-related information were also collected. Moderate predictive performance was found for all three outcomes: area under receiver operating characteristic curve of 0.79 and 0.78 for functioning and LoS, respectively, and moderate concordance, Cohen's K = 0.45, between predicted and observed DD. Predictive models found the Blaylock Risk Assessment Screening Score together with clinicians' judgment relevant to improve predictions for all outcomes (absolute improvement in adjusted and pseudo-R(2) up to 19%). Although the clinicians' estimates were important factors in predicting global functioning, LoS, and DD, more research is needed regarding both methodological aspects and clinical measurements, to improve prognostic clinical indices. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Comparing student clinical self-efficacy and team process outcomes for a DEU, blended, and traditional clinical setting: A quasi-experimental research study.

    Science.gov (United States)

    Plemmons, Christina; Clark, Michele; Feng, Du

    2018-03-01

    Clinical education is vital to both the development of clinical self-efficacy and the integration of future nurses into health care teams. The dedicated education unit clinical teaching model is an innovative clinical partnership, which promotes skill development, professional growth, clinical self-efficacy, and integration as a team member. Blended clinical teaching models are combining features of the dedicated education unit and traditional clinical model. The aims of this study are to explore how each of three clinical teaching models (dedicated education unit, blended, traditional) affects clinical self-efficacy and attitude toward team process, and to compare the dedicated education unit model and blended model to traditional clinical. A nonequivalent control-group quasi-experimental design was utilized. The convenience sample of 272 entry-level baccalaureate nursing students included 84 students participating in a dedicated education unit model treatment group, 66 students participating in a blended model treatment group, and 122 students participating in a traditional model control group. Perceived clinical self-efficacy was evaluated by the pretest/posttest scores obtained on the General Self-Efficacy scale. Attitude toward team process was evaluated by the pretest/posttest scores obtained on the TeamSTEPPS® Teamwork Attitude Questionnaire. All three clinical teaching models resulted in significant increases in both clinical self-efficacy (p=0.04) and attitude toward team process (p=0.003). Students participating in the dedicated education unit model (p=0.016) and students participating in the blended model (pteam process among entry-level baccalaureate nursing students. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. Abdominal tuberculosis: clinical presentation and outcome

    International Nuclear Information System (INIS)

    Kumar, R.; Saddique, M.; Iqbal, P.

    2007-01-01

    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)

  11. Risk Factors, Clinical Presentation, and Outcomes in Overdose With Acetaminophen Alone or With Combination Products: Results From the Acute Liver Failure Study Group.

    Science.gov (United States)

    Serper, Marina; Wolf, Michael S; Parikh, Nikhil A; Tillman, Holly; Lee, William M; Ganger, Daniel R

    2016-01-01

    Acetaminophen (APAP) is the most common cause of acute liver failure (ALF) in the west. It is unknown if APAP overdose in combination with diphenhydramine or opioids confers a different clinical presentation or prognosis. Study objectives were to compare (1) baseline patient characteristics; (2) initial clinical presentation; and (3) clinical outcomes among patients with ALF due to APAP alone or in combination with diphenhydramine or opioids. We analyzed 666 cases of APAP-related liver failure using the Acute Liver Failure Study Group database from 1998 to 2012. The database contains detailed demographic, laboratory, and clinical outcome data, including hemodialysis, transplantation, and death and in-hospital complications such as arrhythmia and infection. The final sample included 666 patients with APAP liver injury. A total 30.3% of patients were overdosed with APAP alone, 14.1% with APAP/diphenhydramine, and 56.6% with APAP/opioids. Patients taking APAP with opioids were older, had more comorbidities, and were more likely to have unintentional overdose (all Ppresentation, 58% in the APAP/opioid group had advanced encephalopathy as compared with 43% with APAP alone (P=0.001) The APAP/diphenhydramine group presented with the highest serum aminotransferase levels, no differences in laboratory values were noted at 3 days postenrollment. No significant differences were observed in clinical outcomes among the groups. Most patients with APAP-induced ALF were taking APAP combination products. There were significant differences in patient characteristics and clinical presentation based on the type of product ingested, however, there were no differences noted in delayed hepatotoxicity or clinical outcomes.

  12. 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

    Directory of Open Access Journals (Sweden)

    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.

  13. Characteristics, clinical course, and outcomes of homeless and non-homeless patients admitted to ICU: A retrospective cohort study.

    Directory of Open Access Journals (Sweden)

    Orla M Smith

    Full Text Available Little is known about homeless patients in intensive care units (ICUs.To compare clinical characteristics, treatments, and outcomes of homeless to non-homeless patients admitted to four ICUs in a large inner-city academic hospital.63 randomly-selected homeless compared to 63 age-, sex-, and admitting-ICU-matched non-homeless patients.Compared to matched non-homeless, homeless patients (average age 48±12 years, 90% male, 87% admitted by ambulance, 56% mechanically ventilated, average APACHE II 17 had similar comorbidities and illness severity except for increased alcohol (70% vs 17%,p<0.001 and illicit drug(46% vs 8%,p<0.001 use and less documented hypertension (16% vs 40%,p = 0.005 or prescription medications (48% vs 67%,p<0.05. Intensity of ICU interventions was similar except for higher thiamine (71% vs 21%,p<0.0001 and nicotine (38% vs 14%,p = 0.004 prescriptions. Homeless patients exhibited significantly lower Glasgow Coma Scores and significantly more bacterial respiratory cultures. Longer durations of antibiotics, vasopressors/inotropes, ventilation, ICU and hospital lengths of stay were not statistically different, but homeless patients had higher hospital mortality (29% vs 8%,p = 0.005. Review of all deaths disclosed that withdrawal of life-sustaining therapy occurred in similar clinical circumstances and proportions in both groups, regardless of family involvement. Using multivariable logistic regression, homelessness did not appear to be an independent predictor of hospital mortality.Homeless patients, admitted to ICU matched to non-homeless patients by age and sex (characteristics most commonly used by clinicians, have higher hospital mortality despite similar comorbidities and illness severity. Trends to longer durations of life supports may have contributed to the higher mortality. Additional research is required to validate this higher mortality and develop strategies to improve outcomes in this vulnerable population.

  14. A Comparative Study of Clinical Presentation and Risk Factors for Adverse Outcome in Patients Hospitalised with Acute Respiratory Disease Due to MERS Coronavirus or Other Causes.

    Directory of Open Access Journals (Sweden)

    Musa A Garbati

    Full Text Available Middle East Respiratory syndrome (MERS first emerged in Saudi Arabia in 2012 and remains a global health concern. The objective of this study was to compare the clinical features and risk factors for adverse outcome in patients with RT-PCR confirmed MERS and in those with acute respiratory disease who were MERS-CoV negative, presenting to the King Fahad Medical City (KFMC in Riyadh between October 2012 and May 2014. The demographics, clinical and laboratory characteristics and clinical outcomes of patients with RT-PCR confirmed MERS-CoV infection was compared with those testing negative MERS-CoV PCR. Health care workers (HCW with MERS were compared with MERS patients who were not health care workers. One hundred and fifty nine patients were eligible for inclusion. Forty eight tested positive for MERS CoV, 44 (92% being hospital acquired infections and 23 were HCW. There were 111 MERS-CoV negative patients with acute respiratory illnesses included in this study as "negative controls". Patient with confirmed MERS-CoV infection were not clinically distinguishable from those with negative MERS-CoV RT-PCR results although diarrhoea was commoner in MERS patients. A high level of suspicion in initiating laboratory tests for MERS-CoV is therefore indicated. Variables associated with adverse outcome were older age and diabetes as a co-morbid illness. Interestingly, co-morbid illnesses other than diabetes were not significantly associated with poor outcome. Health care workers with MERS had a markedly better clinical outcome compared to non HCW MERS patients.

  15. Prediabetes in pregnancy, can early intervention improve outcomes? A feasibility study for a parallel randomised clinical trial.

    Science.gov (United States)

    Hughes, Ruth C E; Rowan, Janet; Williman, Jonathan

    2018-03-03

    Measurement of glycated haemoglobin (HbA1c) in early pregnancy is routine in New Zealand to identify women with diabetes and prediabetes. However, the benefit of early intervention in women with prediabetes is inconclusive. Our aim was to test the feasibility of a two-arm parallel randomised controlled trial of standard care versus early intervention in pregnancies complicated by prediabetes. Two tertiary referral centres in New Zealand. Women measured at booking, without pre-existing diabetes. Randomisation was done by remote web-based allocation into one of two groups. Women in the early intervention group attended an antenatal diabetes clinic, commenced daily home blood glucose monitoring, and medication was prescribed if lifestyle measures failed to maintain target blood glucose levels. Controls received lifestyle education, continued standard care with their midwife and/or obstetrician, and were asked to perform a 75 g oral glucose tolerance test at 24 weeks' gestation with a referral to clinic if this test was positive. Both groups received lifestyle questionnaires at recruitment and in late pregnancy. Recruitment rate, adherence to protocol and validation of potential primary outcomes. Recruitment rates were lower than expected, especially in Māori and Pacific women. Non-adherence to allocated treatment protocol was significant, 42% (95% CI 24% to 61%) in the early intervention group and 30% (95% CI 16% to 51%) in controls. Caesarean section and pre-eclampsia were signalled as potential primary outcomes, due to both the high observed incidence in the control group and ease of measurement. For a future definitive trial, extending the gestation of eligibility and stepped-wedge cluster randomisation may overcome the identified feasibility issues. Consistent with published observational data, pre-eclampsia and emergency caesarean section could be included as primary outcome measures, both of which have a significant impact on maternal and neonatal morbidity and

  16. Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

    Science.gov (United States)

    Ma, Christopher; Panaccione, Remo; Fedorak, Richard N; Parker, Claire E; Khanna, Reena; Levesque, Barrett G; Sandborn, William J; Feagan, Brian G; Jairath, Vipul

    2017-06-09

    Crohn's disease (CD) and ulcerative colitis (UC), the main forms of inflammatory bowel disease (IBD), are chronic, progressive and disabling disorders of the gastrointestinal tract. Although data from randomised controlled trials (RCTs) provide the foundation of evidence that validates medical therapy for IBD, considerable heterogeneity exists in the measured outcomes used in these studies. Furthermore, in recent years, there has been a paradigm shift in IBD treatment targets, moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance, inflammatory biomarkers and histological and radiographic end points. The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development. Accordingly, there exists a need to harmonise measures used in clinical trials through the development of a core outcome set (COS). The development of an IBD-specific COS includes four steps. First, a systematic literature review is performed to identify outcomes previously used in IBD RCTs. Second, semistructured qualitative interviews are conducted with key stakeholders, including patients, clinicians, researchers, pharmaceutical industry representatives, healthcare payers and regulators to identify additional outcomes of importance. Using the outcomes generated from literature review and stakeholder interviews, an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS. Finally, a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials. Given that over 30 novel therapeutic compounds are in development for IBD treatment, the design of robust clinical trials measuring relevant and standardised outcomes is crucial. Standardising outcomes through a COS will reduce heterogeneity in trial reporting, facilitate valid comparisons of new therapies and improve

  17. Outcomes of treatment of drug-susceptible tuberculosis at public sector primary healthcare clinics in Johannesburg, South Africa: A retrospective cohort study.

    Science.gov (United States)

    Budgell, E P; Evans, D; Schnippel, K; Ive, P; Long, L; Rosen, S

    2016-09-05

    Despite the large number of tuberculosis (TB) patients treated in South Africa (SA), there are few descriptions in the published literature of drug-susceptible TB patient characteristics, mode of diagnosis or treatment outcomes in routine public sector treatment programmes. To enhance the evidence base for public sector TB treatment service delivery, we reported the characteristics of and outcomes for a retrospective cohort of adult TB patients at public sector clinics in the Johannesburg Metropolitan Municipality (JHB), SA. We collected medical record data for a retrospective cohort of adult (≥18 years) TB patients registered between 1 April 2011 and 31 March 2012 at three public sector clinics in JHB. Data were abstracted from National TB Programme clinic cards and the TB case registers routinely maintained at study sites. We report patient characteristics, mode of diagnosis, mode of treatment supervision, treatment characteristics, HIV status and treatment outcomes for this cohort. A total of 544 patients were enrolled in the cohort. Most (86%) were new TB cases, 81% had pulmonary TB, 58% were smear-positive at treatment initiation and 71% were HIV co-infected. Among 495 patients with treatment outcomes reported, 80% (n=394) had successful outcomes, 11% (n=55) were lost to follow-up, 8% (n=40) died and 1% (n=6) failed treatment. Primary healthcare clinics in JHB are achieving relatively high rates of success in treating drug-susceptible TB. Missing laboratory results were common, including follow-up smears, cultures and drug susceptibility tests, making it difficult to assess adherence to guidelines and leaving scope for substantial improvements in record-keeping at the clinics involved.

  18. The clinical outcome of childhood masturbation.

    Science.gov (United States)

    Unal, F

    2000-01-01

    This study was performed to investigate the clinical outcome of childhood masturbation. For this purpose 50 children (mean age = 48.7 +/- 24.5 months, 34 girls females and 16 boys males) with masturbation symptoms were examined at first visit to the Department of Child Psychiatry and two years thereafter with psychiatric interviews. The mean masturbation frequency at the initial interview was significantly decreased after two years. It was noted that 39 children (78%) were completely recovered and 11 children (22%) continued to masturbate after two years. Children who did not recover were significantly younger, began to masturbate earlier and masturbated more frequently than others at the time of initial evaluation. It was concluded that the findings about the beneficial effect of sedative drugs in combination with parental guidance, education and means for behavior modification were promising.

  19. Clinical characteristics and outcomes of familial and idiopathic ...

    African Journals Online (AJOL)

    Clinical characteristics and outcomes of familial and idiopathic dilated cardiomyopathy in Cape Town: A comparative study of 120 cases followed up over 14 years. NBA Ntusi, M Badri, F Gumedze, A Wonkam, BM Mayosi ...

  20. Clinical outcomes in traumatic pseudophacocele: A rare clinical entity.

    Science.gov (United States)

    Narang, Priya; Agarwal, Amar

    2017-12-01

    The purpose of this study is to evaluate the clinical outcomes in patients with traumatic pseudophacocele. In this retrospective, interventional case series, scleral wound repair with pars plana vitrectomy and glued intrascleral fixation of an intraocular lens (glued IOL) was performed in 5 eyes of 5 patients. Pupilloplasty was performed in 3 cases whereas aniridia glued IOL fixation was done in 1 case that had total avulsion and loss of iris tissue. The main outcome measures were best-corrected visual acuity (BCVA), intraoperative and postoperative complications during the entire follow-up period. The preoperative vision ranged from hand movement to perception of light in all the patients. The mean postoperative BCVA was 0.42 ± 0.21 Snellen's decimal equivalent (SDE) at final follow-up. Postoperatively, all the cases retained good visual acuity with case 1 and case 2 reporting 0.5 SDE, case 3 had 0.33 SDE, case 5 had 0.67 SDE whereas case 4 had a final visual acuity limited to 0.1 SDE due to associated corneal opacity. The mean follow-up period was 20.2 ± 11.7 months (range from 9 months to 36 months). The IOL was well centered, all the wounds were well apposed and the mean postoperative intraocular pressure was 14.6 ± 1.95 mm Hg. No complications were reported in the entire follow-up period. The clinical outcomes of management of pseudophacocele were encouraging with retention of reasonably good visual potential in all cases.

  1. Time to Angiographic Reperfusion and Clinical Outcome after Acute Ischemic Stroke in the Interventional Management of Stroke Phase III (IMS III) Trial: A Validation Study

    Science.gov (United States)

    Khatri, Pooja; Yeatts, Sharon D.; Mazighi, Mikael; Broderick, Joseph P.; Liebeskind, David S.; Demchuk, Andrew M.; Amarenco, Pierre; Carrozzella, Janice; Spilker, Judith; Foster, Lydia D.; Goyal, Mayank; Hill, Michael D.; Palesch, Yuko Y.; Jauch, Edward C.; Haley, E. Clarke; Vagal, Achala; Tomsick, Thomas A.

    2014-01-01

    BACKGROUND The IMS III Trial did not demonstrate clinical benefit of the endovascular approach compared to IV rt-PA alone for moderate or severe ischemic strokes (NIHSS≥8) enrolled within three hours of stroke onset. Late reperfusion of tissue that is no longer salvageable may be one explanation, as suggested by prior exploratory studies showing an association between time to reperfusion and good clinical outcome. We sought to validate this relationship in the large-scale IMS III trial, and consider its implications for future endovascular trials. METHODS The analysis consisted of the endovascular cohort with proximal arterial occlusions in the anterior circulation that achieved angiographic reperfusion (TICI 2–3) during the endovascular procedure (within 7 hours from the onset of symptoms). Logistic regression was used to model good clinical outcome (90-day modified Rankin 0–2) as a function of the time to reperfusion, and prespecified variables were considered for adjustment. FINDINGS Among 240 proximal vessel occlusions, angiographic reperfusion (TICI 2–3) was achieved in 182 (76%). Mean time to reperfusion was 325 minutes (range 180–418 minutes). Longer time for reperfusion was associated with a decreased likelihood of good clinical outcome (RR [95% CI] for every 30 minute delay: unadjusted 0·85 [0·77–0·94]; adjusted 0·88 [0·80–0·98]). INTERPRETATION We confirm that delay in time to angiographic reperfusion leads to a decreased likelihood of good clinical outcome. Achieving rapid reperfusion may be critical for the successes of future acute endovascular trials. FUNDING: NIH/NINDS (study sponsor), Genentech Inc. (study drug - intra-arterial t-PA), EKOS Corp. (device), Concentric Inc. (device), Cordis Neurovascular, Inc. (device), and Boehringer Ingelheim (European Investigator Meeting support). PMID:24784550

  2. Accuracy of glenoid component placement in total shoulder arthroplasty and its effect on clinical and radiological outcome in a retrospective, longitudinal, monocentric open study.

    Directory of Open Access Journals (Sweden)

    Thomas M Gregory

    Full Text Available BACKGROUND: The success of Total Shoulder Arthroplasty (TSA is believed to depend on the restoration of the natural anatomy of the joint and a key development has been the introduction of modular humeral components to more accurately restore the patient's anatomy. However, there are no peer-reviewed studies that have reported the degree of glenoid component mal-position achieved in clinical practice and the clinical outcome of such mal-position. The main purpose of this study was to assess the accuracy of glenoid implant positioning during TSA and to relate it to the radiological (occurrence of radiolucent lines and osteolysis on CT and clinical outcomes. METHODS: 68 TSAs were assessed with a mean follow-up of 38+/-27 months. The clinical evaluation consisted of measuring the mobility as well as of the Constant Score. The radiological evaluation was performed on CT-scans in which metal artefacts had been eliminated. From the CT-scans radiolucent lines and osteolysis were assessed. The positions of the glenoid and humeral components were also measured from the CT scans. RESULTS: Four position glenoid component parameters were calculated The posterior version (6°±12°; mean ± SD, the superior tilt (12°±17°, the rotation of the implant relative to the scapular plane (3°±14° and the off-set distance of the centre of the glenoid implant from the scapular plane (6±4 mm. An inferiorly inclined implant was found to be associated with higher levels of radiolucent lines while retroversion and non-neutral rotation were associated with a reduced range of motion. CONCLUSION: this study demonstrates that glenoid implants of anatomic TSA are poorly positioned and that this malposition has a direct effect on the clinical and radiological outcome. Thus, further developments in glenoid implantation techniques are required to enable the surgeon to achieve a desired implant position and outcome.

  3. Predictors of functional and clinical outcome in early-onset first-episode psychosis: the child and adolescent first episode of psychosis (CAFEPS) study.

    Science.gov (United States)

    Parellada, Mara; Castro-Fornieles, Josefina; Gonzalez-Pinto, Ana; Pina-Camacho, Laura; Moreno, Dolores; Rapado-Castro, Marta; Otero, Soraya; de la Serna, Elena; Moreno, Carmen; Baeza, Inmaculada; Graell, Montserrat; Arango, Celso

    2015-11-01

    The objective of this study was to study baseline clinical and biological predictors of 2-year outcome in a cohort of children and adolescents with a first episode of psychosis. Standard instruments were used to evaluate symptoms and functioning in 110 children and adolescents (mean age = 15.47 years) with first episode of psychosis at admission (between 2003 and 2005) and after 2-year follow-up. Clinical assessments included diagnostic assessment to yield DSM-IV diagnosis, developmental, premorbid, and past-year data, together with structural neuroimaging and other biological parameters (genetics and oxidative stress). Eighty-three subjects had assessments at baseline (including the Strauss-Carpenter Outcome Scale [SCOS]) and at 2-year follow-up. Association and multistep regression analyses were conducted to show correlates and predictors of primary outcome measures: functional outcome (Children's Global Assessment Scale [CGAS]), improvement (CGAS change), and primary negative symptoms (Proxy for the Deficit Syndrome Scale). The SCOS predicted 27.46% (P < .001) of the variance in CGAS score at 2 years. Baseline severity (measured by CGAS) predicted 30.9% (P < .001) of CGAS improvement after 2 years, and SCOS total score predicted an added 24.1% (P < .001). A diagnosis of nonaffective psychosis, primary negative symptoms, and less white matter at baseline predicted more primary negative symptoms at follow-up. The prediction of functional outcome was not increased by genetic, oxidative stress, or neurostructural markers. Baseline clinical assessments have a better predictive value than biological assessments for 2-year follow-up functioning of children and adolescents with a first episode of psychosis. Patients with primary negative symptoms at baseline continue to have negative symptoms 2 years later, and neurostructural markers predict these. Clinicians must still rely on clinical variables to judge the functional prognosis of early-onset first psychotic episodes

  4. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

    Science.gov (United States)

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

    2011-12-01

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

  5. Clinical manifestations and outcome of tuberculous sclerokeratitis.

    Science.gov (United States)

    Shoughy, Samir S; Jaroudi, Mahmoud O; Tabbara, Khalid F

    2016-09-01

    To study the clinical manifestations and outcome of patients with tuberculous sclerokeratitis treated with antituberculous therapy without concomitant use of systemic steroids. We reviewed retrospectively the medical records of eight consecutive patients with tuberculous sclerokeratitis. Patients were treated unsuccessfully with topical and/or systemic steroids. They underwent complete ophthalmic examination, systemic evaluation, laboratory investigations and imaging. Tuberculin skin test was done with purified protein derivative (PPD) on all patients. The diagnosis of tuberculous sclerokeratitis was made based on clinical findings of scleritis with adjacent peripheral corneal stromal keratitis, positive PPD test of 15 mm of induration or more, response to antituberculous treatment (ATT) within 4 weeks and exclusion of other causes of sclerokeratitis. Antituberculous drugs were given for a minimum of 6 months without concomitant use of corticosteroids. The outcome measure was resolution of the ocular surface inflammation of the sclera and cornea. Eight consecutive patients with a diagnosis of tuberculous sclerokeratitis were included. There were one male and seven female patients. The mean age was 29 years with an age range of 7-43 years. The involvement of the sclera was nodular in six patients and diffuse in two. The involvement of the cornea consisted of peripheral corneal stromal inflammation adjacent to the area of scleritis. Patients responded to antituberculous medications with complete resolution of the sclerokeratitis without topical or systemic anti-inflammatory agents. Antituberculous medications can lead to complete resolution of the sclerokeratitis without concomitant use of steroids, or other anti-inflammatory agents. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  6. Functional heartburn: clinical characteristics and outcome.

    Science.gov (United States)

    Surdea Blaga, Teodora; Dumitrascu, Dan; Galmiche, Jean-Paul; Bruley des Varannes, Stanislas

    2013-03-01

    Patients with heartburn and normal upper gastrointestinal endoscopy, normal oesophageal acid exposure, no symptom-reflux association and who fail to respond to a proton-pump inhibitor are classified as having functional heartburn (FH). This study aimed (i) to characterize the symptoms and functional abnormalities of patients with FH and (ii) to describe their clinical outcome. Among all patients referred for 24 h multichannel intraluminal impedance-pH (MII-pH), patients with FH were identified. The clinical characteristics and high-resolution oesophageal pressure topography recordings of FH patients were analyzed at the time of the 24-h MII-pH test. A symptom-related and health-related quality-of-life questionnaire was then sent to FH patients to assess the long-term outcome. Forty patients fulfilled the criteria for FH, representing 8.5% of the referred population. Twenty-two months after initial testing, 66% of patients still suffered from heartburn. The rate of mixed reflux (liquid/gas) was higher in patients with persisting heartburn at the final evaluation (63 vs. 50%, P=0.04). Sixty-six per cent of patients had one or more manometric abnormalities. Acid clearance time in MII-pH was significantly higher in patients with weak peristalsis than patients with normal peristalsis (60 ± 45 vs. 31 ± 19 s, P=0.03). A high rate of mixed reflux and/or a manometric abnormality were associated with a higher risk of persistent heartburn. FH is a chronic disorder with persisting symptoms in two-thirds of patients. An increased rate of mixed reflux and/or the presence of manometric abnormalities are associated with a higher risk of persisting symptoms and may help to identify the population with unmet therapeutic needs.

  7. Clinical Features and Outcomes of Gastric Ischemia.

    Science.gov (United States)

    Sharma, Ayush; Mukewar, Saurabh; Chari, Suresh T; Wong Kee Song, Louis M

    2017-12-01

    Gastric ischemia is a rare condition associated with poor prognosis. Our study aim was to highlight the clinical features and outcomes of patients with gastric ischemia. A retrospective review of patients diagnosed with isolated gastric ischemia at our institution from January 1, 2000, to May 5, 2016, was performed. Demographic, clinical, endoscopic, radiologic, and outcome variables were abstracted for analysis. Seventeen patients (65% men) with mean age of 69.3 ± 11.3 years and body mass index of 28.8 ± 11.1 were identified. The etiologies for gastric ischemia included local vascular causes (n = 8), systemic hypoperfusion (n = 4), and mechanical obstruction (n = 5). The most common presenting symptoms were abdominal pain (65%), gastrointestinal bleeding (47%), and altered mental status (23%). The typical endoscopic appearance was mucosal congestion and erythema with or without ulceration. Gastric pneumatosis and portal venous air were more commonly seen on CT imaging. Radiologic and/or surgical intervention was needed in 9 patients, while the remaining 8 patients were managed conservatively with acid suppression, antibiotics, and nasogastric tube decompression. The median duration of hospital stay was 15 days (range 1-36 days). There were no cases of rebleeding and the mortality rate as a direct result of gastric ischemia was 24% within 6 months of diagnosis. Although uncommon, gastric ischemia is associated with significant mortality. Endoscopy and CT imaging play an important role in its diagnosis. The management of gastric ischemia is dictated by its severity and associated comorbidities.

  8. The clinical outcome and microbiological profile of bone-anchored hearing systems (BAHS) with different abutment topographies: a prospective pilot study.

    Science.gov (United States)

    Trobos, Margarita; Johansson, Martin Lars; Jonhede, Sofia; Peters, Hanna; Hoffman, Maria; Omar, Omar; Thomsen, Peter; Hultcrantz, Malou

    2018-06-01

    In this prospective clinical pilot study, abutments with different topologies (machined versus polished) were compared with respect to the clinical outcome and the microbiological profile. Furthermore, three different sampling methods (retrieval of abutment, collection of peri-abutment exudate using paper-points, and a small peri-abutment soft-tissue biopsy) were evaluated for the identification and quantification of colonising bacteria. Twelve patients, seven with machined abutment and five with polished abutment, were included in the analysis. Three different sampling procedures were employed for the identification and quantification of colonising bacteria from baseline up to 12 months, using quantitative culturing. Clinical outcome measures (Holgers score, hygiene, pain, numbness and implant stability) were investigated. The clinical parameters, and total viable bacteria per abutment or in tissue biopsies did not differ significantly between the polished and machined abutments. The total CFU/mm 2 abutment and CFU/peri-abutment fluid space of anaerobes, aerobes and staphylococci were significantly higher for the polished abutment. Anaerobic bacteria were detected in the tissue biopsies before BAHS implantation. Anaerobes and Staphylococcus spp. were detected in all three compartments after BAHS installation. For most patients (10/12), the same staphylococcal species were found in at least two of the three compartments at the same time-point. The common skin coloniser Staphylococcus epidermidis was identified in all patients but one (11/12), whereas the pathogen Staphylococcus aureus was isolated in five of the patients. Several associations between clinical and microbiological parameters were found. There was no difference in the clinical outcome with the use of polished versus machined abutment at 3 and 12 months after implantation. The present pilot trial largely confirmed a suitable study design, sampling and analytical methodology to determine the effects

  9. 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 ...

  10. Clinical Manifestations and Outcome of Syphilitic Uveitis

    NARCIS (Netherlands)

    Bollemeijer, Jan G.; Wieringa, Wietse G.; Missotten, Tom O. A. R.; Meenken, Ina; ten Dam-van Loon, Ninette H.; Rothova, Aniki; Los, Leonoor I.

    PURPOSE. To analyze visual outcome, effectiveness of various modes of antibiotic treatment, and prognostic factors in patients with serologically proven syphilitic uveitis. METHODS. The clinical records of 85 patients (139 eyes) diagnosed with syphilitic uveitis between 1984 and 2013 at tertiary

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

    OpenAIRE

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

    2016-01-01

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

  12. Clinical characteristics and pregnancy outcomes of Syrian refugees: a case-control study in a tertiary care hospital in Istanbul, Turkey.

    Science.gov (United States)

    Erenel, Hakan; Aydogan Mathyk, Begum; Sal, Veysel; Ayhan, Isil; Karatas, Suat; Koc Bebek, Arzu

    2017-01-01

    We aimed to compare the clinical characteristics and pregnancy outcomes in women who are Syrian refugees and Turkish women who are non-refugees at a maternity center in Istanbul, Turkey. A total of 600 singleton pregnancies who delivered at Sisli Hamidiye Etfal Training and Research Hospital were included in the study. Demographic data, obstetrical history, clinical findings, obstetrical and neonatal outcomes were compared between 300 Syrian refugees and 300 control patients. The Syrian refugee patients were significantly younger than Turkish patients. The percentage of adolescents aged 12-19 years were significantly higher in the Syrian patients (14.3 vs. 5.3 %, p refugee patients had no antenatal care. However, this ratio was only 7.7 % for the control group (p refugee control patients, refugee women in our study had poor antenatal care but no adverse perinatal outcomes were observed. Further larger multicenter studies may provide more convincing data about obstetric outcomes in the Syrian refugee population as well as adolescent pregnancies in this population.

  13. 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.

  14. The importance of clinical pharmacokinetic–pharmacodynamic studies in unraveling the determinants of early and late tuberculosis outcomes

    OpenAIRE

    McCallum, Andrew; Sloan, Derek

    2017-01-01

    Tuberculosis remains a major infectious cause of morbidity and mortality worldwide. Current antibiotic regimens, constructed prior to the development of modern pharmacokinetic-pharmacodynamic (PK–PD) tools, are based on incomplete understanding of exposure–response relationships in drug susceptible and multidrug resistant tuberculosis. Preclinical and population PK data suggest that clinical PK–PD studies may enable therapeutic drug monitoring for some agents and revised dosingf or others. Fu...

  15. Antenatal clinical pelvimetry in primigravidae and outcome of labour ...

    African Journals Online (AJOL)

    Method: A retrospective study of clinical pelvimetry and outcome of labour in primigravidae. Results: The total number of primigravidae included in the study was 268 and of these, 74 were adjudged to have adequate pelvis at antenatal clinical pelvimetry. The APGAR scores at one and five minutes were significantly higher ...

  16. Predictors of clinical outcome following lumbar disc surgery

    DEFF Research Database (Denmark)

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

    2016-01-01

    scheduled for first time, single-level lumbar discectomy. Participants underwent a standardized preoperative evaluation including real-time ultrasound imaging assessment of lumbar multifidus function, and an 8-week postoperative rehabilitation programme. Clinical outcome was defined by change in disability....... 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...

  17. Pulmonary hydatidosis patterns and clinical outcomes

    Directory of Open Access Journals (Sweden)

    Shadi Hamouri

    2018-02-01

    Full Text Available Background Pulmonary hydatidosis remains a significant health problem in endemic areas. The clinical patterns and presentation vary according to the size, number, location and integrity of the cyst. Aims The aim of this study is to retrospectively evaluate the pattern and outcomes of patients diagnosed with pulmonary hydatidosis treated surgically in a tertiary hospital in northern Jordan. Methods A retrospective review of patients with pulmonary hydatidosis between December 2009 and December 2017 were performed. Data regarding demographic features, clinical presentation, serology testing, clinical outcomes and duration of medical treatment after surgery were obtained. Chest X-Ray and computerized tomography as well as liver ultrasound were the main methods of diagnosis. Parenchyma preserving excisions of the laminated membrane with capitonnage of the remaining cavity were performed in all patients. Albendazole was prescribed for 3– 6 months postoperatively. Results Eighty-eight patients were involved. Mean age was 29.5±16.7 years (range 8–75. Females comprised 52 per cent of the patients. The main presenting symptoms were cough, dyspnea and chest pain. Thirty-two (37 per cent patients had rupture of the cyst at the time of the presentation; 15 patients had direct rupture, 10 had communicating rupture and contained rupture was diagnosed in seven patients. Multiple and/or bilateral lesions were encountered in 25/88 (28.5 per cent and 15 (17 per cent patients respectively. Lower lobes were involved in 73.8 per cent of the cases. The mean hospital stay was 6.53±2.83 days. Post-operative morbidities were developed in 12/88 (13 per cent patients with air leak (5 per cent as the most common morbidity. No recurrences or mortalities were reported in the follow up period. Conclusion Parenchyma preserving cyst excision with capitonnage provides a low postoperative morbidity in patients with both intact and complicated pulmonary hydatidosis. To

  18. Outcome of cervix uteri cancer patients: Clinical treatment results and toxicity profile in a retrospective study from Saudi Arabia.

    Science.gov (United States)

    El Sayed, Mohamed E; Bahadur, Yasir A; Hassouna, Ashraf H; Fawzy, Ehab E; Nasr, Azza M; Sadiq, Bakr B; Dada, Reyad; Sait, Khalid H; Anfinan, Nisrin M

    2017-10-01

    This study evaluated the survival outcome, pattern of failure and prognostic factors in cervix uteri cancer patients. We reviewed the data of 60 patients with stages IB-IVA cancer who were treated between January 2004 and December 2010. Most patients (n = 50; 83%) had squamous cell carcinoma. Stage IIB was the most common presentation (n = 41; 68%). Forty-seven patients (78%) received Cisplatin concurrent with radiotherapy (CRT). The 2- and 4-year overall survival (OS) was 82% and 79%, respectively. Prolongation of the overall treatment time (OAT) for greater than 56 days, advanced stage and pretreatment hemoglobin (Hb) levels (cervix uteri cancer patients and the prognostic factors are comparable to those of previous reports. Orthogonal brachytherapy planning and vaginal infiltration negatively predicted relapse. © 2016 John Wiley & Sons Australia, Ltd.

  19. Basic clinical characteristics and hospital outcomes of acute ...

    African Journals Online (AJOL)

    Basic clinical characteristics and hospital outcomes of acute coronary syndrome patients - Sudan. A.M. Taha, H.O. Mirghani. Abstract. Background: There are Variation in the presentation of the acute coronary syndrome between countries. The present study aimed to investigate the basic clinical characteristics and ...

  20. Unsatisfactory Glucose Management and Adverse Pregnancy Outcomes of Gestational Diabetes Mellitus in the Real World of Clinical Practice: A Retrospective Study.

    Science.gov (United States)

    Feng, Ru; Liu, Lu; Zhang, Yuan-Yuan; Yuan, Zhong-Shang; Gao, Ling; Zuo, Chang-Ting

    2018-05-05

    Facing the increasing prevalence of gestational diabetes mellitus (GDM), this study aimed to evaluate the management of GDM and its association with adverse pregnancy outcomes. The data of 996 inpatients with GDM who terminated pregnancies in our hospital from January 2011 to December 2015 were collected. Treatments during pregnancy and the last hospital admission before delivery were analyzed. Pregnancy outcomes of the GDM patients were compared with 996 nondiabetic subjects matched by delivery year and gestational age. The association between fasting plasma glucose (FPG) and adverse pregnancy outcomes was examined by logistic regression analyses. The average prevalence of GDM over the 5 years was 4.4% (1330/30,191). Within the GDM patients, 42.8% (426/996) received dietary intervention, whereas 19.1% (190/996) received insulin treatment. Adverse outcomes were more likely to occur in patients with unsatisfactory control of blood glucose such as respiratory distress syndrome (RDS, χ 2 = 13.373, P < 0.01). Elevated FPG was identified as an independent risk factor for premature birth (odds ratio [OR] = 1.460, P < 0.001), neonatal care unit admission (OR = 1.284, P < 0.001), RDS (OR = 1.322, P = 0.001), and stillbirth (OR = 1.427, P < 0.001). Management of GDM in the real world of clinical practice was unsatisfactory, which might have contributed to adverse pregnancy outcomes.

  1. Validation of birth outcomes from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS): population-based analysis from the Massachusetts Outcome Study of Assisted Reproductive Technology (MOSART).

    Science.gov (United States)

    Stern, Judy E; Gopal, Daksha; Liberman, Rebecca F; Anderka, Marlene; Kotelchuck, Milton; Luke, Barbara

    2016-09-01

    To assess the validity of outcome data reported to the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) compared with data from vital records and the birth defects registry in Massachusetts. Longitudinal cohort. Not applicable. A total of 342,035 live births and fetal deaths from Massachusetts mothers giving birth in the state from July 1, 2004, to December 31, 2008; 9,092 births and fetal deaths were from mothers who had conceived with the use of assisted reproductive technology (ART) and whose cycle data had been reported to the SART CORS. Not applicable. Percentage agreement between maternal race and ethnicity, delivery outcome (live birth or fetal death), plurality (singleton, twin, or triplet+), delivery date, and singleton birth weight reported in the SART CORS versus vital records; sensitivity and specificity for birth defects among singletons as reported in the SART CORS versus the Massachusetts Birth Defects Monitoring Program (BDMP). There was >95% agreement between the SART CORS and vital records for fields of maternal race/ethnicity, live birth/fetal death, and plurality; birth outcome date was within 1 day with 94.9% agreement and birth weight was within 100 g with 89.6% agreement. In contrast, sensitivity for report of any birth defect was 38.6%, with a range of 18.4%-50.0%, for specific birth defect categories. Although most SART CORS outcome fields are accurately reported, birth defect variables showed poor sensitivity compared with the gold standard data from the BDMP. We suggest that reporting of birth defects be discontinued. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  2. Clinical outcomes of liver transplantation for HBV-related hepatocellular carcinoma: data from the NIH HBV OLT study.

    Science.gov (United States)

    Han, Steven-Huy; Reddy, K Rajender; Keeffe, Emmet B; Soldevila-Pico, Consuelo; Gish, Robert; Chung, Raymond T; Degertekin, Bulent; Lok, Anna

    2011-01-01

    Hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) is an indication for orthotopic liver transplantation (OLT) in patients with tumor stage within the United Network for Organ Sharing criteria. The number of patients listed for HBV-related HCC is increasing, while the number of patients listed for HBV-related cirrhosis is declining presumptively because of the availability of more effective oral nucleos(t)ide analogues. This study presents the final, long-term outcome of patients transplanted for HBV-related HCC in the National Institutes of Health (NIH) HBV OLT Study Group. Ninety-eight patients (52.4%) in the NIH HBV OLT cohort underwent OLT for HBV-related HCC. With a mean follow-up of 36.5 months post-OLT, 12 (12.2%) patients developed recurrence of HCC. Multivariate analysis did not find a statistically significant role of gender, tumor stage at OLT, pre-OLT HCC treatment, recurrence of HBV, or duration of HCC diagnosis pre-OLT in predicting HCC recurrence. Serum alpha-fetoprotein (AFP) level >200 ng/mL at transplant was found to be statistically significant in predicting HCC recurrence (p=0.003). HCC recurrence was significantly associated with decreased post-OLT survival. HCC is the most common indication for OLT in patients with chronic hepatitis B in the era of more effective oral antivirals. Serum AFP at the time of OLT is significantly associated with HCC recurrence. © 2010 John Wiley & Sons A/S.

  3. 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

  4. 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.

  5. The joint impact of smoking and exercise capacity on clinical outcomes among women with suspected myocardial ischemia: the WISE study.

    Science.gov (United States)

    Linke, Sarah E; Rutledge, Thomas; Johnson, B Delia; Olson, Marian B; Bittner, Vera; Cornell, Carol E; Shaw, Leslee J; Eteiba, Wafia; Parashar, Susmita; Sheps, David S; Vido, Diane A; Mulukutla, Suresh; Bairey Merz, C Noel

    2009-04-01

    Although extensive research has been conducted on both smoking and low exercise capacity alone, few studies have examined the joint impact or interaction of these two risk factors. We examined the joint and interactive effects of smoking and self-reported exercise capacity on subsequent clinical events (heart failure, myocardial infarction [MI], stroke, and cardiovascular-related mortality) among women with suspected myocardial ischemia. At baseline (1996-1999), 789 women completed angiographic testing of coronary artery disease (CAD) severity and provided self-report information about their smoking history and exercise capacity as well as demographic and other risk factor data. Incidence of clinical events among the women was tracked for a median of 5.9 years; this analysis was conducted in 2008. In an adjusted survival analysis, women with a positive smoking history and self-reported low exercise capacity had the greatest risk of experiencing a clinical event (HR = 7.7, 95% CI 2.3, 25.5), followed by women with a positive smoking history and self-reported high exercise capacity (HR = 6.9, 95% CI 2.0, 24.6) and those with a negative smoking history and self-reported low exercise capacity (HR = 4.9, 95% CI 1.5, 15.8), relative to women with a negative smoking history and self-reported high exercise capacity. Additional analyses revealed a significant interaction between smoking history and exercise capacity, such that (1) women with a positive smoking history did not experience an additional significantly greater risk due to low exercise capacity, unlike those with a negative smoking history, and (2) all women experienced a significantly greater risk due to a positive smoking history regardless of their exercise capacity. Among women with suspected myocardial ischemia, the combined protective health effects of self-reported high exercise capacity and a negative smoking history remained significant after controlling for preexisting CAD severity and other established

  6. Association between medication adherence and clinical outcomes in patients with chronic kidney disease: a prospective cohort study.

    Science.gov (United States)

    Tangkiatkumjai, Mayuree; Walker, Dawn-Marie; Praditpornsilpa, Kearkiat; Boardman, Helen

    2017-06-01

    There is limited evidence of medication adherence related to progression of chronic kidney disease (CKD) worldwide. The aim of this study was to determine associations between medication adherence and the progression of CKD in outpatients with CKD. This cohort study recruited 339 Thai patients with stages 3-5 CKD. Patients with a glomerular disease or receiving renal replacement therapy before recruitment were excluded. 295 were followed up regarding their serum creatinine, blood pressure, glycated hemoglobin, and low-density lipoprotein cholesterol over 12 months. Medication adherence was measured at baseline using the Thai version of the 8-Item Morisky Medication Adherence Scale ® . The primary outcome was the progression of CKD. The progression of CKD was defined as either a decline in estimated glomerular filtration rate of at least 3 ml/min/1.73 m 2 /year or initiation of renal replacement therapy. Univariate and multivariate analyses were performed using Chi-squared tests and multiple logistic regressions. Twenty-one percent had poor adherence. Younger patients were more likely to have poor adherence (adjusted OR 2.81, 95 % CI 1.45-5.43). Anti-hypertensive agents were the most frequently reported as not being taken (52 %). Patients with poor adherence were associated with the progression of CKD (adjusted OR 1.96, 95 % CI 1.02-3.76). Those with poor adherence were less likely to control their blood pressure, than moderate-to-high adherence group (p < 0.01). The findings suggest that CKD patients with poor medication adherence are more likely to have progression of CKD. Health care providers should acknowledge these findings and provide effective strategies to deal with this issue.

  7. 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.

  8. Operative Technique and Clinical Outcome in Endoscopic Core Decompression of Osteochondral Lesions of the Talus: A Pilot Study

    Science.gov (United States)

    Beck, Sascha; Claßen, Tim; Haversath, Marcel; Jäger, Marcus; Landgraeber, Stefan

    2016-01-01

    Background Revitalizing the necrotic subchondral bone and preserving the intact cartilage layer by retrograde drilling is the preferred option for treatment of undetached osteochondral lesions of the talus (OLT). We assessed the effectiveness of Endoscopic Core Decompression (ECD) in treatment of OLT. Material/Methods Seven patients with an undetached OLT of the medial talar dome underwent surgical treatment using an arthroscopically-guided transtalar drill meatus for core decompression of the lesion. Under endoscopic visualization the OLT was completely debrided while preserving the cartilage layer covering the defect. The drill tunnel and debrided OLT were filled using an injectable bone graft substitute. Various clinical scores, radiographic imaging, and MRI were evaluated after a mean follow-up of 24.1 months. Results The American Orthopedic Foot and Ankle Society Score significantly improved from 71.0±2.4 to 90.3±5.9, and the Foot and Ankle Disability Index improved from 71.8±11.1 to 91.7±4.8. Radiographically, we observed good bone remodelling of the medial talar dome contour within 3 months. In MRI, an alteration of the bony signal of the drill tunnel and the excised OLT remained for more than 12 months. Conclusions First follow-up results for the surgical technique described in this study are highly promising for treatment of undetached stable OLT grade II or transitional stage II–III according to the Pritsch classification. Even lesions larger than 150 mm2 showed good clinical scores, with full restoration of the medial talar dome contour in radiographic imaging. PMID:27362485

  9. 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.

    Science.gov (United States)

    Michalsen, Andreas; Riegert, Markus; Lüdtke, Rainer; Bäcker, Marcus; Langhorst, Jost; Schwickert, Myriam; Dobos, Gustav J

    2005-12-22

    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. 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. 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. Neither Mediterranean diet nor fasting treatments affect the microbiologically assessed intestinal

  10. 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

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    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

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

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    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.

  12. To Study the Incidence, Predictive Factors and Clinical Outcome of Spontaneous Bacterial Peritonitis in Patients of Cirrhosis with Ascites.

    Science.gov (United States)

    Paul, Kavita; Kaur, Jasmine; Kazal, Harbans Lal

    2015-07-01

    To study the prevalence and predictive factors of spontaneous bacterial peritonitis (SBP) in patients of cirrhosis with ascites and to study the clinical characteristics and prognosis of patients with SBP. The present study was conducted on 122 cases admitted in Department of Medicine, through emergency, in Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India. Cases of cirrhosis (irrespective of aetiology) with ascites between the ages of 18-75 years were included in this study. Ascitic fluid of every patient was aspirated under all aseptic measures, before initiation of antibiotic therapy and was sent for biochemical analysis, culture and cytological analysis. Mean age of patients enrolled was 50.30± 10.98 years. 85% were male and 15% were female. Alcohol (73.8%) was the leading cause of cirrhosis followed by HCV (37.7%) and HBV (4.9%). Of the 122 patients studied, 27 (20.4%) patients were diagnosed as having SBP and its variants. Monomicrobial Bacterascites (BA) was present in 5 patients and Culture Negative Neutrocytic Ascites (CNNA) was present in 22 patients. Escherichia coli were the most common isolated organism followed by Klebsiella. The various factors that predispose to development of SBP include low ascitic fluid protein concentration, a high level of serum bilirubin, deranged serum creatinine, high Child-Pugh score and high MELD score. Ascitic fluid analysis remains the single most important test for identifying and assessing a course of SBP. Bedside inoculation of 10-20ml of ascitic fluid into culture bottle at patient bedside will yield better results. Early diagnosis and treatment will reduce the mortality rate in these patients.

  13. The Auckland Cataract Study: 2 year postoperative assessment of aspects of clinical, visual, corneal topographic and satisfaction outcomes

    Science.gov (United States)

    Thompson, A M; Sachdev, N; Wong, T; Riley, A F; Grupcheva, C N; McGhee, C N

    2004-01-01

    Aim: To assess clinical, visual, computerised corneal topographic, and subjective satisfaction with visual acuity, in a cohort of subjects 2 years after phacoemulsification surgery in a public hospital in New Zealand. Methods: Prospective study of a representative sample of 97 subjects (20%) randomly selected from 480 subjects in the original Auckland Cataract Study (ACS) cohort. The clinical assessment protocol was identical to the ACS and included an extensive questionnaire to enable direct comparisons to be made between the two groups. Results: The study population was predominantly female (66%) with a mean age of 76.3 (SD 9.9) years. New systemic and ocular disease affected 18.4% and 10.3% of subjects respectively, and 10.3% required referral to either a general practitioner (2.1%) or ophthalmologist (8.2%). Mean best spectacle corrected visual acuity (BSCVA) was 0.2 (0.2) logMAR units (6/9 Snellen equivalent), with mean spherical equivalent −0.37 (1.01) dioptres (D) and astigmatism −1.07 (0.70) D 2 years postoperatively, compared to mean BSCVA 0.1 (0.2) logMAR units (6/7.5 Snellen equivalent), spherical equivalent −0.59 (1.07) D, and astigmatism −1.14 (0.77) D 4 weeks after surgery. 94.9% of subjects retained a BSCVA of 6/12 or better, irrespective of pre-existing ocular disease. The overall posterior capsule opacification (PCO) rate was 20.4% and this was visually insignificant in all but 3.1% of eyes that had already undergone Nd:YAG posterior capsulotomy. Orbscan II elevation technology demonstrated corneal stability 2 years after uncomplicated phacoemulsification. Although corneal astigmatism was eliminated in approximately half of the subjects 1 month postoperatively, astigmatism showed a tendency to regress towards the preoperative level with local corneal thickening at the site of incision 2 years after cataract surgery. Of fellow eyes, 61.2% had undergone cataract surgery. Overall, 75.3% of subjects were moderately to very satisfied with their

  14. A retrospective study of the clinical characteristics and post-treatment hearing outcome in idiopathic sudden sensorineural hearing loss

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    Purushothaman Ganesan

    2017-02-01

    Full Text Available The purpose of this retrospective study was to analyze the clinical characteristics and document hearing recovery in patients with idiopathic sudden sensorineural hearing loss (ISSNHL. 122 patients diagnosed with unilateral ISSNHL, from March 2009 to December 2014, were treated with oral steroids and pentoxifylline. Hearing change was evaluated by comparing pre-treatment and post-treatment pure-tone average (PTA (500, 1K, and 2K Hz, and categorized into complete, partial, and no recovery of hearing. T-test, Wilcoxon Signed Rank test and Regression analysis were employed to analyze the statistical significance. Of the 122 patients, seventy-one (58% had complete recovery and 34 (28% had partial recovery. The average pre-treatment PTA was 78.3 ± 16.9 dB whereas post-treatment average was 47.0 ± 20.8 dB, showing statistically significant improvement (t=24.89, P≤0.001. The factors such as presence of tinnitus (P=0.005 and initial milder hearing loss (P=0.005 were found to be significant predictors for hearing recovery. Conventional steroid regimes produced a recovery rate in ISSNHL, which exceeds the spontaneous recovery rate. The current study results highlight the importance of medical treatment in the management of ISSNHL.

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

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    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.)

  16. Pharmacists' interventions on clinical asthma outcomes: a systematic review.

    Science.gov (United States)

    Garcia-Cardenas, Victoria; Armour, Carol; Benrimoj, Shalom I; Martinez-Martinez, Fernando; Rotta, Inajara; Fernandez-Llimos, Fernando

    2016-04-01

    The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). Copyright ©ERS 2016.

  17. Clinical Manifestations and Outcome of Syphilitic Uveitis.

    Science.gov (United States)

    Bollemeijer, Jan G; Wieringa, Wietse G; Missotten, Tom O A R; Meenken, Ina; ten Dam-van Loon, Ninette H; Rothova, Aniki; Los, Leonoor I

    2016-02-01

    To analyze visual outcome, effectiveness of various modes of antibiotic treatment, and prognostic factors in patients with serologically proven syphilitic uveitis. The clinical records of 85 patients (139 eyes) diagnosed with syphilitic uveitis between 1984 and 2013 at tertiary centers in The Netherlands were retrospectively analyzed. Mean age was 47 years (range, 27-73 years), 82.4% were male. HIV positivity was found in 28 (35.9%) patients; 13 were newly diagnosed. Most patients had pan (45.9%) or posterior (31.8%) uveitis. On average, logMAR visual acuity (VA) improved significantly from 0.55 at the start of syphilis treatment to 0.34 at 1 month and to 0.27 at 6 months follow-up. Most patients (86.7%) reached disease remission. No differences in efficacy between the various treatment regimens were found. A high logMAR VA at the start of syphilis treatment and a treatment delay of more than 12 weeks were prognostic for a high logMAR VA at 6 months follow-up. Chronicity was not related to any form of treatment, HIV status, or Venereal Disease Research Laboratory test outcome. In this large cohort of 85 patients with syphilitic uveitis, visual outcomes were favorable in the majority of cases. Visual outcome was dependent on VA at the start of syphilis treatment and treatment delay.

  18. Shortfalls in pediatric hydrocephalus clinical outcome analysis.

    Science.gov (United States)

    Walid, Mohammad Sami; Robinson, Joe Sam

    2012-06-01

    In this paper, we used search engine technology to study outcome analysis and cost awareness of child hydrocephalus in the literature. The aggregate hospital charges of hydrocephalus treatment procedures for patients years old was extracted from the Nationwide Inpatient Sample (NIS) data. Hydrocephalus literature was probed through the PubMed biomedical search engine. Aggregate hospital charges associated with ventriculo-peritoneal shunting as the principle procedure for patients years old have increased 1.7-fold over a 13-year period to 235.6 million in 2009. Hospital discharges, however, decreased from 3,390 in 1997 to 2,525 in 2009 (25.5% decrease over 13 years). The number of papers in English language indexed by PubMed in relation to child hydrocephalus in humans increased from 81 papers in 1996 to 133 in 2010 (1.6-fold increase), totaling 1,694 over 15 years. Randomized controlled trials published in relation to child hydrocephalus totaled 16 over the same period (0.94% of child hydrocephalus papers). Papers related to child hydrocephalus with "costs and cost analysis" as medical subject heading totaled 13 papers (0.77%). Over the past 15 years, disappointingly the number of printed child hydrocephalus papers appeared to have only plateaued. Strikingly, only a very small number of these papers were directed toward randomized control studies, the sine qua non of high-grade clinical evidence. Moreover, very few papers make reference to cost analysis or economics in the treatment of hydrocephalus - an issue coming increasingly before the nation at this point.

  19. Posterior lumbar interbody fusion using nonresorbable poly-ether-ether-ketone versus resorbable poly-L-lactide-co-D,L-lactide fusion devices: a prospective, randomized study to assess fusion and clinical outcome

    NARCIS (Netherlands)

    Jiya, T.U.; Smit, T.H.; Deddens, J.; Mullender, M.G.

    2009-01-01

    STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE.: To assess fusion, clinical outcome, and complications. SUMMARY OF BACKGROUND DATA: Resorbable poly-L- lactide-co-D,L-lactide (PLDLLA) cages intended to aid spinal interbody fusion have been introduced into clinical practice within

  20. Antiphospholipid Antibody Titers and Clinical Outcomes in Patients with Recurrent Miscarriage and Antiphospholipid Antibody Syndrome: A Prospective Study

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    Yu Song

    2017-01-01

    Conclusions: Anti-β2-GP1 IgM was the predominant form of antibody in patients with RM and APS. The decreases in antiphospholipid antibody titers correlated with better pregnancy outcomes. The shorter treatment regimen was effective and economical.

  1. Randomized comparison of the clinical outcome of single versus multiple arterial grafts: the ROMA trial-rationale and study protocol.

    Science.gov (United States)

    Gaudino, Mario; Alexander, John H; Bakaeen, Faisal G; Ballman, Karla; Barili, Fabio; Calafiore, Antonio Maria; Davierwala, Piroze; Goldman, Steven; Kappetein, Peter; Lorusso, Roberto; Mylotte, Darren; Pagano, Domenico; Ruel, Marc; Schwann, Thomas; Suma, Hisayoshi; Taggart, David P; Tranbaugh, Robert F; Fremes, Stephen

    2017-12-01

    The primary hypothesis of the ROMA trial is that in patients undergoing primary isolated non-emergent coronary artery bypass grafting, the use of 2 or more arterial grafts compared with a single arterial graft (SAG) is associated with a reduction in the composite outcome of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in these patients, the use of 2 or more arterial grafts compared with a SAG is associated with improved survival. The ROMA trial is a prospective, unblinded, randomized event-driven multicentre trial comprising at least 4300 subjects. Patients younger than 70 years with left main and/or multivessel disease will be randomized to a SAG or multiple arterial grafts to the left coronary system in a 1:1 fashion. Permuted block randomization stratified by the centre and the type of second arterial graft will be used. The primary outcome will be a composite of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary outcome will be all-cause mortality. The primary safety outcome will be a composite of death from any cause, any stroke and any myocardial infarction. In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the SAG group, saphenous vein grafts will be used for all non-left anterior descending target vessels. For patients randomized to the multiple arterial graft group, the main target vessel of the lateral wall will be grafted with either a radial artery or a second internal thoracic artery. Additional grafts for the multiple arterial graft group can be saphenous veins or supplemental arterial conduits. To detect a 20% relative reduction in the primary outcome, with 90% power at 5% alpha and assuming a time-to-event analysis, the sample size must include 845 events (and 3650 patients). To detect a 20% relative

  2. Value of quantitative MRI parameters in predicting and evaluating clinical outcome in conservatively treated patients with chronic midportion Achilles tendinopathy: A prospective study.

    Science.gov (United States)

    Tsehaie, J; Poot, D H J; Oei, E H G; Verhaar, J A N; de Vos, R J

    2017-07-01

    To evaluate whether baseline MRI parameters provide prognostic value for clinical outcome, and to study correlation between MRI parameters and clinical outcome. Observational prospective cohort study. Patients with chronic midportion Achilles tendinopathy were included and performed a 16-week eccentric calf-muscle exercise program. Outcome measurements were the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire and MRI parameters at baseline and after 24 weeks. The following MRI parameters were assessed: tendon volume (Volume), tendon maximum cross-sectional area (CSA), tendon maximum anterior-posterior diameter (AP), and signal intensity (SI). Intra-class correlation coefficients (ICCs) and minimum detectable changes (MDCs) for each parameter were established in a reliability analysis. Twenty-five patients were included and complete follow-up was achieved in 20 patients. The average VISA-A scores increased significantly with 12.3 points (27.6%). The reliability was fair-good for all MRI-parameters with ICCs>0.50. Average tendon volume and CSA decreased significantly with 0.28cm 3 (5.2%) and 4.52mm 2 (4.6%) respectively. Other MRI parameters did not change significantly. None of the baseline MRI parameters were univariately associated with VISA-A change after 24 weeks. MRI SI increase over 24 weeks was positively correlated with the VISA-A score improvement (B=0.7, R 2 =0.490, p=0.02). Tendon volume and CSA decreased significantly after 24 weeks of conservative treatment. As these differences were within the MDC limits, they could be a result of a measurement error. Furthermore, MRI parameters at baseline did not predict the change in symptoms, and therefore have no added value in providing a prognosis in daily clinical practice. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  3. Cohort Study of ECG Left Ventricular Hypertrophy Trajectories: Ethnic Disparities, Associations With Cardiovascular Outcomes, and Clinical Utility.

    Science.gov (United States)

    Iribarren, Carlos; Round, Alfred D; Lu, Meng; Okin, Peter M; McNulty, Edward J

    2017-10-05

    ECG left ventricular hypertrophy (LVH) is a well-known predictor of cardiovascular disease. However, no prior study has characterized patterns of presence/absence of ECG LVH ("ECG LVH trajectories") across the adult lifespan in both sexes and across ethnicities. We examined: (1) correlates of ECG LVH trajectories; (2) the association of ECG LVH trajectories with incident coronary heart disease, transient ischemic attack, ischemic stroke, hemorrhagic stroke, and heart failure; and (3) reclassification of cardiovascular disease risk using ECG LVH trajectories. We performed a cohort study among 75 412 men and 107 954 women in the Northern California Kaiser Permanente Medical Care Program who had available longitudinal exposures of ECG LVH and covariates, followed for a median of 4.8 (range ECG LVH was measured by Cornell voltage-duration product. Adverse trajectories of ECG LVH (persistent, new development, or variable pattern) were more common among blacks and Native American men and were independently related to incident cardiovascular disease with hazard ratios ranging from 1.2 for ECG LVH variable pattern and transient ischemic attack in women to 2.8 for persistent ECG LVH and heart failure in men. ECG LVH trajectories reclassified 4% and 7% of men and women with intermediate coronary heart disease risk, respectively. ECG LVH trajectories were significant indicators of coronary heart disease, stroke, and heart failure risk, independently of level and change in cardiovascular disease risk factors, and may have clinical utility. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  4. Age-related prevalence of diabetes mellitus, cardiovascular disease and anticoagulation therapy use in a urolithiasis population and their effect on outcomes: the Clinical Research Office of the Endourological Society Ureteroscopy Global Study

    NARCIS (Netherlands)

    Daels, F. Pedro J.; Gaizauskas, Andrius; Rioja, Jorge; Varshney, Anil K.; Erkan, Erkan; Ozgok, Yasar; Melekos, Michael; de La Rosette, Jean J. M. C. H.

    2015-01-01

    This study examined the prevalence of risk factors for urological stone surgery and their possible influence on outcome and complications following ureteroscopy (URS). The Clinical Research Office of the Endourological Society Ureteroscopy Global Study collected prospective data on consecutive

  5. Clinical Profile and Outcome of Postthymectomy versus Non-Thymectomy Myasthenia Gravis Patients in the Philippine General Hospital: A 6-Year Retrospective Study.

    Science.gov (United States)

    De Roxas, Ranhel C; Bagnas, Marjorie Anne C; Baldonado, Jobelle Joyce Anne R; Rivera, Jonathan P; Roxas, Artemio A

    2016-01-01

    Myasthenia gravis is an autoimmune neuromuscular disorder characterized by the production of abnormal autoantibodies directed against the receptors present in the neuromuscular junction. It has been the standard practice to offer thymectomy in all generalized myasthenia gravis patients despite the lack of robust evidence. The objectives of this study are to describe the clinical profile and differentiate the clinical outcomes of thymectomy versus non-thymectomy and thymomatous versus non-thymomatous myasthenia gravis patients in the Philippine General Hospital. Between 2009 and 2014, a total of 69 postthymectomy and 16 non-thymectomy patient records were successfully retrieved. The demographic characteristics, surgical approach, and histopathologic results were obtained. The clinical outcome after 6 months or 1 year-follow-up was also determined and grouped according to the following: (1) complete remission, (2) pharmacological remission, (3) no clinical change, (4) worsening symptoms, and (5) mortality. Majority of the patients were females (68.0%) with a mean age of 39.8 years and a mean duration of myasthenic symptoms of 21 months. Using the Myasthenia Gravis Foundation of America classification, 54.1% of patients fell under Class II and 48.2% of them presented with generalized weakness. In this study, 60.8% of postthymectomy myasthenia gravis patients had either complete remission or pharmacologic remission compared with 12.5% among non-thymectomy patients (p-value myasthenia gravis after thymectomy (p-value = 0.29). This study showed that both thymomatous and non-thymomatous myasthenia gravis patients who underwent thymectomy had a higher incidence of complete stable remission and pharmacologic remission as compared with myasthenia gravis patients who did not undergo thymectomy.

  6. Telemedicine for the Management of Glycemic Control and Clinical Outcomes of Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Studies

    Directory of Open Access Journals (Sweden)

    Shaun W. H. Lee

    2017-05-01

    Full Text Available Importance: Telemedicine has been shown to be an efficient and effective means of providing care to patients with chronic disease especially in remote and undeserved regions, by improving access to care and reduce healthcare cost. However, the evidence surrounding its applicability in type 1 diabetes remains scarce and conflicting.Objective: To synthesize evidence and quantify the effectiveness of telemedicine interventions for the management of glycemic and clinical outcomes in type 1 diabetes patients, relative to comparator conditions.Data Sources: MEDLINE, EMBASE, Cochrane Library, Web of Science, PsycINFO, and CINAHL were searched for published articles since inception until December 2016.Study Selection: Original articles reporting the results of randomized controlled studies on the effectiveness of telemedicine in people with type 1 diabetes were included.Data Extraction and Synthesis: Two reviewers independently extracted data, assessed quality, and strength of evidence. Interventions were categorized based upon the telemedicine focus (monitoring, education, consultation, case-management, and peer mentoring.Main Outcome and Measure: Absolute change in glycosylated hemoglobin A1c (HbA1c from baseline to follow-up assessment.Results: A total of 38 studies described in 41 articles were identified. Positive effects on glycemic control were noted with studies examining telemedicine, with a mean reduction of 0.18% at the end of intervention. Studies with longer duration (>6 months who had recruited patients with a higher baseline HbA1c (≥9% were associated with larger effects. Telemedicine interventions that involve individualized assessments, audit with feedback and skill building were also more effective in improving glycemic control. However, no benefits were observed on blood pressure, lipids, weight, quality of life, and adverse events.Conclusions and Relevance: There is insufficient evidence to support telemedicine use for glycemic

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

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    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.

  8. Clinical Outcomes of Characterized Chondrocyte Implantation

    Science.gov (United States)

    Huylebroek, José; Van Der Bauwhede, Jan; Saris, Daniël; Veeckman, Geert; Bobic, Vladimir; Victor, Jan; Almqvist, Karl Fredrik; Verdonk, Peter; Fortems, Yves; Van Lommel, Nel; Haazen, Ludo

    2012-01-01

    Objective: To assess the clinical outcome of patients treated with autologous chondrocyte implantation using ChondroCelect in daily practice. Methods: The study is a cross-sectional analysis of an open-label, noninterventional cohort. The setting was a compassionate use program, involving 43 orthopaedic centers in 7 European countries. The participants were patients treated with ChondroCelect between October 13, 2004 and July 2, 2008. The measurements used were Clinical Global Impression–Improvement and –Efficacy and solicited adverse event reports. Results: Safety data were collected from 334 patients (90.3%), and effectiveness data were from 282 (76.2%) of the 370 patients treated. Mean age at baseline was 33.6 years (range, 12-57 years), 57% were male, and mean body mass index was 25 kg/m2. Mean follow-up was 2.2 years (range, 0.4-4.1 years). A femoral condyle lesion was reported in 66% (288/379) and a patellar lesion in 19% (84/379). Mean lesion size was 3.5 cm2; a collagen membrane was used in 92.4% (328/355). A therapeutic effect was reported in 89% (234/264) of patients overall and in 87% (40/46) of patellar lesion patients. Rates of much or very much improved patients were similar in patients with short- (18 months: 68% [70/103]) (P = 0.68) and were independent of lesion size (>4 cm2: 75.5% [37/49]; ≤4 cm2: 67.7% [111/164]) (P = 0.38). Adverse events were similar to those reported in the randomized trial with the same product, with more arthrofibrosis, more reduced joint mobility, and more crepitations reported in patellar lesions. Overall, less cartilage hypertrophy was noted, probably due to the use of a biological membrane cover. Conclusions: Implantation of ChondroCelect appeared to result in a positive benefit/risk ratio when used in an unselected heterogenous population, irrespective of the follow-up period, lesion size, and type of lesion treated. PMID:26069630

  9. First direct comparison of clinical outcomes between European and Asian cohorts in transcatheter aortic valve implantation: the Massy study group vs. the PREVAIL JAPAN trial.

    Science.gov (United States)

    Watanabe, Yusuke; Hayashida, Kentaro; Takayama, Morimasa; Mitsudo, Kazuaki; Nanto, Shinsuke; Takanashi, Shuichiro; Komiya, Tatsuhiko; Kuratani, Toru; Tobaru, Tetsuya; Goto, Tsuyoshi; Lefèvre, Thierry; Sawa, Yoshiki; Morice, Marie-Claude

    2015-02-01

    The efficacy and safety of transcatheter aortic valve implantation (TAVI) in Asian populations were unknown. The purpose of this study was to compare directly the clinical outcomes of the first Japanese trial and a European single-center experience after TAVI. Between April 2010 and October 2011, 64 patients were included in the PREVAIL JAPAN multicenter trial which was set up to evaluate the safety and efficacy of the Edwards SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) in high-risk Japanese patients with severe aortic stenosis. Between March 2010 and January 2012, 237 consecutive patients treated with TAVI using the Edwards SAPIEN XT™ prosthesis at Institut Cardiovasculaire Paris Sud were prospectively included in the Massy cohort. We compared the clinical outcomes of these two cohorts. Patients were of similar age (83.4±6.6 years vs. 84.5±6.1 years, p=0.25), but logistic EuroSCORE was higher in the Massy cohort (20.2±11.7% vs. 15.6±8.0%, pPREVAIL JAPAN cohort (1.41±0.14m(2) vs. 1.72±0.18m(2); pPREVAIL JAPAN cohort (12.7±11.4mmHg vs. 10.1±3.6mmHg, p=0.01), but satisfactory improvement in 6-month functional status was obtained in both cohorts (76.5% vs. 77.2%, p=0.91). Clinical outcomes after TAVI in the patients included in the PREVAIL JAPAN trial were acceptable and as safe as that of a single-center European cohort. Copyright © 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  10. 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.

  11. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales.

    Science.gov (United States)

    Copay, Anne G; Glassman, Steven D; Subach, Brian R; Berven, Sigurd; Schuler, Thomas C; Carreon, Leah Y

    2008-01-01

    The impact of lumbar spinal surgery is commonly evaluated with three patient-reported outcome measures: Oswestry Disability Index (ODI), the physical component summary (PCS) of the Short Form of the Medical Outcomes Study (SF-36), and pain scales. A minimum clinically important difference (MCID) is a threshold used to measure the effect of clinical treatments. Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method. This study has three purposes. First, to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID. Second, to determine a statistically sound and clinically meaningful MCID for ODI, PCS, back pain scale, and leg pain scale in lumbar spine surgery patients. Third, to compare the discriminative ability of two anchors: a global health assessment and a rating of satisfaction with the results of the surgery. This study is a review of prospectively collected patient-reported outcomes data. A total of 454 patients from a large database of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCS were included in the study. Preoperative and 1-year postoperative scores for ODI, PCS, back pain scale, leg pain scale, health transition item (HTI) of the SF-36, and Satisfaction with Results scales. ODI, SF-36, and pain scales were administered before and 1 year after spinal surgery. Several candidate MCID calculation methods were applied to the data and the resulting values were compared. The HTI of the SF-36 was used as the anchor and compared with a second anchor (Satisfaction with Results scale). Potential MCID calculations yielded a range of values: fivefold for ODI, PCS, and leg pain, 10-fold for back pain. Threshold values obtained with the two anchors were very similar. The minimum detectable change (MDC) appears as a statistically and clinically appropriate MCID value. MCID values

  12. Prediction of Response to Therapy and Clinical Outcome through a Pilot Study of Complete Genetic Assessment of Ovarian Cancer

    Science.gov (United States)

    2015-12-01

    B, PIK3CA, BRCA2, ATM, SETD2, ATRX, MTOR, PIK3R1 Mucinous KRAS, TP53, CDKN2A, SMAD4 , TERT Carcinosarcoma TP53, RB1, APC Granulasa cell ATM...alterations in the PTEN- PI3K- AKT -mTOR pathway in a cohort of 379 ovarian cancer patients. Submitted to American Society of Clinical Oncology Annual meeting

  13. Depression and heart failure associated with clinical COPD questionnaire outcome in primary care COPD patients : A cross-sectional study

    NARCIS (Netherlands)

    Urff, Manon; Van Den Berg, Jan Willem K; Uil, Steven M.; Chavannes, Niels H.; Damoiseaux, Roger Amj

    2014-01-01

    BACKGROUND: Improvement in health-related quality of life (HRQoL) is one of the main goals in treating chronic obstructive pulmonary disease (COPD). Impaired HRQoL in COPD is associated with increased morbidity and mortality, hospitalisations and burden on our health-care system. The Clinical COPD

  14. Clinical Operations Variables are Associated With Blood Pressure Outcomes.

    Science.gov (United States)

    Kressin, Nancy R; Lasser, Karen E; Paasche-Orlow, Michael; Allison, Jeroan; Ash, Arlene S; Adams, William G; Shanahan, Christopher W; Legler, Aaron; Pizer, Steven D

    2015-06-01

    Uncontrolled blood pressure (BP), among patients diagnosed and treated for the condition, remains an important clinical challenge; aspects of clinical operations could potentially be adjusted if they were associated with better outcomes. To assess clinical operations factors' effects on normalization of uncontrolled BP. Observational cohort study. Patients diagnosed with hypertension from a large urban clinical practice (2005-2009). We obtained clinical data on BP, organized by person-month, and administrative data on primary care provider (PCP) staffing. We assessed the resolution of an episode of uncontrolled BP as a function of time-varying covariates including practice-level appointment volume, individual clinicians' appointment volume, overall practice-level PCP staffing, and number of unique PCPs. Among the 7409 unique patients representing 50,403 person-months, normalization was less likely for the patients in whom the episode starts during months when the number of unique PCPs were high [the top quintile of unique PCPs was associated with a 9 percentage point lower probability of normalization (Ppercentage point reduction in the probability of normalization (P=0.01)]. Neither clinician appointment volume nor practice clinician staffing levels were significantly associated with the probability of normalization. Findings suggest that clinical operations factors can affect clinical outcomes like BP normalization, and point to the importance of considering outcome effects when organizing clinical care.

  15. 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.

  16. Trends in clinical characteristics and outcomes of Pre-ART care at a large HIV clinic in Nairobi, Kenya: a retrospective cohort study.

    Science.gov (United States)

    Mecha, Jared O; Kubo, Elizabeth N; Nganga, Lucy W; Muiruri, Peter N; Njagi, Lilian N; Mutisya, Immaculate N; Odionyi, Justine J; Ilovi, Syokau C; Wambui, Mary; Githu, Christopher; Ngethe, Richard; Obimbo, Elizabeth M; Ngumi, Zipporah W

    2016-01-01

    The success of antiretroviral therapy in resource-scarce settings is an illustration that complex healthcare interventions can be successfully delivered even in fragile health systems. Documenting the success factors in the scale-up of HIV care and treatment in resource constrained settings will enable health systems to prepare for changing population health needs. This study describes changing demographic and clinical characteristics of adult pre-ART cohorts, and identifies predictors of pre-ART attrition at a large urban HIV clinic in Nairobi, Kenya. We conducted a retrospective cohort analysis of data on HIV infected adults (≥15 years) enrolling in pre-ART care between January 2004 and September 2015. Attrition (loss to program) was defined as those who died or were lost to follow-up (having no contact with the facility for at least 6 months). We used Kaplan-Meier survival analysis to determine time to event for the different modes of transition, and Cox proportional hazards models to determine predictors of pre-ART attrition. Over the 12 years of observation, there were increases in the proportions of young people (age 15 to 24 years); and patients presenting with early disease (by WHO clinical stage and higher median CD4 cell counts), p = 0.0001 for trend. Independent predictors of attrition included: aHR (95% CI): male gender 1.98 (1.69-2.33), p = 0.0001; age 20-24 years 1.80 (1.37-2.37), p = 0.0001), or 25-34 years 1.22 (1.01-1.47), p = 0.0364; marital status single 1.55 (1.29-1.86), p = 0.0001) or divorced 1.41(1.02-1.95), p = 0.0370; urban residency 1.83 (1.40-2.38), p = 0.0001; CD4 count of 0-100 cells/µl 1.63 (1.003-2.658), p = 0.0486 or CD4 count >500 cells/µl 2.14(1.46-3.14), p = 0.0001. In order to optimize the impact of HIV prevention, care and treatment in resource scarce settings, there is an urgent need to implement prevention and treatment interventions targeting young people and patients entering care with severe

  17. Pregnancy outcome of “delayed start” GnRH antagonist protocol versus GnRH antagonist protocol in poor responders: A clinical trial study

    Directory of Open Access Journals (Sweden)

    Abbas Aflatoonian

    2017-08-01

    Full Text Available Background: Management of poor-responding patients is still major challenge in assisted reproductive techniques (ART. Delayed-start GnRH antagonist protocol is recommended to these patients, but little is known in this regards. Objective: The goal of this study was assessment of delayed-start GnRH antagonist protocol in poor responders, and in vitro fertilization (IVF outcomes. Materials and Methods: This randomized clinical trial included sixty infertile women with Bologna criteria for ovarian poor responders who were candidate for IVF. In case group (n=30, delayed-start GnRH antagonist protocol administered estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation with gonadotropin. Control group (n=30 treated with estrogen priming antagonist protocol. Finally, endometrial thickness, the rates of oocytes maturation, , embryo formation, and pregnancy were compared between two groups. Results: Rates of implantation, chemical, clinical, and ongoing pregnancy in delayed-start cycles were higher although was not statistically significant. Endometrial thickness was significantly higher in case group. There were no statistically significant differences in the rates of oocyte maturation, embryo formation, and IVF outcomes between two groups. Conclusion: There is no significant difference between delayed-start GnRH antagonist protocol versus GnRH antagonist protocol.

  18. The effect of sibutramine prescribing in routine clinical practice on cardiovascular outcomes: a cohort study in the United Kingdom.

    Science.gov (United States)

    Hayes, J F; Bhaskaran, K; Batterham, R; Smeeth, L; Douglas, I

    2015-09-01

    The marketing authorization for the weight loss drug sibutramine was suspended in 2010 following a major trial that showed increased rates of non-fatal myocardial infarction and cerebrovascular events in patients with pre-existing cardiovascular disease. In routine clinical practice, sibutramine was already contraindicated in patients with cardiovascular disease and so the relevance of these influential clinical trial findings to the 'real World' population of patients receiving or eligible for the drug is questionable. We assessed rates of myocardial infarction and cerebrovascular events in a cohort of patients prescribed sibutramine or orlistat in the United Kingdom. A cohort of patients prescribed weight loss medication was identified within the Clinical Practice Research Datalink. Rates of myocardial infarction or cerebrovascular event, and all-cause mortality were compared between patients prescribed sibutramine and similar patients prescribed orlistat, using both a multivariable Cox proportional hazard model, and propensity score-adjusted model. Possible effect modification by pre-existing cardiovascular disease and cardiovascular risk factors was assessed. Patients prescribed sibutramine (N=23,927) appeared to have an elevated rate of myocardial infarction or cerebrovascular events compared with those taking orlistat (N=77,047; hazard ratio 1.69, 95% confidence interval 1.12-2.56). However, subgroup analysis showed the elevated rate was larger in those with pre-existing cardiovascular disease (hazard ratio 4.37, 95% confidence interval 2.21-8.64), compared with those with no cardiovascular disease (hazard ratio 1.52, 95% confidence interval 0.92-2.48, P-interaction=0.0076). All-cause mortality was not increased in those prescribed sibutramine (hazard ratio 0.67, 95% confidence interval 0.34-1.32). Sibutramine was associated with increased rates of acute cardiovascular events in people with pre-existing cardiovascular disease, but there was a low absolute

  19. Clinical, virologic, and immunologic outcomes in lymphoma survivors and in cancer-free, HIV-1-infected patients: a matched cohort study.

    Science.gov (United States)

    Spagnuolo, Vincenzo; Travi, Giovanna; Galli, Laura; Cossarini, Francesca; Guffanti, Monica; Gianotti, Nicola; Salpietro, Stefania; Lazzarin, Adriano; Castagna, Antonella

    2013-08-01

    The objective of this study was to compare immunologic, virologic, and clinical outcomes between living human immunodeficiency virus (HIV)-infected individuals who had a diagnosis of lymphoma versus outcomes in a control group of cancer-free, HIV-infected patients. In this matched cohort study, patients in the case group were survivors of incident lymphomas that occurred between 1997 and June 2010. Controls were living, cancer-free, HIV-infected patients who were matched to cases at a 4:1 ratio by age, sex, nadir CD4 cell count, and year of HIV diagnosis. The date of lymphoma diagnosis served as the baseline in cases and in the corresponding controls. In total, 62 patients (cases) who had lymphoma (20 with Hodgkin disease [HD] and 42 with non-Hodgkin lymphoma [NHL]) were compared with 211 controls. The overall median follow-up was 4.8 years (interquartile range, 2.0-7.9 years). The CD4 cell count at baseline was 278 cells/mm³ (interquartile range, 122-419 cells/mm³) in cases versus 421 cells/mm³ (interquartile range, 222-574 cells/mm³) in controls (P = .003). At the last available visit, the CD4 cell count was 412 cells/mm³ (range, 269-694 cells/mm³) in cases versus 518 cells/mm³ (interquartile range, 350-661 cells/mm³) in controls (P = .087). The proportion of patients who achieved virologic success increased from 30% at baseline to 74% at the last available visit in cases (P = .008) and from 51% to 81% in controls (P = .0286). Patients with HD reached higher CD4 cell counts at their last visit than patients with NHL (589 cells/mm³ [range, 400-841 cells/mm³] vs 332 cells/mm³ [interquartile range, 220-530 cells/mm³], respectively; P = .003). Virologic success was similar between patients with HD and patients with NHL at the last visit. Forty cases (65%) and 76 controls (36%) experienced at least 1 clinical event after baseline (P < .0001); cases were associated with a shorter time to occurrence of the first clinical event compared with controls (P

  20. Clinical Outcome After DK Crush Versus Culotte Stenting of Distal Left Main Bifurcation Lesions: The 3-Year Follow-Up Results of the DKCRUSH-III Study.

    Science.gov (United States)

    Chen, Shao-Liang; Xu, Bo; Han, Ya-Ling; Sheiban, Imad; Zhang, Jun-Jie; Ye, Fei; Kwan, Tak W; Paiboon, Chitprapai; Zhou, Yu-Jie; Lv, Shu-Zheng; Dangas, George D; Xu, Ya-Wei; Wen, Shang-Yu; Hong, Lang; Zhang, Rui-Yan; Wang, Hai-Chang; Jiang, Tie-Ming; Wang, Yan; Sansoto, Teguh; Chen, Fang; Yuan, Zu-Yi; Li, Wei-Min; Leon, Martin B

    2015-08-24

    The present study aimed to investigate the difference in major adverse cardiac events (MACE) at 3 years after double-kissing (DK) crush versus culotte stenting for unprotected left main distal bifurcation lesions (LMDBLs). The multicenter and randomized DKCRUSH-III (Comparison of double kissing crush versus culotte stenting for unprotected distal left main bifurcation lesions: results from a multicenter, randomized, prospective study) showed that DK crush stenting was associated with fewer MACE at 1-year follow-up in patients with LMDBLs compared with culotte stenting. Here, we report the 3-year clinical outcome of the DKCRUSH-III study. A total of 419 patients with LMDBLs who were randomly assigned to either the DK crush or culotte group in the DKCRUSH-III study were followed for 3 year. The primary endpoint was the occurrence of a MACE at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by simple and complex LMDBLs according to the DEFINITION (Definition and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) study criteria. At 3 years, MACE occurred in 49 patients the culotte group and in 17 patients in the DK crush group (cumulative event rates of 23.7% and 8.2%, respectively; p DK crush group (p = 0.007). Complex LMDBLs were associated with a higher rate of MACE (35.3%) at 3 years compared with a rate of 8.1% in patients with simple LMDBLs (p DK] Crush Versus Culotte Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions: DKCRUSH-III, a Multicenter Randomized Study Comparing Double-Stent Techniques; ChiCTR-TRC-11001877). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  1. 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

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

    DEFF Research Database (Denmark)

    Nielsen, Anette Søgaard; Nielsen, Bent

    2015-01-01

    This article describes the design, implementation, and evaluation of a clinical pathway system in a two-cohort quasi-experimental study before and after implementation, controlling for confounders. The main outcome measures were retention in care and sensible alcohol use (defined as abstinent...

  3. Clinical outcome of parotidectomy with reconstruction: Experience of ...

    African Journals Online (AJOL)

    The comprehensive clinical outcome of the malignant cases could not be objectively assessed, as the OS and DFS were 50% at 2-years follow-up. It is our submission that a larger sample size is utilized in subsequent studies and quality of life evaluation is included in the methodology. Keywords: Facial re-animation, neural ...

  4. Clinical Features, Complications and Treatment Outcome of Brucella ...

    African Journals Online (AJOL)

    Purpose: Brucellosis is a multi-systemic infection that is endemic in some parts of the world. The purpose of this study was to examine the epidemiology as well as the clinical and haematological characteristics, complications, and treatment outcome of patients with brucellosis at the King Fahd Hospital of the University ...

  5. Clinical outcomes and mortality before and after implementation of a pediatric sepsis protocol in a limited resource setting: A retrospective cohort study in Bangladesh.

    Directory of Open Access Journals (Sweden)

    Teresa Bleakly Kortz

    Full Text Available Pediatric sepsis has a high mortality rate in limited resource settings. Sepsis protocols have been shown to be a cost-effective strategy to improve morbidity and mortality in a variety of populations and settings. At Dhaka Hospital in Bangladesh, mortality from pediatric sepsis in high-risk children previously approached 60%, which prompted the implementation of an evidenced-based protocol in 2010. The clinical effectiveness of this protocol had not been measured. We hypothesized that implementation of a pediatric sepsis protocol improved clinical outcomes, including reducing mortality and length of hospital stay.This was a retrospective cohort study of children 1-59 months old with a diagnosis of sepsis, severe sepsis or septic shock admitted to Dhaka Hospital from 10/25/2009-10/25/2011. The primary outcome was inpatient mortality pre- and post-protocol implementation. Secondary outcomes included fluid overload, heart failure, respiratory insufficiency, length of hospital stay, and protocol compliance, as measured by antibiotic and fluid bolus administration within 60 minutes of hospital presentation.404 patients were identified by a key-word search of the electronic medical record; 328 patients with a primary diagnosis of sepsis, severe sepsis, or septic shock were included (143 pre- and185 post-protocol in the analysis. Pre- and post-protocol mortality were similar and not statistically significant (32.17% vs. 34.59%, p = 0.72. The adjusted odds ratio (AOR for post-protocol mortality was 1.55 (95% CI, 0.88-2.71. The odds for developing fluid overload were significantly higher post-protocol (AOR 3.45, 95% CI, 2.04-5.85, as were the odds of developing heart failure (AOR 4.52, 95% CI, 1.43-14.29 and having a longer median length of stay (AOR 1.81, 95% CI 1.10-2.96. There was no statistically significant difference in respiratory insufficiency (pre- 65.7% vs. post- 70.3%, p = 0.4 or antibiotic administration between the cohorts (pre- 16.08% vs

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

    Science.gov (United States)

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

    2009-07-01

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

  7. 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

  8. Quality of reporting of descriptive studies in implant dentistry. Critical aspects in design, outcome assessment and clinical relevance

    NARCIS (Netherlands)

    Meijer, Henny J. A.; Raghoebar, Gerry M.

    Objectives: The aim of this study was to conduct a review on quality of reporting on descriptive studies in implant dentistry using the STROBE Statement and to analyse possible changes in quality of reporting on descriptive studies in implant dentistry over time. Material and Methods: A hand search

  9. Clinical outcome of narrow-diameter (3.3-mm) locking-taper implants: a prospective study with 1 to 10 years of follow-up.

    Science.gov (United States)

    Mangano, Francesco; Shibli, Jamil A; Sammons, Rachel L; Veronesi, Giovanni; Piattelli, Adriano; Mangano, Carlo

    2014-01-01

    To evaluate the outcome of narrow-diameter (3.3-mm) locking-taper implants used in the rehabilitation of partially and fully edentulous patients over a 10-year period. Between January 2002 and December 2011, all patients referred to a private dental clinic for treatment with narrow-diameter implants were enrolled in this study. At each annual follow-up session, clinical and radiographic parameters were assessed; the outcome measurements were implant failure, peri-implant marginal bone loss (distance between the implant shoulder and the first visible bone-to-implant contact [DIB]), and biologic and technical complications. The cumulative survival rate (CSR) was assessed using the Kaplan-Meier survival estimator; Tarone-Ware and chi-square analyses were used to evaluate correlations between the study variables. The statistical analysis was performed at the patient- and implant-level. A total of 324 narrow-diameter implants were placed in 279 patients (159 men, 120 women; age: 25 to 73 years). Four implants failed, for an overall CSR of 98.5% (patient-based) and 98.7% (implant-based) at the 10-year follow-up. The survival rate did not differ significantly with respect to patients' sex, age, smoking or parafunctional habits, bone type, prosthetic restoration, or implant location, position, or length. Among the surviving implants, a mean DIB of 0.31 ± 0.23 mm, 0.45 ± 0.27 mm, and 0.69 ± 0.28 mm was observed at the 1-, 5-, and 10-year follow-up examinations, respectively. A few biologic (1.2%) and technical complications (7.5%) were reported. Within the limitations of this study, it can be concluded that narrow-diameter locking-taper implants represent a good treatment option for the prosthetic rehabilitation of partially and totally edentulous patients.

  10. 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.

  11. Antibiotic prescribing on admission to patients with pneumonia and prior outpatient antibiotic treatment: a cohort study on clinical outcome

    NARCIS (Netherlands)

    van de Garde, Ewoudt M. W.; Natsch, Stephanie; Prins, Jan M.; van der Linden, Paul D.

    2015-01-01

    Objective: Most pneumonia treatment guidelines recommend that prior outpatient antibiotic treatment should be considered when planning inpatient antibiotic regimen. Our purpose was to study in patients admitted for community-acquired pneumonia the mode of continuing antibiotic treatment at the

  12. Antibiotic prescribing on admission to patients with pneumonia and prior outpatient antibiotic treatment : A cohort study on clinical outcome

    NARCIS (Netherlands)

    Van De Garde, Ewoudt M W; Natsch, Stephanie; Prins, Jan M.; Van Der Linden, Paul D.

    2015-01-01

    Objective: Most pneumonia treatment guidelines recommend that prior outpatient antibiotic treatment should be considered when planning inpatient antibiotic regimen. Our purpose was to study in patients admitted for community-acquired pneumonia the mode of continuing antibiotic treatment at the

  13. Association of heart rate variability with clinical outcome in Parkinsonian patients after subthalamic deep brain stimulation: A retrospective cohort study

    Directory of Open Access Journals (Sweden)

    Shin-Yuan Chen

    2011-09-01

    Conclusion: Our study showed an improvement in autonomic cardiovascular regulation in Parkinsonian patients with >50% improvement in rating scale after STN-DBS, which implied morbidity reduction in nonmotor symptoms among such patients.

  14. Long-Term Therapy Outcomes When Treating Chronic Kidney Disease Patients with Paricalcitol in German and Austrian Clinical Practice (TOP Study

    Directory of Open Access Journals (Sweden)

    Nicholas Obermüller

    2017-09-01

    Full Text Available Paricalcitol is approved for prevention and therapy of secondary hyperparathyroidism (sHPT in patients with chronic kidney disease (CKD, with only short-term data in clinical routine settings. A 12-month observational study was conducted in Germany and Austria (90 centers, 761 patients from 2008 to 2013. Laboratory values, demographical, and clinical data were documented in 629 dialysis patients and 119 predialysis patients. In predialysis patients, median intact parathormone (iPTH was 180.0 pg/mL (n = 105 at the start of the study, 115.7 pg/mL (n = 105 at last documentation, and 151.8 pg/mL (n = 50 at month 12, with 32.4% of the last documented iPTH values in the KDOQI (Kidney Disease Outcomes Quality Initiative target range. In dialysis patients, median iPTH was 425.5 pg/mL (n = 569 at study start, 262.3 pg/mL (n = 569 at last documentation, and 266.1 pg/mL (n = 318 at month 12, with 36.5% of dialysis patients in the KDOQI target range. Intravenous paricalcitol showed more homogenous iPTH control than oral treatment. Combined analysis of all dialysis patients indicated comparable and stable mean serum calcium and phosphate levels throughout the study. Clinical symptoms, such as itching, bone pain, and fatigue, were improved compared with study entry. The spectrum and frequency of adverse events mirrored the known pattern for patients on dialysis. Paricalcitol is efficacious and has a consistent safety profile in sHPT over 12 months.

  15. Predictors of Clinical Outcomes in Sexually Abused Adolescents.

    Science.gov (United States)

    Tocker, Lotem; Ben-Amitay, Galit; Horesh-Reinman, Netta; Lask, Michal; Toren, Paz

    2017-01-01

    This cross-sectional, case control study examines the association between child sexual abuse and interpersonal and intrapersonal outcomes among 54 adolescents, examining specific clinical measures (depression, anxiety, dissociation, and posttraumatic stress disorder, attachment patterns, self-esteem, self-disclosure, and family environment characteristics). The research results point to a correlation between sexual abuse and higher levels of the clinical measures. In addition, a correlation was found between sexual abuse and level of avoidant attachment, self-esteem, and family environment characteristics. Stepwise hierarchical regressions were conducted to examine how adolescent attributes predicted depression, anxiety, and dissociation beyond the prediction based on sexual abuse. A combination of self-esteem, anxiety attachment, and family cohesiveness made sexual abuse insignificant when predicting levels of depression, anxiety, and dissociation. This study contributes to characterizing the emotional, personal, and family attributes of adolescents who experienced sexual abuse. It also raises questions about the clinical outcomes usually associated with sexual abuse.

  16. Congenital clinical malaria: Incidence, management and outcome ...

    African Journals Online (AJOL)

    Objective: With paucity of documentation of congenital clinical malaria in the world literature, we therefore aimed to review its rates, presentation, management and out come of this problem in neonates at the Usmanu Danfodiyo University Teaching Hospital, Sokoto. Methodology: This prospective study was carried out in ...

  17. Diagnostic issues, clinical characteristics, and outcomes for patients with fungemia

    DEFF Research Database (Denmark)

    Arendrup, Maiken Cavling; Sulim, Sofia; Holm, Anette

    2011-01-01

    This study investigated microbiological, clinical, and management issues and outcomes for Danish fungemia patients. Isolates and clinical information were collected at six centers. A total of 334 isolates, 316 episodes, and 305 patients were included, corresponding to 2/3 of the national episodes...... needed longer incubation. Species distribution varied by age, prior antifungal treatment (57% occurrence of C. glabrata, Saccharomyces cerevisiae, or C. krusei in patients with prior antifungal treatment versus 28% occurrence in those without it; P = 0.007), and clinical specialty (61% occurrence of C...

  18. Diagnostic Issues, Clinical Characteristics, and Outcomes for Patients with Fungemia

    DEFF Research Database (Denmark)

    Arendrup, Maiken Cavling; Sulim, Sofia; Holm, Anette

    2011-01-01

    This study investigated microbiological, clinical, and management issues and outcomes for Danish fungemia patients. Isolates and clinical information were collected at six centers. A total of 334 isolates, 316 episodes, and 305 patients were included, corresponding to 2/3 of the national episodes...... needed longer incubation. Species distribution varied by age, prior antifungal treatment (57% occurrence of C. glabrata, Saccharomyces cerevisiae, or C. krusei in patients with prior antifungal treatment versus 28% occurrence in those without it; P = 0.007), and clinical specialty (61% occurrence of C...

  19. A retrospective, descriptive study of maternal and neonatal transfers, and clinical outcomes of a Primary Maternity Unit in rural Queensland, 2009-2011.

    Science.gov (United States)

    Kruske, Sue; Schultz, Tracy; Eales, Sandra; Kildea, Sue

    2015-03-01

    A widely held view in maternity services in rural Australia is they require 24-h on-site surgical and anaesthetic capability to be considered safe. This study aimed to provide a detailed description of three years of activity (2009-2011) of a rural maternity unit approximately 1h from the nearest surgical service. We describe the reasons for transfer to and from the unit, transfer times and the clinical health outcomes of all women (all risk status) and their babies. This retrospective study utilised contemporaneously, purposefully collected audit data, routinely collected data and medical chart review. Data were analysed based on the model of care that women were allocated to at the time of booking. The PMU provided care to twice as many young women (13.3% MDH vs. 5.1% QLD) and almost five times as many Aboriginal and/or Torres Strait Islander women (27.5% MDH vs. 5.7% QLD). A total of 506 women booked to receive care through a midwifery group practice (MGP), and 377 (74.5%) gave birth at the local facility as planned. Clinical outcomes for women and babies birthing both at the PMU and those transferred were comparable or better than other published data. The results challenge the notion that birthing services can only be offered in rural areas with onsite surgical capability. More PMUs should be made available in rural areas, in line with national and state policy and international evidence. Copyright © 2014 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

  20. Epidemiology, recognition and documentation of sepsis in the pre-hospital setting and associated clinical outcomes: a prospective multicenter study

    NARCIS (Netherlands)

    Alam, Nadia; Doerga, Kirtiedevi B. N. S; Hussain, Tahira; Hussain, Sadia; Holleman, Frits; Kramer, Mark H. H.; Nanayakkara, Prabath W. B.

    2016-01-01

    General practitioners (GPs) and the emergency medical services (EMS) personnel have a pivotal role as points of entry into the acute care chain. This study was conducted to investigate the recognition of sepsis by GPs and EMS personnel and to evaluate the associations between recognition of sepsis

  1. Correlation of serum MMP3 and other biomarkers with clinical outcomes in patients with ankylosing spondylitis: A pilot study

    Science.gov (United States)

    The studies aimed to assess a set of biomarkers for their correlations with disease activity/severity of patients with ankylosing spondylitis (AS). A total of 24 AS patients were treated with etanercept and prospectively followed for 12 weeks. Serum levels of TNF-alpha, IFN-gamma, TGF-beta, IL6, IL1...

  2. Relevance of positive cardiovascular outcome trial results in clinical practice: perspectives from the Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes (ACROSS T2D

    Directory of Open Access Journals (Sweden)

    Schernthaner G

    2017-12-01

    Full Text Available Guntram Schernthaner,1 Kamlesh Khunti,2 Chaim Lotan,3 Michel Burnier,4 Heinz Drexel,5 Martin Prázný61Department of Medicine I, Rudolfstiftung Hospital, Vienna, Austria; 2Diabetes Research Centre, Leicester General Hospital, Leicester, UK; 3Cardiovascular Division, Hadassah Medical Centre, Jerusalem, Israel; 4Division of Nephrology and Hypertension Consultation, University Hospital of Lausanne, Lausanne, Switzerland; 5Vorarlberg Institute for Vascular Investigation and Treatment, Feldkirch, Austria; 6Charles University, Prague, Czech RepublicAbstract: Type 2 diabetes (T2D imposes a substantial disease burden, predominantly from cardiovascular disease (CVD, which accounts for >50% of deaths in this population and leads to a 12-year reduction in the life expectancy of a 60-year-old male patient with T2D and CVD compared with the general population. The results from mandatory cardiovascular outcome trials (CVOTs are therefore of great interest in the field. The Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes meeting program aims to bring together experts from several associated disciplines to provide fair and balanced resources for those involved in the management of patients with T2D. This publication represents the opinions of the faculty on the key learnings from the meeting held in Vienna in the spring of 2017. In particular, we detail how data from the EMPA-REG OUTCOME® [cardiovascular outcomes trial of empagliflozin] and Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER® (liraglutide CVOTs can be practically interpreted across clinical specialities. It is hoped that this translation of CVOT data will achieve a dual treatment paradigm for the management of both raised glucose levels and CV risk in patients with T2D. Keywords: type 2 diabetes, cardiovascular disease, CVOT, SGLT2 inhibitors, GLP-1 agonists, DPP-4 inhibitors

  3. Is There a Relation between ABO Blood Groups and Clinical Outcome in Patients with Pemphigoid? A Case-Control Study.

    Science.gov (United States)

    Bakhtiari, Sedigheh; Toosi, Parviz; Azimi, Somayyeh; Esmaili, Nafiseh; Montazami, Ali; Rafieian, Nasrin

    2016-01-01

    Background. Relationship between blood groups and dermatologic diseases remains controversial and was not yet fully elucidated nor explained clearly. The aim of this study was to examine if any relation exists between different types of pemphigoid diseases and ABO blood group. Methods. In this case-control study, 159 pemphigoid patients and 152 healthy matched-controls were evaluated. All blood group (including Rh status) data for the study was obtained from the hospital medical records. Statistical comparisons were completed with chi-square test and logistic regression. Results. Blood group "O" was found in 32.9% of patients and 38.2% of control group. Blood group "A" was found among 30.8% of patients and 34.2% of control group, while group "B" was reported in 27.4% of cases and 21.1% of controls and "AB" was identified among 8.9% of patients and 6.6% of control group. 84.9% of patients were Rh positive, while in the control group 86.2% of patients were Rh positive. No significant differences were found regarding ABO blood groups (P = 0.46) or Rh (P = 0.76) between pemphigoid patients and control group. Also, older females had the higher risk of developing bullous pemphigoid. Conclusion. We found no relationship between ABO blood groups and pemphigoid disease.

  4. CLINICAL OUTCOMES AND SELF-REPORTED SYMPTOMS IN PATIENTS WITH ACROMEGALY: AN 8-YEAR FOLLOW-UP OF A LANREOTIDE STUDY.

    Science.gov (United States)

    Khairi, Shafaq; Sagvand, Babak Torabi; Pulaski-Liebert, Karen J; Tritos, Nicholas A; Klibanski, Anne; Nachtigall, Lisa B

    2017-01-01

    The aim of this study was to evaluate the proportion of patients with acromegaly who remained on long-term lanreotide depot after completion of an open-label multicenter phase III clinical trial (SALSA: A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel), compare baseline and long-term follow-up symptoms scores, and correlate scores with individual longitudinal clinical outcomes. Records of all subjects previously enrolled at the Massachusetts General Hospital site of SALSA were reviewed. Those who remained on lanreotide were interviewed and asked to complete a questionnaire that they had filled out in SALSA in 2007 regarding their current symptomatology and injection side effects, as well as to complete the Acromegaly Quality of Life Questionnaire. Furthermore, clinical, biochemical, and radiographic data related to acromegaly and its comorbidities were tracked throughout follow-up. Six out of 7 patients chose to remain on lanreotide, and 5 of them continued lanreotide depot through last follow-up, for up to 8 years or in 1 case until death. In all cases, lanreotide remained well tolerated, and insulin-like growth factor-1 levels and pituitary imaging remained well controlled on stable doses. While comorbidities persisted or developed, the self-reported symptom score after up to 8 years of therapy showed a significant decrease in frequency or resolution in symptoms that were reported at baseline. This study shows a significant decrease in frequency or resolution in self-reported symptoms in well-controlled patients receiving long-term lanreotide therapy. AcroQoL = Acromegaly Quality of Life Questionnaire GH = growth hormone GI = gastrointestinal IGF-1 = insulin-like growth factor-1 SALSA = A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel.

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

    Directory of Open Access Journals (Sweden)

    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

  6. 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 ...

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

    Directory of Open Access Journals (Sweden)

    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.

  8. Incidence and Clinical Outcomes of Inflammatory Bowel Disease in South Korea, 2011-2014: A Nationwide Population-Based Study.

    Science.gov (United States)

    Jung, Yoon Suk; Han, Minkyung; Kim, Won Ho; Park, Sohee; Cheon, Jae Hee

    2017-08-01

    The incidence of inflammatory bowel disease (IBD) is increasing in East Asia; however, population-based data from this region are lacking. We conducted a nationwide, population-based study to examine the incidence and disease course of IBD in South Korea. Using the National Health Insurance claims data, we collected data on patients diagnosed with IBD [10,049 with ulcerative colitis (UC) and 5595 with Crohn's disease (CD)] from 2011 to 2014. During the study period, the average annual incidence of UC was 5.0 per 10 5 , while that of CD was 2.8 per 10 5 . Among patients with UC, the cumulative rates of surgery 1 and 4 years after diagnosis were 1.0 and 2.0%; those among patients with CD were 9.0 and 13.9%, respectively. The 1- and 4-year cumulative rates of moderate- to high-dose corticosteroid use were, respectively, 26.6 and 45.2% among patients with UC, and 29.9 and 50.8% among those with CD. Similarly, the 1- and 4-year cumulative rates of immunomodulator use were 14.1 and 26.4% among patients with UC, and 58.3 and 76.1% among those with CD, respectively. With regard to biologic use, the 1- and 4-year cumulative rates were 3.0 and 9.0% among patients with UC, and 11.1 and 31.7% among those with CD, respectively. The recent incidence of IBD in South Korea has been the highest in East Asia. Patients who had been diagnosed recently with IBD showed lower rates of surgery and higher rates of immunomodulator and biologic use compared to those reported ever in South Korea.

  9. The comparison of dietary intake of effective foods on clinical outcomes of rheumatoid arthritis: A case - control study

    Directory of Open Access Journals (Sweden)

    mahsa jalili

    2011-03-01

    Full Text Available Rheumatoid arthritis (RA is one of the common chronic diseases. Some vegetables and oils may reduce the inflammation in RA and citrus fruits, tomatoes, red meat and salty pickles may worsen the pain and tenderness in joints. The objective of this study is to compare dietary intake of some foods in female RA patients with healthy control group. Materials and Methods: In this case-control study, 44 female RA patients were compared with 41 healthy age-matched controls. Quantitative food frequency questionnaire (FFQ was filled to achieve dietary patterns as interview. The data were analyzed by Kolmogrov-Smirnov and histogram for normality test and Mann U Whitney test for comparing differences between groups using SPSS software version 13.5. Results: mean ± standard deviation of body mass index (BMI was 28.6±3.95 and 28.23±4.32 in RA and control groups respectively. Weekly intake of tomato, cantaloupe, tea and spinach in cases was higher than that of controls (p<0.001 although yogurt (p=0.001, berries (p=0.01, peach (p<0.001, coffee (p<0.001, fast foods (p=0.009, fried foods (p=0.003 and mango (p<0.001 were less common foods in RA patients rather than controls. Conclusion: RA patients had more rate of overweight, but difference between two groups were not significant. The intake of some allergen foods like tomato and cantaloupe was higher in RA patients and some antioxidant-rich foods were eaten less in patients compared with controls so,weight reduction and consumption of more fresh vegetables are recommended.

  10. 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.

  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.

  12. Is the radiographic subsidence of stand-alone cages associated with adverse clinical outcomes after cervical spine fusion? An observational cohort study with 2-year follow-up outcome scoring.

    Science.gov (United States)

    Zajonz, Dirk; Franke, Anne-Catherine; von der Höh, Nicolas; Voelker, Anna; Moche, Michael; Gulow, Jens; Heyde, Christoph-Eckhard

    2014-01-01

    The stand-alone treatment of degenerative cervical spine pathologies is a proven method in clinical practice. However, its impact on subsidence, the resulting changes to the profile of the cervical spine and the possible influence of clinical results compared to treatment with additive plate osteosynthesis remain under discussion until present. This study was designed as a retrospective observational cohort study to test the hypothesis that radiographic subsidence of cervical cages is not associated with adverse clinical outcomes. 33 cervical segments were treated surgically by ACDF with stand-alone cage in 17 patients (11 female, 6 male), mean age 56 years (33-82 years), and re-examined after eight and twenty-six months (mean) by means of radiology and score assessment (Medical Outcomes Study Short Form (MOS-SF 36), Oswestry Neck Disability Index (ONDI), painDETECT questionnaire and the visual analogue scale (VAS)). Subsidence was observed in 50.5% of segments (18/33) and 70.6% of patients (12/17). 36.3% of cases of subsidence (12/33) were observed after eight months during mean time of follow-up 1. After 26 months during mean time of follow-up 2, full radiographic fusion was seen in 100%. MOS-SF 36, ONDI and VAS did not show any significant difference between cases with and without subsidence in the two-sample t-test. Only in one type of scoring (painDETECT questionnaire) did a statistically significant difference in t-Test emerge between the two groups (p = 0.03; α = 0.05). However, preoperative painDETECT score differ significantly between patients with subsidence (13.3 falling to 12.6) and patients without subsidence (7.8 dropped to 6.3). The radiological findings indicated 100% healing after stand-alone treatment with ACDF. Subsidence occurred in 50% of the segments treated. No impact on the clinical results was detected in the medium-term study period.

  13. Clinical Features and Treatment Outcomes among Children with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A 20-Year Study in a Tertiary Referral Hospital

    Directory of Open Access Journals (Sweden)

    Susheera Chatproedprai

    2018-01-01

    Full Text Available Aim. To determine the probable causative factors, clinical features, and treatment outcomes of Stevens-Johnson syndrome (SJS, toxic epidermal necrolysis (TEN, and SJS-TEN overlap in children. Methods. A 20-year database review of all children diagnosed with SJS/TEN/SJS-TEN overlap at the King Chulalongkorn Memorial Hospital, Thailand. Results. 36 patients (M : F, 16 : 20 with the mean age of 9.2±4.0 years were identified. There were 20 cases of SJS, 4 cases of SJS-TEN overlap, and 12 cases of TEN. Drugs were the leading cause for the diseases (72.3%; antiepileptics were the most common culprits (36.1%. Cutaneous morphology at presentation was morbilliform rash (83.3%, blister (38.9%, targetoid lesions (25.0%, and purpuric macules (2.8%. Oral mucosa (97.2% and eye (83.3% were the 2 most common mucosal involvements. Majority of the cases (77.8% were treated with systemic corticosteroids, intravenous immunoglobulin, or both. Treatment outcomes between those who received systemic therapy and those who received only supportive care were comparable. Skin and eye were the principal sites of short-term and long-term complications. Conclusions. SJS/TEN are not common but are serious diseases which lead to significant morbidities in children. Early withdrawal of suspicious causes and meticulous supportive care are very important. This study found that the systemic therapy was not superior to supportive care because the treatment outcomes for both groups were comparable.

  14. University clinic and private practice treatment outcomes in Class I extraction and nonextraction patients: A comparative study with the American Board of Orthodontics Objective Grading System.

    Science.gov (United States)

    Mislik, Barbara; Konstantonis, Dimitrios; Katsadouris, Alexios; Eliades, Theodore

    2016-02-01

    The aim of this study was to compare treatment outcomes in university vs private practice settings with Class I patients using the American Board of Orthodontics Objective Grading System. A parent sample of 580 Class I patients treated with and without extractions of 4 first premolars was subjected to discriminant analysis to identify a borderline spectrum of 66 patients regarding the extraction modality. Of these patients, 34 were treated in private orthodontic practices, and 32 were treated in a university graduate orthodontic clinic. The treatment outcomes were evaluated using the 8 variables of the American Board of Orthodontics Objective Grading System. The total scores ranged from 10 to 47 (mean, 25.44; SD, 9.8) for the university group and from 14 to 45 (mean, 25.94; SD, 7.7) for the private practice group. The university group achieved better scores for the variables of buccolingual inclination (mean difference, 2.28; 95% confidence interval [CI], 0.59, 3.98; P = 0.01) and marginal ridges (mean difference, 1.32; 95% CI, 0.28, 2.36; P = 0.01), and the private practice group achieved a better score for the variable of root angulation (mean difference, -0.65; 95% CI, -1.26, -0.03; P = 0.04). However, no statistically intergroup differences were found between the total American Board of Orthodontics Objective Grading System scores (mean difference, -0.5; 95% CI, -3.82, 4.82; P = 0.82). Patients can receive similar quality of orthodontic treatment in a private practice and a university clinic. The orthodontists in the private practices were more successful in angulating the roots properly, whereas the orthodontic residents accomplished better torque control of the posterior segments and better marginal ridges. Copyright © 2016 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

  15. Clinical characteristics of children with severe visual impairment but favorable retinal structural outcomes from the Early Treatment for Retinopathy of Prematurity (ETROP) study.

    Science.gov (United States)

    Siatkowski, R Michael; Good, William V; Summers, C Gail; Quinn, Graham E; Tung, Betty

    2013-04-01

    To describe visual function and associated characteristics at the 6-year examination in children enrolled in the Early Treatment for Retinopathy of Prematurity Study who had unfavorable visual outcomes despite favorable structural outcomes in one or both eyes. The clinical examination records of children completing the 6-year follow-up examination were retrospectively reviewed. Eligible subjects were those with visual acuity of ≤20/200 in each eye (where recordable) and a normal fundus or straightening of the temporal retinal vessels with or without macular ectopia in at least one eye. Data regarding visual function, retinal structure, presence of nystagmus, optic atrophy, optic disk cupping, seizures/shunts, and Functional Independence Measure for Children (ie, WeeFIM: pediatric functional independence measure) developmental test scores were reviewed. Of 342 participants who completed the 6-year examination, 39 (11%) met inclusion criteria. Of these, 29 (74%) had normal retinal structure, 18 (46%) had optic atrophy, and 3 (8%) had increased cupping of the optic disk in at least one eye. Latent and/or manifest nystagmus occurred in 30 children (77%). The presence of nystagmus was not related to the presence of optic atrophy. Of the 39 children, 28 (72%) had a below-normal WeeFIM score. In 25 participants (7%) completing the 6-year examination, cortical visual impairment was considered the primary cause of visual loss. The remainder likely had components of both anterior and posterior visual pathway disease. Clinical synthesis of ocular anatomy and visual and neurologic function is required to determine the etiology of poor vision in these children. Copyright © 2013 American Association for Pediatric Ophthalmology and Strabismus. Published by Mosby, Inc. All rights reserved.

  16. Proposed Optimal Fluoroscopic Targets for Cooled Radiofrequency Neurotomy of the Sacral Lateral Branches to Improve Clinical Outcomes: An Anatomical Study.

    Science.gov (United States)

    Stout, Alison; Dreyfuss, Paul; Swain, Nathan; Roberts, Shannon; Loh, Eldon; Agur, Anne

    2017-11-23

    Current sacroiliac joint (SIJ) cooled radiofrequency (RF) is based on fluoroscopic anatomy of lateral branches (LBs) in three specimens. Recent studies confirm significant variation in LB positions. To determine if common fluoroscopic needle placements for cooled SIJ RF are adequate to lesion all S1-3 LBs. If not, would different targets improve lesion accuracy? The LBs of 20 cadavers were dissected bilaterally (40 SIJs), and 26 G radiopaque wires were sutured to the LBs. With a 10-mm radius ruler centered at each foramen, standard targets were assessed, as judged by a clockface on the right, for S1 and S2 at 2:30, 4:00, and 5:30 positions and at S3 at 2:30 and 4:00. Mirror image targets were assessed on the left. Assuming an 8-mm lesion diameter, the percentage of LBs that would not be ablated for each level was determined. Imaging through the superior end plate of S1 was compared against segment specific (SS) imaging. Nine point four percent of LBs would not be ablated at S1 vs 0.99% at S2 vs 35% at S3, and 60% of the 40 SIJs would be completely denervated using current targets. SS imaging did not improve results. Alternate target locations could improve the miss rate to 2.8% at S1 and 0% at S3 and would ablate all LBs in 95% of SIJs. Using a conservative 8-mm lesion measurement, contemporary cooled RF needle targets are inadequate to lesion all target LBs. Modifications to current targets are recommended to increase the effectiveness of the procedure. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  17. Patient-based and clinical outcomes of implant telescopic attachment-retained mandibular overdentures: a 1-year longitudinal prospective study.

    Science.gov (United States)

    Yunus, Norsiah; Saub, Roslan; Taiyeb Ali, Tara Bai; Salleh, Nosizana Mohd; Baig, Mirza Rustum

    2014-01-01

    The purpose of this study was to evaluate and compare Oral Health-Related Quality of Life (OHRQoL), denture satisfaction, and masticatory performance in edentulous patients provided with mandibular implant-supported overdentures (ISODs) retained with telescopic attachments and those of conventional complete dentures (CCDs). Peri-implant soft tissue changes were also evaluated at various intervals during a 1-year observation period. Participating patients received new CCDs and later received two mandibular interforaminal implants and had their mandibular CCDs converted into ISODs with telescopic attachments. Questionnaires were used to assess OHRQoL (Shortened Oral Health Impact Profile-14, Malaysian version) and denture satisfaction at different stages of treatment with CCDs and ISODs. Objective masticatory performance with the CCDs and ISODs was recorded with a mixing ability test. Evaluations were carried out at 3 months with the new CCDs, 3 months after mandibular ISOD provision, and 1 year after receiving the ISOD. Peri-implant parameters were additionally assessed at specific intervals during the treatment period. The data obtained were statistically analyzed and compared. In the 17 patients who completed the protocol, significant improvements were observed in OHRQoL and patient satisfaction when CCDs were modified to ISODs, after 3 months, and at 1 year. Significantly better mixing ability with the ISOD was noted, with the highest values observed at 1 year. Statistically insignificant differences were observed for all the peri-implant parameters, except for gingival recession, for which significant changes were observed 6 months after ISOD delivery (values had stabilized by 1 year). Telescopic crown attachment-retained mandibular ISODs improved OHRQoL, dental prosthesis satisfaction, and masticatory performance compared to CCDs. Peri-implant soft tissue response and implant stability were found to be favorable after 1 year.

  18. 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.

  19. 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

    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). 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. 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). 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.

  20. Outcome Measures in Myasthenia Gravis: Incorporation Into Clinical Practice.

    Science.gov (United States)

    Muppidi, Srikanth

    2017-03-01

    The development of validated assessment tools for evaluating disease status and response to interventions in patients with myasthenia gravis (MG) has been driven by clinical studies of emerging MG therapies. However, only a small proportion of MG-focused neurology practices have adopted these assessment tools for routine clinical use. This article reviews the suitability of 5 assessment instruments for incorporation into clinical practice, which should be driven by their ability to contribute to improved patient outcomes, and to be implemented within practice personnel and resource constraints. It is recommended that assessments based on both physician-evaluated and patient-reported outcomes be selected, to adequately evaluate both point-in-time symptom load and functional impact of MG symptoms over time. Provider resource allocation and reimbursement issues may be the most significant roadblocks to successful ongoing use of these tools; to that end, the addition of regular assessments to MG standards of care is recommended.

  1. Physiotherapy-led arthroplasty review clinic: a preliminary outcomes analysis.

    Science.gov (United States)

    Large, Kate E; Page, Carolyn J; Brock, Kim; Dowsey, Michelle M; Choong, Peter F M

    2014-11-01

    With the rising demand for Orthopaedics in the healthcare sector, service delivery innovations need to be explored to accommodate the increasing workload. Senior Musculoskeletal Physiotherapists have the specialised skills in the assessment of musculoskeletal conditions to determine the impact of surgery on patient outcomes. The aim of the present study was to compare outcomes between a physiotherapy-led arthroplasty review clinic (PT clinic) and the traditional model of orthopaedic surgeon review (OS clinic) after hip and knee replacement. This study was a retrospective case-controlled audit using a comprehensive database. Twenty-four patients who had a hip arthroplasty and 52 patients who had a knee arthroplasty were reviewed solely by the PT clinic at 3, 6 and 12 months after surgical reviews. These patients were matched 1:2 against patients seen only by the OS clinic. The outcome measures included International Knee Score (IKS), Harris Hip Score (HHS) and the Short Form (SF)-12. There were no significant differences in HHS or SF-12 scores for patients after hip arthroplasty. Significant differences for knee arthroplasty were observed favouring the PT clinic; IKS, PT clinic 147.6 (37.07), OS clinic 135.4 (35.68), P≤0.01, and physical component of the SF-12, PT clinic 41.98 (10.45), OS clinic 37.20 (10.44), Pphysiotherapy-led arthroplasty review clinic appears to be a safe and effective service alternative to reviews conducted by orthopaedic surgeons. WHAT IS KNOWN ABOUT THE TOPIC?: Osteoarthritis (OA) is a leading cause of musculoskeletal pain and disability and the burden of the disease is rapidly increasing. Joint arthroplasty surgery is the mainstay of treatment for people with end-stage OA; it is a high-cost, high-volume procedure that dominates surgical wait lists around Australia. Long-term follow up is encouraged by the Arthroplasty Society of Australia and endorsed by the Australian Orthopaedics Association, but it is acknowledged that it is impossible

  2. 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

    Directory of Open Access Journals (Sweden)

    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.

  3. Contrast-enhanced T1 mapping-based extracellular volume fraction independently predicts clinical outcome in patients with non-ischemic dilated cardiomyopathy: a prospective cohort study

    Energy Technology Data Exchange (ETDEWEB)

    Youn, Jong-Chan [Hallym University College of Medicine, Division of Cardiology, Dongtan Sacred Heart Hospital, Hwaseong (Korea, Republic of); Yonsei University College of Medicine, Division of Cardiology, Severance Cardiovascular Hospital, Seoul (Korea, Republic of); Hong, Yoo Jin; Lee, Hye-Jeong; Han, Kyunghwa; Suh, Young Joo; Hur, Jin; Kim, Young Jin; Choi, Byoung Wook [Yonsei University College of Medicine, Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Seoul (Korea, Republic of); Shim, Chi Young; Hong, Geu-Ru; Kang, Seok-Min [Yonsei University College of Medicine, Division of Cardiology, Severance Cardiovascular Hospital, Seoul (Korea, Republic of)

    2017-09-15

    We aimed to evaluate the prognostic role of cardiac magnetic resonance imaging (CMR)-based extracellular volume fraction (ECV) in patients with non-ischemic dilated cardiomyopathy (NIDCM) and compare it with late gadolinium enhancement (LGE) parameters. This was a single-center, prospective, cohort study of 117 NIDCM patients (71 men, 51.9 ± 16.7 years) who underwent clinical 3.0-T CMR. Myocardial ECV and LGE were quantified on the left ventricular myocardium. The presence of midwall LGE was also detected. Nineteen healthy subjects served as controls. The primary end points were cardiovascular (CV) events defined by CV death, rehospitalization due to heart failure, and heart transplantation. During the follow-up period (median duration, 11.2 months; 25{sup th}-75{sup th} percentile, 7.8-21.9 months), the primary end points occurred in 19 patients (16.2%). The ECV (per 3% and 1% increase) was associated with a hazard ratio of 1.80 and 1.22 (95% confidence interval [CI], 1.48-2.20 and 1.14-1.30, respectively; p < 0.001) for the CV events. Multivariable analysis also indicated that ECV was an independent prognostic factor and had a higher prognostic value (Harrell's c statistic, 0.88) than LGE quantification values (0.77) or midwall LGE (0.80). CMR-based ECV independently predicts the clinical outcome in NIDCM patients. (orig.)

  4. Study to Measure the impact of Pharmacists and Pharmacy Services (STOMPP on Medication Non-Adherence: Medication Adherence and Clinical Outcomes

    Directory of Open Access Journals (Sweden)

    Sharrel Pinto, BS Pharm, DMM, MS, PhD

    2018-02-01

    Full Text Available Objective: To compare the impact of various pharmacy-based services on medication adherence and clinical outcomes. Design: Prospective, randomized control trial Setting: A local endocrinology group (clinic setting and community pharmacies belonging to a regional integrated delivery network (IDN in Toledo, OH Population: Subjects included within this study had type 2 diabetes, were prescribed a minimum of five medications, at least 18 years of age, having the ability to self-administer medications as prescribed, and be able to speak and understand English. Subjects were required to have Paramount health insurance, must be willing and able to provide informed consent, actively participate in the assigned MTM sessions, and have adequate transportation to attend the sessions at a participating pharmacy.  Methods: Patients were recruited through flyers at practice sites, referrals from physicians and pharmacists, and direct mailers. Members of the research team would screen patients to assess their eligibility to participate in the study. Patients who fit the inclusion criteria were randomized into one of the following four different groups: Pill Bottle (PB, Blister Pack (BP, Pill Bottle + Medication Therapy Management (PB+MTM, and Adherence Pharmacy (BP+MTM. Patients enrolled in the BP groups had their medications synchronized. Patients in the AP group were given the option to have their medications delivered, if needed. Practice innovation: We partnered with a regional integrated delivery network (IDN with multiple community pharmacy practice sites and a practice group of endocrinologists. A new practice model called Adherence Pharmacy was conceptualized and implemented within the community setting and was accessible to patients. Main Outcomes Measures: Medication adherence, measured using proportions of days covered (PDC and pill count scores at baseline, 3 months, 6 months, 9 months, and 12 months; Hemoglobin A1c (HbA1c, body mass index (BMI

  5. The association between patient-reported self-management behavior, intermediate clinical outcomes, and mortality in patients with type 2 diabetes: results from the KORA-A study.

    Science.gov (United States)

    Laxy, Michael; Mielck, Andreas; Hunger, Matthias; Schunk, Michaela; Meisinger, Christa; Rückert, Ina-Maria; Rathmann, Wolfgang; Holle, Rolf

    2014-06-01

    Little is known about the impact of diabetes self-management behavior (SMB) on long-term outcomes. We aimed to examine the association among patient-reported SMB, intermediate clinical outcomes, and mortality in patients with type 2 diabetes. Data were collected from 340 patients with type 2 diabetes of the KORA-A study (1997/1998) who were recruited from two previous population-based surveys (n = 161) and a myocardial infarction registry (n = 179) in southern Germany. Based on previous methodological work, a high level of SMB was defined as being compliant with at least four of six different self-care dimensions, comprising physical exercise, foot care, blood glucose self-monitoring, weight monitoring, having a diet plan, and keeping a diabetes diary. The vital status of the participants was observed until 2009. Multivariable linear, logistic, and Cox regression models were applied to assess the association with intermediate clinical outcomes at baseline and to predict mortality over the follow-up period, adjusted for sociodemographic, behavioral, and disease-related factors. In the cross-sectional perspective, a high level of SMB was weakly associated with a lower glycated hemoglobin A1c level (-0.44% [-4.8 mmol/mol] [95% CI -0.88 to 0.00]), but not with low-density lipoprotein cholesterol, systolic blood pressure, or the presence of microalbuminuria, peripheral arterial disease, or polyneuropathy. During a mean follow-up time of 11.6 years, 189 patients died. SMB was a preventive factor for all-cause (hazard ratio 0.61 [95% CI 0.40-0.91]) and cardiovascular mortality (0.65 [95% CI 0.41-1.03]). Although measuring SMB is difficult and the used operationalization might be limited, our results give some indication that a high level of SMB is associated with prolonged life expectancy in patients with type 2 diabetes and highlight the potential impact of the patients' active contribution on the long-term trajectory of the disease. We assume that the used proxy for SMB

  6. Survival and clinical outcome of dogs with ischaemic stroke

    DEFF Research Database (Denmark)

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

    2013-01-01

    The objectives of the present study were to investigate survival time, possible predictors of survival and clinical outcome in dogs with ischaemic stroke. A retrospective study of dogs with a previous diagnosis of ischaemic stroke diagnosed by magnetic resonance imaging (MRI) was performed....... The association between survival and the hypothesised risk factors was examined using univariable exact logistic regression. Survival was examined using Kaplan-Meier and Cox regression. Twenty-two dogs were identified. Five dogs (23%) died within the first 30days of the stroke event. Median survival in 30-day...... 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...

  7. Clinical Outcomes of Virologically-Suppressed Patients with Pre-existing HIV-1 Drug Resistance Mutations Switching to Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in the SPIRIT Study.

    Science.gov (United States)

    Porter, Danielle P; Toma, Jonathan; Tan, Yuping; Solberg, Owen; Cai, Suqin; Kulkarni, Rima; Andreatta, Kristen; Lie, Yolanda; Chuck, Susan K; Palella, Frank; Miller, Michael D; White, Kirsten L

    2016-02-01

    Antiretroviral regimen switching may be considered for HIV-1-infected, virologically-suppressed patients to enable treatment simplification or improve tolerability, but should be guided by knowledge of pre-existing drug resistance. The current study examined the impact of pre-existing drug resistance mutations on virologic outcomes among virologically-suppressed patients switching to Rilpivirine (RPV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF). SPIRIT was a phase 3b study evaluating the safety and efficacy of switching to RPV/FTC/TDF in virologically-suppressed HIV-1-infected patients. Pre-existing drug resistance at baseline was determined by proviral DNA genotyping for 51 RPV/FTC/TDF-treated patients with known mutations by historical RNA genotype and matched controls and compared with clinical outcome at Week 48. Drug resistance mutations in protease or reverse transcriptase were detected in 62.7% of patients by historical RNA genotype and in 68.6% by proviral DNA genotyping at baseline. Proviral DNA sequencing detected 89% of occurrences of NRTI and NNRTI resistance-associated mutations reported by historical genotype. Mutations potentially affecting RPV activity, including E138A/G/K/Q, Y181C, and H221Y, were detected in isolates from 11 patients by one or both assays. None of the patients with single mutants had virologic failure through Week 48. One patient with pre-existing Y181Y/C and M184I by proviral DNA genotyping experienced virologic failure. Nineteen patients with K103N present by historical genotype were confirmed by proviral DNA sequencing and 18/19 remained virologically-suppressed. Virologic success rates were high among virologically-suppressed patients with pre-existing NRTI and NNRTI resistance-associated mutations who switched to RPV/FTC/TDF in the SPIRIT study. While plasma RNA genotyping remains preferred, proviral DNA genotyping may provide additional value in virologically-suppressed patients for whom historical resistance

  8. 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.

    Directory of Open Access Journals (Sweden)

    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.

  9. Long-term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3-year results from the STROLL study.

    Science.gov (United States)

    Bunte, Matthew C; Cohen, David J; Jaff, Michael R; Gray, William A; Magnuson, Elizabeth A; Li, Haiyan; Feiring, Andrew; Cioppi, Marco; Hibbard, Robert; Gray, Bruce; Khatib, Yazan; Jessup, David; Patarca, Roberto; Du, Jing; Stoll, Hans-Peter; Massaro, Joe; Safley, David M

    2018-03-09

    To evaluate the clinical and health status outcomes of patients undergoing superficial femoral artery (SFA) revascularization using the Shape Memory Alloy Recoverable Technology (S.M.A.R.T.®) nitinol self-expanding stent through 3 years of follow-up. Limited long-term data are available describing the durability of benefits after femoropopliteal revascularization. In a multicenter, prospective, core-lab adjudicated study, 250 subjects with de novo or restenotic femoropopliteal arterial lesions were treated with the S.M.A.R.T.® stent. The primary endpoint of target vessel patency, a composite of ultrasound-assessed patency and freedom from clinically driven target lesion revascularization (TLR), was evaluated through 3 years. Secondary endpoints included stent fracture and health status. Health status was measured using generic and disease-specific instruments, including the Peripheral Artery Questionnaire (PAQ). At 3-year follow-up, Kaplan-Meier estimated target vessel patency was 72.7%, freedom from clinically driven TLR was 78.5%, and the incidence of stent fracture was 3.6%. The PAQ summary score was markedly impaired at baseline (mean 37.3 ± 19.6 points) and improved substantially at 1 month (mean change from baseline of 31.4 points, 95% CI: 28.5-34.3; P PAQ were largely preserved through 3 years of follow-up (mean change from baseline, 28.0 points, 95% CI: 24.3-31.7; P < 0.0001). In patients undergoing revascularization for moderately complex SFA disease, use of the self-expanding S.M.A.R.T® stent was associated with a high rate of target vessel patency through 3 years and led to substantial and sustained health status benefits. © 2018 Wiley Periodicals, Inc.

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

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    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

  11. New echocardiographic predictors of clinical outcome in patients presenting with heart failure and a preserved left ventricular ejection fraction: a subanalysis of the Ka (Karolinska) Ren (Rennes) Study.

    Science.gov (United States)

    Donal, Erwan; Lund, Lars H; Oger, Emmanuel; Hage, Camilla; Persson, Hans; Reynaud, Amélie; Ennezat, Pierre-Vladimir; Bauer, Fabrice; Drouet, Elodie; Linde, Cecilia; Daubert, Claude

    2015-07-01

    To identify electrocardiographic and echocardiographic predictors of mortality and hospitalizations for heart failure (HF) in the KaRen study. KaRen is a prospective, observational study of the long-term outcomes of patients presenting with heart failure and a preserved ejection fraction (HFpEF). We identified 538 patients who presented with acute cardiac decompensation, a >100 pg/mL serum b-type natriuretic peptide (BNP) or >300 pg/mL N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration and a left ventricular ejection fraction (LVEF) >45%. After 4-8 weeks of standard treatment, 413 patients (mean age = 76 ± 9 years, 55.9% women) returned for analyses of their clinical status, laboratory screen, and detailed electrocardiographic and Doppler echocardiographic recordings. They were followed for a mean of 28 months thereafter. The primary study endpoint was time to death from all causes or first hospitalization for heart failure. Mean LVEF was 62.4 ± 6.9% and median NT-proBNP 1410 pmol/L. PR interval >200 ms was present in 11.2% of patients and 14.9% had a >120 ms QRS duration, with left bundle branch block in only 6.3%. Over a mean follow-up of 28 months, 177 patients (42.9%) reached a primary study endpoint, including 61 deaths and 116 hospitalizations for heart failure. After adjustment for age, gender, New York Heart Association class, atrial fibrillation history, creatinine, sodium, BNP, ejection fraction, and right ventricular fractional shortening, only E/e' remained as a predictor, with a hazard ratio = 1.49 and P = 0.0012. The incidence of hospitalizations for HF and deaths in KaRen was high and E/e' predicted adverse clinical outcomes. These observations should help in the risk stratification and therapy of HFpEF. © 2015 The Authors. European Journal of Heart Failure © 2015 European Society of Cardiology.

  12. Does an Injection of Adipose-Derived Mesenchymal Stem Cells Loaded in Fibrin Glue Influence Rotator Cuff Repair Outcomes? A Clinical and Magnetic Resonance Imaging Study.

    Science.gov (United States)

    Kim, Yong Sang; Sung, Chang Hun; Chung, Sung Hoon; Kwak, Sang Joon; Koh, Yong Gon

    2017-07-01

    The mesenchymal stem cell (MSC)-based tissue engineering approach has been developed to improve the treatment of rotator cuff tears. Hypothesis/Purpose: The purpose was to determine the effect of an injection of adipose-derived MSCs loaded in fibrin glue during arthroscopic rotator cuff repair on clinical outcomes and to evaluate its effect on structural integrity using magnetic resonance imaging (MRI). The hypothesis was that the application of adipose-derived MSCs would improve outcomes after the surgical repair of a rotator cuff tear. Cohort study; Level of evidence, 3. Among 182 patients treated with arthroscopic surgery for a rotator cuff tear, 35 patients treated with arthroscopic rotator cuff repair alone (conventional group) were matched with 35 patients who underwent arthroscopic rotator cuff repair with an injection of adipose-derived MSCs loaded in fibrin glue (injection group) based on sex, age, and lesion size. Outcomes were assessed with respect to the visual analog scale (VAS) for pain, range of motion (ROM) (including forward flexion, external rotation at the side, and internal rotation at the back), and functional measures of the Constant score and University of California, Los Angeles (UCLA) shoulder rating scale. Repaired tendon structural integrity was assessed by using MRI at a minimum of 12 months after surgery, and the mean clinical follow-up was 28.8 ± 4.2 months in the conventional group and 28.3 ± 3.8 months in the injection group. The mean VAS score at rest and during motion improved significantly in both groups after surgery. However, there were no significant differences between the groups at the final follow-up ( P = .256 and .776, respectively). Compared with preoperative measurements, forward flexion and external rotation at the side significantly improved at the final follow-up in both groups (all P rotation at the back were observed in either group ( P = .625 and .834 for the conventional and injection groups, respectively

  13. Clinical features and outcome analysis of intracranial hydatid cysts

    International Nuclear Information System (INIS)

    Khan, M.M.; Shah, M.; Ayub, S.; Ahmad, A.; Aman, A.; Shah, M.A.; Rehman, R.U.

    2016-01-01

    Background: Hydatid cyst of the brain is a serious zoonotic parasitic infection which have profound health consequences if left untreated. The surgical excision of the cysts are rewarding for both the patient the neurosurgeon. Methods: The study was conducted prospectively at Department of Neurosurgery Hayatabad Medical Complex Peshawar from January 2013 to December 2014. Patients with a diagnosis of intracranial hydatid cysts were included, clinical and radiological features recorded, intervention and postoperative outcome were analysed. Results: Eleven patients with a male to female ratio of 1.7:1. Mean age was 12.4 (SD±6.5) years with median GCS on arrival of 10 (SD±2.5). Clinical features were headache (81.8 percentage), vomiting (90.9 percentage), seizures (36.4 percentage), focal deficits (54.5 percentage) and papilloedema (72.7 percentage). The median GCS on discharge was 13 (SD±1.1) while GOS at 1 month follow up was 4 (SD±0.7). The bivariate analysis showed inverse correlation (R2=-0.68; p=0.02) between duration of symptoms and outcome while GCS on admission was positively correlated (rs=0.75; p=0.007) with the outcome. There was no mortality. Conclusion: Despite its rarity the clinical features are non-specific while radiological features help in establishing diagnosis. Earlier diagnosis and prompt intervention is the key to favourable outcome. (author)

  14. Healthcare resource use, comorbidity, treatment and clinical outcomes for patients with primary intracranial tumors: a Swedish population-based register study.

    Science.gov (United States)

    Bergqvist, Jenny; Iderberg, Hanna; Mesterton, Johan; Bengtsson, Nils; Wettermark, Björn; Henriksson, Roger

    2017-03-01

    Primary intracranial tumors are relatively uncommon and heterogeneous, which make them challenging to study. We coupled data from unique Swedish population-based registries in order to deeper analyze the most common intracranical tumor types. Patient characteristics (e.g. comorbidities), care process measures like adherence to national guidelines, healthcare resource use and clinical outcome was evaluated. A register-based study including several population-based registries for all patients living in Stockholm-Gotland, diagnosed with primary intracranial tumor between 2001 and 2013 was performed. Patient characteristics were captured and investigated in relation to survival, healthcare resource use (inpatient-, outpatient- and primary care) and treatment process. High-grade glioma and meningioma were the most common tumor types and most patients (76%) were above the age of 40 in the patient population (n = 3664). Older age, comorbidity (Elixhauser comorbidity index) and type of tumor (high-grade glioma) were associated with lower survival rate and increased use of healthcare resources, analyzed for patients living in Stockholm (n = 3031). The analyses of healthcare use and survival showed no differences between males and females, when stratifying by tumor types. Healthcare processes were not always consistent with existing national treatment recommendations for patients with high-grade gliomas (n = 474) with regard to specified lead times, analyzed in the Swedish Brain Tumor Registry, as also observed at the national level. Age, comorbidity and high-grade gliomas, but not sex, were associated with decreased survival and increased use of healthcare resources. Fewer patients than aimed for in national guidelines received care according to specified lead times. The analysis of comprehensive population-based register data can be used to improve future care processes and outcomes.

  15. Antimicrobial susceptibility profile, treatment outcome and serotype distribution of clinical isolates of Salmonella enterica subspecies enterica: a 2-year study from Kerala, South India

    Directory of Open Access Journals (Sweden)

    Harichandran D

    2017-03-01

    Full Text Available Deepa Harichandran, Kavitha Radhakrishnan Dinesh Department of Microbiology, Amrita School of Medicine, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham University, Kochi, Kerala, India Background/purpose: Typhoid and paratyphoid fever continue to be important causes of illness and death in parts of Asia, being associated with poor sanitation and consumption of unsafe food and water. Antimicrobial resistance has emerged to traditional first-line drugs, namely, the fluoroquinolones, as well as to third-generation cephalosporins, posing challenges to treatment. Azithromycin has proven to be an effective alternative for treatment of uncomplicated typhoid fever. The purpose of this study was to determine the antimicrobial susceptibility, clinical outcome and serotype distribution pattern of clinical isolates belonging to Salmonella enterica subspecies enterica. Methodology: All clinical isolates of S. enterica obtained from blood, sterile body fluids, as well as stool and urine samples at Amrita Institute of Medical Sciences and Research Centre, Kerala, India, between August 2011 and July 2013 were included in the study and processed based on standard microbiology protocols. Results: A total of 118 isolates of Salmonella were obtained during the study period. Out of these, 79 were of S. Typhi (66.95%, followed by isolates of S. Paratyphi A (22; 18.64% and S. Typhimurium 12 (10.17%. Five isolates could not be identified further. There was 100% susceptibility to ceftriaxone in all S. enterica subspecies. Ciprofloxacin susceptibility was 32.91% for S. Typhi and 40.90% for S. Paratyphi A as determined by the disk diffusion method. The susceptibility profile of S. Typhi isolates to different antimicrobials was as follows: chloramphenicol (94.93%, ampicillin (77.21%, cotrimoxazole (75.94% and azithromycin (78.48%. For S. Typhi, the minimum inhibitory concentration (MIC of ciprofloxacin required to inhibit the growth

  16. Levothyroxine Poisoning - Symptoms and Clinical Outcome

    DEFF Research Database (Denmark)

    Nygaard, Birgitte; Saedder, Eva A; Dalhoff, Kim

    2015-01-01

    Levothyroxine (LT), T4, poisoning is rarely associated with a severe outcome. However, cases with significant complications have been reported. The aim of this study was to identify factors associated with symptoms of poisoning including late-onset symptoms. All enquiries to the Danish Poison...... Information Centre (DPIC) concerning LT poisoning between March 2007 and September 2012 were reviewed and the following parameters were recorded: age, dose, time from ingestion, multiple drug intake and symptoms. To evaluate the frequency of late-onset symptoms, a subgroup of patients without initial symptoms...... patients, neither in children nor in adults (age 16-92 years) (p poisoning at the time of enquiry; however, in 9 of 21 (43%) patients, we were able to contact, late-onset symptoms existed. In none of the cases...

  17. Clinical outcomes and costs for people with complex psychosis; a naturalistic prospective cohort study of mental health rehabilitation service users in England.

    Science.gov (United States)

    Killaspy, Helen; Marston, Louise; Green, Nicholas; Harrison, Isobel; Lean, Melanie; Holloway, Frank; Craig, Tom; Leavey, Gerard; Arbuthnott, Maurice; Koeser, Leonardo; McCrone, Paul; Omar, Rumana Z; King, Michael

    2016-04-07

    Mental 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 into inpatient mental health rehabilitation services, we carried out a prospective study to investigate longitudinal outcomes and costs for patients of these services and the predictors of better outcome. Inpatient mental health rehabilitation services across England that scored above average (median) on a standardised quality assessment tool used in a previous national survey were eligible for the study. Unit quality was reassessed and costs of care and patient characteristics rated using standardised tools at recruitment. Multivariable regression modelling was used to investigate the relationship between service quality, patient characteristics and the following clinical outcomes at 12 month follow-up: social function; length of admission in the rehabiliation unit; successful community discharge (without readmission or community placement breakdown) and costs of care. Across England, 50 units participated and 329 patients were followed over 12 months (94 % of those recruited). Service quality was not associated with patients' social function or length of admission (median 16 months) at 12 months but most patients were successfully discharged (56 %) or ready for discharge (14 %), with associated reductions in the costs of care. Factors associated with successful discharge were the recovery orientation of the service (OR 1.04, 95 % CI 1.00-1.08), and patients' activity (OR 1.03, 95 % CI 1.01-1.05) and social skills (OR 1.13, 95 % CI 1.04-1.24) at recruitment. Inpatient mental health

  18. Childhood Pars Planitis; Clinical Features and Outcomes

    Directory of Open Access Journals (Sweden)

    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. Hyperglycemia and Clinical Outcome in Aneurysmal Subarachnoid Hemorrhage A Meta-Analysis

    NARCIS (Netherlands)

    Kruyt, Nyika D.; Biessels, Geert Jan; de Haan, Rob J.; Vermeulen, Marinus; Rinkel, Gabriel J. E.; Coert, Bert; Roos, Yvo B. W. E. M.

    2009-01-01

    Background and Purpose-Hyperglycemia may worsen outcome after aneurysmal subarachnoid hemorrhage. We performed a systematic review to investigate the relation between admission hyperglycemia and outcome after aneurysmal subarachnoid hemorrhage. Methods-We included cohort studies or clinical trials

  20. What are the effects of varenicline compared with nicotine replacement therapy on long-term smoking cessation and clinically important outcomes? Protocol for a prospective cohort study.

    Science.gov (United States)

    Davies, Neil M; Taylor, Gemma; Taylor, Amy E; Thomas, Kyla H; Windmeijer, Frank; Martin, Richard M; Munafò, Marcus R

    2015-11-05

    Smoking is a major avoidable cause of ill-health and premature death. Treatments that help patients successfully quit smoking have an important effect on health and life expectancy. Varenicline is a medication that can help smokers successfully quit smoking. However, there are concerns that it may cause adverse effects, such as increase in the occurrence of depression, self-harm and suicide and cardiovascular disease. In this study we aim to examine the effects of varenicline versus other smoking cessation pharmacotherapies on smoking cessation, health service use, all-cause and cause-specific mortality and physical and mental health conditions. In this project we will investigate the effects of varenicline compared to nicotine replacement therapies on: (1) long-term smoking cessation and whether these effects differ by area level deprivation; and (2) the following clinically-important outcomes: rate of general practice and hospital attendance; all-cause mortality and death due to diseases of the respiratory system and cardiovascular disease; and a primary care diagnosis of respiratory illness, myocardial infarction or depression and anxiety. The study is based on a cohort of patients prescribed these smoking cessation medications from the Clinical Practice Research Datalink (CPRD). We will use three methods to overcome confounding: multivariable adjusted Cox regression, propensity score matched Cox regression, and instrumental variable regression. The total expected sample size for analysis will be at least 180,000. Follow-up will end with the earliest of either an 'event' or censoring due to the end of registration or death. Ethics approval was not required for this study. This project has been approved by the CPRD's Independent Scientific Advisory Committee (ISAC). We will disseminate our findings via publications in international peer-reviewed journals and presentations at international conferences. Published by the BMJ Publishing Group Limited. For permission

  1. CD63 and GLUT-1 Overexpression Could Predict a Poor Clinical Outcome in GIST: A Study of 54 Cases with Follow-Up

    Directory of Open Access Journals (Sweden)

    Piotr Lewitowicz

    2016-01-01

    Full Text Available Background and Goals. In light of current knowledge, it seems that alternations underlying GISTs are well explained, although all that is enhanced by various aspects on a daily basis. More recently, attention has been pointed towards exosomes as important particles able to modify healthy and also diseased tissues including cancer. The goal of the present study was an analysis of CD9, CD63, and GLUT-1 as a marker of hypoxia status within 54 cases of GIST and evaluation of their predictive value. Methods. 54 cases of patients suffering from GIST were enrolled into the study, predominantly in the gastric location. All operated cases had no Imatinib and other chemotherapies up to the day of operation. Expression of targeted proteins was performed by immunohistochemistry and, after that, the results with tabulated clinical data were compared by Kaplan-Meier method and multivariate Cox proportional hazard model of statistical analysis. Results. Our results presented a marked dependence of worsening clinical outcome with high expression CD63 (p=0.008 as well as with GLUT-1 (p=0.014. We noted a strict correlation of GLUT-1 expression with CD63 expression (p=0.03, which could confirm the thesis about the contribution of exosomes in intratumoural hypoxia status. The collected material did not confirm CD9 contribution. Conclusions. As presented here, CD63 and GLUT-1 have a prognostic value in GIST cases. The results confirm the other studies in this scope and can be used in future as an additional prognostic factor.

  2. Clinical Presentation and Outcome of Patients With Optic Pathway Glioma.

    Science.gov (United States)

    Robert-Boire, Viviane; Rosca, Lorena; Samson, Yvan; Ospina, Luis H; Perreault, Sébastien

    2017-10-01

    Optic pathway gliomas (OPGs) occur sporadically or in patients with neurofibromatosis type 1 (NF1). The purpose of this study was to evaluate the clinical presentation at diagnosis and at progression of patients with OPGs. We conducted a chart review of patients with OPGs diagnosed in a single center over a period of 15 years. Demographic data including age, sex, NF1 status, clinical presentation, and outcome were collected. Of the 40 patients who were identified, 23 had sporadic tumors (57.5%) and 17 had NF1-related tumors (42.5%). Among the children with NF1, there was a significant overrepresentation of girls (82.3%) (P = 0.02), while among the children without NF1, there were slightly more boys (56.5%) than girls (43.5%). The presence of nystagmus was strongly associated with sporadic optic pathway gliomas. Poor visual outcome was related to tumor affecting both optic pathways, hydrocephalus at diagnosis, and optic nerve atrophy. Of the 40 patients, five died of OPG complications (12.5%) and all had sporadic tumors. Our cohort is one of the largest with OPGs and a detailed description of the clinical presentation both at diagnosis and at progression. We observed a significant difference between sporadic and NF1 optic pathway gliomas in terms of demographics, clinical presentation, and outcome. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Fibrocartilaginous embolic myelopathy: demographics, clinical presentation, and functional outcomes.

    Science.gov (United States)

    Moore, Brittany J; Batterson, Anna M; Luetmer, Marianne T; Reeves, Ronald K

    2018-05-25

    Retrospective cohort study. To describe the demographics, clinical presentation, and functional outcomes of fibrocartilaginous embolic myelopathy (FCEM). Academic inpatient rehabilitation unit in the midwestern United States. We retrospectively searched our database to identify patients admitted between January 1, 1995 and March 31, 2016, with a high probability of FCEM. Demographic, clinical, and functional outcome measures, including Functional Independence Measure (FIM) information was obtained by chart review. We identified 31 patients with findings suggestive of FCEM (52% male), which was 2% of the nontraumatic spinal cord injury population admitted to inpatient rehabilitation. The age distribution was bimodal, with peaks in the second and sixth-to-seventh decades. The most common clinical presentation was acute pain and rapid progression of neurologic deficits consistent with a vascular myelopathy. Only three patients (10%) had FCEM documented as a diagnostic possibility. Most patients had paraplegia and neurologically incomplete injuries and were discharged to home. Nearly half of the patients required no assistive device for bladder management at discharge, but most were discharged with medications for bowel management. Median FIM walking locomotion score for all patients was 5, but most patients were discharged using a wheelchair for primary mobility. Median motor FIM subscale score was 36 at admission and 69 at discharge, with a median motor efficiency of 1.41. FCEM may be underdiagnosed and should be considered in those with the appropriate clinical presentation, because their functional outcomes may be more favorable than those with other causes of spinal cord infarction.

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

    Directory of Open Access Journals (Sweden)

    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.

  5. 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

  6. Clinical outcome of narrow diameter implants inserted into allografts

    Directory of Open Access Journals (Sweden)

    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.

  7. Clinical profile and 30-day outcome of women with acute coronary syndrome as a first manifestation of ischemic heart disease: A single-center observational study.

    Science.gov (United States)

    Nanjappa, Veena; Aniyathodiyil, Gopi; Keshava, R

    2016-01-01

    Gender disparity, with respect to women receiving less medical therapy, undergoing fewer invasive procedures, and experiencing worse outcome than men, has been noted in various observational and randomized trials, though guidelines on acute coronary syndrome (ACS) are gender-neutral. Indian data with focus on women with ACS are lacking. This study was undertaken to give us an insight on the clinical presentation, risk factors, and in-hospital outcome of ACS in women and at 30 days. 133 successive cases of women presenting with ACS, who met the inclusion criteria between 2012 and 2014, were included. Cases were grouped into ST elevation myocardial infarction (STEMI), non ST elevation myocardial infarction (NSTEMI), and unstable angina (UA). The mean age was 64.4±11 years. The mean BMI was 23.64±3.23kg/m(2). Diabetes was present in 58.3% in NSTEMI, 65.1% in STEMI, and 57.1% in UA group. Hypertension was found in 75% of NSTEMI, 60.2% of STEMI, and 71.4% of UA group. Severe MR was found in 11.1% of NSTEMI and 3.6% of STEMI patients. 8.3% of NSTEMI and 15.7% of STEMI patients presented in Killips class IV. Single vessel disease was most commonly found across the spectrum of ACS. 68.7% patients in STEMI group underwent primary angioplasty. 5.6% of NSTEMI and 7.2% in STEMI group had contrast-induced nephropathy (CIN). All deaths were noted in STEMI group with eight in-hospital deaths and three during 30-day follow-up period. Killips class III and IV and higher grace score (>150) were predictors of in-hospital mortality. Chronic kidney disease, ischemic mitral regurgitation, LV clot, and in-hospital cardiac arrest were associated with higher risk. Copyright © 2016. Published by Elsevier B.V.

  8. Financial Impact of the Robotic Approach in Liver Surgery: A Comparative Study of Clinical Outcomes and Costs Between the Robotic and Open Technique in a Single Institution.

    Science.gov (United States)

    Daskalaki, Despoina; Gonzalez-Heredia, Raquel; Brown, Marc; Bianco, Francesco M; Tzvetanov, Ivo; Davis, Myriam; Kim, Jihun; Benedetti, Enrico; Giulianotti, Pier C

    2017-04-01

    One of the perceived major drawbacks of minimally invasive techniques has always been its cost. This is especially true for the robotic approach and is one of the main reasons that has prevented its wider acceptance among hospitals and surgeons. The aim of our study was to evaluate the clinical outcomes and economic impact of robotic and open liver surgery in a single institution. Sixty-eight robotic and 55 open hepatectomies were performed at our institution between January 1, 2009 and December 31, 2013. Demographics, perioperative data, and postoperative outcomes were collected and compared between the two groups. An independent company performed the financial analysis. The economic parameters comprised direct variable costs, direct fixed costs, and indirect costs. Mean estimated blood loss was significantly less in the robotic group (438 versus 727.8 mL; P = .038). Overall morbidity was significantly lower in the robotic group (22% versus 40%; P = .047). Clavien III/IV complications were also lower, with 4.4% in the robotic versus 16.3% in the open group (P = .043). The length of stay in the intensive care unit (ICU) was shorter for patients who underwent a robotic procedure (2.1 versus 3.3 days; P = .004). The average total cost, including readmissions, was $37,518 for robotic surgery and $41,948 for open technique. Robotic liver resections had less overall morbidity, ICU, and hospital stay. This translates into decreased average costs for robotic surgery. These procedures are financially comparable to open resections and do not represent a financial burden to the hospital.

  9. Oral Health-related quality of life and clinical outcomes of immediately or delayed loaded implants in the rehabilitation of edentulous jaws: a retrospective comparative study.

    Science.gov (United States)

    Cosola, Saverio; Marconcini, Simone; Giammarinaro, Enrica; Poli, Gian L; Covani, Ugo; Barone, Antonio

    2018-04-16

    Patient-centred outcomes are being given great attention by the dental scientific community. The Oral Health Impact Profile -14 questionnaire (OHIP-14) has been introduced to address patients' success criteria when describing the impact of oral rehabilitations on quality of life (OHrQoL). Thirty-five patients wearing a full-arch implant-prosthesis being in place between 4 and 6 years before this analysis were considered eligible and then enrolled in the present retrospective study. According to their prosthetic anamnesis, two groups were defined: delayed loading group (IL-group) and immediate loading group (IL-group). At the moment of analysis, clinical and radiographic parameters were collected, and patients were asked to complete the Oral Health Impact Profile -14 questionnaire (OHIP-14) in order to measure their OHrQoL. Independent t-test showed total OHIP-14 scores to be not significantly different between groups; however, the domains "Functional limitation" and "physical disability" resulted significantly higher in patients within the DL-group. On the contrary, social disability was higher in the IL-group. When the comparison was performed taking sex into account, no significant differences between groups were highlighted. Instead, the stratification for years of follow-up led to significant evidences. When the follow-up was shorter (less-than-5 years), the functional limitation reported scores were higher. Within the limitations of this study, the analysis supports the absence of significant differences between immediate loading and delayed loading full-arch protocol in term of clinical, radiological parameters and OHrQoL.

  10. Comparative study of balloon and metal olive dilators for endoscopic management of benign anastomotic rectal strictures: clinical and cost-effectiveness outcomes.

    Science.gov (United States)

    Xinopoulos, Dimitrios; Kypreos, Dimitrios; Bassioukas, Stefanos P; Korkolis, Dimitrios; Mavridis, Konstantinos; Scorilas, Andreas; Dimitroulopoulos, Dimitrios; Loukou, Argyro; Paraskevas, Emmanouel

    2011-03-01

    Postoperative anastomotic strictures frequently complicate colorectal resection. Currently, various endoscopic techniques are being employed in their management, but the establishment of an optimal therapeutic strategy is still pending. The purpose of our study is to compare through-the-scope (TTS) balloon dilators versus Eder-Puestow metal olive dilators in the treatment of postoperative benign rectal strictures, considering the clinical outcome and cost-effectiveness of each method. A total of 39 patients with benign anastomotic rectal stenosis were retrospectively studied. In group A, 15 patients underwent dilation with Eder-Puestow metal olives, while in group B 19 patients were treated by means of TTS balloon dilators. The technical and clinical success of dilation, complications, number of repeated sessions required, disease-free time intervals, and the overall cost of each procedure were evaluated. Dilations were technically successful in all patients. No major complications occurred in either group. The number of dilations needed, rate of stricture recurrence, and duration of stenosis-free time intervals were not statistically significantly different between the two groups. Both methods proved more effective in older patients, given the greater number of dilations required in younger patients of both groups and higher frequency of stricture relapse in younger balloon-dilated patients (median 64.00 years) compared with older ones (median 75.00 years) (p = 0.001). An indisputable advantage of the Eder-Puestow technique, compared with TTS balloon dilators, is the low cost of equipment (median 22.30 compared with 680 , respectively; p Puestow bougies or TTS balloon dilators. However, metal olivary tips seem to surpass balloon dilators when considering the obvious economical benefits of the first method.

  11. 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. © 2015 John Wiley & Sons Ltd.

  12. The effect of polytrauma as a possible confounder in the outcome of monotraumatic vs polytraumatic paraplegic patients: a clinical cohort study.

    Science.gov (United States)

    Putz, C; Schuld, C; Gantz, S; Grieser, T; Akbar, M; Moradi, B; Wiedenhöfer, B; Fürstenberg, C H; Gerner, H J; Rupp, R

    2011-06-01

    Clinical cohort study. To evaluate if the impact of the severity of the trauma as a possible confounding factor influences the neurological and functional recovery in paraplegia during the course of a 6-month follow-up period after injury. Spinal Cord Injury Center, Heidelberg University Hospital, Germany. A retrospective monocentric analysis, from 2002 to 2008, of the Heidelberg European Multicenter Study about spinal cord injury database was performed. We included 31 paraplegic patients (neurological level T1-T12) who were assigned either to a monotrauma (polytraumaschluessel (PTS) 1) or to a polytrauma (PTS≥2) group. The American Spinal Injury Association Impairment Scale, lower extremity motor score, pin prick, light touch and the spinal cord independence measure (SCIM) were obtained at five distinct time points after trauma. Data were analyzed using Mann-Whitney U-test (αpressure sores between 3 and 6 months (P=0.031). The mean length of primary rehabilitation in the polytrauma group was 5.5 vs 3.6 months in monotrauma. The prognosis of polytraumatic paraplegics in terms of neurological recovery is not inferior to those with monotrauma. Multiple-injured patients need a prolonged hospital stay to reach the functional outcome of monotraumatic patients.

  13. The association between peripheral total IGF-1, IGFBP-3, and IGF-1/IGFBP-3 and functional and cognitive outcomes in the Mayo Clinic Study of Aging.

    Science.gov (United States)

    Wennberg, Alexandra M V; Hagen, Clinton E; Machulda, Mary M; Hollman, John H; Roberts, Rosebud O; Knopman, David S; Petersen, Ronald C; Mielke, Michelle M

    2018-06-01

    Levels of insulin-like growth factor (IGF)-1, IGF-binding protein (IGFBP)-3, and their ratio in the blood may be useful for monitoring those at risk of cognitive and functional decline. However, the association between IGF measures and functional and cognitive outcomes has been mixed, and the associations may vary by sex. The present study investigated the cross-sectional, sex-specific associations between serum measures total IGF-1, IGFBP-3, and the IGF-1/IGFBP-3 ratio, gait speed, and cognition in 1320 cognitively unimpaired participants aged 50-95 years enrolled in the Mayo Clinic Study of Aging. We used multivariable linear regression models to determine the association between IGF measures and gait speed or cognitive test performance by sex. IGF measures were not associated with cognitive or functional performance among men. Among women, higher levels of log total IGF-1 and IGFBP-3 were associated with better performance in attention, visuospatial, and global cognitive domains, independent of the gait speed. These findings suggest that among women, IGF measures are associated with cognition, and these associations are independent of function. Copyright © 2018 Elsevier Inc. All rights reserved.

  14. Community to clinic navigation to improve diabetes outcomes

    Directory of Open Access Journals (Sweden)

    Nancy E. Schoenberg

    2017-03-01

    Full Text Available Rural residents experience rates of Type 2 Diabetes Mellitus (T2DM that are considerably higher than their urban or suburban counterparts. Two primary modifiable factors, self-management and formal clinical management, have potential to greatly improve diabetes outcomes. “Community to Clinic Navigation to Improve Diabetes Outcomes,” is the first known randomized clinical trial pilot study to test a hybrid model of diabetes self-management education plus clinical navigation among rural residents with T2DM. Forty-one adults with T2DM were recruited from two federally qualified health centers in rural Appalachia from November 2014–January 2015. Community health workers provided navigation, including helping participants understand and implement a diabetes self-management program through six group sessions and, if needed, providing assistance in obtaining clinic visits (contacting providers' offices for appointments, making reminder calls, and facilitating transportation and dependent care. Pre and post-test data were collected on T2DM self-management, physical measures, demographics, psychosocial factors, and feasibility (cost, retention, and satisfaction. Although lacking statistical significance, some outcomes indicate trends in positive directions, including diet, foot care, glucose monitoring, and physical health, including decreased HbA1c and triglyceride levels. Process evaluations revealed high levels of satisfaction and feasibility. Due to the limited intervention dose, modest program expenditures (~$29,950, and a severely affected population most of whom had never received diabetes education, outcomes were not as robust as anticipated. Given high rates of satisfaction and retention, this culturally appropriate small group intervention holds promise for hard to reach rural populations. Modifications should include expanded recruitment venues, sample size, intervention dosage and longer term assessment.

  15. Effect of Supine vs Prone Position on Outcomes of Percutaneous Nephrolithotomy in Staghorn Calculi: Results From the Clinical Research Office of the Endourology Society Study

    DEFF Research Database (Denmark)

    Astroza, Gaston; Lipkin, Michael; Neisius, Andreas

    2013-01-01

    To analyze the effect of patient positioning on outcomes of percutaneous nephrolithotomy (PNL) among patients with staghorn stones. The choice of optimal position for these patients undergoing PNL remains challenging. No previous studies exclusively addressing this point have been performed....

  16. Bonding to oxide ceramics—laboratory testing versus clinical outcome.

    Science.gov (United States)

    Kern, Matthias

    2015-01-01

    Despite a huge number of published laboratory bonding studies on dental oxide ceramics clinical long-term studies on resin bonded oxide ceramic restorations are rare. The purpose of this review is to present the best available clinical evidence for successful bonding of dental oxide ceramic restorations. Clinical trials with resin-bonded restorations that had no or only limited mechanical retention and were made from alumina or zirconia ceramic were identified using an electronic search in PubMed database. Overall 10 publications with clinical trials could be identified. Their clinical outcome was compared with that laboratory bond strength studies. Clinical data provide strong evidence that air-abrasion at a moderate pressure in combination with using phosphate monomer containing primers and/or luting resins provide long-term durable bonding to glass-infiltrated alumina and zirconia ceramic under the humid and stressful oral conditions. As simple and clinically reliable bonding methods to oxide ceramics exist, the rationale for development of alternative bonding methods might be reconsidered especially when these methods are more time consuming or require rather complicated and/or technique sensitive procedures. Copyright © 2014 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

  17. Symptoms of anxiety and depression in type 2 diabetes: Associations with clinical diabetes measures and self-management outcomes in the Norwegian HUNT study.

    Science.gov (United States)

    Naicker, Kiyuri; Øverland, Simon; Johnson, Jeffrey A; Manuel, Douglas; Skogen, Jens C; Sivertsen, Børge; Colman, Ian

    2017-10-01

    To determine if symptoms of depression and anxiety are differentially associated with clinical diabetes measures and self-management behaviours in individuals with Type 2 diabetes, and whether these associations vary by patient sex. A cross-sectional analysis using data from 2035 adults with Type 2 diabetes in the Nord-Trøndelag Health Study. Multivariate logistic regression was used to explore associations between symptoms of depression and anxiety and waist girth, HDL cholesterol, systolic blood pressure, triglycerides, c-reactive protein, glycemic control, diet adherence, exercise, glucose monitoring, foot checks for ulcers, and the subjective patient experience. Analyses were stratified by sex. Depression was associated with a lower likelihood of avoiding saturated fats (OR=0.20 [95% CI: 0.06, 0.68]) and increased odds of physical inactivity (OR=1.69 [95% CI: 1.37, 2.72]). Anxiety was associated with increased odds of eating vegetables (OR=1.66 [95% CI: 1.02, 2.73]), and an over two-fold increase of feeling that having diabetes is difficult. In women, anxiety was associated with elevated c-reactive protein levels (OR=1.57 [95% CI: 1.05, 2.34]). In men, depressive symptoms were associated with elevated HbA1c (OR=5.00 [95% CI: 1.15, 8.23). Symptoms of depression and anxiety were differentially associated with some key diabetes-related measures. Our results suggest sex-specific differences with respect to two important clinical outcomes (i.e., anxiety and CRP in women and depression and glycemic control in men). These findings should alert practitioners to the importance of detection and management of psychological symptoms in individuals with Type 2 diabetes. Copyright © 2017. Published by Elsevier Ltd.

  18. A phase I study of combination vaccine treatment of five therapeutic epitope-peptides for metastatic colorectal cancer; safety, immunological response, and clinical outcome.

    Science.gov (United States)

    Hazama, Shoichi; Nakamura, Yusuke; Takenouchi, Hiroko; Suzuki, Nobuaki; Tsunedomi, Ryouichi; Inoue, Yuka; Tokuhisa, Yoshihiro; Iizuka, Norio; Yoshino, Shigefumi; Takeda, Kazuyoshi; Shinozaki, Hirokazu; Kamiya, Akira; Furukawa, Hiroyuki; Oka, Masaaki

    2014-03-10

    To evaluate the safety of combination vaccine treatment of multiple peptides, phase I clinical trial was conducted for patients with advanced colorectal cancer using five novel HLA-A*2402-restricted peptides, three peptides derived from oncoantigens, ring finger protein 43 (RNF43), 34 kDa-translocase of the outer mitochondrial membrane (TOMM34), and insulin-like growth factor-II mRNA binding protein 3 (KOC1), and the remaining two from angiogenesis factors, vascular endothelial growth factor receptor 1 (VEGFR1) and VEGFR2. Eighteen HLA- A*2402-positive colorectal cancer patients who had failed to standard therapy were enrolled in this study. 0.5 mg, 1.0 mg or 3.0 mg each of the peptides was mixed with incomplete Freund's adjuvant and then subcutaneously injected at five separated sites once a week. We also examined possible effect of a single site injection of "the cocktail of 5 peptides" on the immunological responses. ELISPOT assay was performed before and after vaccinations in the schedule of every 4 weeks. The vaccine treatment using multiple peptides was well tolerated without any severe treatment-associated systemic adverse events. Dose-dependent induction of peptide-specific cytotoxic T lymphocytes was observed. The single injection of "peptides cocktail" did not diminish the immunological responses. Regarding the clinical outcome, one patient achieved complete response and 6 patients revealed stable disease for 4 to 7 months. The median overall survival time (MST) was 13.5 months. Patients, in which we detected induction of cytotoxic T lymphocytes specific to 3 or more peptides, revealed significantly better prognosis (MST; 27.8 months) than those with poorer immune responses (MST; 3.7 months) (p = 0.032). Our cancer vaccine treatment using multiple peptides is a promising approach for advanced colorectal cancer with the minimum risk of systemic adverse reactions. UMIN-CTR number UMIN000004948.

  19. Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes.

    Science.gov (United States)

    Gibson, E J; Begum, N; Koblbauer, I; Dranitsaris, G; Liew, D; McEwan, P; Tahami Monfared, A A; Yuan, Y; Juarez-Garcia, A; Tyas, D; Lees, M

    2018-01-01

    Economic models in oncology are commonly based on the three-state partitioned survival model (PSM) distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O) suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs). The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%). Increased sophistication in the representation of disease dynamics in economic models is desirable when attempting to model treatment response in I-O. However, the assumptions underlying different model structures and the availability of data for health state mapping may be important limiting factors.

  20. Core outcome sets for research and clinical practice

    NARCIS (Netherlands)

    Chiarotto, Alessandro; Ostelo, Raymond W.; Turk, Dennis C.; Buchbinder, Rachelle; Boers, Maarten

    2017-01-01

    Background This masterclass introduces the topic of core outcome sets, describing rationale and methods for developing them, and providing some examples that are relevant for clinical research and practice. Method A core outcome set is a minimum consensus-based set of outcomes that should be

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Directory of Open Access Journals (Sweden)

    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. Intracranial tuberculosis in children: CT appearance and clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Wallace, R C; Burton, E M; Gerald, B E [Le Bonheur Children' s Medical Center, Memphis, TN (United States). Dept. of Radiology Tennessee Univ., Memphis (United States); Barrett, F F; Leggiadro, R J [Le Bonheur Children' s Medical Center, Memphis, TN (United States). Dept. of Pediatrics Tennessee Univ., Memphis (United States); Lasater, O E [Le Bonheur Children' s Medical Center, Memphis, TN (United States). Dept. of Pathology Tennessee Univ., Memphis (United States)

    1991-05-01

    We retrospectively evaluated the CT studies of 9 children who presented with intracranial tuberculosis during 1981-1987, and compared their radiographic appearance with the clinical outcome. The most common radiographic findings were: 1) Ventriculomegaly (7/9), 2) tuberculoma formation (6/9), and 3) infarction (4/9). Of 7 patients with ventriculomegaly, 3 required a ventricular shunt and 2 had spontaenous resolution of ventricular dilatation. Four children with ventriculomegaly were moderately or severely retarded, one had cognitive dysfunction, and one was neurologically normal. Four of six children with tuberculoma also had infarction and/or ventriculomegaly; of these four children, three were moderately or severely retarded. Two patients with tuberculoma as the only intracranial abnormality had complete resolution or the granuloma with normal neurologic outcome following antituberculous therapy. The four children with large vessel infarction also had ventriculomegaly; three had poor clinical outcome. The presence of tuberculoma alone is not necessarily predictive of poor neurologic outcome; age less than 20 months, infarct, and/or ventriculomegaly are usually associated with sequelae. (orig.).

  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. The Influence of Body Mass Index on Outcomes in Ureteroscopy: Results from the Clinical Research Office of Endourological Society URS Global Study.

    Science.gov (United States)

    Krambeck, Amy; Wijnstok, Nienke; Olbert, Peter; Mitroi, George; Bariol, Simon; Shah, Hemendra N; El-Abd, Ahmed S; Onal, Bulent; de la Rosette, Jean

    2017-01-01

    Although ureteroscopy (URS) has been established as a viable treatment for stones in obese patients, its safety and success has not been fully elucidated. The current study describes the worldwide prevalence of obesity in patients with urolithiasis and examines trends in URS outcomes, safety, and efficacy. This study utilized the Clinical Research Office of the Endourological Society (CROES) URS Global Study, which was a prospective, multicenter study including 11,885 patients treated with URS for urinary stones at 1 of 114 urology departments across 32 countries. The relationship between body mass index (BMI), diabetes, and creatinine, with retreatment, stone-free rates, complications, and long hospital stay, was examined with a multivariate logistic regression analyses. Of the 10,099 URS patients with BMI data, 17.4% were obese and 2.2% were super obese. Overall, 86.7% patients were stone free and 16.8% required retreatment. Higher BMI was associated with lower stone-free rates, and any deviation from normal weight was associated with higher retreatment rates. In multivariate analysis controlling for several variables including stone size, the association between BMI and lower stone-free rates with higher retreatment rates persisted. Intraoperative complications occurred in 518 (5.1%) patients, and 343 (3.4%) experienced a postoperative complication. Postoperative complications were more frequent in the underweight and super obese subjects, and there was no relationship between BMI and intraoperative complications. Although URS for stone disease was found to be an overall safe procedure for obese and super obese patients, efficacy of the procedure may be lower compared with normal-weight subjects and higher retreatment rates may be necessary.

  6. BAX protein expression and clinical outcome in epithelial ovarian cancer.

    Science.gov (United States)

    Tai, Y T; Lee, S; Niloff, E; Weisman, C; Strobel, T; Cannistra, S A

    1998-08-01

    Expression of the pro-apoptotic protein BAX sensitizes ovarian cancer cell lines to paclitaxel in vitro by enhancing the pathway of programmed cell death. The present study was performed to determine the relationship between BAX expression and clinical outcome in 45 patients with newly diagnosed ovarian cancer. BAX protein expression was analyzed by immunohistochemistry, and its relationship with clinical outcome was determined. Assessment of BAX mRNA transcript levels and mutational analysis of the BAX coding region were also performed. BAX protein was expressed at high levels (defined as > or = 50% of tumor cells positive) in tumor tissue from 60% of newly diagnosed patients. All patients whose tumors expressed high levels of BAX achieved a complete response (CR) to first-line chemotherapy that contained paclitaxel plus a platinum analogue, compared with 57% of patients in the low-BAX group (P = .036). After a median follow-up of 1.9 years, the median disease-free survival (DFS) of patients in the high-BAX group has not been reached, compared with a median DFS of 1.1 years for low-BAX expressors (P = .0061). BAX retained independent prognostic significance in multivariate analysis when corrected for stage and histology. BAX mRNA transcripts were easily detected in samples with low BAX protein expression, and no BAX mutations were identified. The correlation between high BAX levels and improved clinical outcome suggests that an intact apoptotic pathway is an important determinant of chemoresponsiveness in ovarian cancer patients who receive paclitaxel.

  7. Metabolomic analysis of 92 pulmonary embolism patients from a nested case-control study identifies metabolites associated with adverse clinical outcomes.

    Science.gov (United States)

    Zeleznik, O A; Poole, E M; Lindstrom, S; Kraft, P; Van Hylckama Vlieg, A; Lasky-Su, J A; Harrington, L B; Hagan, K; Kim, J; Parry, B A; Giordano, N; Kabrhel, C

    2018-03-01

    Essentials Risk-stratification often fails to predict clinical deterioration in pulmonary embolism (PE). First-ever high-throughput metabolomics analysis of risk-stratified PE patients. Changes in circulating metabolites reflect a compromised energy metabolism in PE. Metabolites play a key role in the pathophysiology and risk stratification of PE. Background Patients with acute pulmonary embolism (PE) exhibit wide variation in clinical presentation and outcomes. Our understanding of the pathophysiologic mechanisms differentiating low-risk and high-risk PE is limited, so current risk-stratification efforts often fail to predict clinical deterioration and are insufficient to guide management. Objectives To improve our understanding of the physiology differentiating low-risk from high-risk PE, we conducted the first-ever high-throughput metabolomics analysis (843 named metabolites) comparing PE patients across risk strata within a nested case-control study. Patients/methods We enrolled 92 patients diagnosed with acute PE and collected plasma within 24 h of PE diagnosis. We used linear regression and pathway analysis to identify metabolites and pathways associated with PE risk-strata. Results When we compared 46 low-risk with 46 intermediate/high-risk PEs, 50 metabolites were significantly different after multiple testing correction. These metabolites were enriched in the following pathways: tricarboxylic acid (TCA) cycle, fatty acid metabolism (acyl carnitine) and purine metabolism, (hypo)xanthine/inosine containing. Additionally, energy, nucleotide and amino acid pathways were downregulated in intermediate/high-risk PE patients. When we compared 28 intermediate-risk with 18 high-risk PE patients, 41 metabolites differed at a nominal P-value level. These metabolites were enriched in fatty acid metabolism (acyl cholines), and hemoglobin and porphyrin metabolism. Conclusion Our results suggest that high-throughput metabolomics can provide insight into the

  8. Predicting HIV RNA virologic outcome at 52-weeks follow-up in antiretroviral clinical trials. The INCAS and AVANTI Study Groups.

    Science.gov (United States)

    Raboud, J M; Rae, S; Montaner, J S

    2000-08-15

    To determine the ability of intermediate plasma viral load (pVL) measurements to predict virologic outcome at 52 weeks of follow-up in clinical trials of antiretroviral therapy. Individual patient data from three clinical trials (INCAS, AVANTI-2 and AVANTI-3) were combined into a single database. Virologic success was defined to be plasma viral load (pVL) <500 copies/ml at week 52. The sensitivity and specificity of intermediate pVL measurements below the limit of detection, 100, 500, 1000, and 5000 copies/ml to predict virologic success were calculated. The sensitivity, specificity, and positive and negative predictive values of a pVL measurement <1000 copies/ml at week 16 to predict virologic outcome at week 52 were 74%, 74%, 48%, and 90%, respectively, for patients on double therapy. For patients on triple therapy, the sensitivity, specificity, and positive and negative predictive values of a pVL measurement <50 copies/ml at week 16 to predict virologic outcome were 68%, 68%, 80%, and 47%, respectively. For patients receiving double therapy, a poor virologic result at an intermediate week of follow-up is a strong indicator of virologic failure at 52 weeks whereas intermediate virologic success is no guarantee of success at 1 year. For patients on triple therapy, disappointing intermediate results do not preclude virologic success at 1 year and intermediate successes are more likely to be sustained.

  9. Clinical outcomes of elite controllers, viremic controllers, and long-term nonprogressors in the US Department of Defense HIV natural history study.

    Science.gov (United States)

    Okulicz, Jason F; Marconi, Vincent C; Landrum, Michael L; Wegner, Scott; Weintrob, Amy; Ganesan, Anuradha; Hale, Braden; Crum-Cianflone, Nancy; Delmar, Judith; Barthel, Vincent; Quinnan, Gerald; Agan, Brian K; Dolan, Matthew J

    2009-12-01

    Durable control of human immunodeficiency virus (HIV) replication and lack of disease progression in the absence of antiretroviral therapy were studied in a military cohort of 4586 subjects. We examined groups of elite controllers (ie, subjects with plasma HIV RNA levels of <50 copies/mL; prevalence, 0.55% [95% confidence interval {CI}, 0.35%-0.80%]), viremic controllers (ie, subjects with plasma HIV RNA levels of 50-2000 copies/mL; prevalence, 3.34% [95% CI, 2.83%-3.91%]), and subjects with a lack of disease progression (ie, long-term nonprogressors [LTNPs]) through 7 years of follow-up (LTNP7s; prevalence, 3.32% [95% CI, 2.70%-4.01%]) or 10 years of follow-up (LTNP10s; prevalence, 2.04% [95% CI, 1.52%-2.68%]). For elite and viremic controllers, spontaneous virologic control was established early and was typically observed when the initial viral load measurement was obtained within 1 year of estimated seroconversion. Elite controllers had favorable time to development of AIDS (P=.048), a CD4 cell count of 350 cells/microL (P= .009), and more-stable CD4 cell trends, compared with viremic controllers. LTNPs defined by 10-year versus 7-year criteria had a longer survival time (P=.001), even after adjustment for differing periods of invulnerability (P= .042). Definitions of controllers and LTNPs describe distinct populations whose differing clinical outcomes improve with the stringency of criteria, underscoring the need for comparability between study populations.

  10. Acute myocardial infarction in very young adults: A clinical presentation, risk factors, hospital outcome index, and their angiographic characteristics in North India-AMIYA Study.

    Science.gov (United States)

    Sinha, Santosh Kumar; Krishna, Vinay; Thakur, Ramesh; Kumar, Ashutosh; Mishra, Vikas; Jha, Mukesh Jitendra; Singh, Karandeep; Sachan, Mohit; Sinha, Rupesh; Asif, Mohammad; Afdaali, Nasar; Mohan Varma, Chandra

    2017-03-01

    India is currently in the fourth stage of epidemiological transitions where cardiovascular disease is the leading cause of mortality and morbidity. Purpose of the present study was to assess the risk factors, clinical presentation, angiographic profile including severity, and in-hospital outcome of very young adults (aged ≤ 30 years) with first acute myocardial infarction (AMI). Total of 1,116 consecutive patients with ST-segment elevation acute myocardial infarction (STEMI) were studied between March 2013 and February 2015 at LPS Institute of Cardiology, Kanpur, Uttar Pradesh, India. Mean age of the patients was 26.3 years. Risk factors were smoking (78.5%), family history of premature coronary artery disease (CAD) (46.8%), obesity (39.1%), physical inactivity (38.7%) and stressful life events (29.6%). The most common symptom and presentation was chest pain and anterior wall myocardial infarction (AWMI) in 94.8% and 58.8%, respectively. About 80.6% of patients had obstructive CAD with single vessel disease (57.6%), double-vessel disease (12.9%) and left main involvement (3.2%). Left anterior descending (LAD) was commonest culprit artery (58.1%) followed by right coronary artery in 28.2%. In-hospital mortality was 2.8%. Percutaneous coronary intervention was performed in 71.6% of patients. Median number and length of stent were 1.18 and 28 ± 16 mm, respectively. AMI in very young adult occurred most commonly in male. Smoking was the most common risk factor. AWMI owing to LAD artery involvement was the most common presentation. Mean time of presentation after symptom onset was 16.9 hours. In contrast to western population, it is characterised by earlier onset, delayed presentation, more severity, diffuse disease, and more morbidity but with favourable in-hospital mortality.

  11. 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.

  12. Clinical outcomes of facial transplantation: a review.

    Science.gov (United States)

    Shanmugarajah, Kumaran; Hettiaratchy, Shehan; Clarke, Alex; Butler, Peter E M

    2011-01-01

    A total of 18 composite tissue allotransplants of the face have currently been reported. Prior to the start of the face transplant programme, there had been intense debate over the risks and benefits of performing this experimental surgery. This review examines the surgical, functional and aesthetic, immunological and psychological outcomes of facial transplantation thus far, based on the predicted risks outlined in early publications from teams around the world. The initial experience has demonstrated that facial transplantation is surgically feasible. Functional and aesthetic outcomes have been very encouraging with good motor and sensory recovery and improvements to important facial functions observed. Episodes of acute rejection have been common, as predicted, but easily controlled with increases in systemic immunosuppression. Psychological improvements have been remarkable and have resulted in the reintegration of patients into the outside world, social networks and even the workplace. Complications of immunosuppression and patient mortality have been observed in the initial series. These have highlighted rigorous patient selection as the key predictor of success. The overall early outcomes of the face transplant programme have been generally more positive than many predicted. This initial success is testament to the robust approach of teams. Dissemination of outcomes and ongoing refinement of the process may allow facial transplantation to eventually become a first-line reconstructive option for those with extensive facial disfigurements. Copyright © 2011 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  13. Tuberculous spondylodiscitis: epidemiology, clinical features, treatment, and outcome.

    Science.gov (United States)

    Trecarichi, E M; Di Meco, E; Mazzotta, V; Fantoni, M

    2012-04-01

    Tuberculous spondylodiscitis (TS) is a rare but serious clinical condition which may lead to severe deformity and early or late neurological complications. To discuss certain aspects of the approach to TSs, focusing upon epidemiology, diagnosis, and treatment outcome. For the purpose of this review, a literature search was performed using the Pubmed database through to 19th October 2011 to identify studies published in the last 20 years, concerned in epidemiological, clinical, diagnostic, and therapeutical aspects of TS in adults. Only studies drafted in English language and reporting case series of more than 20 patients have been included. TS has been reported to accounts for 1-5% of all TB cases, and for about 50% of the cases of articulo-skeletal TB infections. Despite the actual availability of more effective diagnostic tools, early recognition of TS remains difficult and a high index of suspicion is needed due to the chronic nature of the disease and its insidious and variable clinical presentation. A prompt diagnosis is required to improve long term outcome, and a microbiological confirmation is recommended to enable appropriate choice of anti-mycobacterial agents. Surgery has an important role in alleviating pain, correcting deformities and neurological impairment, and restoring function. Further studies are required to assess the appropriate duration of anti-microbial treatment, also in regarding of a combined surgical approach.

  14. Solitary rectal ulcer syndrome: clinical findings, surgical treatment, and outcomes.

    Science.gov (United States)

    Torres, Carlos; Khaikin, Marat; Bracho, Jorge; Luo, Cheng Hua; Weiss, Eric G; Sands, Dana R; Cera, Susan; Nogueras, Juan J; Wexner, Steven D

    2007-11-01

    Solitary rectal ulcer syndrome (SRUS) is a rare disorder often misdiagnosed as a malignant ulcer. Histopathological features of SRUS are characteristic and pathognomonic; nevertheless, the endoscopic and clinical presentations may be confusing. The aim of the present study was to assess the clinical findings, surgical treatment, and outcomes in patients who suffer from SRUS. A retrospective chart review was undertaken, from January 1989 to May 2005 for all patients who were diagnosed with SRUS. Data recorded included: patient's age, gender, clinical presentation, past surgical history, diagnostic and preoperative workup, operative procedure, complications, and outcomes. During the study period, 23 patients were diagnosed with SRUS. Seven patients received only medical treatment, and in three patients, the ulcer healed after medical treatment. Sixteen patients underwent surgical treatment. In four patients, the symptoms persisted after surgery. Two patients presented with postoperative rectal bleeding requiring surgical intervention. Three patients developed late postoperative sexual dysfunction. One patient continued suffering from rectal pain after a colostomy was constructed. Median follow-up was 14 (range 2-84) months. The results of this study show clearly that every patient with SRUS must be assessed individually. Initial treatment should include conservative measures. In patients with refractory symptoms, surgical treatment should be considered. Results of anterior resection and protocolectomy are satisfactory for solitary rectal ulcer.

  15. Outcome of self-expandable metallic stent deployment in patients with malignant gastroduodenal outlet obstruction and Niti-S and WallFlex comparison: a multicenter retrospective clinical study.

    Science.gov (United States)

    Kato, Hironari; Kawamoto, Hirofumi; Matsumoto, Kazuya; Moriyama, Ichiro; Kamada, Hideki; Tsutsumi, Koichiro; Goto, Daisuke; Fukuba, Nobuhiko; Kato, Kiyohito; Sonoyama, Hiroki; Isomoto, Hajime; Okada, Hiroyuki

    2016-08-01

    Several studies report on the outcomes of self-expandable metallic stents (SEMSs) deployment for malignant gastric outlet obstruction (GOO). However, data was mostly based on the analysis of single-center studies including only a small number of patients. This study aimed to evaluate clinical outcomes after the deployment of SEMS in patients with malignant GOO and to compare the clinical outcomes of two metallic stents with different designs. Altogether 125 consecutive patients from five institutions were included. Clinical outcomes were evaluated according to technical success, clinical success, stent patency period, survival period and complications. A comparison of clinical outcomes between Niti-S pyloric/duodenal and WallFlex duodenal stents was also undertaken. Rates for clinical and technical success were 100% and 92.0%, respectively. The median stent patency and survival periods were 72.0 days (range 3-775 days) and 75.0 days (range 3-775 days), respectively. The rate of overall adverse events was 28.8%. The rate of stent dysfunction was 16.8%, and that of adverse events, except stent dysfunction was 12.0%. Massive bleeding occurred in two patients as a late complication. The clinical success rate for Niti-S stent was significantly higher than that for WallFlex stent (96.2% vs 84.8%, P = 0.023). We successfully deployed a SEMS in malignant GOO. The selection of a SEMS with a lower axial force may be important for patients to resume the oral food intake. Additionally, consideration must be given to the appropriate management of fatal bleeding as a late complication. © 2016 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

  16. Clinical Features and Treatment Outcomes among Children with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A 20-Year Study in a Tertiary Referral Hospital

    OpenAIRE

    Susheera Chatproedprai; Vanvara Wutticharoenwong; Therdpong Tempark; Siriwan Wananukul

    2018-01-01

    Aim. To determine the probable causative factors, clinical features, and treatment outcomes of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS-TEN overlap in children. Methods. A 20-year database review of all children diagnosed with SJS/TEN/SJS-TEN overlap at the King Chulalongkorn Memorial Hospital, Thailand. Results. 36 patients (M : F, 16 : 20) with the mean age of 9.2±4.0 years were identified. There were 20 cases of SJS, 4 cases of SJS-TEN overlap, and 12 cases...

  17. Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame

    International Nuclear Information System (INIS)

    Nagata, Yasushi; Takayama, Kenji; Matsuo, Yukinori; Norihisa, Yoshiki; Mizowaki, Takashi; Sakamoto, Takashi; Sakamoto, Masato; Mitsumori, Michihide; Shibuya, Keiko; Araki, Norio; Yano, Shinsuke; Hiraoka, Masahiro

    2005-01-01

    Purpose: To evaluate the clinical outcomes of 48 Gy of three-dimensional stereotactic radiotherapy in four fractions for treating Stage I lung cancer using a stereotactic body frame. Methods and Materials: Forty-five patients who were treated between September 1998 and February 2004 were included in this study. Thirty-two patients had Stage IA lung cancer, and the other 13 had Stage IB lung cancer where tumor size was less than 4 cm in diameter. Three-dimensional treatment planning using 6-10 noncoplanar beams was performed to maintain the target dose homogeneity and to decrease the irradiated lung volume >20 Gy. All patients were irradiated using a stereotactic body frame and received four single 12 Gy high doses of radiation at the isocenter over 5-13 (median = 12) days. Results: Seven tumors (16%) completely disappeared after treatment (CR) and 38 tumors (84%) decreased in size by 30% or more (PR). Therefore, all tumors showed local response. During the follow-up of 6-71 (median = 30) months, no pulmonary complications greater than an National Cancer Institute-Common Toxicity Criteria of Grade 3 were noted. No other vascular, cardiac, esophageal, or neurologic toxicities were encountered. Forty-four (98%) of 45 tumors were locally controlled during the follow-up period. However, regional recurrences and distant metastases occurred in 3 and 5 of T1 patients and zero and 4 of T2 patients, respectively. For Stage IA lung cancer, the disease-free survival and overall survival rates after 1 and 3 years were 80% and 72%, and 92% and 83%, respectively, whereas for Stage IB lung cancer, the disease-free survival and overall survival rates were 92% and 71%, and 82% and 72%, respectively. Conclusion: Forty-eight Gy of 3D stereotactic radiotherapy in 4 fractions using a stereotactic body frame is useful for the treatment of Stage I lung tumors

  18. Professional Rugby Union players have a 60% greater risk of time loss injury after concussion: a 2-season prospective study of clinical outcomes

    Science.gov (United States)

    Cross, Matthew; Kemp, Simon; Smith, Andrew; Trewartha, Grant; Stokes, Keith

    2016-01-01

    Aim To investigate incidence of concussion, clinical outcomes and subsequent injury risk following concussion. Methods In a two-season (2012/2013, 2013/2014) prospective cohort study, incidence of diagnosed match concussions (injuries/1000 h), median time interval to subsequent injury of any type (survival time) and time spent at each stage of the graduated return to play pathway were determined in 810 professional Rugby Union players (1176 player seasons). Results Match concussion incidence was 8.9/1000 h with over 50% occurring in the tackle. Subsequent incidence of any injury for players who returned to play in the same season following a diagnosed concussion (122/1000 h, 95% CI 106 to 141) was 60% higher (IRR 1.6, 95% CI 1.4 to 1.8) than for those who did not sustain a concussion (76/1000 h, 95% CI 72 to 80). Median time to next injury following return to play was shorter following concussion (53 days, 95% CI 41 to 64) than following non-concussive injuries (114 days, 95% CI 85 to 143). 38% of players reported recurrence of symptoms or failed to match their baseline neurocognitive test during the graduated return to play protocol. Summary and conclusions Players who returned to play in the same season after a diagnosed concussion had a 60% greater risk of time-loss injury than players without concussion. A substantial proportion of players reported recurrence of symptoms or failed to match baseline neurocognitive test scores during graduated return to play. These data pave the way for trials of more conservative and comprehensive graduated return to play protocols, with a greater focus on active rehabilitation. PMID:26626266

  19. Improving health outcomes for young people with long term conditions: The role of digital communication in current and future patient-clinician communication for NHS providers of specialist clinical services for young people - LYNC study protocol.

    Science.gov (United States)

    Griffiths, Frances E; Atherton, Helen; Barker, Jack R; Cave, Jonathan Ak; Dennick, Kathryn; Dowdall, Peter; Fraser, Joe; Huxley, Caroline; Kim, Sung-Wook; Madan, Jason J; Matharu, Harjit; Musumadi, Luhanga; Palmer, Tom M; Paul, Moli; Sankaranarayanan, Sailesh; Slowther, Anne-Marie; Sujan, Mark A; Sutcliffe, Paul A; Sturt, Jackie

    2015-01-01

    Young people living with long term conditions are vulnerable to health service disengagement. This endangers their long term health. Studies report requests for digital forms of communication - email, text, social media - with their health care team. Digital clinical communication is troublesome for the UK NHS. In this article we aim to present the research protocol for evaluating the impacts and outcomes of digital clinical communications for young people living with long term conditions and provide critical analysis of their use, monitoring and evaluation by NHS providers (LYNC study: Long term conditions, Young people, Networked Communications). The research involves: (a) patient and public involvement activities with 16-24 year olds with and without long term health conditions; (b) six literature reviews; (c) case studies - the main empirical part of the study - and (d) synthesis and a consensus meeting. Case studies use a mixed methods design. Interviews and non-participant observation of practitioners and patients communicating in up to 20 specialist clinical settings will be combined with data, aggregated at the case level (non-identifiable patient data) on a range of clinical outcomes meaningful within the case and across cases. We will describe the use of digital clinical communication from the perspective of patients, clinical staff, support staff and managers, interviewing up to 15 young people and 15 staff per case study. Outcome data includes emergency admissions, A&E attendance and DNA (did not attend) rates. Case studies will be analysed to understand impacts of digital clinical communication on patient health outcomes, health care costs and consumption, ethics and patient safety.

  20. An observational European study on clinical outcomes associated with current management strategies for non-variceal upper gastrointestinal bleeding (ENERGIB-Turkey).

    Science.gov (United States)

    Mungan, Zeynel

    2012-01-01

    This observational, retrospective cohort study assessed outcomes of the current management strategies for nonvariceal upper gastrointestinal bleeding in several European countries (Belgium, Greece, Italy, Norway, Portugal, Spain, and Turkey) (NCT00797641; ENERGIB). Turkey contributed 23 sites to this study. Adult patients (≥18 years old) consecutively admitted to hospital and who underwent endoscopy for overt non-variceal upper gastrointestinal bleeding (hematemesis, melena or hematochezia, with other clinical/laboratory evidence of acute upper GI blood loss) were included in the study. Data were collected from patient medical records regarding bleeding continuation, re-bleeding, pharmacological treatment, surgery, and mortality during a 30-day follow-up period. A total of 423 patients (67.4% men; mean age: 57.8 ± 18.9 years) were enrolled in the Turkish study centers, of whom 96.2% were admitted to hospital with acute non-variceal upper gastrointestinal bleeding. At admission, the most common symptom was melena (76.1%); 28.6% of patients were taking aspirin, 19.9% were on non-steroidal anti-inflammatory drugs, and 7.3% were on proton pump inhibitors. The most common diagnoses were duodenal (45.2%) and gastric (27.7%) ulcers and gastritis/gastric erosions (26.2%). Patients were most often managed in general medical wards (45.4%). A gastrointestinal team was in charge of treatment in 64.8% of cases. Therapeutic procedures were performed in 32.4% of patients during endoscopy. After the endoscopy, most patients (94.6%) received proton pump inhibitors. Mean (SD) hospital stay was 5.36 ± 4.91 days. The cumulative proportions of continued bleeding/re-bleeding, complications and mortality within 30 days of the non-variceal upper gastrointestinal bleeding episode were 9.0%, 5.7% and 2.8%, respectively. In the Turkish sub-group of patients, the significant risk factors for bleeding continuation or re-bleeding were age >65 years, presentation with hematemesis or shock

  1. Survival and clinical outcome of dogs with ischaemic stroke.

    Science.gov (United States)

    Gredal, H; Toft, N; Westrup, U; Motta, L; Gideon, P; Arlien-Søborg, P; Skerritt, G C; Berendt, M

    2013-06-01

    The objectives of the present study were to investigate survival time, possible predictors of survival and clinical outcome in dogs with ischaemic stroke. A retrospective study of dogs with a previous diagnosis of ischaemic stroke diagnosed by magnetic resonance imaging (MRI) was performed. The association between survival and the hypothesised risk factors was examined using univariable exact logistic regression. Survival was examined using Kaplan-Meier and Cox regression. Twenty-two dogs were identified. Five dogs (23%) died within the first 30days of the stroke event. Median survival in 30-day 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 excellent in seven of 17 (41%) 30-day survivors. Another seven 30-day survivors experienced new acute neurological signs within 6-17months of the initial stroke event; in two of those cases a new ischaemic stroke was confirmed by MRI. In conclusion, dogs with ischaemic stroke have a fair to good prognosis 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. Copyright © 2012 Elsevier Ltd. All rights reserved.

  2. 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

  3. AN OBSERVATIONAL CLINICAL STUDY OF ASSESSING THE UTILITY OF PSS (POISON SEVERITY SCORE AND GCS (GLASGOW COMA SCALE SCORING SYSTEMS IN PREDICTING SEVERITY AND CLINICAL OUTCOMES IN OP POISONING

    Directory of Open Access Journals (Sweden)

    S. Chandrasekhar

    2017-05-01

    Full Text Available BACKGROUND Organophosphorus compound poisoning is the most common poisonings in India because of easy availability often requiring ICU care and ventilator support. Clinical research has indicated that respiratory failure is the most important cause of death due to organophosphorus poisoning. It results in respiratory muscle weakness, pulmonary oedema, respiratory depression, increased secretions and bronchospasm. These complications and death can be prevented with timely institution of ventilator support. MATERIALS AND METHODS Hundred consecutive patients admitted with a history of organophosphorus poisoning at Kurnool Medical College, Kurnool, were taken for study after considering the inclusion and exclusion criteria. Detailed history, confirmation of poisoning, examination and other than routine investigations, serum pseudocholinesterase and arterial blood gas analysis was done. The severity and clinical outcomes in OP poisoning is graded by PSS (poison severity score and GCS (Glasgow coma scale scoring systems. RESULTS This study was conducted in 100 patients with male preponderance. Majority of poisoning occurred in 21-30 age group (n=5. Most common compound consumed in our study was methyl parathion and least common was phosphoran. Slightly more than half of the patients consumed less than 50 mL of poison. 21 patients consumed between 50 to 100 mL. Distribution of poison severity score of patients studied showed 45 cases of grade 1 poisoning. 26 cases of grade 2 poisoning, 23 cases of grade 3 poisoning and 6 cases of grade 4 poisoning (death within first 24 hours. Distribution of GCS score of patients studied GCS scores were <10 in 25 patients at admission and 24 patients after 24 hours. GCS scores were ≥10 in 75 patients at admission and 76 patients after 24 hours. Poison severity score is not prognostic, but merely defines severity of OP poisoning at a given time. CONCLUSION Both Glasgow coma scale and poison severity scoring systems

  4. Use of outcome measures in pulmonary hypertension clinical trials.

    Science.gov (United States)

    Parikh, Kishan S; Rajagopal, Sudarshan; Arges, Kristine; Ahmad, Tariq; Sivak, Joseph; Kaul, Prashant; Shah, Svati H; Tapson, Victor; Velazquez, Eric J; Douglas, Pamela S; Samad, Zainab

    2015-09-01

    To evaluate the use of surrogate measures in pulmonary hypertension (PH) clinical trials and how it relates to clinical practice. Studies of pulmonary arterial hypertension (PAH) employ a variety of surrogate measures in addition to clinical events because of a small patient population, participant burden, and costs. The use of these measures in PH drug trials is poorly defined. We searched PubMed/MEDLINE/Embase for randomized or prospective cohort PAH clinical treatment trials from 1985 to 2013. Extracted data included intervention, trial duration, study design, patient characteristics, and primary and secondary outcome measures. To compare with clinical practice, we assessed the use of surrogate measures in a clinical sample of patients on PH medications at Duke University Medical Center between 2003 and 2014. Between 1985 and 2013, 126 PAH trials were identified and analyzed. Surrogate measures served as primary endpoints in 119 trials (94.0%). Inclusion of invasive hemodynamics decreased over time (78.6%, 75.0%, 52.2%; P for trend = .02), while functional testing (7.1%, 60.0%, 81.5%; P for trend clinical assessments regularly incorporated serial echocardiography and 6-minute walk distance tests (92% and 95% of patients, respectively) and repeat measurement of invasive hemodynamics (46% of patients). The majority of PAH trials have utilized surrogate measures as primary endpoints. The use of these surrogate endpoints has evolved significantly over time with increasing use of patient-centered endpoints and decreasing or stable use of imaging and invasive measures. In contrast, imaging and invasive measures are commonly used in contemporary clinical practice. Further research is needed to validate and standardize currently used measures. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Prothrombin time is predictive of low plasma prothrombin concentration and clinical outcome in patients with trauma hemorrhage: analyses of prospective observational cohort studies.

    Science.gov (United States)

    Balendran, Clare A; Lövgren, Ann; Hansson, Kenny M; Nelander, Karin; Olsson, Marita; Johansson, Karin J; Brohi, Karim; Fries, Dietmar; Berggren, Anders

    2017-03-14

    Fibrinogen and prothrombin have been suggested to become rate limiting in trauma associated coagulopathy. Administration of fibrinogen is now recommended, however, the importance of prothrombin to patient outcome is unknown. We have utilized two trauma patient databases (database 1 n = 358 and database 2 n = 331) to investigate the relationship of plasma prothrombin concentration on clinical outcome and coagulation status. Database 1 has been used to assess the relationship of plasma prothrombin to administered packed red blood cells (PRBC), clinical outcome and coagulation biomarkers (Prothrombin Time (PT), ROTEM EXTEM Coagulation Time (CT) and Maximum Clot Firmness (MCF)). ROC analyses have been performed to investigate the ability of admission coagulation biomarkers to predict low prothrombin concentration (database 1), massive transfusion and 24 h mortality (database 1 and 2). The importance of prothrombin was further investigated in vitro by PT and ROTEM assays in the presence of a prothrombin neutralizing monoclonal antibody and following step-wise dilution. Patients who survived the first 24 h had higher admission prothrombin levels compared to those who died (94 vs.67 IU/dL). Patients with lower transfusion requirements within the first 24 h (≤10 units of PRBCs) also had higher admission prothrombin levels compared to patients with massive transfusion demands (>10 units of PRBCs) (95 vs.62 IU/dL). Admission PT, in comparison to admission ROTEM EXTEM CT and MCF, was found to be a better predictor of prothrombin concentration <60 IU/dL (AUC 0.94 in database 1), of massive transfusion (AUC 0.92 and 0.81 in database 1 and 2 respectively) and 24 h mortality (AUC 0.90 and 0.78 in database 1 and 2, respectively). In vitro experiments supported a critical role for prothrombin in coagulation and demonstrated that PT and ROTEM EXTEM CT are sensitive methods to measure low prothrombin concentration. Our analyses suggest that prothrombin concentration

  6. Revision hip preservation surgery with hip arthroscopy: clinical outcomes.

    Science.gov (United States)

    Domb, Benjamin G; Stake, Christine E; Lindner, Dror; El-Bitar, Youseff; Jackson, Timothy J

    2014-05-01

    To analyze and report the clinical outcomes of a cohort of patients who underwent revision hip preservation with arthroscopy and determine predictors of positive and negative outcomes. During the study period from April 2008 to December 2010, all patients who underwent revision hip preservation with arthroscopy were included. This included patients who had previous open surgery and underwent revision with arthroscopy. Patient-reported outcome (PRO) scores were obtained preoperatively and at 3-month, 1-year, 2-year, and 3-year follow-up time points. Any revision surgeries and conversions to total hip arthroplasty were noted. A multiple regression analysis was performed to look for positive and negative predictive factors for improvement in PROs after revision hip arthroscopy. Forty-seven hips in 43 patients had completed 2 years' follow-up or needed total hip arthroplasty. The mean length of follow-up was 29 months (range, 24 to 47 months). Of the hips, 31 (66%) had either unaddressed or incompletely treated femoroacetabular impingement. There was a significant improvement in all PRO scores at a mean of 29 months after revision (P arthroscopy can achieve moderately successful outcomes and remains a viable treatment strategy after failed primary hip preservation surgery. Preoperative predictors of success after revision hip arthroscopy include segmental labral defects, unaddressed or incompletely addressed femoroacetabular impingement, heterotopic ossification, and previous open surgery. Level IV, therapeutic case series. Copyright © 2014 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  7. Clinical outcome scoring of intra-articular calcaneal fractures

    NARCIS (Netherlands)

    Schepers, Tim; Heetveld, Martin J.; Mulder, Paul G. H.; Patka, Peter

    2008-01-01

    Outcome reporting of intra-articular calcaneal fractures is inconsistent. This study aimed to identify the most cited outcome scores in the literature and to analyze their reliability and validity. A systematic literature search identified 34 different outcome scores. The most cited outcome score

  8. Subcutaneous interferon β-1a in pediatric patients with multiple sclerosis: Regional differences in clinical features, disease management, and treatment outcomes in an international retrospective study.

    Science.gov (United States)

    Krupp, Lauren B; Pohl, Daniela; Ghezzi, Angelo; Boyko, Alexey; Tenembaum, Silvia; Chen, Liang; Aycardi, Ernesto; Banwell, Brenda

    2016-04-15

    To further understand management of pediatric patients with multiple sclerosis (MS), we examined disease features, clinical practice patterns, and response to treatment in the United States (US) and seven other countries ('rest of World'; ROW). Anonymized data, recorded as part of routine clinical practice, were obtained from medical records (1997-2009) of study participants (who received subcutaneous interferon β-1a before age 18 years) from the US and ROW. Samples were stratified by age (preadolescents [managed differently, compared with ROW patients. Future prospective studies are needed to confirm these observations and ascertain their clinical significance. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  9. Comparison of clinical outcomes after drug-eluting balloon and drug-eluting stent use for in-stent restenosis related acute myocardial infarction: a retrospective study

    Directory of Open Access Journals (Sweden)

    Chih-Yuan Fang

    2018-04-01

    Full Text Available Background Good results of drug-eluting balloon (DEB use are achieved in in-stent restenosis (ISR lesions, small vessel disease, long lesions, and bifurcations. However, few reports exist about DEB use in acute myocardial infarction (AMI with ISR. This study’s aim was to evaluate the efficacy of DEB for AMI with ISR. Methods Between November 2011 and December 2015, 117 consecutive patients experienced AMI including ST-segment elevation MI, and non-ST-segment elevation MI due to ISR, and received percutaneous coronary intervention (PCI. We divided our patients into two groups: (1 PCI with further DEB, and (2 PCI with further drug-eluting stent (DES. Clinical outcomes such as target lesion revascularization, target vessel revascularization, recurrent MI, stroke, cardiovascular mortality, and all-cause mortality were analyzed. Results The patients’ average age was 68.37 ± 11.41 years; 69.2% were male. A total of 75 patients were enrolled in the DEB group, and 42 patients were enrolled in the DES group. The baseline characteristics between the two groups were the same without statistical differences except for gender. Peak levels of cardiac biomarker, pre- and post-PCI cardiac function were similar between two groups. The major adverse cardiac cerebral events rate (34.0% vs. 35.7%; p = 0.688 and cardiovascular mortality rate (11.7% vs. 12.8%; p = 1.000 were similar in both groups. Conclusions DEB is a reasonable strategy for AMI with ISR. Compared with DES, DEB is an alternative strategy which yielded acceptable short-term outcomes and similar 1-year clinical outcomes.

  10. 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.

  11. 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...... developed recently and have not been established in the literature. Although currently used generic and activity-level measures have limitations, as well, they should be considered, depending on the specific goals of the study. Additional research is needed to assess the properties of these measures fully...

  12. Outcomes of clinical trial: tinnitus masking versus tinnitus retraining therapy.

    Science.gov (United States)

    Henry, James A; Schechter, Martin A; Zaugg, Tara L; Griest, Susan; Jastreboff, Pawel J; Vernon, Jack A; Kaelin, Christine; Meikle, Mary B; Lyons, Karen S; Stewart, Barbara J

    2006-02-01

    A controlled clinical study was conducted to evaluate prospectively the clinical efficacy of tinnitus masking (TM) and tinnitus retraining therapy (TRT) in military veterans having clinically significant tinnitus. Qualifying patients were placed into the two groups in an alternating manner (to avoid selection bias), and treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index) and the verbally administered TRT interview forms. Findings are presented from the three written questionnaires, and from two of the interview questions (percentage time aware of, and annoyed by, tinnitus). Outcomes were analyzed on an intent-to-treat basis, using a multilevel modeling approach. Of the 123 patients enrolled, 118 were included in the analysis. Both groups showed significant declines (improvements) on these measures, with the TRT decline being significantly greater than for TM. The greater declines in TRT compared to TM occurred most strongly in patients who began treatment with a "very big" tinnitus problem. When patients began treatment with a "moderate" tinnitus problem, the benefits of TRT compared to TM were more modest.

  13. Clinical outcomes and survival in AA amyloidosis patients

    Directory of Open Access Journals (Sweden)

    Yavuz Ayar

    Full Text Available Abstract Aim Amyloid A amyloidosis is a rare complication of chronic inflammatory conditions. Most patients with amyloid A amyloidosis present with nephropathy and it leads to renal failure and death. We studied clinical characteristics and survival in patients with amyloid A amyloidosis. Methods: A total of 81 patients (51 males, 30 females with renal biopsy proven amyloid A amyloidosis were analyzed retrospectively. The patients were divided into good and poor outcomes groups according to survival results. Results: Most of the patients (55.6% had nephrotic range proteinuria at diagnosis. Most frequent underlying disorders were familial Mediterranean fever (21.2% and rheumatoid arthritis (10.6% in the good outcome group and malignancy (20% in the poor outcome group. Only diastolic blood pressure in the good outcome group and phosphorus level in the poor outcome group was higher. Serum creatinine levels increased after treatment in both groups, while proteinuria in the good outcome group decreased. Increase in serum creatinine and decrease in estimated glomerular filtration rate of the poor outcome group were more significant in the good outcome group. At the time of diagnosis 18.5% and 27.2% of all patients had advanced chronic kidney disease (stage 4 and 5, respectively. Median duration of renal survival was 65 ± 3.54 months. Among all patients, 27.1% were started dialysis treatment during the follow-up period and 7.4% of all patients underwent kidney transplantation. Higher levels of systolic blood pressure [hazard ratios 1.03, 95% confidence interval: 1-1.06, p = 0.036], serum creatinine (hazard ratios 1.25, 95% confidence interval: 1.07-1.46, p = 0.006 and urinary protein excretion (hazard ratios 1.08, 95% confidence interval: 1.01-1.16, p = 0.027 were predictors of end-stage renal disease. Median survival of patients with organ involvement was 50.3 ± 16 months. Conclusion Our study indicated that familial Mediterranean fever constituted

  14. Effect of the prosthesis-patient mismatch on long-term clinical outcomes after isolated aortic valve replacement for aortic stenosis: a prospective observational study.

    Science.gov (United States)

    Hong, Soonchang; Yi, Gijong; Youn, Young-Nam; Lee, Sak; Yoo, Kyung-Jong; Chang, Byung-Chul

    2013-11-01

    The effect of prosthesis-patient mismatch (PPM) on clinical outcomes after aortic valve replacement remains controversial. We evaluated effect of PPM on long-term clinical outcomes after isolated aortic valve replacement in patients with predominant aortic stenosis. We analyzed data from patients with predominant aortic stenosis who underwent isolated aortic valve replacement between January 1995 and July 2010. The indexed effective orifice area, obtained by dividing the in vivo effective orifice area by the patient's body surface area, was used to define PPM as clinically nonsignificant (group I, 224 patients), mild (group II, 52 patients), moderate (group III, 39 patients), and severe (group IV, 36 patients). Early survival was not significantly different among the groups, but overall survival was decreased gradually in group IV. Overall survival at 12 years was lower in group IV than in group I (92.8% ± 2.7% vs 67.0 ± 10.1, respectively; P = .001). Cardiac-related-death-free survival at 12 years was lower in patients with severe PPM. Left ventricular mass index decreased during the follow-up period in all groups. But left ventricular mass index was less decreased in group IV compared with groups I, II, and III. Age, severe PPM, and ejection fraction <40%, and New York Heart Association Functional Class IV were independent risk factors of overall survival on multivariate analysis. Severe PPM was an independent risk factor for cardiac-related death. Severe PPM showed an adverse effect on long-term survival, and was an independent risk factor for cardiac-related death. In addition, patients with severe PPM showed less decreasing left ventricular mass index during follow-up. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  15. Admission Hyperglycemia and Clinical Outcome in Cerebral Venous Thrombosis

    NARCIS (Netherlands)

    Zuurbier, Susanna M.; Hiltunen, Sini; Tatlisumak, Turgut; Peters, Guusje M.; Silvis, Suzanne M.; Haapaniemi, Elena; Kruyt, Nyika D.; Putaala, Jukka; Coutinho, Jonathan M.

    2016-01-01

    Background and Purpose-Admission hyperglycemia is associated with poor clinical outcome in ischemic and hemorrhagic stroke. Admission hyperglycemia has not been investigated in patients with cerebral venous thrombosis. Methods-Consecutive adult patients with cerebral venous thrombosis were included

  16. Severe hyperthyroidism: aetiology, clinical features and treatment outcome.

    Science.gov (United States)

    Iglesias, P; Dévora, O; García, J; Tajada, P; García-Arévalo, C; Díez, J J

    2010-04-01

    Severe hyperthyroidism (SH) is a serious medical disorder that can compromise life. There have not been systematic studies in which SH has been evaluated in detail. Here, our aims were: (1) to analyse both clinical and analytical features and outcome in patients with SH and (2) to compare these data with those found in more usual forms of hyperthyroidism. Patients and methods All patients diagnosed of SH (free thyroxine, FT4 > 100 pmol/l, NR: 11-23) seen in our endocrinology clinic in the last 15 years were studied and compared with a sample of patients with mild (mH; FT4, 23-50 pmol/l) and moderate (MH; FT4, 51-100 pmol/l) hyperthyroidism. Aetiology, clinical analytical and imaging data at diagnosis, therapeutic response and outcome were registered. Results A total of 107 patients with overt hyperthyroidism (81 females, mean age +/- SD 46.9 +/- 16.1 years) were evaluated. We studied a historic group with SH (n = 21; 14 females, 40.9 +/- 17.2 years) and, as a comparator group, we analyszed the data of 86 hyperthyroid patients (67 females, 48.4 +/- 15.5.6 years, NS) comparable in age and gender. The comparator group was classified in MH (n = 37, 26 females, 47.2 +/- 16.6 years) and mH (n = 49, 41 females, 49.4 +/- 14.8 years). In comparison with mH group, SH patients were significantly (P hyperthyroidism. FT4 was the only independent predictor of cure [OR 0.98 (CI 95%, 0.97-0.99), P hyperthyroidism is usually de novo and is accompanied by more clinical signs, symptoms, and analytical derangements, as well as higher titres of TRAb at diagnosis than milder forms of hyperthyroidism. The present data are not able to show differences in treatment modality, time to achieve cure, and remission rate among patients with mild, moderate and severe hyperthyroidism.

  17. Comparing 2 Whiplash Grading Systems to Predict Clinical Outcomes.

    Science.gov (United States)

    Croft, Arthur C; Bagherian, Alireza; Mickelsen, Patrick K; Wagner, Stephen

    2016-06-01

    Two whiplash severity grading systems have been developed: Quebec Task Force on Whiplash-Associated Disorders (QTF-WAD) and the Croft grading system. The majority of clinical studies to date have used the modified grading system published by the QTF-WAD in 1995 and have demonstrated some ability to predict outcome. But most studies include only injuries of lower severity (grades 1 and 2), preventing a broader interpretation. The purpose of this study was assess the ability of these grading systems to predict clinical outcome within the context of a broader injury spectrum. This study evaluated both grading systems for their ability to predict the bivalent outcome, recovery, within a sample of 118 whiplash patients who were part of a previous case-control designed study. Of these, 36% (controls) had recovered, and 64% (cases) had not recovered. The discrete bivariate distribution between recovery status and whiplash grade was analyzed using the 2-tailed cross-tabulation statistics. Applying the criteria of the original 1993 Croft grading system, the subset comprised 1 grade 1 injury, 32 grade 2 injuries, 53 grade 3 injuries, and 32 grade 4 injuries. Applying the criteria of the modified (QTF-WAD) grading system, there were 1 grade 1 injury, 89 grade 2 injuries, and 28 grade 3 injuries. Both whiplash grading systems correlated negatively with recovery; that is, higher severity grades predicted a lower probability of recovery, and statistically significant correlations were observed in both, but the Croft grading system substantially outperformed the QTF-WAD system on this measure. The Croft grading system for whiplash injury severity showed a better predictive measure for recovery status from whiplash injuries as compared with the QTF-WAD grading system.

  18. Clinical outcomes of endovascularly managed iatrogenic renal hemorrhages

    International Nuclear Information System (INIS)

    Chiramel, George Koshy; Keshava, Shyamkumar Nidugala; Moses, Vinu; Kekre, Nitin; Tamilarasi, V; Devasia, Anthony

    2015-01-01

    To evaluate the effectiveness of endovascular management in iatrogenic renal injuries with regard to clinical status on follow-up and requirements for repeat angiography and embolization. This retrospective study included patients who were referred for endovascular management of significant hemorrhage following an iatrogenic injury. Data was recorded from the Picture Archiving and Communication system (PACS) and electronic medical records. The site and type of iatrogenic injury, imaging findings, treatment, angiography findings, embolization performed, clinical status on follow-up, and requirement for repeat embolization were recorded. The outcomes were clinical resolution, nephrectomy, or death. Clinical findings were recorded on follow-up visits to the clinic. Statistical analysis was performed using descriptive statistics. Seventy patients were included in this study between January 2000 and June 2012. A bleeding lesion (a pseudoaneurysm or arteriovenous fistula) was detected during the first angiogram in 55 patients (78.6%) and was selectively embolized. Fifteen required a second angiography as there was no clinical improvement and five required a third angiography. Overall, 66 patients (94.3%) showed complete resolution and 4 patients (5.7%) died. Three patients (4.3%) underwent nephrectomy for clinical stabilization even after embolization. There were no major complications. The two minor complications resolved spontaneously. Angiography and embolization is the treatment of choice in iatrogenic renal hemorrhage. Upto 20% of initial angiograms may not reveal the bleed and repeat angiography is required to identify a recurrent or unidentified bleed. The presence of multiple punctate bleeders on angiography suggests an enlarging subcapsular hematoma and requires preoperative embolization and nephrectomy

  19. Clinical and radiological outcome of the Total Evolutive Shoulder System (TESS®) reverse shoulder arthroplasty: a prospective comparative non-randomised study.

    Science.gov (United States)

    Kadum, Bakir; Mukka, Sebastian; Englund, Erling; Sayed-Noor, Arkan; Sjödén, Göran

    2014-05-01

    The aims of this study were to assess the function and quality of life after the Total Evolutive Shoulder System (TESS) reverse shoulder arthroplasty (RSA), to evaluate the radiological stability of the stemless version and to address the effect of arm lengthening and scapular notching (SN) on the outcome. This was a prospective comparative non-randomised study. A total of 37 consecutive patients (40 shoulders) underwent TESS RSA between October 2007 and January 2012; 16 were stemless and 26 were stemmed. At a mean follow-up of 39 months (15-66), we evaluated range of motion (ROM), pain and functional outcome with QuickDASH and quality of life with EQ-5D score. Radiologically, component positioning, signs of loosening, SN and arm length difference were documented. We found a significant improvement in functional outcome and reduction of pain in both stemmed and stemless groups. No humeral loosening was evident, but there were four glenoid loosenings. In 12 shoulders that developed SN, seven already had scapular bone impression (SBI) evident on initial post-operative radiographs. Glenoid overhang seemed to decrease the risk of SN. Arm lengthening was associated with better EQ-5D but did not influence ROM or functional outcome. Reverse shoulder arthroplasty markedly improved shoulder function. SN is of concern in RSA, but proper positioning of the glenoid component may prevent its development.

  20. Clinical Profile and Visual Outcome of Ocular Bartonellosis in Malaysia

    OpenAIRE

    Tan, Chai Lee; Fhun, Lai Chan; Tai, Evelyn Li Min; Abdul Gani, Nor Hasnida; Muhammed, Julieana; Tuan Jaafar, Tengku Norina; Ahmad Tajudin, Liza Sharmini; Wan Hitam, Wan-Hazabbah

    2017-01-01

    Background. Ocular bartonellosis can present in various ways, with variable visual outcome. There is limited data on ocular bartonellosis in Malaysia. Objective. We aim to describe the clinical presentation and visual outcome of ocular bartonellosis in Malaysia. Materials and Methods. This was a retrospective review of patients treated for ocular bartonellosis in two ophthalmology centers in Malaysia between January 2013 and December 2015. The diagnosis was based on clinical features, support...

  1. Clinical Outcomes of Colorectal Cancer in Kenya | Saidi | Annals of ...

    African Journals Online (AJOL)

    Background The incidence of colorectal cancer in Africa is increasing. True data on clinical outcomes of the disease is hampered by follow up challenges. Method Follow up data of 233 patients treated for colorectal cancer between 2005 and 2010 at various Nairobi hospitals were evaluated. The primary outcome was ...

  2. Subacute Thyroiditis: Clinical Presentation and Long Term Outcome

    Science.gov (United States)

    Alfadda, Assim A.; Sallam, Reem M.; Elawad, Ghadi E.; AlDhukair, Hisham; Alyahya, Mossaed M.

    2014-01-01

    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. PMID:24803929

  3. 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 laser wavelengths in adjunct to SRP offers significant improvements of 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

  4. 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®).

    Science.gov (United States)

    Höybye, Charlotte; Sävendahl, Lars; Christesen, Henrik Thybo; Lee, Peter; Pedersen, Birgitte Tønnes; Schlumpf, Michael; Germak, John; Ross, Judith

    2013-01-01

    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. The NordiNet® International Outcome Study (IOS) and the American Norditropin® Web Enabled Research (ANSWER Program®) are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepidemiological data. The studies include pediatric and adult patients receiving Norditropin®, as prescribed by their physicians. The studies gather long-term data on the safety and effectiveness of reallife treatment with the recombinant human GH, Norditropin®. We describe the origins, aims, objectives, and design methodology of the studies, as well as their governance and validity, strengths, and limitations. The NordiNet® IOS and ANSWER Program® studies will provide valid insights into the effectiveness and safety of GH treatment across a diverse and large patient population treated in accordance with real-world clinical practice and following the Good Pharmacoepidemiological Practice and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines.

  5. The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease.

    Science.gov (United States)

    Adams, George L; Mustapha, Jihad; Gray, William; Hargus, Nick J; Martinsen, Brad J; Ansel, Gary; Jaff, Michael R

    2016-04-01

    Most peripheral artery disease (PAD) clinical device trials are supported by commercial manufacturers and designed for regulatory device approval, with extensive inclusion/exclusion criteria to support homogeneous patient populations. High-risk patients with advanced disease, including critical limb ischemia (CLI), are often excluded leading to difficulty in translating trial results into real-world clinical practice. As a result, physicians have no direct guidance regarding the use of endovascular devices. There is a need for objectively assessed studies to evaluate clinical, functional, and economic outcomes in PAD patient populations. LIBERTY is a prospective, observational, multicenter study sponsored by Cardiovascular Systems Inc (St Paul, MN) to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity PAD. Approximately 1,200 patients will be enrolled and followed up to 5 years: 500 patients in the "Claudicant Rutherford 2-3" arm, 600 in the "CLI Rutherford 4-5" arm, and 100 in the "CLI Rutherford 6" arm. The study will use 4 core laboratories for independent analysis and will evaluate the following: procedural and lesion success, rates of major adverse events, duplex ultrasound interpretations, wound status, quality of life, 6-minute walk test, and economic analysis. The LIBERTY Patient Risk Score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions in this patient population. LIBERTY will investigate real-world PAD patients treated with endovascular revascularization with rigorous study guidelines and independent oversight of outcomes. This study will provide observational, all-comer patient clinical data to guide future endovascular therapy. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  6. Effect of the male factor on the clinical outcome of intracytoplasmic sperm injection combined with preimplantation aneuploidy testing: observational longitudinal cohort study of 1,219 consecutive cycles.

    Science.gov (United States)

    Mazzilli, Rossella; Cimadomo, Danilo; Vaiarelli, Alberto; Capalbo, Antonio; Dovere, Lisa; Alviggi, Erminia; Dusi, Ludovica; Foresta, Carlo; Lombardo, Francesco; Lenzi, Andrea; Tournaye, Herman; Alviggi, Carlo; Rienzi, Laura; Ubaldi, Filippo Maria

    2017-12-01

    To evaluate the impact of the male factor on the outcomes of intracytoplasmic sperm injection (ICSI) cycles combined with preimplantation genetic testing for aneuploidies (PGT-A). Observational longitudinal cohort study. Private in vitro fertilization (IVF) center. A total of 1,219 oocyte retrievals divided into five study groups according to sperm parameters: normozoospermia (N), moderate male factor (MMF), severe oligoasthenoteratozoospermia (OAT-S), obstructive azoospermia (OA), and nonobstructive azoospermia (NOA). ICSI with ejaculated/surgically retrieved sperm, blastocyst culture, trophectoderm-based quantitative polymerase chain reaction PGT-A, and frozen-warmed euploid embryo transfer (ET). The primary outcome measures were fertilization, blastocyst development, and euploidy rates; the secondary outcome measures were live birth and miscarriage rates. Perinatal and obstetrical outcomes were monitored as well. A total of 9,042 metaphase II oocytes were inseminated. The fertilization rate was significantly reduced in MMF, OAT-S, OA, and NOA compared with N (74.8%, 68.7%, 67.3%, and 53.1% vs. 77.2%). The blastocyst rate per fertilized oocyte was significantly reduced in MMF and NOA compared with N (48.6% and 40.6% vs. 49.3%). The timing of blastocyst development also was affected in OA and NOA. Logistic regression analysis adjusted for confounders highlighted NOA as a negative predictor of obtaining an euploid blastocyst per OPU (odds ratio 0.5). When the analysis was performed per obtained blastocyst, however, no correlation between male factor and euploidy rate was observed. Embryo transfers also resulted in similar live birth and miscarriage rates. No impact of sperm factor on obstetrical/perinatal outcomes was observed. Severe male factor impairs early embryonic competence in terms of fertilization rate and developmental potential. However, the euploidy rate and implantation potential of the obtained blastocysts are independent from sperm quality

  7. Ebola outbreak in Conakry, Guinea: epidemiological, clinical, and outcome features.

    Science.gov (United States)

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

    2014-12-01

    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. A prospective study was conducted from March 25 to August 20, 2014. The diagnosis of Ebola virus infection was made on real-time PCR. Ninety patients, with a positive test result, were hospitalized. Their mean age was 34.12±14.29 years and 63% were male patients. Most worked in the informal sector (38%) and in the medical and paramedical staff (physicians 12%, nurses 6%, and laboratory technicians 1%). Most patients lived in the Conakry suburbs (74%) and in Boffa (11%). The main clinical signs were physical asthenia (80%) and fever (72%). Hemorrhagic signs were observed in 26% of patients. The comparison of clinical manifestations showed that hiccups (P=0.04), respiratory distress (P=0.04), and hemorrhagic symptoms (P=0.01) were more frequent among patients who died. Malaria (72%) and diabetes (2%) were the most frequent co-morbidities. The crude case fatality rate was 44% [95% confidence interval (33-54%)]. The average hospital stay was 7.96±5.81 days. The first Ebola outbreak in Conakry was characterized by the young age of patients, discrete hemorrhagic signs related to lethality. Its control relies on a strict use of preventive measures. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  8. Clinical Outcomes of Penile Prosthesis Implantation Surgery

    Directory of Open Access Journals (Sweden)

    Onur Dede

    2016-06-01

    Full Text Available Objective: We aimed to evaluating the outcomes of in­flatable penile prosthesis implantations and partner sat­isfaction. Methods: Data of 52 patients who underwent penile prosthesis implantation in single center between May 2010 and December 2015 were retrospectively analyzed. Types of prosthesis, complication and satisfaction rates of patients were recorded by EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire was used. Results: The mean age was 49.2±14.7 years for patients. The mean follow-up durations for 34.3±12.5 months. The mean hospital stay was 3.84±1.52 days. Evaluating of the couples satisfaction revealed that 44 (84% of the patient were very satisfied. There was not any complication and no patient need to underwent revision surgery. Conclusion: Inflatable penile prosthesis implants, with high levels of treatment success, patient and partner sat­isfaction, are effective and safe options for treatment of organic erectile dysfunction with acceptable complication and revision rates.

  9. The Value of Median Nerve Sonography as a Predictor for Short- and Long-Term Clinical Outcomes in Patients with Carpal Tunnel Syndrome: A Prospective Long-Term Follow-Up Study.

    Directory of Open Access Journals (Sweden)

    Alexander Marschall

    Full Text Available To investigate the prognostic value of B-mode and Power Doppler (PD ultrasound of the median nerve for the short- and long-term clinical outcomes of patients with carpal tunnel syndrome (CTS.Prospective study of 135 patients with suspected CTS seen 3 times: at baseline, then at short-term (3 months and long-term (15-36 months follow-up. At baseline, the cross-sectional area (CSA of the median nerve was measured with ultrasound at 4 levels on the forearm and wrist. PD signals were graded semi-quantitatively (0-3. Clinical outcomes were evaluated at each visit with the Boston Questionnaire (BQ and the DASH Questionnaire, as well as visual analogue scales for the patient's assessment of pain (painVAS and physician's global assessment (physVAS. The predictive values of baseline CSA and PD for clinical outcomes were determined with multivariate logistic regression models.Short-term and long-term follow-up data were available for 111 (82.2% and 105 (77.8% patients, respectively. There was a final diagnosis of CTS in 84 patients (125 wrists. Regression analysis revealed that the CSA, measured at the carpal tunnel inlet, predicted short-term clinical improvement according to BQ in CTS patients undergoing carpal tunnel surgery (OR 1.8, p = 0.05, but not in patients treated conservatively. Neither CSA nor PD assessments predicted short-term improvement of painVAS, physVAS or DASH, nor was any of the ultrasound parameters useful for the prediction of long-term clinical outcomes.Ultrasound assessment of the median nerve at the carpal tunnel inlet may predict short-term clinical improvement in CTS patients undergoing carpal tunnel release, but long-term outcomes are unrelated to ultrasound findings.

  10. Clinical outcome in measles patients hospitalized with complications

    International Nuclear Information System (INIS)

    Rehman, A.U.; Saeed, T.

    2008-01-01

    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)

  11. Balancing the need to rapidly scale-up and improve clinical outcomes in antiretroviral programmes in developing countries: lessons from an Indian programmatic cohort study.

    Science.gov (United States)

    Bock, Peter; Beyers, Nulda; Fidler, Sarah

    2014-10-01

    Antiretroviral treatment (ART) is highly effective reducing mortality and AIDS-related morbidity in HIV-infected people and at preventing transmission of HIV between individuals. The article reviewed for this commentary reported on data from an Indian ART cohort that showed low median baseline CD4 counts and high rates of mortality and loss to follow-up. Programme implementers in developing regions need to balance the need for rapid scale-up and simultaneous improvement in clinical outcomes. Challenges outlined support HIV treatment strategies that combine improved HIV diagnosis, linkage to care and provision of ART with a strong community-based component. © The Author 2014. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  12. Pragmatic controlled trial to prevent childhood obesity in maternity and child health care clinics: pregnancy and infant weight outcomes (The VACOPP Study)

    OpenAIRE

    Mustila, Taina; Raitanen, Jani; Keskinen, P?ivi; Saari, Antti; Luoto, Riitta

    2013-01-01

    Background According to current evidence, the prevention of obesity should start early in life. Even the prenatal environment may expose a child to unhealthy weight gain; maternal gestational diabetes is known to be among the prenatal risk factors conducive to obesity. Here we report the effects of antenatal dietary and physical activity counselling on pregnancy and infant weight gain outcomes. Methods The study was a non-randomised controlled pragmatic trial aiming to prevent childhood obesi...

  13. Clinical outcomes in hypertensive or diabetes patients who ...

    African Journals Online (AJOL)

    Background: The use of complementary medicines in addition to medical prescription by patients with hypertension, diabetes and other chronic diseases presents a challenge for healthcare providers in Nigeria and globally. There is very little data on the clinical outcomes in these patients. Objectives: To evaluate clinical ...

  14. Minimally invasive unicompartmental knee replacement: Midterm clinical outcome.

    Science.gov (United States)

    Tian, Shaoqi; Liu, Jiangjun; Yuan, Wanqing; Wang, Yuanhe; Ha, Chengzhi; Liu, Lun; Li, Qicai; Yang, Xu; Sun, Kang

    2017-01-01

    The purpose of this study was to explore the midterm clinical outcomes of unicompartmental knee replacement (UKR) for medial knee arthropathy through a minimally invasive approach (MIA). From January 2006 to June 2010, 442 consecutive patients (485 knees) were included in the study. All patients underwent MIA-UKR with the mobile bearing Oxford phrase III prosthesis. The incision was made starting 1 cm medial to the medial pole of the patella and extending distally to the tibial tubercle. Radiographic evaluations include femorotibial angle (FTA) from coronal x-rays and rectified varus deformity angle, while clinical evaluations included Knee Society Score (KSS, clinical score and function score), the Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index and visual analog scale (VAS) for pain. Patients followed-up at 1, 3, 6, 12 months after surgery and each year thereafter. Four hundreds and two patients completed the entire follow-up, 40 patients (45 knees) were lost to follow-up. The average follow-up time was 73.0 ± 1.9 months. The mean length of the incisions was 5.0 ± 0.2 cm. The average FTA decreased from 183.6° ± 5.1° preoperatively to 174.3° ± 4.2° postoperatively, and the mean rectified varus deformity angle was 9.3° ± 1.2°. The KSS clinical score improved from 42.4 ± 2.9 to 92.9 ± 3.8, and the function score improved from 53.5 ± 3.8 to 93.5 ± 4.0. The WOMAC score improved from 47.5 ± 3.1 preoperatively to 12.3 ± 1.5 at the last evaluation. The VAS dropped from 7.8 ± 1.9 preoperatively to 1.6 ± 0.2 postoperatively. All clinical evaluations (KSS, WOMAC, VAS) were significantly different (p clinical outcomes of MIA-UKR are satisfactory in a Chinese patient population, which is a good surgical option for patients with medial arthropathy of the knee. However, longer-term follow-up studies should be performed in these patients.

  15. Minimally invasive unicompartmental knee replacement: Midterm clinical outcome.

    Directory of Open Access Journals (Sweden)

    Shaoqi Tian

    Full Text Available The purpose of this study was to explore the midterm clinical outcomes of unicompartmental knee replacement (UKR for medial knee arthropathy through a minimally invasive approach (MIA.From January 2006 to June 2010, 442 consecutive patients (485 knees were included in the study. All patients underwent MIA-UKR with the mobile bearing Oxford phrase III prosthesis. The incision was made starting 1 cm medial to the medial pole of the patella and extending distally to the tibial tubercle. Radiographic evaluations include femorotibial angle (FTA from coronal x-rays and rectified varus deformity angle, while clinical evaluations included Knee Society Score (KSS, clinical score and function score, the Western Ontario and McMaster Universities Arthritis Index (WOMAC osteoarthritis index and visual analog scale (VAS for pain. Patients followed-up at 1, 3, 6, 12 months after surgery and each year thereafter.Four hundreds and two patients completed the entire follow-up, 40 patients (45 knees were lost to follow-up. The average follow-up time was 73.0 ± 1.9 months. The mean length of the incisions was 5.0 ± 0.2 cm. The average FTA decreased from 183.6° ± 5.1° preoperatively to 174.3° ± 4.2° postoperatively, and the mean rectified varus deformity angle was 9.3° ± 1.2°. The KSS clinical score improved from 42.4 ± 2.9 to 92.9 ± 3.8, and the function score improved from 53.5 ± 3.8 to 93.5 ± 4.0. The WOMAC score improved from 47.5 ± 3.1 preoperatively to 12.3 ± 1.5 at the last evaluation. The VAS dropped from 7.8 ± 1.9 preoperatively to 1.6 ± 0.2 postoperatively. All clinical evaluations (KSS, WOMAC, VAS were significantly different (p < 0.05 from pre and post-operative evaluations. The survival rate was 99.1% at 73 months, and the revision rate was 0.9%.The midterm clinical outcomes of MIA-UKR are satisfactory in a Chinese patient population, which is a good surgical option for patients with medial arthropathy of the knee. However, longer

  16. Social cognitive markers of short-term clinical outcome in first-episode psychosis.

    Science.gov (United States)

    Montreuil, Tina; Bodnar, Michael; Bertrand, Marie-Claude; Malla, Ashok K; Joober, Ridha; Lepage, Martin

    2010-07-01

    In psychotic disorders, impairments in cognition have been associated with both clinical and functional outcome, while deficits in social cognition have been associated with functional outcome. As an extension to a recent report on neurocognition and short-term clinical outcome in first-episode psychosis (FEP), the current study explored whether social cognitive deficits could also identify poor short-term clinical outcome among FEP patients. We defined the social-cognition domain based on the scores from the Hinting Task and the Four Factor Tests of Social Intelligence. Data were collected in 45 FEP patients and 26 healthy controls. The patients were divided into good- and poor-outcome groups based on clinical data at six months following initiation of treatment. Social cognition was compared among 27 poor-outcome, 18 good-outcome, and 26 healthy-control participants. Outcome groups significantly differed in the social cognition domain (z-scores: poor outcome=-2.0 [SD=1.4]; good outcome=-1.0 [SD=1.0]; p=0.005), with both groups scoring significantly lower than the control group (psocial cognition appears to be compromised in all FEP patients compared to healthy controls. More interestingly, significant differences in social cognitive impairments exist between good and poor short-term clinical outcome groups, with the largest effect found in the Cartoon Predictions subtest.

  17. Need for Outcome Scenario Analysis of Clinical Trials in Diabetes.

    Science.gov (United States)

    Garcia-Verdugo, Rosa; Erbach, Michael; Schnell, Oliver

    2017-03-01

    Since the FDA requirement for cardiovascular safety of all new antihyperglycemic drugs to enter the market, the number and extent of phase 3 clinical trials has markedly increased. Unexpected trial results imply an enormous economic, personal and time cost and has deleterious effects over R&D. To prevent unforeseen developments in clinical trials, we recommend performing a comprehensive prospective outcome scenario analysis before launching the trial. In this commentary, we discuss the most important factors to take in consideration for prediction of clinical trial outcome scenarios and propose a theoretical model for decision making.

  18. Occurrence, clinical features and outcome of canine pancreatitis (80 cases).

    Science.gov (United States)

    Pápa, Kinga; Máthé, Akos; Abonyi-Tóth, Zsolt; Sterczer, Agnes; Psáder, Roland; Hetyey, Csaba; Vajdovich, Péter; Vörös, Károly

    2011-03-01

    Medical records of 80 dogs diagnosed with acute pancreatitis during a 4-year period were evaluated regarding history, breed predilection, clinical signs and additional examination findings. Cases were selected if compatible clinical symptoms, increased serum activity of amylase or lipase and morphologic evidence of pancreatitis by ultrasonography, laparotomy or necropsy were all present. Like in other studies, neutered dogs had an increased risk of developing acute pancreatitis. Although breed predilection was consistent with earlier reports, some notable differences were also observed. Apart from Dachshunds, Poodles, Cocker Spaniels and Fox Terriers, the sled dogs (Laikas, Alaskan Malamutes) also demonstrated a higher risk for pancreatitis according to our results. Concurrent diseases occurred in 56 dogs (70%), diabetes mellitus (n = 29, 36%) being the most common. Clinical signs of acute pancreatitis were similar to those observed in other studies. The study group represented a dog population with severe acute pancreatitis, having a relatively high mortality rate (40%) compared to data of the literature. Breed, age, gender, neutering and body condition had no significant association with the outcome. Hypothermia (p = 0.0413) and metabolic acidosis (p = 0.0063) correlated significantly with poor prognosis and may serve as valuable markers for severity assessment in canine acute pancreatitis.

  19. Impact of clinical registries on quality of patient care and clinical outcomes: A systematic review.

    Directory of Open Access Journals (Sweden)

    Dewan Md Emdadul Hoque

    Full Text Available Clinical quality registries (CQRs are playing an increasingly important role in improving health outcomes and reducing health care costs. CQRs are established with the purpose of monitoring quality of care, providing feedback, benchmarking performance, describing pattern of treatment, reducing variation and as a tool for conducting research.To synthesise the impact of clinical quality registries (CQRs as an 'intervention' on (I mortality/survival; (II measures of outcome that reflect a process or outcome of health care; (III health care utilisation; and (IV healthcare-related costs.The following electronic databases were searched: MEDLINE, EMBASE, CENTRAL, CINAHL and Google Scholar. In addition, a review of the grey literature and a reference check of citations and reference lists within articles was undertaken to identify relevant studies in English covering the period January 1980 to December 2016. The PRISMA-P methodology, checklist and standard search strategy using pre-defined inclusion and exclusion criteria and structured data extraction tools were used. Data on study design and methods, participant characteristics attributes of included registries and impact of the registry on outcome measures and/or processes of care were extracted.We identified 30102 abstracts from which 75 full text articles were assessed and finally 17 articles were selected for synthesis. Out of 17 studies, six focused on diabetes care, two on cardiac diseases, two on lung diseases and others on organ transplantations, rheumatoid arthritis, ulcer healing, surgical complications and kidney disease. The majority of studies were "before after" design (#11 followed by cohort design (#2, randomised controlled trial (#2, experimental non randomised study and one cross sectional comparison. The measures of impact of registries were multifarious and included change in processes of care, quality of care, treatment outcomes, adherence to guidelines and survival. Sixteen of 17

  20. Cardiovascular Magnetic Resonance Imaging-Incremental Value in a Series of 361 Patients Demonstrating Cost Savings and Clinical Benefits: An Outcome-Based Study.

    Science.gov (United States)

    Hegde, Vinayak A; Biederman, Robert Ww; Mikolich, J Ronald

    2017-01-01

    This study was designed to assess the clinical impact and cost-benefit of cardiovascular magnetic resonance imaging (CMR). In the face of current health care cost concerns, cardiac imaging modalities have come under focused review. Data related to CMR clinical impact and cost-benefit are lacking. Retrospective review of 361 consecutive patients (pts) who underwent CMR exams was conducted. Indications for CMR were tabulated for appropriateness criteria. Components of the CMR exam were identified along with evidence of clinical impact. The cost of each CMR exam was ascertained along with cost savings attributable to the CMR exam for calculation of an incremental cost-effectiveness ratio. A total of 354 of 361 pts (98%) had diagnostic quality studies. Of the 361 pts, 350 (97%) had at least 1 published Appropriateness Criterion for CMR. A significant clinical impact attributable to CMR exam results was observed in 256 of 361 pts (71%). The CMR exam resulted in a new diagnosis in 69 of 361 (27%) pts. Cardiovascular magnetic resonance imaging results avoided invasive procedures in 38 (11%) pts and prevented additional diagnostic testing in 26 (7%) pts. Comparison of health care savings using CMR as opposed to current standards of care showed a net cost savings of $833 037, ie, per patient cost savings of $2308. Cardiovascular magnetic resonance imaging provides diagnostic image quality in >98% of cases. Cardiovascular magnetic resonance imaging findings have documentable clinical impact on patient management in 71% of pts undergoing the exam, in a cost beneficial manner.

  1. The impact of an hematocrit of 20% during normothermic cardiopulmonary bypass for elective low risk coronary artery bypass graft surgery on oxygen delivery and clinical outcome – a randomized controlled study [ISRCTN35655335

    Science.gov (United States)

    von Heymann, Christian; Sander, Michael; Foer, Achim; Heinemann, Anja; Spiess, Bruce; Braun, Jan; Krämer, Michael; Grosse, Joachim; Dohmen, Pascal; Dushe, Simon; Halle, Jürgen; Konertz, Wolfgang F; Wernecke, Klaus-Dieter; Spies, Claudia

    2006-01-01

    Introduction Cardiopulmonary bypass (CPB) induces hemodilutional anemia, which frequently requires the transfusion of blood products. The objective of this study was to evaluate oxygen delivery and consumption and clinical outcome in low risk patients who were allocated to an hematocrit (Hct) of 20% versus 25% during normothermic CPB for elective coronary artery bypass graft (CABG) surgery. Methods This study was a prospective, randomized and controlled trial. Patients were subjected to normothermic CPB (35 to 36°C) and were observed until discharge from the intensive care unit (ICU). Outcome measures were calculated whole body oxygen delivery, oxygen consumption and clinical outcome. A nonparametric multivariate analysis of variance for repeated measurements and small sample sizes was performed. Results In a total of 54 patients (25% Hct, n = 28; 20% Hct, n = 26), calculated oxygen delivery (p = 0.11), oxygen consumption (p = 0.06) and blood lactate (p = 0.60) were not significantly different between groups. Clinical outcomes were not different between groups. Conclusion These data indicate that an Hct of 20% during normothermic CPB maintained calculated whole body oxygen delivery above a critical level after elective CABG surgery in low risk patients. The question of whether a transfusion trigger in excess of 20% Hct during normothermic CPB is still supported requires a larger prospective and randomized trial. PMID:16606474

  2. CKD Self-management: Phenotypes and Associations With Clinical Outcomes.

    Science.gov (United States)

    Schrauben, Sarah J; Hsu, Jesse Y; Rosas, Sylvia E; Jaar, Bernard G; Zhang, Xiaoming; Deo, Rajat; Saab, Georges; Chen, Jing; Lederer, Swati; Kanthety, Radhika; Hamm, L Lee; Ricardo, Ana C; Lash, James P; Feldman, Harold I; Anderson, Amanda H

    2018-03-24

    To slow chronic kidney disease (CKD) progression and its complications, patients need to engage in self-management behaviors. The objective of this study was to classify CKD self-management behaviors into phenotypes and assess the association of these phenotypes with clinical outcomes. Prospective cohort study. Adults with mild to moderate CKD enrolled in the Chronic Renal Insufficiency Cohort (CRIC) Study. 3,939 participants in the CRIC Study recruited between 2003 and 2008 served as the derivation cohort and 1,560 participants recruited between 2013 and 2015 served as the validation cohort. CKD self-management behavior phenotypes. CKD progression, atherosclerotic events, heart failure events, death from any cause. Latent class analysis stratified by diabetes was used to identify CKD self-management phenotypes based on measures of body mass index, diet, physical activity, blood pressure, smoking status, and hemoglobin A 1c concentration (if diabetic); Cox proportional hazards models. 3 identified phenotypes varied according to the extent of implementation of recommended CKD self-management behaviors: phenotype I characterized study participants with the most recommended behaviors; phenotype II, participants with a mixture of recommended and not recommended behaviors; and phenotype III, participants with minimal recommended behaviors. In multivariable-adjusted models for those with and without diabetes, phenotype III was strongly associated with CKD progression (HRs of 1.82 and 1.49), death (HRs of 1.95 and 4.14), and atherosclerotic events (HRs of 2.54 and 1.90; each P diabetes. No consensus definition of CKD self-management; limited to baseline behavior data. There are potentially 3 CKD self-management behavior phenotypes that distinguish risk for clinical outcomes. These phenotypes may inform the development of studies and guidelines regarding optimal self-management. Copyright © 2018 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights

  3. Definition of Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage as an Outcome Event in Clinical Trials and Observational Studies Proposal of a Multidisciplinary Research Group

    NARCIS (Netherlands)

    Vergouwen, Mervyn D. I.; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J. E.; Wijdicks, Eelco F.; Muizelaar, J. Paul; Mendelow, A. David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G.; Macdonald, R. Loch; Diringer, Michael N.; Broderick, Joseph P.; Dreier, Jens P.; Roos, Yvo B. W. E. M.

    2010-01-01

    Background and Purpose-In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of

  4. “Silent” Diabetes and Clinical Outcome After Treatment With Contemporary Drug-Eluting Stents : The BIO-RESORT Silent Diabetes Study

    NARCIS (Netherlands)

    von Birgelen, Clemens; Kok, Marlies M.; Sattar, Naveed; Zocca, Paolo; Doelman, Cees; Kant, Gert D.; Löwik, Marije M.; van der Heijden, Liefke C.; Sen, Hanim; van Houwelingen, Gert K.; Stoel, Martin G.; Louwerenburg, J. (Hans) W.; Hartmann, Marc; de Man, Frits H.A.F.; Linssen, Gerard C.M.; Doggen, Carine J.M.; Tandjung, Kenneth

    2018-01-01

    Objectives: This study sought to assess the prevalence and clinical impact of silent diabetes and pre-diabetes in “nondiabetic” percutaneous coronary intervention (PCI) all-comers. Background: Patients with undetected and thus untreated (silent) diabetes may have higher event risks after PCI with

  5. Benchmarking Outpatient Rehabilitation Clinics Using Functional Status Outcomes.

    Science.gov (United States)

    Gozalo, Pedro L; Resnik, Linda J; Silver, Benjamin

    2016-04-01

    To utilize functional status (FS) outcomes to benchmark outpatient therapy clinics. Outpatient therapy data from clinics using Focus on Therapeutic Outcomes (FOTO) assessments. Retrospective analysis of 538 clinics, involving 2,040 therapists and 90,392 patients admitted July 2006-June 2008. FS at discharge was modeled using hierarchical regression methods with patients nested within therapists within clinics. Separate models were estimated for all patients, for those with lumbar, and for those with shoulder impairments. All models risk-adjusted for intake FS, age, gender, onset, surgery count, functional comorbidity index, fear-avoidance level, and payer type. Inverse probability weighting adjusted for censoring. Functional status was captured using computer adaptive testing at intake and at discharge. Clinic and therapist effects explained 11.6 percent of variation in FS. Clinics ranked in the lowest quartile had significantly different outcomes than those in the highest quartile (p < .01). Clinics ranked similarly in lumbar and shoulder impairments (correlation = 0.54), but some clinics ranked in the highest quintile for one condition and in the lowest for the other. Benchmarking models based on validated FS measures clearly separated high-quality from low-quality clinics, and they could be used to inform value-based-payment policies. © Health Research and Educational Trust.

  6. Prospective outcomes of injury study.

    Science.gov (United States)

    Derrett, S; Langley, J; Hokowhitu, B; Ameratunga, S; Hansen, P; Davie, G; Wyeth, E; Lilley, R

    2009-10-01

    In New Zealand (NZ), 20% of adults report a disability, of which one-third is caused by injury. No prospective epidemiological studies of predictors of disability following all-cause injury among New Zealanders have been undertaken. Internationally, studies have focused on a limited range of predictors or specific injuries. Although these studies provide useful insights, applicability to NZ is limited given the importance of NZ's unique macro-social factors, such as NZ's no-fault accident compensation and rehabilitation scheme, the Accident Compensation Corporation (ACC). (1) To quantitatively determine the injury, rehabilitation, personal, social and economic factors leading to disability outcomes following injury in NZ. (2) To qualitatively explore experiences and perceptions of injury-related outcomes in face-to-face interviews with 15 Māori and 15 other New Zealanders, 6 and 12 months after injury. Four geographical regions within NZ. Prospective cohort study with telephone interviews 1, 4 and 12 months after injury. 2500 people (including 460 Māori), aged 18-64 years, randomly selected from ACC's entitlement claims register (people likely to be off work for at least 1 week or equivalent). Telephone interviews, electronic hospital and ACC injury data. Exposures include demographic, social, economic, work-related, health status, participation and/or environmental factors. Primary: disability (including WHODAS II) and health-related quality of life (including EQ-5D). Secondary: participation (paid and unpaid activities), life satisfaction and costs. Separate regression models will be developed for each of the outcomes. Repeated measures outcomes will be modelled using general estimating equation models and generalised linear mixed models.

  7. Clinical Outcomes following median to radial nerve transfers

    Science.gov (United States)

    Ray, Wilson Z.; Mackinnon, Susan E.

    2010-01-01

    Purpose In this study the authors evaluate the clinical outcomes in patients with radial nerve palsy who underwent nerve transfers utilizing redundant fascicles of median nerve (innervating the flexor digitorum superficialis and flexor carpi radialis muscles) to the posterior interosseous nerve and the nerve to the extensor carpi radialis brevis. Methods A retrospective review of the clinical records of 19 patients with radial nerve injuries who underwent nerve transfer procedures using the median nerve as a donor nerve were included. All patients were evaluated using the Medical Research Council (MRC) grading system. Results The mean age of patients was 41 years (range 17 – 78 years). All patients received at least 12 months of follow-up (20.3 ± 5.8 months). Surgery was performed at a mean of 5.7 ± 1.9 months post-injury. Post-operative functional evaluation was graded according to the following scale: grades MRC 0/5 - MRC 2/5 were considered poor outcomes, while MRC of 3/5 was a fair result, MRC grade 4/5 was a good result, and grade 4+/5 was considered an excellent outcome. Seventeen patients (89%) had a complete radial nerve palsy while two patients (11%) had intact wrist extension but no finger or thumb extension. Post-operatively all patients except one had good to excellent recovery of wrist extension. Twelve patients recovered good to excellent finger and thumb extension, two patients had fair recovery, five patients had a poor recovery. Conclusions The radial nerve is a commonly injured nerve, causing significant morbidity in affected patients. The median nerve provides a reliable source of donor nerve fascicles for radial nerve reinnervation. This transfer was first performed in 1999 and evolved over the subsequent decade. The important nuances of both surgical technique and motor re-education critical for to the success of this transfer have been identified and are discussed. PMID:21168979

  8. Clinical outcomes of hydronephrosis in patients with systemic lupus erythematosus.

    Science.gov (United States)

    Hong, Seokchan; Kim, Yong-Gil; Ahn, Soo Min; Bae, Seung-Hyeon; Lim, Doo-Ho; Kim, Jeong Kon; Lee, Chang-Keun; Yoo, Bin

    2016-12-01

    Hydronephrosis is a rare complication of systemic lupus erythematosus (SLE). Bladder and/or gastrointestinal involvement in SLE are associated with development of hydronephrosis, but the management and treatment outcomes of hydronephrosis are largely unknown. Therefore, we investigated the clinical manifestations and factors associated with the treatment response in patients with SLE complicated by hydronephrosis. A retrospective analysis was performed of all 634 SLE patients who underwent computed tomography and/or ultrasonography between January 1998 and December 2013. We reviewed the clinical characteristics and treatment outcomes of patients with SLE-associated hydronephrosis. Hydronephrosis was identified in 15 patients with SLE complicated by cystitis and/or enteritis. All patients were treated initially with moderate to high doses of corticosteroids. A follow-up imaging study showed that 11 (73.3%) of 15 patients experienced improvements in hydronephrosis, and urinary obstruction was resolved without urological intervention in the majority of these patients (8/11, 72.7%). The four patients who experienced no improvement in hydronephrosis were older than those who responded to treatment (median age [interquartile range]; 43.0 [37.5-53.0] years vs. 28.0 [21.0-38.5] years; P = 0.026). In addition, delayed treatment (≥ 1 month after onset of symptoms) with corticosteroids was more frequently observed in the non-responding patients than in the responding patients (P = 0.011). Our findings suggest that treatment with corticosteroids alone leads to favorable outcomes in patients with SLE-associated hydronephrosis, except when treatment is delayed, particularly in elderly patients. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

  9. Patterns and clinical outcomes of lithium treatment

    NARCIS (Netherlands)

    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

  10. Clinical Outcome Scoring of Intra-articular Calcaneal Fractures

    NARCIS (Netherlands)

    T. Schepers (Tim); M.J. Heetveld (Martin); P.G.H. Mulder (Paul); P. Patka (Peter)

    2008-01-01

    textabstractOutcome reporting of intra-articular calcaneal fractures is inconsistent. This study aimed to identify the most cited outcome scores in the literature and to analyze their reliability and validity. A systematic literature search identified 34 different outcome scores. The most cited

  11. 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. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. Clinical characteristics of patients assessed within an Improving Access to Psychological Therapies (IAPT) service: results from a naturalistic cohort study (Predicting Outcome Following Psychological Therapy; PROMPT).

    Science.gov (United States)

    Hepgul, Nilay; King, Sinead; Amarasinghe, Myanthi; Breen, Gerome; Grant, Nina; Grey, Nick; Hotopf, Matthew; Moran, Paul; Pariante, Carmine M; Tylee, André; Wingrove, Janet; Young, Allan H; Cleare, Anthony J

    2016-02-27

    A substantial number of patients do not benefit from first line psychological therapies for the treatment of depression and anxiety. Currently, there are no clear predictors of treatment outcomes for these patients. The PROMPT project aims to establish an infrastructure platform for the identification of factors that predict outcomes following psychological treatment for depression and anxiety. Here we report on the first year of recruitment and describe the characteristics of our sample to date. One hundred and forty-seven patients awaiting treatment within an Improving Access to Psychological Therapies (IAPT) service were recruited between February 2014 and February 2015 (representing 48 % of those eligible). Baseline assessments were conducted to collect information on a variety of clinical, psychological and social variables including a diagnostic interview using the Mini International Neuropsychiatric Interview (MINI). Our initial findings showed that over a third of our sample were not presenting to IAPT services for the first time, and 63 % had been allocated to receive higher intensity IAPT treatments. Approximately half (46 %) were taking prescribed psychotropic medication (most frequently antidepressants). Co-morbidity was common: 72 % of the sample met criteria for 2 or more current MINI diagnoses. Our initial data also indicated that 16 % met criteria for borderline personality disorder and 69 % were at high risk of personality disorder. Sixty-one percent scored above the screening threshold for bipolarity. Over half of participants (55 %) reported experiencing at least one stressful life event in the previous 12 months, whilst 67 % reported experiencing at least one form of childhood trauma. Our results to date highlight the complex nature of patients seen within an urban IAPT service, with high rates of psychiatric comorbidity, personality disorder, bipolarity and childhood trauma. Whilst there are significant challenges associated with researching

  13. Quality of life, clinical outcomes and safety of early prophylactic levothyroxine administration in patients with Graves' hyperthyroidism undergoing radioiodine therapy: a randomized controlled study.

    Science.gov (United States)

    Taïeb, David; Bournaud, Claire; Eberle, Marie-Claude; Catargi, Bogdan; Schvartz, Claire; Cavarec, Marie-Béatrice; Faugeron, Isabelle; Toubert, Marie-Elisabeth; Benisvy, Danielle; Archange, Cendrine; Mundler, Olivier; Caron, Philippe; Abdullah, Ahmad Esmaeel; Baumstarck, Karine

    2016-04-01

    While radioiodine therapy is commonly used for treating Graves' disease, a prolonged and clinical hypothyroidism may result in disabling symptoms leading to deterioration of quality of life (QoL) of patients. Introducing levothyroxine (LT4) treatment in the early post-therapeutic period may be an interesting approach to limit this phenomenon. A multicenter, prospective, open-label randomized controlled trial enrolled 94 patients with Graves' hyperthyroidism randomly assigned to the experimental group (n=46) (group A: early prophylactic LT4 treatment) or the control group (n=48) (group B: standard follow-up). The primary endpoint was the 6-month QoL. The secondary endpoints were other QoL scores such as Graves' ophthalmopathy (GO) outcomes, thyroid function tests and safety. The primary endpoint at 6 months was achieved: the mental composite score (MCS) of Short Form 36 (SF-36) was significantly higher in group A compared to group B (P=0.009). Four other dimension scores of the SF-36 and four dimension scores of the thyroid-specific patient-reported outcome (ThyPRO) significantly differed between the two groups, indicating better QoL in group A. After adjustment for variables, the early LT4 administration strategy was found as an independent factor for only two scores of SF-36: the MCS and the general health (GH) score. There were no differences in GO, final thyroid status and changes in the anti-TSH receptor antibodies (TRAbs) levels between the two groups. No adverse cardiovascular event was reported. Early LT4 administration post-radioactive iodine (RAI) could represent a safe potential benefit for patients with regard to QoL. The optimal strategy taking into account administered RAI activities and LT4 treatment dosage and timing remains to be determined. © 2016 European Society of Endocrinology.

  14. Impact of vacuum-assisted closure (VAC) therapy on clinical outcomes of patients with sternal wound infections: a meta-analysis of non-randomized studies.

    Science.gov (United States)

    Falagas, Matthew E; Tansarli, Giannoula S; Kapaskelis, Anastasios; Vardakas, Konstantinos Z

    2013-01-01

    To examine the impact of VAC therapy on mortality of patients with sternal wound infections after cardiothoracic surgery. Controversial results regarding mortality of patients with sternal wound infections were published. We performed a systematic search in PubMed and Scopus. Mortality was the primary outcome of the meta-analysis. Recurrences, complications and length of stay were secondary outcomes. Twenty-two retrospective studies including 2467 patients were eligible for inclusion. Patients treated with VAC had significantly lower mortality compared to those treated without VAC [2233 patients, RR = 0.40, (95% CI 0.28, 0.57)]. This finding was consistent regardless of the study design, the exclusion of studies with positive findings, the criteria for establishment of the compared groups, the time of mortality assessment or the type of infections under study, provided that adequate data was available. VAC therapy was associated with fewer recurrences (RR = 0.34, 95% CI: 0.19-0.59). The meta-analysis did not show any difference in the length of stay (RR = -2.25, 95% CI: -7.52-3.02). VAC therapy was associated with lower mortality than other surgical techniques in retrospective cohorts of patients with DSWIs following cardiothoracic surgery.

  15. Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes

    Directory of Open Access Journals (Sweden)

    Gibson EJ

    2018-03-01

    Full Text Available EJ Gibson,1 N Begum,1 I Koblbauer,1 G Dranitsaris,2 D Liew,3 P McEwan,4 AA Tahami Monfared,5,6 Y Yuan,7 A Juarez-Garcia,7 D Tyas,8 M Lees9 1Wickenstones Ltd, Didcot, UK; 2Augmentium Pharma Consulting Inc, Toronto, ON, Canada; 3Department of Epidemiology and Preventive Medicine, Alfred Hospital, Monash University, Melbourne, VIC, Australia; 4Health Economics and Outcomes Research Ltd, Cardiff, UK; 5Bristol-Myers Squibb Canada, Saint-Laurent, QC Canada; 6Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada; 7Bristol-Myers Squibb, Princeton, NJ, USA; 8Bristol-Myers Squibb, Uxbridge, UK; 9Bristol-Myers Squibb, Rueil-Malmaison, France Background: Economic models in oncology are commonly based on the three-state partitioned survival model (PSM distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. Materials and methods: This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs. Results: The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%. Conclusion: Increased sophistication in the representation of disease dynamics in economic models

  16. Clinical Infectious Outcomes Associated with Biofilm-related Infections: a Retrospective Chart Review

    Science.gov (United States)

    2015-06-07

    infectious outcomes. Methods: 221 clinical isolates collected from 2005 to 2012 and previously characterized for biofilm formation were studied. Clinical...chronic infection on multivariate analysis. Conclusions: Bacteria species, but not clinical characteristics, were associated with biofilm formation on...the implication of biofilms in a majority of human infections [2]. Biofilm formation also has been linked with poor wound healing [3], burn wound

  17. Elevated Potassium Levels in Patients With Congestive Heart Failure: Occurrence, Risk Factors, and Clinical Outcomes: A Danish Population-Based Cohort Study.

    Science.gov (United States)

    Thomsen, Reimar Wernich; Nicolaisen, Sia Kromann; Hasvold, Pål; Garcia-Sanchez, Ricardo; Pedersen, Lars; Adelborg, Kasper; Egfjord, Martin; Egstrup, Kenneth; Sørensen, Henrik Toft

    2018-05-22

    Data on the true burden of hyperkalemia in patients with heart failure (HF) in a real-world setting are limited. Incidence rates of hyperkalemia (first blood test with a potassium level >5.0 mmol/L) in primary or hospital care were assessed in a population-based cohort of patients with incident HF diagnoses in northern Denmark from 2000 to 2012. Risk factors and clinical outcomes were compared in patients with HF with versus without hyperkalemia. Of 31 649 patients with HF, 39% experienced hyperkalemia (mean follow-up, 2.2 years). Risks of experiencing a second, third, or fourth event were 43%, 54%, and 60%, respectively. Among patients with HF with stage 3A, 3B, 4, or 5 kidney dysfunction, 26%, 35%, 44%, and 48% experienced hyperkalemia within the first year. Important hyperkalemia risk factors included chronic kidney disease (prevalence ratio, 1.46; 95% confidence interval [CI], 1.43-1.49), diabetes mellitus (prevalence ratio, 1.38; 95% CI, 1.32-1.45), and spironolactone use (prevalence ratio, 1.48; 95% CI, 1.42-1.54). In patients with HF who developed hyperkalemia, 53% had any acute-care hospitalization 6 months before the hyperkalemia event, increasing to 74% 6 months after hyperkalemia (before-after risk ratio, 1.41; 95% CI, 1.38-1.44). Compared with matched patients with HF without hyperkalemia, adjusted 6-month hazard ratios in patients with hyperkalemia were 2.75-fold (95% CI, 2.65-2.85) higher for acute-care hospitalization and 3.39-fold (95% CI, 3.19-3.61) higher for death. Almost 4 in 10 patients with HF develop hyperkalemia, and many patients have recurrent hyperkalemia episodes. Hyperkalemia risk is strongly associated with degree of reduced kidney function and use of spironolactone. Hyperkalemia is associated with severe clinical outcomes and death in HF. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  18. 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.

  19. Enteric duplication in children: clinical presentation and outcome.

    Science.gov (United States)

    Rasool, Naima; Safdar, Chaudhry Aqeel; Ahmad, Asrar; Kanwal, Shehla

    2013-06-01

    Enteric duplication (ED) is an anomaly with varied presentations and possible involvement of the alimentary tract. Once diagnosed, resection of the lesion and the involved part of the gut is usually required. The aim of this study was to evaluate the clinical presentations, diagnostic investigations, management and outcomes of patients with ED. This was a descriptive case study conducted at the Department of Paediatric Surgery, Military Hospital, Rawalpindi, Pakistan, from January 2005 to January 2011. The medical records of all patients diagnosed with ED were retrospectively analysed with respect to age, presentation, investigations, site and type of lesion, surgical procedures, histological findings and complications. A total of nine patients were managed during the study period. The patients' ages ranged from three months to five years. Four out of nine EDs were rectal duplications. Three EDs were of the cystic type, five were of the tubular type and one was a complex mixed anomaly. Patients presented with varied symptoms, with the two most common being the presence of an abdominal mass and bleeding per rectum. Diagnosis was mainly achieved based on magnetic resonance imaging and computed tomography, although Meckel's scan provided accurate diagnosis in three of the nine patients. All the cysts were resected without any major complications, and patients were event-free during the five-year follow-up. EDs should be kept in mind when examining patients with an abdominal mass and bleeding per rectum. Meckel's scan can provide accurate diagnosis of EDs with bleeding. Prompt diagnosis and management results in satisfactory outcomes.

  20. Does quality improvement work in neonatology improve clinical outcomes?

    Science.gov (United States)

    Ellsbury, Dan L; Clark, Reese H

    2017-04-01

    Quality improvement initiatives in neonatology have been promoted as an important way of improving outcomes of newborns. The purpose of this review is to examine the effectiveness of recent quality improvement work in improving the outcomes of infants requiring neonatal intensive care. Quality improvement collaboratives and single-center projects demonstrate improvement of clinical processes and outcomes in neonatology that impact both preterm and term infants. Declines in morbidities, resource use, and length of stay have been associated with reductions in healthcare costs. Recent quality improvement work has shown evidence of improvement in clinical outcomes in neonatal intensive care patients. These improvements have important implications for the reduction of healthcare costs in this population.

  1. Religion, Spirituality, and HIV Clinical Outcomes: A Systematic Review of the Literature.

    Science.gov (United States)

    Doolittle, B R; Justice, A C; Fiellin, D A

    2018-06-01

    This systematic review evaluates the association between religion, spirituality and clinical outcomes in HIV-infected individuals. A systematic literature review was conducted for all English language articles published between 1980 and 2016 in relevant databases. Six hundred fourteen studies were evaluated. 15 met inclusion criteria. Ten (67%) studies reported a positive association between religion or spirituality and a clinical HIV outcome. Two (13%) studies failed to detect such an association; and two (13%) demonstrated a negative association. One study (7%) identified features of religiosity and spirituality that had both negative and positive associations with HIV clinical outcomes. Recognizing the religious or spiritual commitments of patients may serve as an important component of patient care. Further longitudinal studies and interventions might be required to further clarify the potential impact of religion and spirituality on HIV clinical outcomes.

  2. Clinical outcomes and survival surrogacy studies of prostate-specific antigen declines following enzalutamide in men with metastatic castration-resistant prostate cancer previously treated with docetaxel.

    Science.gov (United States)

    Armstrong, Andrew J; Saad, Fred; Phung, De; Dmuchowski, Carl; Shore, Neal D; Fizazi, Karim; Hirmand, Mohammad; Forer, David; Scher, Howard I; Bono, Johann De

    2017-06-15

    In the AFFIRM trial, enzalutamide significantly increased overall survival (OS) for men with metastatic castration-resistant prostate cancer (mCRPC) after chemotherapy versus placebo and significantly decreased prostate-specific antigen (PSA) levels. The goal of this post hoc analysis was to associate levels of PSA decline from baseline after enzalutamide with clinical outcomes in the postchemotherapy mCRPC setting. Men in the AFFIRM trial (n = 1199) were grouped by maximal PSA decline in the first 90 days of treatment. Kaplan-Meier estimates evaluated the association of defined PSA changes from baseline with OS, progression-free survival (PFS), radiographic PFS (rPFS), and pain response. Each PSA decline category was assessed for OS surrogacy using Prentice criteria, proportion of treatment effect explained (PTE), and proportion of variation explained. Men treated with enzalutamide had improved OS (hazard ratio, 0.63; P 19.0; P .20). PSA declines of any, ≥30%, and ≥50% following enzalutamide were associated with greater clinical and pain response and improvements in PFS and OS. Surrogacy of PSA decline for OS was not fully established, possibly due to lack of PSA declines with placebo, and discordant results between PSA and imaging responses over time, and because some declines were not durable due to rapid resistance development. However, a lack of PSA decline by 90 days following enzalutamide treatment was a poor prognosis indicator in this setting. Conclusions from sensitivity analyses of maximal PSA decline from baseline over the entire treatment period are consistent with PSA declines restricted to the first 90 days. Cancer 2017;123:2303-2311. © 2017 American Cancer Society. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

  3. Clinical outcomes and survival surrogacy studies of prostate‐specific antigen declines following enzalutamide in men with metastatic castration‐resistant prostate cancer previously treated with docetaxel

    Science.gov (United States)

    Saad, Fred; Phung, De; Dmuchowski, Carl; Shore, Neal D.; Fizazi, Karim; Hirmand, Mohammad; Forer, David; Scher, Howard I.; Bono, Johann De

    2017-01-01

    BACKGROUND In the AFFIRM trial, enzalutamide significantly increased overall survival (OS) for men with metastatic castration‐resistant prostate cancer (mCRPC) after chemotherapy versus placebo and significantly decreased prostate‐specific antigen (PSA) levels. The goal of this post hoc analysis was to associate levels of PSA decline from baseline after enzalutamide with clinical outcomes in the postchemotherapy mCRPC setting. METHODS Men in the AFFIRM trial (n = 1199) were grouped by maximal PSA decline in the first 90 days of treatment. Kaplan‐Meier estimates evaluated the association of defined PSA changes from baseline with OS, progression‐free survival (PFS), radiographic PFS (rPFS), and pain response. Each PSA decline category was assessed for OS surrogacy using Prentice criteria, proportion of treatment effect explained (PTE), and proportion of variation explained. RESULTS Men treated with enzalutamide had improved OS (hazard ratio, 0.63; P 19.0; P .20). CONCLUSIONS PSA declines of any, ≥30%, and ≥50% following enzalutamide were associated with greater clinical and pain response and improvements in PFS and OS. Surrogacy of PSA decline for OS was not fully established, possibly due to lack of PSA declines with placebo, and discordant results between PSA and imaging responses over time, and because some declines were not durable due to rapid resistance development. However, a lack of PSA decline by 90 days following enzalutamide treatment was a poor prognosis indicator in this setting. Conclusions from sensitivity analyses of maximal PSA decline from baseline over the entire treatment period are consistent with PSA declines restricted to the first 90 days. Cancer 2017;123:2303–2311. © 2017 American Cancer Society. PMID:28171710

  4. Acquire uterine vascular malformation: Clinical outcome of transarterial embolization

    International Nuclear Information System (INIS)

    Kang, Chae Hoon; Yang, Seung Boo; Goo, Dong Erk; Kim, Yong Jae; Lee, Jae Myung; Lee, Woong Hee

    2017-01-01

    To evaluate clinical outcomes of transarterial embolization of bilateral uterine arteries (UAE) in patients with acquired uterine vascular malformation (UVM). This retrospective study was performed on the medical records of all 19 patients who underwent transarterial embolization of bilateral UAE for the treatment of symptomatic UVMs from January 2003 to June 2011. Embolization was performed via the unilateral femoral artery approach with a catheter and angiographic techniques. Clinical success was defined as definitive resolution of abnormal vaginal bleeding. Post-procedural complications included all adverse events related to the embolization procedure. A total of 20 procedures were performed in 19 patients. One patient required repeat embolization because of incomplete embolization related to prominent high flow malformation. Clinically, in all patients, bleeding was controlled immediately after embolization. No complications occurred in all patients during the follow up period. In all patients who underwent successful UAE, menstrual cycles were normally restored within 1-2 months. Normal pregnancy with term delivery was observed in two of the 19 cases. Transarterial bilateral UAE is a safe and effective treatment in patients with vaginal bleeding caused by acquired UVM, and it allows the possibility of future pregnancy

  5. Acquire uterine vascular malformation: Clinical outcome of transarterial embolization

    Energy Technology Data Exchange (ETDEWEB)

    Kang, Chae Hoon [Dept. of Radiology, Gangneung Asan Hospital, Gangneung (Korea, Republic of); Yang, Seung Boo; Goo, Dong Erk; Kim, Yong Jae; Lee, Jae Myung; Lee, Woong Hee [Dept. of Radiology, Soonchunhyang University Gumi Hospital, Gumi (Korea, Republic of)

    2017-02-15

    To evaluate clinical outcomes of transarterial embolization of bilateral uterine arteries (UAE) in patients with acquired uterine vascular malformation (UVM). This retrospective study was performed on the medical records of all 19 patients who underwent transarterial embolization of bilateral UAE for the treatment of symptomatic UVMs from January 2003 to June 2011. Embolization was performed via the unilateral femoral artery approach with a catheter and angiographic techniques. Clinical success was defined as definitive resolution of abnormal vaginal bleeding. Post-procedural complications included all adverse events related to the embolization procedure. A total of 20 procedures were performed in 19 patients. One patient required repeat embolization because of incomplete embolization related to prominent high flow malformation. Clinically, in all patients, bleeding was controlled immediately after embolization. No complications occurred in all patients during the follow up period. In all patients who underwent successful UAE, menstrual cycles were normally restored within 1-2 months. Normal pregnancy with term delivery was observed in two of the 19 cases. Transarterial bilateral UAE is a safe and effective treatment in patients with vaginal bleeding caused by acquired UVM, and it allows the possibility of future pregnancy.

  6. Mushroom poisoning in children: clinical presentation and outcome

    International Nuclear Information System (INIS)

    Jan, M.A.; Khan, Z.; Siddiqui, T.S.

    2008-01-01

    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)

  7. 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.

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

    Directory of Open Access Journals (Sweden)

    K. Wölfling

    2014-01-01

    Full Text Available 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.

  9. Clinical outcome in MPFL reconstruction with and without tuberositas transposition.

    Science.gov (United States)

    Mulliez, A; Lambrecht, D; Verbruggen, D; Van Der Straeten, C; Verdonk, P; Victor, J

    2017-09-01

    There are several surgical options for recurrent patella dislocations. As the reconstruction of the medial patellofemoral ligament (MPFL) has been proven to restore stability, it has become more accepted. Aim of this study was to investigate the clinical outcome after MPFL reconstruction as an isolated procedure or in association with a transposition of the tibial tubercle (in case of patella alta or an excessive TT-TG) in a large prospective cohort study. Additionally, the effect on patellar height was analysed radiographically using the Caton-Deschamps index. In a large prospective cohort study of 129 knees in 124 patients (81 females, 48 males, mean age 22.8 ± 7.7 years), 91 knees received primary MPFL reconstruction (group 1) and 38 were a combination with a transposition of the tibial tubercle (group 2). The clinical follow-up was evaluated using KOOS and Kujala scores preoperatively and 1 year postoperatively. Patient satisfaction, complications and revision surgery were recorded. Overall, Kujala improved significantly from 53.5 (SD 22.7) preoperatively to 74.7 (SD 20.5) postoperatively (p < 0.01). All KOOS subdomains improved significantly (p < 0.01). No significant difference for Kujala score between groups was noticed. Revision rate was (5/129) 3.9 %. Reconstruction was supplemented with a transfer of the tibial tuberosity in (38/129) 29.4 % of the cases and shows a comparable outcome. MPFL reconstruction is a viable treatment option for episodic patellar dislocation. A concomitant tuberositas transposition is useful in selected patients. I.

  10. Outcomes Analysis of Chief Cosmetic Clinic Over 13 Years.

    Science.gov (United States)

    Walker, Nicholas J; Crantford, John C; Rudolph, Megan A; David, Lisa R

    2018-06-01

    Adequate resident training in aesthetic surgery has become increasingly important with rising demand. Chief resident aesthetic clinics allow hands on experience with an appropriate amount of autonomy. The purpose of this study was to compare resident cosmetic clinic outcomes to those reported in the literature. Furthermore, we sought to assess how effective these clinics can be in preparing residents in performing common aesthetic surgery procedures. A retrospective chart review of 326 patients and 714 aesthetic procedures in our chief cosmetic clinic over a 13-year period was performed, and complication and revision rates were recorded. In addition, an electronic survey was sent to 26 prior chief residents regarding their experience and impressions of the chief resident aesthetic clinic. A total of 713 procedures were performed on 326 patients. Patient ages ranged from 5 to 75 years old (mean, 40.8 years old) with a mean follow-up of 76.2 days. On average, there were 56 procedures performed per year. Of the 714 total procedures performed, there were 136 minor procedures and 578 major procedures. Of the 136 minor procedures, there were no complications and there was 1 revision of a cosmetic injection. Of the 578 major procedures, the overall complication rate was 6.1% and the revision rate was 12.8%. Complication and revision rates for each individual surgery were further analyzed and compared with the literature. The complication rates for these procedures fell within the reference ranges reported. In regards to the chief resident survey, there was a 77% response rate. All respondents reported that the chief resident clinic positively affected their residency education and future practice. Ninety percent of respondents felt "very comfortable" performing facelifts, body contouring, and aesthetic breast surgery. No respondents completed a subsequent cosmetic fellowship, and 60% stated that their positive experience in chief clinic contributed to their decision not

  11. Cardiovascular Magnetic Resonance Imaging—Incremental Value in a Series of 361 Patients Demonstrating Cost Savings and Clinical Benefits: An Outcome-Based Study

    Science.gov (United States)

    Hegde, Vinayak A; Biederman, Robert WW; Mikolich, J Ronald

    2017-01-01

    BACKGROUND This study was designed to assess the clinical impact and cost-benefit of cardiovascular magnetic resonance imaging (CMR). In the face of current health care cost concerns, cardiac imaging modalities have come under focused review. Data related to CMR clinical impact and cost-benefit are lacking. METHODS AND RESULTS Retrospective review of 361 consecutive patients (pts) who underwent CMR exams was conducted. Indications for CMR were tabulated for appropriateness criteria. Components of the CMR exam were identified along with evidence of clinical impact. The cost of each CMR exam was ascertained along with cost savings attributable to the CMR exam for calculation of an incremental cost-effectiveness ratio. A total of 354 of 361 pts (98%) had diagnostic quality studies. Of the 361 pts, 350 (97%) had at least 1 published Appropriateness Criterion for CMR. A significant clinical impact attributable to CMR exam results was observed in 256 of 361 pts (71%). The CMR exam resulted in a new diagnosis in 69 of 361 (27%) pts. Cardiovascular magnetic resonance imaging results avoided invasive procedures in 38 (11%) pts and prevented additional diagnostic testing in 26 (7%) pts. Comparison of health care savings using CMR as opposed to current standards of care showed a net cost savings of $833 037, ie, per patient cost savings of $2308. CONCLUSIONS Cardiovascular magnetic resonance imaging provides diagnostic image quality in >98% of cases. Cardiovascular magnetic resonance imaging findings have documentable clinical impact on patient management in 71% of pts undergoing the exam, in a cost beneficial manner. PMID:28579858

  12. Cardiovascular Magnetic Resonance Imaging—Incremental Value in a Series of 361 Patients Demonstrating Cost Savings and Clinical Benefits: An Outcome-Based Study

    Directory of Open Access Journals (Sweden)

    Vinayak A Hegde

    2017-05-01

    Full Text Available Background: This study was designed to assess the clinical impact and cost-benefit of cardiovascular magnetic resonance imaging (CMR. In the face of current health care cost concerns, cardiac imaging modalities have come under focused review. Data related to CMR clinical impact and cost-benefit are lacking. Methods and Results: Retrospective review of 361 consecutive patients (pts who underwent CMR exams was conducted. Indications for CMR were tabulated for appropriateness criteria. Components of the CMR exam were identified along with evidence of clinical impact. The cost of each CMR exam was ascertained along with cost savings attributable to the CMR exam for calculation of an incremental cost-effectiveness ratio. A total of 354 of 361 pts (98% had diagnostic quality studies. Of the 361 pts, 350 (97% had at least 1 published Appropriateness Criterion for CMR. A significant clinical impact attributable to CMR exam results was observed in 256 of 361 pts (71%. The CMR exam resulted in a new diagnosis in 69 of 361 (27% pts. Cardiovascular magnetic resonance imaging results avoided invasive procedures in 38 (11% pts and prevented additional diagnostic testing in 26 (7% pts. Comparison of health care savings using CMR as opposed to current standards of care showed a net cost savings of $833 037, ie, per patient cost savings of $2308. Conclusions: Cardiovascular magnetic resonance imaging provides diagnostic image quality in >98% of cases. Cardiovascular magnetic resonance imaging findings have documentable clinical impact on patient management in 71% of pts undergoing the exam, in a cost beneficial manner.

  13. Clinical and Radiologic Outcomes of Submerged and Nonsubmerged Bone-Level Implants with Internal Hexagonal Connections in Immediate Implantation: A 5-Year Retrospective Study.

    Science.gov (United States)

    Wu, Shiyu; Wu, Xiayi; Shrestha, Rachana; Lin, Jinying; Feng, Zhicai; Liu, Yudong; Shi, Yunlin; Huang, Baoxin; Li, Zhipeng; Liu, Quan; Zhang, Xiaocong; Hu, Mingxuan; Chen, Zhuofan

    2018-02-01

    To evaluate the 5-year clinical and radiologic outcome of immediate implantation using submerged and nonsubmerged techniques with bone-level implants and internal hexagonal connections and the effects of potential influencing factors. A total of 114 bone-level implants (XiVE S plus) with internal hexagonal connections inserted into 72 patients were included. Patients were followed up for 5 years. A t-test was used to statistically evaluate the marginal bone loss between the submerged and nonsubmerged groups. The cumulative survival rate (CSR) was calculated according to the life table method and illustrated with Kaplan-Meier survival curves. Comparisons of the CSR between healing protocols, guided bone regeneration, implants with different sites, lengths, and diameters were performed using log-rank tests. The 5-year cumulative implant survival rates with submerged and nonsubmerged healing were 94% and 96%, respectively. No statistically significant differences in terms of marginal bone loss, healing protocol, application of guided bone regeneration, implant site, or length were observed. High CSRs and good marginal bone levels were achieved 5 years after immediate implantation of bone-level implants with internal hexagonal connections using both the submerged and nonsubmerged techniques. Factors such as implant length, site, and application of guided bone regeneration did not have an impact on the long-term success of the implants. © 2017 by the American College of Prosthodontists.

  14. Evaluating Maternity Units: a prospective cohort study of freestanding midwife-led primary maternity units in New Zealand—clinical outcomes

    Science.gov (United States)

    Grigg, Celia P; Tracy, Sally K; Tracy, Mark; Daellenbach, Rea; Kensington, Mary; Monk, Amy; Schmied, Virginia

    2017-01-01

    Objective To compare maternal and neonatal birth outcomes and morbidities associated with the intention to give birth in a freestanding primary level midwife-led maternity unit (PMU) or tertiary level obstetric-led maternity hospital (TMH) in Canterbury, Aotearoa/New Zealand. Design Prospective cohort study. Participants 407 women who intended to give birth in a PMU and 285 women who intended to give birth at the TMH in 2010–2011. All of the women planning a TMH birth were ‘low risk’, and 29 of the PMU cohort had identified risk factors. Primary outcomes Mode of birth, Apgar score of less than 7 at 5 min and neonatal unit admission. Secondary outcomes: labour onset, analgesia, blood loss, third stage of labour management, perineal trauma, non-pharmacological pain relief, neonatal resuscitation, breastfeeding, gestational age at birth, birth weight, severe morbidity and mortality. Results Women who planned a PMU birth were significantly more likely to have a spontaneous vaginal birth (77.9%vs62.3%, adjusted OR (AOR) 1.61, 95% CI 1.08 to 2.39), and significantly less likely to have an instrumental assisted vaginal birth (10.3%vs20.4%, AOR 0.59, 95% CI 0.37 to 0.93). The emergency and elective caesarean section rates were not significantly different (emergency: PMU 11.6% vs TMH 17.5%, AOR 0.88, 95% CI 0.55 to 1.40; elective: PMU 0.7% vs TMH 2.1%, AOR 0.34, 95% CI 0.08 to 1.41). There were no significant differences between the cohorts in rates of 5 min Apgar score of <7 (2.0%vs2.1%, AOR 0.82, 95% CI 0.27 to 2.52) and neonatal unit admission (5.9%vs4.9%, AOR 1.44, 95% CI 0.70 to 2.96). Planning to give birth in a primary unit was associated with similar or reduced odds of intrapartum interventions and similar odds of all measured neonatal well-being indicators. Conclusions The results of this study support freestanding midwife-led primary-level maternity units as physically safe places for well women to plan to give birth, with these women having

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

    Directory of Open Access Journals (Sweden)

    S. Nicole Culos-Reed

    2012-01-01

    Full Text Available Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related qu