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Sample records for prospective clinical outcome

  1. Markers of neuroinflammation and neuronal injury in bipolar disorder: Relation to prospective clinical outcomes.

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    Isgren, Anniella; Sellgren, Carl; Ekman, Carl-Johan; Holmén-Larsson, Jessica; Blennow, Kaj; Zetterberg, Henrik; Jakobsson, Joel; Landén, Mikael

    2017-10-01

    Neuroimmune mechanisms have been linked to the pathophysiology of bipolar disorder based on studies of biomarkers in plasma, cerebrospinal fluid (CSF), and postmortem brain tissue. There are, however, no longitudinal studies investigating if CSF markers of neuroinflammation and neuronal injury predict clinical outcomes in patients with bipolar disorder. We have in previous studies found higher CSF concentrations of interleukin-8 (IL-8), monocyte chemoattractant protein 1 (MCP-1/CCL-2), chitinase-3-like protein 1 (CHI3L1/YKL-40), and neurofilament light chain (NF-L) in euthymic patients with bipolar disorder compared with controls. Here, we investigated the relationship of these CSF markers of neuroinflammation and neuronal injury with clinical outcomes in a prospective study. 77 patients with CSF analyzed at baseline were followed for 6-7years. Associations of baseline biomarkers with clinical outcomes (manic/hypomanic and depressive episodes, suicide attempts, psychotic symptoms, inpatient care, GAF score change) were investigated. Baseline MCP-1 concentrations were positively associated with manic/hypomanic episodes and inpatient care during follow-up. YKL-40 concentrations were negatively associated with manic/hypomanic episodes and with occurrence of psychotic symptoms. The prospective negative association between YKL-40 and manic/hypomanic episodes survived multiple testing correction. Concentrations of IL-8 and NF-L were not associated with clinical outcomes. High concentrations of these selected CSF markers of neuroinflammation and neuronal injury at baseline were not consistently associated with poor clinical outcomes in this prospective study. The assessed proteins may be involved in adaptive immune processes or reflect a state of vulnerability for bipolar disorder rather than being of predictive value for disease progression. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. 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.

  3. 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.

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

    Directory of Open Access Journals (Sweden)

    Nadya M Belenky

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

  5. Impact of positive and negative lesion site remodeling on clinical outcomes: insights from PROSPECT.

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    Inaba, Shinji; Mintz, Gary S; Farhat, Naim Z; Fajadet, Jean; Dudek, Dariusz; Marzocchi, Antonio; Templin, Barry; Weisz, Giora; Xu, Ke; de Bruyne, Bernard; Serruys, Patrick W; Stone, Gregg W; Maehara, Akiko

    2014-01-01

    This study investigated coronary artery remodeling patterns associated with clinical outcomes. In the prospective, multicenter PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree: An Imaging Study in Patients With Unstable Atherosclerotic Lesions) study, reported predictors of nonculprit lesion (NCL) major adverse cardiac events (MACE) were an intravascular ultrasound (IVUS) minimal lumen area (MLA) ≤4 mm(2), a plaque burden ≥70%, and a IVUS-virtual histology (VH) thin-cap fibroatheroma (TCFA), but not lesion site remodeling. Overall, 697 consecutive patients with an acute coronary syndrome were enrolled and underwent 3-vessel gray-scale and IVUS-VH; 3,223 NCLs were identified by IVUS. The remodeling index (RI) was calculated as the external elastic membrane area at the MLA site divided by the average of the proximal and distal reference external elastic membrane areas. First, one third of the patients were randomly selected to determine RI cutoffs related to NCL MACE (development cohort). Receiver-operating characteristic analysis showed that there were 2 separate cut points that predicted NCL MACE: RI = 0.8789 and RI = 1.0046 (area under the curve = 0.663). These cut points were used to define negative remodeling as an RI 1.00. Second, we used the remaining two-thirds of patients to validate these cut points with respect to lesion morphology and clinical outcomes (validation cohort). Kaplan-Meier curve analysis in the validation cohort showed that NCL MACE occurred more frequent (and equally) in negative and positive remodeling lesions compared with intermediate remodeling lesions. In this cohort, negative remodeling lesions had the smallest MLA, positive remodeling lesions had the largest plaque burden, and VH TCFA, especially VH TCFA with multiple necrotic cores, was most common in negatively remodeling lesions. The present study showed the novel concept that positive and negative lesion site remodeling was

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

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    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

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

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    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.

  8. 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.

  9. 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

  10. 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.

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

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    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

  12. 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

  13. PROSPECT Eligibility and Clinical Outcomes: Results From the Pan-Canadian Rectal Cancer Consortium.

    Science.gov (United States)

    Bossé, Dominick; Mercer, Jamison; Raissouni, Soundouss; Dennis, Kristopher; Goodwin, Rachel; Jiang, Di; Powell, Erin; Kumar, Aalok; Lee-Ying, Richard; Price-Hiller, Julie; Heng, Daniel Y C; Tang, Patricia A; MacLean, Anthony; Cheung, Winson Y; Vickers, Michael M

    2016-09-01

    The PROSPECT trial (N1048) is evaluating the selective use of chemoradiation in patients with cT2N1 and cT3N0-1 rectal cancer undergoing sphincter-sparing low anterior resection. We evaluated outcomes of PROSPECT-eligible and -ineligible patients from a multi-institutional database. Data from patients with locally advanced rectal cancer who received chemoradiation and low anterior resection from 2005 to 2014 were retrospectively collected from 5 Canadian centers. Overall survival, disease-free survival (DFS), recurrence-free survival (RFS), and time to local recurrence (LR) were estimated using the Kaplan-Meier method, and a multivariate analysis was performed adjusting for prognostic factors. A total of 566 (37%) of 1531 patients met the PROSPECT eligibility criteria. Eligible patients were more likely to have better PS (P = .0003) and negative circumferential resection margin (P PROSPECT eligibility was associated with improved DFS (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.61-0.91), overall survival (HR, 0.73; 95% CI, 0.57-0.95), and RFS (HR, 0.68; 95% CI, 0.54-0.86) in univariate analyses. In multivariate analysis, only RFS remained significantly improved for PROSPECT-eligible patients (HR, 0.75; 95% CI, 0.57-1.00, P = .0499). The 3-year DFS and freedom from LR for PROSPECT-eligible patients were 79.1% and 97.4%, respectively, compared to 71.1% and 96.8% for PROSPECT-ineligible patients. Real-world data corroborate the eligibility criteria used in the PROSPECT study; the criteria identify a subgroup of patients in whom risk of recurrence is lower and in whom selective use of chemoradiation should be actively examined. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. 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

  15. 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

  16. 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 ...

  17. Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

    Science.gov (United States)

    Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

    2018-01-01

    Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0

  18. 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.

  19. 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.

  20. 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

  1. 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.

  2. 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...

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

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    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.

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

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    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.

  5. 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.

  6. Proton Therapy for Breast Cancer After Mastectomy: Early Outcomes of a Prospective Clinical Trial

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    MacDonald, Shannon M., E-mail: smacdonald@partners.org [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States); Patel, Sagar A.; Hickey, Shea [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States); Specht, Michelle [Department of Surgical Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States); Isakoff, Steven J. [Division of Hematology and Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States); Gadd, Michele; Smith, Barbara L. [Department of Surgical Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States); Yeap, Beow Y. [Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States); Adams, Judith; DeLaney, Thomas F.; Kooy, Hanne; Lu, Hsiao-Ming; Taghian, Alphonse G. [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts (United States)

    2013-07-01

    Purpose: Dosimetric planning studies have described potential benefits for the use of proton radiation therapy (RT) for locally advanced breast cancer. We report acute toxicities and feasibility of proton delivery for 12 women treated with postmastectomy proton radiation with or without reconstruction. Methods and Materials: Twelve patients were enrolled in an institutional review board-approved prospective clinical trial. The patients were assessed for skin toxicity, fatigue, and radiation pneumonitis during treatment and at 4 and 8 weeks after the completion of therapy. All patients consented to have photographs taken for documentation of skin toxicity. Results: Eleven of 12 patients had left-sided breast cancer. One patient was treated for right-sided breast cancer with bilateral implants. Five women had permanent implants at the time of RT, and 7 did not have immediate reconstruction. All patients completed proton RT to a dose of 50.4 Gy (relative biological effectiveness [RBE]) to the chest wall and 45 to 50.4 Gy (RBE) to the regional lymphatics. No photon or electron component was used. The maximum skin toxicity during radiation was grade 2, according to the Common Terminology Criteria for Adverse Events (CTCAE). The maximum CTCAE fatigue was grade 3. There have been no cases of RT pneumonitis to date. Conclusions: Proton RT for postmastectomy RT is feasible and well tolerated. This treatment may be warranted for selected patients with unfavorable cardiac anatomy, immediate reconstruction, or both that otherwise limits optimal RT delivery using standard methods.

  7. Proton Therapy for Breast Cancer After Mastectomy: Early Outcomes of a Prospective Clinical Trial

    International Nuclear Information System (INIS)

    MacDonald, Shannon M.; Patel, Sagar A.; Hickey, Shea; Specht, Michelle; Isakoff, Steven J.; Gadd, Michele; Smith, Barbara L.; Yeap, Beow Y.; Adams, Judith; DeLaney, Thomas F.; Kooy, Hanne; Lu, Hsiao-Ming; Taghian, Alphonse G.

    2013-01-01

    Purpose: Dosimetric planning studies have described potential benefits for the use of proton radiation therapy (RT) for locally advanced breast cancer. We report acute toxicities and feasibility of proton delivery for 12 women treated with postmastectomy proton radiation with or without reconstruction. Methods and Materials: Twelve patients were enrolled in an institutional review board-approved prospective clinical trial. The patients were assessed for skin toxicity, fatigue, and radiation pneumonitis during treatment and at 4 and 8 weeks after the completion of therapy. All patients consented to have photographs taken for documentation of skin toxicity. Results: Eleven of 12 patients had left-sided breast cancer. One patient was treated for right-sided breast cancer with bilateral implants. Five women had permanent implants at the time of RT, and 7 did not have immediate reconstruction. All patients completed proton RT to a dose of 50.4 Gy (relative biological effectiveness [RBE]) to the chest wall and 45 to 50.4 Gy (RBE) to the regional lymphatics. No photon or electron component was used. The maximum skin toxicity during radiation was grade 2, according to the Common Terminology Criteria for Adverse Events (CTCAE). The maximum CTCAE fatigue was grade 3. There have been no cases of RT pneumonitis to date. Conclusions: Proton RT for postmastectomy RT is feasible and well tolerated. This treatment may be warranted for selected patients with unfavorable cardiac anatomy, immediate reconstruction, or both that otherwise limits optimal RT delivery using standard methods

  8. 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

  9. 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.

  10. 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

  11. 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

  12. Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis

    DEFF Research Database (Denmark)

    Heiligenhaus, Arnd; Foeldvari, Ivan; Edelsten, Clive

    2012-01-01

    To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis.......To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis....

  13. 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).

  14. 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.

  15. 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

  16. 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

  17. Clinical outcomes after percutaneous transforaminal endoscopic discectomy for lumbar disc herniation : A prospective case series

    NARCIS (Netherlands)

    Gadjradj, Pravesh S.; van Tulder, Maurits W.; Dirven, Clemens M. F.; Peul, Wilco C.; Harhangi, B. Sanjay

    Objective Throughout the last decades, full-endoscopic techniques to treat lumbar disc herniation (LDH) have gained popularity in clinical practice. To date, however, no Class I evidence on the efficacy of percutaneous transforaminal endoscopic discectomy (PTED) has been published, and studies

  18. Clinical outcomes after percutaneous transforaminal endoscopic discectomy for lumbar disc herniation: A prospective case series

    NARCIS (Netherlands)

    P.S. Gadjradj (Pravesh S.); M.W. van Tulder (Maurits); C.M.F. Dirven (Clemens); W.C. Peul (Wilco); B.S. Harhangi (Biswadjiet)

    2016-01-01

    markdownabstract__Objective__ Throughout the last decades, full-endoscopic techniques to treat lumbar disc herniation (LDH) have gained popularity in clinical practice. To date, however, no Class I evidence on the efficacy of percutaneous transforaminal endoscopic discectomy (PTED) has been

  19. 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

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

    Science.gov (United States)

    Kodkani, Pranjal S

    2016-01-01

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

  1. Uterine Artery Embolization Versus Laparoscopic Uterine Artery Occlusion: The Outcomes of a Prospective, Nonrandomized Clinical Trial

    International Nuclear Information System (INIS)

    Mara, Michal; Kubinova, Kristyna; Maskova, Jana; Horak, Petr; Belsan, Tomas; Kuzel, David

    2012-01-01

    Purpose: To compare outcomes of two different types of occlusive therapy of uterine fibroids. Methods: Women with fibroid(s) unsuitable for laparoscopic myomectomy (LM) were treated with uterine artery embolization (UAE) or laparoscopic uterine artery occlusion (LUAO). Results: Before the procedure, patients treated with UAE (n = 100) had a dominant fibroid greater in size (68 vs. 48 mm) and a mean age lower (33.1 vs. 34.9 years) than surgically treated patients (n = 100). After 6 months, mean shrinkage of fibroid volume was 53 % after UAE and 39 % after LUAO (p = 0.063); 82 % of women after UAE, but only 23 % after LUAO, had complete myoma infarction (p = 0.001). Women treated with UAE had more complications (31 vs. 11 cases, p = 0.006) and greater incidence of hysteroscopically verified intrauterine necrosis (31 vs. 3 %, p = 0.001). Both groups were comparable in markers of ovarian functions and number of nonelective reinterventions. The groups did not differ in pregnancy (69 % after UAE vs. 67 % after LUAO), delivery (50 vs. 46 %), or abortion (34 vs. 33 %) rates. The mean birth weight of neonates was greater (3270 vs. 2768 g, p = 0.013) and the incidence of intrauterine growth restriction lower (13 vs. 38 %, p = 0.046) in post-UAE patients. Conclusion: Both methods are effective in the treatment of women with future reproductive plans and fibroids not suitable for LM. UAE is more effective in causing complete ischemia of fibroids, but it is associated with greater risk of intrauterine necrosis. Both methods have low rate of serious complications (except for a high abortion rate).

  2. Uterine Artery Embolization Versus Laparoscopic Uterine Artery Occlusion: The Outcomes of a Prospective, Nonrandomized Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Mara, Michal; Kubinova, Kristyna, E-mail: kristyna.kubinova@gmail.com [General Faculty Hospital and 1st Medical Faculty of Charles University, Department of Obstetrics and Gynecology (Czech Republic); Maskova, Jana [Aberdeen Royal Infirmary, Department of Radiology (United Kingdom); Horak, Petr [General Faculty Hospital and 1st Medical Faculty of Charles University, Department of Obstetrics and Gynecology (Czech Republic); Belsan, Tomas [Central Military Hospital, Department of Radiology (Czech Republic); Kuzel, David [General Faculty Hospital and 1st Medical Faculty of Charles University, Department of Obstetrics and Gynecology (Czech Republic)

    2012-10-15

    Purpose: To compare outcomes of two different types of occlusive therapy of uterine fibroids. Methods: Women with fibroid(s) unsuitable for laparoscopic myomectomy (LM) were treated with uterine artery embolization (UAE) or laparoscopic uterine artery occlusion (LUAO). Results: Before the procedure, patients treated with UAE (n = 100) had a dominant fibroid greater in size (68 vs. 48 mm) and a mean age lower (33.1 vs. 34.9 years) than surgically treated patients (n = 100). After 6 months, mean shrinkage of fibroid volume was 53 % after UAE and 39 % after LUAO (p = 0.063); 82 % of women after UAE, but only 23 % after LUAO, had complete myoma infarction (p = 0.001). Women treated with UAE had more complications (31 vs. 11 cases, p = 0.006) and greater incidence of hysteroscopically verified intrauterine necrosis (31 vs. 3 %, p = 0.001). Both groups were comparable in markers of ovarian functions and number of nonelective reinterventions. The groups did not differ in pregnancy (69 % after UAE vs. 67 % after LUAO), delivery (50 vs. 46 %), or abortion (34 vs. 33 %) rates. The mean birth weight of neonates was greater (3270 vs. 2768 g, p = 0.013) and the incidence of intrauterine growth restriction lower (13 vs. 38 %, p = 0.046) in post-UAE patients. Conclusion: Both methods are effective in the treatment of women with future reproductive plans and fibroids not suitable for LM. UAE is more effective in causing complete ischemia of fibroids, but it is associated with greater risk of intrauterine necrosis. Both methods have low rate of serious complications (except for a high abortion rate).

  3. 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

  4. 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

  5. Selection of Sperm Based on Hypo-Osmotic Swelling May Improve ICSI Outcome: A Preliminary Prospective Clinical Trial

    Directory of Open Access Journals (Sweden)

    Nasim Charehjooy

    2014-03-01

    Full Text Available Background: The intra-cytoplasmic sperm injection (ICSI technique selects sperm according to morphology and motility. However, these parameters cannot predict the chromatin integrity of sperm. Considering the detrimental effects of DNA-damaged sperm on reproductive outcomes, novel sperm selection procedures have been proposed to circumvent the possibility of inseminating DNA-damaged sperm. It has been shown that different potential hypo-osmotic swelling test (HOST patterns possess the potential to differentiate between sperm that have intact or damaged chromatin. Therefore, for the first time, this preliminary study evaluates the role of HOST as a sperm selection procedure in a clinical setting. Materials and Methods: In this preliminary prospective clinical trial study, we divided infertile couples diagnosed with male infertility into two groups. In the treatment group (n=39, half of the oocytes were inseminated by sperm selected following density gradient centrifugation (DGC group. The remaining oocytes from the treatment group were inseminated by sperm chosen according to HOST pattern (c, d or e following DGC processing (HOST group. In the control group (n=63, all oocytes were inseminated by sperm chosen after DGC. Results: There was a significantly higher percentage of embryos that had good quality, implantation, and chemical pregnancy rates in the HOST group compared to the DGC group (p≤0.05. Conclusion: This study has shown that selecting sperm according to membrane functionality (HOST pattern rather morphology and viability may open a new window in our approach for determining the appropriate sperm for ICSI, particularly in individuals with severe male infertility (Registration Number: IRCT201307087223N2.

  6. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  8. Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine

    DEFF Research Database (Denmark)

    Liu, Jian-Ping; Han, Mei; Li, Xin-Xue

    2013-01-01

    Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.......Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications....

  9. The association of financial difficulties with clinical outcomes in cancer patients: secondary analysis of 16 academic prospective clinical trials conducted in Italy.

    Science.gov (United States)

    Perrone, F; Jommi, C; Di Maio, M; Gimigliano, A; Gridelli, C; Pignata, S; Ciardiello, F; Nuzzo, F; de Matteis, A; Del Mastro, L; Bryce, J; Daniele, G; Morabito, A; Piccirillo, M C; Rocco, G; Guizzaro, L; Gallo, C

    2016-12-01

    Cancer may cause financial difficulties, but its impact in countries with public health systems is unknown. We evaluated the association of financial difficulties with clinical outcomes of cancer patients enrolled in academic clinical trials performed within the Italian public health system. Data were pooled from 16 prospective multicentre trials in lung, breast or ovarian cancer, using the EORTC quality of life (QOL) C30 questionnaire. Question 28 scores financial difficulties related to disease or treatment in four categories from 'not at all' to 'very much'. We defined financial burden (FB) as any financial difficulty reported at baseline questionnaire, and financial toxicity (FT) as score worsening in a subsequent questionnaire. We investigated (i) the association of FB with clinical outcomes (survival, global QOL response [questions 29/30] and severe toxicity), and (ii) the association of FT with survival. Multivariable analyses were performed using logistic regression models or the Cox model adjusting for trial, gender, age, region and period of enrolment, baseline global QOL and, where appropriate, FB and global QOL response. Results are reported as odds ratio (OR) or hazard ratio (HR) with 95% confidence intervals (CI). At baseline 26% of the 3670 study patients reported FB, significantly correlated with worse baseline global QOL. FB was not associated with risks of death (HR 0.94, 95% CI 0.85-1.04, P = 0.23) and severe toxicity (OR 0.90, 95% CI 0.76-1.06, P = 0.19) but was predictive of a higher chance of worse global QOL response (OR 1.35, 95% CI 1.08-1.70, P = 0.009). During treatment, 2735 (74.5%) patients filled in subsequent questionnaires and 616 (22.5%) developed FT that was significantly associated with an increased risk of death (HR 1.20, 95% CI 1.05-1.37, P = 0.007). Several sensitivity analyses confirmed these findings. Even in a public health system, financial difficulties are associated with relevant cancer patients outcomes like QOL and

  10. 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.

  11. 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

  12. 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

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

    Directory of Open Access Journals (Sweden)

    Amelia Scott

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

  14. 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

  15. 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.

  16. 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.

  17. Late acute graft-versus-host disease: a prospective analysis of clinical outcomes and circulating angiogenic factors.

    Science.gov (United States)

    Holtan, Shernan G; Khera, Nandita; Levine, John E; Chai, Xiaoyu; Storer, Barry; Liu, Hien D; Inamoto, Yoshihiro; Chen, George L; Mayer, Sebastian; Arora, Mukta; Palmer, Jeanne; Flowers, Mary E D; Cutler, Corey S; Lukez, Alexander; Arai, Sally; Lazaryan, Aleksandr; Newell, Laura F; Krupski, Christa; Jagasia, Madan H; Pusic, Iskra; Wood, William; Renteria, Anne S; Yanik, Gregory; Hogan, William J; Hexner, Elizabeth; Ayuk, Francis; Holler, Ernst; Watanaboonyongcharoen, Phandee; Efebera, Yvonne A; Ferrara, James L M; Panoskaltsis-Mortari, Angela; Weisdorf, Daniel; Lee, Stephanie J; Pidala, Joseph

    2016-11-10

    Late acute (LA) graft-versus-host disease (GVHD) is persistent, recurrent, or new-onset acute GVHD symptoms occurring >100 days after allogeneic hematopoietic cell transplantation (HCT). The aim of this analysis is to describe the onset, course, morbidity, and mortality of and examine angiogenic factors associated with LA GVHD. A prospective cohort of patients (n = 909) was enrolled as part of an observational study within the Chronic GVHD Consortium. Eighty-three patients (11%) developed LA GVHD at a median of 160 (interquartile range, 128-204) days after HCT. Although 51 out of 83 (61%) achieved complete or partial response to initial therapy by 28 days, median failure-free survival was only 7.1 months (95% confidence interval, 3.4-19.1 months), and estimated overall survival (OS) at 2 years was 56%. Given recently described alterations of circulating angiogenic factors in classic acute GVHD, we examined whether alterations in such factors could be identified in LA GVHD. We first tested cases (n = 55) and controls (n = 50) from the Chronic GVHD Consortium and then validated the findings in 37 cases from Mount Sinai Acute GVHD International Consortium. Plasma amphiregulin (AREG; an epidermal growth factor [EGF] receptor ligand) was elevated, and an AREG/EGF ratio at or above the median was associated with inferior OS and increased nonrelapse mortality in both cohorts. Elevation of AREG was detected in classic acute GVHD, but not chronic GVHD. These prospective data characterize the clinical course of LA GVHD and demonstrate alterations in angiogenic factors that make LA GVHD biologically distinct from chronic GVHD. © 2016 by The American Society of Hematology.

  18. 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.

  19. 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

  20. 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

  1. 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.

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

    Directory of Open Access Journals (Sweden)

    Andrzej Kotela

    2015-01-01

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

  3. Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry.

    Science.gov (United States)

    Stemmer, Salomon M; Steiner, Mariana; Rizel, Shulamith; Soussan-Gutman, Lior; Ben-Baruch, Noa; Bareket-Samish, Avital; Geffen, David B; Nisenbaum, Bella; Isaacs, Kevin; Fried, Georgeta; Rosengarten, Ora; Uziely, Beatrice; Svedman, Christer; McCullough, Debbie; Maddala, Tara; Klang, Shmuel H; Zidan, Jamal; Ryvo, Larisa; Kaufman, Bella; Evron, Ella; Karminsky, Natalya; Goldberg, Hadassah; Shak, Steven; Liebermann, Nicky

    2017-01-01

    The 21-gene Recurrence Score® (RS) assay is a validated prognostic/predictive tool in ER + early-stage breast cancer. However, clinical outcome data from prospective studies in RS ≥ 11 patients are lacking, as are relevant real-life clinical practice data. In this retrospective analysis of a prospectively designed registry, we evaluated treatments/clinical outcomes in patients undergoing RS-testing through Clalit Health Services. The analysis included N0 ER + HER2-negative breast cancer patients who were RS-tested from 1/2006 through 12/2010. Medical records were reviewed to verify treatments/recurrences/survival. The cohort included 1801 patients (median follow-up, 6.2 years). Median age was 60 years, 50.4% were grade 2 and 81.1% had invasive ductal carcinoma; 48.9% had RS < 18, 40.7% RS 18-30, and 10.4% RS ≥ 31, with chemotherapy use of 1.4, 23.7, and 87.2%, respectively. The 5-year Kaplan-Meier estimates for distant recurrence were 0.8, 3.0, and 8.6%, for patients with RS < 18, RS 18-30 and RS ≥ 31, respectively; the corresponding 5-year Kaplan-Meier estimates for breast cancer death were 0.0, 0.9, and 6.2%. Chemotherapy-untreated patients with RS < 11 ( n  = 304) and 11-25 ( n  = 1037) (TAILORx categorizatio n ) had 5-year Kaplan-Meier estimates for distant recurrence risk/breast cancer death of 1.0%/0.0% and 1.3%/0.4%, respectively. Our results extend those of the prospective TAILORx trial: the 5-year Kaplan-Meier estimates for distant recurrence and breast cancer death rate for the RS < 18 patients were very low supporting the use of endocrine therapy alone. Furthermore, in chemotherapy-untreated patients with RS 11-25 (where TAILORx patients were randomized to chemoendocrine or endocrine therapy alone), 5-year distant recurrence rates were also very low, suggesting that chemotherapy would not have conferred clinically meaningful benefit.

  4. Impact of BMI on clinical outcomes of NOAC therapy in daily care - Results of the prospective Dresden NOAC Registry (NCT01588119).

    Science.gov (United States)

    Tittl, L; Endig, S; Marten, S; Reitter, A; Beyer-Westendorf, I; Beyer-Westendorf, J

    2018-03-14

    Direct acting non-Vitamin K antagonist oral anticoagulants (NOAC) are characterized by a fixed dosing regimen. Despite the potential for relative underdosing due to large distribution volumes, dose adjustments for patients with high body mass index (BMI) are not recommended. Since efficacy and safety data in obese patients are scarce, we evaluated the impact of BMI on clinical outcomes in daily care patients treated with NOAC for stroke prevention in atrial fibrillation or venous thromboembolism. Using prospectively collected data from a non-interventional registry, cardiovascular (CV), major bleeding events (MB) and all-cause mortality were evaluated according to BMI classes. All outcome events were centrally adjudicated using standard scientific definitions. Between November 1st 2011 and December 31st 2016, 3432 patients were enrolled into the registry (61.3% rivaroxaban; 20% apixaban; 10.1% dabigatran, 8.6% edoxaban; mean follow-up 998.1 ± 542.9 days; median 1004 days). With increasing BMI (range 13.7-57.2 kg/m 2 ), the proportion of patients receiving standard (vs. reduced) NOAC dose increased from 64.7% (underweight) to 78.9% (obesity). Although obese patients had more cardiovascular risk factors compared to normal weight patients, on-treatment rates of clinical outcomes (CV, MB, all-cause-mortality) were lowest in overweight and obese patients. In a large set of real-life NOAC recipients we found no indication that high BMI is associated with inferior NOAC effectiveness or safety, which is in line with recent epidemiological data of a "BMI paradox" that indicates a somewhat protective effect of higher BMI regarding unfavourable outcomes also in patients receiving fixed dose NOAC anticoagulation without dose adjustment for higher BMI. Copyright © 2017. Published by Elsevier B.V.

  5. Laparoscopic versus open liver segmentectomy: prospective, case-matched, intention-to-treat analysis of clinical outcomes and cost effectiveness.

    Science.gov (United States)

    Polignano, Francesco M; Quyn, Aaron J; de Figueiredo, Rodrigo S M; Henderson, Nikola A; Kulli, Christoph; Tait, Iain S

    2008-12-01

    Reduction in hospital stay, blood loss, postoperative pain and complications are common findings after laparoscopic liver resection, suggesting that the laparoscopic approach may be a suitable alternative to open surgery. Some concerns have been raised regarding cost effectiveness of this procedure and potential implications of its large-scale application. Our aim has been to determine cost effectiveness of laparoscopic liver surgery by a case-matched, case-control, intention-to-treat analysis of its costs and short-term clinical outcomes compared with open surgery. Laparoscopic liver segmentectomies and bisegmentectomies performed at Ninewells Hospital and Medical School between 2005 and 2007 were considered. Resections involving more than two Couinaud segments, or involving any synchronous procedure, were excluded. An operation-magnitude-matched control group was identified amongst open liver resections performed between 2004 and 2007. Hospital costs were obtained from the Scottish Health Service Costs Book (ISD Scotland) and average national costs were calculated. Cost of theatre time, disposable surgical devices, hospital stay, and high-dependency unit (HDU) and intensive care unit (ICU) usage were the main endpoints for comparison. Secondary endpoints were morbidity and mortality. Statistical analysis was performed with Student's t-test, chi(2) and Fisher exact test as most appropriate. Twenty-five laparoscopic liver resections were considered, including atypical resection, segmentectomy and bisegmentectomy, and they were compared to 25 matching open resections. The two groups were homogeneous by age, sex, coexistent morbidity, magnitude of resection, prevalence of liver cirrhosis and indications. Operative time (p < 0.03), blood loss (p < 0.0001), Pringle manoeuvre (p < 0.03), hospital stay (p < 0.003) and postoperative complications (p < 0.002) were significantly reduced in the laparoscopic group. Overall hospital cost was significantly lower in the

  6. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

  8. EFFECT OF CEREBROPROTEIN HYDROLYSATE WITH CITICOLINE VERSUS CITICOLINE ALONE IN THE INITIAL MANAGEMENT OF HEAD INJURY AND ITS CLINICAL OUTCOME “A PROSPECTIVE RANDOMISED COMPARATIVE STUDY”

    Directory of Open Access Journals (Sweden)

    Varadaraju D. N

    2017-06-01

    Full Text Available BACKGROUND Traumatic brain injury is an important cause of morbidity. It also represents the most frequent reason for neurological illness after headache. Compared with other types of brain insult, traumatic brain injury produces more diffuse injury causing more cognitive and neuropsychiatric disturbances. Various drugs have been used in an attempt to improve the clinical outcome, citicoline and Cerebrolysin hydrolysate have been used to improve the clinical outcome in traumatic brain injury. The evidence thus far has been conflicting with reports in favour and against the use of these drugs in the clinical benefit of the patients with traumatic brain injury. We attempt to determine the benefits and advantages of using these drugs in the management of traumatic brain injury. MATERIALS AND METHODS This is a prospective study comprising 60 patients of head injury admitted in the Department of Neurosurgery at Vydehi Institute of Medical Sciences and Research Centre, Bangalore. The purpose of the current study is to evaluate the effect of cerebroprotein hydrolysate with citicoline compared to citicoline alone in the initial management of head injury and its clinical outcome and to assess the improvement. RESULTS Sixty patients with head injury were recruited and divided into group A and group B randomly. The mean age was 43.5 years with 43 male patients and 17 female patients. The GCS at admission of 27 patients was mild head injury and of 33 patients was moderate head injury. Group A had 13 patients with mild head injury and 17 patients with moderate head injury. Group B had 14 patients with mild and 16 patients with moderate head injury at the time of admission. The GCS was assessed at 1 week and 3 weeks. On assessing the patients at 1 week, group A had 14 patients with mild head injury and 16 patients with moderate head injury, whereas group B had 14 patients with mild and 16 patients with moderate head injury. The extended Glasgow Outcome Scale

  9. Comparative evaluation of pregnancy outcome in gonadotrophin-clomiphene combination vs clomiphene alone in polycystic ovarian syndrome and unexplained infertility-A prospective clinical trial

    Directory of Open Access Journals (Sweden)

    Shiuli Mukherjee

    2010-01-01

    Full Text Available Objectives: A large prospective clinical trial was conducted to compare the efficacy of single dose uFSH and clomiphene citrate combination with clomiphene citrate alone for ovulation induction to improve the pregnancy rate. Materials and Methods: The study was a randomized, prospective clinical trial. Totally, 1527 infertile women (4381 cycles with polycystic ovarian syndrome (PCOS (n=911/2573 cycles and unexplained infertility (n=616/1808 cycles were randomized into two groups. Group A received single dose of uFSH on D 3 of menstrual cycle along with clomiphene. Group B received clomiphene only for ovulation induction. We compared the pregnancy rate and miscarriage rate between two groups. Results: Group A had a pregnancy rate of 17% compared to 8.3% of Group B which was significantly higher (P=0.0001. The miscarriage rate was 11% in Group A and 10% in Group B which was not significant (P=0.99. Pregnancy rates in PCOS women were 22% in Group A and 9.3% in Group B which shows significantly higher pregnancy rate (P=0.0001 in anovulatory infertility. But in unexplained infertility, there was no significant difference in pregnancy rate between Group A (11% and Group B(6.3%. Miscarriage rates were 8.8% and 9.5% in Group A and Group B, respectively, in PCOS women and 14% and 13% in women with unexplained infertility. Conclusion: Addition of single dose of uFSH improves pregnancy outcome particularly in anovulatory infertility (WHO II. Correction of unexplained infertility may need more than simple correction of possible subtle ovulatory effect.

  10. Decline of Cosmetic Outcomes Following Accelerated Partial Breast Irradiation Using Intensity Modulated Radiation Therapy: Results of a Single-Institution Prospective Clinical Trial

    International Nuclear Information System (INIS)

    Liss, Adam L.; Ben-David, Merav A.; Jagsi, Reshma; Hayman, James A.; Griffith, Kent A.; Moran, Jean M.; Marsh, Robin B.; Pierce, Lori J.

    2014-01-01

    Purpose: To report the final cosmetic results from a single-arm prospective clinical trial evaluating accelerated partial breast irradiation (APBI) using intensity modulated radiation therapy (IMRT) with active-breathing control (ABC). Methods and Materials: Women older than 40 with breast cancer stages 0-I who received breast-conserving surgery were enrolled in an institutional review board-approved prospective study evaluating APBI using IMRT administered with deep inspiration breath-hold. Patients received 38.5 Gy in 3.85-Gy fractions given twice daily over 5 consecutive days. The planning target volume was defined as the lumpectomy cavity with a 1.5-cm margin. Cosmesis was scored on a 4-category scale by the treating physician. Toxicity was scored according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0). We report the cosmetic and toxicity results at a median follow-up of 5 years. Results: A total of 34 patients were enrolled. Two patients were excluded because of fair baseline cosmesis. The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women at a median follow-up of 2.5 years. At a median follow-up of 5 years, further decline in the cosmetic outcome was observed in 5 women. Cosmesis at the time of last assessment was 43.3% excellent, 30% good, 20% fair, and 6.7% poor. Fibrosis according to CTCAE at last assessment was 3.3% grade 2 toxicity and 0% grade 3 toxicity. There was no correlation of CTCAE grade 2 or greater fibrosis with cosmesis. The 5-year rate of local control was 97% for all 34 patients initially enrolled. Conclusions: In this prospective trial with 5-year median follow-up, we observed an excellent rate of tumor control using IMRT-planned APBI. Cosmetic outcomes, however, continued to decline, with 26.7% of women having a fair to poor cosmetic result. These results underscore the need for continued cosmetic assessment for patients treated with APBI by technique

  11. Decline of Cosmetic Outcomes Following Accelerated Partial Breast Irradiation Using Intensity Modulated Radiation Therapy: Results of a Single-Institution Prospective Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Liss, Adam L. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Ben-David, Merav A. [Department of Radiation Oncology, The Sheba Medical Center, Ramat Gan (Israel); Jagsi, Reshma; Hayman, James A. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Griffith, Kent A. [Biostatistics Unit, University of Michigan, Ann Arbor, Michigan (United States); Moran, Jean M.; Marsh, Robin B. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Pierce, Lori J., E-mail: ljpierce@umich.edu [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States)

    2014-05-01

    Purpose: To report the final cosmetic results from a single-arm prospective clinical trial evaluating accelerated partial breast irradiation (APBI) using intensity modulated radiation therapy (IMRT) with active-breathing control (ABC). Methods and Materials: Women older than 40 with breast cancer stages 0-I who received breast-conserving surgery were enrolled in an institutional review board-approved prospective study evaluating APBI using IMRT administered with deep inspiration breath-hold. Patients received 38.5 Gy in 3.85-Gy fractions given twice daily over 5 consecutive days. The planning target volume was defined as the lumpectomy cavity with a 1.5-cm margin. Cosmesis was scored on a 4-category scale by the treating physician. Toxicity was scored according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0). We report the cosmetic and toxicity results at a median follow-up of 5 years. Results: A total of 34 patients were enrolled. Two patients were excluded because of fair baseline cosmesis. The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women at a median follow-up of 2.5 years. At a median follow-up of 5 years, further decline in the cosmetic outcome was observed in 5 women. Cosmesis at the time of last assessment was 43.3% excellent, 30% good, 20% fair, and 6.7% poor. Fibrosis according to CTCAE at last assessment was 3.3% grade 2 toxicity and 0% grade 3 toxicity. There was no correlation of CTCAE grade 2 or greater fibrosis with cosmesis. The 5-year rate of local control was 97% for all 34 patients initially enrolled. Conclusions: In this prospective trial with 5-year median follow-up, we observed an excellent rate of tumor control using IMRT-planned APBI. Cosmetic outcomes, however, continued to decline, with 26.7% of women having a fair to poor cosmetic result. These results underscore the need for continued cosmetic assessment for patients treated with APBI by technique.

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

    Directory of Open Access Journals (Sweden)

    David Noriega

    2015-01-01

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

  13. Clinical outcome 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.

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

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    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.)

  15. Clinical outcomes of prospectively treated 140 women with early stage breast cancer using accelerated partial breast irradiation with 3 dimensional computerized tomography based brachytherapy

    International Nuclear Information System (INIS)

    Budrukkar, Ashwini; Gurram, Lavanya; Upreti, Ritu Raj; Munshi, Anusheel; Jalali, Rakesh; Badwe, Rajendra; Parmar, Vani; Shet, Tanuja; Gupta, Sudeep; Wadasadawala, Tabassum; Sarin, Rajiv

    2015-01-01

    Purpose: To study the clinical outcomes of women with early breast cancer (EBC) treated with accelerated partial breast irradiation (APBI) with multicatheter interstitial brachytherapy (MIB) using 3 dimensional computerized tomography (3DCT) based planning. Materials and methods: During August 2005 to January 2013, 140 women with EBC were treated prospectively with APBI using high dose rate (HDR) MIB. After 3DCT based planning patients were treated to a dose of 34 Gy/10 #/1 week with bid regimen. Results: Median age was 57 years and tumor size 2 cm (range: 0.6–3.2 cm). Infiltrating duct carcinoma (IDC) was the most common histology; grade III tumors were seen in 82%. Median dose homogeneity index (DHI) was 0.76 (range: 0.49–0.85). The median coverage index (CI) of the cavity was 90% (61.4–100) and 80.5% (53.6–97.4) for planning target volume (PTV). Median follow up was 60 months (1–102 months). The 5 and 7 year local control rates (LC) were 97% and 92% respectively. Her2 positivity was the only prognostic factor which had an adverse impact on LC (p = 0.01). Five and 7 year disease free survival (DFS) and overall survival (OAS) were 93%, 84%, 97.5% and 89% respectively. Good to excellent cosmetic outcomes at last follow up were seen in 87 (77%) women. Conclusions: 3DCT based MIB results in excellent long term outcomes and good to excellent cosmesis. Her2 positivity has an adverse impact on LC rates

  16. Efficacy of Clopidogrel and Clinical Outcome When Clopidogrel Is Coadministered With Atorvastatin and Lansoprazole: A Prospective, Randomized, Controlled Trial.

    Science.gov (United States)

    Zhang, Jian-rong; Wang, Di-qing; Du, Jun; Qu, Guang-su; Du, Jian-lin; Deng, Song-bai; Liu, Ya-jie; Cai, Jin-xi; She, Qiang

    2015-12-01

    This prospective, randomized, nonblind, controlled trial evaluated the effects of clopidogrel on platelet function upon coadministration with atorvastatin and lansoprazole. One hundred four adult patients with non-ST-segment elevated acute coronary syndrome (NSTE-ACS) who underwent percutaneous coronary intervention (PCI) with drug-eluting stent implantation were included. All patients were treated with standard dual antiplatelet therapy (DAPT) plus rosuvastatin 10  mg daily after the operation. On the sixth day after PCI, patients were randomly divided into 4 groups, Group A: DAPT + atorvastatin 20  mg daily (a change from rosuvastatin to atorvastatin) + lansoprazole 30  mg daily, Group B: DAPT + atorvastatin 20  mg daily (a change from rosuvastatin to atorvastatin), Group C: DAPT + lansoprazole 30  mg daily (continuing to take rosuvastatin), Group D is the control group. Additional drugs were used according to the situation of patients. Platelet function and concentrations of platelet activation markers (granular membrane protein 140 (P-selectin), thromboxane B2 (TXB2), and human soluble cluster of differentiation 40 ligand (sCD40L)) were assessed before randomization and at 15- and 30-day follow-up visits. All patients were maintained on treatment for 6 months and observed for bleeding and ischemic events. A total of 104 patients were enrolled, 27 patients in group A, 26 patients in Group B/C, 25 patients in Group D separately, and all the patients were analyzed. There were no differences in platelet function and the levels of platelet activation markers (P-selectin, TXB2, and sCD40L) among or within the 4 groups at the 3 time points of interest (P > 0.05). In the subsequent 6 months, no significant bleeding events occurred, and 12 patients experienced ischemic events, these results were also not significantly different among the groups (P > 0.05). In patients diagnosed with NSTE-ACS who have had drug-eluting stent implantation

  17. 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.

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

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    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

  19. 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.

  20. Satisfaction and Clinical Outcomes Among Patients with Immediately Loaded Mandibular Overdentures Supported by One or Two Dental Implants: Results of a 5-Year Prospective Randomized Clinical Trial.

    Science.gov (United States)

    Kronstrom, Mats; Davis, Ben; Loney, Robert; Gerrow, Jack; Hollender, Lars

    The purpose of this study was to evaluate patient satisfaction and clinical outcomes among subjects with mandibular overdentures supported by one or two immediately placed dental implants 5 years after loading. Thirty-six subjects (16 men and 20 women) received one or two dental implants in the anterior mandible, and all implants were loaded the day of surgery. Subjects were scheduled for follow-up 3-, 6-, and 12 months after implant placement and thereafter annually for 4 more years. Patient satisfaction scores were measured with the Oral Health Impact Profile-EDENT (OHIPEDENT) questionnaire. Seventeen subjects (7 male and 10 female) with a mean age of 59.4 years (range, 44 to 74 years) were available for the 5-year follow-up examination. Nine subjects with 10 failing implants were excluded during the first year and nine subjects were lost to follow-up. No implants failed between the 12- and 60-month follow-up examinations, and the need for denture maintenance was low. Mean peri-implant bone change was 0.92 mm, and the Spearman test failed to show correlation between the insertion torque value and implant stability quotient. Patient satisfaction scores increased significantly when compared with baseline values and continued to be high for both groups, with no significant differences. Ten implants in nine subjects failed early, but no failures were observed after the 12-month examination. No significant differences were found between subjects in the two groups with respect to implant survival rates and peri-implant bone loss, and patient satisfaction scores continued to be high. Although patient satisfaction and implant success were high during the 12- to 60-month period, the results should be interpreted with caution because of the high number of failing implants and patients lost to follow-up. More research is needed to study outcomes of treatment with immediately loaded mandibular implant overdentures.

  1. Clinical and radiographic outcomes of medial open-wedge high tibial osteotomy with Anthony-K plate: prospective minimum five year follow-up data.

    Science.gov (United States)

    Altay, Mehmet Akif; Ertürk, Cemil; Altay, Nuray; Mercan, Ahmet Şükrü; Sipahioğlu, Serkan; Kalender, Ali Murat; Işıkan, Uğur Erdem

    2016-07-01

    The purpose of this study was to prospectively evaluate the clinical and radiographic outcomes, and complication rates, after a minimum of five years of follow-up after medial open wedge high tibial osteotomy (MOWHTO) using an Anthony-K plate. MOWHTO was performed on 35 knees of 34 consecutive patients. A visual analogue scale (VAS), and Western Ontario and McMaster University Osteoarthritis (WOMAC) and Lysholm scores, were used in clinical evaluation. Upon radiographic assessment, alignment was expressed as the femorotibial angle (FTA). The posterior tibial slope (PTS) and the Insall-Salvati Index (ISI) were also measured. VAS, WOMAC, and Lysholm scores improved significantly upon follow-up (p FTA was 4.68 ± 4.39° varus pre-operatively; at the last post-operative follow-up, the value was 8.43 ± 2.02° valgus. The mean correction angle was 13.1 ± 2.7°. A significant increase in PTS was evident (p < 0.01), as was a significant decrease in the ISI (p < 0.01). The overall complication rate was 8.6 %. The Anthony-K plate affords accurate correction, initially stabilises the osteotomy after surgery, and maintains such stability until the osteotomy gap is completely healed, without correction loss. The plate survival rate was 97.2 % after a minimum of five years of follow-up. The plate increased the PTS, as do other medial osteotomy fixation plates.

  2. Surgical outcome of motor deficits and neurological status in brainstem cavernous malformations based on preoperative diffusion tensor imaging: a prospective randomized clinical trial.

    Science.gov (United States)

    Li, Da; Jiao, Yu-Ming; Wang, Liang; Lin, Fu-Xin; Wu, Jun; Tong, Xian-Zeng; Wang, Shuo; Cao, Yong

    2018-03-16

    OBJECTIVE Surgical management of brainstem lesions is challenging due to the highly compact, eloquent anatomy of the brainstem. This study aimed to evaluate the safety and efficacy of preoperative diffusion tensor imaging (DTI) and diffusion tensor tractography (DTT) in brainstem cavernous malformations (CMs). METHODS A prospective randomized controlled clinical trial was performed by using stratified blocked randomization. The primary eligibility criterion of the study was being a surgical candidate for brainstem CMs (with informed consent). The study enrolled 23 patients who underwent preoperative DTI/DTT and 24 patients who did not (the control group). The pre- and postoperative muscle strength of both limbs and modified Rankin Scale (mRS) scores were evaluated. Muscle strength of any limb at 12 months after surgery at the clinic visit was the primary outcome; worsened muscle strength was considered to be a poor outcome. Outcome assessors were blinded to patient management. This study reports the preliminary results of the interim analysis. RESULTS The cohort included 47 patients (22 women) with a mean age of 35.7 years. The clinical baselines between these 2 groups were not significantly different. In the DTI/DTT group, the corticospinal tract was affected in 17 patients (73.9%): it was displaced, deformed/partially interrupted, or completely interrupted in 6, 7, and 4 patients, respectively. The surgical approach and brainstem entry point were adjusted in 3 patients (13.0%) based on DTI/DTT data. The surgical morbidity of the DTI/DTT group (7/23, 30.4%) was significantly lower than that of the control group (19/24, 79.2%, p = 0.001). At 12 months, the mean mRS score (1.1, p = 0.034) and percentage of patients with worsened motor deficits (4.3%, p = 0.006) were significantly lower in the DTI/DTT group than in the control group (1.7% and 37.5%). Multivariate logistic regression identified the absence of preoperative DTI/DTT (OR 0.06, 95% CI 0.01-0.73, p = 0

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. Impact of Pre-Diabetes on Coronary Plaque Composition and Clinical Outcome in Patients With Acute Coronary Syndromes: An Analysis From the PROSPECT Study.

    Science.gov (United States)

    Farhan, Serdar; Redfors, Björn; Maehara, Akiko; McAndrew, Thomas; Ben-Yehuda, Ori; De Bruyne, Bernard; Mehran, Roxana; Giustino, Gennaro; Kirtane, Ajay J; Serruys, Patrick W; Mintz, Gary S; Stone, Gregg W

    2017-10-14

    The aim of this study was to investigate the impact of pre-diabetes (pre-DM) on coronary plaque characteristics and ischemic outcomes in patients with acute coronary syndromes (ACS). Pre-DM (i.e., the early stages of glucometabolic disturbance) is common among patients with ACS, but the extent to which pre-DM influences coronary plaque characteristics and the risk for adverse ischemic events is unclear. In the PROSPECT (Providing Regional Observations to Study Predictors of Events in Coronary Tree) study, patients with ACS underwent quantitative coronary angiography, grayscale intravascular ultrasound, and radiofrequency intravascular ultrasound after successful percutaneous coronary intervention. Patients were divided into 3 groups according to their glucometabolic status, as defined by the American Diabetes Association: normal glucose metabolism (NGM), pre-DM, and diabetes mellitus (DM). These groups were compared with regard to coronary plaque characteristics and the risk for major adverse cardiac events (MACEs) (defined as cardiac death or arrest, myocardial infarction, or rehospitalization for unstable or progressive angina). Among 547 patients, 162 (29.6%) had NGM, 202 (36.9%) had pre-DM, and 183 (33.4%) had DM. There were no significant differences between the groups with regard to intravascular ultrasound findings indicative of vulnerable plaques. Patients with DM had a higher crude rate of MACEs than those with pre-DM or NGM (25.9% vs. 16.3% and 16.1%; p = 0.03 and p = 0.02, respectively). In an adjusted Cox regression model using NGM as the reference group, DM (hazard ratio: 2.20; 95% confidence interval: 1.25 to 3.86; p = 0.006) but not pre-DM (hazard ratio: 1.29; 95% confidence interval: 0.71 to 2.33; p = 0.41) was associated with increased risk for MACEs. Impaired glucose metabolism is common among patients presenting with ACS. DM but not pre-DM is associated with an increased risk for MACEs. Thus, preventing patients from progressing from pre

  13. Athletic groin pain (part 1): a prospective anatomical diagnosis of 382 patients--clinical findings, MRI findings and patient-reported outcome measures at baseline.

    Science.gov (United States)

    Falvey, É C; King, E; Kinsella, S; Franklyn-Miller, A

    2016-04-01

    Athletic groin pain remains a common field-based team sports time-loss injury. There are few reports of non-surgically managed cohorts with athletic groin pain. To describe clinical presentation/examination, MRI findings and patient-reported outcome (PRO) scores for an athletic groin pain cohort. All patients had a history including demographics, injury duration, sport played and standardised clinical examination. All patients underwent MRI and PRO score to assess recovery. A clinical diagnosis of the injured anatomical structure was made based on these findings. Statistical assessment of the reliability of accepted standard investigations undertaken in making an anatomical diagnosis was performed. 382 consecutive athletic groin pain patients, all male, enrolled. Median time in pain at presentation was (IQR) 36 (16-75) weeks. Most (91%) played field-based ball-sports. Injury to the pubic aponeurosis (PA) 240 (62.8%) was the most common diagnosis. This was followed by injuries to the hip in 81 (21.2%) and adductors in 56 (14.7%) cases. The adductor squeeze test (90° hip flexion) was sensitive (85.4%) but not specific for the pubic aponeurosis and adductor pathology (negative likelihood ratio 1.95). Analysed in series, positive MRI findings and tenderness of the pubic aponeurosis had a 92.8% post-test probability. In this largest cohort of patients with athletic groin pain combining clinical and MRI diagnostics there was a 63% prevalence of PA injury. The adductor squeeze test was sensitive for athletic groin pain, but not specific individual pathologies. MRI improved diagnostic post-test probability. No hernia or incipient hernia was diagnosed. NCT02437942. 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/

  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

    2017-08-29

    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. Prospective cohort study. 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. Mode of birth, Apgar score of less than 7 at 5 min and neonatal unit admission. 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. 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 maternity units as physically safe places for well women to plan to give birth, with these women having higher rates of spontaneous vaginal births and lower rates of interventions and their associated morbidities than those who planned a tertiary hospital birth, with no differences in neonatal outcomes. © 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.

  15. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-11-01

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

  17. Dentoskeletal outcomes of a rapid maxillary expander with differential opening in patients with bilateral cleft lip and palate: A prospective clinical trial

    Science.gov (United States)

    Garib, Daniela; De Cássia Moura Carvalho Lauris, Rita; Calil, Louise Resti; De Medeiros Alves, Arthur César; Janson, Guilherme; De Almeida, Araci Malagodi; Cevidanes, Lúcia Helena Soares; Lauris, José Roberto Pereira

    2017-01-01

    Introduction The purpose of this 2-arm parallel study was to evaluate the dentoskeletal effects of rapid maxillary expansion with differential opening (EDO) compared with the hyrax expander in patients with complete bilateral cleft lip and palate. Methods A sample of patients with complete bilateral cleft lip and palate was prospectively and consecutively recruited. Eligibility criteria included participants in the mixed dentition with lip and palate repair performed during early childhood and maxillary arch constriction with a need for maxillary expansion before the alveolar bone graft procedure. The participants were consecutively divided into 2 study groups. The experimental and control groups comprised patients treated with rapid maxillary expansion using EDO and the hyrax expander, respectively. Cone-beam computed tomography examinations and digital dental models of the maxillary dental arches were obtained before expansion and 6 months postexpansion. Standardized cone-beam computed tomography coronal sections were used for measuring maxillary transverse dimensions and posterior tooth inclinations. Digital dental models were used for assessing maxillary dental arch widths, arch perimeters, arch lengths, palatal depths, and posterior tooth inclinations. Blinding was used only during outcome assessment. The chi-square test was used to compare the sex ratios between groups (P <0.05). Intergroup comparisons were performed using independent t tests with the Bonferroni correction for multiple tests. Results Fifty patients were recruited and analyzed in their respective groups. The experimental group comprised 25 patients (mean age, 8.8 years), and the control group comprised 25 patients (mean age, 8.6 years). No intergroup significant differences were found for age, sex ratio, and dentoskeletal variables before expansion. No significant differences were found between the EDO and the hyrax expander groups regarding skeletal changes. The EDO promoted significantly

  18. 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

  19. Five-months-postoperative neuropsychological outcome from a pilot prospective randomized clinical trial of thalamic deep brain stimulation for Tourette syndrome.

    Science.gov (United States)

    Schoenberg, Mike R; Maddux, Brian N; Riley, David E; Whitney, Christina M; Ogrocki, Paula K; Gould, Deborah; Maciunas, Robert J

    2015-02-01

    Tourette syndrome (TS) is a neuropsychiatric disorder presenting with motor and/or sonic tics associated with frontostriatal dysfunction. This study provided pilot data of the neuropsychological safety of bilateral thalamic deep brain stimulation (DBS) to treat medication-refractory TS in adults. This study used a repeated-measures design with pretest and 3-month follow-up from start of continuous bilateral DBS. Five male patients underwent DBS surgery for medically refractory TS. Repeated-measures ANOVA was used to evaluate for any change in neuropsychological test scores, employing a false discovery rate. Outcome measures included 14 neuropsychological tests assessing psychomotor speed, attention, memory, language, visuoconstructional, and executive functions, as well as subjective mood ratings of depression and anxiety. Average age was 28.2 years (SD = 7.5) with 12-17 years of education. Participants were disabled by tics, with a tic frequency of 50-80 per minute before surgery. At baseline, subjects' cognitive function was generally average, although mild deficits in sequencing and verbal fluency were present, as were clinically mild obsessive-compulsive symptoms. At 3 months of continuous DBS (5 months after implantation), 3 of 5 participants had clinical reductions in motor and sonic tics. Cognitive scores generally remained stable, but declines of moderate to large effect size (Cohen's d > 0.6) in verbal fluency, visual immediate memory, and reaction time were observed. Fewer symptoms of depression and anxiety, as well as fewer obsessions and compulsions, were reported after 3 months of continuous high-frequency DBS. Bilateral centromedian-parafascicular thalamic DBS for medically refractory TS shows promise for treatment of medically refractory TS without marked neuropsychological morbidity. Symptoms of depression and anxiety improved. © 2014 International Neuromodulation Society.

  20. Introducing robotic surgery into an endometrial cancer service--a prospective evaluation of clinical and economic outcomes in a UK institution.

    Science.gov (United States)

    Ind, Thomas E J; Marshall, Chris; Hacking, Matthew; Harris, Michelle; Bishop, Liz; Barton, Desmond; Bridges, Jane E; Shepherd, John H; Nobbenhuis, Marielle

    2016-03-01

    We have assessed how the introduction of robotics in a publicly funded endometrial cancer service affects clinical and economic outcomes. The study included 196 women. Costs were divided into those for wards, high dependency, staffing, theatres, pharmacy, blood products, imaging, pathology and rehabilitation. Capital depreciation was included. Prior to the introduction of robotics, 78/130 (60.0%) cases were performed open, compared to 17/66 (25.8%) afterwards (p < 0.0001). The median operative time increased 37 min (95% CI 17-55 min; p = 0.0002); the median blood loss was 55 ml lower (95% CI 0-150 ml; p = 0.0181); the stay was 2 days shorter (95% CI 1-3; p < 0.0001). Complications reduced from 64/130 (49.2%) to 19/66 (28.8%) (p = 0.0045). Costs reduced from £11 476 to £10 274 (p = 0.0065). Conversions for 'straight stick' surgery were 18.2% (14/77) compared to 0.0% (0/24) for robotics (p = 0.0164). Introducing robotics resulted in fewer laparotomies, shorter stays, fewer complications and lower costs. © 2015 The Authors. The International Journal of Medical Robotics and Computer Assisted Surgery Published by John Wiley & Sons Ltd.

  1. WE-AB-207B-12: Prospective Study of the Relationship Between Dose-Volume Clinical Toxicity and Patient Reported Outcomes in Lung Cancer Patients Treated with SBRT

    Energy Technology Data Exchange (ETDEWEB)

    Mayyas, E; Vance, S; Brown, S; Liu, J; Kim, J; Zhen, S; Devpura, S; Ajlouni, M; Salim, S; Chetty, I; Movsas, B [Henry Ford Health System, Detroit, MI (United States)

    2016-06-15

    Purpose: To determine in a prospective study, the correlation between radiation dose/volume, clinical toxicities and patient-reported, quality of life (QOL) resulting from lung SBRT. Methods: For 106 non-small cell lung cancer (NSCLC) patients receiving SBRT (12 Gy × 4), symptoms including cough, dyspnea, fatigue and pneumonitis were measured at baseline (before treatment), after treatment and 3, 6, and 12 months post-treatment. Toxicity was graded from zero to five. Dosimetric parameters such as the MLD, D10%, D20%, and lung subvolumes (V10 and V20) were obtained from the treatment plan. Dosimetric parameters and number of patients demonstrating toxicity ≥ grade 2 were tabulated. Linear regression analysis was used to calculate correlations between MLD and D10, D20, V10 and V20. Results: The percentages of patients with > grade 2 pneumonitis, fatigue, cough, and dyspnea over 3 to 12 months increased from 0.0% to 3.5%, 3.2% to 10.5%, 4.3% to 8.3%, and 10.8% to 18.8%, respectively. Computed dose indices D10%, D20% were 7.9±4.8 Gy and 3.0±2.3 Gy, respectively. MLD ranged from 0.34 Gy up to 9.9 Gy with overall average 3.0±1.7 Gy. The averages of the subvolumes V10 and V20 were respectively 8.9±5.3% and 3.0±2.4%. The linear regression analysis showed that V10 and D10 demonstrated the strongest correlation to MLD; R2= 0.92 and 0.87, respectively. V20, and D20 were also strongly correlated with MLD; R2 = 0.81 and 0.84 respectively. A correlation was also found to exist between MLD > 2 Gy and ≥ grade 2 cough and dyspnea. Subvolume values for 2Gy MLD were 5.3% for V10 and 2% for V20. Conclusion: Dosimetric indices: MLD ≥ 2Gy, D10 ≥ 5Gy and V10 ≥ 5% of the total lung volume were predictive of > grade 2 cough and dyspnea QOL data. The QOL results are a novel component of this work. acknowledgement of the Varian grant support.

  2. Clinical and patient-reported outcomes of zirconia-based implant fixed dental prostheses: Results of a prospective case series 5 years after implant placement.

    Science.gov (United States)

    Spies, Benedikt Christopher; Witkowski, Siegbert; Vach, Kirstin; Kohal, Ralf-Joachim

    2018-01-01

    To evaluate the clinical and patient-reported outcome of all-ceramic zirconia implant supported fixed dental prostheses (FDPs) 5 years after implant installation. Thirteen patients were treated with two terminally placed one-piece zirconia implants for a three-unit FDP each. The FDPs consisted of a CAD/CAM-fabricated zirconia framework over-pressed with a fluor-apatite veneering ceramic and were adhesively cemented. Survival and success were assessed by applying modified US Public Health Service (USPHS) criteria and preparation of Kaplan-Meier (KM) plots. Alpha and Bravo ratings were accepted for success (among others including small area veneer chippings and occlusal roughness), whereas Charlie ratings allowing for intra-oral correction (e.g., polishing) were accepted for survival. Furthermore, patient-reported outcome measures (PROMs) were analyzed with the help of visual analogue scales (VAS). Wilcoxon matched-pairs signed-rank test (USPHS criteria) and linear mixed models (PROMs) were used to evaluate time effects on response variables. All patients were available 61.8 ± 1.1 months after implant installation (53.6 ± 3.1 months after final prosthesis insertion). FDP survival was 100%. Significant incidence of veneer chipping (p = .0096) and occlusal roughness (p = .0019) was observed. Charlie rated extent of both phenomena resulted in a KM success estimate of 38.5% (95% CI: 14.1%-62.8%; seven FDPs with obvious roughness, three of them with extended veneer chipping). Compared with the pre-treatment assessments (30%-81% of satisfaction), all surveys at prosthetic delivery showed significantly improved VAS scores (66%-93%; p ≤ .038), except for speech (p = .341). Concerning function, esthetics and self-esteem, no decrease in satisfaction could be observed until the end of follow-up (90%-96%; p ≥ .057), whereas perception of sense (92%) and speech (95%) increased over time (p ≤ .030). Occurrence of technical complications did not correlate

  3. Clinical outcomes in ER+ HER2 -node-positive breast cancer patients who were treated according to the Recurrence Score results: evidence from a large prospectively designed registry.

    Science.gov (United States)

    Stemmer, Salomon M; Steiner, Mariana; Rizel, Shulamith; Geffen, David B; Nisenbaum, Bella; Peretz, Tamar; Soussan-Gutman, Lior; Bareket-Samish, Avital; Isaacs, Kevin; Rosengarten, Ora; Fried, Georgeta; McCullough, Debbie; Svedman, Christer; Shak, Steven; Liebermann, Nicky; Ben-Baruch, Noa

    2017-01-01

    The Recurrence Score® is increasingly used in node-positive ER+ HER2-negative breast cancer. This retrospective analysis of a prospectively designed registry evaluated treatments/outcomes in node-positive breast cancer patients who were Recurrence Score-tested through Clalit Health Services from 1/2006 through 12/2011 ( N  = 709). Medical records were reviewed to verify treatments/recurrences/survival. Median follow-up, 5.9 years; median age, 62 years; 53.9% grade 2; 69.8% tumors ≤ 2 cm; 84.5% invasive ductal carcinoma; 42.0% N1mi, and 37.2%/15.5%/5.2% with 1/2/3 positive nodes; 53.4% Recurrence Score < 18, 36.4% Recurrence Score 18-30, and 10.2% Recurrence Score ≥ 31. Overall, 26.9% received adjuvant chemotherapy: 7.1%, 39.5%, and 86.1% in the Recurrence Score < 18, 18-30, and ≥ 31 group, respectively. The 5-year Kaplan-Meier estimates for distant recurrence were 3.2%, 6.3%, and 16.9% for these respective groups and the corresponding 5-year breast cancer death estimates were 0.5%, 3.4%, and 5.7%. In Recurrence Score < 18 patients, 5-year distant-recurrence rates for N1mi/1 positive node/2-3 positive nodes were 1.2%/4.4%/5.4%. As patients were not randomized to treatment and treatment decision is heavily influenced by Recurrence Score, analysis of 5-year distant recurrence by chemotherapy use was exploratory and should be interpreted cautiously: In Recurrence Score < 18, recurrence rate was 7.7% in chemotherapy-treated ( n  = 27) and 2.9% in chemotherapy-untreated patients ( n  = 352); P  = 0.245. In Recurrence Score 18-30, recurrence rate in chemotherapy-treated patients ( n  = 102) was significantly lower than in untreated patients ( n  = 156) (1.0% vs. 9.7% P  = 0.019); in Recurrence Score ≤ 25 (the RxPONDER study cutoff), recurrence rate was 2.3% in chemotherapy-treated ( n  = 89) and 4.4% in chemotherapy-untreated patients ( n  = 488); P  = 0.521. In conclusion, our findings

  4. Effect of branched chain amino acid enrichment of total parenteral nutrition on nitrogen sparing and clinical outcome of sepsis and trauma: a prospective randomized double blind trial

    NARCIS (Netherlands)

    von Meyenfeldt, M. F.; Soeters, P. B.; Vente, J. P.; van Berlo, C. L.; Rouflart, M. M.; de Jong, K. P.; van der Linden, C. J.; Gouma, D. J.

    1990-01-01

    Administration of extra branched chain amino acids (BCAA) has been associated with a nitrogen sparing effect in septic and traumatized patients. Whether nitrogen sparing is associated with decreased morbidity and mortality rates is unknown. We therefore undertook a prospective, randomized, double

  5. Sublingual immunotherapy in patients with house dust mite allergic rhinitis: prospective study of clinical outcomes over a two-year period.

    Science.gov (United States)

    Soh, J Y; Thalayasingam, M; Ong, S; Loo, E X L; Shek, L P; Chao, S S

    2016-03-01

    Sublingual immunotherapy in patients with allergic rhinitis sensitised to house dust mites is safe, but its efficacy is controversial and sublingual immunotherapy with Blomia tropicalis has not yet been studied. This study sought to evaluate the efficacy of sublingual immunotherapy with house dust mite extract in children and adults with house dust mite allergic rhinitis over a period of two years. A prospective observational study was conducted of children and adults diagnosed with house dust mite allergic rhinitis who were treated with sublingual immunotherapy from 2008 to 2012. Total Nasal Symptom Scores, Mini Rhinoconjunctivitis Quality of Life scores and medication usage scores were assessed prospectively. Thirty-nine patients, comprising 24 children and 15 adults, were studied. Total Nasal Symptom Scores and Mini Rhinoconjunctivitis Quality of Life scores dropped significantly at three months into therapy, and continued to improve. Medication usage scores improved at one year into immunotherapy. Sublingual immunotherapy with house dust mite extracts, including B tropicalis, is efficacious as a treatment for patients with house dust mite allergic rhinitis.

  6. Implant rehabilitation of the atrophic edentulous maxilla including immediate fixed provisional restoration without the use of bone grafting: a review of 1-year outcome data from a long-term prospective clinical trial.

    Science.gov (United States)

    Toljanic, Joseph A; Baer, Russell A; Ekstrand, Karl; Thor, Andreas

    2009-01-01

    The literature suggests that predictable integration can be achieved when dental implant placement is combined with immediate fixed provisional restoration in a variety of clinical situations. Fewer data are available, however, regarding outcomes for immediate provisional restoration of implants in the edentulous maxilla. This report presents 1-year data acquired from a long-term prospective clinical trial designed to assess outcomes following the immediate provisional fixed restoration of implants in the atrophic edentulous maxilla without the use of bone augmentation. Fifty-one subjects diagnosed with an atrophic edentulous maxilla received a total of 306 implants (six implants per subject) followed by fixed provisional restoration within 24 hours of implant placement. No subjects underwent grafting to enhance bone volume in preparation for implant treatment. Data acquired included bone quantity and quality, implant dimensions, implant locations, and implant placement stability. Subjects returned for 1-year follow-up examinations to assess implant integration and restoration function. Periapical radiographs were obtained and compared to baseline images to assess marginal bone height maintenance. At the 3-month follow-up examination, 294 of 306 implants placed in 51 subjects were found to be integrated. This represents a cumulative implant survival rate of 96%. At the 1-year follow-up examination, mean marginal bone loss of 0.5 mm was noted, with no further loss of implants. These results support the contention that predictable long-term outcomes may be obtained for the atrophic edentulous maxilla when treated with an implant rehabilitation protocol that includes immediate fixed provisional restoration without the use of bone grafting. This strategy offers a promising treatment alternative for the patient with an atrophic edentulous maxilla.

  7. 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.

  8. Association between surgical indications, operative risk, and clinical outcome in infective endocarditis: a prospective study from the International Collaboration on Endocarditis.

    Science.gov (United States)

    Chu, Vivian H; Park, Lawrence P; Athan, Eugene; Delahaye, Francois; Freiberger, Tomas; Lamas, Cristiane; Miro, Jose M; Mudrick, Daniel W; Strahilevitz, Jacob; Tribouilloy, Christophe; Durante-Mangoni, Emanuele; Pericas, Juan M; Fernández-Hidalgo, Nuria; Nacinovich, Francisco; Rizk, Hussien; Krajinovic, Vladimir; Giannitsioti, Efthymia; Hurley, John P; Hannan, Margaret M; Wang, Andrew

    2015-01-13

    Use of surgery for the treatment of infective endocarditis (IE) as related to surgical indications and operative risk for mortality has not been well defined. The International Collaboration on Endocarditis-PLUS (ICE-PLUS) is a prospective cohort of consecutively enrolled patients with definite IE from 29 centers in 16 countries. We included patients from ICE-PLUS with definite left-sided, non-cardiac device-related IE who were enrolled between September 1, 2008, and December 31, 2012. A total of 1296 patients with left-sided IE were included. Surgical treatment was performed in 57% of the overall cohort and in 76% of patients with a surgical indication. Reasons for nonsurgical treatment included poor prognosis (33.7%), hemodynamic instability (19.8%), death before surgery (23.3%), stroke (22.7%), and sepsis (21%). Among patients with a surgical indication, surgical treatment was independently associated with the presence of severe aortic regurgitation, abscess, embolization before surgical treatment, and transfer from an outside hospital. Variables associated with nonsurgical treatment were a history of moderate/severe liver disease, stroke before surgical decision, and Staphyloccus aureus etiology. The integration of surgical indication, Society of Thoracic Surgeons IE score, and use of surgery was associated with 6-month survival in IE. Surgical decision making in IE is largely consistent with established guidelines, although nearly one quarter of patients with surgical indications do not undergo surgery. Operative risk assessment by Society of Thoracic Surgeons IE score provides prognostic information for survival beyond the operative period. S aureus IE was significantly associated with nonsurgical management. © 2014 American Heart Association, Inc.

  9. Thrombocytopenia during Pregnancy and Its Outcome – A Prospective Study

    Directory of Open Access Journals (Sweden)

    Pallavi Satish Vishwekar

    2017-01-01

    Full Text Available Background: Thrombocytopenia is second to anemia as the most common hematological abnormality during pregnancy. Accurate etiological diagnosis is essential for optimal therapeutic management and thus can prevent maternal and fetal morbidity and mortality. Aims and Objectives: To determine various etiologies of maternal thrombocytopenia, their complications and fetomaternal outcome compared with normal pregnancy. Material and Methods: A prospective study was carried out in tertiary hospital, 1460 pregnant women who attended the Antenatal clinic regularly were enrolled. All were screened for thrombocytopenia in third trimester (after 28 weeks, women with normal platelet (n=1350 were taken in control group and those with low counts less than 150 x109/L (n=130 were included in study group. Etiology and fetomaternal outcome of thrombocytopenia in third trimester of pregnancy were evaluated and compared. Results: Gestational thrombocytopenia was the commonest etiology (68.46%. Incidence of thrombocytopenia due to severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelet (HELLP syndrome in study group was 18.46% and 7.69% of them had medical cause like malarial or dengue fever. Major causes were Gestational Thrombocytopenia (GT, Idiopathic Thrombocytopenic Purpura (ITP, preeclampsia, HELLP syndrome, malaria, and dengue. Maternal complications due to bleeding tendencies like placental abruption, postpartum hemorrhage were evident in the study population. Fetal complications were significantly higher in study group. Early neonatal thrombocytopenia depended on etiology rather than severity of maternal thrombocytopenia. Conclusions: Outcome of pregnancy with moderate to severe thrombocytopenia depends mainly on the etiology of thrombocytopenia. Adverse outcomes are especially seen with pregnancy complicated by preeclampsia and HELLP syndrome. Fetomaternal outcome is favorable in gestational thrombocytopenia. Thus accurate etiological

  10. Prospective observational research on the clinical profile and outcome analysis among a cohort of patients sustaining traumatic cervical spine and cord injury in a peripheral tertiary spine care centre in Nepal [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Sunil Munakomi

    2017-11-01

    Full Text Available Background: In developing nations like Nepal, spinal cord injury has multispectral consequences for both the patient and their family members. It has the tendency to cripple and handicap the patients, and burn out their caretakers, both physically and mentally. Furthermore, the centralization of health care with only a handful of dedicated rehabilitation centers throughout Nepal further places patients into disarray. This study was carried out as a pilot study to determine the modes of injury, age groups affected, clinical profiles and patterns of injury sustained, as well as the efficacy of managing a subset of patients, who have sustained cervical spine and cord injuries. Methods: This was a prospective cohort study comprising of 163 patients enrolled over a period of three years that were managed in the spine unit of College of Medical Sciences, Bharatpur, Nepal. Results: Road traffic accidents were implicated in 51% of these patients. 65% of them were in the age group of 30-39 years. Traumatic subluxation occurred in 73 patients with maximum involvement of the C4/5 region (28.76%. Good outcome was seen in patients with ASIA ‘C’ and ‘D’ with 55% of patients showed improvement from ‘C’ to ‘D’ and 95% of patients showed improvement from ‘D’ to ‘E’ at 1 year follow up. The overall mortality in the patients undergoing operative interventions was only 1.98%. Conclusions: The prevalence of cervical spine injuries in the outreach area is still significant. The outcome of managing these patients, even in the context of a resource limited setup in a spine unit outside the capital city of a developing nation, can be as equally as effective and efficient compared to the outcome from a well-equipped and dedicated spine unit elsewhere.

  11. Clinical Outcomes of 1 kHz Subperception Spinal Cord Stimulation in Implanted Patients With Failed Paresthesia-Based Stimulation: Results of a Prospective Randomized Controlled Trial.

    Science.gov (United States)

    North, James M; Hong, Kyung-Soo Jason; Cho, Philip Young

    2016-10-01

    Pain relief via spinal cord stimulation (SCS) has historically revolved around producing paresthesia to replace pain, with success measured by the extent of paresthesia-pain overlap. In a recent murine study, by Shechter et al., showed the superior efficacy of high frequency SCS (1 kHz and 10 kHz) at inhibiting the effects of mechanical hypersensitivity compared to sham or 50 Hz stimulation. In the same study, authors report there were no differences in efficacy between 1 kHz and 10 kHz delivered at subperception stimulation strength (80% of motor threshold). Therefore, we designed a randomized, 2 × 2 crossover study of low frequency supra-perception SCS vs. subperception SCS at 1 kHz frequency in order to test whether subperception stimulation at 1 kHz was sufficient to provide effective pain relief in human subjects. Twenty-two subjects with SCS, and inadequate pain relief based on numeric pain rating scale (NPRS) scores (>5) were enrolled, and observed for total of seven weeks (three weeks of treatment, one week wash off, and another three weeks of treatment). Subjects were asked to rate their pain on NPRS as a primary efficacy variable, and complete the Oswestry Disability Index (ODI) and Patient's Global Impression of Change (PGIC) as secondary outcome measures. Out of 22 subjects that completed the study, 21 subjects (95%) reported improvements in average, best, and worst pain NPRS scores. All NPRS scores were significantly lower with subperception stimulation compared to paresthesia-based stimulation (p paresthesia based stimulation on ODI scores (p = 3.9737 × 10 -5 ) and PGIC scores (p = 3.0396 × 10 -5 ). © 2016 International Neuromodulation Society.

  12. 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.

  13. 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.

  14. Prospective Lymphedema Surveillance in a Clinic Setting

    Directory of Open Access Journals (Sweden)

    Janet Chance-Hetzler

    2015-08-01

    Full Text Available The potential impact of breast cancer-related lymphedema (LE is quite extensive, yet it often remains under-diagnosed until the later stages. This project examines the effectiveness of prospective surveillance in post-surgical breast cancer patients. A retrospective analysis of 49 out of 100 patients enrolled in a longitudinal prospective study at a Midwestern breast center evaluates: (1 time required for completion of bilateral limb measurements and Lymphedema Breast Cancer Questionnaire (LBCQ; (2 referral to LE management with limb volume increase (LVI and/or LBCQ symptoms; and (3 cost of LE management at lower LVI (≥5%–≤10% versus traditional (≥10%. Findings revealed a visit timeframe mean of 40.3 min (range = 25–60; 43.6% of visits were ≤30-min timeframe. Visit and measurement times decreased as clinic staff gained measurement experience; measurement time mean was 17.9 min (range = 16.9–18.9. LBCQ symptoms and LVI were significantly (p < 0.001 correlated to LE referral; six of the nine patients referred (67% displayed both LBCQ symptoms/LVI. Visits with no symptoms reported did not result in referral, demonstrating the importance of using both indicators when assessing early LE. Lower threshold referral provides compelling evidence of potential cost savings over traditional threshold referral with reported costs of: $3755.00 and $6353.00, respectively (40.9% savings.

  15. Prospective association of common eating disorders and adverse outcomes.

    Science.gov (United States)

    Field, Alison E; Sonneville, Kendrin R; Micali, Nadia; Crosby, Ross D; Swanson, Sonja A; Laird, Nan M; Treasure, Janet; Solmi, Francesca; Horton, Nicholas J

    2012-08-01

    Anorexia nervosa and bulimia nervosa (BN) are rare, but eating disorders not otherwise specified (EDNOS) are relatively common among female participants. Our objective was to evaluate whether BN and subtypes of EDNOS are predictive of developing adverse outcomes. This study comprised a prospective analysis of 8594 female participants from the ongoing Growing Up Today Study. Questionnaires were sent annually from 1996 through 2001, then biennially through 2007 and 2008. Participants who were 9 to 15 years of age in 1996 and completed at least 2 consecutive questionnaires between 1996 and 2008 were included in the analyses. Participants were classified as having BN (≥ weekly binge eating and purging), binge eating disorder (BED; ≥ weekly binge eating, infrequent purging), purging disorder (PD; ≥ weekly purging, infrequent binge eating), other EDNOS (binge eating and/or purging monthly), or nondisordered. BN affected ∼1% of adolescent girls; 2% to 3% had PD and another 2% to 3% had BED. Girls with BED were almost twice as likely as their nondisordered peers to become overweight or obese (odds ratio [OR]: 1.9 [95% confidence interval: 1.0-3.5]) or develop high depressive symptoms (OR: 2.3 [95% confidence interval: 1.0-5.0]). Female participants with PD had a significantly increased risk of starting to use drugs (OR: 1.7) and starting to binge drink frequently (OR: 1.8). PD and BED are common and predict a range of adverse outcomes. Primary care clinicians should be made aware of these disorders, which may be underrepresented in eating disorder clinic samples. Efforts to prevent eating disorders should focus on cases of subthreshold severity.

  16. Prospective Clinical Study of Precision Oncology in Solid Tumors.

    Science.gov (United States)

    Sohal, Davendra P S; Rini, Brian I; Khorana, Alok A; Dreicer, Robert; Abraham, Jame; Procop, Gary W; Saunthararajah, Yogen; Pennell, Nathan A; Stevenson, James P; Pelley, Robert; Estfan, Bassam; Shepard, Dale; Funchain, Pauline; Elson, Paul; Adelstein, David J; Bolwell, Brian J

    2015-11-09

    Systematic studies evaluating clinical benefit of tumor genomic profiling are lacking. We conducted a prospective study in 250 patients with select solid tumors at the Cleveland Clinic. Eligibility required histopathologic diagnosis, age of 18 years or older, Eastern Cooperative Oncology Group performance status 0-2, and written informed consent. Tumors were sequenced using FoundationOne (Cambridge, MA). Results were reviewed at the Cleveland Clinic Genomics Tumor Board. Outcomes included feasibility and clinical impact. Colorectal (25%), breast (18%), lung (13%), and pancreatobiliary (13%) cancers were the most common diagnoses. Median time from consent to result was 25 days (range = 3-140). Of 223 evaluable samples, 49% (n = 109) of patients were recommended a specific therapy, but only 11% (n = 24) received such therapy: 12 on clinical trials, nine off-label, three on-label. Lack of clinical trial access (n = 49) and clinical deterioration (n = 29) were the most common reasons for nonrecommendation/nonreceipt of genomics-driven therapy. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  17. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial.

    Science.gov (United States)

    Rizzo, P; Raffone, E; Benedetto, V

    2010-06-01

    The aim of the study was to evaluate the efficacy of a treatment with myo-inositol plus folic acid plus melatonin compared with myo-inositol plus folic acid alone on oocyte quality in women underwent in vitro fertilization (IVF) cycles. A prospective, clinical trial. Starting on the day of GnRH administration, 65 women undergoing IVF cycles were randomized in two groups to receive myo-inositol plus folic acid plus melatonin (32 women, group A), and myo-inositol plus folic acid (33 women, group B), administered continuously. Primary endpoints were number of morphologically mature oocytes retrieved (MII oocytes), embryo quality, and pregnancy rate. Secondary endpoints were the total number of oocytes retrieved (immature and mature oocytes), fertilization rate per number of retrieved oocytes and embryo cleavage rate. The mean number of oocytes retrieved did not differ between the two groups (7.88 +/- 1.76 vs 7.67 +/- 1.88; P=0.65). Whereas the group cotreated with melatonin reported a significantly greater mean number of mature oocytes (6.56 +/- 1.64 vs 5.76 +/- 1.56; P=0.047) and a lower mean number of immature oocytes (1.31 +/- 0.74 vs. 1.91 +/- 0.68; P=0.001). The mean number of embyos of top-quality (class 1 and 2) resulted higher in the group A (1.69 +/- 0.64 vs 1.24 +/- 0.75; P=0.01). Fertilization rate did not differ between the two groups. A total of 22 pregnancies were obtained (13 in group A and 9 in group B; P=0.26). Clinical pregnancy rate and implantation rate were in tendency higher in the group cotreated with melatonin, although the differences did not reach statistical significance. Biochemical pregnancy rate and abortion rate were similar in both groups. melatonin ameliorates the activity of myo-inositol and folic acid by improving oocyte quality and pregnancy outcome in women with low oocyte quality history.

  18. Serum levels of 14-3-3η protein supplement C-reactive protein and rheumatoid arthritis-associated antibodies to predict clinical and radiographic outcomes in a prospective cohort of patients with recent-onset inflammatory polyarthritis.

    Science.gov (United States)

    Carrier, Nathalie; Marotta, Anthony; de Brum-Fernandes, Artur J; Liang, Patrick; Masetto, Ariel; Ménard, Henri A; Maksymowych, Walter P; Boire, Gilles

    2016-02-01

    Age, C-Reactive Protein (CRP) and autoantibodies (Abs) are associated with worse prognosis in patients with recent-onset inflammatory polyarthritis (EPA). Serum 14-3-3η protein is a joint-derived biomarker that up-regulates cytokines and enzymes that perpetuate local and systemic inflammation and may contribute to joint damage. Our objective was to evaluate, over a 5-year prospective period of observation, the additional prognostic potential of serum 14-3-3η protein in EPA patients. Clinical variables, serum and radiographs (scored according to the Sharp/van der Heijde (SvH) method) were collected serially. Relationships between serum 14-3-3η protein and other biomarkers were computed with Spearman correlations. Outcomes were Simple Disease Activity Index (SDAI) scores and joint damage progression: ΔSvH for SvH score and ΔErosion for its Erosive component. The additional predictive contribution of 14-3-3η was defined using generalized estimating equations (GEE) and generalized linear mixed models (GLMM). Among 331 patients, baseline 14-3-3η was ≥0.19 and ≥0.50 ng/ml in 153 (46.2 %) and 119 (36.0 %), respectively; CRP was >8.0 mg/L in 207 (62.5 %), and at least one Ab (Rheumatoid Factor, anti-CCP2 or anti-Sa/citrullinated vimentin) was positive in 170 (51.5 %). Elevated 14-3-3η levels moderately correlated with positive Abs, but not with elevated CRP. Baseline 14-3-3η ≥0.19 ng/ml was associated with more radiographic progression over 5 years. The optimal levels of baseline 14-3-3η to predict radiographic progression was defined by ROC curves at 0.50 ng/ml. Levels of 14-3-3η ≥0.50 ng/ml at baseline were associated with lower likelihoods of ever reaching SDAI remission (RR 0.79 (95 % CI 0.64-0.98), p = 0.03) and higher subsequent progression of Total and Erosion SvH scores. Elevated levels of 14-3-3η during follow-up also predicted higher subsequent progression, even in patients in SDAI remission. Decreases of 14-3-3η levels by at least 0

  19. Building sustainable multi-functional prospective electronic clinical data systems.

    Science.gov (United States)

    Randhawa, Gurvaneet S; Slutsky, Jean R

    2012-07-01

    A better alignment in the goals of the biomedical research enterprise and the health care delivery system can help fill the large gaps in our knowledge of the impact of clinical interventions on patient outcomes in the real world. There are several initiatives underway to align the research priorities of patients, providers, researchers, and policy makers. These include Agency for Healthcare Research and Quality (AHRQ)-supported projects to build flexible prospective clinical electronic data infrastructure that meet the needs of these diverse users. AHRQ has previously supported the creation of 2 distributed research networks as a new approach to conduct comparative effectiveness research (CER) while protecting a patient's confidential information and the proprietary needs of a clinical organization. It has applied its experience in building these networks in directing the American Recovery and Reinvestment Act funds for CER to support new clinical electronic infrastructure projects that can be used for several purposes including CER, quality improvement, clinical decision support, and disease surveillance. In addition, AHRQ has funded a new Electronic Data Methods forum to advance the methods in clinical informatics, research analytics, and governance by actively engaging investigators from the American Recovery and Reinvestment Act-funded projects and external stakeholders.

  20. Clinical outcome and radiographic results after operative treatment of Scheuermann's disease

    NARCIS (Netherlands)

    Poolman, R. W.; Been, H. D.; Ubags, L. H.

    2002-01-01

    The aim of this prospective study was to evaluate radiographic findings, patient satisfaction and clinical outcome, and to report complications and instrumentation failure after operative treatment of Scheuermann's disease using a combined anterior and posterior spondylodesis. The loss of sagittal

  1. The influence of neck thrombus on clinical outcome and aneurysm morphology after endovascular aneurysm repair

    NARCIS (Netherlands)

    F.M.V. Bastos Gonçalves (Frederico); H.J.M. Verhagen (Hence); K. Chinsakchai (Khamin); J.W. van Keulen (Jasper); M.T. Voûte (Michiel); H.J.A. Zandvoort (Herman); F.L. Moll (Frans); J.A. van Herwaarden (Joost)

    2012-01-01

    textabstractObjective: This study investigated the influence of significant aneurysm neck thrombus in clinical and morphologic outcomes after endovascular aneurysm repair (EVAR). Methods: The patient population was derived from a prospective EVAR database from two university institutions in The

  2. 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 ...

  3. The clinical characteristics, therapy and outcome of 85 adults with acute lymphoblastic leukemia and t(4;11)(q21;q23)/MLL-AFF1 prospectively treated in the UKALLXII/ECOG2993 trial

    Science.gov (United States)

    Marks, David I.; Moorman, Anthony V.; Chilton, Lucy; Paietta, Elisabeth; Enshaie, Amir; DeWald, Gordon; Harrison, Christine J.; Fielding, Adele K.; Foroni, Letizia; Goldstone, Anthony H.; Litzow, Mark R.; Luger, Selina M.; McMillan, Andrew K.; Racevskis, Janis; Rowe, Jacob M.; Tallman, Martin S.; Wiernik, Peter; Lazarus, Hillard M.

    2013-01-01

    The biology and outcome of adult t(4;11)(q21;q23)/MLL-AFF1 acute lymphoblastic leukemia are poorly understood. We describe the outcome and delineate prognostic factors and optimal post-remission therapy in 85 consecutive patients (median age 38 years) treated uniformly in the prospective trial UKALLXII/ECOG2993. The immunophenotype of this leukemia was pro-B (CD10NEG). Immaturity was further suggested by high expression of the stem-cell antigens, CD133 and CD135, although CD34 expression was significantly lower than in t(4;11)-negative patients. Complete remission was achieved in 77 (93%) patients but only 35% survived 5 years (95% CI: 25–45%); the relapse rate was 45% (95% CI: 33–58%). Thirty-one patients underwent allogeneic transplantation in first remission (15 sibling donors and 16 unrelated donors): with 5-year survival rates of 56% and 67% respectively, only 2/31 patients relapsed. This compares with a 24% survival rate and 59% relapse rate in 46 patients who received post-remission chemotherapy. A major determinant of outcome was age with 71% of patients aged <25 years surviving. Younger patients had lower relapse rates (19%) but most received allografts in first complete remission. In conclusion, multivariate analysis did not demonstrate an advantage of allografting over chemotherapy but only five younger patients received chemotherapy. Prospective trials are required to determine whether poor outcomes in older patients can be improved by reduced-intensity conditioning allografts. NCT00002514 www.clinicaltrials.gov PMID:23349309

  4. 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....

  5. 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...

  6. MANAGEMENT AND OUTCOMES FROM APPENDECTOMY: AN INTERNATIONAL, PROSPECTIVE, MULTICENTRE STUDY.

    Science.gov (United States)

    Camilleri-Brennan, J; Drake, T; Spence, R; Bhangu, A; Harrison, E

    2017-09-01

    To identify variation in surgical management and outcomes of appendicitis across low, middle and high Human Development Index (HDI) country groups. Multi-centre, international prospective cohort study of consecutive patients undergoing emergency appendectomy over a 6-month period. Follow-up lasted 30 days. Primary outcome measure was overall complication rate. 4546 patients from 52 countries underwent appendectomy (2499 high, 1540 middle and 507 low HDI groups). Complications were more frequent in low-HDI (OR 3.81, 95% CI 2.78 to 5.19, p accounting for case-mix, laparoscopy was still associated with fewer complications (OR 0.55, 95% CI 0.42 to 0.71, pintroduction of laparoscopy that if overcome, could result in significantly improved outcomes for patients in low-resource environments, with potential for wider health-system benefits.

  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. Outcome of retrospective and prospective multicenter cooperative clinical studies of spinal lipoma aiming for elucidating its natural history and for planning its treatment, and usefulness of neuroendoscope in its diagnosis and surgery assistance

    International Nuclear Information System (INIS)

    Suzuki, Michiyasu; Nomura, Sadahiro; Oi, Shizuo; Mori, Hiroshi; Nonaka, Yuichiro; Tamogami, Ryo; Khasawneh, Nidal; Jianxin, Du

    2008-01-01

    The rate of manifestation of spinal lipoma (SL) is essentially unknown and propriety of its treatment is still controversial. Started in 2006 a prospective study by 7 facilities (COE-SB Top 7) to elucidate the natural history by such a mean as seeing the age distribution in SL manifestation, and to find applicable factors for conducting prophylactic surgery by such evaluation as improvable symptoms and surgical complication. Facilities also retrospectively summarized their outcomes of surgery and of conservative follow-up in the past 5 years. Further, evaluated was the usefulness of neuroendoscopic observation and assistance in diagnosis and operation, because diagnosis for predicting the neurological prognosis is often difficult by preoperative MRI alone and is changeable by surgical findings due to complex SL structures. This paper is a report describing tentative results of the prospective study above in the first 1 year, of the retrospective one and of the endoscopic utility. Subjects were 45 patients (21 cases, <1 year after birth; asymptomatic, 29 and symptomatic, 16) in the prospective study and 261 patients (asymptomatic, 159 and symptomatic, 102) in the retrospective. The endoscope used was an Oi-Samii Handy Pro type. Neurological symptom was assessed by Spina Befida Neurological Scale (1992). Patients were classified according to Embryo-pathogenetic and Surgico-anatomical Classification of Spina Bifida (2002). Results were: the prevalence was 15% at birth and increased afterwards; prognosis post surgery was poor in transitional SL; symptomatic improvement by operation was small; operative complication was scarce; and endoscope was conceivably useful for diagnosis and operative assistance. (R.T.)

  9. 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?...

  10. The effect of diabetes mellitus on outcomes of patients with nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: data from a prospective double-blind clinical trial comparing treatment with linezolid versus vancomycin.

    Science.gov (United States)

    Equils, Ozlem; da Costa, Christopher; Wible, Michele; Lipsky, Benjamin A

    2016-09-06

    The presence of diabetes mellitus increases the risk of several severe infections, but data on its effect on treatment outcomes in patients with nosocomial pneumonia (NP) caused by methicillin-resistant Staphylococcus aureus (MRSA) are limited. We retrospectively analyzed data from a double-blind, randomized, multi-center, international clinical trial of culture-confirmed MRSA NP that compared treatment with linezolid to vancomycin. Specifically, we evaluated the clinical and microbiologic outcomes of patients with and without diabetes in the modified intent to treat population at end-of-treatment (EOT) and end-of-study (EOS, 7-30 days post-EOT). Among 448 enrolled patients 183 (40.8 %) had diabetes mellitus, 87 (47.5 %) of whom received linezolid and 96 (52.5 %) vancomycin. Baseline demographic and clinical characteristics were similar for the two treatment groups. Clinical success rates at EOS were 57.6 % with linezolid and 39.3 % with vancomycin, while microbiological success rates were 58.9 % with linezolid and 41.1 % with vancomycin. Among diabetic patients, rates of mortality and study drug-related adverse effects were similar between the treatment groups. Overall day 28 mortality rates were higher among diabetic patients compared to non-diabetic patients (23.5 vs 14.7 %, respectively: RD = 8.8 %, 95 % CI [1.4, 16.3]). Among diabetic patients with MRSA NP, treatment with linezolid, compared to vancomycin, was associated with higher clinical and microbiologic success rates, and comparable adverse event rates. NCT00084266 .

  11. 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?...

  12. 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 ...

  13. 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

  14. 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)

  15. Immediate Loading of Implants in the Edentulous Maxilla with a Fixed Provisional Restoration without Bone Augmentation: A Report on 5-Year Outcomes Data Obtained from a Prospective Clinical Trial.

    Science.gov (United States)

    Toljanic, Joseph A; Ekstrand, Karl; Baer, Russell A; Thor, Andreas

    2016-01-01

    Successful immediate loading of implants in the edentulous maxilla has been previously reported. The purpose of this 5-year prospective study was to further assess long-term outcomes following immediate loading of implants in the edentulous maxilla with fixed provisional restorations without the use of bone augmentation procedures. Subjects with edentulous maxillary arches each received six implants placed in native bone without augmentation. Where insufficient posterior bone volume existed, angled implant placement was employed. Fixed provisional restorations were delivered within 24 hours of implant placement. Implant placement locations, insertion torque values, and implant dimensions were recorded. Definitive fixed prostheses were placed within 24 weeks following implantation. Baseline implant site marginal bone levels were measured using periapical radiographs. Baseline peri-implant plaque and bleeding scores were obtained. Subjects were examined 6 months after implant placement and then annually for 5 years with follow-up periapical radiographs and plaque/bleeding scores obtained. Fifty-one subjects received a total of 306 implants. Forty subjects with 232 implants returned for the final follow-up appointment representing a 5-year implant survival proportion of 93% with a mean marginal bone loss of 0.44 ± 1.25 mm for this group. Thirty-nine of these 40 subjects continued to function with fixed restorations with the remaining subject functioning with a non-implant-retained removable prosthesis. Within the limitations of this study, predictable long-term implant rehabilitation outcomes were demonstrated for the edentulous maxilla using an immediate loading protocol without bone augmentation.

  16. Clinical science: prospects, payment and public policy.

    Science.gov (United States)

    Raslavicus, P A

    1999-01-01

    The last several decades of this century have witnessed significant changes in health care financing and delivery. Similar changes have occurred within laboratory medicine. While government involvement has been principally in insurance and the control of costs through regulation, the demise of the Clinton Health Plan ushered in an era of deregulation and market competition. In this environment, clinical science and clinical scientists have a new challenge: to prove their worth by establishing methods in which their services and tests are more clinically efficient than competing approaches.

  17. Influence of body habitus on feasibility and outcome of laparoscopic liver resections: a prospective study.

    Science.gov (United States)

    Ratti, Francesca; D'Alessandro, Valentina; Cipriani, Federica; Giannone, Fabio; Catena, Marco; Aldrighetti, Luca

    2016-06-01

    The aim of the present study was to prospectively investigate whether the anthropometric measures of A Body Shape Index (ABSI, taking into account waist circumference adjusted for height and weight) affects feasibility and outcome of laparoscopic liver resections. One hundred patients undergoing laparoscopic liver resection were prospectively included in the study (2014-2015). Preoperative clinical parameters, including body mass index (BMI) and ABSI were evaluated for associations with intraoperative outcome and postoperative results (morbidity, mortality and functional recovery). Twenty-two and 78 patients underwent major and minor hepatectomies, respectively. Conversion rate was 9%, mean blood loss was 210 ± 115 ml. Postoperative morbidity was 15% and mortality was nil. Mean length of stay was 4 days. When considering the entire series, ABSI was not associated with intra and postoperative outcome. After stratification of patients according to difficulty score, Pearson's correlation demonstrated an association between ABSI and intraoperative blood loss (P = 0.03) and time for functional recovery (P = 0.05) in patients undergoing resections with high score of difficulty. Body habitus has an influence on outcome of laparoscopic liver resections with high degree of difficulty, while feasibility and outcome of low difficulty resections seem not to be affected by anthropometric measures. © 2016 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

  18. Detailed prospective peer review in a community radiation oncology clinic.

    Science.gov (United States)

    Mitchell, James D; Chesnut, Thomas J; Eastham, David V; Demandante, Carlo N; Hoopes, David J

    In 2012, we instituted detailed prospective peer review of new cases. We present the outcomes of peer review on patient management and time required for peer review. Peer review rounds were held 3 to 4 days weekly and required 2 physicians to review pertinent information from the electronic medical record and treatment planning system. Eight aspects were reviewed for each case: 1) workup and staging; 2) treatment intent and prescription; 3) position, immobilization, and simulation; 4) motion assessment and management; 5) target contours; 6) normal tissue contours; 7) target dosimetry; and 8) normal tissue dosimetry. Cases were marked as, "Meets standard of care," "Variation," or "Major deviation." Changes in treatment plan were noted. As our process evolved, we recorded the time spent reviewing each case. From 2012 to 2014, we collected peer review data on 442 of 465 (95%) radiation therapy patients treated in our hospital-based clinic. Overall, 91 (20.6%) of the cases were marked as having a variation, and 3 (0.7%) as major deviation. Forty-two (9.5%) of the cases were altered after peer review. An overall peer review score of "Variation" or "Major deviation" was highly associated with a change in treatment plan (P peer review. Indicators on position, immobilization, simulation, target contours, target dosimetry, motion management, normal tissue contours, and normal tissue dosimetry were significantly associated with a change in treatment plan. The mean time spent on each case was 7 minutes. Prospective peer review is feasible in a community radiation oncology practice. Our process led to changes in 9.5% of cases. Peer review should focus on technical factors such as target contours and dosimetry. Peer review required 7 minutes per case. Published by Elsevier Inc.

  19. No difference in outcome for open versus arthroscopic rotator cuff repair: a prospective comparative trial.

    Science.gov (United States)

    Bayle, Xavier; Pham, Thuy-Trang; Faruch, Marie; Gobet, Aurelie; Mansat, Pierre; Bonnevialle, Nicolas

    2017-12-01

    Arthroscopic techniques tend to become the gold standard in rotator cuff repair. However, little data are reported in the literature regarding the improvement of postoperative outcomes and re-tear rate relative to conventional open surgery. The aim of this study was to compare clinical outcomes and cuff integrity after arthroscopic versus open cuff repair. We prospectively assessed clinical outcomes and cuff integrity after an arthroscopic or open rotator cuff repair with a minimum follow-up of 12 months. Clinical evaluation was based on Constant score, Simple Shoulder Value (SSV) and American Shoulder and Elbow Score (ASES). Rotator cuff healing was explored with ultrasound. 44 patients in arthroscopic group A (mean age 56-year-old) and 43 in open group O (mean age 61-year-old) fulfilled the inclusion criteria. Tendons were repaired with a single row technique associated with biceps tenodesis and subacromial decompression. All objective clinical scores significantly improved postoperatively in both groups. No statistical difference was identified between group A and O regarding, respectively, Constant score (72 vs 75 points; p = 0.3), ASES score (88 vs 91 points; p = 0.3), and SSV (81 vs 85%). The overall rate of re-tear (Sugaya type IV or V) reached 7 and 9%, respectively, in group A and O (p = 0.8). This study did not prove any difference of arthroscopic over open surgery in case of rotator cuff repair regarding clinical outcome and cuff integrity at 1-year follow-up. Prospective comparative study.

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

    NARCIS (Netherlands)

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

    2018-01-01

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

  1. Maternal thyroid function and the outcome of external cephalic version: a prospective cohort study

    Science.gov (United States)

    2011-01-01

    Background To investigate the relation between maternal thyroid function and the outcome of external cephalic version (ECV) in breech presentation. Methods Prospective cohort study in 141 women (≥ 35 weeks gestation) with a singleton fetus in breech. Blood samples for assessing thyroid function were taken prior to ECV. Main outcome measure was the relation between maternal thyroid function and ECV outcome indicated by post ECV ultrasound. Results ECV success rate was 77/141 (55%), 41/48 (85%) in multipara and 36/93 (39%) in primipara. Women with a failed ECV attempt had significantly higher TSH concentrations than women with a successful ECV (p breech (OR: 0.30, 95% CI: 0.10-0.93) and placenta anterior (OR: 0.31, 95% CI: 0.11-0.85) were independently related to ECV success. Conclusions Higher TSH levels increase the risk of ECV failure. Trial registration number ClinicalTrials.gov: NCT00516555 PMID:21269431

  2. Maternal thyroid function and the outcome of external cephalic version: a prospective cohort study

    Directory of Open Access Journals (Sweden)

    van der Donk Riet W

    2011-01-01

    Full Text Available Abstract Background To investigate the relation between maternal thyroid function and the outcome of external cephalic version (ECV in breech presentation. Methods Prospective cohort study in 141 women (≥ 35 weeks gestation with a singleton fetus in breech. Blood samples for assessing thyroid function were taken prior to ECV. Main outcome measure was the relation between maternal thyroid function and ECV outcome indicated by post ECV ultrasound. Results ECV success rate was 77/141 (55%, 41/48 (85% in multipara and 36/93 (39% in primipara. Women with a failed ECV attempt had significantly higher TSH concentrations than women with a successful ECV (p Conclusions Higher TSH levels increase the risk of ECV failure. Trial registration number ClinicalTrials.gov: NCT00516555

  3. Clinical Linguistics--Retrospect and Prospect.

    Science.gov (United States)

    Grunwell, Pamela

    In the past 20 years, linguistics has gained a prominent position in speech and language pathology in Britain, evolving into a new field, clinical linguistics. It includes three related areas of activity: training of speech pathologists/therapists; professional practice; and research. Linguistics and speech/language pathology have developed as…

  4. Prospective evaluation of outcome measures in free-flap surgery.

    LENUS (Irish Health Repository)

    Kelly, John L

    2004-08-01

    Free-flap failure is usually caused by venous or arterial thrombosis. In many cases, lack of experience and surgical delay also contribute to flap loss. The authors prospectively analyzed the outcome of 57 free flaps over a 28-month period (January, 1999 to April, 2001). The setting was a university hospital tertiary referral center. Anastomotic technique, ischemia time, choice of anticoagulant, and the grade of surgeon were recorded. The type of flap, medications, and co-morbidities, including preoperative radiotherapy, were also documented. Ten flaps were re-explored (17 percent). There were four cases of complete flap failure (6.7 percent) and five cases of partial failure (8.5 percent). In patients who received perioperative systemic heparin or dextran, there was no evidence of flap failure (p = .08). The mean ischemia time was similar in flaps that failed (95 +\\/- 29 min) and in those that survived (92 +\\/- 34 min). Also, the number of anastomoses performed by trainees in flaps that failed (22 percent), was similar to the number in flaps that survived (28 percent). Nine patients received preoperative radiotherapy, and there was complete flap survival in each case. This study reveals that closely supervised anastomoses performed by trainees may have a similar outcome to those performed by more senior surgeons. There was no adverse effect from radiotherapy or increased ischemia time on flap survival.

  5. 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.

  6. Surgical outcomes for perforated peptic ulcer: A prospective case series at an academic hospital in Monrovia, Liberia

    OpenAIRE

    Moses, J. Fallah; Hughes, Christopher D.; Patel, Pratik B.; Chao, Tiffany E.; Konneh, Solomane A.; Jallabah, Torsou Y.; Kikubaire, Michael Kiiza; Meara, John G.; Hagander, Lars

    2015-01-01

    Introduction The incidence of perforated peptic ulcer remains high in low and middle-income countries. Mortality can be significant, and early surgical management with careful evaluation of pre-operative risk factors is essential. The purpose of this study was to describe the clinical outcomes of surgical treatment for perforated peptic ulcer disease in Liberia and to explore risk factors for adverse outcomes. Methods This study prospectively examined 20 consecutive patients undergoing primar...

  7. Case-Mix, Care Processes, and Outcomes in Medically-Ill Patients Receiving Mechanical Ventilation in a Low-Resource Setting from Southern India: A Prospective Clinical Case Series.

    Science.gov (United States)

    Karthikeyan, Balasubramanian; Kadhiravan, Tamilarasu; Deepanjali, Surendran; Swaminathan, Rathinam Palamalai

    2015-01-01

    Mechanical ventilation is a resource intensive organ support treatment, and historical studies from low-resource settings had reported a high mortality. We aimed to study the outcomes in patients receiving mechanical ventilation in a contemporary low-resource setting. We prospectively studied the characteristics and outcomes (disease-related, mechanical ventilation-related, and process of care-related) in 237 adults mechanically ventilated for a medical illness at a teaching hospital in southern India during February 2011 to August 2012. Vital status of patients discharged from hospital was ascertained on Day 90 or later. Mean age of the patients was 40 ± 17 years; 140 (51%) were men. Poisoning and envenomation accounted for 98 (41%) of 237 admissions. In total, 87 (37%) patients died in-hospital; 16 (7%) died after discharge; 115 (49%) were alive at 90-day assessment; and 19 (8%) were lost to follow-up. Weaning was attempted in 171 (72%) patients; most patients (78 of 99 [79%]) failing the first attempt could be weaned off. Prolonged mechanical ventilation was required in 20 (8%) patients. Adherence to head-end elevation and deep vein thrombosis prophylaxis were 164 (69%) and 147 (62%) respectively. Risk of nosocomial infections particularly ventilator-associated pneumonia was high (57.2 per 1,000 ventilator-days). Higher APACHE II score quartiles (adjusted HR [95% CI] quartile 2, 2.65 [1.19-5.89]; quartile 3, 2.98 [1.24-7.15]; quartile 4, 5.78 [2.45-13.60]), and new-onset organ failure (2.98 [1.94-4.56]) were independently associated with the risk of death. Patients with poisoning had higher risk of reintubation (43% vs. 20%; P = 0.001) and ventilator-associated pneumonia (75% vs. 53%; P = 0.001). But, their mortality was significantly lower compared to the rest (24% vs. 44%; P = 0.002). The case-mix considerably differs from other settings. Mortality in this low-resource setting is similar to high-resource settings. But, further improvements in care processes

  8. Case-Mix, Care Processes, and Outcomes in Medically-Ill Patients Receiving Mechanical Ventilation in a Low-Resource Setting from Southern India: A Prospective Clinical Case Series.

    Directory of Open Access Journals (Sweden)

    Balasubramanian Karthikeyan

    Full Text Available Mechanical ventilation is a resource intensive organ support treatment, and historical studies from low-resource settings had reported a high mortality. We aimed to study the outcomes in patients receiving mechanical ventilation in a contemporary low-resource setting.We prospectively studied the characteristics and outcomes (disease-related, mechanical ventilation-related, and process of care-related in 237 adults mechanically ventilated for a medical illness at a teaching hospital in southern India during February 2011 to August 2012. Vital status of patients discharged from hospital was ascertained on Day 90 or later.Mean age of the patients was 40 ± 17 years; 140 (51% were men. Poisoning and envenomation accounted for 98 (41% of 237 admissions. In total, 87 (37% patients died in-hospital; 16 (7% died after discharge; 115 (49% were alive at 90-day assessment; and 19 (8% were lost to follow-up. Weaning was attempted in 171 (72% patients; most patients (78 of 99 [79%] failing the first attempt could be weaned off. Prolonged mechanical ventilation was required in 20 (8% patients. Adherence to head-end elevation and deep vein thrombosis prophylaxis were 164 (69% and 147 (62% respectively. Risk of nosocomial infections particularly ventilator-associated pneumonia was high (57.2 per 1,000 ventilator-days. Higher APACHE II score quartiles (adjusted HR [95% CI] quartile 2, 2.65 [1.19-5.89]; quartile 3, 2.98 [1.24-7.15]; quartile 4, 5.78 [2.45-13.60], and new-onset organ failure (2.98 [1.94-4.56] were independently associated with the risk of death. Patients with poisoning had higher risk of reintubation (43% vs. 20%; P = 0.001 and ventilator-associated pneumonia (75% vs. 53%; P = 0.001. But, their mortality was significantly lower compared to the rest (24% vs. 44%; P = 0.002.The case-mix considerably differs from other settings. Mortality in this low-resource setting is similar to high-resource settings. But, further improvements in care processes

  9. 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.

  10. [Clinical nursing manpower: development and future prospects].

    Science.gov (United States)

    Lin, Chiou-Fen; Kao, Ching-Chiu

    2014-04-01

    The significant changes in nursing manpower utilization in Taiwan over the past two decades are due in large part to the implementation of the National Health Insurance program and the rising need for long-term care. The changes have impacted clinical nursing manpower utilization in two important ways. Firstly, there has been a substantial increase in overall demand for nursing manpower. In particular, the need for clinical nurses has nearly quadrupled during this time period. Secondly, the level of difficulty involved in patient care has risen dramatically, with factors including increased disease severity and increased care quality expectations, among others. These changes, coupled with demands on nursing manpower imposed from other sectors, underpin and further exacerbate the problem of nursing manpower shortages throughout the healthcare system. To raise the quality of the nursing work environment, the Ministry of Health and Welfare (MOHW) brought together Taiwan's key professional nursing organizations to promote 10 care-reform strategies, establish the nursing-aid manpower system, and create the nursing classification system as an approach to effectively attract nurses to take positions in the medical system.

  11. Prospective of clinical drugs for radioprotection

    International Nuclear Information System (INIS)

    Alok, Amit; Kumar, Sandeep; Kumar, Arun; Chaudhury, N.K.

    2014-01-01

    We are living in an era of nuclear power where power derived from nuclear reaction is used for power generation as well as for nuclear weapons. The terrorism and the threat of dirty bombs looms around the civilized population. Therefore, there is a need to develop radioprotector which could prevent against the harmful effect of radiation. The research on radioprotector started more than fifty years ago but still there is no approved radioprotector in the drug market. Hundreds of lead molecule have been screened and have shown varying amount of radioprotection either in vitro or in vivo or in both. Only one drug amifostine was approved by FDA but due to its toxicity in head and neck cancer, this drug is no more in use. Antioxidants too have proven to be a potential radioprotector but the dose required for radioprotection is too high for maintenance of homeostasis in physiological system. We have taken an alternative approach of using clinical drugs like diclofenac and tetracycline for development of approach for radioprotection and reported the radioprotective role of diclofenac. The advantage of using clinical drug is its wide availability in the market and the ease with which it could be channelized for radioprotection. Antiradical assays have demonstrated possible use of tetracycline for radioprotection. Tetracycline has also ability to reduce oxidative damages ex vivo. Studies related to comet assay as well as antioxidant assays in different organs are in progress for designing further work for efficacy and elucidation of mechanisms. (author)

  12. Coleopteran Antimicrobial Peptides: Prospects for Clinical Applications

    Directory of Open Access Journals (Sweden)

    Monde Ntwasa

    2012-01-01

    Full Text Available Antimicrobial peptides (AMPs are activated in response to septic injury and have important roles in vertebrate and invertebrate immune systems. AMPs act directly against pathogens and have both wound healing and antitumor activities. Although coleopterans comprise the largest and most diverse order of eukaryotes and occupy an earlier branch than Drosophila in the holometabolous lineage of insects, their immune system has not been studied extensively. Initial research reports, however, indicate that coleopterans possess unique immune response mechanisms, and studies of these novel mechanisms may help to further elucidate innate immunity. Recently, the complete genome sequence of Tribolium was published, boosting research on coleopteran immunity and leading to the identification of Tribolium AMPs that are shared by Drosophila and mammals, as well as other AMPs that are unique. AMPs have potential applicability in the development of vaccines. Here, we review coleopteran AMPs, their potential impact on clinical medicine, and the molecular basis of immune defense.

  13. Prospects of Nanotechnology in Clinical Immunodiagnostics

    Directory of Open Access Journals (Sweden)

    Abdull S. Aldwayyan

    2010-07-01

    Full Text Available Nanostructured materials are promising compounds that offer new opportunities as sensing platforms for the detection of biomolecules. Having micrometer-scale length and nanometer-scale diameters, nanomaterials can be manipulated with current nanofabrication methods, as well as self-assembly techniques, to fabricate nanoscale bio-sensing devices. Nanostructured materials possess extraordinary physical, mechanical, electrical, thermal and multifunctional properties. Such unique properties advocate their use as biomimetic membranes to immobilize and modify biomolecules on the surface of nanoparticles. Alignment, uniform dispersion, selective growth and diameter control are general parameters which play critical roles in the successful integration of nanostructures for the fabrication of bioelectronic sensing devices. In this review, we focus on different types and aspects of nanomaterials, including their synthesis, properties, conjugation with biomolecules and their application in the construction of immunosensing devices. Some key results from each cited article are summarized by relating the concept and mechanism behind each sensor, experimental conditions and the behavior of the sensor under different conditions, etc. The variety of nanomaterial-based bioelectronic devices exhibiting novel functions proves the unique properties of nanomaterials in such sensing devices, which will surely continue to expand in the future. Such nanomaterial based devices are expected to have a major impact in clinical immunodiagnostics, environmental monitoring, security surveillance and for ensuring food safety.

  14. 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.

  15. Esthetic outcome and alterations of soft tissue around single implant crowns: a 2-year prospective study.

    Science.gov (United States)

    Gu, Ying-Xin; Shi, Jun-Yu; Zhuang, Long-Fei; Qiao, Shi-Chong; Xu, You-You; Lai, Hong-Chang

    2015-08-01

    The aim of this prospective study was to assess the esthetic outcome and alterations of peri-implant soft tissue using tissue-level implants. Furthermore, the influencing factors, including grafting and gingival biotype, of esthetic outcome of peri-implant soft tissue were also evaluated. Of 38 patients with single missing anterior tooth in maxilla were treated with a Straumann (®) Standard Plus SLA implant. Bone augmentation was performed in 24 patients. Follow-up was conducted at 12 and 24 months after definitive crowns placement. Esthetic outcome using the pink esthetic score/white esthetic score (PES/WES) and clinical parameters were evaluated. The mean PES/WES value at baseline, 1-year, and 2-year examination was 13.79, 14.87, and 14.96. Significant improvement was found between baseline and 1-year examination (P esthetic area. Favorable short-term esthetic outcome and stability of soft tissue around single implant crowns can be expected in patients with or without graft. However, graft procedures might have an unfavorable effect on the esthetic outcome. Gingival biotype can be considered as prognostic factor for esthetic outcome. RCTs with long-term follow-up are needed to provide evidence for the long-term stability of peri-implant soft tissue using tissue-level implant systems. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  16. 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

  17. [Current status and clinical application prospect of Akabane's test].

    Science.gov (United States)

    Wang, Wenjie; Du, Yanjun

    2016-06-12

    The Akabane's test is one of the meridian diagnostic methods. Compared with the current meridian diagnostic methods, it has the advantages of convenience and efficiency, but it also has several disadvantages such as the accuracy is difficult to control, the outcome interpretation is limited, etc. In this paper, the influence factors of Akabane's test were analyzed one by one, especially proposed personal opinion on outcome interpretation, which could ascertain the location and nature of disease, leading to disease syndrome. With accurate syndrome, the treatment plan could be established. The application prospect of Akabane's test was initially explored, and it was proposed that wearable automation equipment could be one of the development directions.

  18. 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.

  19. Telemedicine in a pediatric headache clinic: A prospective survey.

    Science.gov (United States)

    Qubty, William; Patniyot, Irene; Gelfand, Amy

    2018-05-08

    The aim of this prospective study was to survey our patients about their experience with our clinic's telemedicine program to better understand telemedicine's utility for families, and to improve patient satisfaction and ultimately patient care. This was a prospective survey study of patients and their families who had a routine telemedicine follow-up visit with the University of California San Francisco Pediatric Headache Program. The survey was administered to patients and a parent(s) following their telemedicine visit. Fifty-one of 69 surveys (74%) were completed. All (51/51) patients and families thought that (1) telemedicine was more convenient compared to a clinic visit, (2) telemedicine caused less disruption of their daily routine, and (3) they would choose to do telemedicine again. The mean round-trip travel time from home to clinic was 6.8 hours (SD ± 8.6 hours). All participants thought telemedicine was more cost-effective than a clinic visit. Parents estimated that participating in a telemedicine visit instead of a clinic appointment saved them on average $486. This prospective, pediatric headache telemedicine study shows that telemedicine is convenient, perceived to be cost-effective, and patient-centered. Providing the option of telemedicine for routine pediatric headache follow-up visits results in high patient and family satisfaction. © 2018 American Academy of Neurology.

  20. 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.)

  1. 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.)

  2. 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.

  3. 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)

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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/

  9. 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.

  10. 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.

  11. Stroke presentation and outcome in developing countries: a prospective study in the Gambia.

    Science.gov (United States)

    Garbusinski, Johanne M; van der Sande, Marianne A B; Bartholome, Emmanuel J; Dramaix, Michèle; Gaye, Alieu; Coleman, Rosalind; Nyan, Ousman A; Walker, Richard W; McAdam, Keith P W J; Walraven, Gys E

    2005-07-01

    Despite increasing burden of stroke in Africa, prospective descriptive data are rare. Our objective was to describe, in The Gambia, the clinical outcome of stroke patients admitted to the Royal Victoria Teaching Hospital in the capital Banjul, to assess mortality and morbidity, and propose preventive and therapeutic measures. Prospective data were collected on consecutive patients older than 15 years old admitted between February 2000 and February 2001 with the diagnosis of nonsubarachnoid stroke. Risk factors, clinical characteristics, and social consequences were assessed using a modified National Institutes of Health Stroke Scale (mNIHSS), the Barthel Activity in Daily Living scale, the Siriraj score for subtypes, and the Bamford criteria for location/extension. Patients were followed-up at home up to 1 year after discharge. Ninety-one percent (148/162) of eligible patients were enrolled and followed-up. Hypertension and smoking were the most prevalent risk factors. Severity was high at admission, especially in women, and was strongly correlated to the outcome. mNIHSS and consciousness level on admission were strong predictors of the mortality risk. Swallowing difficulties at admission, fever, lung infection, and no aspirin treatment were, independently, risk factors for a lethal outcome susceptible to being addressed by treatment. Mortality was 41% in-hospital and 62% after 1 year. In survivors, autonomy levels improved over time. Drug compliance was poor. At home, family members provided care. Long-term socioeconomic and cultural activities were affected in most patients. Case-fatality was high compared with Western cohorts. Preventive measures can be developed. Rational treatment, in the absence of head imaging for initial assessment, requires adapted protocols. Providers should be trained, both at hospital and community levels.

  12. 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.

  13. Clinical Features and Outcome of Mucormycosis

    Directory of Open Access Journals (Sweden)

    Carlos Rodrigo Camara-Lemarroy

    2014-01-01

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

  14. Sinonasal outcomes following endoscopic anterior skull base surgery with nasoseptal flap reconstruction: a prospective study.

    Science.gov (United States)

    Hanson, M; Patel, P M; Betz, C; Olson, S; Panizza, B; Wallwork, B

    2015-07-01

    To assess nasal morbidity resulting from nasoseptal flap use in the repair of skull base defects in endoscopic anterior skull base surgery. Thirty-six patients awaiting endoscopic anterior skull base surgery were prospectively recruited. A nasoseptal flap was used for reconstruction in all cases. Patients were assessed pre-operatively and 90 days post-operatively via the Sino-Nasal Outcome Test 20 questionnaire and visual analogue scales for nasal obstruction, pain, secretions and smell; endoscopic examination findings and mucociliary clearance times were also recorded. Sino-Nasal Outcome Test 20 questionnaire data and visual analogue scale scores for pain, smell and secretions showed no significant differences between pre- and post-operative outcomes, with visual analogue scale scores for nasal obstruction actually showing a significant improvement (p = 0.0007). A significant deterioration for both flap and non-flap sides was demonstrated post-operatively on endoscopic examination (p = 0.002 and p = 0.02 respectively). Whilst elevation of a nasoseptal flap in endoscopic surgery of the anterior skull base engendered significant clinical deterioration on examination post-operatively, quality of life outcomes showed that no such deterioration was subjectively experienced by the patient. In fact, there was significant nasal airway improvement following nasoseptal flap reconstruction.

  15. 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

  16. Methadone and perinatal outcomes: a prospective cohort study.

    LENUS (Irish Health Repository)

    Cleary, Brian J

    2012-08-01

      Methadone use in pregnancy has been associated with adverse perinatal outcomes and neonatal abstinence syndrome (NAS). This study aimed to examine perinatal outcomes and NAS in relation to (i) concomitant drug use and (ii) methadone dose.

  17. Prospective registration of clinical trials in India: strategies, achievements & challenges.

    Science.gov (United States)

    Tharyan, Prathap

    2009-02-01

    This paper traces the development of the Clinical Trial Registry-India (CTRI) against the backdrop of the inequities in healthcare and the limitations in the design, conduct, regulation, oversight and reporting of clinical trials in India. It describes the scope and goals of the CTRI, the data elements it seeks and the process of registering clinical trials. It reports progress in trial registration in India and discusses the challenges in ensuring that healthcare decisions are informed by all the evidence. A descriptive survey of developments in clinical trial registration in India from publications in the Indian medical literature supplemented by first hand knowledge of these developments and an evaluation of how well clinical trials registered in the CTRI up to 10 January, 2009 comply with the requirements of the CTRI and the World Health Organization's International Clinical Trial Registry (WHO ICTRP). Considerable inequities exist within the Indian health system. Deficiencies in healthcare provision and uneven regulation of, and access to, affordable healthcare co-exists with a large private health system of uneven quality. India is now a preferred destination for outsourced clinical trials but is plagued by poor ethical oversight of the many trial sites and scant information of their existence. The CTRI's vision of conforming to international requirements for transparency and accountability but also using trial registration as a means of improving trial design, conduct and reporting led to the selection of registry-specific dataset items in addition to those endorsed by the WHO ICTRP. Compliance with these requirements is good for the trials currently registered but these trials represent only a fraction of the trials in progress in India. Prospective trial registration is a reality in India. The challenges facing the CTRI include better engagement with key stakeholders to ensure increased prospective registration of clinical trials and utilization of

  18. International prospective observational study of upper gastrointestinal haemorrhage: Does weekend admission affect outcome?

    DEFF Research Database (Denmark)

    Murray, Iain A.; Dalton, Harry R.; Stanley, Adrian J.

    2017-01-01

    Introduction Out of hours admissions have higher mortality for many conditions but upper gastrointestinal haemorrhage studies have produced variable outcomes. Methods Prospective study of 12 months consecutive admissions of upper gastrointestinal haemorrhage from four international high volume...

  19. Prospect Theory and Public Service Outcomes: When do Citizen Prefer Risky Reforms to Reforms with Certain Outcomes?

    DEFF Research Database (Denmark)

    Bækgaard, Martin

    Prospect theory (Kahneman and Tversky 1979; Tversky and Kahneman 1992) has been widely acknowledged in the social sciences as a potential frame for understanding how people deal with uncertainty. Yet, little is known about whether key expectations from prospect theory also hold in a complex public...... service setting with outcomes in multiple dimensions. In this paper I draw on prospect theory to examine under what conditions citizens prefer uncertain – but potentially advantageous – reforms to reforms with more certain outcomes. Using a population based survey experiment with participation of 1......,395 Danish citizens I find support for some of the expectations derived from prospect theory while the evidence is in outright opposition to the expectations in other instances. Most notably, I find that that citizens are more willing to take risks if reforms are associated with gains than...

  20. Meta-analysis of Clinical and Radiographic Outcomes After Arthroscopic Single-Row Versus Double-Row Rotator Cuff Repair

    OpenAIRE

    Perser, Karen; Godfrey, David; Bisson, Leslie

    2011-01-01

    Context: Double-row rotator cuff repair methods have improved biomechanical performance when compared with single-row repairs. Objective: To review clinical outcomes of single-row versus double-row rotator cuff repair with the hypothesis that double-row rotator cuff repair will result in better clinical and radiographic outcomes. Data Sources: Published literature from January 1980 to April 2010. Key terms included rotator cuff, prospective studies, outcomes, and suture techniques. Study Sele...

  1. 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.

  2. Neurological outcomes following suicidal hanging: A prospective study of 101 patients

    Directory of Open Access Journals (Sweden)

    Mohammed Turab Jawaid

    2017-01-01

    Full Text Available Context: Survivors of suicidal hanging can have variable neurological outcomes – from complete recovery to irreversible brain damage. Literature on the neurological outcomes in these patients is confined to retrospective studies and case series. Hence, this prospective study was carried out. Aims: The aim is to study the neurological outcomes in suicidal hanging. Settings and Design: This was a prospective observational study carried out from July 2014 to July 2016. Subjects and Methods: Consecutive patients admitted to the emergency and medicine wards were included in the study. Details of the clinical and radiological findings, course in hospital and at 1 month postdischarge were analyzed. Statistical Analysis Used: Statistical analysis was performed using IBM SPSS advanced statistics 20.0 (SPSS Inc., Chicago, USA. Univariate analysis was performed using Chi-square test for significance and Odd's ratio was calculated. Results: Of the 101 patients, 6 died and 4 had residual neuro deficits. Cervical spine injury was seen in 3 patients. Interestingly, 39 patients could not remember the act of hanging (retrograde amnesia. Hypotension, pulmonary edema, Glasgow coma scale (GCS score <8 at admission, need for mechanical ventilation, and cerebral edema on plain computed tomography were more in those with amnesia as compared to those with normal memory and these findings were statistically significant. Conclusions: Majority of patients recovered without any sequelae. Routine imaging of cervical spine may not be warranted in all patients, even in those with poor GCS. Retrograde amnesia might be more common than previously believed and further studies are needed to analyze this peculiar feature.

  3. The South African Surgical Outcomes Study: A 7-day prospective ...

    African Journals Online (AJOL)

    To investigate the perioperative mortality and need for critical care admission in patients undergoing inpatient non-cardiac surgery in SA. Methods. A 7-day national, multicentre, prospective, observational cohort study of all patients ≥16 years of age undergoing inpatient noncardiac surgery between 19 and 26 May 2014 at ...

  4. Anterior or posterior surgery for right thoracic adolescent idiopathic scoliosis (AIS)? A prospective cohorts' comparison using radiologic and functional outcomes.

    Science.gov (United States)

    Rushton, Paul R P; Grevitt, Michael P; Sell, Philip J

    2015-04-01

    Prospective cohort study. Prospectively compare patient-reported as well as clinical and radiologic outcomes after anterior or posterior surgery for right thoracic adolescent idiopathic scoliosis (AIS) in a single center by the same surgeons. Anterior and posterior spinal instrumentation and arthrodesis are both well-established treatments of thoracic AIS. The majority of studies comparing the 2 approaches have focused on radiographic outcomes. There remains a paucity of prospectively gathered patient-reported outcomes comparing surgical approaches. Forty-two consecutive patients with right thoracic AIS were treated in a single center by one of 2 surgeons with either anterior (n=18) or posterior (n=24) approaches and followed up for over 2 years. Radiographic, clinical, and patient-reported outcomes of the Modified Scoliosis Research Society Outcome Instrument were gathered and analyzed by an independent surgeon. Patients reported significant improvements in all areas of the Modified Scoliosis Research Society Outcome Instrument, especially pain and self-image domains. There were no significant differences in the degree of improvement in any domains between the groups. Posterior and anterior surgery corrected rib hump by 53% and 61%, respectively (P=0.4). The Main thoracic curve Cobb angle was corrected from 69 to 26 degrees (62%) by posterior surgery and 61 to 23 degrees (64%) by anterior surgery (P=0.6). Posterior surgery significantly reduced kyphosis and lumbosacral lordosis. Anterior surgery had no overall affect of sagittal alignment but seemed able to correct those hypokyphotic preoperatively. Complications differed and were largely approach-related--intrathoracic in anterior and wound-related in posterior surgery. Patients with right thoracic AIS of differing curve types but otherwise similar preoperatively demonstrated that anterior and posterior surgery are largely equivalent. Patient-reported outcomes are improved similarly by either approach. Both offer

  5. Psychological predictors of outcome in vertical banded gastroplasty: a 6 months prospective pilot study.

    Science.gov (United States)

    Leombruni, Paolo; Pierò, Andrea; Dosio, Davide; Novelli, Alessia; Abbate-Daga, Giovanni; Morino, Mario; Toppino, Mauro; Fassino, Secondo

    2007-07-01

    At present, bariatric surgery is the most effective treatment for morbid obesity. Several factors appear to influence the patient's ability to adjust to the postoperative condition, but reliable predictors are lacking. The aim of this study was to assess whether psychological presurgical variables can predict outcome of vertical banded gastroplasty (VBG) in the short term. 38 severely obese patients (6 men and 32 women) underwent laparoscopic VBG. All were assessed prospectively at TO (before surgery) and at T6 (6 months after surgery) with a semi-structured interview and a battery of psychological tests: State Trait Anger Expression Inventory (STAXI), Eating Disorder Inventory (EDI-2), Symptom Checklist 90 (SCL-90), Beck Depression Inventory (BDI), Binge Eating Scale (BES), Body Shape Questionnaire (BSQ), and (only at TO) the Temperament and Character Inventory (TCI). The comparison between TO and T6 found a significant weight loss and an improvement in several dimensions of EDI-2, BDI, and BSQ, together with an increase in the frequency of vomiting. Self-directedness (TCI) and Body Dissatisfaction (EDI-2) appear to be predictors of short-term outcome regarding weight loss. Self-transcendence (TCI) is associated with emerging side-effects. Although larger and longer studies are necessary to confirm these data, Self directedness and Self trascendence emerge as predictors of 6 months clinical and psychological outcome of VBG.

  6. Enduring improvement in Oswestry Disability Index outcomes following lumbar microscopic interlaminar decompression: An appraisal of prospectively collected patient outcomes.

    Science.gov (United States)

    Khan, Muhammad Babar; Bashir, Muhammad Umair; Kumar, Rajesh; Enam, Syed Ather

    2015-01-01

    Our present study aims to assess the short and long-term postoperative outcome of microscopic interlaminar decompression from a neurosurgical center in a developing country and also aims to further determine any predictors of functional outcome. All patients with moderate to severe symptomatic stenosis undergoing elective posterior lumbar spinal decompression were prospectively enrolled in a database. Preoperative, 2 weeks and 2 years postoperative Oswestry Disability Index (ODI) scores were determined for all patients. These scores were retrospectively compared using repeated measures analysis of variance. Further, linear regression modelling was applied to determine the effect of preoperative ODI, body mass index, age, prior physiotherapy, duration of symptoms, and single or multiple level decompression on the change in ODI at 2 weeks and 2 years follow-up respectively. A total of 60 consecutive patients (40 males, 20 females) were included for statistical analysis. The percentage of patients with a minimum clinically important difference (MCID), using an ODI threshold value of 10, was 86.7% (n = 52) at the 2 weeks postoperative follow-up. At the 2 years follow-up assessment, 3.3% (n = 2) patients who had earlier not achieved MCID did so, 78.3% (n = 47) of patients were found to have a change in ODI score of <10 or no change, while 18.3% (n = 11) reported a deterioration in their ODI scores. The preoperative ODI score was an independent predictor of change in ODI score at 2 weeks and 2 years respectively (P < 0.0005). The duration of symptoms prior to surgery was found to predict the change in ODI at 2 years follow-up (P = 0.04). The evidence regarding the long-term and short-term efficacy of microscopic interlaminar decompression in symptomatic lumbar stenosis is overwhelming. Preoperative ODI scores and duration of symptoms prior to surgery can predict postoperative outcomes.

  7. 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

  8. 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.

  9. 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.

  10. 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...

  11. Prospective evaluation of a clinical guideline recommending hospital length of stay in upper gastrointestinal tract hemorrhage.

    Science.gov (United States)

    Hay, J A; Maldonado, L; Weingarten, S R; Ellrodt, A G

    Upper gastrointestinal tract hemorrhage (UGIH) is a common and potentially life-threatening disorder. Resource utilization can vary without adverse effect on patient outcome. Clinical practice guidelines are a potential solution to reduce variation in practice while improving patient outcomes. To validate prospectively the safety, acceptability, and impact of a clinical practice guideline defining the medically appropriate length of stay (LOS) for patients hospitalized with UGIH. Prospective, controlled time-series study with an alternate-month design. Outcome surveyors and patients were blinded to study group allocation. GUIDELINE: A retrospectively validated scoring system using 4 independent variables: hemodynamics, time from bleeding, comorbidity, and esophagogastroduodenoscopy (EGD) findings to predict risk of adverse events. The quantitative risk for the low-risk subset was 0.6% (95% confidence interval [CI], 0.0%-2.0%) for subsequent complications and 0% (95% CI, 0.0%-0.9%) for life-threatening complications from this retrospective evaluation. A 1000-bed, not-for-profit, university-affiliated teaching hospital. Consecutive adult patients hospitalized for acute UGIH. Concurrent feedback of guideline recommendation (same-day hospital discharge) to physicians caring for patients at low risk for complication. No risk information was provided during control months. Seventy percent (209/299) of UGIH patients achieved low-risk status according to the guideline and were therefore potentially suitable for early discharge from the hospital. Providing real-time quantitative risk information (intervention group only) was associated with an increase in guideline compliance from 30% to 70% (Preduction of 1.7 days per patient; P<.001). No differences in complications, patient health status, or patient satisfaction were found when measured 1 month after discharge. An independent variable predicting decreased hospital LOS for low-risk UGIH patients was early EGD

  12. Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

    Science.gov (United States)

    2014-01-01

    Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611

  13. Depressive Symptoms, Exercise Capacity, and Clinical Outcomes After Lung Transplantation.

    Science.gov (United States)

    Smith, Patrick J; Byrd, Rebecca; Lusby, Megan; Clausen, Emily; Snyder, Laurie D

    2018-05-01

    Depressive symptoms are common among lung transplant recipients and have been associated with worse clinical outcomes. However, few studies have examined the association between depressive symptoms assessed at multiple time points or behavioral mechanisms by which posttransplant depressive symptoms may confer greater clinical risk. We therefore examined the associations between depressive symptoms, exercise capacity, chronic lung allograft dysfunction (CLAD), and mortality prospectively in a large sample of lung transplant recipients. Between July 2009 and February 2016, 251 lung transplant recipients were assessed before transplantation and again approximately 3 weeks and 3 months after transplant. Depressive symptoms were assessed using the Centers for Epidemiologic Studies of Depression scale. Functional exercise capacity was assessed using the 6-minute walk test. Cox proportional hazards models were used to examine the associations between depressive symptoms, exercise capacity, CLAD, and mortality. During a median (range) follow-up of 4.5 (0.1 to 6.3) years, 53 participants (21%) died. Greater depressive symptoms (hazard ratio [HR] = 1.39 [95% CI = 1.05 to 1.84], p = .021) and poorer exercise capacity (HR = 0.58 [95% CI = 0.38 to 0.90], p = .021) assessed 3 months after transplant were both independently associated with mortality. Although greater depressive symptoms were associated with lower exercise capacity (β = -0.14, p = .039), exercise capacity did not mediate the association between depressive symptoms and mortality. In secondary analyses, depressive symptoms were independently predictive of CLAD (HR = 1.29 [95% CI = 1.01 to 1.65], p = .045) and the composite outcome of CLAD and mortality in a clustered event model (HR = 1.30 [1.09 to 1.56], p = .005). Depressive symptoms are associated with mortality and CLAD after lung transplantation, independent of exercise capacity.

  14. 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

  15. Predictors of outcomes and refractoriness in status epilepticus: A prospective study.

    Science.gov (United States)

    Atmaca, Murat Mert; Bebek, Nerses; Baykan, Betül; Gökyiğit, Ayşen; Gürses, Candan

    2017-10-01

    The objective of this study was to determine the predictors of outcomes and refractoriness in status epilepticus (SE). This is a prospective study of 59 adult patients with SE who were admitted to the Emergency Department between February 2012 and December 2013. The effects of clinical, demographic, and electrophysiologic features of patients with SE were evaluated. To evaluate outcome in SE, STESS, mSTESS, and EMSE scales were used. Logistic regression analysis showed that being aged ≥65years (p=0.02, OR: 17.68, 95% CI: [1.6-198.4]) for the short term and having potentially fatal etiology (p=0.027, OR: 11.7, 95% CI: [1.3-103]) for the long term were the only independent predictors of poor outcomes; whereas, the presence of periodic epileptiform discharges (PEDs) in EEG was the only independent predictor of refractoriness (p=0.032, OR: 13.7, 95% CI: [1.3-148.5]). The patients with ≥3 Status Epilepticus Severity Score (STESS) did not have poorer outcomes in the short- (p=0.157) and long term (p=0.065). There was no difference between patients with 0-2, 3-4, and ≥4 mSTESS in the short- and long term in terms of outcome (p=0.28 and 0.063, respectively). Also, there was no difference between subgroups (convulsive SE [CSE], nonconvulsive SE [NCSE], and epilepsia partialis continua [EPC]) in terms of STESS and mSTESS. When patients with EPC were excluded, both STESS and mSTESS scores of the patients correlated with poorer long-term outcomes (p=0.025 and 0.017, respectively). The patients with ≥64 points in the Epidemiology-based Mortality in SE-Etiology, age, comorbidity, EEG (EMSE-EACE) score and those with ≥27 points in EMSE-Etiology, age, comorbidity (EMSE-EAC) score did not have poorer outcomes in the short term (p=0.06 and 0.274, respectively) while they had significantly poorer outcome in the long term (pStatus epilepticus was terminated with intravenous (IV) levetiracetam (LEV) in 68.75% of patients and with IV phenytoin (PHT) in 83.3% of patients. No

  16. 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...

  17. 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.

  18. 3D laparoscopic surgery: a prospective clinical trial.

    Science.gov (United States)

    Agrusa, Antonino; Di Buono, Giuseppe; Buscemi, Salvatore; Cucinella, Gaspare; Romano, Giorgio; Gulotta, Gaspare

    2018-04-03

    Since it's introduction, laparoscopic surgery represented a real revolution in clinical practice. The use of a new generation three-dimensional (3D) HD laparoscopic system can be considered a favorable "hybrid" made by combining two different elements: feasibility and diffusion of laparoscopy and improved quality of vision. In this study we report our clinical experience with use of three-dimensional (3D) HD vision system for laparoscopic surgery. Between 2013 and 2017 a prospective cohort study was conducted at the University Hospital of Palermo. We considered 163 patients underwent to laparoscopic three-dimensional (3D) HD surgery for various indications. This 3D-group was compared to a retrospective-prospective control group of patients who underwent the same surgical procedures. Considerating specific surgical procedures there is no significant difference in term of age and gender. The analysis of all the groups of diseases shows that the laparoscopic procedures performed with 3D technology have a shorter mean operative time than comparable 2D procedures when we consider surgery that require complex tasks. The use of 3D laparoscopic technology is an extraordinary innovation in clinical practice, but the instrumentation is still not widespread. Precisely for this reason the studies in literature are few and mainly limited to the evaluation of the surgical skills to the simulator. This study aims to evaluate the actual benefits of the 3D laparoscopic system integrating it in clinical practice. The three-dimensional view allows advanced performance in particular conditions, such as small and deep spaces and promotes performing complex surgical laparoscopic procedures.

  19. Direct stent puncture technique for intraluminal stent recanalization in the superficial femoral and popliteal arteries in-stent occlusion: Outcomes from a prospective clinical analysis of diabetics with critical limb ischemia

    Energy Technology Data Exchange (ETDEWEB)

    Palena, Luis Mariano, E-mail: marianopalena@hotmail.com; Manzi, Marco

    2013-07-15

    Purpose: To evaluate the efficacy and safety of “Direct Stent Puncture” technique for intraluminal stent recanalization in the femoro-popliteal segments. Methods and Materials: A cohort of diabetics who had symptomatic in-stent occlusion of the superficial femoral or popliteal arteries underwent endovascular recanalization. After antegrade failure, direct stent puncture technique was performed. The primary end-point was to efficacy assessment, intended as technical success and clinical improvement. The secondary end-point was safety assessment, intended as free of complication rate. Results: Fifty-four patients (37 men; 73.6 ± 8.5 years) underwent direct stent puncture technique, after several unsuccessful antegrade attempts to cross the occluded stent. Technical success for intraluminal stent recanalization was achieved in 53/54 (98.2%) of cases and failed in 1/54 (1.8%). Clinical improvement was obtained in 51/54 (94.4%) of cases, with regression of the clinical symptoms and improvement of the TcPO{sub 2}, from 3 ± 18 mmHg to 43 ± 11 mmHg after 15 days (p < 0.001). Free of complications rate was 92.5%. In 2/54 (3.7%) of cases distal embolization occurred, in 1/54 (1.9%) case a sudden vessel thrombosis was diagnosed after 12 hours and in 1/54 (1.9%) case hematoma at the stent puncture site was observed. Conclusions: Direct Stent Puncture technique is an efficacy and safety option for intraluminal stent recanalization in the femoro-popliteal segment in-stent occlusion.

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

    Science.gov (United States)

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

    2018-05-01

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

  1. Non-dystrophic myotonia: prospective study of objective and patient reported outcomes.

    Science.gov (United States)

    Trivedi, Jaya R; Bundy, Brian; Statland, Jeffrey; Salajegheh, Mohammad; Rayan, Dipa Raja; Venance, Shannon L; Wang, Yunxia; Fialho, Doreen; Matthews, Emma; Cleland, James; Gorham, Nina; Herbelin, Laura; Cannon, Stephen; Amato, Anthony; Griggs, Robert C; Hanna, Michael G; Barohn, Richard J

    2013-07-01

    Non-dystrophic myotonias are rare diseases caused by mutations in skeletal muscle chloride and sodium ion channels with considerable phenotypic overlap between diseases. Few prospective studies have evaluated the sensitivity of symptoms and signs of myotonia in a large cohort of patients. We performed a prospective observational study of 95 participants with definite or clinically suspected non-dystrophic myotonia recruited from six sites in the USA, UK and Canada between March 2006 and March 2009. We used the common infrastructure and data elements provided by the NIH-funded Rare Disease Clinical Research Network. Outcomes included a standardized symptom interview and physical exam; the Short Form-36 and the Individualized Neuromuscular Quality of Life instruments; electrophysiological short and prolonged exercise tests; manual muscle testing; and a modified get-up-and-go test. Thirty-two participants had chloride channel mutations, 34 had sodium channel mutations, nine had myotonic dystrophy type 2, one had myotonic dystrophy type 1, and 17 had no identified mutation. Phenotype comparisons were restricted to those with sodium channel mutations, chloride channel mutations, and myotonic dystrophy type 2. Muscle stiffness was the most prominent symptom overall, seen in 66.7% to 100% of participants. In comparison with chloride channel mutations, participants with sodium mutations had an earlier age of onset of stiffness (5 years versus 10 years), frequent eye closure myotonia (73.5% versus 25%), more impairment on the Individualized Neuromuscular Quality of Life summary score (20.0 versus 9.44), and paradoxical eye closure myotonia (50% versus 0%). Handgrip myotonia was seen in three-quarters of participants, with warm up of myotonia in 75% chloride channel mutations, but also 35.3% of sodium channel mutations. The short exercise test showed ≥10% decrement in the compound muscle action potential amplitude in 59.3% of chloride channel participants compared with 27

  2. Prospective Clinical Study to Evaluate Clinical Performance of a Powered Surgical Stapler in Video-assisted Thoracoscopic Lung Resections

    DEFF Research Database (Denmark)

    Licht, Peter B; Ribaric, Goran; Crabtree, Traves

    2015-01-01

    Video-assisted thoracic surgery (VATS) research often focuses on postoperative air leak, with special consideration for prolonged air leak. There is limited clinical data regarding how stapling devices might affect performance and postoperative outcomes, including air leak. This prospective...... of postoperative air leaks, including prolonged air leak. Additional data collected included intraoperative details and postoperative outcomes. Prolonged air leak occurred in 22 subjects (10.3%) across procedures (152 lobectomies, 63 wedge resections, and 11 occurrences of wedge resection plus lobectomy......). There were no significant differences in occurrence or duration of PAL between the U.S. and Europe. Regional differences were observed for intraoperative leak testing and cartridge selection relative to tissue type. Despite differences in surgical technique between continents, no major or significant...

  3. Transportal anterior cruciate ligament reconstruction with quadrupled hamstring tendon graft: A prospective outcome study

    Directory of Open Access Journals (Sweden)

    Chandan Kumar

    2017-01-01

    Full Text Available Background: Anterior cruciate ligament (ACL reconstruction has been one of the most commonly performed procedures throughout the world. Unsatisfactory outcome with conventional ACL reconstruction has been attributed to nonanatomic graft placement. Researchers have advised placing the graft in the native footprint of ACL to avoid nonanatomic graft placement. The goal of this study was to analyze the outcome of anatomic single bundle ACL reconstruction using transportal technique. Materials and Methods: This was a prospective outcome study conducted on 85 consecutive patients of ACL reconstruction of which 62 patients met inclusion and exclusion criteria and were analyzed for final results. All the patients underwent ACL reconstruction by quadrupled hamstring tendon graft using transportal technique and the accessory anteromedial (AAM portal for femoral tunnel creation. The graft was fixed with endobutton on femoral side and bioabsorbable screw on the tibial side. Patients were evaluated for range of motion, International Knee Documentation Committee (IKDC score, and Lysholm scores at a minimum followup period of 2 years. The mean pre- and postoperative scores were compared using Wilcoxon signed-rank test. Results: The mean Lysholm and IKDC scores improved significantly (P < 0.0001 from preoperative value. According to IKDC score, 90.3% (n = 56 were either normal or near normal at final followup. According to Lysholm score, 75.8% of patients had excellent and 13.3% had good results. Preoperatively, pivot shift was present in 85.5% (n = 53 of patients which reduced to 4.8% (n = 3 postoperatively. Infection and knee stiffness occurred in two patients, and femoral tunnel blowout and graft re-rupture occurred in one patient each. Conclusion: Anatomic ACL reconstruction by AAM portal is a reproducible technique which gives good clinical outcome at short-term followup.

  4. Sleep disorders in pregnancy and their association with pregnancy outcomes: a prospective observational study.

    Science.gov (United States)

    Sharma, S K; Nehra, A; Sinha, S; Soneja, M; Sunesh, K; Sreenivas, V; Vedita, D

    2016-03-01

    Sleep disturbances such as insomnia, nocturnal awakenings, restless legs syndrome, habitual snoring, and excessive daytime sleepiness are frequent during pregnancy, and these have been linked to adverse maternal and fetal outcomes. A prospective observational study was performed in high-risk Indian pregnant women. We used modified Berlin questionnaire (MBQ), Pittsburgh sleep quality index (PSQI), International Restless Legs Syndrome Study Group 2011 criteria, and Epworth sleepiness scale to diagnose various sleep disorders, such as symptomatic OSA, poor sleep quality and insomnia, RLS, and excessive daytime sleepiness, respectively, in successive trimesters of pregnancy. Outcome variables of interest were development of gestational hypertension (GH), gestational diabetes mellitus (GDM), and cesarean delivery (CS); the Apgar scores; and low birth weight (LBW). The relationship between sleep disorders and outcomes was explored using logistic regression analysis. Outcome data were obtained in 209 deliveries. As compared to nonsnorers, women who reported snoring once, twice, and thrice or more had odds ratios for developing GH-4.0 (95 % CI 1.3-11.9), 1.5 (95 % CI 0.5-4.5), and 2.9 (95 % CI 1.0-8.2) and for undergoing CS-5.3 (95 % CI 1.7-16.3), 4.9 (95 % CI 1.8-13.1), and 5.1 (95 % CI 1.9-14.9), respectively. Pregnant women who were persistently positive on MBQ had increased odds for GH and CS. Snoring and high-risk MBQ in pregnant women are strong risk factors for GH and CS. In view of the significant morbidity and health care costs, simple screening of pregnant women with questionnaires such as MBQ may have clinical utility.

  5. Gender effect on clinical features of achalasia: a prospective study

    Directory of Open Access Journals (Sweden)

    Mahdavinia Mahboobeh

    2006-04-01

    Full Text Available Abstract Background Achalasia is a well-characterized esophageal motor disorder but the rarity of the disease limits performing large studies on its demographic and clinical features. Methods Prospectively, 213 achalasia patients (110 men and 103 women were enrolled in the study. The diagnosis established by clinical, radiographic, and endoscopic as well as manometry criteria. All patients underwent a pre-designed clinical evaluation before and within 6 months after the treatment. Results Solid dysphagia was the most common clinical symptom in men and women. Chest pain was the only symptom which was significantly different between two groups and was more complained by women than men (70.9% vs. 54.5% P value= 0.03. Although the occurrence of chest pain significantly reduced after treatment in both groups (P Conclusion It seems that chest pain is the distinct symptom of achalasia which is affected by sex as well as age and does not relate to the duration of illness, LESP and the type of treatment achalasia patients receive.

  6. 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

  7. Gastric stromal tumors: clinical presentations diagnosis and outcome

    International Nuclear Information System (INIS)

    Hussain, D.; Zafar, H.; Raja, A.J.

    2006-01-01

    To determine the clinical presentations, of gastric stromal tumors with diagnostic methods, pathology and outcome after surgery. All patients of age 14 years and above, diagnosed histopathologically to have gastric stromal tumors were included. The data of these patients was collected retrospectively from January 1988 to December 1998, and prospectively from January 1999 to December 2002. All the patients were studied as a single group. There were 11 patients. Their mean age was 54 years, with 8 males and 3 females. Five patients presented with upper gastrointestinal bleeding, and 4 with lower gastrointestinal bleeding. Eight patients had pain in epigastrium and 2 had vomiting. Upper gastrointestinal endoscopy was done in all patients, and ultrasound was done in 4 patients. CT scan was done in 7 patients. Preoperative diagnosis could be made in 6 patients. Only one patient had liver metastasis. Wedge resection was performed in 5 proximal gastrectomy with gastroesophageal anastomosis in 3, and partial gastrectomy with gastrojejunostomy in another 3 patients. The mean tumor size was 8.0 centimeters. Two patients had benign, 2 had intermediate and 7 had malignant tumors. The mean duration of followup was 41 months. Follow-up was completed in 8 patients, out of whom 6 were alive, and 2 patients expired due to other causes at the time of completion of this study. (author)

  8. PROGNOSTIC SIGNIFICANCE OF CLINICAL, HISTOPATHOLOGICAL, AND MOLECULAR CHARACTERISTICS OF MEDULLOBLASTOMAS IN THE PROSPECTIVE HIT2000 MULTICENTER CLINICAL TRIAL COHORT

    Science.gov (United States)

    Pietsch, Torsten; Schmidt, Rene; Remke, Marc; Korshunov, Andrey; Hovestadt, Volker; Jones, David TW; Felsberg, Jörg; Kaulich, Kerstin; Goschzik, Tobias; Kool, Marcel; Northcott, Paul A.; von Hoff, Katja; von Bueren, André O.; Friedrich, Carsten; Skladny, Heyko; Fleischhack, Gudrun; Taylor, Michael D.; Cremer, Friedrich; Lichter, Peter; Faldum, Andreas; Reifenberger, Guido; Rutkowski, Stefan; Pfister, Stefan M.

    2014-01-01

    BACKGROUND: This study aimed to prospectively evaluate clinical, histopathological and molecular variables for outcome prediction in medulloblastoma patients. METHODS: Patients from the HIT2000 cooperative clinical trial were prospectively enrolled based on the availability of sufficient tumor material and complete clinical information. This revealed a cohort of 184 patients (median age 7.6 years), which was randomly split at a 2:1 ratio into a training (n = 127), and a validation (n = 57) dataset. All samples were subjected to thorough histopathological investigation, CTNNB1 mutation analysis, quantitative PCR, MLPA and FISH analyses for cytogenetic variables, and methylome analysis. RESULTS: By univariable analysis, clinical factors (M-stage), histopathological variables (large cell component, endothelial proliferation, synaptophysin pattern), and molecular features (chromosome 6q status, MYC amplification, TOP2A copy-number, subgrouping) were found to be prognostic. Molecular consensus subgrouping (WNT, SHH, Group 3, Group 4) was validated as an independent feature to stratify patients into different risk groups. When comparing methods for the identification of WNT-driven medulloblastoma, this study identified CTNNB1 sequencing and methylation profiling to most reliably identify these patients. After removing patients with particularly favorable (CTNNB1 mutation, extensive nodularity) or unfavorable (MYC amplification) markers, a risk score for the remaining “intermediate molecular risk” population dependent on age, M-stage, pattern of synaptophysin expression, and MYCN copy-number status was identified and validated, with speckled synaptophysin expression indicating worse outcome. CONCLUSIONS: Methylation subgrouping and CTNNB1 mutation status represent robust tools for the risk-stratification of medulloblastoma. A simple clinico-pathological risk score for “intermediate molecular risk” patients was identified, which deserves further validation

  9. Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes.

    Science.gov (United States)

    Coyle, Patricia K; Cohen, Bruce A; Leist, Thomas; Markowitz, Clyde; Oleen-Burkey, MerriKay; Schwartz, Marc; Tullman, Mark J; Zwibel, Howard

    2014-03-13

    Data sources for MS research are numerous but rarely provide an objective measure of drug therapy compliance coupled with patient-reported health outcomes. The objective of this paper is to describe the methods and baseline characteristics of the Therapy Optimization in MS (TOP MS) study designed to investigate the relationship between disease-modifying therapy compliance and health outcomes. TOP MS was designed as a prospective, observational, nationwide patient-focused study using an internet portal for data entry. The protocol was reviewed and approved by Sterling IRB. The study was registered with ClinicalTrials.gov. It captured structured survey data monthly from MS patients recruited by specialty pharmacies. Data collection included the clinical characteristics of MS such as MS relapses. Disability, quality of life and work productivity and activity impairment were assessed quarterly with well-validated scales. When events like severe fatigue or new or worsening depression were reported, feedback was provided to treating physicians. The therapy compliance measure was derived from pharmacy drug shipment records uploaded to the study database. The data presented in this paper use descriptive statistics. The TOP MS Study enrolled 2966 participants receiving their disease-modifying therapy (DMT) from specialty pharmacies. The mean age of the sample was 49 years, 80.4% were female, 89.9% were Caucasian and 55.7% were employed full or part time. Mean time since first symptoms was 11.5 years; mean duration since diagnosis was 9.5 years. Patient-reported EDSS was 3.5; 72.2% had a relapsing-remitting disease course. The most commonly reported symptoms at the time of enrollment were fatigue (74.7%), impaired coordination or balance (61.8%) and numbness and tingling (61.2%). Half of the sample was using glatiramer acetate and half was using beta-interferons. Demographic and clinical characteristics of the TOP MS sample at enrollment are consistent with other community

  10. 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.

  11. OUTCOME OF PREGNANCIES COMPLICATED BY THREATENED ABORTION IN THE SECOND TRIMESTER OF PREGNANCY - PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Rajeswary

    2015-11-01

    Full Text Available AIM: To compare the outcome of pregnancies complicated by bleeding per vaginum between 14- 20 weeks with those not complicated by bleeding per vaginum before 20 weeks. To evaluate the potential determinants of outcome such as gestational age at bleeding, number of bleeding episodes, extent of placental separation or sub chorionic bleed, incidence of complications as placenta previa, abruptio placenta, development of gestational hypertension and pre eclampsia, intra uterine growth restriction, and neonatal outcomes as birth weight, mode of delivery, neonatal ICU admission, and congenital anomalies. SETTINGS AND DESIGN: This was a prospective, comparative study, for a duration of one year. STUDY POPULATION: Cases- 100 women admitted in IMCH with first episode of bleeding per vaginum between 14- 20 weeks and continuing their pregnancy after 20 weeks. CONTROLS: 200 uncomplicated pregnancies attending antenatal outpatient clinic which were followed up till delivery. EXCLUSION CRITERIA: 1. Women with history of threatened abortion in first trimester were not included in the study. 2. Subjects age more than 35 years. 3. Previous history of abortion. 4. Any significant medical, surgical or gynecological history. RESULTS: When patients who presented with bleeding pv after completion of 1st trimester were analyzed by USS, a significant number of them had evidence of sub chorionic bleed, heavier the bleed, more the likelihood of presence of sub placental hematoma. There was no significant difference in prevalence of development of hypertensive disorders of pregnancy in both study groups. There was no significant rise in ante partum hemorrhage between cases and controls. Incidence of IUGR, PPROM, PRE TERM LABOR was significantly increased in study group. LSCS rate was not significantly different in both groups. In this study, there was no significant difference in incidence of congenital anomalies in both groups. STUDY AREA: Tertiary health center

  12. The South African Surgical Outcomes Study: A 7-day prospective ...

    African Journals Online (AJOL)

    Neurosurgery. 133 (3.4). 122 (3.2). 11 (8.9). 1.84 (0.88 - 3.85). 0.11. Thoracic. 65 (1.7). 64 (1.7). 1 (0.8). 0.32 (0.04 - 2.39). 0.32. Other. 513 (13.1). 489 (12.9) ...... Appendix 1. Full author list. B M Biccard, PhD, Perioperative Research Group, Discipline of. Anaesthesiology and Critical Care, School of Clinical Medicine,.

  13. Biomarkers in differentiating clinical dengue cases: A prospective cohort study

    Directory of Open Access Journals (Sweden)

    Gary Kim Kuan Low

    2015-12-01

    Full Text Available Objective: To evaluate five biomarkers (neopterin, vascular endothelial growth factor-A, thrombomodulin, soluble vascular cell adhesion molecule 1 and pentraxin 3 in differentiating clinical dengue cases. Methods: A prospective cohort study was conducted whereby the blood samples were obtained at day of presentation and the final diagnosis were obtained at the end of patients’ follow-up. All patients included in the study were 15 years old or older, not pregnant, not infected by dengue previously and did not have cancer, autoimmune or haematological disorder. Median test was performed to compare the biomarker levels. A subgroup Mann-Whitney U test was analysed between severe dengue and non-severe dengue cases. Monte Carlo method was used to estimate the 2-tailed probability (P value for independent variables with unequal number of patients. Results: All biomarkers except thrombomodulin has P value < 0.001 in differentiating among the healthy subjects, non-dengue fever, dengue without warning signs and dengue with warning signs/severe dengue. Subgroup analysis for all the biomarkers between severe dengue and non-severe dengue cases was not statistically significant except vascular endothelial growth factor-A (P < 0.05. Conclusions: Certain biomarkers were able to differentiate the clinical dengue cases. This could be potentially useful in classifying and determining the severity of dengue infected patients in the hospital.

  14. Prospective Clinical Testing of Regulatory Dendritic Cells in Organ Transplantation.

    Science.gov (United States)

    Thomson, Angus W; Zahorchak, Alan F; Ezzelarab, Mohamed B; Butterfield, Lisa H; Lakkis, Fadi G; Metes, Diana M

    2016-01-01

    Dendritic cells (DC) are rare, professional antigen-presenting cells with ability to induce or regulate alloimmune responses. Regulatory DC (DCreg) with potential to down-modulate acute and chronic inflammatory conditions that occur in organ transplantation can be generated in vitro under a variety of conditions. Here, we provide a rationale for evaluation of DCreg therapy in clinical organ transplantation with the goal of promoting sustained, donor-specific hyporesponsiveness, while lowering the incidence and severity of rejection and reducing patients' dependence on anti-rejection drugs. Generation of donor- or recipient-derived DCreg that suppress T cell responses and prolong transplant survival in rodents or non-human primates has been well-described. Recently, good manufacturing practice (GMP)-grade DCreg have been produced at our Institution for prospective use in human organ transplantation. We briefly review experience of regulatory immune therapy in organ transplantation and describe our experience generating and characterizing human monocyte-derived DCreg. We propose a phase I/II safety study in which the influence of donor-derived DCreg combined with conventional immunosuppression on subclinical and clinical rejection and host alloimmune responses will be examined in detail.

  15. Intrapartum amnioinfusion for meconium-stained fluid: meta-analysis of prospective clinical trials.

    Science.gov (United States)

    Pierce, J; Gaudier, F L; Sanchez-Ramos, L

    2000-06-01

    To evaluate the effectiveness of intrapartum prophylactic amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid. We identified prospective clinical trials of amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid (AF) published in English by using computerized databases, references in published studies, and index reviews. We analyzed prospective studies of intrapartum amnioinfusion for meconium-stained AF. In every case, group allocation was based exclusively on meconium in AF. Only published studies with clearly documented outcome data were included. The trials were evaluated for meconium below the vocal cords, meconium aspiration syndrome, fetal acidemia, cesarean delivery, and postpartum endometritis. Each trial was evaluated for the quality of its methodology, inclusion and exclusion criteria, adequacy of randomization, amnioinfusion protocols, definition of outcomes, and statistical analyses. Thirteen studies met inclusion criteria for our systematic review. Odds ratios (ORs) with their 95% confidence intervals (CIs) were calculated for each outcome. Estimates of ORs and risk differences for dichotomous outcomes were calculated using random and fixed-effects models. We tested for homogeneity across the studies. We found that intrapartum amnioinfusion significantly reduced the frequency of meconium aspiration syndrome (OR 0.30; 95% CI 0.19, 0. 46), of meconium below the vocal cords, and neonatal acidemia. Subjects allocated to receive amnioinfusion also had a significantly lower overall cesarean rate (OR 0.74, 95% CI 0.59, 0.93) without increased postpartum endometritis. Amnioinfusion in cases of meconium-stained fluid significantly improves neonatal outcome, lowers the cesarean delivery rate, and does not increase the postpartum endometritis rate.

  16. Myopathies of endocrine disorders: A prospective clinical and biochemical study

    Directory of Open Access Journals (Sweden)

    Vikas Sharma

    2014-01-01

    Full Text Available Introduction: Major categories of endocrine myopathy include those associated with: Adrenal dysfunction (as in Cushing′s disease or steroid myopathy; thyroid dysfunction (as in myxedema coma or thyrotoxic myopathy; vitamin D deficiency; parathyroid dysfunction; and pituitary dysfunction. Steroid myopathy is the most common endocrine myopathy. Objective: To study the etiology, varied presentations, and outcome after therapy of patients with endocrine myopathies. Materials and Methods: Myopathy was evaluated by the standard clinical procedures: Detailed clinical history, manual muscle strength testing, and creatine phosphokinase (CPK. Endocrine disorders were diagnosed as per clinical features and biochemical parameters. The treatment was given to patients as per underlying endocrine disease. Myopathy was assessed before and after treatment. Results: Out of the 37 patients who were diagnosed with endocrine myopathies, thyroid dysfunction was the most common cause (17 cases, followed by vitamin D deficiency in nine, adrenal dysfunction in six, parathyroid dysfunction in three, and pituitary dysfunction in two. Some patients had atypical presentation (repeated falls in one, tongue fasciculations in one, neck weakness in five, one with ptosis and facial weakness, asymmetrical onset in one, and calf hypertrophy in one. The serum creatine kinase (CK concentration did not correlate with muscle weakness. Following the treatment regimen which was specific for a given myopathy, 26 patients recovered fully. Conclusion: We found varied clinical presentations of endocrine myopathies. All the patients with neuromuscular complaints should be investigated for endocrine causes because significant number of them recovers fully with specific treatment.

  17. A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias.

    Science.gov (United States)

    McLorie, G; Joyner, B; Herz, D; McCallum, J; Bagli, D; Merguerian, P; Khoury, A

    2001-05-01

    Hypospadias repair is a common operation performed by pediatric urologists. Perhaps the greatest variable and source of controversy of postoperative care is the surgical dressing. We hypothesized that using no dressing would achieve surgically comparable results to those traditionally achieved by a postoperative dressing and it would also simplify postoperative parent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hypospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proximal and 60 with distal hypospadias on an outpatient basis. Ethics and Internal Review Board approval, and informed consent were obtained. Boys were then prospectively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on postoperative care were distributed to all families and a questionnaire was distributed to the parents at the initial followup. Surgical outcome was evaluated and questionnaire responses were analyzed. Fisher's exact test was done to test the significance of differences in surgical outcomes and questionnaire responses. A total of 117 boys completed the prospective randomized trial. Surgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 101 questionnaires for response analysis. The type or absence of the dressing did not correlate with the need for repeat procedures, urethrocutaneous fistula, or meatal stenosis or regression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fellow. These findings were statistically

  18. A novel rapid access testicular cancer clinic: prospective evaluation after one year.

    Science.gov (United States)

    Carey, K; Davis, N F; Elamin, S; Ahern, P; Brady, C M; Sweeney, P

    2016-02-01

    Our institution has recently developed a rapid access outpatient clinic to investigate men with testicular lumps and/or pain suspicious for testicular cancer (TCa). To present our experience after 12 months. All referrals to the rapid access testicular clinic (RATC) clinic were prospectively analysed from 01/01/2013 to 01/01/2014. The primary outcome variable was incidence of TCa in the referred patient cohort. Secondary outcome variables were waiting times prior to clinical review and waiting times prior to radical orchidectomy in patients diagnosed with TCa. Seventy-four new patients were referred to the RATC during the 1-year period and the mean age was 34 (range 15-81 years). TCa was the most common diagnosis and was found in 18 (25 %) patients. Patients diagnosed with TCa underwent radical orchidectomy, a median of 3 (range 1-5) days after their initial GP referral. Patients requiring surgical intervention for benign scrotal pathology underwent their procedure a median of 32 (range 3-61) days after their initial referral. Of the 18 patients diagnosed with TCa, 9 (50 %) were diagnosed with a seminomatous germ cell tumour on histopathology. The RATC is a new initiative in Ireland that provides expedient and definitive treatment of patients with newly diagnosed TCa. Early treatment will ultimately improve long-term prognosis in this patient cohort.

  19. The progression of 102 Brazilian patients with bipolar disorder: outcome of first 12 months of prospective follow-up

    Directory of Open Access Journals (Sweden)

    Fernanda Novis

    2014-03-01

    Full Text Available INTRODUCTION: Prospective studies have shown that the course of bipolar disorder (BD is characterized by the persistence of symptoms, predominantly depression, along most of the time. However, to our knowledge, no studies in Latin America have investigated it. OBJECTIVES: To replicate international studies using a Brazilian sample to prospectively analyze treatment outcomes in the first year and to determine potential chronicity factors. METHODS: We followed up 102 patients with BD for 12 months and evaluated the number of months with affective episodes and the intensity of manic and depressive symptoms using the Young Mania Rating Scale (YMRS and the Hamilton Depression Scale (HAM-D17. Sociodemographic and retrospective clinical data were examined to determine possible predictors of outcome. RESULTS: Almost 50% of the patients had symptoms about half of the time, and there was a predominance of depressive episodes. Disease duration and number of depressive episodes were predictors of chronicity. Depressive polarity of the first episode and a higher number of depressive episodes predicted the occurrence of new depressive episodes. CONCLUSION: In general, BD outcome seems to be poor in the first year of monitoring, despite adequate treatment. There is a predominance of depressive symptoms, and previous depressive episodes are a predictor of new depressive episodes and worse outcome.

  20. Maternal thyroid function and the outcome of external cephalic version: a prospective cohort study

    NARCIS (Netherlands)

    Kuppens, S.M.I.; Kooistra, L.; Hasaart, T.H.M.; Donk, M.W.; Vader, H.; Oei, S.G.; Pop, V.J.

    2011-01-01

    Background To investigate the relation between maternal thyroid function and the outcome of external cephalic version (ECV) in breech presentation. Methods Prospective cohort study in 141 women (= 35 weeks gestation) with a singleton fetus in breech. Blood samples for assessing thyroid function were

  1. Predictors and Health-Related Outcomes of Positive Body Image in Adolescent Girls: A Prospective Study

    Science.gov (United States)

    Andrew, Rachel; Tiggemann, Marika; Clark, Levina

    2016-01-01

    This study aimed to investigate prospective predictors and health-related outcomes of positive body image in adolescent girls. In so doing, the modified acceptance model of intuitive eating was also examined longitudinally. A sample of 298 girls aged 12 to 16 years completed a questionnaire containing measures of body appreciation, potential…

  2. Eradication of tephritid fruit fly pest populations: outcomes and prospects.

    Science.gov (United States)

    Suckling, David Maxwell; Kean, John M; Stringer, Lloyd D; Cáceres-Barrios, Carlos; Hendrichs, Jorge; Reyes-Flores, Jesus; Dominiak, Bernard C

    2016-03-01

    The number of insect eradication programmes is rising in response to globalisation. A database of arthropod and plant pathogen eradications covers 1050 incursion responses, with 928 eradication programmes on 299 pest and disease taxa in 104 countries (global eradication database b3.net.nz/gerda). A subset of the database was assembled with 211 eradication or response programmes against 17 species of fruit flies (Tephritidae) in 31 countries, in order to investigate factors affecting the outcome. The failure rate for fruit fly eradication programmes was about 7%, with 0% for Ceratitis capitata (n = 85 programmes) and 0% for two Anastrepha species (n = 12 programmes), but 12% for 13 Bactrocera species (n = 108 programmes). A number of intended eradication programmes against long-established populations were not initiated because of cost and other considerations, or evolved during the planning phase into suppression programmes. Cost was dependent on area, ranged from $US 0.1 million to $US 240 million and averaged about $US 12 million (normalised to $US in 2012). In addition to the routine use of surveillance networks, quarantine and fruit destruction, the key tactics used in eradication programmes were male annihilation, protein bait sprays (which can attract both sexes), fruit destruction and the sterile insect technique. Eradication success generally required the combination of several tactics applied on an area-wide basis. Because the likelihood of eradication declines with an increase in the area infested, it pays to invest in effective surveillance networks that allow early detection and delimitation while invading populations are small, thereby greatly favouring eradication success. © 2014 Society of Chemical Industry.

  3. Eradication of tephritid fruit fly pest populations: outcomes and prospects

    International Nuclear Information System (INIS)

    Suckling, David Maxwell; Kean, John M.; Stringer, Lloyd D.; Cáceres-Barrios, Carlos; Hendrichs, Jorge; Reyes-Flores, Jesus; Dominiak, Bernard C.

    2015-01-01

    BACKGROUND: The number of insect eradication programmes is rising in response to globalisation. A database of arthropod and plant pathogen eradications covers 1050 incursion responses, with 928 eradication programmes on 299 pest and disease taxa in 104 countries (global eradication database b3.net.nz/gerda). METHODS: A subset of the database was assembled with 211 eradication or response programmes against 17 species of fruit flies (Tephritidae) in 31 countries, in order to investigate factors affecting the outcome. RESULTS: The failure rate for fruit fly eradication programmes was about 7%, with 0% for Ceratitis capitata (n=85 programmes) and 0% for two Anastrepha species (n=12 programmes), but 12% for 13 Bactrocera species (n=108 programmes). A number of intended eradication programmesagainst long-established populations were not initiated because of cost and other considerations, or evolved during the planning phase into suppression programmes. Cost was dependent on area, ranged from $US 0.1 million to $US 240 million and averaged about $US 12 million (normalised to $US in 2012). In addition to the routine use of surveillance networks, quarantine and fruit destruction, the key tactics used in eradication programmes were male annihilation, protein bait sprays (which can attract both sexes), fruit destruction and the sterile insect technique. CONCLUSIONS: Eradication success generally required the combination of several tactics applied on an area-wide basis. Because the likelihood of eradication declines with an increase in the area infested, it pays to invest in effective surveillance networks that allow early detection and delimitation while invading populations are small, thereby greatly favouring eradication success. (author)

  4. 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...

  5. 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 ...

  6. 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

  7. Comparison of a trifocal intraocular lens with a+3.0 D bifocal IOL: results of a prospective randomized clinical trial

    NARCIS (Netherlands)

    Jonker, S.M.R.; Bauer, N.J.C.; Makhotkina, N.Y.; Berendschot, T.T.J.M.; van den Biggelaar, F.J.H.M.; Nuijts, R.M.M.A.

    Purpose To compare visual outcomes in patients with cataract surgery and bilateral implantation of a trifocal or bifocal intraocular lens (IOL). Setting University Eye Clinic Maastricht, the Netherlands. Design Prospective randomized clinical trial. Methods Eyes with cataract and less than 1.0

  8. 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...

  9. [Clinical trials of laparoscopic gastric cancer surgery in South Korea: review and prospect].

    Science.gov (United States)

    Zhu, Chunchao; Zhao, Gang; Cao, Hui

    2018-02-25

    Laparoscopic technology is gradually accepted in gastric cancer surgery, whose efficacy has been demonstrated by some clinical researches. Randomized controlled trials (RCT) are considered as the most important evidence to prove clinical outcomes of laparoscopic surgery for gastric cancer. Korean gastric surgeons have made great contributions to RCT in laparoscopic gastric cancer surgery. KLASS (Korean Laparoscopic Gastrointestinal Surgery Study Group) is one of the most important forerunner and global leader of clinical trials of gastric cancer treatment. KLASS series clinical trials are attracting global attention because of the significant value of surgical treatment for gastric cancer. The RCTs in Korea involve in many aspects of laparoscopic gastrectomy for gastric cancer, including laparoscopy application in early gastric cancer (KLASS-01, KLASS-03 and KLASS-07), advanced gastric cancer (KLASS-02 and KLASS-06), function-preserving gastrectomy (KLASS-04,KLASS-05) and sentinel node navigation surgery (SENORITA trial). In order to share some informations of these RCTs, we review and prospect some important clinical trials of laparoscopic gastric cancer surgery in Korea. With the experience of Korean gastric surgeons, we can make more progress in our own clinical trials of laparoscopic gastric cancer surgery.

  10. Perioperative vitamin D levels correlate with clinical outcomes after ankle fracture fixation.

    Science.gov (United States)

    Warner, Stephen J; Garner, Matthew R; Nguyen, Joseph T; Lorich, Dean G

    2016-03-01

    Hypovitaminosis D is common in patients undergoing orthopaedic trauma surgery. While previous studies have shown that vitamin D levels correlate with functional outcome after hip fracture surgery, the significance of vitamin D levels on outcomes after surgery in other orthopaedic trauma patients is unknown. The purpose of this study was to determine if vitamin D levels correlated with outcomes in ankle fracture patients. We reviewed a prospective registry of patients who underwent operative treatment for ankle fractures from 2003 to 2012. Preoperative serum 25-hydroxyvitamin D (25[OH]D) levels were measured, and the primary and secondary outcomes included foot and ankle outcome scores (FAOS) and ankle range of motion. Data were also collected on patient comorbidities, articular malreductions, and wound complications. Included patients had at least 12 months of clinical outcome data. Ninety-eight patients operatively treated for ankle fractures met our inclusion criteria. Of these 98 patients, 36 (37%) were deficient in vitamin D (ankle fractures, preoperative vitamin D deficiency correlated with inferior clinical outcomes at a minimum of 1 year follow-up. Our study suggests that deficient vitamin D levels may result in worse outcomes in orthopaedic trauma patients recovering from fracture fixation.

  11. 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...

  12. 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 ...

  13. The effect of a clinical medical librarian on in-patient care outcomes*

    Science.gov (United States)

    Esparza, Julia M.; Shi, Runhua; McLarty, Jerry; Comegys, Marianne; Banks, Daniel E.

    2013-01-01

    Objective: The research sought to determine the effect of a clinical medical librarian (CML) on outcomes of in-patients on the internal medicine service. Methods: A prospective study was performed with two internal medicine in-patient teams. Team 1 included a CML who accompanied the team on daily rounds. The CML answered questions posed at the point of care immediately or in emails post-rounds. Patients on Team 2, which did not include a CML, as well as patients who did not require consultation by the CML on Team 1, served as the control population. Numerous clinical and library metrics were gathered on each question. Results: Patients on Team 1 who required an answer to a clinical question were more ill and had a longer length of stay, higher costs, and higher readmission rates compared to those in the control group. Using a matched pair analysis, we showed no difference in clinical outcomes between the intervention group and the control group. Conclusions: This study is the largest attempt to prospectively measure changes in patient outcomes when physicians were accompanied by a CML on rounds. This approach may serve as a model for further studies to define when and how CMLs are most effective. PMID:23930088

  14. The effect of a clinical medical librarian on in-patient care outcomes.

    Science.gov (United States)

    Esparza, Julia M; Shi, Runhua; McLarty, Jerry; Comegys, Marianne; Banks, Daniel E

    2013-07-01

    The research sought to determine the effect of a clinical medical librarian (CML) on outcomes of in-patients on the internal medicine service. A prospective study was performed with two internal medicine in-patient teams. Team 1 included a CML who accompanied the team on daily rounds. The CML answered questions posed at the point of care immediately or in emails post-rounds. Patients on Team 2, which did not include a CML, as well as patients who did not require consultation by the CML on Team 1, served as the control population. Numerous clinical and library metrics were gathered on each question. Patients on Team 1 who required an answer to a clinical question were more ill and had a longer length of stay, higher costs, and higher readmission rates compared to those in the control group. Using a matched pair analysis, we showed no difference in clinical outcomes between the intervention group and the control group. This study is the largest attempt to prospectively measure changes in patient outcomes when physicians were accompanied by a CML on rounds. This approach may serve as a model for further studies to define when and how CMLs are most effective.

  15. Prospective, Multicentre, Nationwide Clinical Data from 600 Cases of Acute Pancreatitis.

    Directory of Open Access Journals (Sweden)

    Andrea Párniczky

    Full Text Available The aim of this study was to analyse the clinical characteristics of acute pancreatitis (AP in a prospectively collected, large, multicentre cohort and to validate the major recommendations in the IAP/APA evidence-based guidelines for the management of AP.Eighty-six different clinical parameters were collected using an electronic clinical research form designed by the Hungarian Pancreatic Study Group.600 adult patients diagnosed with AP were prospectively enrolled from 17 Hungarian centres over a two-year period from 1 January 2013.With respect to aetiology, biliary and alcoholic pancreatitis represented the two most common forms of AP. The prevalence of biliary AP was higher in women, whereas alcoholic AP was more common in men. Hyperlipidaemia was a risk factor for severity, lack of serum enzyme elevation posed a risk for severe AP, and lack of abdominal pain at admission demonstrated a risk for mortality. Abdominal tenderness developed in all the patients with severe AP, while lack of abdominal tenderness was a favourable sign for mortality. Importantly, lung injury at admission was associated with mortality. With regard to laboratory parameters, white blood cell count and CRP were the two most sensitive indicators for severe AP. The most common local complication was peripancreatic fluid, whereas the most common distant organ failure in severe AP was lung injury. Deviation from the recommendations in the IAP/APA evidence-based guidelines on fluid replacement, enteral nutrition and timing of interventions increased severity and mortality.Analysis of a large, nationwide, prospective cohort of AP cases allowed for the identification of important determinants of severity and mortality. Evidence-based guidelines should be observed rigorously to improve outcomes in AP.

  16. 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.

  17. Falling caesarean section rate and improving intra-partum outcomes: a prospective cohort study.

    Science.gov (United States)

    Amin, Pina; Zaher, Summia; Penketh, Richard; Cherian, Sobha; Collis, Rachel E; Sanders, Julia; Bhal, Kiron

    2018-02-19

    To evaluate caesarean section (CS) rates and moderate to severe hypoxaemic ischaemic encephalopathy (HIE) rates with other core intra-partum outcomes following reconfiguration of maternity services in Cardiff, South Wales, UK. Cohort study of births from 2006 to 2015. A University tertiary referral centre for foetal and maternal medicine with 6000 births/year, University Hospital of Wales, United Kingdom. Data relating to births from 1 January 2006 to 31 December 2015 were extracted from the computerized maternity database on a yearly basis. Case notes of all mothers and babies for the same duration were hand searched for documentation of HIE. HIE data was also collected prospectively by neonatologist (SC) and obstetrician (PA). Incidence of caesarean section births, babies with moderate to severe HIE, instrumental vaginal births, obstetric anal sphincter injuries (OASIS) associated with instrumental delivery, and major post-partum haemorrhage (MPPH) of 2500 mL or more. During this 10-year period, a downward trend in emergency CS rate was seen from 15.6% in 2006 to 10.5% in 2015, reducing total CS rate from 25.5% in 2006 to 21.2% in 2015. A downward trend in the incidence of moderate and severe HIE was seen over the same period. There was an increase in operative vaginal births (OVB) from 12.8% to 15%. The rate of spontaneous vaginal births (SVB) remained stable. The incidence of OASIS remained constant and MPPH rate has fallen. Following amalgamation of two medium sized obstetric units and the opening of a Midwifery Led Unit (MLU), core intrapartum outcomes have improved. Contributing factors are the introduction of regular multidisciplinary training with enhanced team working, compulsory education for obstetricians and midwives on cardiotocograph (CTG) interpretation, increased consultant presence on delivery suite, robust risk management systems and broad multidisciplinary agreement on clinical guidelines promoting vaginal birth.

  18. 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 ...

  19. 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 ...

  20. 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 ...

  1. Timing of renal replacement therapy and clinical outcomes in critically ill patients with severe acute kidney injury

    NARCIS (Netherlands)

    Bagshaw, Sean M.; Uchino, Shigehiko; Bellomo, Rinaldo; Morimatsu, Hiroshi; Morgera, Stanislao; Schetz, Miet; Tan, Ian; Bouman, Catherine; Macedo, Ettiene; Gibney, Noel; Tolwani, Ashita; Oudemans-van Straaten, Heleen M.; Ronco, Claudio; Kellum, John A.; French, Craig; Mulder, John; Pinder, Mary; Roberts, Brigit; Botha, John; Mudholkar, Pradeen; Holt, Andrew; Hunt, Tamara; Honoré, Patrick Maurice; Clerbaux, Gaetan; Schetz, Miet Maria; Wilmer, Alexander; Yu, Luis; Macedo, Ettiene V.; Laranja, Sandra Maria; Rodrigues, Cassio José; Suassuna, José Hermógenes Rocco; Ruzany, Frederico; Campos, Bruno; Leblanc, Martine; Senécal, Lynne; Gibney, R. T. Noel; Johnston, Curtis; Brindley, Peter; Tan, Ian K. S.; Chen, Hui De; Wan, Li; Rokyta, Richard; Krouzecky, Ales; Neumayer, Hans-Helmut; Detlef, Kindgen-Milles; Mueller, Eckhard; Tsiora, Vicky; Sombolos, Kostas; Mustafa, Iqbal; Suranadi, Iwayan; Bar-Lavie, Yaron; Nakhoul, Farid; Ceriani, Roberto; Bortone, Franco; Zamperetti, Nereo; Pappalardo, Federico; Marino, Giovanni; Calabrese, Prospero; Monaco, Francesco; Liverani, Chiara; Clementi, Stefano; Coltrinari, Rosanna; Marini, Benedetto; Fuke, Nobuo; Miyazawa, Masaaki; Katayama, Hiroshi; Kurasako, Toshiaki; Hirasaw, Hiroyuki; Oda, Shigeto; Tanigawa, Koichi; Tanaka, Keiichi; Oudemans-van Straaten, Helena Maria; de Pont, Anne-Cornelie J. M.; Bugge, Jan Frederik; Riddervold, Fridtjov; Nilsen, Paul Age; Julsrud, Joar; Teixeira e Costa, Fernando; Marcelino, Paulo; Serra, Isabel Maria; Yaroustovsky, Mike; Grigoriyanc, Rachik; Lee, Kang Hoe; Loo, Shi; Singh, Kulgit; Barrachina, Ferran; Llorens, Julio; Sanchez-Izquierdo-Riera, Jose Angel; Toral-Vazquez, Darío; Wizelius, Ivar; Hermansson, Dan; Gaspert, Tomislav; Maggiorini, Marco; Davenport, Andrew; Lombardi, Raúl; Llopart, Teresita; Venkataraman, Ramesh; Kellum, John; Murray, Patrick; Trevino, Sharon; Benjamin, Ernest; Hufanda, Jerry; Paganini, Emil; Warnock, David; Guirguis, Nabil

    2009-01-01

    The aim of this study is to evaluate the relationship between timing of renal replacement therapy (RRT) in severe acute kidney injury and clinical outcomes. This was a prospective multicenter observational study conducted at 54 intensive care units (ICUs) in 23 countries enrolling 1238 patients.

  2. Outcome of radioiodine therapy without, on or 3 days off carbimazole: a prospective interventional three-group comparison

    International Nuclear Information System (INIS)

    Walter, Martin A.; Christ-Crain, Mirjam; Mueller, Beat; Schindler, Christian; Mueller-Brand, Jan

    2006-01-01

    Carbimazole ameliorates hyperthyroidism but reduces radioiodine uptake and adversely affects the outcome of simultaneous radioiodine therapy. We explored whether withdrawal of carbimazole for 3 days can restore the outcome of radioiodine treatment without concurrent exacerbation of hyperthyroidism. By generating three groups with comparable radioiodine uptake, we also investigated whether the effect of carbimazole depends on the radioiodine uptake. Stratified by a radioiodine uptake >30%, 227 consecutive adult patients were prospectively assigned to radioiodine therapy (target dose 200 Gy) without, on or 3 days off carbimazole. Patients were clinically (Crooks-Wayne score) and biochemically (T 3 , fT 4 , TSH) followed up after 3, 6 and 12 months. Primary endpoint was outcome 12 months after radioiodine therapy. A total of 207 patients completed follow-up (toxic nodular goitre, n=117; Graves' disease, n=90). The overall success rate was 71.5%. Patients without and 3 days off carbimazole had similar biochemical (81.4% and 83.3%, respectively; p=0.82) and clinical outcomes [median (range) Crooks-Wayne score 0 (0-16) and 1 (0-10), respectively; p=0.73], which were both higher than in patients on carbimazole [42.6%, p 4 , T 3 and TSH. (orig.)

  3. 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.

  4. 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.

  5. Toward Fully Automated Multicriterial Plan Generation: A Prospective Clinical Study

    International Nuclear Information System (INIS)

    Voet, Peter W.J.; Dirkx, Maarten L.P.; Breedveld, Sebastiaan; Fransen, Dennie; Levendag, Peter C.; Heijmen, Ben J.M.

    2013-01-01

    Purpose: To prospectively compare plans generated with iCycle, an in-house-developed algorithm for fully automated multicriterial intensity modulated radiation therapy (IMRT) beam profile and beam orientation optimization, with plans manually generated by dosimetrists using the clinical treatment planning system. Methods and Materials: For 20 randomly selected head-and-neck cancer patients with various tumor locations (of whom 13 received sequential boost treatments), we offered the treating physician the choice between an automatically generated iCycle plan and a manually optimized plan using standard clinical procedures. Although iCycle used a fixed “wish list” with hard constraints and prioritized objectives, the dosimetrists manually selected the beam configuration and fine tuned the constraints and objectives for each IMRT plan. Dosimetrists were not informed in advance whether a competing iCycle plan was made. The 2 plans were simultaneously presented to the physician, who then selected the plan to be used for treatment. For the patient group, differences in planning target volume coverage and sparing of critical tissues were quantified. Results: In 32 of 33 plan comparisons, the physician selected the iCycle plan for treatment. This highly consistent preference for the automatically generated plans was mainly caused by the improved sparing for the large majority of critical structures. With iCycle, the normal tissue complication probabilities for the parotid and submandibular glands were reduced by 2.4% ± 4.9% (maximum, 18.5%, P=.001) and 6.5% ± 8.3% (maximum, 27%, P=.005), respectively. The reduction in the mean oral cavity dose was 2.8 ± 2.8 Gy (maximum, 8.1 Gy, P=.005). For the swallowing muscles, the esophagus and larynx, the mean dose reduction was 3.3 ± 1.1 Gy (maximum, 9.2 Gy, P<.001). For 15 of the 20 patients, target coverage was also improved. Conclusions: In 97% of cases, automatically generated plans were selected for treatment because of

  6. 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.

  7. 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.

  8. Predictors and health-related outcomes of positive body image in adolescent girls: A prospective study.

    Science.gov (United States)

    Andrew, Rachel; Tiggemann, Marika; Clark, Levina

    2016-03-01

    This study aimed to investigate prospective predictors and health-related outcomes of positive body image in adolescent girls. In so doing, the modified acceptance model of intuitive eating was also examined longitudinally. A sample of 298 girls aged 12 to 16 years completed a questionnaire containing measures of body appreciation, potential predictors, and a range of health outcomes, at 2 time points separated by 1 year. Longitudinal change regression models showed that perceived body acceptance by others (positively), self-objectification and social comparison (negatively), and body appreciation (positively) prospectively predicted intuitive eating 1 year later, consistent with the acceptance model of intuitive eating. Perceived body acceptance by others was the only proposed predictor to prospectively predict an increase in body appreciation over time. Time 1 body appreciation prospectively predicted a decrease in dieting, alcohol, and cigarette use, and an increase in physical activity 1 year later. In particular, girls with low body appreciation were more likely than girls with high body appreciation to take up alcohol and cigarette use between time points. The results highlight body appreciation as an important target for interventions designed to prevent or delay the uptake of alcohol and cigarette consumption among girls. More broadly, they suggest that a positive body image can confer considerable benefit for adolescent girls. (c) 2016 APA, all rights reserved).

  9. Early vs late orthodontic treatment of deepbite: a prospective clinical trial in growing subjects.

    Science.gov (United States)

    Baccetti, Tiziano; Franchi, Lorenzo; Giuntini, Veronica; Masucci, Caterina; Vangelisti, Andrea; Defraia, Efisio

    2012-07-01

    The aim of this prospective clinical trial was to compare the outcomes of prepubertal vs pubertal treatment of deepbite patients with a protocol including biteplane and fixed appliances. A sample of 58 subjects with deepbite completed the study. A total of 34 subjects received treatment with removable biteplane appliances in the mixed dentition at a prepubertal stage of skeletal maturation (early treatment group), and 24 subjects were treated at a pubertal stage of skeletal maturation in the permanent dentition (late treatment group). All subjects of both groups were reevaluated after an average period of 15 months after the completion of fixed appliance therapy. Treatment outcomes were assessed statistically after a phase with removable biteplane appliances and at the posttreatment observation. Treatment duration was significantly shorter in the early treatment group than in the late treatment group. Overbite reduction was significantly greater in the late treatment group (-3.1 mm) than in the early treatment group (-1.4 mm). In the late treatment group, 92% of the patients had a corrected overbite 1 year after therapy. Treatment of deepbite at puberty in the permanent dentition leads to significantly more favorable outcomes than treatment before puberty in the mixed dentition. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

  10. Multicentre prospective evaluation of implant-assisted mandibular removable partial dentures: surgical and prosthodontic outcomes.

    Science.gov (United States)

    Payne, Alan G T; Tawse-Smith, Andrew; Wismeijer, Daniel; De Silva, Rohana K; Ma, Sunyoung

    2017-01-01

    To determine implant survival and prosthodontic maintenance of implant-assisted mandibular removable partial dentures in a multicentre prospective study up to 10 years. Forty-eight participants with mandibular distal extension partial dentures were selected. A control group of 12 New Zealand participants had new conventional mandibular partial dentures made. Three test groups of 36 participants in New Zealand (n = 12), the Netherlands (n = 12) and Colombia (n = 12) had bilateral distal implants placed. Surgical and prosthodontic outcomes were documented with only healing caps placed (Stage 1) and with an attachment system (Stage 2). No implants failed after 3 years. Four late implant failures in three participants occurred in New Zealand (two unilateral implant failures after 5 and 8 years and two bilateral implant failures in the same participant after 6 and 10 years); two unilateral late implant failures occurred in the Netherlands and no late failures in Colombia. Implant survival rate was 92% by 10 years. Resonance frequency measurements were taken at surgery implant stability quotient (ISQ) 62.44 ± 7.46; range 40 - 79), baseline (ISQ 63.22 ± 6.17; range 50 - 74) and after 3 years (ISQ 66.38 ± 6.77; range 55 - 83). In New Zealand and Colombia, measured crestal bone levels were 2.03 ± 0.71 mm and 2.20 ± 0.81 mm, respectively, at baseline and 3 years. For Stage I, principal prosthodontic maintenance issues were loose healing caps among 10 New Zealand participants, four Colombian participants and one Netherlands participant. For Stage 2, matrix activation and overdenture puncture fractures resulted in 41 events (25 participants) in New Zealand over 10 years, whilst over 3 years, there were 14 events in nine Colombian participants and six events in five Netherlands participants. This clinical multicentre research complements previous case reports, case series, retrospective and prospective studies on the notion of implant

  11. Abnormal vaginal microbiota may be associated with poor reproductive outcomes: a prospective study in IVF patients.

    Science.gov (United States)

    Haahr, T; Jensen, J S; Thomsen, L; Duus, L; Rygaard, K; Humaidan, P

    2016-04-01

    What is the diagnostic performance of qPCR assays compared with Nugent scoring for abnormal vaginal microbiota and for predicting the success rate of IVF treatment? The vaginal microbiota of IVF patients can be characterized with qPCR tests which may be promising tools for diagnosing abnormal vaginal microbiota and for prediction of clinical pregnancy in IVF treatment. Bacterial vaginosis (BV) is a common genital disorder with a prevalence of approximately 19% in the infertile population. BV is often sub-clinical with a change of the vaginal microbiota from being Lactobacillus spp. dominated to a more heterogeneous environment with anaerobic bacteria, such as Gardnerella vaginalis and Atopobium vaginae. Few studies have been conducted in infertile women, and some have suggested a negative impact on fecundity in the presence of BV. A cohort of 130 infertile patients, 90% Caucasians, attending two Danish fertility clinics for in vitro fertilization (IVF) treatment from April 2014-December 2014 were prospectively enrolled in the trial. Vaginal swabs from IVF patients were obtained from the posterior fornix. Gram stained slides were assessed according to Nugent's criteria. PCR primers were specific for four common Lactobacillus spp., G. vaginalis and A. vaginae. Threshold levels were established using ROC curve analysis. The prevalence of BV defined by Nugent score was 21% (27/130), whereas the prevalence of an abnormal vaginal microbiota was 28% (36/130) defined by qPCR with high concentrations of Gardnerella vaginalis and/or Atopobium vaginae. The qPCR diagnostic approach had a sensitivity and specificity of respectively 93% and 93% for Nugent-defined BV. Furthermore, qPCR enabled the stratification of Nugent intermediate flora. Eighty-four patients completed IVF treatment. The overall clinical pregnancy rate was 35% (29/84). Interestingly, only 9% (2/22) with qPCR defined abnormal vaginal microbiota obtained a clinical pregnancy (P = 0.004). Although a total of 130

  12. Procalcitonin levels in sepsis and its association with clinical outcome in southern India.

    Science.gov (United States)

    Rebello, Alex; Thabah, Molly Mary; Dutta, Tarun Kumar; Bobby, Zachariah; Harish, B N; Mehalingam, Vadivelan

    2017-10-01

    Procalcitonin has been found to be a good marker for the diagnosis of sepsis. However, data on procalcitonin levels to predict the clinical outcome in patients with sepsis are limited. The aim of our study was to estimate serum procalcitonin levels in patients with sepsis and to identify its relationship with the clinical outcome. This was a prospective observational study conducted on 112 patients with sepsis admitted to the medical wards and medical intensive care unit of a tertiary care teaching hospital. Serum procalcitonin was measured at baseline before antibiotic administration and on day 5. The clinical outcome studied was death or survival on day 28. Baseline mean serum procalcitonin was highest in patients with septic shock and lowest in patients having sepsis without organ dysfunction. Mean values of procalcitonin at baseline and on day 5 were significantly higher in non-survivors when compared with survivors. There was a significant difference in the change in procalcitonin levels from baseline to day 5 between survivors and non-survivors, with survivors having declining values on day 5 while non-survivors had increasing values from baseline. The baseline APACHE II and SOFA scores also showed a significant correlation with the baseline procalcitonin level. Declining values of procalcitonin therefore indicate a favourable clinical outcome in patients with sepsis.

  13. 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.

  14. 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

  15. Hair mercury concentrations and in vitro fertilization (IVF) outcomes among women from a fertility clinic

    Science.gov (United States)

    Ehrlich, Shelley; Smith, Kristen; Williams, Paige L.; Chavarro, Jorge E.; Batsis, Maria; Toth, Thomas L.; Hauser, Russ

    2015-01-01

    Total hair mercury (Hg) was measured among 205 women undergoing in vitro fertilization (IVF) treatment and the association with prospectively collected IVF outcomes (229 IVF cycles) was evaluated. Hair Hg levels (median=0.62 ppm, range: 0.03-5.66 ppm) correlated with fish intake (r=0.59), and exceeded the recommended EPA reference of 1ppm in 33% of women. Generalized linear mixed models with random intercepts accounting for within-woman correlations across treatment cycles were used to evaluate the association of hair Hg with IVF outcomes adjusted for age, body mass index, race, smoking status, infertility diagnosis, and protocol type. Hair Hg levels were not related to ovarian stimulation outcomes (peak estradiol levels, total and mature oocyte yields) or to fertilization rate, embryo quality, clinical pregnancy rate or live birth rate. PMID:25601638

  16. Posttraumatic hydrocephalus: a clinical, neuroradiologic, and neuropsychologic assessment of long-term outcome.

    Science.gov (United States)

    Mazzini, Letizia; Campini, Riccardo; Angelino, Elisabetta; Rognone, Felice; Pastore, Ilaria; Oliveri, Giuseppe

    2003-11-01

    To detect the clinical and radiologic characteristics of posttraumatic hydrocephalus (PTH), to define its prognostic value, and to assess the effects of shunt surgery. Correlational study on a prospective cohort. Brain injury rehabilitation center. One hundred forty patients with severe traumatic brain injury (TBI) referred to an inpatient intensive rehabilitation unit of primary care in a university-based system. Not applicable. The Glasgow Outcome Scale (GOS), Disability Rating Scale (DRS), FIM instrument, and Neurobehavioural Rating Scale (NRS), as well as single-photon emission computed tomography (SPECT) and magnetic resonance imaging. PTH was found in 45% of patients. Risk factors for PTH were as follows: age (PTBI. It influences functional and behavioral outcome and the appearance of posttraumatic epilepsy. The selection of patients for surgery can be defined principally on a clinical basis. SPECT may be helpful for differentiating ventricular enlargement due to cortical atrophy and hydrocephalus.

  17. Can shared care deliver better outcomes for patients undergoing total hip replacement? A prospective assessment of patient outcomes and associated service use

    NARCIS (Netherlands)

    Rosendal, H.; Beekum, W.T. van; Nijhof, P.; Witte, L.P. de; Schrijvers, A.J.P.

    2000-01-01

    Objectives: To assess whether shared care for patients undergoing total hip replacement delivers better outcomes compared to care as usual. Design: Prospective, observational cohort study. Setting: Two regions in the Netherlands where different organisational health care models have been

  18. The first pharmacist-managed anticoagulation clinic under a collaborative practice agreement in Qatar: clinical and patient-oriented outcomes.

    Science.gov (United States)

    Elewa, H F; AbdelSamad, O; Elmubark, A E; Al-Taweel, H M; Mohamed, A; Kheir, N; Mohamed Ibrahim, M I; Awaisu, A

    2016-08-01

    Optimal outpatient anticoagulation management requires a systematic and coordinated approach. Extensive evidence regarding the benefits of pharmacist-managed anticoagulation services has been reported in the literature. The quality and outcomes associated with pharmacist-managed anticoagulation clinics under collaborative practice agreements in the Middle East have rarely been reported. The first pharmacist-managed ambulatory anticoagulation clinic in Qatar was launched at Al-Wakrah Hospital in March 2013. The objectives of this study were to: (i) describe the practice model of the clinic, (ii) evaluate the quality of the clinic [i.e. the time in therapeutic range (TTR)] and the clinical outcomes (i.e. the efficacy and safety), and (iii) determine the patients' satisfaction and overall quality of life (QoL). Clinical outcome data were collected through a retrospective chart review of all patients managed from March 2013 to October 2014 at the pharmacist-managed anticoagulation clinic. Furthermore, the patient-oriented outcomes data were prospectively collected using the 24-item Duke Anticoagulation Satisfaction Scale (DASS). Each item was assessed using a 7-point Likert-type scale on which lower scores indicated better QoL and greater satisfaction. The clinical outcome data analyses included 119 patients who were enrolled at the clinic during the 19-month study period. The mean number of international normalized ratio (INR) tests/month was 65 ± 9, the average testing frequency was 2·7 ± 1·6 weeks, and the average %TTR was 76·8 ± 22·9%. There was one major bleeding event (0·67%/year), 12 minor bleeding events (8%/year) and two thromboembolic events (1·35%/year) recorded during the study period. Of the 119 patients, 50 participated in the satisfaction and QoL survey. The median (IQR) total QoL score of these subjects was 63 (48) (minimum-maximum achievable score: 24-168). Seventy-six per cent of the patients indicated 'a lot to very much' in terms of their

  19. Mapping clinical outcomes expectations to treatment decisions: an application to vestibular schwannoma management.

    Science.gov (United States)

    Cheung, Steven W; Aranda, Derick; Driscoll, Colin L W; Parsa, Andrew T

    2010-02-01

    Complex medical decision making obligates tradeoff assessments among treatment outcomes expectations, but an accessible tool to perform the necessary analysis is conspicuously absent. We aimed to demonstrate methodology and feasibility of adapting conjoint analysis for mapping clinical outcomes expectations to treatment decisions in vestibular schwannoma (VS) management. Prospective. Tertiary medical center and US-based otologists/neurotologists. Treatment preference profiles among VS stakeholders-61 younger and 74 older prospective patients, 61 observation patients, and 60 surgeons-were assessed for the synthetic VS case scenario of a 10-mm tumor in association with useful hearing and normal facial function. Treatment attribute utility. Conjoint analysis attribute levels were set in accordance to the results of a meta-analysis. Forty-five case series were disaggregated to formulate microsurgery facial nerve and hearing preservation outcomes expectations models. Attribute utilities were computed and mapped to the realistic treatment choices of translabyrinthine craniotomy, middle fossa craniotomy, and gamma knife radiosurgery. Among the treatment attributes of likelihoods of causing deafness, temporary facial weakness for 2 months, and incurable cancer within 20 years, and recovery time, permanent deafness was less important to tumor surgeons, and temporary facial weakness was more important to tumor surgeons and observation patients (Wilcoxon rank-sum, p knife radiosurgery. Mapping clinical outcomes expectations to treatment decisions for a synthetic clinical scenario revealed inhomogeneous drivers of choice selection among study cohorts. Medical decision engines that analyze personal preferences of outcomes expectations for VS and many other diseases may be developed to promote shared decision making among health care stakeholders and transparency in the informed consent process.

  20. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

    Science.gov (United States)

    Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

    2017-09-01

    There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  1. Failure to Thrive: A Prospective Study in a Pediatric Gastroenterology Clinic.

    Science.gov (United States)

    Larson-Nath, Catherine M; Goday, Praveen S

    2016-06-01

    We aimed to describe the clinical characteristics, diagnostic work-up, interventions, and outcomes of children referred to a pediatric gastroenterology clinic with the diagnosis of failure to thrive (FTT). We prospectively enrolled 110 children seen for the first time in our pediatric gastroenterology clinic for FTT. Standard demographic information, history, and anthropometric data were collected at initial and follow-up visits. We also obtained data about diagnostic workup, therapeutic interventions, and growth outcomes. Seventy patients (63.6%) were boys with a median age of 0.79 years (interquartile range 0.36-1.98). Of the 91 children with follow-up data, 81 (89%) were found to have nonorganic etiologies of their FTT. The majority of children (56.4%) underwent laboratory evaluation. Imaging and endoscopic evaluations were performed in fewer patients (29.6 and 10.2%, respectively). Endoscopic intervention yielded a diagnosis in 16.7% of patients while the positive result rates for laboratory testing and imaging were 3.2% and 3.1%, respectively. The most common therapeutic interventions included increasing calories (71.8%), avoiding grazing (71.8%), and structuring meals and snacks (67.3%). Compared with nonadherent children, children who were adherent with standard behavioral and nutritional interventions showed a higher positive change in z scores for weight (0.36 vs -0.01, P = 0.001) and body mass index (0.58 vs -0.18, P = 0.031). The majority of children in a pediatric gastroenterology clinic with FTT have nonorganic etiologies of their failure to thrive. Laboratory, imaging, and endoscopic evaluation are rarely positive and should be judiciously performed. Adherence to standardized interventions leads to improved growth.

  2. Critical Care Follow-up Clinics: A Scoping Review of Interventions and Outcomes.

    Science.gov (United States)

    Lasiter, Sue; Oles, Sylwia K; Mundell, James; London, Susan; Khan, Babar

    2016-01-01

    The purpose of this scoping review is to identify evidence describing benefits of interventions provided in intensive care unit (ICU) survivor follow-up clinics. Advances in ICU treatments have increased the number of survivors who require specialized care for ICU-related sequelae. Intensive care unit survivor follow-up clinics exist, yet little is known about the nature and impact of interventions provided in such clinics. A scoping review of publications about in-person post-ICU follow-up care was undertaken. Ten databases were searched yielding 111 relevant unique publication titles and abstracts. Sample heterogeneity supported using a scoping review method. After excluding nonrelated publications, 33 reports were fully reviewed. Twenty international publications were included that described ICU follow-up clinic interventions and/or outcomes. Authors discussed very diverse interventions in 15 publications, and 9 reported some level of intervention effectiveness. Evidence was strongest that supported the use of prospective diaries as an intervention to prevent or improve psychological symptoms, whereas evidence to support implementation of other interventions was weak. Although ICU follow-up clinics exist, evidence for interventions and effectiveness of treatments in these clinics remains underexplored. Intensive care unit survivor follow-up clinics provide a venue for further interdisciplinary intervention research that could lead to better health outcomes for ICU survivors.

  3. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries

    DEFF Research Database (Denmark)

    Reaney, Matthew; Mathieu, Chantal; Ostenson, Claes-Göran

    2013-01-01

    who did not meet this endpoint) and Diabetes Health Profile-18 scores (versus the main cohorts). High levels of missing data were observed for all PRO measures in both cohorts compared with those for clinical outcomes. CONCLUSIONS: These data from a clinical practice study support those from clinical...... clinical practice are lacking. We examined PROs in patients initiating injectable treatment in the CHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy) study. METHODS: CHOICE was a 24-month, prospective observational study conducted in six European......BACKGROUND: Improvements in the clinical condition of patients with type 2 diabetes are often accompanied by improvements in health-related quality of life and other patient-reported outcomes (PROs), but data assessing injectable treatment initiation from the patient's perspective in routine...

  4. Arthrocentesis and Temporomandibular Joint Disorders: Clinical and Radiological Results of a Prospective Study

    Directory of Open Access Journals (Sweden)

    Giacomo De Riu

    2013-01-01

    Full Text Available Purpose. We evaluated the efficacy of arthrocentesis in the treatment of temporomandibular joint (TMJ disorders. Material and Methods. In this prospective clinical case series, 30 consecutive patients with TMJ disorders underwent arthrocentesis using saline and sodium hyaluronate injections. Outcome measures were TMJ pain, maximum mouth opening (MMO, joint noises, and anatomical changes in the TMJ architecture. Patients were evaluated using cone-beam computed tomography (CBCT and magnetic resonance imaging (MRI at the beginning of treatment and 60 days after the last arthrocentesis. Pretreatment and posttreatment clinical parameters were compared using paired and unpaired t-tests, and McNemar’s test was used to evaluate CBCT and MRI changes (. Results. At 1-year follow-up examinations, visual analogue scale scores indicated that pain was reduced significantly and mean postoperative MMO was increased significantly. CBCT findings showed no significant change, and MRI showed only slight reductions in inflammatory signs. Conclusions. Within the limitations of this study, we can conclude that arthrocentesis is a simple, minimally invasive procedure with a relatively low risk of complications and significant clinical benefits in patients with TMJ disorders. This trial is registered with NCT01903512.

  5. Clinical profile and outcome of Dengue fever cases.

    Science.gov (United States)

    Ratageri, Vinod H; Shepur, T A; Wari, P K; Chavan, S C; Mujahid, I B; Yergolkar, P N

    2005-08-01

    Dengue fever is on rise globally. In India, Dengue epidemics are expanding geographically, even into the rural areas. Dengue can present with varied manifestations. The mortality rate has been brought down with high index of suspicion, strict monitoring and proper fluid resuscitation. Herewith, we are presenting clinical features and outcome of Dengue cases seen in and around Hubli (North Karnataka).

  6. Clinical profile and outcome of parathyroid adenoma-associated pancreatitis

    Directory of Open Access Journals (Sweden)

    Mohsin Aslam

    2018-01-01

    Conclusions: Estimating serum calcium after an episode of unexplained pancreatitis is important and can help minimize delay in diagnosing primary hyperparathyroidism, and possibly prevent the progression of pancreatitis. Parathyroidectomy improves the clinical outcome of primary hyperparathyroidism and prevents further attacks of pancreatitis.

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

    DEFF Research Database (Denmark)

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

    2015-01-01

    BACKGROUND: We examined the association of sex with clinical characteristics and outcomes in patients following myocardial infarction (MI) in the Valsartan in Acute Myocardial Infarction Trial (VALIANT). METHODS AND RESULTS: A total of 4570 women and 10 133 men with heart failure (HF), left...

  8. The impact of antioxidant supplementation on clinical outcomes in ...

    African Journals Online (AJOL)

    Methodology: A systematic review and meta-analysis of the English literature was performed to determine the effect of antioxidant micronutrient supplementation on clinically important outcomes in the critically ill. Pubmed, Google Scholar and Science Direct electronic databases were searched for papers published ...

  9. Causes and Clinical Outcomes in Neonates with Acute Abdomen ...

    African Journals Online (AJOL)

    Causes and Clinical Outcomes in Neonates with Acute Abdomen Requiring Surgery at ... Neonatal surgery is challenging, particularly in the emergency setting whereby ... Other causes included peritonitis (6.9%) and abdominal wall defects (4.7%). ... accounting for 13 cases (30.2%) and mortality was 34.9 % ( 15 neonates).

  10. Short term clinical outcome of children with rotavirus infection at ...

    African Journals Online (AJOL)

    Background: Rotavirus infection is the single most common cause of acute gastroenteritis in children under five years of age. Rotavirus gastroenteritis has a high morbidity and mortality in children in Kenya. Objectives: To determine the short term clinical outcome for children admitted to Kenyatta National Hospital with ...

  11. 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...

  12. Clinical Features and the Factors Associated with Poor Outcome of ...

    African Journals Online (AJOL)

    Clinical Features and the Factors Associated with Poor Outcome of. Measles Patients at Queen Elizabeth Central Hospital. Robin L Broadhead. Paul Courtright. Lincy Misoya. Affiliation: 1. Department of Paediatrics College of. Medicine University of Malawi. 2. International Eye FoundatiQn. 3. Department of Paediatrics ...

  13. 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 ...

  14. 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 ...

  15. Development in Children with Achondroplasia: A Prospective Clinical Cohort Study

    Science.gov (United States)

    Ireland, Penelope J.; Donaghey, Samantha; McGill, James; Zankl, Andreas; Ware, Robert S.; Pacey, Verity; Ault, Jenny; Savarirayan, Ravi; Sillence, David; Thompson, Elizabeth; Townshend, Sharron; Johnston, Leanne M.

    2012-01-01

    Aim: Achondroplasia is characterized by delays in the development of communication and motor skills. While previously reported developmental profiles exist across gross motor, fine motor, feeding, and communication skills, there has been no prospective study of development across multiple areas simultaneously. Method: This Australasian…

  16. An Exploration of Prospective Teachers' Learning of Clinical Interview Techniques

    Science.gov (United States)

    Groth, Randall E.; Bergner, Jennifer A.; Burgess, Claudia R.

    2016-01-01

    The present study followed four prospective teachers through the process of learning to interview during an undergraduate research project experience. Participants conducted and video recorded a series of interviews with children. They also carried out guided analyses of the videos and written artefacts from the interviews to formulate conjectures…

  17. A 5 year prospective study of patient-relevant outcomes after total knee replacement

    DEFF Research Database (Denmark)

    Nilsdotter, A-K; Toksvig-Larsen, S; Roos, E M

    2008-01-01

    men, mean age 71 (51-86) assigned for TKR at the Department of Orthopaedics at Lund University Hospital were included in the study. The self-administered questionnaires Knee injury and Osteoarthritis Outcome Score (KOOS) and SF-36 were mailed preoperatively and 6 months, 12 months and at 5 years......OBJECTIVE: To prospectively describe self-reported outcomes up to 5 years after total knee replacement (TKR) in Osteoarthritis (OA) and to study which patient-relevant factors may predict outcomes for pain and physical function (PF). METHODS: 102 consecutive patients with knee OA, 63 women and 39...... postoperatively. RESULTS: Response rate at 5 years was 86%. At 6 months significant improvement was seen in all KOOS and SF-36 scores (P

  18. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Mendenhall, Nancy P.; Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong; Williams, Christopher R.; Costa, Joseph; Henderson, Randal H.

    2014-01-01

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes

  19. Five-Year Outcomes from 3 Prospective Trials of Image-Guided Proton Therapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Mendenhall, Nancy P., E-mail: menden@shands.ufl.edu [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Hoppe, Bradford S.; Nichols, Romaine C.; Mendenhall, William M.; Morris, Christopher G.; Li, Zuofeng; Su, Zhong [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Williams, Christopher R.; Costa, Joseph [Division of Urology, College of Medicine, University of Florida, Jacksonville, Florida (United States); Henderson, Randal H. [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States)

    2014-03-01

    Purpose: To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer. Methods and Materials: A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years. Results: Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence. Conclusions: Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes.

  20. 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...

  1. 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...

  2. Statistical Machines for Trauma Hospital Outcomes Research: Application to the PRospective, Observational, Multi-Center Major Trauma Transfusion (PROMMTT Study.

    Directory of Open Access Journals (Sweden)

    Sara E Moore

    Full Text Available Improving the treatment of trauma, a leading cause of death worldwide, is of great clinical and public health interest. This analysis introduces flexible statistical methods for estimating center-level effects on individual outcomes in the context of highly variable patient populations, such as those of the PRospective, Observational, Multi-center Major Trauma Transfusion study. Ten US level I trauma centers enrolled a total of 1,245 trauma patients who survived at least 30 minutes after admission and received at least one unit of red blood cells. Outcomes included death, multiple organ failure, substantial bleeding, and transfusion of blood products. The centers involved were classified as either large or small-volume based on the number of massive transfusion patients enrolled during the study period. We focused on estimation of parameters inspired by causal inference, specifically estimated impacts on patient outcomes related to the volume of the trauma hospital that treated them. We defined this association as the change in mean outcomes of interest that would be observed if, contrary to fact, subjects from large-volume sites were treated at small-volume sites (the effect of treatment among the treated. We estimated this parameter using three different methods, some of which use data-adaptive machine learning tools to derive the outcome models, minimizing residual confounding by reducing model misspecification. Differences between unadjusted and adjusted estimators sometimes differed dramatically, demonstrating the need to account for differences in patient characteristics in clinic comparisons. In addition, the estimators based on robust adjustment methods showed potential impacts of hospital volume. For instance, we estimated a survival benefit for patients who were treated at large-volume sites, which was not apparent in simpler, unadjusted comparisons. By removing arbitrary modeling decisions from the estimation process and concentrating

  3. Clinical results and functional outcomes after direct intralaminar screw repair of spondylolysis.

    Science.gov (United States)

    Menga, Emmanuel N; Kebaish, Khaled M; Jain, Amit; Carrino, John A; Sponseller, Paul D

    2014-01-01

    Prospective analysis. Our objective was to analyze clinical and functional results of patients with spondylolysis treated via direct intralaminar screw fixation and autograft, a minimally invasive and motion-preserving surgery. Spondylolysis is usually treated nonoperatively; multiple surgical techniques are available when nonoperative measures fail. No studies evaluate the clinical and functional outcomes and their correlation with pars defect size and disc morphology on magnetic resonance imaging. We reviewed patients with spondylolysis treated with intralaminar screw fixation and bone grafting from 2000 through 2010. Of the 31 patients (mean age, 16 yr; range, 10-37 yr), 25 (81%) were competitive athletes. Preoperative computed tomographic scans were used to measure the pars defect size, and preoperative magnetic resonance images were graded using Pfirrmann classification for correlation with postoperative outcomes. Student t test was used for analysis (significance, P spondylolysis repair for persistent pain starting 18 months after intralaminar screw fixation, 2 patients sustained unilateral intralaminar screw fractures at L5, and 1 patient required irrigation and debridement for a superficial postoperative infection. There was no correlation among preoperative magnetic resonance imaging disc morphology, defect size on computed tomography, patient age, and clinical outcomes. Direct repair of spondylolysis with intralaminar screws offers a low profile, reliable treatment with good functional outcome and a low complication rate in active patients. 4.

  4. Role of Serum Lactate and Malarial Retinopathy in Prognosis and Outcome of Falciparum and Vivax Cerebral Malaria: A Prospective Cohort Study in Adult Assamese Tribes

    OpenAIRE

    Chaudhari, Kaustubh Suresh; Uttarwar, Sahil Prashant; Tambe, Nikhil Narayan; Sharma, Rohan S; Takalkar, Anant Arunrao

    2016-01-01

    Introduction: There is no comprehensive data or studies relating to clinical presentation and prognosis of cerebral malaria (CM) in the tribal settlements of Assam. High rates of transmission and deaths from complicated malaria guided us to conduct a prospective observational cohort study to evaluate the factors associated with poor outcome and prognosis in patients of CM. Materials and Methods: We admitted 112 patients to the Bandarpara and Damodarpur Tribal Health Centers (THCs) between 201...

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

    DEFF Research Database (Denmark)

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

    2008-01-01

    of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT...

  6. 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

  7. Quality of optometry referrals to neovascular age-related macular degeneration clinic: a prospective study

    OpenAIRE

    Muen, Wisam J; Hewick, Simon A

    2011-01-01

    Objectives To evaluate the quality of referrals to a neovascular age-related macular degeneration clinic from optometrists using the standard Rapid Access Referral Form (RARF) from the Royal College of Ophthalmologists. Design A prospective study. Prospective data were gathered from all optometry referrals using the RARF, between the periods of December 2006 to August 2009. These were assessed for accuracy of history, clinical signs and final diagnosis as compared to a macula expert. Setting ...

  8. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

    Science.gov (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

    2016-03-22

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

  9. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    International Nuclear Information System (INIS)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina

    2016-01-01

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

  10. 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.

  11. 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.

  12. Coronary Stents: The Impact of Technological Advances on Clinical Outcomes.

    Science.gov (United States)

    Mennuni, Marco G; Pagnotta, Paolo A; Stefanini, Giulio G

    2016-02-01

    Percutaneous coronary interventions (PCI) were proposed in the late 1970s as an alternative to surgical coronary artery bypass grafting for the treatment of coronary artery disease. Important technological progress has been made since. Balloon angioplasty was replaced by bare metal stents, which allowed to permanently scaffold the coronary vessel avoiding acute recoil and abrupt occlusion. Thereafter, the introduction of early generation drug-eluting stents (DES) has significantly improved clinical outcomes, primarily by markedly reducing the risk of restenosis. New generation DES with thinner stent struts, novel durable or biodegradable polymer coatings, and new limus antiproliferative agents, have further improved upon the safety and efficacy profile of early generation DES. The present article aims to review the impact of technological advances on clinical outcomes in the field of PCI with coronary stents, and to provide a brief overview on clinical margins of improvement and unmet needs of available DES.

  13. A prospective, controlled clinical evaluation of surgical stabilization of severe rib fractures.

    Science.gov (United States)

    Pieracci, Fredric M; Lin, Yihan; Rodil, Maria; Synder, Madelyne; Herbert, Benoit; Tran, Dong Kha; Stoval, Robert T; Johnson, Jeffrey L; Biffl, Walter L; Barnett, Carlton C; Cothren-Burlew, Clay; Fox, Charles; Jurkovich, Gregory J; Moore, Ernest E

    2016-02-01

    Previous studies of surgical stabilization of rib fractures (SSRF) have been limited by small sample sizes, retrospective methodology, and inclusion of only patients with flail chest. We performed a prospective, controlled evaluation of SSRF as compared with optimal medical management for severe rib fracture patterns among critically ill trauma patients. We hypothesized that SSRF improves acute outcomes. We conducted a 2-year clinical evaluation of patients with any of the following rib fracture patterns: flail chest, three or more fractures with bicortical displacement, 30% or greater hemithorax volume loss, and either severe pain or respiratory failure despite optimal medical management. In the year 2013, all patients were managed nonoperatively. In the year 2014, all patients were managed operatively. Outcomes included respiratory failure, tracheostomy, pneumonia, ventilator days, tracheostomy, length of stay, daily maximum incentive spirometer volume, narcotic requirements, and mortality. Univariate and multivariable analyses were performed. Seventy patients were included, 35 in each group. For the operative group, time from injury to surgery was 2.4 day, operative time was 1.5 hours, and the ratio of ribs fixed to ribs fractured was 0.6. The operative group had a significantly higher RibScore (4 vs. 3, respectively, p fracture patterns. Therapeutic study, level II.

  14. 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...

  15. Cancer of the larynx: the outcomes of conventionally fractionated radiotherapy in prospective and retrospective studies. Is the meaning of conventionality the same?

    International Nuclear Information System (INIS)

    Hliniak, A.; Michalski, W.; Kraszewska, E.; Szutkowski, Z.; Jarzabski, A.

    2001-01-01

    Two studies on the radiotherapy of laryngeal cancer were completed at the Radiotherapy Department of the Cancer Center Warsaw at the end of 1999. One of them was a multicenter randomized clinical trial, and the second one - a retrospective study on patients treated between years 1989 and 1995. An opinion exists that the trial outcomes of the conventional arm correspond to the outcomes of everyday practice. The subject of the study was to evaluate this thesis, and to find out, whether the outcomes of prospective and retrospective studies following the same treatment protocol are comparable. Selection criteria were - age ≤75, WHO 0-1, T1, T2, T3, N0, M0 stage of glottic and supraglottic laryngeal cancer. The treatment was: 66 Gy/2 Gy/33 fraction/45 days. The prospective group had - 199 patients, and the retrospective group: 150 patients. The two groups were comparable according to the age, site, sex and mean hemoglobin level. There was a significant difference in T-stage and performance status between the two groups. Overall survival, local control and CR-response were analyzed. To eliminate the influence of the differences in T=stage and performance status, regression models were applied - Cox's for survival and local control, logit for CR-response endpoint. The protocol compliance (prospective, retrospective) was as follows - total dose: (88%, 49%), treatment time: (47%, 11%) respectively. Three-year survival for the prospective and the retrospective groups were 89% and 74%, respectively (p=0.035), CR-response rates were 96% and 75%, respectively (p<0.001). There were no significant differences in probability of local recurrence in CR patients. A better outcome of treatment was observed in the prospective study group. It is probably due to a certain 'over-selection' of patients for the prospective study and many deviations from the therapeutic protocol in the historical group. 'Conventional treatment' has the same meaning in the prospective and retrospective

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

    Science.gov (United States)

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

    2017-08-01

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

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. Achieving clinical nurse specialist competencies and outcomes through interdisciplinary education.

    Science.gov (United States)

    Sievers, Beth; Wolf, Sherry

    2006-01-01

    Without formal education, many healthcare professionals fail to develop interdisciplinary team skills; however, when students are socialized to interdisciplinary practice through academic clinical learning experiences, effective collaboration skills can be developed. Increasingly, educational environments are challenged to include clinical experiences for students that teach and model interdisciplinary collaboration. The purpose of this quality improvement initiative was to create an interdisciplinary educational experience for clinical nurse specialist (CNS) students and postgraduate physicians. The interdisciplinary learning experience, supported by an educational grant, provided an interdisciplinary cohort of learners an opportunity to engage in a clinically focused learning experience. The interdisciplinary cohort consisted of CNS students and physicians in various stages of postgraduate training. The clinical experience selected was a quality improvement initiative in which the students were introduced to the concepts and tools of quality improvement. During this 1-month clinical experience, students applied the new skills by implementing a quality improvement project focusing on medication reconciliation in the outpatient setting. The CNS core competencies and outcomes were used to shape the experience for the CNS students. The CNS students exhibited 5 of the 7 essential characteristics of the CNS (leadership, collaboration, consultation skills, ethical conduct, and professional attributes) while demonstrating competencies and fulfilling performance expectations. During this learning experience, the CNS students focused on competencies and outcomes in the organizational sphere of influence. Multiple facilitating factors and barriers were identified. This interdisciplinary clinical experience in a quality improvement initiative provided valuable opportunities for CNS students to develop essential CNS characteristics and to explore practice competencies in the

  2. A prospective outcome and cost-effectiveness comparison between two ligament reattachment techniques using suture anchors for chronic ankle instability.

    Science.gov (United States)

    Cho, Byung-Ki; Kim, Yong-Min; Park, Kyoung-Jin; Park, Ji-Kang; Kim, Do-Kyoon

    2015-02-01

    There are various ligament reattachment techniques for the modified Brostrom procedure. There have been few comparative studies on recently developed techniques. This prospective study was performed to compare the functional outcomes of 2 different ligament reattachment techniques using suture anchors. We furthermore evaluated the cost-effectiveness of the suture bridge technique. Forty-five amateur athletes under 30 years of age were followed for more than 2 years. Twenty-four procedures with the suture anchor technique and 21 procedures with the suture bridge technique were performed by one surgeon. The functional evaluation consisted of the American Orthopaedic Foot & Ankle Society (AOFAS) score, Foot and Ankle Outcome Score (FAOS), Karlsson score, Sefton grading system, and the period to return to various forms of exercise (jogging, spurt running, jumping, one leg standing for >1 minute, walking on uneven ground, and going down stairs). Measurement of talar tilt angle and anterior talar translation was obtained from stress radiographs to evaluate mechanical stability. There were no significant differences on AOFAS score, FAOS, Karlsson score, Sefton grade, and stress radiographs. There were no significant differences on the return to exercises, except for jumping. As the most common complication, there were 3 cases of skin irritation by suture materials in the suture anchor group and 2 cases of intraoperative breakage of the suture anchor in suture bridge group. Both ligament reattachment techniques using suture anchors showed similar functional outcomes. Considering the additional medical expenses incurred by more suture anchors, the modified Brostrom procedure using the suture bridge technique had low cost-effectiveness. Proper indication and clinical usefulness of suture bridge technique for chronic ankle instability will be addressed in further studies. Level II, prospective comparative study. © The Author(s) 2014.

  3. Exploring Prospective Teachers’ Reflections in the Context of Conducting Clinical Interviews

    Directory of Open Access Journals (Sweden)

    Rukiye Didem Taylan

    2018-04-01

    Full Text Available This study investigated prospective mathematics teachers’ reflections on the experience of designing and conducting one-to-one clinical interviews with middle school students in the context of an elective course on use of video in teacher learning. Prospective teachers were asked to write about weaknesses and strengths in student understanding as well as their own performance as an interviewer in terms of asking questions and responding to student thinking in their reflections on conducting clinical interviews. Furthermore, prospective teachers were also asked to reflect on what they would do differently in order to conduct better clinical interviews. Nature of prospective teachers’ reflections were analyzed by using existing frameworks (through constructs of reflection-on-action and reflection-for-action and by using thematic analysis. Results of data analyses revealed that prospective teachers had more difficulties in providing meaningful reflection-for-action which was related to alternative decisions and planning for future similar interviews. Thematic analysis results revealed prospective teachers’ learning were grouped under three categories: conducting clinical interviews as part of being a teacher, complexity of conducting clinical interviews, and personal theories about middle school students. There are implications for both teacher learning and research.

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

    Directory of Open Access Journals (Sweden)

    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. Outcome of radioiodine therapy without, on or 3 days off carbimazole: a prospective interventional three-group comparison

    Energy Technology Data Exchange (ETDEWEB)

    Walter, Martin A. [University Hospital, Institute of Nuclear Medicine, Basel (Switzerland); University Hospital Basel, Division of Endocrinology, Diabetology and Clinical Nutrition, Basel (Switzerland); Christ-Crain, Mirjam; Mueller, Beat [University Hospital Basel, Division of Endocrinology, Diabetology and Clinical Nutrition, Basel (Switzerland); Schindler, Christian [University Hospital Basel, Institute of Social and Preventive Medicine, Basel (Switzerland); Mueller-Brand, Jan [University Hospital, Institute of Nuclear Medicine, Basel (Switzerland)

    2006-06-15

    Carbimazole ameliorates hyperthyroidism but reduces radioiodine uptake and adversely affects the outcome of simultaneous radioiodine therapy. We explored whether withdrawal of carbimazole for 3 days can restore the outcome of radioiodine treatment without concurrent exacerbation of hyperthyroidism. By generating three groups with comparable radioiodine uptake, we also investigated whether the effect of carbimazole depends on the radioiodine uptake. Stratified by a radioiodine uptake >30%, 227 consecutive adult patients were prospectively assigned to radioiodine therapy (target dose 200 Gy) without, on or 3 days off carbimazole. Patients were clinically (Crooks-Wayne score) and biochemically (T{sub 3}, fT{sub 4}, TSH) followed up after 3, 6 and 12 months. Primary endpoint was outcome 12 months after radioiodine therapy. A total of 207 patients completed follow-up (toxic nodular goitre, n=117; Graves' disease, n=90). The overall success rate was 71.5%. Patients without and 3 days off carbimazole had similar biochemical (81.4% and 83.3%, respectively; p=0.82) and clinical outcomes [median (range) Crooks-Wayne score 0 (0-16) and 1 (0-10), respectively; p=0.73], which were both higher than in patients on carbimazole [42.6%, p<0.001; Crooks-Wayne score 3 (0-30), p<0.03]. Time to achieve cure was delayed on carbimazole. No changes in thyroid hormone levels occurred after 3 days' discontinuation of carbimazole. Logistic regression revealed that all observed cure rates were independent of entity, sex, age, thyroid volume, radioiodine uptake, radioiodine half-life, fT{sub 4}, T{sub 3} and TSH. (orig.)

  6. One-Year Outcomes Following Directional Atherectomy of Popliteal Artery Lesions: Subgroup Analysis of the Prospective, Multicenter DEFINITIVE LE Trial

    Science.gov (United States)

    Rastan, Aljoscha; McKinsey, James F.; Garcia, Lawrence A.; Rocha-Singh, Krishna J.; Jaff, Michael R.; Harlin, Stuart; Kamat, Suraj; Janzer, Sean; Zeller, Thomas

    2017-01-01

    Purpose: To report the effectiveness of directional atherectomy for the treatment of popliteal artery occlusive disease. Methods: This subset of the prospective, multicenter, single-arm DEFINITIVE LE trial included 158 patients (mean age 72.0±10.9 years; 82 men) who underwent directional atherectomy in 162 popliteal artery lesions between 2009 and 2011. Forty-eight (30.4%) patients were suffering from critical limb ischemia (CLI). The mean lesion length was 5.8±3.9 cm; 38 (23.5%) arteries were occluded. The primary outcome measure for patients with intermittent claudication (IC) was duplex ultrasound–defined primary patency at 1 year; the outcome for subjects with CLI was freedom from major amputation of the target limb at 1 year. Outcomes and adverse events were independently assessed. Results: Procedure success (≤30% residual stenosis) was achieved in 84.4% of treated lesions; adjunctive stenting was required in 6 (3.7%) of the 162 lesions. The 1-year primary patency rate was 75.0% (IC patients 78.2% and CLI patients 67.5%, p=0.118). The freedom from major amputation in both cohorts was 100%. In both IC and CLI patients, significant improvements were demonstrated at 1 year in the Rutherford category, walking distance, and quality of life in comparison to baseline. Conclusion: This study indicates that directional atherectomy in popliteal arteries leads to favorable technical and clinical results at 1 year for claudicant as well as CLI patients. PMID:29117818

  7. Disability outcome measures in multiple sclerosis clinical trials

    DEFF Research Database (Denmark)

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

    2012-01-01

    Many of the available disability outcome measures used in clinical trials of multiple sclerosis are insensitive to change over time, inadequately validated, or insensitive to patient-perceived health status or quality of life. Increasing focus on therapies that slow or reverse disability...... recommend practical refinements. Conversely, although substantial data support the multiple sclerosis functional composite as an alternative measure, changes to its component tests and scoring method are needed. Novel approaches, including the use of composite endpoints, patient-reported outcomes...... progression makes it essential to refine existing measures or to develop new tools. Major changes to the expanded disability status scale should be avoided to prevent the loss of acceptance by regulators as a measure for primary outcomes in trials that provide substantial evidence of effectiveness. Rather, we...

  8. Comparison of statistical and clinical predictions of functional outcome after ischemic stroke.

    Directory of Open Access Journals (Sweden)

    Douglas D Thompson

    Full Text Available To determine whether the predictions of functional outcome after ischemic stroke made at the bedside using a doctor's clinical experience were more or less accurate than the predictions made by clinical prediction models (CPMs.A prospective cohort study of nine hundred and thirty one ischemic stroke patients recruited consecutively at the outpatient, inpatient and emergency departments of the Western General Hospital, Edinburgh between 2002 and 2005. Doctors made informal predictions of six month functional outcome on the Oxford Handicap Scale (OHS. Patients were followed up at six months with a validated postal questionnaire. For each patient we calculated the absolute predicted risk of death or dependence (OHS≥3 using five previously described CPMs. The specificity of a doctor's informal predictions of OHS≥3 at six months was good 0.96 (95% CI: 0.94 to 0.97 and similar to CPMs (range 0.94 to 0.96; however the sensitivity of both informal clinical predictions 0.44 (95% CI: 0.39 to 0.49 and clinical prediction models (range 0.38 to 0.45 was poor. The prediction of the level of disability after stroke was similar for informal clinical predictions (ordinal c-statistic 0.74 with 95% CI 0.72 to 0.76 and CPMs (range 0.69 to 0.75. No patient or clinician characteristic affected the accuracy of informal predictions, though predictions were more accurate in outpatients.CPMs are at least as good as informal clinical predictions in discriminating between good and bad functional outcome after ischemic stroke. The place of these models in clinical practice has yet to be determined.

  9. 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.

  10. Clinical Manifestations and Outcomes of West Nile Virus Infection

    Directory of Open Access Journals (Sweden)

    James J. Sejvar

    2014-02-01

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

  11. 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...

  12. Outcome Measures for Clinical Trials in Down Syndrome.

    Science.gov (United States)

    Esbensen, Anna J; Hooper, Stephen R; Fidler, Deborah; Hartley, Sigan L; Edgin, Jamie; d'Ardhuy, Xavier Liogier; Capone, George; Conners, Frances A; Mervis, Carolyn B; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J; Urv, Tiina

    2017-05-01

    Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the National Institutes of Health (NIH) assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This article focuses on measures in the areas of cognition and behavior.

  13. Dairy intake in relation to in vitro fertilization outcomes among women from a fertility clinic.

    Science.gov (United States)

    Afeiche, M C; Chiu, Y-H; Gaskins, A J; Williams, P L; Souter, I; Wright, D L; Hauser, R; Chavarro, J E

    2016-03-01

    Is dairy food consumption associated with live birth among women undergoing infertility treatment? There was a positive association between total dairy food consumption and live birth among women ≥35 years of age. Dairy food intake has been previously related to infertility risk and measures of fertility potential but its relation to infertility treatment outcomes are unknown. Our study population comprised a total of 232 women undergoing 353 in vitro fertilization (IVF) treatment cycles between February 2007 and May 2013, from the Environment and Reproductive Health study, an ongoing prospective cohort. Diet was assessed before assisted reproductive technology (ART) treatment using a validated food frequency questionnaire. Study outcomes included ovarian stimulation outcomes (endometrial thickness, estradiol levels and oocyte yield), fertilization rates, embryo quality measures and clinical outcomes (implantation, clinical pregnancy and live birth rates). We used generalized linear mixed models with random intercepts to account for multiple ART cycles per woman while simultaneously adjusting for age, caloric intake, BMI, race, smoking status, infertility diagnosis, protocol type, alcohol intake and dietary patterns. The age- and calorie-adjusted difference in live birth between women in the highest (>3.0 servings/day) and lowest (Switzerland and completed this work while at the Harvard School of Public Health. The other authors declare no conflicts of interest. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  14. Pregnancy outcome in women with epilepsy in Western China: A prospective hospital based study.

    Science.gov (United States)

    He, Shixu; Zhu, Huili; Qiu, Xiangmiao; Zhu, Xi; Peng, Anjiao; Duan, Jianan; Chen, Lei

    2017-09-01

    Gaps exist in the diagnosis and treatment of women with epilepsy (WWE) between China and Euro-American countries. We aim to find out and share our experience of the multidisciplinary integrated treatment for WWE. We prospectively registered WWE who were diagnosed by both epileptologists and obstetrician in our green way system for the past 5years (2009-2015). Registration information include years of education, epilepsy history, seizure type and frequency, pregnancy and delivery complications, delivery mode, and Apgar score of newborn. All data were analyzed by SAS 9.3 version. We included 137 cases of maternal epilepsy (155 pregnancies with average maternal age of 26years old). 18 cases underwent epilepsy surgery before pregnancy. 103 pregnancies (66.45%) were cesarean section, 52 (33.55%) were natural childbirth, only 10 pregnancies have pregnancy complications, 2 have delivery complication, and 15 have seizures during delivery process. Most offspring were healthy when they were born (only 11 newborn got Apgar score<7). For drug treatment, patients never took AEDs or withdrew AEDs in 55 (35.48%) pregnancies. For folic acid supplementation, only 9 (5.81%) achieved the dose recommended by ILAE guideline (5mg/day). For the seizure frequency, 108 pregnancies (69.68%) did not changed, 3 (1.94%) reduced, 44(28.39%) increased and mainly increased in the first and last trimesters. For feeding way, 90 (58.06%) chose artificial feeding, followed by 39 (16.77%) of mixed feeding and 26 of breastfeeding. Clinical features and perinatal outcome of Chinese WWE are similar to western WWE. For mode of delivery, even suggested by our epileptologists and obstetrician to deliver naturally, more patients selected cesarean section. Moreover, withdrawal of AEDs during pregnancy is common. Therefore, it is necessary to pay more attention to standard management of WWE and establish a more practical green way for WWE in China, to keep up with developed countries and improve the health

  15. Treatment of lateral epicondilitis using three different local injection modalities: a randomized prospective clinical trial.

    Science.gov (United States)

    Dogramaci, Yunus; Kalaci, Aydiner; Savaş, Nazan; Duman, I Gokhan; Yanat, A Nedim

    2009-10-01

    To determine the effectiveness of three different local injection modalities in the treatment of lateral epicondilitis. In a prospective randomized study on lateral epicondilitis, 75 patients were divided into three equal groups A, B and C (n = 25) and were treated using three different method of local injection. The patients in group A were treated with local injection of a steroid (1 mL triamcinolone) combined with local anaesthetic (1 mL lidocaine), those in group B were treated with injection of local anaesthetic (1 mL lidocaine) combined with peppering technique and those in group C with local injection of a steroid (1 mL triamcinolone) combined with local anaesthetic (1 mL lidocaine) and peppering technique. The outcome was defined by measuring the elbow pain during the activity using a 10-cm visual analogue scale (VAS) and satisfaction with the treatment using a scoring system based on the criteria of the Verhaar et al. at 3 weeks and 6 months after the injection and compared with the pre-treatment condition. There were significant (P = 0.006) differences in the successful outcomes between the three groups at 6 months. In group C in which local steroid + peppering injection technique were used; excellent results were obtained in 84% of patients comparing to 36% and 48% for patients in groups A and B, respectively. The successful outcomes were statistically higher in group C comparing to group A (P = 0.002) and group B (P = 0.011). In all groups, there was a significantly lower pain (VAS) at the 3-week and 6-month follow-ups comparing to the pre-treatment condition. VAS measured at 6-month follow-up were significantly lower in group C comparing to other groups (P = 0.002). In the treatment of lateral epicondilitis, combination of corticosteroid injections with peppering is more effective than corticosteroid injections or peppering injections alone and produces better clinical results.

  16. Clinical outcomes of temporary shunting for infants with cerebral pseudomeningocele.

    Science.gov (United States)

    Mattei, Tobias A; Sambhara, Deepak; Bond, Brandon J; Lin, Julian

    2014-02-01

    Although in the case of subdural collections temporary shunting has been suggested as a viable alternative for definitive drainage of the accumulated fluid until restoration of the normal CSF dynamics, there is no agreement on the best management strategy for pseudomeningocele. The authors performed a retrospective chart review in order to evaluate the clinical outcomes of infants temporarily shunted for pseudomeningocele without encephalocele at our institution (The University of Illinois at Peoria/Illinois Neurological Institute) in the period from 2004 to 2012. The epidemiological characteristics, clinical management, and final outcomes of such subpopulation were compared with a control group which received temporary shunting for subdural hematomas (SDH) during the same period. Four patients (100% male) ranging in age from 8.9 to 27.1 months (mean = 13.88) with pseudomeningocele and 17 patients (64.7% male) ranging in age from 1.9 to 11.8 months (mean = 4.15) with SDH were identified. Although the initial management included sequential percutaneous subdural tapping in 82% of the patients, all children ultimately failed such strategy, requiring either subdural-peritoneal (81% of the cases) or subgaleal-peritoneal (19% of the cases) shunting. The mean implant duration was 201 days for the pseudomeningocele group and 384 days for the SDH one. Mean post-shunt hospitalization was 2 days for patients with pseudomeningocele and 4 days for patients with SDH. There was no statistical difference in terms of complications, length of hospitalization post-shunting, or clinical outcomes between the patients with pseudomeningocele and those with SDH. Temporary shunting of infants with pseudo-meningocele constitutes a viable therapeutic alternative with favorable clinical outcomes and a low risk of shunt dependency similar to those of children with SDH.

  17. 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.).

  18. A comparison of functional outcome in patients sustaining major trauma: a multicentre, prospective, international study.

    Directory of Open Access Journals (Sweden)

    Timothy H Rainer

    Full Text Available OBJECTIVES: To compare 6 month and 12 month health status and functional outcomes between regional major trauma registries in Hong Kong and Victoria, Australia. SUMMARY BACKGROUND DATA: Multicentres from trauma registries in Hong Kong and the Victorian State Trauma Registry (VSTR. METHODS: Multicentre, prospective cohort study. Major trauma patients and aged ≥18 years were included. The main outcome measures were Extended Glasgow Outcome Scale (GOSE functional outcome and risk-adjusted Short-Form 12 (SF-12 health status at 6 and 12 months after injury. RESULTS: 261 cases from Hong Kong and 1955 cases from VSTR were included. Adjusting for age, sex, ISS, comorbid status, injury mechanism and GCS group, the odds of a better functional outcome for Hong Kong patients relative to Victorian patients at six months was 0.88 (95% CI: 0.66, 1.17, and at 12 months was 0.83 (95% CI: 0.60, 1.12. Adjusting for age, gender, ISS, GCS, injury mechanism and comorbid status, Hong Kong patients demonstrated comparable mean PCS-12 scores at 6-months (adjusted mean difference: 1.2, 95% CI: -1.2, 3.6 and 12-months (adjusted mean difference: -0.4, 95% CI: -3.2, 2.4 compared to Victorian patients. Keeping age, gender, ISS, GCS, injury mechanism and comorbid status, there was no difference in the MCS-12 scores of Hong Kong patients compared to Victorian patients at 6-months (adjusted mean difference: 0.4, 95% CI: -2.1, 2.8 or 12-months (adjusted mean difference: 1.8, 95% CI: -0.8, 4.5. CONCLUSION: The unadjusted analyses showed better outcomes for Victorian cases compared to Hong Kong but after adjusting for key confounders, there was no difference in 6-month or 12-month functional outcomes between the jurisdictions.

  19. Early EEG for outcome prediction of postanoxic coma: prospective cohort study with cost-minimization analysis.

    Science.gov (United States)

    Sondag, Lotte; Ruijter, Barry J; Tjepkema-Cloostermans, Marleen C; Beishuizen, Albertus; Bosch, Frank H; van Til, Janine A; van Putten, Michel J A M; Hofmeijer, Jeannette

    2017-05-15

    We recently showed that electroencephalography (EEG) patterns within the first 24 hours robustly contribute to multimodal prediction of poor or good neurological outcome of comatose patients after cardiac arrest. Here, we confirm these results and present a cost-minimization analysis. Early prognosis contributes to communication between doctors and family, and may prevent inappropriate treatment. A prospective cohort study including 430 subsequent comatose patients after cardiac arrest was conducted at intensive care units of two teaching hospitals. Continuous EEG was started within 12 hours after cardiac arrest and continued up to 3 days. EEG patterns were visually classified as unfavorable (isoelectric, low-voltage, or burst suppression with identical bursts) or favorable (continuous patterns) at 12 and 24 hours after cardiac arrest. Outcome at 6 months was classified as good (cerebral performance category (CPC) 1 or 2) or poor (CPC 3, 4, or 5). Predictive values of EEG measures and cost-consequences from a hospital perspective were investigated, assuming EEG-based decision- making about withdrawal of life-sustaining treatment in the case of a poor predicted outcome. Poor outcome occurred in 197 patients (51% of those included in the analyses). Unfavorable EEG patterns at 24 hours predicted a poor outcome with specificity of 100% (95% CI 98-100%) and sensitivity of 29% (95% CI 22-36%). Favorable patterns at 12 hours predicted good outcome with specificity of 88% (95% CI 81-93%) and sensitivity of 51% (95% CI 42-60%). Treatment withdrawal based on an unfavorable EEG pattern at 24 hours resulted in a reduced mean ICU length of stay without increased mortality in the long term. This gave small cost reductions, depending on the timing of withdrawal. Early EEG contributes to reliable prediction of good or poor outcome of postanoxic coma and may lead to reduced length of ICU stay. In turn, this may bring small cost reductions.

  20. A Comparison of Functional Outcome in Patients Sustaining Major Trauma: A Multicentre, Prospective, International Study

    Science.gov (United States)

    Rainer, Timothy H.; Yeung, Hiu Hung; Gabbe, Belinda J.; Yuen, Kai Y.; Ho, Hiu F.; Kam, Chak W.; Chang, Annice; Poon, Wai S.; Cameron, Peter A.; Graham, Colin A.

    2014-01-01

    Objectives To compare 6 month and 12 month health status and functional outcomes between regional major trauma registries in Hong Kong and Victoria, Australia. Summary Background Data Multicentres from trauma registries in Hong Kong and the Victorian State Trauma Registry (VSTR). Methods Multicentre, prospective cohort study. Major trauma patients and aged ≥18 years were included. The main outcome measures were Extended Glasgow Outcome Scale (GOSE) functional outcome and risk-adjusted Short-Form 12 (SF-12) health status at 6 and 12 months after injury. Results 261 cases from Hong Kong and 1955 cases from VSTR were included. Adjusting for age, sex, ISS, comorbid status, injury mechanism and GCS group, the odds of a better functional outcome for Hong Kong patients relative to Victorian patients at six months was 0.88 (95% CI: 0.66, 1.17), and at 12 months was 0.83 (95% CI: 0.60, 1.12). Adjusting for age, gender, ISS, GCS, injury mechanism and comorbid status, Hong Kong patients demonstrated comparable mean PCS-12 scores at 6-months (adjusted mean difference: 1.2, 95% CI: −1.2, 3.6) and 12-months (adjusted mean difference: −0.4, 95% CI: −3.2, 2.4) compared to Victorian patients. Keeping age, gender, ISS, GCS, injury mechanism and comorbid status, there was no difference in the MCS-12 scores of Hong Kong patients compared to Victorian patients at 6-months (adjusted mean difference: 0.4, 95% CI: −2.1, 2.8) or 12-months (adjusted mean difference: 1.8, 95% CI: −0.8, 4.5). Conclusion The unadjusted analyses showed better outcomes for Victorian cases compared to Hong Kong but after adjusting for key confounders, there was no difference in 6-month or 12-month functional outcomes between the jurisdictions. PMID:25157522

  1. Percutaneous coronary intervention in asians- are there differences in clinical outcome?

    Directory of Open Access Journals (Sweden)

    Chua Terrance S

    2011-05-01

    Full Text Available Abstract Background Ethnic differences in clinical outcome after percutaneous coronary intervention (PCI have been reported. Data within different Asian subpopulations is scarce. We aim to explore the differences in clinical profile and outcome between Chinese, Malay and Indian Asian patients who undergo PCI for coronary artery disease (CAD. Methods A prospective registry of consecutive patients undergoing PCI from January 2002 to December 2007 at a tertiary care center was analyzed. Primary endpoint was major adverse cardiovascular events (MACE of myocardial infarction (MI, repeat revascularization and all-cause death at six months. Results 7889 patients underwent PCI; 7544 (96% patients completed follow-up and were included in the analysis (79% males with mean age of 59 years ± 11. There were 5130 (68% Chinese, 1056 (14% Malays and 1001 (13.3% Indian patients. The remaining 357 (4.7% patients from other minority ethnic groups were excluded from the analysis. The primary end-point occurred in 684 (9.1% patients at six months. Indians had the highest rates of six month MACE compared to Chinese and Malays (Indians 12% vs. Chinese 8.2% vs. Malays 10.7%; OR 1.55 95%CI 1.24-1.93, p Conclusion These data indicate that ethnic variations in clinical outcome exist following PCI. In particular, Indian patients have higher six month event rates compared to Chinese and Malays. Future studies are warranted to elucidate the underlying mechanisms behind these variations.

  2. Clinical leadership development and education for nurses: prospects and opportunities

    Directory of Open Access Journals (Sweden)

    Joseph ML

    2015-07-01

    Full Text Available M Lindell Joseph, Diane L Huber College of Nursing, The University of Iowa, Iowa City, IA, USA Abstract: With the implementation of the Affordable Care Act, elevated roles for nurses of care coordinator, clinical nurse leader, and advanced practice registered nurse have come to the forefront. Because change occurs so fast, matching development and education to job requirements is a challenging forecasting endeavor. The purpose of this article is to envision clinical leadership development and education opportunities for three emerging roles. The adoption of a common framework for intentional leadership development is proposed for clinical leadership development across the continuum of care. Solutions of innovation and interdependency are framed as core concepts that serve as an opportunity to better inform clinical leadership development and education. Additionally, strategies are proposed to advance knowledge, skills, and abilities for crucial implementation of improvements and new solutions at the point of care. Keywords: clinical leadership, nursing leadership, CNL, care coordination, innovation, interdependency

  3. 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.

  4. TIAM1 variants improve clinical outcome in neuroblastoma.

    Science.gov (United States)

    Sanmartín, Elena; Yáñez, Yania; Fornés-Ferrer, Victoria; Zugaza, José L; Cañete, Adela; Castel, Victoria; Font de Mora, Jaime

    2017-07-11

    Identification of tumor driver mutations is crucial for improving clinical outcome using a personalized approach to the treatment of cancer. Neuroblastoma is a tumor of the peripheral sympathetic nervous system for which only a few driver alterations have been described including MYCN amplification and ALK mutations. We assessed 106 primary neuroblastoma tumors by next generation sequencing using a customized amplicon-based gene panel. Our results reveal that genetic variants in TIAM1 gene associate with better clinical outcome, suggesting a role for these TIAM1 variants in preventing progression of this disease. The detected variants are located within the different domains of TIAM1 that signal to the upstream regulator RAS and downstream effector molecules MYC and RAC, which are all implicated in neuroblastoma etiology and progression. Clinical outcome was improved in tumors where a TIAM1 variant was present concomitantly with either ALK mutation or MYCN amplification. Given the function of these signaling molecules in cell survival, proliferation, differentiation and neurite outgrowth, our data suggest that the TIAM1-mediated network is essential to neuroblastoma and thus, inhibiting TIAM1 reflects a rational strategy for improving therapy efficacy in neuroblastoma.

  5. 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.

  6. 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.

  7. Prospect for application of umbilical cord blood to clinical treatment of radiation sickness

    International Nuclear Information System (INIS)

    Jia Tingzhen; Ke Xiaoyan

    1998-01-01

    Objective: To look forward to the prospect for application of umbilical cord blood to clinical treatment of radiation sickness by analyzing the results using umbilical cord blood in laboratory experiments and clinical research. Method: The data on umbilical cord blood published in literature are reviewed. Results: The umbilical blood is rich in hematopoietic stem/progenitor cells, low in immunological activity of lymphocytes, expanded significantly ex vivo under selected culture condition readily available and collected easily. Conclusion: With the above advantages, the prospect for application of umbilical cord blood is encouraging, particularly in the clinical treatment of radiation sickness

  8. Clinical and economic outcomes assessment in nuclear cardiology

    International Nuclear Information System (INIS)

    Shaw, L.J.; Miller, D.D.; Berman, D.S.; Hachamovitch, R.

    2000-01-01

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

  9. A prospective, randomized, double-blind clinical trial of one nano ...

    African Journals Online (AJOL)

    Abstract. Background: Recently, manufacturers have introduced bulk‑fill composite resins that reportedly can be placed in increments of 4 mm or greater. Objective: The purpose of this article was to report the results of 12 months prospective randomized clinical trial that evaluated the clinical performance of one ...

  10. A Prospective, Randomized, Double-blind Clinical Trial of One Nano ...

    African Journals Online (AJOL)

    2015-12-16

    Dec 16, 2015 ... prospective randomized clinical trial that evaluated the clinical performance of one high‑viscosity bulk‑fill composite resin in Class II cavities of posterior teeth. .... amount of glass ionomer needed was used to cover the calcium ...

  11. Catastrophizing and Depressive Symptoms as Prospective Predictors of Outcomes Following Total Knee Replacement

    Directory of Open Access Journals (Sweden)

    Robert R Edwards

    2009-01-01

    Full Text Available Several recent reports suggest that pain-related catastrophizing is a risk factor for poor acute pain outcomes following surgical interventions. However, it has been less clear whether levels of catastrophizing influence longer-term postoperative outcomes. Data were analyzed from a relatively small number (n=43 of patients who underwent total knee replacement and were followed for 12 months after their surgery. Previous research has suggested that high levels of both catastrophizing and depression are associated with elevated acute postoperative pain complaints among patients undergoing knee surgery. In this sample, catastrophizing and depression at each of the assessment points were studied as prospective predictors of pain (both global pain ratings and pain at night at the subsequent assessment point over the course of one year. The predictive patterns differed somewhat across measures of pain reporting; depressive symptoms were unique predictors of greater global pain complaints, while catastrophizing was a specific and unique predictor of elevated nighttime pain. While surgical outcomes following total knee replacement are, on average, quite good, a significant minority of patients continue to experience long-term pain. The present findings suggest that high levels of catastrophizing and depression may promote enhanced pain levels, indicating that interventions designed to reduce catastrophizing and depressive symptoms may have the potential to further improve joint replacement outcomes.

  12. The Impact of Parental Personality on Birth Outcomes: A Prospective Cohort Study.

    Directory of Open Access Journals (Sweden)

    Naho Morisaki

    Full Text Available To investigate the effect of parental personality on birth outcomes.Prospective cohort study.727 pregnant women and 579 spouses receiving antenatal care at a single-center in rural Tokyo, Japan during 2010-2013.We measured the association between maternal effect of parental personality traits assessed by the Cloninger's Temperament and Character Inventory on birth outcomes, using multiple regression and adjusting for demographics.Maternal self-transcendence personality was inversely associated with gestational age [-0.26 (95% confidence interval (CI: -0.51 to -0.01 weeks per unit] and positively associated with preterm birth [odds ratio (OR 2.60 (95% CI: 1.00 to 6.75 per unit], while paternal self-transcendence personality was positively associated with gestational age [0.31 (95% CI: 0.07 to 0.55 weeks per unit]. Maternal reward dependence was positively associated with fetal growth [0.30 (95% CI: 0.02 to 0.59 per unit]. Other maternal and paternal personality traits associated with adverse maternal behavior, such as novelty seeking, harm avoidance and self-directedness, were not associated with birth outcomes.We found that specific parental personality traits can be associated with birth outcomes.

  13. Prospective Patient-Related Outcome Evaluation of Secondary Cleft Rhinoplasty Using a Validated Questionnaire.

    Science.gov (United States)

    Sawyer, Adam R; Robinson, Stephen; Cadier, Michael

    2017-07-01

    To evaluate patient satisfaction and quality of life following secondary cleft rhinoplasty. Prospective consecutive patient, single unit, single surgeon study. Spires Cleft Centre, Salisbury, Wilshire, United Kingdom, and private practice. 56 (27 secondary cleft rhinoplasty) patients completed evaluation forms preoperatively and 3 to 6 months postoperatively. Subjective assessment was performed using a validated Rhinoplasty Outcomes Evaluation (ROE) questionnaire. This instrument comprises six questions that capture three quality-of-life domains: physical, mental/emotional, and social. Rhinoplasty outcomes evaluation scores were calculated (range = 0 to 100) to indication satisfaction with rhinoplasty outcomes. Average age was 28 years (range = 18 to 59 years). There was a significant subjective improvement in the total ROE evaluation scores from 28 ± 10 to 80 ± 11 (P aesthetic appearance improved from 0.3 ± 0.2 to 3.2 ± 0.3 (P < .01) in secondary cleft rhinoplasty. No significant change was seen in breathing capacity in secondary cleft rhinoplasty (from 2.7 ± 0.3 to 3.2 ± 0.2; P = .29). All patients said they would undergo the procedure again. Our results demonstrate high patient satisfaction after cleft rhinoplasty with particular regard to cosmetic appearance. These results are similar to those for noncleft rhinoplasty. We would recommend the use of this simple and quick validated outcome tool with all rhinoplasty patients.

  14. Memory and decision making: Effects of sequential presentation of probabilities and outcomes in risky prospects.

    Science.gov (United States)

    Millroth, Philip; Guath, Mona; Juslin, Peter

    2018-06-07

    The rationality of decision making under risk is of central concern in psychology and other behavioral sciences. In real-life, the information relevant to a decision often arrives sequentially or changes over time, implying nontrivial demands on memory. Yet, little is known about how this affects the ability to make rational decisions and a default assumption is rather that information about outcomes and probabilities are simultaneously available at the time of the decision. In 4 experiments, we show that participants receiving probability- and outcome information sequentially report substantially (29 to 83%) higher certainty equivalents than participants with simultaneous presentation. This holds also for monetary-incentivized participants with perfect recall of the information. Participants in the sequential conditions often violate stochastic dominance in the sense that they pay more for a lottery with low probability of an outcome than participants in the simultaneous condition pay for a high probability of the same outcome. Computational modeling demonstrates that Cumulative Prospect Theory (Tversky & Kahneman, 1992) fails to account for the effects of sequential presentation, but a model assuming anchoring-and adjustment constrained by memory can account for the data. By implication, established assumptions of rationality may need to be reconsidered to account for the effects of memory in many real-life tasks. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

  15. 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.

  16. The fate of prospective spine studies registered on www.ClinicalTrials.gov.

    Science.gov (United States)

    Ohnmeiss, Donna D

    2015-03-01

    There has been concern expressed about research ethics with respect to not fully reporting data collected during clinical studies. One site available for all clinical trials is ClinicalTrials.gov. The original purpose of this site was to facilitate patients seeking a trial for the treatment of their particular condition. The internationally available site offers general information about the study, sponsor name, principal investigator, patient selection criteria, enrollment goal, study design, outcome measures, participating centers, initiation date, date posted, date completed, and other pertinent data. The site can be used to identify studies conducted for a particular condition or intervention. The purpose of this study was to investigate the fate of spine-related studies registered on www.ClinicalTrials.gov, with particular focus on the publication rate of completed trials. Analysis and classification of clinical studies posted on an international research registry Web page and literature search for related publications. Not applicable. The primary outcome measure was publication of the study registered on ClinicalTrials.gov. Multiple searches were conducted on ClinicalTrials.gov Web site to identify studies related to commonly treated spinal conditions, including herniated disc, degenerative disc disease, stenosis, and spondylolisthesis. Studies related to tumors, fractures, or that included nonspine conditions were not included. For studies classified as completed more than 18 months before this review, literature searches were conducted to determine if the results of the study had been published and factors related to publication. The author has no financial conflict related to this work. There were 263 spine-related studies identified from searches on the ClinicalTrials.gov site. Data on the site had the studies classified as follows: 72 completed, 70 active, not recruiting (generally indicates collecting follow-up data), 74 recruiting, 11 recruiting by

  17. Clinical and nutritional outcomes in children with idiopathic superior mesenteric artery syndrome.

    Science.gov (United States)

    Shiu, Jr-Rung; Chao, Hsun-Chin; Luo, Chih-Cheng; Lai, Ming-Wei; Kong, Man-Shan; Chen, Shih-Yen; Chen, Chien-Chang; Wang, Chao-Jan

    2010-08-01

    There are no available data for outcomes in children's idiopathic superior mesenteric artery syndrome (SMAS) strictly treated conservatively. The aim of the study was to evaluate clinical and nutritional outcome in children with idiopathic SMAS. A 1-year prospective observation study of effects of treatment and outcome was performed in 27 children (8 boys, 19 girls) with idiopathic SMAS who underwent an upper gastrointestinal (UGI) series, ultrasound measurement of the aortomesenteric angle, treatment, clinical assessment, growth evaluation, and regular clinical visits for more than 12 months. Mean age of the patients was 11.77 +/- 2.15 years. The major clinical complaints were postprandial pain or fullness (88.9%), vomiting (55.6%), and early satiety (51.9%). Eight patients (29.6%) had weight loss. The UGI series revealed typical features of SMAS. The aortomesenteric angle on ultrasound was 10 degrees to 19 degrees. The height of most patients (92.6%) was above the 10th percentile, whereas 15 (55.6%) patients weighed below the 10th percentile. Six patients underwent surgical intervention (3 for obstruction and 3 for persistent anorexia with weight loss), and their clinical symptoms and weight status improved steadily during the follow-up months. Among the 21 patients not subject to surgical intervention, 11 (52.4%) experienced a reduction of symptoms >50% after 3 months of treatment, and weight-for-age percentile increased significantly after 6 months of treatment. Overall, a significant increase in the weight-for-age status was seen in the patients with surgical treatment or with medication only after 6 and 12 months of treatment. An aortomesenteric angle children with idiopathic SMAS. A duodenojejunostomy can effectively relieve the obstructive symptoms, such as anorexia, and improve nutritional status, whereas long-term medical treatment may aid in relieving the clinical symptoms, promoting appetite, and improving nutritional status in pediatric patients with

  18. Cardiac asthma in elderly patients: incidence, clinical presentation and outcome

    Directory of Open Access Journals (Sweden)

    Ray Patrick

    2007-05-01

    Full Text Available Abstract Background Cardiac asthma is common, but has been poorly investigated. The objective was to compare the characteristics and outcome of cardiac asthma with that of classical congestive heart failure (CHF in elderly patients. Methods Prospective study in an 1,800-bed teaching hospital. Results Two hundred and twelve consecutive patients aged ≥ 65 years presenting with dyspnea due to CHF (mean age of 82 ± 8 years were included. Findings of cardiac echocardiography and natriuretic peptides levels were used to confirm CHF. Cardiac asthma patients were defined as a patient with CHF and wheezing reported by attending physician upon admission to the emergency department. The CHF group (n = 137 and the cardiac asthma group (n = 75, differed for tobacco use (34% vs. 59%, p 2 (47 ± 15 vs. 41 ± 11 mmHg, p Conclusion Patients with cardiac asthma represented one third of CHF in elderly patients. They were more hypercapnic and experienced more distal airway obstruction. However, outcomes were similar.

  19. Clinic Attendance for Medication Refills and Medication Adherence amongst an Antiretroviral Treatment Cohort in Uganda: A Prospective Study

    Directory of Open Access Journals (Sweden)

    Setor Kunutsor

    2010-01-01

    Full Text Available Background. Regular clinic attendance for antiretroviral (ARV drug refills is important for successful clinical outcomes in HIV management. Methods. Clinic attendance for ARV drug refills and medication adherence using a clinic-based pill count in 392 adult patients receiving antiretroviral therapy (ART in a district hospital in Uganda were prospectively monitored over a 28-week period. Results. Of the 2267 total scheduled clinic visits, 40 (1.8% were missed visits. Among the 392 clients, 361 (92% attended all appointments for their refills (regular attendance. Clinic attendance for refills was statistically significantly associated with medication adherence with regular attendant clients having about fourfold greater odds of achieving optimal (≥95% medication adherence [odds ratio (OR=3.89, 95% CI: 1.48 to 10.25, exact P=.013]. In multivariate analysis, clients in age category 35 years and below were less likely to achieve regular clinic attendance. Conclusion. Monitoring of clinic attendance may be an objective and effective measure and could be a useful adjunct to an adherence measure such as pill counting in resource-constrained settings. Where human resource constraints do not allow pill counts or other time-consuming measures, then monitoring clinic attendance and acting on missed appointments may be an effective proxy measure.

  20. A Prospective Study on the Clinical and Microbiological Spectrum of Endophthalmitis in a Specific Region in Denmark

    DEFF Research Database (Denmark)

    Solborg Bjerrum, Søren; Hamoudi, Hassan; Friis-Møller, Alice

    2016-01-01

    PURPOSE: To study the clinical and microbiological spectrum of endophthalmitis with emphasis on clinical features, visual outcomes and risks of surgical complications. METHODS: A prospective observational study was conducted between 2012 and 2013 in a specific region in Denmark. Patients were...... clinically examined before, during and after surgical intervention for endophthalmitis. RESULTS: Fifty eyes with endophthalmitis were included. Endophthalmitis after cataract surgery (post-cataract), anti-VEGF (vascular endothelial growth factor) intravitreal injections (post-injection) and cases...... of endogenous endophthalmitis were responsible for 40, 28 and 18% of all cases, respectively. There was no difference in the microbiological spectrum in post-cataract patients and post-injection patients, but patients with post-cataract endophthalmitis presented statistically significantly more frequently...

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

    Directory of Open Access Journals (Sweden)

    Apolone Giovanni

    2003-04-01

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

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

    Science.gov (United States)

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

    2015-08-01

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

  4. Multidisciplinary Team Contributions Within a Dedicated Outpatient Palliative Radiotherapy Clinic: A Prospective Descriptive Study

    International Nuclear Information System (INIS)

    Pituskin, Edith; Fairchild, Alysa; Dutka, Jennifer; Gagnon, Lori; Driga, Amy; Tachynski, Patty; Borschneck, Jo-Ann; Ghosh, Sunita

    2010-01-01

    Purpose: Patients with bone metastases may experience pain, fatigue, and decreased mobility. Multiple medications for analgesia are often required, each with attendant side effects. Although palliative-intent radiotherapy (RT) is effective in decreasing pain, additional supportive care interventions may be overlooked. Our objective was to describe the feasibility of multidisciplinary assessment of patients with symptomatic bone metastases attending a dedicated outpatient palliative RT clinic. Methods and Materials: Consecutive patients referred for RT for painful bone metastases were screened for symptoms and needs relevant to their medications, nutritional intake, activities of daily living, and psychosocial and spiritual concerns from January 1 to December 31, 2007. Consultations by appropriate team members and resulting recommendations were collected prospectively. Patients who received RT were contacted by telephone 4 weeks later to assess symptom outcomes. Results: A total of 106 clinic visits by 82 individual patients occurred. As determined by screening form responses, the clinical Pharmacist, Occupational Therapist, Registered Dietician and Social Worker were consulted to provide assessments and recommendations within the time constraints presented by 1-day palliative RT delivery. In addition to pain relief, significant improvements in tiredness, depression, anxiety, drowsiness and overall well-being were reported at 4 weeks. Conclusions: Systematic screening of this population revealed previously unmet needs, addressed in the form of custom verbal and written recommendations. Multidisciplinary assessment is associated with a high number of recommendations and decreased symptom distress. Our findings lend strong support to the routine assessment by multiple supportive care professionals for patients with advanced cancer being considered for palliative RT.

  5. 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

  6. Clinical outcomes of childhood x-irradiation for lymphoid hyperplasia

    International Nuclear Information System (INIS)

    Pottern, L.M.

    1987-01-01

    A prospective study was conducted to explore the relationship between childhood x-irradiation for lymphoid hyperplasia and the subsequent development of thyroid gland and other head and neck disorders. All individuals under 18 years of age who were x-irradiated for lymphoid hyperplasia during the years 1938-69 at Children's Hospital Medical Center, Boston comprised the exposed population. The comparison group consisted of non-exposed, surgically treated individuals. The study included a health questionnaire and a clinical examination component. A history of thyroid cancer was reported by 11 exposed subjects and no non-exposed subjects. Significantly elevated standardized incidence ratios of thyroid cancer were seen for both exposed males and females, 19.9 and 12.1, respectively. The average thyroid radiation dose was 25.8 rads and the mean latency period was 17.3 years

  7. What Factors are Predictive of Patient-reported Outcomes? A Prospective Study of 337 Shoulder Arthroplasties.

    Science.gov (United States)

    Matsen, Frederick A; Russ, Stacy M; Vu, Phuong T; Hsu, Jason E; Lucas, Robert M; Comstock, Bryan A

    2016-11-01

    Although shoulder arthroplasties generally are effective in improving patients' comfort and function, the results are variable for reasons that are not well understood. We posed two questions: (1) What factors are associated with better 2-year outcomes after shoulder arthroplasty? (2) What are the sensitivities, specificities, and positive and negative predictive values of a multivariate predictive model for better outcome? Three hundred thirty-nine patients having a shoulder arthroplasty (hemiarthroplasty, arthroplasty for cuff tear arthropathy, ream and run arthroplasty, total shoulder or reverse total shoulder arthroplasty) between August 24, 2010 and December 31, 2012 consented to participate in this prospective study. Two patients were excluded because they were missing baseline variables. Forty-three patients were missing 2-year data. Univariate and multivariate analyses determined the relationship of baseline patient, shoulder, and surgical characteristics to a "better" outcome, defined as an improvement of at least 30% of the maximal possible improvement in the Simple Shoulder Test. The results were used to develop a predictive model, the accuracy of which was tested using a 10-fold cross-validation. After controlling for potentially relevant confounding variables, the multivariate analysis showed that the factors significantly associated with better outcomes were American Society of Anesthesiologists Class I (odds ratio [OR], 1.94; 95% CI, 1.03-3.65; p = 0.041), shoulder problem not related to work (OR, 5.36; 95% CI, 2.15-13.37; p factors listed above. The area under the receiver operating characteristic curve generated from the cross-validated enhanced predictive model was 0.79 (generally values of 0.7 to 0.8 are considered fair and values of 0.8 to 0.9 are considered good). The false-positive fraction and the true-positive fraction depended on the cutoff probability selected (ie, the selected probability above which the prediction would be classified as

  8. Prospective study of Centurion® versus Infiniti® phacoemulsification systems: surgical and visual outcomes

    Directory of Open Access Journals (Sweden)

    Lawrence J. Oh

    2017-11-01

    Full Text Available AIM: To evaluate surgical outcomes (SOs and visual outcomes (VOs in cataract surgery comparing the Centurion® phacoemulsification system (CPS with the Infiniti® phacoemulsification system (IPS. METHODS: Prospective, consecutive study in a single-site private practice. Totally 412 patients undergoing cataract surgery with either the CPS using the 30-degree balanced® tip (n=207 or the IPS using the 30-degree Kelman® tip (n=205. Intraoperative and postoperative outcomes were documented prospectively up to one month follow-up. Nuclear sclerosis (NS grade, cumulated dissipated energy (CDE, preoperative corrected distance visual acuity (CDVA, and CDVA at one month were recorded. RESULTS: CDE was 13.50% less in the whole CPS compared with the whole IPS subcohort. In eyes with NS grade III or greater, CDE was 28.87% less with CPS (n=70 compared with IPS (n=44 (P=0.010. Surgical complications were not statistically different between the two subcohorts (P=0.083, but in the one case of vitreous loss using the CPS, CDVA of 6/4 was achieved at one month. The mean CDVAs (VOs at one month for NS grade III and above cataracts were -0.17 logMAR (6/4.5 in the CPS and -0.15 logMAR (6/4.5 in the IPS subcohort respectively (P=0.033. CONCLUSION: CDE is 28.87% less, and VOs are significantly improved, in denser cataracts in the CPS compared with the IPS. The authors recommend the CPS for cases with denser nuclei.

  9. Prospective study of Centurion® versus Infiniti® phacoemulsification systems: surgical and visual outcomes.

    Science.gov (United States)

    Oh, Lawrence J; Nguyen, Chu Luan; Wong, Eugene; Wang, Samuel S Y; Francis, Ian C

    2017-01-01

    To evaluate surgical outcomes (SOs) and visual outcomes (VOs) in cataract surgery comparing the Centurion ® phacoemulsification system (CPS) with the Infiniti ® phacoemulsification system (IPS). Prospective, consecutive study in a single-site private practice. Totally 412 patients undergoing cataract surgery with either the CPS using the 30-degree balanced ® tip ( n =207) or the IPS using the 30-degree Kelman ® tip ( n =205). Intraoperative and postoperative outcomes were documented prospectively up to one month follow-up. Nuclear sclerosis (NS) grade, cumulated dissipated energy (CDE), preoperative corrected distance visual acuity (CDVA), and CDVA at one month were recorded. CDE was 13.50% less in the whole CPS compared with the whole IPS subcohort. In eyes with NS grade III or greater, CDE was 28.87% less with CPS ( n =70) compared with IPS ( n =44) ( P =0.010). Surgical complications were not statistically different between the two subcohorts ( P =0.083), but in the one case of vitreous loss using the CPS, CDVA of 6/4 was achieved at one month. The mean CDVAs (VOs) at one month for NS grade III and above cataracts were -0.17 logMAR (6/4.5) in the CPS and -0.15 logMAR (6/4.5) in the IPS subcohort respectively ( P =0.033). CDE is 28.87% less, and VOs are significantly improved, in denser cataracts in the CPS compared with the IPS. The authors recommend the CPS for cases with denser nuclei.

  10. A prospective, longitudinal study to evaluate the clinical utility of a predictive algorithm that detects risk of opioid use disorder

    Science.gov (United States)

    Brenton, Ashley; Lee, Chee; Lewis, Katrina; Sharma, Maneesh; Kantorovich, Svetlana; Smith, Gregory A; Meshkin, Brian

    2018-01-01

    Purpose The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use. Specifically, we sought to assess how physicians were using the profile in patient care and how its use affected patient outcomes. Patients and methods A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 5,397 patients across 100 clinics in the USA. Using a patent-protected, validated algorithm combining specific genetic risk factors with phenotypic traits, patients were categorized into low-, moderate-, and high-risk patients for opioid abuse. Physicians who ordered precision medicine testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. The patient outcomes associated with each treatment action were carefully documented. Results Physicians used the profile to guide treatment decisions for over half of the patients. Of those, guided treatment decisions for 24.5% of the patients were opioid related, including changing the opioid prescribed, starting an opioid, or titrating a patient off the opioid. Treatment guidance was strongly influenced by profile-predicted opioid use disorder (OUD) risk. Most importantly, patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, including better pain management by medication adjustments, with an average pain decrease of 3.4 points on a scale of 1–10. Conclusion Patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, as measured by decreased pain levels resulting from better pain management with prescribed medications. The clinical utility of the profile is twofold. It provides clinically actionable recommendations that can be used to 1) prevent OUD through limiting initial opioid

  11. 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.

  12. A Prospective Cohort Study on the Clinical Utility of Second ...

    African Journals Online (AJOL)

    2017-06-28

    Jun 28, 2017 ... the clinical utility of second trimester MABP in the prediction of preeclampsia. Methods: This ..... the convenience of a single cutoff value for decision making, a systematic review and meta‑analysis[17] showed that MABP was a ...

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

    Science.gov (United States)

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

    2018-01-01

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

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

    International Nuclear Information System (INIS)

    Fadoo, Z.; Saleem, A.F.

    2008-01-01

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

  15. 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.

  16. 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.

  17. Clinical long-term outcome of septal myectomy for obstructive hypertrophic cardiomyopathy in infants.

    Science.gov (United States)

    Schleihauf, Julia; Cleuziou, Julie; Pabst von Ohain, Jelena; Meierhofer, Christian; Stern, Heiko; Shehu, Nerejda; Mkrtchyan, Naira; Kaltenecker, Emanuel; Kühn, Andreas; Nagdyman, Nicole; Hager, Alfred; Seidel, Heide; Lange, Rüdiger; Ewert, Peter; Wolf, Cordula M

    2018-03-01

    Surgical septal myectomy is performed to relieve left ventricular outflow tract narrowing in severe drug-refractory obstructive hypertrophic cardiomyopathy. The objective of this study was to assess the perioperative and long-term clinical outcome of this procedure performed during infancy. Clinical, transthoracic echocardiographic, electrocardiographic, 24-h Holter, cardiopulmonary exercise test and genetic data were extracted by medical record review. A subset of patients underwent additional prospective detailed clinical evaluation including cardiac magnetic resonance imaging with contrast. Surgery was performed in 23 paediatric patients between 1978 and 2015 at the German Heart Centre Munich. Twelve patients had undergone surgery during infancy (≤ 1 year) (Group A), 11 between 1 and 18 years of age (Group B). The underlying genetic diagnosis was Noonan syndrome spectrum and non-syndromic hypertrophic cardiomyopathy. As compared to Group B, patients in Group A showed more concomitant cardiac procedures and received more homologous transfusions. One perioperative death occurred in Group A, and none in Group B. Two patients in Group A but no patient in Group B required redo septal myectomy. The long-term clinical outcome was similar between the 2 groups. One patient in Group B required cardioverter-defibrillator/pacemaker implantation for higher degree atrioventricular block and none in Group A. There was no evidence of differences in myocardial fibrosis between groups on long-term follow-up magnetic resonance imaging. Surgical septal myectomy can be performed safely during infancy with favourable perioperative and long-term clinical outcome but with a trend towards a higher reoperation rate later in life. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  18. Insight, psychopathology, explanatory models and outcome of schizophrenia in India: a prospective 5-year cohort study

    Directory of Open Access Journals (Sweden)

    Johnson Shanthi

    2012-09-01

    Full Text Available Abstract Background The sole focus of models of insight on bio-medical perspectives to the complete exclusion of local, non-medical and cultural constructs mandates review. This study attempted to investigate the impact of insight, psychopathology, explanatory models of illness on outcome of first episode schizophrenia. Method Patients diagnosed to have DSM IV schizophrenia (n = 131 were assessed prospectively for insight, psychopathology, explanatory models of illness at baseline, 6, 12 and 60 months using standard instruments. Multiple linear and logistic regression and generalized estimating equations (GEE were employed to assess predictors of outcome. Results We could follow up 95 (72.5% patients. Sixty-five of these patients (68.4% achieved remission. There was a negative relationship between psychosis rating and insight scores. Urban residence, fluctuating course of the initial illness, and improvement in global functioning at 6 months and lower psychosis rating at 12 months were significantly related to remission at 5 years. Insight scores, number of non-medical explanatory models and individual explanatory models held during the later course of the illness were significantly associated with outcome. Analysis of longitudinal data using GEE showed that women, rural residence, insight scores and number of non-medical explanatory models of illness held were significantly associated with BPRS scores during the study period. Conclusions Insight, the disease model and the number of non-medical model positively correlated with improvement in psychosis arguing for a complex interaction between the culture, context and illness variables. These finding argue that insight and explanatory models are secondary to psychopathology, course and outcome of the illness. The awareness of mental illness is a narrative act in which people make personal sense of the many challenges they face. The course and outcome of the illness, cultural context

  19. Aetiological patterns and management outcome of paediatric head trauma: one-year prospective study.

    Science.gov (United States)

    Emejulu, J K C; Shokunbi, M T

    2010-09-01

    Trauma is the most common cause ofpaediatric deaths. In 75% ofpaediatric trauma deaths, head injury is responsible, and most are from falls. Recent reports from Nigeria, however, appear to indicate a predominance of road traffic accidents, instead of falls. To evaluate the aetiology of paediatric head trauma, management protocols and outcome from our Centre, in order to acquire a baseline data base and recommend measures to reduce childhood trauma. A prospective study of all paediatric head trauma cases presenting to Nnamdi Azikiwe University Teaching Hospital, Nnewi, for 12months from April 21, 2006 to April 20, 2007, was done and collated data subsequently analyzed. The paediatric age group was taken as = 15 years, and grading of head injury was with the Glasgow Coma Scale (3-15) and the modified scale for non-verbal children; while outcome was measured with the Glasgow Outcome Scale (1-5). Out of 334 patients treated within the period of study, 210 were head trauma cases. Of these, 52 were paediatric head trauma, representing 24.8% of all head trauma cases; and 19.2% (10 of 52) of them were aged 0-2 years. About 62% (32 of 52) were males. Falls and RTA were each responsible in 25 (48.1%) cases. Mild head injury occurred in 31 (59.6%), and 49 (94.2%) patients were evaluated by plain radiography. Treatment was conservative in 39 (75%) cases; with satisfactory outcome in 36 (69.2%), and a mortality rate of 15.4%. Road traffic injury, mostly from motorcycles, has become the major cause of morbidity and mortality amongst the paediatric age group, especially the male gender, and outcome from management is mostly satisfactory.

  20. 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

  1. 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.

  2. Clinical characteristics, drug resistance, and treatment outcomes among tuberculosis patients with diabetes in Peru.

    Science.gov (United States)

    Magee, M J; Bloss, E; Shin, S S; Contreras, C; Huaman, H Arbanil; Ticona, J Calderon; Bayona, J; Bonilla, C; Yagui, M; Jave, O; Cegielski, J P

    2013-06-01

    Diabetes is a risk factor for active tuberculosis (TB). Data are limited regarding the association between diabetes and TB drug resistance and treatment outcomes. We examined characteristics of TB patients with and without diabetes in a Peruvian cohort at high risk for drug-resistant TB. Among TB patients with diabetes (TB-DM), we studied the association between diabetes clinical/management characteristics and TB drug resistance and treatment outcomes. During 2005-2008, adults with suspected TB with respiratory symptoms in Lima, Peru, who received rapid drug susceptibility testing (DST), were prospectively enrolled and followed during treatment. Bivariate and Kaplan-Meier analyses were used to examine the relationships of diabetes characteristics with drug-resistant TB and TB outcomes. Of 1671 adult TB patients enrolled, 186 (11.1%) had diabetes. TB-DM patients were significantly more likely than TB patients without diabetes to be older, have had no previous TB treatment, and to have a body mass index (BMI) >18.5 kg/m(2) (pdiabetes, and 12% and 28%, respectively, among TB-DM patients. Among 149 TB-DM patients with DST results, 104 (69.8%) had drug-susceptible TB and 45 (30.2%) had drug-resistant TB, of whom 29 had multidrug-resistant TB. There was no association between diabetes characteristics and drug-resistant TB. Of 136 TB-DM patients with outcome information, 107 (78.7%) had a favorable TB outcome; active diabetes management was associated with a favorable outcome. Diabetes was common in a cohort of TB patients at high risk for drug-resistant TB. Despite prevalent multidrug-resistant TB among TB-DM patients, the majority had a favorable TB treatment outcome. Copyright © 2013 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  3. Meta-analysis of Clinical and Radiographic Outcomes After Arthroscopic Single-Row Versus Double-Row Rotator Cuff Repair.

    Science.gov (United States)

    Perser, Karen; Godfrey, David; Bisson, Leslie

    2011-05-01

    Double-row rotator cuff repair methods have improved biomechanical performance when compared with single-row repairs. To review clinical outcomes of single-row versus double-row rotator cuff repair with the hypothesis that double-row rotator cuff repair will result in better clinical and radiographic outcomes. Published literature from January 1980 to April 2010. Key terms included rotator cuff, prospective studies, outcomes, and suture techniques. The literature was systematically searched, and 5 level I and II studies were found comparing clinical outcomes of single-row and double-row rotator cuff repair. Coleman methodology scores were calculated for each article. Meta-analysis was performed, with treatment effect between single row and double row for clinical outcomes and with odds ratios for radiographic results. The sample size necessary to detect a given difference in clinical outcome between the 2 methods was calculated. Three level I studies had Coleman scores of 80, 74, and 81, and two level II studies had scores of 78 and 73. There were 156 patients with single-row repairs and 147 patients with double-row repairs, both with an average follow-up of 23 months (range, 12-40 months). Double-row repairs resulted in a greater treatment effect for each validated outcome measure in 4 studies, but the differences were not clinically or statistically significant (range, 0.4-2.2 points; 95% confidence interval, -0.19, 4.68 points). Double-row repairs had better radiographic results, but the differences were also not statistically significant (P = 0.13). Two studies had adequate power to detect a 10-point difference between repair methods using the Constant score, and 1 study had power to detect a 5-point difference using the UCLA (University of California, Los Angeles) score. Double-row rotator cuff repair does not show a statistically significant improvement in clinical outcome or radiographic healing with short-term follow-up.

  4. 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.

  5. Evaluation of aesthetic and functional outcomes in rhinoplasty surgery: a prospective study.

    Science.gov (United States)

    Sena Esteves, Sara; Gonçalves Ferreira, Miguel; Carvalho Almeida, João; Abrunhosa, José; Almeida E Sousa, Cecília

    Evaluation of surgery outcome measured by patient satisfaction or quality of life is very important, especially in plastic surgery. There is increasing interest in self-reporting outcomes evaluation in plastic surgery. The aim of our study was to determine patient satisfaction in regard to nose appearance and function with the use of a validated questionnaire, before and after rhinoplasty surgery. A prospective study was realized at a tertiary centre. All rhinoplasty surgeries performed in adults between February 2013 and August 2014 were included. Many patients underwent additional nasal surgery such as septoplasty or turbinoplasty. The surgical procedures and patients' characteristics were also recorded. Among 113 patients, 107 completed the questionnaires and the follow-up period. Analysis of pre-operative and post-operative Rhinoplasty Evaluation Outcome showed a significant improvement after 3 and 6 months in functional and aesthetic questions (pprocedures, primary or revision surgery and open versus closed approach. We found that patients with lower literacy degree were more satisfied with the procedure. Rhinoplasty surgery significantly improved patient quality of life regarding nose function and appearance. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  6. [Usher syndrome: clinical features, diagnostic options, and therapeutic prospects].

    Science.gov (United States)

    Seeliger, M W; Fischer, M D; Pfister, M

    2009-06-01

    Usher syndrome denotes a clinically and genetically heterogeneous combination of retinitis pigmentosa and sensorineural deafness. The division into subtypes I, II, and III is based on the degree of hearing loss: Type I is characterized by deafness from birth together with ataxia and retarded motor development, type II by a stationary deafness of a moderate degree, and type III by a progressive deafness with adult onset. In Germany, Usher syndrome currently bears particular relevance because in January 2009 a new compulsory screening of auditory function in newborn infants was introduced. Consequently, it can be expected that a higher number of patients with Usher syndrome will be identified in early childhood and referred to ophthalmologists. The focus of this work is to introduce the typical clinical picture of Usher syndrome, summarize diagnostic options, and give an overview of therapeutic strategies.

  7. Prospective Clinical Testing of Regulatory Dendritic Cells in Organ Transplantation

    OpenAIRE

    Thomson, Angus W.; Zahorchak, Alan F.; Ezzelarab, Mohamed B.; Butterfield, Lisa H.; Lakkis, Fadi G.; Metes, Diana M.

    2016-01-01

    Dendritic cells (DC) are rare, professional antigen-presenting cells with ability to induce or regulate alloimmune responses. Regulatory DC (DCreg) with potential to down-modulate acute and chronic inflammatory conditions that occur in organ transplantation can be generated in vitro under a variety of conditions. Here, we provide a rationale for evaluation of DCreg therapy in clinical organ transplantation with the goal of promoting sustained, donor-specific hyporesponsiveness, while lowering...

  8. What Is the Outcome of an Incision and Drainage Procedure in Endodontic Patients? A Prospective, Randomized, Single-blind Study.

    Science.gov (United States)

    Beus, Hannah; Fowler, Sara; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike; Jatana, Courtney

    2018-02-01

    There are no prospective endodontic studies to determine the outcome of an incision and drainage (I&D) procedure for swelling in healthy, endodontic patients. The purpose of this prospective, randomized, single-blind study was to compare the postoperative course of I&D with drain placement versus a mock I&D procedure with mock drain placement after endodontic debridement in swollen emergency patients with symptomatic teeth and a pulpal diagnosis of necrosis. Eighty-one adult emergency patients presenting with clinical swelling received either penicillin or, if allergic, clindamycin and complete endodontic debridement, and then were randomly divided into 2 treatment groups: I&D with drain placement or a mock I&D procedure with mock drain placement. At the end of the appointment, all patients received a combination of ibuprofen/acetaminophen and, if needed, an opioid-containing escape medication. Patients recorded their pain and medication use for 4 days postoperatively. Success was defined as no or mild postoperative pain and no use of an opioid-containing escape medication. Success was evaluated using repeated measure mixed model logistic regression. Both groups had a decrease in postoperative pain and medication use over the 4 days. The mock I&D group had significantly higher success than the I&D group (odds ratio = 2.00; 95% confidence interval, 1.16-3.41). The success rate was 45% with the mock I&D and 33% with the I&D. After endodontic debridement, patients who received a mock I&D procedure with mock drain placement had more success than patients who received I&D with drain placement. Both groups clinically improved over 4 days. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  9. Therapeutic horticulture in clinical depression: a prospective study.

    Science.gov (United States)

    Gonzalez, Marianne Thorsen; Hartig, Terry; Patil, Grete Grindal; Martinsen, Egil W; Kirkevold, Marit

    2009-01-01

    Clinically depressed persons suffer from impaired mood and distortion of cognition. This study assessed changes in depression severity and perceived attentional capacity of clinically depressed adults (N=18) during a 12-week therapeutic horticulture program. The Beck Depression Inventory (BDI) and Attentional Function Index (AFI) were administered at baseline, twice during (4 and 8 weeks), and immediately after the intervention (12 weeks), and at a 3-month follow-up. Experiences of being away and fascination related to the intervention were measured at 4, 8, and 12 weeks. The mean BDI score declined 9.7 points from pretest (27.3) to posttest (p or =6) for 72% of the cases. The mean AFI score increased 10.2 points from pretest (68.8) to posttest (p = .06). The greatest change in BDI and AFI scores occurred in the initial weeks of the intervention. The reduction in BDI scores remained significant and clinically relevant at the 3-month follow-up (N=16). The decline in depression severity during the intervention correlated strongly with the degree to which the participants found that it captured their attention. Therapeutic horticulture may decrease depression severity and improve perceived attentional capacity by engaging effortless attention and interrupting rumination.

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

    Science.gov (United States)

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

    2015-09-01

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

  11. 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

  12. Pattern of spinal compression (retrospective and prospective clinical study)

    International Nuclear Information System (INIS)

    Ahmed, Abubakr Darrag Salim

    1997-04-01

    Seventy two patients with spinal cord compressions were admitted to the national centre for neurological sciences in the period between january 1995 and december 1996. Male female ratio was 2.5:1 and the mean age was 40.5 years, myelogram was found to be the most helpful investigation in (90.3%) of patients and plain x-ray was abnormal in (43%) of patients. Tumors were found as the cause of compression in (26.4%), disc prolapse in (26.4%) of patients, spinal injuries in 13.8%, arachnoid cysts in (8.3%) of patients and tuberculosis in (8.3%). Other causes like spinal osteopathy, syringomyelia, spinal hematomas, spinal canal stenosis and spinal haemangiomas were also encountered. Thick ligamentum flavum was found in (25%) of cases, mostly in association with other pathologies, and as the sole compressing pathology in only two patients. The patients were followed up for a period from one month to two years, 41.6% of them were cured completely, while 37.5% were partially improved, 5.6% showed no improvement, 5.6% were died, 9.7% lost their follow up. The factors affecting the outcome were found to be, the duration of the condition before presentation for treatment, presence of blocks in myelograms, and the type of the pathology, disc and benign tumors gave the best outcome. Urinary complications like urine incontinence, urinary tract infection, and urine retention, were observed in (26.4%, 30.6%, 11.1%) of patients respectively, D.V.T. occurred in (15.3%) of patients and the mortality rate was (5.6%) and the major cause of death was pulmonary embolism. (Author)

  13. A systematic review of preoperative predictors for postoperative clinical outcomes following lumbar discectomy.

    Science.gov (United States)

    Wilson, Courtney A; Roffey, Darren M; Chow, Donald; Alkherayf, Fahad; Wai, Eugene K

    2016-11-01

    outcomes. It may be possible for certain preoperative factors to be targeted for clinical evaluation by spine surgeons to assess the suitability of patients for lumbar discectomy surgery, the hope being to thereby improve postoperative clinical outcomes. Prospective cohort studies are required to increase the level of evidence with regard to significant predictive factors. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Clinical outcomes in pediatric hemodialysis patients in the USA: lessons from CMS' ESRD CPM Project.

    Science.gov (United States)

    Neu, Alicia M; Frankenfield, Diane L

    2009-07-01

    Although prospective randomized trials have provided important information and allowed the development of evidence-based guidelines in adult hemodialysis (HD) patients, with approximately 800 prevalent pediatric HD patients in the United States, such studies are difficult to perform in this population. Observational data obtained through the Center for Medicare & Medicaid Services' (CMS') End Stage Renal Disease (ESRD) Clinical Performance Measures (CPM) Project have allowed description of the clinical care provided to pediatric HD patients as well as identification of risk factors for failure to reach adult targets for clinical parameters such as hemoglobin, single-pool Kt/V (spKt/V) and serum albumin. In addition, studies linking data from the ESRD CPM Project and the United States Renal Data System have allowed evaluation of associations between achievement of those targets and the outcomes of hospitalization and death. The results of those studies, while unable to prove cause and effect, suggest that the adult ESRD CPM targets may assist in identifying pediatric HD patients at risk for poor outcomes.

  15. The Association of Visual Impairment With Clinical Outcomes in Hemodialysis Patients.

    Science.gov (United States)

    Hong, Yu Ah; Kim, Suk Young; Kim, Su-Hyun; Kim, Young Ok; Jin, Dong Chan; Song, Ho Chul; Choi, Euy Jin; Kim, Yong-Lim; Kim, Yon-Su; Kang, Shin-Wook; Kim, Nam-Ho; Yang, Chul Woo; Kim, Yong Kyun

    2016-05-01

    Visual impairment limits people's ability to perform daily tasks and affects their quality of life. We evaluated the impact of visual impairment on clinical outcomes in hemodialysis (HD) patients.HD patients were selected from the Clinical Research Center registry a prospective cohort study on dialysis patients in Korea. Visual impairment was defined as difficulty in daily life due to decreased visual acuity or blindness. The primary outcome was all-cause mortality and the secondary outcomes were cardiovascular and infection-related hospitalization.A total of 3250 patients were included. Seven hundred thirty (22.5%) of the enrolled patients had visual impairment. The median follow-up period was 30 months. The Kaplan-Meier curve and log-rank test showed that all-cause mortality rates (P visual impairment than in patients without visual impairment. In the multivariable analysis, visual impairment had significant predictive power for all-cause mortality (Hazard ratio [HR], 1.77, 95% confidence interval [CI], 1.21-2.61, P = 0.004) and cardiovascular hospitalization (HR 1.45 [1.00-1.90], P = 0.008) after adjusting for confounding variables. Of these 3250 patients, 634 patients from each group were matched by propensity scores. In the propensity score matched analysis, patients with visual impairment had independently significant associations with increased all-cause mortality (HR 1.69 [1.12-2.54], P = 0.01) and cardiovascular hospitalization (HR 1.48 [1.08-2.02], P = 0.01) compared with patients without visual impairment after adjustment for confounding variables.Our data demonstrated that visual impairment was an independent risk factor for clinical adverse outcomes in HD patients.

  16. Clinical, Pathological, and Surgical Outcomes for Adult Pineoblastomas.

    Science.gov (United States)

    Gener, Melissa A; Conger, Andrew R; Van Gompel, Jamie; Ariai, Mohammad S; Jentoft, Mark; Meyer, Fredric B; Cardinal, Jeremy S; Bonnin, José M; Cohen-Gadol, Aaron A

    2015-12-01

    Pineoblastomas are uncommon primitive neuroectodermal tumors that occur mostly in children; they are exceedingly rare in adults. Few published reports have compared the various aspects of these tumors between adults and children. The authors report a series of 12 pineoblastomas in adults from 2 institutions over 24 years. The clinical, radiologic, and pathologic features and clinical outcomes were compared with previously reported cases in children and adults. Patient age ranged from 24 to 81 years, and all but 1 patient exhibited symptoms of obstructive hydrocephalus. Three patients underwent gross total resection, and subtotal resection was performed in 3 patients. Diagnostic biopsy specimens were obtained in an additional 6 patients. Pathologically, the tumors had the classical morphologic and immunohistochemical features of pineoblastomas. Postoperatively, 10 patients received radiotherapy, and 5 patients received chemotherapy. Compared with previously reported cases, several differences were noted in clinical outcomes. Of the 12 patients, only 5 (42%) died of their disease (average length of survival, 118 months); 5 patients (42%) are alive with no evidence of disease (average length of follow-up, 92 months). One patient died of unrelated causes, and one was lost to follow-up. Patients with subtotal resections or diagnostic biopsies did not suffer a worse prognosis. Of the 9 patients with biopsy or subtotal resection, 4 are alive, 4 died of their disease, and 1 died of an unrelated hemorrhagic cerebral infarction. Although this series is small, the data suggest that pineoblastomas in adults have a less aggressive clinical course than in children. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. 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.

  18. [The Spectrum of Neuromyotonia: Clinics, Therapy and Outcome].

    Science.gov (United States)

    Wenninger, S; Schoser, B

    2015-08-01

    Neuromyotonia (NM), Isaacs-Zschoke-Mertens syndrome or continuous muscle fiber activity (CMFA), is a rare condition associated with VGKC-antibodies. Clinically, fasciculations, myokymias, muscle stiffness and a myotonic appearance of movements after contraction are typical findings. In addition, CNS-symptoms vary from moderate fatigue, poor concentration and autonomic symptoms to severe encephalopathy in Morvan's syndrome. In electromyography, spontaneous irregular discharges can be found frequently with typical di-, tri- or multiplet single motor unit discharges. In up to 60 %, serum antibodies against VGKC-complexes can be detected. Patients with neuromyotonia were evaluated for clinical symptoms, response to treatment and outcome over a five-year period of follow-up. For evaluation, we used video recording of clinical symptoms, electroneurography, electromyography and myosonography as well as immunological tests (VGKC-complex antibody including CASPR2 and IGL1). Furthermore, cerebral fluid and screening for neoplasias were done. Patients with evidence for neuropathy, myopathy or motor neuron disease, even if diagnosed in the follow-up, were excluded. In 3 of 5 patients, neuromyotonia was diagnosed by electromyography and positive VGKC antibodies. In two patients, diagnosis was based on typical clinical symptoms and electromyographical changes. Anticonvulsants (carbamazepine) for symptomatic treatment were moderately effective in four patients; treatment with i. v. immunoglobulins was highly successful in one patient with high positive VGKC-complex antibody titers. In one patient with low-titer VGKC antibodies, neither anticonvulsants nor i. v. immunoglobulins nor prednisone was a successful treatment. Neuromyotonia is a rare, treatable condition. However, due to the high variability of symptoms, response to therapy and outcome, neuromyotonia treatment needs to be highly individualized. © Georg Thieme Verlag KG Stuttgart · New York.

  19. MIH supplementation strategies: prospective clinical and laboratory trial.

    Science.gov (United States)

    Baroni, C; Marchionni, S

    2011-03-01

    The use of calcium-phosphate casein on hypomineralized molars (molar incisor hypomineralization, MIH) has been proposed but not clinically investigated. Qualitative and quantitative effects of supplementation with a calcium-phosphate casein product on MIH molars were monitored over a period of three years. Molar replicas, minimally invasive biopsies and their SEM microphotographs, plus ESEM/EDX semi-quantitative peaks of elements present in affected enamel were evaluated. Mineralization, morphology, and porosity appeared markedly improved, with calcium and phosphate levels reaching almost normal levels at three years' follow-up. The hypothesis tested was rejected, since calcium-phosphate casein improved enamel morphology in vivo.

  20. Stress Underestimation and Mental Health Outcomes in Male Japanese Workers: a 1-Year Prospective Study.

    Science.gov (United States)

    Izawa, Shuhei; Nakamura-Taira, Nanako; Yamada, Kosuke Chris

    2016-12-01

    Being appropriately aware of the extent of stress experienced in daily life is essential in motivating stress management behaviours. Excessive stress underestimation obstructs this process, which is expected to exert adverse effects on health. We prospectively examined associations between stress underestimation and mental health outcomes in Japanese workers. Web-based surveys were conducted twice with an interval of 1 year on 2359 Japanese male workers. Participants were asked to complete survey items concerning stress underestimation, depressive symptoms, sickness absence, and antidepressant use. Multiple logistic regression analysis revealed that high baseline levels of 'overgeneralization of stress' and 'insensitivity to stress' were significantly associated with new-onset depressive symptoms (OR = 2.66 [95 % CI, 1.54-4.59], p stress underestimation, including stress insensitivity and the overgeneralization of stress, could exert adverse effects on mental health.

  1. Antimicrobial stewardship: a review of prospective audit and feedback systems and an objective evaluation of outcomes.

    Science.gov (United States)

    Chung, Gladys W; Wu, Jia En; Yeo, Chay Leng; Chan, Douglas; Hsu, Li Yang

    2013-02-15

    Antimicrobial stewardship is an emerging field currently defined by a series of strategies and interventions aimed toward improving appropriate prescription of antibiotics in humans in all healthcare settings. The ultimate goal is the preservation of current and future antibiotics against the threat of antimicrobial resistance, although improving patient safety and reducing healthcare costs are important concurrent aims. Prospective audit and feedback interventions are probably the most widely practiced of all antimicrobial stewardship strategies. Although labor-intensive, they are more easily accepted by physicians compared with formulary restriction and preauthorization strategies and have a higher potential for educational opportunities. Objective evaluation of antimicrobial stewardship is critical for determining the success of such programs. Nonetheless, there is controversy over which outcomes to measure and there is a pressing need for novel study designs that can objectively assess antimicrobial stewardship interventions despite the limitations inherent in the structure of most such programs.

  2. Pregnancy outcome after risk assessment of occupational exposure to organic solvents: a prospective cohort study.

    Science.gov (United States)

    Testud, François; D'Amico, Andrea; Lambert-Chhum, Rachel; Garayt, Christelle; Descotes, Jacques

    2010-11-01

    A rational medical, occupational and toxicological approach is instrumental to select objectively among pregnant women exposed to chemicals at the workplace those who should be withdrawn or benefit from improvements of working conditions. Risk assessment is based on a comprehensive review of compounds' hazards and a thorough evaluation of the actual exposure including biomonitoring whenever as possible. Since 1996, the Lyon Poison Center has been conducting a prospective follow-up of pregnant women exposed to chemicals at the workplace. Of these, 206 exposed to organic solvents since conception were selected and matched with 206 exposed to a non-embryotoxic agent. Total withdrawal from the workplace was recommended in 22% of cases, but exposure was not considered to be hazardous to pregnancy in 51%. Overall, no increase in adverse outcomes was found. Maintaining pregnant women at their workplace, particularly most of the laboratory technicians, is reasonably possible after careful toxicological risk assessment. Copyright © 2010 Elsevier Inc. All rights reserved.

  3. Prospective randomized clinical studies involving reirradiation. Lessons learned

    International Nuclear Information System (INIS)

    Nieder, Carsten; Langendijk, Johannes A.; Guckenberger, Matthias; Grosu, Anca L.

    2016-01-01

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [de

  4. Nanotechnology Strategies To Advance Outcomes in Clinical Cancer Care.

    Science.gov (United States)

    Hartshorn, Christopher M; Bradbury, Michelle S; Lanza, Gregory M; Nel, Andre E; Rao, Jianghong; Wang, Andrew Z; Wiesner, Ulrich B; Yang, Lily; Grodzinski, Piotr

    2018-01-23

    Ongoing research into the application of nanotechnology for cancer treatment and diagnosis has demonstrated its advantages within contemporary oncology as well as its intrinsic limitations. The National Cancer Institute publishes the Cancer Nanotechnology Plan every 5 years since 2005. The most recent iteration helped codify the ongoing basic and translational efforts of the field and displayed its breadth with several evolving areas. From merely a technological perspective, this field has seen tremendous growth and success. However, an incomplete understanding of human cancer biology persists relative to the application of nanoscale materials within contemporary oncology. As such, this review presents several evolving areas in cancer nanotechnology in order to identify key clinical and biological challenges that need to be addressed to improve patient outcomes. From this clinical perspective, a sampling of the nano-enabled solutions attempting to overcome barriers faced by traditional therapeutics and diagnostics in the clinical setting are discussed. Finally, a strategic outlook of the future is discussed to highlight the need for next-generation cancer nanotechnology tools designed to address critical gaps in clinical cancer care.

  5. Oral health status and adverse pregnancy outcomes among pregnant women in Haryana, India: A prospective study

    Directory of Open Access Journals (Sweden)

    Puneet Singh Talwar

    2015-01-01

    Full Text Available Background: Women′s oral health is affected by certain conditions such as pregnancy, puberty, menstrual cycle, menopause and nonphysiological conditions such as hormonal contraception and hormonal therapy. This study was conducted to assess the oral health status and treatment needs of pregnant women and to correlate periodontal health with adverse pregnancy outcomes like preterm birth (PTB and low birth weight (LBW. Materials and Methods: A prospective study was undertaken at a Government Hospital in Haryana. Pregnant women who were in their third trimester of pregnancy and visited the hospital for routine ante-natal check-up constituted the final sample size (223. Dental caries and periodontal status were assessed using a WHO Proforma-1997. None of the subjects were in the habit of taking alcohol, chewing and smoking tobacco. The main outcome measures were gestational age and weight of the newborn. Data were analyzed using SPSS package version 13. Results: Decayed, missing and filled teeth index of the subjects was 2.87. Extraction was indicated in younger subjects when compared to the older ones. Bleeding was the main finding, which was present in 47.5% of the study subjects, followed by calculus. 63 more than 60% of subjects of subjects with 4-5 mm attachment loss belonged to 20-24 years age-group. There was a statistically significant association of probing depths and attachment loss with adverse pregnancy outcomes (P < 0.05 (PTB and LBW. Conclusion: There is a significant association between maternal periodontitis and pregnancy outcomes in the present study. It is recommended that suitable measures be undertaken by various health organizations to prevent periodontal problems among this particular group.

  6. Maternal vitamin D status and infant outcomes in rural Vietnam: a prospective cohort study.

    Directory of Open Access Journals (Sweden)

    Sarah Hanieh

    Full Text Available Vitamin D deficiency affects 1 billion people globally. It has an important role in bone homeostasis, brain development and modulation of the immune system and yet the impact of antenatal vitamin D deficiency on infant outcomes is poorly understood. We assessed the association of 25- hydroxyvitamin D levels (25-OHD in late pregnancy and early infant growth and developmental outcomes in rural Vietnam.A prospective cohort study of 960 women who had previously participated in a double-blind cluster randomized controlled trial of antenatal micronutrient supplementation in rural Vietnam was undertaken. Maternal 25-OHD concentration was measured at 32 weeks gestation, and infants were followed until 6 months of age. Main outcome measures were cognitive, motor, socio-emotional and language scores using the Bayley Scales of Infant Development, 3rd edition, and infant length-for-age z scores at 6 months of age.60% (582/960 of women had 25-OHD levels <75 nmol/L at 32 weeks gestation. Infants born to women with 25-OHD deficiency (<37.5 nmol/L had reduced developmental language scores compared to those born to women who were vitamin D replete (≥75 nmol/L (Mean Difference (MD -3.48, 95% Confidence Interval (CI -5.67 to -1.28. For every 25 nmol increase in 25-OHD concentration in late pregnancy, infant length-for-age z scores at 6 months of age decreased by 0.08 (95% CI -0.15 to -0.02.Low maternal 25- hydroxyvitamin D levels during late pregnancy are of concern in rural Vietnam, and are associated with reduced language developmental outcomes at 6 months of age. Our findings strengthen the evidence for giving vitamin D supplementation during pregnancy.

  7. Maternal vitamin D status and infant outcomes in rural Vietnam: a prospective cohort study.

    Science.gov (United States)

    Hanieh, Sarah; Ha, Tran T; Simpson, Julie A; Thuy, Tran T; Khuong, Nguyen C; Thoang, Dang D; Tran, Thach D; Tuan, Tran; Fisher, Jane; Biggs, Beverley-Ann

    2014-01-01

    Vitamin D deficiency affects 1 billion people globally. It has an important role in bone homeostasis, brain development and modulation of the immune system and yet the impact of antenatal vitamin D deficiency on infant outcomes is poorly understood. We assessed the association of 25- hydroxyvitamin D levels (25-OHD) in late pregnancy and early infant growth and developmental outcomes in rural Vietnam. A prospective cohort study of 960 women who had previously participated in a double-blind cluster randomized controlled trial of antenatal micronutrient supplementation in rural Vietnam was undertaken. Maternal 25-OHD concentration was measured at 32 weeks gestation, and infants were followed until 6 months of age. Main outcome measures were cognitive, motor, socio-emotional and language scores using the Bayley Scales of Infant Development, 3rd edition, and infant length-for-age z scores at 6 months of age. 60% (582/960) of women had 25-OHD levels language scores compared to those born to women who were vitamin D replete (≥75 nmol/L) (Mean Difference (MD) -3.48, 95% Confidence Interval (CI) -5.67 to -1.28). For every 25 nmol increase in 25-OHD concentration in late pregnancy, infant length-for-age z scores at 6 months of age decreased by 0.08 (95% CI -0.15 to -0.02). Low maternal 25- hydroxyvitamin D levels during late pregnancy are of concern in rural Vietnam, and are associated with reduced language developmental outcomes at 6 months of age. Our findings strengthen the evidence for giving vitamin D supplementation during pregnancy.

  8. 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)

  9. Intraocular lens iris fixation. Clinical and macular OCT outcomes

    Science.gov (United States)

    2012-01-01

    Background To assess the efficacy, clinical outcomes, visual acuity (VA), incidence of adverse effects, and complications of peripheral iris fixation of 3-piece acrylic IOLs in eyes lacking capsular support. Thirteen patients who underwent implantation and peripheral iris fixation of a 3-piece foldable acrylic PC IOL for aphakia in the absence of capsular support were followed after surgery. Clinical outcomes and macular SD-OCT (Cirrus OCT; Carl Zeiss Meditec, Germany) were analyzed. Findings The final CDVA was 20/40 or better in 8 eyes (62%), 20/60 or better in 12 eyes (92%), and one case of 20/80 due to corneal astigmatism and mild persistent edema. No intraoperative complications were reported. There were seven cases of medically controlled ocular hypertension after surgery due to the presence of viscoelastic in the AC. There were no cases of cystoid macular edema, chronic iridocyclitis, IOL subluxation, pigment dispersion, or glaucoma. Macular edema did not develop in any case by means of SD-OCT. Conclusions We think that this technique for iris suture fixation provides safe and effective results. Patients had substantial improvements in UDVA and CDVA. This surgical strategy may be individualized however; age, cornea status, angle structures, iris anatomy, and glaucoma are important considerations in selecting candidates for an appropriate IOL fixation method. PMID:23050659

  10. Intraocular lens iris fixation. Clinical and macular OCT outcomes

    Directory of Open Access Journals (Sweden)

    Garcia-Rojas Leonardo

    2012-10-01

    Full Text Available Abstract Background To assess the efficacy, clinical outcomes, visual acuity (VA, incidence of adverse effects, and complications of peripheral iris fixation of 3-piece acrylic IOLs in eyes lacking capsular support. Thirteen patients who underwent implantation and peripheral iris fixation of a 3-piece foldable acrylic PC IOL for aphakia in the absence of capsular support were followed after surgery. Clinical outcomes and macular SD-OCT (Cirrus OCT; Carl Zeiss Meditec, Germany were analyzed. Findings The final CDVA was 20/40 or better in 8 eyes (62%, 20/60 or better in 12 eyes (92%, and one case of 20/80 due to corneal astigmatism and mild persistent edema. No intraoperative complications were reported. There were seven cases of medically controlled ocular hypertension after surgery due to the presence of viscoelastic in the AC. There were no cases of cystoid macular edema, chronic iridocyclitis, IOL subluxation, pigment dispersion, or glaucoma. Macular edema did not develop in any case by means of SD-OCT. Conclusions We think that this technique for iris suture fixation provides safe and effective results. Patients had substantial improvements in UDVA and CDVA. This surgical strategy may be individualized however; age, cornea status, angle structures, iris anatomy, and glaucoma are important considerations in selecting candidates for an appropriate IOL fixation method.

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

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    Chai Lee Tan

    2017-01-01

    Full Text Available 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, supported by a positive Bartonella spp. serology. Results. Of the 19 patients in our series, females were predominant (63.2%. The mean age was 29.3 years. The majority (63.2% had unilateral involvement. Five patients (26.3% had a history of contact with cats. Neuroretinitis was the most common presentation (62.5%. Azithromycin was the antibiotic of choice (42.1%. Concurrent systemic corticosteroids were used in approximately 60% of cases. The presenting visual acuity was worse than 6/18 in approximately 60% of eyes; on final review, 76.9% of eyes had a visual acuity better than 6/18. Conclusion. Ocular bartonellosis tends to present with neuroretinitis. Azithromycin is a viable option for treatment. Systemic corticosteroids may be considered in those with poor visual acuity on presentation.

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

    Science.gov (United States)

    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, supported by a positive Bartonella spp. serology. Results. Of the 19 patients in our series, females were predominant (63.2%). The mean age was 29.3 years. The majority (63.2%) had unilateral involvement. Five patients (26.3%) had a history of contact with cats. Neuroretinitis was the most common presentation (62.5%). Azithromycin was the antibiotic of choice (42.1%). Concurrent systemic corticosteroids were used in approximately 60% of cases. The presenting visual acuity was worse than 6/18 in approximately 60% of eyes; on final review, 76.9% of eyes had a visual acuity better than 6/18. Conclusion. Ocular bartonellosis tends to present with neuroretinitis. Azithromycin is a viable option for treatment. Systemic corticosteroids may be considered in those with poor visual acuity on presentation.

  13. 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

  14. Volvulus in term and preterm infants - clinical presentation and outcome.

    Science.gov (United States)

    Horsch, Sandra; Albayrak, Bilge; Tröbs, Ralf-Bodo; Roll, Claudia

    2016-06-01

    Our aim was to assess if term and preterm infants with volvulus showed different patterns with regard to pathogenesis, clinical presentation and outcome. We reviewed the medical records and imaging data of infants aged less than six months with volvulus treated in a single surgical referral centre from 2006-2013. Volvulus was diagnosed in 19 infants, with no anatomical anomaly in three of the 12 preterm infants and one of the seven term infants. Most cases (74%) presented during the first eight days of life. Later presentations occurred exclusively in preterm infants, with only one of the five having no anatomic anomalies. Bilious vomiting was the leading symptom in six of the seven term infants, while the symptoms in preterm infants were rather nonspecific. Intestinal necrosis, with the need for bowel resection, occurred in one term (14%) infant and nine (75%) preterm infants. The clinical presentation and outcome of volvulus differed between preterm and term infants, but the rate and distribution of underlying anomalies did not differ. Symptoms in preterm infants were often nonspecific and led to a delay in diagnosis. This might have contributed to the higher rate of intestinal necrosis in preterm infants. ©2016 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  15. PROTON RADIATION THERAPY: CLINICAL APPLICATION OPPORTUNITIES AND RESEARCH PROSPECTS

    Directory of Open Access Journals (Sweden)

    M. V. Zabelin

    2018-01-01

    Full Text Available This article is the review of literature concerning use of proton beam therapy in treatment of oncology. The staticized data on comparison of effi ciency of this method at an eye melanoma are lit. Advantages of proton therapy on the level of local control and depression of frequency of development of the radio induced cataract are refl ected in the provided data. In evident material the technology of preparation and carrying out radiation of an eye is shortly covered with a fascicle of protons. The experience of use of proton therapy of tumors of a skull base got for the last several decades, showed good results. Physical properties of a fascicle of protons allow to achieve the maximum dose conformality, having lowered, thereby, a radial load on the next crucial anatomical structures. The presented material on an oncopediatrics shows insuffi cient knowledge of scientists concerning advantage of a fascicle of protons over modern methods of photon radiation. There are only preliminary clinical results concerning generally of treatment of cranyopharyngiomas. At cancer therapy of a mammary gland, proton therapy showed the best local control of postoperative recurrent tumors, and also depression of a dose load on the contralateral party. The available results of the retrospective analysis of clinical data in the University medical center of Lome Linda, testify to advantages of proton therapy of the localized prostate cancer. The lack of a biochemical recurrence and a local tumoral progression within 5 years after radiation was shown. The data obtained from experience of use of proton radiation therapy with passively scattered fascicle for cancer therapy of a prostate at an early stage showed the admixed results in comparison with modern methods of radiation therapy with the modulated intensity. In treatment of non-small cell cancer of mild advantage of proton therapy aren’t absolutely proved yet. There are data on extreme toxicity of a combination

  16. EVERREST prospective study: a 6-year prospective study to define the clinical and biological characteristics of pregnancies affected by severe early onset fetal growth restriction.

    Science.gov (United States)

    Spencer, Rebecca; Ambler, Gareth; Brodszki, Jana; Diemert, Anke; Figueras, Francesc; Gratacós, Eduard; Hansson, Stefan R; Hecher, Kurt; Huertas-Ceballos, Angela; Marlow, Neil; Marsál, Karel; Morsing, Eva; Peebles, Donald; Rossi, Carlo; Sebire, Neil J; Timms, John F; David, Anna L

    2017-01-23

    Fetal growth restriction (FGR) is a serious obstetric condition for which there is currently no treatment. The EVERREST Prospective Study has been designed to characterise the natural history of pregnancies affected by severe early onset FGR and establish a well phenotyped bio-bank. The findings will provide up-to-date information for clinicians and patients and inform the design and conduct of the EVERREST Clinical Trial: a phase I/IIa trial to assess the safety and efficacy of maternal vascular endothelial growth factor (VEGF) gene therapy in severe early onset FGR. Data and samples from the EVERREST Prospective Study will be used to identify ultrasound and/or biochemical markers of prognosis in pregnancies with an estimated fetal weight (EFW) economic impact; psychological impact; neonatal condition, progress and complications; and infant growth and neurodevelopment to 2 years of corrected age in surviving infants. Standardised longitudinal ultrasound measurements are performed, including: fetal biometry; uterine artery, umbilical artery, middle cerebral artery, and ductus venosus Doppler velocimetry; and uterine artery and umbilical vein volume blood flow. Samples of maternal blood and urine, amniotic fluid (if amniocentesis performed), placenta, umbilical cord blood, and placental bed (if caesarean delivery performed) are collected for bio-banking. An initial analysis of maternal blood samples at enrolment is planned to identify biochemical markers that are predictors for fetal or neonatal death. The findings of the EVERREST Prospective Study will support the development of a novel therapy for severe early onset FGR by describing in detail the natural history of the disease and by identifying women whose pregnancies have the poorest outcomes, in whom a therapy might be most advantageous. The findings will also enable better counselling of couples with affected pregnancies, and provide a valuable resource for future research into the causes of FGR. NCT02097667

  17. Neglected ends: clinical ethics consultation and the prospects for closure.

    Science.gov (United States)

    Fiester, Autumn

    2015-01-01

    Clinical ethics consultations (CECs) are sometimes deemed complete at the moment when the consultants make a recommendation. In CECs that involve actual ethical conflict, this view of a consult's endpoint runs the risk of overemphasizing the conflict's resolution at the expense of the consult's process, which can have deleterious effects on the various parties in the conflict. This overly narrow focus on reaching a decision or recommendation in consults that involve profound moral disagreement can result in two types of adverse, lingering sequelae: moral distress or negative moral emotions. The problem, succinctly named, is that such consults have insufficient "closure" for patients, families, and providers. To promote closure, and avoid the ills of moral distress and the moral emotions, I argue that CECs need to prioritize assisted conversation between the different stakeholders in these conflicts, what is often referred to as "bioethics mediation."

  18. 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.

  19. 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

  20. 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.

  1. Improvement of the clinical outcome in Ankylosing spondylitis by balneotherapy.

    Science.gov (United States)

    Yurtkuran, Merih; Ay, Alev; Karakoç, Yüksel

    2005-07-01

    This study is designed to show the efficacy of balneotherapy and balneotherapy (BT) + nonsteroid antiinflammatory drug (NSAID) use in Ankylosing spondylitis (AS) patients. In this prospective study, BT, BT+ NSAID and NSAID therapy in 61 patients with AS were evaluated by ASAS core set. BT group (21 patients) was treated only with BT for 20 min, once a day, 5 days a week, over a period of 3 weeks. BT+NSAID group (20 patients) was treated with 1000 mg naproxen as well as BT. NSAID group (20 patients) was treated with 1000 mg naproxen. All of the participants did respiratory and postural exercises for 20 min a day and for the whole study period. Each patient was evaluated on admission (before treatment), at the end of the therapy and 6 months after the treatment. At the end of the study, statistically significant improvement was observed in all the clinical parameters of the patients in BT (G1), BT+NSAID (G2) and NSAID (G3) groups. This significant symptomatic and clinical improvement was maintained even 6 months after the treatment. The changes from baseline to follow up were similar in G1 and G2 except duration of morning stiffness (DMS) and chest expansion (CE). Improvements in CE and DMS were better in G1 and G2, respectively. Improvements observed in G1 and G2 were superior to the improvements observed in G3 for the variables of morning pain, nocturnal pain, DMS, global well being of the patient, occiput-wall distance, CE, finger to floor distance and functional index. In Schober test, improvement observed in G1 was statistically superior to G3. We concluded that BT can be suggested as an effective symptomatic treatment modality in patients with AS. Furthermore, sufficient improvement in clinical parameters can be obtained by BT alone.

  2. 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.

  3. 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

  4. Preoperative MRI findings predict two-year postoperative clinical outcome in lumbar spinal stenosis.

    Directory of Open Access Journals (Sweden)

    Pekka Kuittinen

    Full Text Available To study the predictive value of preoperative magnetic resonance imaging (MRI findings for the two-year postoperative clinical outcome in lumbar spinal stenosis (LSS.84 patients (mean age 63±11 years, male 43% with symptoms severe enough to indicate LSS surgery were included in this prospective observational single-center study. Preoperative MRI of the lumbar spine was performed with a 1.5-T unit. The imaging protocol conformed to the requirements of the American College of Radiology for the performance of MRI of the adult spine. Visual and quantitative assessment of MRI was performed by one experienced neuroradiologist. At the two-year postoperative follow-up, functional ability was assessed with the Oswestry Disability Index (ODI 0-100% and treadmill test (0-1000 m, pain symptoms with the overall Visual Analogue Scale (VAS 0-100 mm, and specific low back pain (LBP and specific leg pain (LP separately with a numeric rating scale from 0-10 (NRS-11. Satisfaction with the surgical outcome was also assessed.Preoperative severe central stenosis predicted postoperatively lower LP, LBP, and VAS when compared in patients with moderate central stenosis (p<0.05. Moreover, severe stenosis predicted higher postoperative satisfaction (p = 0.029. Preoperative scoliosis predicted an impaired outcome in the ODI (p = 0.031 and lowered the walking distance in the treadmill test (p = 0.001. The preoperative finding of only one stenotic level in visual assessment predicted less postoperative LBP when compared with patients having 2 or more stenotic levels (p = 0.026. No significant differences were detected between quantitative measurements and the patient outcome.Routine preoperative lumbar spine MRI can predict the patient outcome in a two-year follow up in patients with LSS surgery. Severe central stenosis and one-level central stenosis are predictors of good outcome. Preoperative finding of scoliosis may indicate worse functional ability.

  5. Prospective clinical evaluation of an electronic portal imaging device

    International Nuclear Information System (INIS)

    Michalski, Jeff M.; Graham, Mary V.; Bosch, Walter R.; Wong, John; Gerber, Russell L.; Cheng, Abel; Tinger, Alfred; Valicenti, Richard K.

    1996-01-01

    Purpose: To determine whether the clinical implementation of an electronic portal imaging device can improve the precision of daily external beam radiotherapy. Methods and Materials: In 1991, an electronic portal imaging device was installed on a dual energy linear accelerator in our clinic. After training the radiotherapy technologists in the acquisition and evaluation of portal images, we performed a randomized study to determine whether online observation, interruption, and intervention would result in more precise daily setup. The patients were randomized to one of two groups: those whose treatments were actively monitored by the radiotherapy technologists and those that were imaged but not monitored. The treating technologists were instructed to correct the following treatment errors: (a) field placement error (FPE) > 1 cm; (b) incorrect block; (c) incorrect collimator setting; (d) absent customized block. Time of treatment delivery was recorded by our patient tracking and billing computers and compared to a matched set of patients not participating in the study. After the patients radiation therapy course was completed, an offline analysis of the patient setup error was planned. Results: Thirty-two patients were treated to 34 anatomical sites in this study. In 893 treatment sessions, 1,873 fields were treated (1,089 fields monitored and 794 fields unmonitored). Ninety percent of the treated fields had at least one image stored for offline analysis. Eighty-seven percent of these images were analyzed offline. Of the 1,011 fields imaged in the monitored arm, only 14 (1.4%) had an intervention recorded by the technologist. Despite infrequent online intervention, offline analysis demonstrated that the incidence of FPE > 10 mm in the monitored and unmonitored groups was 56 out of 881 (6.1%) and 95 out of 595 (11.2%), respectively; p 10 mm was confined to the pelvic fields. The time to treat patients in this study was 10.78 min (monitored) and 10.10 min (unmonitored

  6. Prospective randomized clinical studies involving reirradiation. Lessons learned

    Energy Technology Data Exchange (ETDEWEB)

    Nieder, Carsten [Nordland Hospital, Department of Oncology and Palliative Medicine, Bodoe (Norway); University of Tromsoe, Department of Clinical Medicine, Faculty of Health Sciences, Tromsoe (Norway); Langendijk, Johannes A. [University Medical Centre Groningen, Department of Radiation Oncology, Groningen (Netherlands); Guckenberger, Matthias [University Hospital Zuerich, Department of Radiation Oncology, Zuerich (Switzerland); Grosu, Anca L. [University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany)

    2016-10-15

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [German] Eine Rebestrahlung kann fuer viele Patienten mit rezidivierenden Malignomen eine nuetzliche Option bieten. Der Zweck dieser Studie bestand darin, alle in der juengeren Vergangenheit publizierten randomisierten Studien zu beurteilen, da deren methodische Staerken und Schwaechen, Ergebnisse und resultierende Implikationen bzw. offene Fragen die Planung kuenftiger Studien wesentlich beeinflussen koennen. Systematische Uebersicht aller zwischen 2000 und 2015 veroeffentlichten Studien (Literatursuche ueber PubMed, Scopus und Web of Science). Ausgewertet wurden 9 Studien, in die vor allem Patienten mit Kopf-Hals-Tumoren eingeschlossen waren. Im Median hatten 69 Patienten teilgenommen. Das

  7. 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

  8. The effect of neuromuscular blockade on canine laparoscopic ovariectomy: A double-blinded, prospective clinical trial

    NARCIS (Netherlands)

    van Goethem, B.; van Nimwegen, S.A.; Akkerdaas, L.C.; Murrell, J.C.; Kirpensteijn, J.

    2012-01-01

    The Effect of Neuromuscular Blockade on Canine Laparoscopic Ovariectomy: A Double-Blinded, Prospective Clinical Trial Bart Van Goethem, Diplomate ECVS, Sebastiaan Alexander van Nimwegen, PhD, Ies Akkerdaas, DVM, Joanna Claire Murrell, BVSc., PhD, Diplomate ECVAA, and Jolle Kirpensteijn, PhD,

  9. High frequency audiometry in prospective clinical research of ototoxicity due to platinum derivatives

    NARCIS (Netherlands)

    van der Hulst, R. J.; Dreschler, W. A.; Urbanus, N. A.

    1988-01-01

    The results of clinical use of routine high frequency audiometry in monitoring the ototoxic side effects of platinum and its derivatives are described in this prospective study. After demonstrating the reproducibility of the technique, we discuss the first results of an analysis of ototoxic side

  10. Neuropsychological outcomes after Gamma Knife radiosurgery for mesial temporal lobe epilepsy: a prospective multicenter study.

    Science.gov (United States)

    Quigg, Mark; Broshek, Donna K; Barbaro, Nicholas M; Ward, Mariann M; Laxer, Kenneth D; Yan, Guofen; Lamborn, Kathleen

    2011-05-01

    To assess outcomes of language, verbal memory, cognitive efficiency and mental flexibility, mood, and quality of life (QOL) in a prospective, multicenter pilot study of Gamma Knife radiosurgery (RS) for mesial temporal lobe epilepsy (MTLE). RS, randomized to 20 Gy or 24 Gy comprising 5.5-7.5 ml at the 50% isodose volume, was performed on mesial temporal structures of patients with unilateral MTLE. Neuropsychological evaluations were performed at preoperative baseline, and mean change scores were described at 12 and 24 months postoperatively. QOL data were also available at 36 months. Thirty patients were treated and 26 were available for the final 24-month neuropsychological evaluation. Language (Boston Naming Test), verbal memory (California Verbal Learning Test and Logical Memory subtest of the Wechsler Memory Scale-Revised), cognitive efficiency and mental flexibility (Trail Making Test), and mood (Beck Depression Inventory) did not differ from baseline. QOL scores improved at 24 and 36 months, with those patients attaining seizure remission by month 24s accounting for the majority of the improvement. The serial changes in cognitive outcomes, mood, and QOL are unremarkable following RS for MTLE. RS may provide an alternative to open surgery, especially in those patients at risk of cognitive impairment or who desire a noninvasive alternative to open surgery. Wiley Periodicals, Inc. © 2011 International League Against Epilepsy.

  11. Nausea, vomiting, and heartburn in pregnancy: a prospective look at risk, treatment, and outcome.

    Science.gov (United States)

    Naumann, Christopher R; Zelig, Craig; Napolitano, Peter G; Ko, Cynthia W

    2012-08-01

    To examine risk factors, treatment, and outcomes for nausea/vomiting (N/V) and heartburn during pregnancy. We included 2731 women from a prospective cohort study of gallbladder disease in pregnancy. Subjects completed questionnaires at enrollment, early third trimester, and 4-6 weeks postpartum. We used logistic regression to examine independent predictors of upper gastrointestinal symptoms. Ninety-five percent of pregnant women experienced either heartburn and/or N/V. Independent predictors for heartburn included prepregnancy heartburn (OR 5.28, 95% CI 3.78-7.37), multigravidity, prepregnancy body mass index, and pregnancy weight gain. Independent predictors for N/V included prepregnancy N/V (OR 2.25, 95% CI 1.52-3.31), other digestive problems prepregnancy, younger age, single gestation, and carrying a female fetus. 11% of women with N/V and 47% of women with heartburn used pharmacologic therapy. Infants born to women with heartburn had significantly higher birth weights (p = 0.03), but gestational age at delivery was not significantly different. N/V was not associated with birth weight or gestational age at delivery. 19.7% of women with heartburn during pregnancy reported postpartum heartburn. Heartburn and N/V are common pregnancy symptoms, particularly among women with a history of such symptoms. Neither condition appears to adversely affect the outcome of pregnancy. Pregnancy-related heartburn predisposes to early postpartum heartburn.

  12. 42 CFR 482.80 - Condition of participation: Data submission, clinical experience, and outcome requirements for...

    Science.gov (United States)

    2010-10-01

    ..., clinical experience, and outcome requirements for initial approval of transplant centers. 482.80 Section... Hospitals Transplant Center Data Submission, Clinical Experience, and Outcome Requirements § 482.80 Condition of participation: Data submission, clinical experience, and outcome requirements for initial...

  13. Prospective assessment of the safety and early outcomes of sublaminar band placement for the prevention of proximal junctional kyphosis.

    Science.gov (United States)

    Viswanathan, Vibhu K; Kukreja, Sunil; Minnema, Amy J; Farhadi, H Francis

    2018-05-01

    OBJECTIVE Proximal junctional kyphosis (PJK) can progress to proximal junctional failure (PJF), a widely recognized early and serious complication of multisegment spinal instrumentation for the treatment of adult spinal deformity (ASD). Sublaminar band placement has been suggested as a possible technique to prevent PJK and PJF but carries the theoretical possibility of a paradoxical increase in these complications as a result of the required muscle dissection and posterior ligamentous disruption. In this study, the authors prospectively assess the safety as well as the early clinical and radiological outcomes of sublaminar band insertion at the upper instrumented vertebra (UIV) plus 1 level (UIV+1). METHODS Between August 2015 and February 2017, 40 consecutive patients underwent either upper (T2-4) or lower (T8-10) thoracic sublaminar band placement at the UIV+1 during long-segment thoracolumbar arthrodesis surgery. Outcome measures were prospectively collected and uploaded to a web-based REDCap database specifically designed to include demographic, clinical, and radiological data. All patients underwent clinical assessment, as well as radiological assessment with anteroposterior and lateral 36-inch whole-spine standing radiographs both pre- and postoperatively. RESULTS Forty patients (24 women and 16 men) were included in this study. Median age at surgery was 64.0 years with an IQR of 57.7-70.0 years. Median follow-up was 12 months (IQR 6-15 months). Three procedure-related complications were noted, including 2 intraoperative cerebrospinal spinal fluid leaks and 1 transient neurological deficit. Median visual analog scale (VAS) scores for back pain significantly improved after surgery (preoperatively: 8.0, IQR 6.0-10.0; 1-year follow-up: 2.0, IQR 0.0-6.0; p = 0.001). Median Oswestry Disability Index (version 2.1a) scores also significantly improved after surgery (preoperatively: 56.0, IQR 45.0-64.0; 1-year follow-up: 46.0, IQR 22.2-54.0; p < 0.001). Sagittal

  14. 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

  15. Pediatric supraglottic airway devices in clinical practice: A prospective observational study.

    Science.gov (United States)

    Kleine-Brueggeney, Maren; Gottfried, Anne; Nabecker, Sabine; Greif, Robert; Book, Malte; Theiler, Lorenz

    2017-09-02

    Supraglottic airway devices (SGA) are commonly used in pediatric anesthesia and serve as primary or back-up devices for difficult airway management. Most SGA are marketed without proper clinical evaluation. The purpose of this study was to evaluate the performance of the pediatric LMA Supreme™, Air-Q® and Ambu® Aura-i™. This prospective observational study was performed at Bern University Hospital, Switzerland. With ethics committee approval and a waiver for written informed consent 240 children undergoing elective surgery with an ASA class I-III and a weight of 5-30 kg were included. Three different pediatric supraglottic airway devices were assessed: The LMA Supreme™, Air-Q® and Ambu® Aura-i™. Primary outcome parameter was airway leak pressure. Secondary outcome parameters included first attempt and overall success rate, insertion time, fiberoptic view through the SGA, and adverse events. The primary hypothesis was that the mean airway leak pressure of each tested SGA was 20 cmH 2 O ± 10%. None of the SGA showed a mean airway leak pressure of 20 cmH 2 O ± 10%, but mean airway leak pressures differed significantly between devices [LMA Supreme™ 18.0 (3.4) cmH 2 O, Air-Q® 15.9 (3.2) cmH 2 O, Ambu® Aura-i™ 17.3 (3.7) cmH 2 O, p < 0.001]. First attempt success rates (LMA Supreme™ 100%, Air-Q® 90%, Ambu® Aura-i™ 91%, p = 0.02) and overall success rates (LMA S