Sample records for compared main outcome

  1. Discrepancy between results and abstract conclusions in industry- vs nonindustry-funded studies comparing topical prostaglandins.

    PubMed

    Alasbali, Tariq; Smith, Michael; Geffen, Noa; Trope, Graham E; Flanagan, John G; Jin, Yaping; Buys, Yvonne M

    2009-01-01

    To investigate the relationship between industry- vs nonindustry-funded publications comparing the efficacy of topical prostaglandin analogs by evaluating the correspondence between the statistical significance of the publication's main outcome measure and its abstract conclusions. Retrospective, observational cohort study. English publications comparing the ocular hypotensive efficacy between any or all of latanoprost, travoprost, and bimatoprost were searched from the MEDLINE database. Each article was reviewed by three independent observers and was evaluated for source of funding, study quality, statistically significant main outcome measure, correspondence between results of main outcome measure and abstract conclusion, number of intraocular pressure outcomes compared, and journal impact factor. Funding was determined by published disclosure or, in cases of no documented disclosure, the corresponding author was contacted directly to confirm industry funding. Discrepancies were resolved by consensus. The main outcome measure was correspondence between abstract conclusion and reported statistical significance of the publications' main outcome measure. Thirty-nine publications were included, of which 29 were industry funded and 10 were nonindustry funded. The published abstract conclusion was not consistent with the results of the main outcome measure in 18 (62%) of 29 of the industry-funded studies compared with zero (0%) of 10 of the nonindustry-funded studies (P = .0006). Twenty-six (90%) of the industry-funded studies had proindustry abstract conclusions. Twenty-four percent of the industry-funded publications had a statistically significant main outcome measure; however, 90% of the industry-funded studies had proindustry abstract conclusions. Both readers and reviewers should scrutinize publications carefully to ensure that data support the authors' conclusions.

  2. Sex differences in left main coronary artery stenting: Different characteristics but similar outcomes for women compared with men.

    PubMed

    Shin, Eun-Seok; Lee, Cheol Whan; Ahn, Jung-Min; Lee, Pil Hyung; Chang, Mineok; Kim, Min-Ju; Yoon, Sung-Han; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Park, Seung-Jung

    2018-02-15

    The clinical outcomes for women compared with men undergoing left main PCI were sparse. We compared the characteristics and long-term outcomes in women versus men after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for unprotected left main CAD. We identified 2328 patients (545 women; 1783 men) with unprotected left main CAD who received PCI with DES between January 2007 and December 2013 in the Interventional Cardiology Research In-cooperation Society-left MAIN revascularization (IRIS-MAIN) registry. The primary outcome was a composite of death from any cause, myocardial infarction, or stroke. The median follow-up time was 2.9years (interquartile range: 1.0-4.1years). Women were older, had a higher incidence of insulin-requiring diabetes mellitus and hypertension, and more commonly presented with acute coronary syndrome than men. Left main ostial lesion was more common in women, whereas left main bifurcation lesion with more extensive CAD was more common in men. The incidence of primary outcome was similar between the two groups (10.8% vs. 10.8%, respectively, log-rank p=0.587). The results were similar after adjustment for baseline variables and consistent across major subgroups. The need for target lesion revascularization was significantly higher in women than in men (8.8% vs. 5.7%, respectively, p<0.05) but the sex bias was not confirmed after adjusting for confounders. Women, as compared to men, had different clinical and lesion characteristics but similar long-term outcomes after PCI with DES for left main CAD. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Melancholic and atypical depression as predictor and moderator of outcome in cognitive behavior therapy and pharmacotherapy for adult depression.

    PubMed

    Cuijpers, Pim; Weitz, Erica; Lamers, Femke; Penninx, Brenda W; Twisk, Jos; DeRubeis, Robert J; Dimidjian, Sona; Dunlop, Boadie W; Jarrett, Robin B; Segal, Zindel V; Hollon, Steven D

    2017-03-01

    Melancholic and atypical depression are widely thought to moderate or predict outcome of pharmacological and psychological treatments of adult depression, but that has not yet been established. This study uses the data from four earlier trials comparing cognitive behavior therapy (CBT) versus antidepressant medications (ADMs; and pill placebo when available) to examine the extent to which melancholic and atypical depression moderate or predict outcome in an "individual patient data" meta-analysis. We conducted a systematic search for studies directly comparing CBT versus ADM, contacted the researchers, integrated the resulting datasets from these studies into one big dataset, and selected the studies that included melancholic or atypical depressive subtyping according to DSM-IV criteria at baseline (n = 4, with 805 patients). After multiple imputation of missing data at posttest, mixed models were used to conduct the main analyses. In none of the analyses was melancholic or atypical depression found to significantly moderate outcome (indicating a better or worse outcome of these patients in CBT compared to ADM; i.e., an interaction), predict outcome independent of treatment group (i.e., a main effect), or predict outcome within a given modality. The outcome differences between patients with melancholia or atypical depression versus those without were consistently very small (all effect sizes g < 0.10). We found no indication that melancholic or atypical depressions are significant or relevant moderators or predictors of outcome of CBT and ADM. © 2016 Wiley Periodicals, Inc.

  4. Global Risk Score and Clinical SYNTAX Score as Predictors of Clinical Outcomes of Patients Undergoing Unprotected Left Main Percutaneous Catheter Intervention

    PubMed Central

    Cuenza, Lucky; Collado, Marianne P.; Ho Khe Sui, James

    2017-01-01

    Background Risk stratification is an important component of left main percutaneous catheter intervention (PCI) which has emerged as a feasible alternative to cardiac surgery. We sought to compare the clinical SYNTAX score and the global risk score in predicting outcomes of patients undergoing unprotected left main PCI in our institution. Methods Clinical, angiographic and procedural characteristics of 92 patients who underwent unprotected left main PCI (mean age 62 ± 12.1 years) were analyzed. Patients were risk stratified into tertiles of high, intermediate and low risk using the global risk score (GRS) and the clinical SYNTAX score (CSS) and were prospectively followed up at 1 year for the occurrence of major adverse cardiovascular events (MACEs), defined as a composite of all cause mortality, cardiac mortality, non-fatal myocardial infarction, stroke, coronary artery bypass, and target vessel revascularization. Results There were 26 (28.2%) who experienced MACEs, of which 10 (10.8%) patients died. Multivariable hazards analysis showed that the GRS (hazard ratio (HR) = 5.5, P = 0.001) and CSS (HR = 4.3, P = 0.001) were both independent predictors of MACEs. Kaplan-Meier analysis showed higher incidence of MACEs with the intermediate and higher risk categories compared to those classified as low risk. Receiver-operator characteristic analysis showed that the GRS has better discriminatory ability than the CSS in the prediction of 1 year MACEs (0.891 vs. 0.743, P = 0.007). Conclusion The GRS and CSS are predictive of outcomes after left main PCI. The GRS appears to have superior predictive and prognostic utility compared to the CSS. This study emphasizes the importance of combining both anatomic and clinical variables for optimum prognostication and management decisions in left main PCI. PMID:29317974

  5. Heart-lung transplantation: pediatric indications and outcomes

    PubMed Central

    2014-01-01

    As indications for heart-lung transplant (HLT) have changed to some degree in the past 30 years, this treatment is being used less frequently in children due to more advanced care of severe heart and lung disease. This is fortunate as the outcomes for HLT are poor compared to other solid organ transplants and this is mainly due to the poorer outcome of the lung graft. PMID:25132980

  6. Lessons from Elsewhere?: Comparative Music Education in Times of Globalization

    ERIC Educational Resources Information Center

    Kertz-Welzel, Alexandra

    2015-01-01

    In recent years, comparative education and comparative music education became important fields of research. Due to globalization, but also to international student assessments, it is most common to compare the outcomes of entire school systems or specific subject areas. The main goal is to identify the most successful systems and their best…

  7. Generalizability of EXCEL and NOBLE results to a large registry population with unprotected left main coronary artery disease.

    PubMed

    Lee, Pil Hyung; Kang, Se Hun; Han, Seungbong; Ahn, Jung-Min; Bae, Jae Seok; Lee, Cheol Hyun; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Lee, Cheol Whan; Park, Seong-Wook; Park, Duk-Woo; Park, Seung-Jung

    2017-12-01

    The aim of this study was to determine how trial-based findings of EXCEL and NOBLE might be interpreted and generalizable in 'real-world' settings with comparison of data from the large-scaled, all-comer Interventional Research Incorporation Society-Left MAIN Revascularization (IRIS-MAIN) registry. We compared baseline clinical and procedural characteristics and also determined how the relative treatment effect of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) was different in EXCEL and NOBLE, compared with those of the multicenter, IRIS-MAIN registry (n=2481). The primary outcome for between-study comparison was a composite of death, myocardial infarction (MI), or stroke. There were between-study differences in patient risk profiles (age, BMI, diabetes, and clinical presentation), lesion complexities, and procedural characteristics (stent type, the use of off-pump surgery, and radial artery); the proportion of diabetes and acute coronary syndrome was particularly lower in NOBLE than in other studies. Although there was interstudy heterogeneity for the protocol definition of MI, the risks for serious composite outcome of death, MI, or stroke were similar between PCI and CABG in EXCEL [hazard ratio (HR): 1.00; 95% confidence interval (CI): 0.79-1.26; P=0.98] and in the matched cohort of IRIS-MAIN (HR: 1.08; 95%CI: 0.85-1.38; P=0.53), whereas it was significantly higher after PCI than after CABG in NOBLE (HR: 1.47; 95%CI: 1.06-2.05; P=0.02), which was driven by more common MI and stroke after PCI. In the comparison of a large-sized, all-comer registry, the EXCEL trial might represent better generalizability with respect to baseline characteristics and observed clinical outcomes compared with the NOBLE trial.

  8. [Patient-reported and patient-weighted outcomes in ophthalmology].

    PubMed

    Scheibler, F; Finger, R P; Grosselfinger, R; Dintsios, C-M

    2010-03-01

    Considering patients' values and preferences in comparative effectiveness research (CER) is one of the main challenges in ophthalmology (value-based medicine). This article defines core terms in CER. The concept of patient-relevant (or patient-important) outcomes is distinguished from patient-reported outcomes (PRO) by means of examples in the field of ophthalmology. In order to be able to give a consistant recommendation if an intervention leads to conflicting results for different outcomes (trade-off), a ranking of outcomes will be necessary. Examples of studies in glaucoma patients are provided that demonstrate the possibilities of ranking of outcomes based on patient preferences.

  9. Significance of off-pump coronary artery bypass grafting compared with percutaneous coronary intervention: a propensity score analysis.

    PubMed

    Marui, Akira; Kimura, Takeshi; Tanaka, Shiro; Furukawa, Yutaka; Kita, Toru; Sakata, Ryuzo

    2012-01-01

    Although there have been several studies that compared the efficacy of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), the impact of off-pump CABG (OPCAB) has not been well elucidated. The objective of the present study was to compare the outcomes after PCI, on-pump CABG (ONCAB), and OPCAB in patients with multivessel and/or left main disease. Among the 9877 patients undergoing first PCI using bare-metal stents or CABG who were enrolled in the CREDO-Kyoto Registry, 6327 patients with multivessel and/or left main disease were enrolled into the present study (67.9±9.8 years old). Among them, 3877 patients received PCI, 1388 ONCAB, and 1069 OPCAB. Median follow-up was 3.5 years. Comparing PCI with all CABG (ONCAB and OPCAB), propensity-score-adjusted all-cause mortality after PCI was higher than that CABG (hazard ratio (95% confidence interval): 1.37 (1.15-1.63), p<0.01). The incidence of stroke was lower after PCI than that after CABG (0.75 (0.59-0.96), p=0.02). CABG was associated with better survival outcomes than PCI in the elderly (interaction p=0.04). Comparing OPCAB with PCI or ONCAB, propensity-score-adjusted all-cause mortality after PCI was higher than that after OPCAB (1.50 (1.20-1.86), p<0.01). Adjusted mortality was similar between ONCAB and OPCAB (1.18 (0.93-1.51), p=0.33). The incidence of stroke after OPCAB was similar to that after PCI (0.98 (0.71-1.34), p>0.99), but incidence of stroke after ONCAB was higher than that after OPCAB (1.59 (1.16-2.18), p<0.01). In patients with multivessel and/or left main disease, CABG, particularly OPCAB, is associated with better survival outcomes than PCI using bare-metal stents. Survival outcomes are similar between ONCAB and OPCAB.

  10. Coronary Artery Bypass Surgery Versus Drug-Eluting Stent Implantation for Left Main or Multivessel Coronary Artery Disease: A Meta-Analysis of Individual Patient Data.

    PubMed

    Lee, Cheol Whan; Ahn, Jung-Min; Cavalcante, Rafael; Sotomi, Yohei; Onuma, Yoshinobu; Suwannasom, Pannipa; Tenekecioglu, Erhan; Yun, Sung-Cheol; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Serruys, Patrick W; Park, Seung-Jung

    2016-12-26

    The authors undertook a patient-level meta-analysis to compare long-term outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in 3,280 patients with left main or multivessel coronary artery disease (CAD). The relative efficacy and safety of CABG versus PCI with DES for left main or multivessel CAD remain controversial. Data were pooled from the BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease), PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery vs. Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trials. The primary outcome was a composite of all-cause death, myocardial infarction, or stroke. The median follow-up was 60 months, and follow-up was completed for 96.2% of patients. The rate of primary outcome was significantly lower with CABG than with PCI (13.0% vs. 16.0%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.69 to 1.00; p = 0.046). The difference was mainly driven by reduction in myocardial infarction (HR: 0.46; 95% CI: 0.33 to 0.64; p < 0.001). There was significant interaction between treatment effect and types of CAD, showing CABG to be superior compared with PCI with DES in patients with multivessel CAD (p = 0.001), but no between-group difference in those with left main CAD (p = 0.427). The rates for all-cause death and stroke were similar between the 2 groups. By contrast, the need for repeat revascularization was significantly lower in the CABG group compared with the PCI group. CABG, as compared with PCI with DES, reduced long-term rates of the composite of all-cause death, myocardial infarction, or stroke in patients with left main or multivessel CAD. The advantage of CABG over PCI with DES was particularly pronounced in those with multivessel CAD. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  11. Prevention of chronic PTSD with early cognitive behavioral therapy. A meta-analysis using mixed-effects modeling.

    PubMed

    Kliem, Sören; Kröger, Christoph

    2013-11-01

    Post-traumatic stress disorder (PTSD) is of great interest to public health, due to the high burden it places on both the individual and society. We meta-analyzed randomized-controlled trials to examine the effectiveness of early trauma-focused cognitive-behavioral treatment (TFCBT) for preventing chronic PTSD. Systematic bibliographic research was undertaken to find relevant literature from on-line databases (Pubmed, PsycINFO, Psyndex, Medline). Using a mixed-effect approach, we calculated effect sizes (ES) for the PTSD diagnoses (main outcome) as well as PTSD and depressive symptoms (secondary outcomes), respectively. Calculations of ES from pre-intervention to first follow-up assessment were based on 10 studies. A moderate effect (ES = 0.54) was found for the main outcome, whereas ES for secondary outcomes were predominantly small (ES = 0.27-0.45). The ES for the main outcome decreased to small (ES = 0.34) from first follow-up to long-term follow-up assessment. The mean dropout rate was 16.7% pre- to post-treatment. There was evidence for the impact of moderators on different outcomes (e.g., the number of sessions on PTSD symptoms). Future studies should include survivors of other trauma types (e.g., burn injuries) rather than predominantly survivors of accidents and physical assault, and should compare early TFCBT with other interventions that previously demonstrated effectiveness. Copyright © 2013 Elsevier Ltd. All rights reserved.

  12. Conducting Configurational Comparative Research with Qualitative Comparative Analysis: A Hands-On Tutorial for Applied Evaluation Scholars and Practitioners

    ERIC Educational Resources Information Center

    Thiem, Alrik

    2017-01-01

    The search for necessary and sufficient causes of some outcome of interest, referred to as "configurational comparative research," has long been one of the main preoccupations of evaluation scholars and practitioners. However, only the last three decades have witnessed the evolution of a set of formal methods that are sufficiently…

  13. Maternal characteristics and birth outcomes of pregnant women who had offspring with congenital ear abnormalities - a population-based case-control study.

    PubMed

    Paput, László; Bánhidy, Ferenc; Czeizel, Andrew E

    2011-09-01

    To describe the maternal characteristics and birth outcomes of newborn infants affected with isolated ear congenital abnormalities (IECA), mainly isolated anotia/microtia and unclassified multiple congenital abnormalities (CAs) including anotia/microtia (UMAM). Cases with IECA and UMAM were compared with their matched controls and all controls without any defect and malformed controls affected with other defects in the population-based large dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities. The mothers of 354 cases with IECA did not show significant difference in age, but their mean birth order was higher while their socio-economic status based on the maternal employment status was lower compared to the figures of their matched controls. There was a male excess among cases with microtia and mainly with UMAM. The evaluation of birth outcomes of newborns affected with IECA indicated intrauterine fetal growth retardation. Newborn infants with isolated microtia had intrauterine growth retardation and the association of this developmental defect localized for a small region of head with the general fetal development raises interesting theoretical question.

  14. Significance of off-pump coronary artery bypass grafting compared with percutaneous coronary intervention: a propensity score analysis

    PubMed Central

    Marui, Akira; Kimura, Takeshi; Tanaka, Shiro; Furukawa, Yutaka; Kita, Toru; Sakata, Ryuzo

    2012-01-01

    OBJECTIVE Although there have been several studies that compared the efficacy of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), the impact of off-pump CABG (OPCAB) has not been well elucidated. The objective of the present study was to compare the outcomes after PCI, on-pump CABG (ONCAB), and OPCAB in patients with multivessel and/or left main disease. METHODS Among the 9877 patients undergoing first PCI using bare-metal stents or CABG who were enrolled in the CREDO-Kyoto Registry, 6327 patients with multivessel and/or left main disease were enrolled into the present study (67.9 ± 9.8 years old). Among them, 3877 patients received PCI, 1388 ONCAB, and 1069 OPCAB. Median follow-up was 3.5 years. RESULTS Comparing PCI with all CABG (ONCAB and OPCAB), propensity-score-adjusted all-cause mortality after PCI was higher than that CABG (hazard ratio (95% confidence interval): 1.37 (1.15–1.63), p < 0.01). The incidence of stroke was lower after PCI than that after CABG (0.75 (0.59–0.96), p = 0.02). CABG was associated with better survival outcomes than PCI in the elderly (interaction p = 0.04). Comparing OPCAB with PCI or ONCAB, propensity-score-adjusted all-cause mortality after PCI was higher than that after OPCAB (1.50 (1.20–1.86), p < 0.01). Adjusted mortality was similar between ONCAB and OPCAB (1.18 (0.93–1.51), p = 0.33). The incidence of stroke after OPCAB was similar to that after PCI (0.98 (0.71–1.34), p > 0.99), but incidence of stroke after ONCAB was higher than that after OPCAB (1.59 (1.16–2.18), p < 0.01). CONCLUSIONS In patients with multivessel and/or left main disease, CABG, particularly OPCAB, is associated with better survival outcomes than PCI using bare-metal stents. Survival outcomes are similar between ONCAB and OPCAB. PMID:21676626

  15. Effect of Heliox on Respiratory Outcomes during Rigid Bronchoscopy in Term Lambs.

    PubMed

    Sowder, Justin C; Dahl, Mar Janna; Zuspan, Kaitlin R; Albertine, Kurt H; Null, Donald M; Barneck, Mitchell D; Grimmer, J Fredrik

    2018-03-01

    Objective To (1) compare physiologic changes during rigid bronchoscopy during spontaneous and mechanical ventilation and (2) evaluate the efficacy of a helium-oxygen (heliox) gas mixture as compared with room air during rigid bronchoscopy. Study Design Crossover animal study evaluating physiologic parameters during rigid bronchoscopy. Outcomes were compared with predicted computational fluid analysis. Setting Simulated ventilation via computational fluid dynamics analysis and term lambs undergoing rigid bronchoscopy. Methods Respiratory and physiologic outcomes were analyzed in a lamb model simulating bronchoscopy during foreign body aspiration to compare heliox with room air. The main outcome measures were blood oxygen saturation, heart rate, blood pressure, partial pressure of oxygen, and partial pressure of carbon dioxide. Computational fluid dynamics analysis was performed with SOLIDWORKS within a rigid pediatric bronchoscope during simulated ventilation comparing heliox with room air. Results For room air, lambs desaturated within 3 minutes during mechanical ventilation versus normal oxygen saturation during spontaneous ventilation ( P = .01). No improvement in respiratory outcomes was seen between heliox and room air during mechanical ventilation. Computational fluid dynamics analysis demonstrates increased turbulence within size 3.5 bronchoscopes when comparing heliox and room air. Meaningful comparisons could not be made due to the intolerance of the lambs to heliox in vivo. Conclusion During mechanical ventilation on room air, lambs desaturate more quickly during rigid bronchoscopy on settings that should be adequate. Heliox does not improve ventilation during rigid bronchoscopy.

  16. Clinical outcomes after estimated versus calculated activity of radioiodine for the treatment of hyperthyroidism: systematic review and meta-analysis.

    PubMed

    de Rooij, A; Vandenbroucke, J P; Smit, J W A; Stokkel, M P M; Dekkers, O M

    2009-11-01

    Despite the long experience with radioiodine for hyperthyroidism, controversy remains regarding the optimal method to determine the activity that is required to achieve long-term euthyroidism. To compare the effect of estimated versus calculated activity of radioiodine in hyperthyroidism. Design Systematic review and meta-analysis. We searched the databases Medline, EMBASE, Web of Science, and Cochrane Library for randomized and nonrandomized studies, comparing the effect of activity estimation methods with dosimetry for hyperthyroidism. The main outcome measure was the frequency of treatment success, defined as persistent euthyroidism after radioiodine treatment at the end of follow-up in the dose estimated and calculated dosimetry group. Furthermore, we assessed the cure rates of hyperthyroidism. Three randomized and five nonrandomized studies, comparing the effect of estimated versus calculated activity of radioiodine on clinical outcomes for the treatment of hyperthyroidism, were included. The weighted mean relative frequency of successful treatment outcome (euthyroidism) was 1.03 (95% confidence interval (CI) 0.91-1.16) for estimated versus calculated activity; the weighted mean relative frequency of cure of hyperthyroidism (eu- or hypothyroidism) was 1.03 (95% CI 0.96-1.10). Subgroup analysis showed a relative frequency of euthyroidism of 1.03 (95% CI 0.84-1.26) for Graves' disease and of 1.05 (95% CI 0.91-1.19) for toxic multinodular goiter. The two main methods used to determine the activity in the treatment of hyperthyroidism with radioiodine, estimated and calculated, resulted in an equally successful treatment outcome. However, the heterogeneity of the included studies is a strong limitation that prevents a definitive conclusion from this meta-analysis.

  17. Economic Evaluation Plan (EEP) for A Very Early Rehabilitation Trial (AVERT): An international trial to compare the costs and cost-effectiveness of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset with usual stroke unit care.

    PubMed

    Sheppard, Lauren; Dewey, Helen; Bernhardt, Julie; Collier, Janice M; Ellery, Fiona; Churilov, Leonid; Tay-Teo, Kiu; Wu, Olivia; Moodie, Marj

    2016-06-01

    A key objective of A Very Early Rehabilitation Trial is to determine if the intervention, very early mobilisation following stroke, is cost-effective. Resource use data were collected to enable an economic evaluation to be undertaken and a plan for the main economic analyses was written prior to the completion of follow up data collection. To report methods used to collect resource use data, pre-specify the main economic evaluation analyses and report other intended exploratory analyses of resource use data. Recruitment to the trial has been completed. A total of 2,104 participants from 56 stroke units across three geographic regions participated in the trial. Resource use data were collected prospectively alongside the trial using standardised tools. The primary economic evaluation method is a cost-effectiveness analysis to compare resource use over 12 months with health outcomes of the intervention measured against a usual care comparator. A cost-utility analysis is also intended. The primary outcome in the cost-effectiveness analysis will be favourable outcome (modified Rankin Scale score 0-2) at 12 months. Cost-utility analysis will use health-related quality of life, reported as quality-adjusted life years gained over a 12 month period, as measured by the modified Rankin Scale and the Assessment of Quality of Life. Outcomes of the economic evaluation analysis will inform the cost-effectiveness of very early mobilisation following stroke when compared to usual care. The exploratory analysis will report patterns of resource use in the first year following stroke. © 2016 World Stroke Organization.

  18. Health and Occupational Outcomes Among Injured, Nonstandard Shift Workers.

    PubMed

    Wong, Imelda S; Smith, Peter M; Mustard, Cameron A; Gignac, Monique A M

    2015-11-01

    This study compares health and occupational outcomes following a work-related injury for nonstandard and day-shift workers. National Population Health Survey data were used to explore outcomes 2 years post-work injury. Retrospective-matched cohort analyses examined main effects and interactions of shift schedule and work injury with changes in health, shift schedule, and labor force status. Models were adjusted for respondent characteristics, baseline health status, and occupational strength requirements. Injured nonstandard shift workers reported lower health utility index scores, compared with uninjured and injured daytime workers and uninjured nonstandard-shift workers. No significant interactions between shift and injury were found with schedule change and leaving the labor force. Injured nonstandard-shift workers are as likely to remain employed as other groups, but may be vulnerable in terms of diminished health.

  19. Impact of Renal Hilar Control on Outcomes of Robotic Partial Nephrectomy: Systematic Review and Cumulative Meta-analysis.

    PubMed

    Cacciamani, Giovanni E; Medina, Luis G; Gill, Tania S; Mendelsohn, Alec; Husain, Fatima; Bhardwaj, Lokesh; Artibani, Walter; Sotelo, Renè; Gill, Inderbir S

    2018-02-05

    During robotic partial nephrectomy (RPN), various techniques of hilar control have been described, including on-clamp, early unclamping, selective/super-selective clamping, and completely-unclamped RPN. To evaluate the impact of various hilar control techniques on perioperative, functional, and oncological outcomes of RPN for tumors. We conducted a systematic literature review and meta-analysis of all comparative studies on various hilar control techniques during RPN using PubMed, Scopus, and Web of Science according to the Preferred Reporting Items for Systematic Review and Meta-analysis statement, and Methods and Guide for Effectiveness and Comparative Effectiveness Review of the Agency for Healthcare Research and Quality. Cumulative meta-analysis of comparative studies was conducted using Review Manager 5.3. Of 987 RPN publications in the literature, 19 qualified for this analysis. Comparison of off-clamp versus on-clamp RPN (n=9), selective clamping versus on-clamp RPN (n=3), super selective clamping versus on-clamp RPN (n=5), and early unclamped versus on-clamp (n=3) were reported. Patients undergoing RPN using off-clamp, selective/super selective, or early unclamp techniques had higher estimated blood loss compared with on-clamp RPN (weight mean difference [WMD]: 47.83, p=0.000, WMD: 41.06, p=0.02, and WMD: 37.50, p=0.47); however, this did not seem clinically relevant, since transfusion rates were similar (odds ratio [OR]: 0.98, p=0.95, OR: 0.72, p=0.7, and OR: 1.36, p=0.33, respectively). All groups appeared similar with regards to hospital stay, transfusions, overall and major complications, and positive cancer margin rates. Short- and long-term renal functional outcomes appeared superior in the off-clamp and super selective clamp groups compared with the on-clamp RPN cohort. Off-clamp, selective/super selective clamp, and early unclamp hilar control techniques are safe and feasible approaches for RPN surgery, with similar perioperative and oncological outcomes compared with on-clamp RPN. Minimizing global renal ischemia may provide superior renal function preservation. However, higher quality data are necessary for definitive conclusions in this regard. The objective of partial nephrectomy is to treat the cancer while maximizing renal function preservation. Clamping the main vessels is done primarily to reduce the blood loss during partial nephrectomy; however, vascular clamping can compromise kidney function. In order to avoid clamping, various techniques have been described. Our analysis showed that techniques that avoid main renal artery clamping during RPN are associated with better renal function preservation, yet deliver non-inferior perioperative and oncological outcomes as compared with robotic partial nephrectomy procedures that clamp the main vessels. Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  20. INTEGRATING EPIDEMIOLOGY AND TOXICOLOGY IN NEUROTOXICITY RISK ASSESSMENT.

    EPA Science Inventory

    This manuscript provides an overview of the use of data from toxicology and epidemiology studies for neurotoxicity risk assessment. Parameters such as the use of subjects, study designs, exposures, and measured outcomes are compared and contrasted. The main concern for use of d...

  1. Young Adult Outcomes of Children Growing up with Chronic Illness: An analysis of the National Longitudinal Study of Adolescent Health

    PubMed Central

    Maslow, Gary R.; Haydon, Abigail; Ford, Carol Ann; Halpern, Carolyn Tucker

    2012-01-01

    Objective To examine young adult outcomes in a nationally representative US cohort of young adults who grew up with a chronic illness. Design Secondary analysis of nationally representative data from Wave III (2001) of the National Longitudinal Study of Adolescent Health. Setting United States Participants The analytic sample included 13,236 young adults 18–28 years old at Wave III. Main Exposure Self-report of a chronic physical illness (asthma, cancer, diabetes or epilepsy) in adolescence. Respondents with (1) asthma or (2) non-asthma chronic illness (cancer, diabetes, or epilepsy) were compared to subjects without these conditions. Main Outcome Measures Self-report of high school graduation, ever having a job, having a current job, living with parents, and ever receiving public assistance. Results Three percent of young adults had non-asthma chronic illness (cancer, diabetes, or epilepsy) and 16% had asthma. The majority of young adults with chronic illness graduated high school (81%) and were currently employed (60%). However, compared to healthy young adults, those with a non-asthma chronic illness were significantly less likely to graduate high school, ever have a job, or have a current job and were more likely to receive public assistance. When compared to young adults with asthma, young adults with non-asthma chronic illness again had significantly worse young adult outcomes on all measures. Conclusions Most young adults growing up with chronic illness graduate high school and are employed. However, these young adults are significantly less likely than their healthy peers to achieve these important educational and vocational milestones. PMID:21383274

  2. Peripheral Distribution of Thrombus Does Not Affect Outcomes After Surgical Pulmonary Embolectomy.

    PubMed

    Pasrija, Chetan; Shah, Aakash; George, Praveen; Mohammed, Isa; Brigante, Francis A; Ghoreishi, Mehrdad; Jeudy, Jean; Taylor, Bradley S; Gammie, James S; Griffith, Bartley P; Kon, Zachary N

    2018-04-04

    Thrombus located distal to the main or primary pulmonary arteries has been previously viewed as a relative contraindication to surgical pulmonary embolectomy. We compared outcomes for surgical pulmonary embolectomy for submassive and massive pulmonary embolism (PE) in patients with central versus peripheral thrombus burden. All consecutive patients (2011-2016) undergoing surgical pulmonary embolectomy at a single center were retrospectively reviewed. Based on computed tomographic angiography of each patient, central PE was defined as any thrombus originating within the lateral pericardial borders (main or right/left pulmonary arteries). Peripheral PE was defined as thrombus exclusively beyond the lateral pericardial borders, involving the lobar pulmonary arteries or distal. The primary outcome was in-hospital and 90-day survival. 70 patients were identified: 52 (74%) with central PE and 18 (26%) with peripheral PE. Preoperative vital signs and right ventricular dysfunction were similar between the two groups. Compared to the central PE cohort, operative time was significantly longer in the peripheral PE group (191 vs. 210 minutes, p<0.005)). Median right ventricular dysfunction decreased from moderate dysfunction preoperatively to no dysfunction at discharge in both groups. Overall 90-day survival was 94%, with 100% survival in patients with submassive PE in both cohorts. This single center experience demonstrates excellent overall outcomes for surgical pulmonary embolectomy with resolution of right ventricular dysfunction, and comparable morbidity and mortality for central and peripheral PE. In an experienced center and when physiologically warranted, surgical pulmonary embolectomy for peripheral distribution of thrombus is both technically feasible and effective. Copyright © 2018. Published by Elsevier Inc.

  3. Differential reward responses during competition against in- and out-of-network others.

    PubMed

    Fareri, Dominic S; Delgado, Mauricio R

    2014-04-01

    Social interactions occur within a variety of different contexts--cooperative/competitive--and often involve members of our social network. Here, we investigated whether social network modulated the value placed on positive outcomes during a competitive context. Eighteen human participants played a simple card-guessing game with three different competitors: a close friend (in-network), a confederate (out-of-network) and a random number generator (non-social condition) while undergoing functional magnetic resonance imaging. Neuroimaging results at the time of outcome receipt demonstrated a significant main effect of competitor across multiple regions of medial prefrontal cortex, with Blood Oxygen Level Dependent (BOLD) responses strongest when competing against one's friend compared with all other conditions. Striatal BOLD responses demonstrated a more general sensitivity to positive compared with negative monetary outcomes, which an exploratory analysis revealed to be stronger when interacting with social, compared with non-social, competitors. Interestingly, a Granger causality analysis indicated directed influences sent from an medial prefrontal cortex (mPFC) region, which shows social network differentiation of outcomes, and the ventral striatum bilaterally. Our results suggest that when competing against others of varying degrees of social network, mPFC differentially values these outcomes, perhaps treating in-network outcomes as more informative, leaving the striatum to more general value computations.

  4. Differential reward responses during competition against in- and out-of-network others

    PubMed Central

    Fareri, Dominic S.

    2014-01-01

    Social interactions occur within a variety of different contexts––cooperative/competitive––and often involve members of our social network. Here, we investigated whether social network modulated the value placed on positive outcomes during a competitive context. Eighteen human participants played a simple card-guessing game with three different competitors: a close friend (in-network), a confederate (out-of-network) and a random number generator (non-social condition) while undergoing functional magnetic resonance imaging. Neuroimaging results at the time of outcome receipt demonstrated a significant main effect of competitor across multiple regions of medial prefrontal cortex, with Blood Oxygen Level Dependent (BOLD) responses strongest when competing against one’s friend compared with all other conditions. Striatal BOLD responses demonstrated a more general sensitivity to positive compared with negative monetary outcomes, which an exploratory analysis revealed to be stronger when interacting with social, compared with non-social, competitors. Interestingly, a Granger causality analysis indicated directed influences sent from an medial prefrontal cortex (mPFC) region, which shows social network differentiation of outcomes, and the ventral striatum bilaterally. Our results suggest that when competing against others of varying degrees of social network, mPFC differentially values these outcomes, perhaps treating in-network outcomes as more informative, leaving the striatum to more general value computations. PMID:23314007

  5. Investigations of Crashes Involving Pregnant Occupants

    PubMed Central

    Klinich, Kathleen DeSantis; Schneider, Lawrence W.; Moore, Jamie L.; Pearlman, Mark D.

    2000-01-01

    Case reports of 16 crashes involving pregnant occupants are presented that illustrate the main conclusions of a crash-investigation program that includes 42 crashes investigated to date. Some unusual cases that are exceptions to the overall trends are also described. The study indicates a strong association between adverse fetal outcome and both crash severity and maternal injury. Proper restraint use, with and without airbag deployment, generally leads to acceptable fetal outcomes in lower severity crashes, while it does not affect fetal outcome in high-severity crashes. Compared to properly restrained pregnant occupants, improperly restrained occupants have a higher risk of adverse fetal outcome in lower severity crashes, which comprise the majority of all motor-vehicle collisions. PMID:11558095

  6. Relations and effects of transformational leadership: a comparative analysis with traditional leadership styles.

    PubMed

    Molero, Fernando; Cuadrado, Isabel; Navas, Marisol; Morales, J Francisco

    2007-11-01

    This study has two main goals: (a) to compare the relationship between transformational leadership and other important leadership styles (i.e., democratic versus autocratic or relations- and task-oriented leadership) and (b) to compare the effects of transformational leadership and the other styles on some important organizational outcomes such as employees' satisfaction and performance. For this purpose, a sample of 147 participants, working in 35 various work-teams, was used. Results show high correlations between transformational leadership, relations-oriented, democratic, and task-oriented leadership. On the other hand, according to the literature, transformational leadership, especially high levels, significantly increases the percentage of variance accounted for by other leadership styles in relevant organizational outcome variables (subordinates' performance, satisfaction and extra effort).

  7. A retrospective study of viral central nervous system infections: relationship amongst aetiology, clinical course and outcome.

    PubMed

    Calleri, Guido; Libanore, Valentina; Corcione, Silvia; De Rosa, Francesco G; Caramello, Pietro

    2017-04-01

    To describe the clinical pattern of viral central nervous system (CNS) infections and compare meningitis and encephalitis. This is a retrospective study reporting the clinical characteristics and outcome of 138 cases of viral meningitis and meningoencephalitis in a real life experience at a referral centre in Turin, Northern Italy. Enteroviruses were predominant in younger patients who were mainly presenting with signs of meningitis, had shorter hospital admission and absence of complications, whereas herpesviruses had more often signs of encephalitis, were more frequent in elderly patients, had longer hospital admission and frequent complications and sequelae. Two main clinical entities with different epidemiology, clinical aspects and prognosis may be identified within the group of viral CNS inefctions.

  8. Outcome of Assisted Reproductive Technology (ART) and Subsequent Self-Reported Life Satisfaction

    PubMed Central

    Kuivasaari-Pirinen, Paula; Koivumaa-Honkanen, Heli; Hippeläinen, Maritta; Raatikainen, Kaisa; Heinonen, Seppo

    2014-01-01

    Objective To compare life satisfaction between women with successful or unsuccessful outcome after assisted reproductive treatment (ART) by taking into account the time since the last ART. Design Cohort study. Setting Tertiary hospital. Patients A total of 987 consecutive women who had undergone ART during 1996–2007 were invited and altogether 505 women participated in the study. Interventions A postal enquiry with a life satisfaction scale. Main Outcome Measure Self-reported life satisfaction in respect to the time since the last ART. Results In general, women who achieved a live birth after ART had a significantly higher life satisfaction than those who had unsuccessful ART, especially when compared in the first three years. The difference disappeared in the time period of 6–9 years after ART. The unsuccessfully treated women who had a child by some other means before or after the unsuccessful ART had comparable life satisfaction with successfully treated women even earlier. Conclusions Even if unsuccessful ART outcome is associated with subsequent lower level of life satisfaction, it does not seem to threaten the long-term wellbeing. PMID:25393846

  9. Bifurcation Culprit Lesions in ST-segment Elevation Myocardial Infarction: Procedural Success and 5-year Outcome Compared With Nonbifurcation Lesions.

    PubMed

    Salinas, Pablo; Mejía-Rentería, Hernán; Herrera-Nogueira, Raúl; Jiménez-Quevedo, Pilar; Nombela-Franco, Luis; Núñez-Gil, Iván Javier; Gonzalo, Nieves; Del Trigo, María; Pérez-Vizcayno, María José; Quirós, Alicia; Escaned, Javier; Macaya, Carlos; Fernández-Ortiz, Antonio

    2017-08-09

    We assessed short- and long-term outcomes of primary angioplasty in ST-segment elevation myocardial infarction by comparing bifurcation culprit lesions (BCL) with non-BCL. Observational study with a propensity score matched control group. Among 2746 consecutive ST-segment elevation myocardial infarction patients, we found 274 (10%) patients with BCL. The primary outcome was a composite endpoint including all-cause death, myocardial infarction, coronary artery bypass grafting or target vessel revascularization, assessed at 30-days and 5-years. Baseline characteristics showed no differences after propensity matching (1:1). In the BCL group, the most frequent strategy was provisional stenting of the main branch (84%). Compared with the non-BCL group, the procedures were technically more complex in the BCL group in terms of need for balloon dilatation (71% BCL vs 59% non-BCL; P = .003), longer procedural time (70 ± 29minutes BCL vs 62.8 ± 28.9minutes non-BCL; P = .004) and contrast use (256.2 ± 87.9mL BCL vs 221.1 ± 82.3mL non-BCL; P < .001). Main branch angiographic success was similar (93.4% BCL vs 93.8% non-BCL; P = .86). Thirty-day all-cause mortality was similar between groups: 4.7% BCL vs 5.1% non-BCL; P = .84. At the 5-year follow-up, there were no differences in all-cause death (12% BCL vs 13% non-BCL; P = .95) or the combined event (22% BCL vs 21% non-BCL; P = .43). Primary angioplasty of a BCL was technically more complex; however, main branch angiographic success was similar, and there were no differences in long-term prognosis compared with non-BCL patients. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  10. Plant-based ointments versus usual care in the management of chronic skin diseases: a comparative analysis on outcome and safety.

    PubMed

    Jong, Miek C; Ermuth, Ulrike; Augustin, Matthias

    2013-10-01

    To assess the outcome and safety of plant-based ointments versus usual care in the management of chronic skin diseases. Prospective mono-centric comparative analysis. Patients were recruited at an outpatient dermatology clinic and treated with plant-based ointments or care as usual. Main outcome criterion was the response rate, defined as the proportion of patients experiencing 'complete recovery' or 'major improvement' at 6, 12 and 24 months. Secondary outcome criteria were quality of life (SF-12 and EQ-5D), patient satisfaction and safety of treatment. A total of 112 patients with chronic skin diseases were evaluated of which 44 were treated with plant-based ointments (PO) and 68 received usual care (UC). The majority of patients suffered from psoriasis (PO: 50%; UC: 56%) or eczema (PO: 41%; UC: 32%) and were treated with homoeopathic topical ointments containing mahonia or cardiospermum or usual care creams containing calcipotriene and corticosteroids. The only significant difference in baseline status between the two groups was in disease severity score (PO: 1.8±0.7 versus UC: 2.4±0.8, p=0.0004). After two years, the main outcome of responders to treatment was 52.3% (95%-CI: 36.1-64.9) in the ointment and 41.2% (95%-CI: 20.4-42.2) in the UC group. Change in SF-12 (2 years compared to baseline), adjusted for baseline disease severity, was not significantly different between both groups; PO: 5.4 (95%-CI: 3.4-7.3) versus UC: 3.2 (95%-CI: 1.5-4.9). The adjusted EQ-5D was found to be significantly different between the two groups after two years, in favour of the ointment group; PO: 0.113 (95%-CI: 0.052-0.174) and UC: -0.008 (95%-CI: -0.055-0.038). Other secondary outcome parameters such as patient satisfaction and number of adverse drug reactions were comparable. The outcome of this study suggests at least therapeutic equivalence between plant-based ointments and usual care management of chronic skin diseases. As this non-randomised study was open to selection and other bias, further rigorous studies are needed to demonstrate the effectiveness of these topical products. Copyright © 2013 Elsevier Ltd. All rights reserved.

  11. Prediction of antiepileptic drug treatment outcomes using machine learning

    NASA Astrophysics Data System (ADS)

    Colic, Sinisa; Wither, Robert G.; Lang, Min; Zhang, Liang; Eubanks, James H.; Bardakjian, Berj L.

    2017-02-01

    Objective. Antiepileptic drug (AED) treatments produce inconsistent outcomes, often necessitating patients to go through several drug trials until a successful treatment can be found. This study proposes the use of machine learning techniques to predict epilepsy treatment outcomes of commonly used AEDs. Approach. Machine learning algorithms were trained and evaluated using features obtained from intracranial electroencephalogram (iEEG) recordings of the epileptiform discharges observed in Mecp2-deficient mouse model of the Rett Syndrome. Previous work have linked the presence of cross-frequency coupling (I CFC) of the delta (2-5 Hz) rhythm with the fast ripple (400-600 Hz) rhythm in epileptiform discharges. Using the I CFC to label post-treatment outcomes we compared support vector machines (SVMs) and random forest (RF) machine learning classifiers for providing likelihood scores of successful treatment outcomes. Main results. (a) There was heterogeneity in AED treatment outcomes, (b) machine learning techniques could be used to rank the efficacy of AEDs by estimating likelihood scores for successful treatment outcome, (c) I CFC features yielded the most effective a priori identification of appropriate AED treatment, and (d) both classifiers performed comparably. Significance. Machine learning approaches yielded predictions of successful drug treatment outcomes which in turn could reduce the burdens of drug trials and lead to substantial improvements in patient quality of life.

  12. A comparative analysis of the outcomes of aortic cuffs and converters for endovascular graft migration.

    PubMed

    Thomas, Bradley G; Sanchez, Luis A; Geraghty, Patrick J; Rubin, Brian G; Money, Samuel R; Sicard, Gregorio A

    2010-06-01

    Proximal attachment failure, often leading to graft migration, is a severe complication of endovascular aneurysm repair (EVAR). Aortic cuffs have been used to treat proximal attachment failure with mixed results. The Zenith Renu AAA Ancillary Graft (Cook Inc, Bloomington, Ind) is available in two configurations: converter and main body extension. Both provide proximal extension with active fixation for the treatment of pre-existing endovascular grafts with failed or failing proximal fixation or seal in patients who are not surgical candidates. We prospectively compared the outcomes of patient treatment with these two device configurations. From September 2005 to May 2008, a prospective, nonrandomized, postmarket registry was conducted to collect data from 151 patients treated at 95 institutions for proximal aortic endovascular graft failure using the Renu graft. Treatment indications included inadequate proximal fixation or seal, for example, migration, and type I and III endoleak. A total of 136 patients (90%) had migration, 111 (74%) had endoleak, and 94 (62%) had endoleaks and graft migration. AneuRx grafts were present in 126 patients (83%), of which 89 (59%) were treated with a converter and 62 (41%) with a main body extension. Outcomes using converters vs main body extensions for endoleak rates, changes in aneurysm size, and ruptures were compared. Preprocedural demographics between the two groups did not differ significantly. Procedural success rates were 98% for the converter group and 100% for the main body extension group. At a mean follow-up of 12.8 +/- 7.5 months, no type III endoleaks (0%)were identified in the converter group, and five (8%) were identified in the main body extension group. There were no aneurysm ruptures in patients treated with converters (0%) and three ruptures (5%) in patients treated with main body extensions. Each patient with aneurysm rupture had been treated with a Renu main body extension, developed a type III endoleak, and underwent surgical conversion. Two of the three patients died postoperatively. Proximal attachment failure and graft migration are potentially lethal complications of EVAR. Proximal graft extension using an aortic cuff is the easiest technique for salvaging an endovascular graft. Unfortunately, it has a predictable failure mode (development of a type III endoleak due to component separation) and is associated with a significantly higher failure rate than with the use of a converter. EVAR salvage with a converter and a femorofemoral bypass is a more complex but superior option for endovascular graft salvage. Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

  13. A Comparative Study of Data Mining Techniques on Football Match Prediction

    NASA Astrophysics Data System (ADS)

    Rosli, Che Mohamad Firdaus Che Mohd; Zainuri Saringat, Mohd; Razali, Nazim; Mustapha, Aida

    2018-05-01

    Data prediction have become a trend in today’s business or organization. This paper is set to predict match outcomes for association football from the perspective of football club managers and coaches. This paper explored different data mining techniques used for predicting the match outcomes where the target class is win, draw and lose. The main objective of this research is to find the most accurate data mining technique that fits the nature of football data. The techniques tested are Decision Trees, Neural Networks, Bayesian Network, and k-Nearest Neighbors. The results from the comparative experiments showed that Decision Trees produced the highest average prediction accuracy in the domain of football match prediction by 99.56%.

  14. Binocular function to increase visual outcome in patients implanted with a diffractive trifocal intraocular lens.

    PubMed

    Kretz, Florian T A; Müller, Matthias; Gerl, Matthias; Gerl, Ralf H; Auffarth, Gerd U

    2015-08-21

    To evaluate binocular visual outcome for near, intermediate and distance compared to monocular visual outcome at the same distances in patients implanted with a diffractive trifocal intraocular lens (IOL). The study comprised of 100 eyes of 50 patients that underwent bilateral refractive lens exchange or cataract surgery with implantation of a multifocal diffractive IOL (AT LISA tri 839MP, Carl Zeiss Meditech, Germany). A complete ophthalmological examination was performed preoperatively and 3 month postoperatively. The main outcome measures were monocular and binocular uncorrected distance (UDVA), corrected distance (CDVA), uncorrected intermediate (UIVA), and uncorrected near visual acuities (UNVA), keratometry, and manifest refraction. The mean age was 59.28 years ± 9.6 [SD] (range 44-79 years), repectively. There was significant improvement in UDVA, UIVA, UNVA and CDVA. Comparing the monocular results to the binocular results there was a statistical significant better binocular outcome in all distances (UDVA p = 0.036; UIVA p < 0.0001; UNVA p = 0.001). The postoperative manifest refraction was in 86 % of patients within ± 0.50 [D]. The trifocal IOL improved near, intermediate, and distance vision compared to preoperatively. In addition a statistical significant increase for binocular visual function in all distances could be found. German Clinical Trials Register (DRKS) DRKS00007837.

  15. A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study.

    PubMed

    Buller, Harry R; Lensing, Anthonie W A; Prins, Martin H; Agnelli, Giancarlo; Cohen, Alexander; Gallus, Alexander S; Misselwitz, Frank; Raskob, Gary; Schellong, Sebastian; Segers, Annelise

    2008-09-15

    We performed a randomized dose-ranging study, double-blind for rivaroxaban doses and open-label for the comparator (low-molecular-weight heparin followed by vitamin K antagonists) to assess the optimal dose of rivaroxaban for the treatment of deep vein thrombosis. A total of 543 patients with acute deep-venous thrombosis received rivaroxaban 20, 30, or 40 mg once daily or comparator. Treatment lasted for 84 days. The primary efficacy outcome was the 3-month incidence of the composite of symptomatic venous thromboembolic complications and asymptomatic deterioration in thrombotic burden as assessed by comparison of ultrasound and perfusion lung scanning at day 84 with baseline. The main safety outcome was the composite of major bleeding and clinically relevant nonmajor bleeding. A total of 449 (83%) of the 543 patients could be included in the per-protocol population. The primary efficacy outcome occurred in 6.1%, 5.4%, and 6.6% of the rivaroxaban 20-, 30-, and 40-mg treatment groups, respectively, and in 9.9% of those receiving standard therapy. The main safety outcome occurred in 5.9%, 6.0%, and 2.2% of the rivaroxaban 20-, 30-, and 40-mg treatment groups, respectively, and in 8.8% of those receiving standard therapy. These results with simple fixed-dose oral regimens justify phase 3 evaluations (www.ClinicalTrials.gov no.NCT00395772).

  16. Impact of 10% SF6 Gas Compared to 100% Air Tamponade in Descemet's Membrane Endothelial Keratoplasty.

    PubMed

    Rickmann, Annekatrin; Szurman, Peter; Jung, Sacha; Boden, Karl Thomas; Wahl, Silke; Haus, Arno; Boden, Katrin; Januschowski, Kai

    2018-04-01

    To compare the clinical outcomes following Descemet's membrane endothelial keratoplasty (DMEK) with 100% air tamponade versus 10% sulfur hexafluoride (SF 6 ) tamponade. Retrospective analysis of 108 consecutive DMEK cases subdivided by anterior chamber tamponade with 54 eyes receiving 10% SF 6 and 54 eyes receiving 100% air injection. A post-hoc matched analysis revealed no statistically significant differences between the groups. The main outcome measurements were the complication rate, including intra- and postoperative complications and graft detachment rate requiring re-bubbling. Clinical outcome included best-corrected visual acuity (BCVA), endothelial cell count (ECC), and central corneal thickness (CCT) measured 1, 3, and 6 months after DMEK surgery. The graft detachment rate with consecutive re-bubbling was 18.5% in the air group and 22.2% in the SF 6 group (p = 0.2). Remaining small peripheral graft detachments with a clear cornea occurred more often in the 100% air group (air: 22.2%; 12/54, 6/12 inferior compared to SF 6 : 7.4%; 4/54, 2/4 inferior; p = 0.06). The primary graft failure rate was comparable between the two groups. No complete graft detachment occurred. Outcome results for BCVA, ECC, and CCT at all follow-up time points were comparable between the two groups. The clinical outcomes (including re-bubbling rate, primary graft failure rate, and endothelial cell loss) were comparable with 100% air versus 10% SF 6 tamponade, whereas other studies suggest that a higher SF 6 concentration (20%) may result in a lower re-bubbling rate.

  17. Comparison of Complications and Surgical Outcomes of Adolescent Idiopathic Scoliosis Between Junior Attending Surgeons and Senior Attending Surgeons.

    PubMed

    Qiao, Jun; Xiao, Lingyan; Xu, Leilei; Shi, Benlong; Qian, Bangping; Zhu, Zezhang; Qiu, Yong

    2018-04-24

    To our knowledge, few studies have compared complications and surgical outcomes of adolescent idiopathic scoliosis (AIS) between junior attending surgeons and senior attending surgeons. To compare surgical strategies, complications, and outcomes of posterior corrective surgery for AIS between junior attending surgeons and senior attending surgeons. According to experience level of operation surgeons, the patients were assigned to 2 groups. Group A was the "junior surgeon" group. Group B was the "senior surgeon" group. The following parameters were compared between the 2 groups: age, sex, diagnosis, hospital of record, surgeon experience level, type of instrumentation, type of screws, estimated blood loss, duration of surgery, length of fusion, correction techniques, main curve correction, and thoracic kyphosis correction. A total of 132 patients with AIS were included in group A, whereas 207 were in group B. The translational technique was used more often in group A (P < 0.05). whereas the derotation technique was used more often in group B (P < 0.05). Senior surgeons used more monoaxial screws than junior surgeons (P < 0.05). The junior group had significantly greater estimated blood loss than the senior group (P < 0.05). The senior group had significant better correction rates of severe main curve (>70°) and thoracic kyphosis than the junior group (P < 0.05). Senior attending surgeons outperformed junior surgeons in blood loss control, thoracic kyphosis correction, and correction of severe curves. Copyright © 2018 Elsevier Inc. All rights reserved.

  18. Quality of care for patients with type 2 diabetes mellitus in the Netherlands and the United States: a comparison of two quality improvement programs.

    PubMed

    Valk, Gerlof D; Renders, Carry M; Kriegsman, Didi M W; Newton, Katherine M; Twisk, Jos W R; van Eijk, Jacques Th M; van der Wal, Gerrit; Wagner, Edward H

    2004-08-01

    To assess differences in diabetes care and patient outcomes by comparing two multifaceted quality improvement programs in two different countries, and to increase knowledge of effective elements of such programs. Primary care in the ExtraMural Clinic (EMC) of the Department of General Practice of the Vrije Universiteit in Amsterdam, the Netherlands, and the Group Health Cooperative (GHC), a group-model health maintenance organization (HMO) in western Washington State in the United States. Data were collected from 1992 to 1997. In this observational study two diabetes cohorts in which a quality improvement program was implemented were compared. Both programs included a medical record system, clinical practice guidelines, physician educational meetings, audit, and feedback. Only the Dutch program (EMC) included guidelines on the structure of diabetes care and a recall system. Only the GHC program included educational outreach visits, formation of multidisciplinary teams, and patient self-management support. Included were 379 EMC patients, and 2,119 GHC patients with type 2 diabetes mellitus. Main process outcomes were: annual number of diabetes visits, and number of HbA1c and blood lipid measurements. Main patient outcomes were HbA1c and blood lipid levels. Multilevel analysis was used to adjust for dependency between repeated observations within one patient and for clustering of patients within general practices. In the EMC process outcomes and glycemic control improved more than at GHC, however, GHC had better baseline measures. There were no differences between programs on blood lipid control. During follow-up, intensification of pharmacotherapy was noted at both sites. Differences noted between programs were in line with differences in diabetes guidelines. Following implementation of guidelines and organizational improvement efforts, change occurred primarily in the process outcomes, rather than in the patient outcomes. Although much effort was put into improving process and patient outcomes, both complex programs still showed only moderate effects.

  19. Hepatocellular carcinoma with main portal vein tumor thrombus: a comparative study comparing hepatectomy with or without neoadjuvant radiotherapy.

    PubMed

    Li, Nan; Feng, Shuang; Xue, Jie; Wei, Xu-Biao; Shi, Jie; Guo, Wei-Xing; Lau, Wan-Yee; Wu, Meng-Chao; Cheng, Shu-Qun; Meng, Yan

    2016-06-01

    Hepatocellular carcinoma (HCC) with main portal vein tumor thrombus (mPVTT) has a poor prognosis even after surgical resection. Whether neoadjuvant radiotherapy improves surgical outcomes is currently unknown. The aim of this study was to compare the survival of patients with resectable HCC and mPVTT who underwent neoadjuvant therapy to those who underwent surgery alone. A non-randomized comparative study was performed. For patients in the neoadjuvant radiotherapy group, three-dimensional conformal radiotherapy was administrated with a daily fraction of 300 cGy in 6 consecutive days. Hepatectomy was carried out 4 weeks after completion of irradiation. 95 patients were enrolled into this study. In the neoadjuvant radiotherapy group (n = 45), 12 patients showed gross radiological reduction in extent of PVTT. In 6 patients, the extent of PVTT was reduced to be within the ipsilateral side of the portal vein. When compared with patients who underwent surgery alone (n = 50), neoadjuvant radiotherapy significantly decreased the rates of HCC recurrence and HCC-related death, with hazard ratios of 0.36 (95% CI, 0.19-0.70) and 0.32 (95% CI, 0.18-0.57), respectively. For patients with HCC with mPVTT, neoadjuvant radiotherapy before partial hepatectomy provided better postoperative survival outcomes than partial hepatectomy alone. Copyright © 2016 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.

  20. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review

    PubMed Central

    Wang, Bo

    2015-01-01

    Objective To characterize the types of comparators and endpoints used in efficacy trials for approvals of supplemental indications, compared with the data supporting these drugs’ originally approved indications. Design Systematic review. Setting Publicly accessible data on supplemental indications approved by the US Food and Drug Administration from 2005 to 2014. Main outcome measures Types of comparators (active, placebo, historical, none) and endpoints (clinical outcomes, clinical scales, surrogate) in the efficacy trials for these drugs’ supplemental and original indication approvals. Results The cohort included 295 supplemental indications. Thirty per cent (41/136) of supplemental approvals for new indications were supported by efficacy trials with active comparators, compared with 51% (47/93) of modified use approvals and 11% (7/65) of approvals expanding the patient population (P<0.001), almost all of which related to pediatric patients (61/65; 94%). Trials using clinical outcome endpoints led to approval for 32% (44/137) of supplemental approvals for new indications, 30% (28/93) of modified indication approvals, and 22% (14/65) of expanded population approvals (P=0.29). Orphan drugs had supplemental approvals for 40 non-orphan indications, which were supported by similar proportions of trials using active comparators (28% (11/40) for non-orphan supplemental indications versus 24% (10/42) for original orphan indications; P=0.70) and clinical outcome endpoints (25% (10/40) versus 31% (13/42); P=0.55). Conclusions Wide variations were seen in the evidence supporting approval of supplemental indications, with the fewest active comparators and clinical outcome endpoints used in trials leading to supplemental approvals that expanded the patient population. PMID:26400844

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

    PubMed Central

    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

  2. Is β-blocker (atenolol) a preferred antihypertensive in acute intracerebral hemorrhage?

    PubMed

    Kalita, Jayantee; Misra, Usha Kant; Kumar, Bishwanath

    2013-07-01

    The mortality in intracerebral hemorrhage (ICH) is mainly due to raised intracranial pressure, and its complications mediated by sympathetic overactivity. There is paucity of studies evaluating the role of β-blockers in the outcome of ICH. This study reports the role of atenolol in reducing mortality, pneumonia, systemic inflammatory response syndrome (SIRS), and 3 months outcome in the patients with hypertensive ICH. 138 consecutive patients with hypertensive ICH were included and their stroke risk factors and clinical details were recorded. Consciousness was assessed by Glasgow Coma Scale and severity of stroke by Canadian Neurological Scale. Volume of hematoma was measures on CT scan and occurrence of SIRS and pneumonia were noted. 3 months outcome was categorized into good (Barthel index >12) and poor (BI < 12). The patients were categorized into those receiving atenolol and nonatenolol. The effects of atenolol on stroke outcome parameters were evaluated. Seventy-nine patients received atenolol and 59 did not and they mainly received amlodipine. There was no difference in the base line clinical characteristics between the two groups except smoking (P = 0.01) and baseline blood pressure (P = 0.007). Atenolol significantly reduced the mortality (11.4 vs 37.3 %, P < 0.0001), SIRS (16.4 vs 40.9 %, P = 0.007), and pneumonia (8.9 vs 30.5 %, P = 0.002) compared to those not receiving atenolol. At 3 months, patients with atenolol had insignificantly better outcome compared to nonatenolol group (49.1 vs 31.9 %, P = 0.11). Use of atenolol in hypertensive ICH results in reduction in mortality, SIRS, and pneumonia which may be due to its β-adrenergic blocking effect.

  3. Monitoring Educational Performance in the Caribbean. World Bank Working Paper.

    ERIC Educational Resources Information Center

    di Gropello, Emanuela

    This study represents a first attempt at providing a comprehensive quantification of educational outcomes in the Caribbean region. Its main objectives are: (1) to define a set of operationally relevant education indicators; (2) to provide a database of comparable education indicators in Caribbean countries where data is available, namely Belize,…

  4. Attributions of responsibility and affective reactions to decision outcomes.

    PubMed

    Zeelenberg, M; van der Pligt, J; de Vries, N K

    2000-06-01

    Immediate affective reactions to outcomes are more intense following decisions to act than following decisions not to act. This finding holds for both positive and negative outcomes. We relate this "actor-effect" to attribution theory and argue that decision makers are seen as more responsible for outcomes when these are the result of a decision to act as compared to a decision not to act. Experiment 1 (N = 80) tests the main assumption underlying our reasoning and shows that affective reactions to decision outcomes are indeed more intense when the decision maker is seen as more responsible. Experiment 2 (N = 40) tests whether the actor effect can be predicted on the basis of differential attributions following action and inaction. Participants read vignettes in which active and passive actors obtained a positive or negative outcome. Action resulted in more intense affect than inaction, and positive outcomes resulted in more intense affect than negative outcomes. Experiment 2 further shows that responsibility attributions and affective reactions to outcomes are highly correlated; that is, more extreme affective reactions are associated with more internal attributions. We discuss the implications for research on post-decisional reactions.

  5. Simple repair approach for mitral regurgitation in Barlow disease.

    PubMed

    Ben Zekry, Sagit; Spiegelstein, Dan; Sternik, Leonid; Lev, Innon; Kogan, Alexander; Kuperstein, Rafael; Raanani, Ehud

    2015-11-01

    Mitral valve repair for myxomatous Barlow disease is a challenging procedure requiring complex surgery with less than optimal results. The use of ring-only repair has been previously reported but never analyzed or followed-up. We investigated this simple valve repair approach for patients with Barlow disease and multisegment involvement causing mainly central jet. Of 572 patients who underwent mitral valve repair for mitral regurgitation at our medical center, 24 with Barlow disease (aged 47 ± 14 years; 46% male) underwent ring-only repair. Patients were characterized by severely enlarged mitral valve annulus, multisegment prolapse involving both leaflets, and demonstrated mainly a central wide regurgitant jet. Surgical technique included only the implantation of a large mitral annuloplasty ring. Early and late outcome results were compared with those of the remaining patients who underwent conventional mitral valve repair for degenerative disease (controls). All ring-only patients presented with moderate-severe/severe mitral regurgitation (vena contracta, 0.6 ± 0.1 cm; regurgitation volume, 52 ± 17 mL), with mainly a central jet and almost preserved ejection fraction (59% ± 6%). Cardiopulmonary bypass and crossclamp times were significantly shorter compared with controls (P < .0001). At follow-up (ring-only, 38 ± 36 months and controls, 36 ± 29 months), there were no late deaths in the ring-only group compared with 19 (4%) in the controls. Late follow-up revealed New York Heart Association functional class I or II in 95% of ring-only patients, compared with 90% of controls. Freedom from recurrent moderate or severe mitral regurgitation was 100% and 89% in the ring-only and control groups, respectively. Mitral annuloplasty for Barlow disease patients with multisegment involvement and mainly central regurgitant jet is both simple and reproducible with excellent late outcomes. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  6. Long-term outcomes of twins based on the intended mode of delivery.

    PubMed

    Fox, Nathan S; Cohen, Natalie; Odom, Elizabeth; Gupta, Simi; Lam-Rachlin, Jennifer; Saltzman, Daniel H; Rebarber, Andrei

    2018-08-01

    Recent studies have shown that for twin pregnancies with a cephalic presenting first twin, planned vaginal delivery is not associated with adverse short-term neonatal outcomes, as compared to planned cesarean delivery. Our objective was to compare long-term outcomes in twins, based on planned mode of delivery. This was a prospective, observational cohort of twin pregnancies delivered by a single MFM practice. All the patients with a twin pregnancy >34 weeks delivered from 2005-2014 were surveyed regarding pediatric outcomes at or after 2 years of life. The survey was mail-based, with phone follow-up for nonresponses or for clarification of answers. Using chi-square, Student's t-tests, and regression analysis we compared outcomes between women who planned a vaginal (with active management of the second stage) versus cesarean delivery. The main outcome measures were: (1) a composite of major adverse outcomes (death, cerebral palsy, necrotizing enterocolitis, chronic renal, heart, or lung disease); (2) a composite of minor adverse outcomes (learning disability, speech therapy, occupational therapy, physical therapy). Five hundred and thirty-two women met inclusion criteria and 354 (66.5%) responded. 178 (50.3%) women planned to have a cesarean delivery (100% of whom had a cesarean delivery) and 176 (49.7%) women planned to have a vaginal delivery (83% of whom had a vaginal delivery). The average age of the children at the time of the survey was 5.9 years. There were no differences in any pediatric outcomes between the two groups. After controlling for maternal age, IVF, obesity, and preeclampsia, the planned mode of delivery was not associated with a composite of major adverse outcomes (aOR 0.673, 95% CI 0.228, 1.985), nor a composite of minor adverse outcomes (aOR 0.767, 95% CI 0.496, 1.188). Planned vaginal delivery with active management of the second stage of labor in twin pregnancies >34 weeks is not associated with adverse childhood outcomes.

  7. One-year outcome after first-ever stroke according to stroke subtype, severity, risk factors and pre-stroke treatment. A population-based study from Tartu, Estonia.

    PubMed

    Vibo, R; Kõrv, J; Roose, M

    2007-04-01

    The aim of the current study was to evaluate the outcome at 1 year following a first-ever stroke based on a population-based registry from 2001 to 2003 in Tartu, Estonia. The outcome of first-ever stroke was assessed in 433 patients by stroke risk factors, demographic data and stroke severity at onset using the Barthel Index (BI) score and the modified Rankin Score (mRS) at seventh day, 6 months and 1 year. Female sex, older age, blood glucose value >10 mmol/l on admission and more severe stroke on admission were the best predictors of dependency 1 year following the first-ever stroke. At 1 year, the percentage of functionally dependent patients was 20% and the survival rate was 56%. The use of antihypertensive/antithrombotic medication prior to stroke did not significantly affect the outcome. The survival rate of stroke patients in Tartu is lower compared with other studied populations. The outcome of stroke was mainly determined by the initial severity of stroke and by elevated blood glucose value on admission. Patients with untreated hypertension had more severe stroke and trend for unfavourable outcome compared with those who were on treatment.

  8. Comparative effects of meditation and exercise on physical and psychosocial health outcomes: a review of randomized controlled trials.

    PubMed

    Edwards, Meghan K; Loprinzi, Paul D

    2018-03-01

    No review papers have examined studies that have directly compared non-active forms of meditation with exercise to evaluate effects on physical or psychosocial outcomes, which was the purpose of this paper. Studies were included if they had a randomized controlled trial (RCT) design, included a non-active form of meditation and exercise as intervention arms, and evaluated physical or psychosocial outcomes. The quality of included RCTs was rated using the Cochrane Collaboration's tool for assessing risk of bias in randomized trials. Five RCTs met the inclusion criteria. The total sample size across all studies was N = 325. Of the main outcomes assessed across the five studies, meditation was shown to be more effective than the exercise comparison arm when evaluating the psychosocial outcomes of anxiety, altruism, and life changes. Additionally, meditation was more effective at reducing chronic neck pain at rest and pain-related bothersomeness. Exercise, however, was more effective in improving physical health-related quality of life, HDL and LDL cholesterol, and fasting blood glucose levels. The interventions were found to be comparable when evaluating the outcomes of well-being, ethanol consumption, and perceived stress levels. Four of the evaluated studies were determined to have an overall 'unclear' risk of bias and one study was found to have a 'high' risk of bias. Exercise and non-active meditation may uniquely influence various health-related outcomes. A continued exploration of the effects of exercise and non-active meditation in controlled trials may yield a better understanding of their benefits.

  9. Primary Care Outcomes Questionnaire: psychometric testing of a new instrument.

    PubMed

    Murphy, Mairead; Hollinghurst, Sandra; Cowlishaw, Sean; Salisbury, Chris

    2018-06-01

    Patients attend primary care for many reasons and to achieve a range of possible outcomes. There is currently no Patient Reported Outcome Measure (PROM) designed to capture these diverse outcomes, and trials of interventions in primary care may thus fail to detect beneficial effects. This study describes the psychometric testing of the Primary Care Outcomes Questionnaire (PCOQ), which was designed to capture a broad range of outcomes relevant to primary care. Questionnaires were administered in primary care in South West England. Patients completed the PCOQ in GP waiting rooms before a consultation, and a second questionnaire, including the PCOQ and seven comparator PROMs, after 1 week. Psychometric testing included exploratory factor analysis on the PCOQ, internal consistency, correlation coefficients between domain scores and comparator measures, and repeated measures effect sizes indicating change across 1 week. In total, 602 patients completed the PCOQ at baseline, and 264 (44%) returned the follow-up questionnaire. Exploratory factor analysis suggested four dimensions underlying the PCOQ items: health and wellbeing, health knowledge and self-care, confidence in health provision, and confidence in health plan. Each dimension was internally consistent and correlated as expected with comparator PROMs, providing evidence of construct validity. Patients reporting an improvement in their main problem exhibited small to moderate improvements in relevant domain scores on the PCOQ. The PCOQ was acceptable, feasible, showed strong psychometric properties, and was responsive to change. It is a promising new tool for assessment of outcomes of primary care interventions from a patient perspective. © British Journal of General Practice 2018.

  10. Rasch-family models are more valuable than score-based approaches for analysing longitudinal patient-reported outcomes with missing data.

    PubMed

    de Bock, Élodie; Hardouin, Jean-Benoit; Blanchin, Myriam; Le Neel, Tanguy; Kubis, Gildas; Bonnaud-Antignac, Angélique; Dantan, Étienne; Sébille, Véronique

    2016-10-01

    The objective was to compare classical test theory and Rasch-family models derived from item response theory for the analysis of longitudinal patient-reported outcomes data with possibly informative intermittent missing items. A simulation study was performed in order to assess and compare the performance of classical test theory and Rasch model in terms of bias, control of the type I error and power of the test of time effect. The type I error was controlled for classical test theory and Rasch model whether data were complete or some items were missing. Both methods were unbiased and displayed similar power with complete data. When items were missing, Rasch model remained unbiased and displayed higher power than classical test theory. Rasch model performed better than the classical test theory approach regarding the analysis of longitudinal patient-reported outcomes with possibly informative intermittent missing items mainly for power. This study highlights the interest of Rasch-based models in clinical research and epidemiology for the analysis of incomplete patient-reported outcomes data. © The Author(s) 2013.

  11. Motion versus fixed distraction of the joint in the treatment of ankle osteoarthritis: a prospective randomized controlled trial.

    PubMed

    Saltzman, Charles L; Hillis, Stephen L; Stolley, Mary P; Anderson, Donald D; Amendola, Annunziato

    2012-06-06

    Initial reports have shown the efficacy of fixed distraction for the treatment of ankle osteoarthritis. We hypothesized that allowing ankle motion during distraction would result in significant improvements in outcomes compared with distraction without ankle motion. We conducted a prospective randomized controlled trial comparing the outcomes for patients with advanced ankle osteoarthritis who were managed with anterior osteophyte removal and either (1) fixed ankle distraction or (2) ankle distraction permitting joint motion. Thirty-six patients were randomized to treatment with either fixed distraction or distraction with motion. The patients were followed for twenty-four months after frame removal. The Ankle Osteoarthritis Scale (AOS) was the main outcome variable. Two years after frame removal, subjects in both groups showed significant improvement compared with the status before treatment (p < 0.02 for both groups). The motion-distraction group had significantly better AOS scores than the fixed-distraction group at twenty-six, fifty-two, and 104 weeks after frame removal (p < 0.01 at each time point). At 104 weeks, the motion-distraction group had an overall mean improvement of 56.6% in the AOS score, whereas the fixed-distraction group had a mean improvement of 22.9% (p < 0.01). Distraction improved the patient-reported outcomes of treatment of ankle osteoarthritis. Adding ankle motion to distraction showed an early and sustained beneficial effect on outcome.

  12. Obstetric and perinatal outcomes of singletons after single blastocyst transfer: is there any difference according to blastocyst morphology?

    PubMed

    Bouillon, Céline; Celton, Noémie; Kassem, Sandra; Frapsauce, Cynthia; Guérif, Fabrice

    2017-08-01

    A strong correlation between blastocyst morphology and implantation has been shown by many studies. The consequences and effects of assisted reproductive techniques on children's short and long-term health have always been a source of discussion. The obstetric and perinatal outcome of singletons according to blastocyst morphology has rarely been evaluated. The aim of this observational study is to determine whether a relationship exists between blastocyst morphology and obstetric and perinatal outcomes. A total of 799 singleton clinical pregnancies were analysed after transfer of a single fresh blastocyst on day 5 between 2006 and 2013. Blastocysts were divided into four groups based on their morphology on day 5: group 1 = good morphology blastocysts; group 2 = fair morphology blastocysts; group 3 = poor morphology blastocysts and group 4 = early (B1/B2) blastocysts. Obstetric and perinatal outcomes were compared between the four groups. After adjustment for some confounding variables, main obstetric and perinatal outcomes after transfer of blastocysts with poor morphological characteristics were not associated with increased adverse obstetric and perinatal events. Sex ratio was significantly higher in group 1 compared with groups 2, 3 and 4, and in Group 2 compared with Group 3 (P < 0.001) even after adjustment (P < 0.05). Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  13. Impact of an electronic sepsis initiative on antibiotic use and health care facility-onset Clostridium difficile infection rates.

    PubMed

    Hiensch, Robert; Poeran, Jashvant; Saunders-Hao, Patricia; Adams, Victoria; Powell, Charles A; Glasser, Allison; Mazumdar, Madhu; Patel, Gopi

    2017-10-01

    Although integrated, electronic sepsis screening and treatment protocols are thought to improve patient outcomes, less is known about their unintended consequences. We aimed to determine if the introduction of a sepsis initiative coincided with increases in broad-spectrum antibiotic use and health care facility-onset (HCFO) Clostridium difficile infection (CDI) rates. We used interrupted time series data from a large, tertiary, urban academic medical center including all adult inpatients on 4 medicine wards (June 2011-July 2014). The main exposure was implementation of the sepsis screening program; the main outcomes were the use of broad-spectrum antibiotics (including 3 that were part of an order set designed for the sepsis initiative) and HCFO CDI rates. Segmented regression analyses compared outcomes in 3 time segments: before (11 months), during (14 months), and after (12 months) implementation of a sepsis initiative. Antibiotic use and HFCO CDI rates increased during the period of implementation and the period after implementation compared with baseline; these increases were highest in the period after implementation (level change, 50.4 days of therapy per 1,000 patient days for overall antibiotic use and 10.8 HCFO CDIs per 10,000 patient days; P < .05). Remarkably, the main drivers of overall antibiotic use were not those included in the sepsis order set. The implementation of an electronic sepsis screening and treatment protocol coincided with increased broad-spectrum antibiotic use and HCFO CDIs. Because these protocols are increasingly used, further study of their unintended consequences is warranted. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  14. Characteristics and Differences of Lifelong Learning Policy Implementation for the Elderly in Thailand

    ERIC Educational Resources Information Center

    Dhirathiti, Nopraenue S.; Pichitpatja, Pojjana

    2018-01-01

    The study examined the process of policy implementation of lifelong learning for the elderly in Thailand, covering four main regions within the country. The study empirically compared inputs, processes, outputs, and outcomes of policy implementation in the north, south, northeast, and central regions of Thailand and captured the rigor of policy…

  15. Postoperative dynamic extension splinting compared with fixation with Kirschner wires and static splinting in contractures of burned hands: a comparative study of 57 cases in 9 years.

    PubMed

    Tan, Onder; Atik, Bekir; Dogan, Ali; Uslu, Mustafa; Alpaslan, Suleyman

    2007-01-01

    Skin grafting is widely used for the treatment of postburn contractures. Their main disadvantage, a tendency to contract again, can be reduced and better outcomes achieved by postoperative splinting. In this study we compared the outcomes of dynamic and static splinting postoperatively. Of the 57 patients managed by split grafts, 36 (44 hands) had Kirschner (K) wires applied with static splints, whereas 21 (26 hands) had dynamic splinting. The mean age was 11 (range 2-37) and 15 (range 2-50) years in the two groups. Before and after the operation, basic hand functions were evaluated clinically, and the results analysed statistically. The mean follow-up times were 18 and 14 months respectively, and recurrence rates were 22% and 14%. We think that the postoperative dynamic splinting is superior to fixation with K-wires with or without static splints.

  16. The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial.

    PubMed

    Pedersen-Bjergaard, Ulrik; Kristensen, Peter L; Beck-Nielsen, Henning; Nørgaard, Kirsten; Perrild, Hans; Christiansen, Jens S; Jensen, Tonny; Parving, Hans-Henrik; Thorsteinsson, Birger; Tarnow, Lise

    2017-01-01

    The evidence for optimal insulin treatment in type 1 diabetes is mainly based on randomised controlled trials applying a parallel-group design. Such trials yield robust general results but crucial individual treatment effects cannot be extracted. We aimed to assess the potential for further improvement of outcomes by personalized insulin therapy by analyzing data from a cross-over trial at individual level. Post hoc analysis of data from a two-year multicentre, prospective, randomised, open, blinded endpoint (PROBE) trial (the HypoAna trial). In a cross-over design 114 patients with type 1 diabetes and recurrent severe hypoglycemia were treated with basal-bolus therapy based on analog (detemir/aspart) or human (NPH/regular) insulin aiming at maintenance of baseline HbA1c levels. For each patient a superior outcome was defined as fewer events of severe hypoglycemia defined by need for third party treatment assistance or a more than 0.4% (4.4mmol/mol) lower HbA1c. Only one quarter had comparable outcome of the two treatments in terms of rate of severe hypoglycemia or HbA1c. Twice as many patients had superior outcome of analog-based as compared to human insulin-based insulin treatment. The rate of severe hypoglycemia with the superior treatment was lower compared to the rates obtained with analog insulin and with human insulin (0.67, 1.09, and 1.57 episode per patient-year, respectively (p<0.0001)). Personalized insulin treatment of type 1 diabetes based on single-patient evidence may improve outcomes significantly compared to a general treatment approach. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  17. The cost-effectiveness of supported employment for adults with autism in the United Kingdom

    PubMed Central

    Megnin-Viggars, Odette; Cheema, Nadir; Howlin, Patricia; Baron-Cohen, Simon; Pilling, Stephen

    2014-01-01

    Adults with autism face high rates of unemployment. Supported employment enables individuals with autism to secure and maintain a paid job in a regular work environment. The objective of this study was to assess the cost-effectiveness of supported employment compared with standard care (day services) for adults with autism in the United Kingdom. Thus, a decision-analytic economic model was developed, which used outcome data from the only trial that has evaluated supported employment for adults with autism in the United Kingdom. The main analysis considered intervention costs, while cost-savings associated with changes in accommodation status and National Health Service and personal social service resource use were examined in secondary analyses. Two outcome measures were used: the number of weeks in employment and the quality-adjusted life year. Supported employment resulted in better outcomes compared with standard care, at an extra cost of £18 per additional week in employment or £5600 per quality-adjusted life year. In secondary analyses that incorporated potential cost-savings, supported employment dominated standard care (i.e. it produced better outcomes at a lower total cost). The analysis suggests that supported employment schemes for adults with autism in the United Kingdom are cost-effective compared with standard care. Further research needs to confirm these findings. PMID:24126866

  18. Estradiol and Antagonist Pretreatment Prior to Microdose Leuprolide in in Vitro Fertilization. Does It Improve IVF Outcomes in Poor Responders as Compared to Oral Contraceptive Pill?

    PubMed

    Elassar, Alyaa; Nulsen, John; Engmann, Lawrence; Benadiva, Claudio

    2015-01-01

    To compare in vitro fertilization (IVF) outcomes in low responders stimulated with microdose leuprolide protocol (ML) following pretreatment with either oral contraceptive pill (OCP) or luteal estradiol (E2) + GnRH antagonist (E2 + antag) for follicular synchronization prior to controlled ovarian hyperstimulation (COH). This was a retrospective study of 130 women, who were poor responders, undergoing IVF with either OCP/ML or E2+ antag/ML protocols. The main outcome measures were ongoing pregnancy rates, number of oocytes retrieved, and cancellation rate. Both groups were similar in baseline characteristics. There were no significant differences in gonadotropin requirement, cancellation rate, and number of embryos transferred. Ongoing pregnancy rates (40% vs. 15%) were significantly higher in the OCP/ML group. Trends toward greater number of oocytes retrieved (7.7 ± 3.4 vs. 5.9 ± 4.2) and improved implantation rates (20% vs. 12%) were also noted, but these did not reach statistical significance. E2+antag pretreatment does not appear to improve IVF outcomes in ML protocol when compared to the standard OCP in poor responders. Randomized trials with adequate power to study the optimal method of steroid pretreatments appear justified.

  19. Effect of progressive muscle relaxation versus intake of ginger powder on dysmenorrhoea amongst the nursing students in Pune.

    PubMed

    Halder, Annesa

    2012-01-01

    The present study was conducted to examine the comparative efficacy of progressive muscle relaxation and the oral intake of ginger on symptoms of dysmenorrhoea among nursing students of Pune, Maharashtra. The study students (n = 75) were divided into three groups, two experimental and one control Ginger powder 1 gm per dose was administered twice a day with warm water after meal to the second experimental group during the first three days of their menstruation. Main outcome measures were the severity of selected symptoms of dysmenorrhoea. The daily symptom calendar, a 5-point Likert Scale was used to assess the severity of selected symptoms of dysmenorrhoea. Main outcome measures were the severity of selected symptoms of dysmenorrhoea, which were analysed using MANOVA. It was concluded that in treating symptoms of dysmenorrhoea, ginger powder has efficacy superior to progressive muscle relaxation.

  20. Association between thymic function and allogeneic hematopoietic stem cell transplantation outcome: results of a pediatric study.

    PubMed

    Saglio, Francesco; Cena, Silvia; Berger, Massimo; Quarello, Paola; Boccasavia, Viola; Ferrando, Federica; Pittana, Laura; Bruno, Benedetto; Fagioli, Franca

    2015-06-01

    Robust T cell function recovery has been shown to be crucial in determining allogeneic hematopoietic stem cell transplantation (HSCT) outcome, and there is growing evidence that the thymus plays a central role in regulating this process. We performed a long-term analysis of the role of thymic activity recovery in a population of pediatric patients undergoing allogeneic HSCT by signal joint T cell receptor excision circle (sjTREC) quantification. In this study, characterized by a long-term follow-up (median, 72 months), we found patients with higher levels of sjTRECs before transplantation had a statistically significant reduced risk of death compared with patients with lower values (relative risk, .31; 95% confidence interval, .30 to .32; P = .02), showing this different outcome was mainly related to a reduction of relapse incidence (14% versus 43%, P = .02). Unlike previous reports, we observed no correlation between sjTREC levels and lymphocyte recovery. Moreover, we confirmed that only graft-versus-host disease influenced thymic activity after transplantation. In conclusion, our results suggest an association between pretransplantation thymic activity and the long-term outcome of pediatric patients undergoing HSCT, mainly through a reduction of relapse opportunities. Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  1. The Clinical Significance of Digital Examination-Indicated Cerclage in Women with a Dilated Cervix at 14 0/7 - 29 6/7 Weeks

    PubMed Central

    Ko, Hyun Sun; Jo, Yun Seong; Kil, Ki Cheol; Chang, Ha Kyun; Park, Yong-Gyu; Park, In Yang; Lee, Guisera; Kim, Sajin; Shin, Jong Chul

    2011-01-01

    Objective. This study was to compare pregnancy outcomes between cerclage and expectant management in wemen with a dilated cervix. Design. Retrospective multicenter cohort study. Setting. Five hospitals of Catholic University Medical Center Network in Korea. Population. A total of 173 women between 14 0/7 and 29 6/7 weeks' gestation with cervical dilation of 1 cm or greater by digital examination. Methods. Pregnancy outcomes were compared according to cerclage or expectant management, with the use of propensity-score matching. Main Outcome Measures. Primary outcome was time from presentation until delivery (weeks). Secondary outcomes were gestational age at delivery, neonatal survival, morbidity, preterm birth, and so on. Results. Of 173 women, 116 received a cerclage (cerclage group), and 57 were managed expectantly without cerclage (expectant group). Cervical dilation at presentation, and the use of amniocentesis performed to exclude subclinical chorioamnionitis differed between two groups. In the overall matched cohort, there was significant difference in the time from presentation until delivery (cerclage vs. expectant group, 10.6±6.2 vs. 2.9±3.2 weeks, p <0.0001). While there was no significant difference in the neonatal survival between two groups, there werelower neonatal morbidity as well as higher pregnancy maintenance rate at 28, 32, 34 and 37 weeks' gestation in the cerclage group, compared with the expectant group. Conclusion. This study suggests that digital examination-indicated cerclage appears to prolong gestation and decrease neonatal morbidity, compared with expectant management in women with cervical dilation between 14 0/7 and 29 6/7 weeks. PMID:21960743

  2. Effect of Transcendental Meditation on Employee Stress, Depression, and Burnout: A Randomized Controlled Study

    PubMed Central

    Elder, Charles; Nidich, Sanford; Moriarty, Francis; Nidich, Randi

    2014-01-01

    Context: Workplace stress and burnout are pervasive problems, affecting employee performance and personal health. Objective: To evaluate the effects of the Transcendental Meditation program on psychological distress and burnout among staff at a residential therapeutic school for students with severe behavioral problems. Design: A total of 40 secondary schoolteachers and support staff at the Bennington School in Vermont, a therapeutic school for children with behavioral problems, were randomly assigned to either practice of the Transcendental Meditation program or a wait-list control group. The Transcendental Meditation course was provided by certified instructors. Main Outcome Measures: Outcome measures were assessed at baseline and at four months, and included perceived stress, depression, and burnout. A multivariate analysis of covariance was used to determine overall effects. Results: Analysis of the 4-month intervention data indicated a significant improvement in the main outcomes of the study resulting from practice of the Transcendental Meditation program compared with controls (Wilks Λ [3,28] = 0.695; p = 0.019). Results of univariate F tests indicated a significant reduction of all main outcome measures: perceived stress (F[1,32] = 13.42; p = < 0.001); depression (F[1,32] = 6.92; p = 0.013); and overall teacher burnout (F[1,32] = 6.18; p = 0.018). Effect sizes ranged from 0.40 to 0.94. Conclusions: The Transcendental Meditation program was effective in reducing psychological distress in teachers and support staff working in a therapeutic school for students with behavioral problems. These findings have important implications for employees’ job performance as well as their mental and physical health. PMID:24626068

  3. Quality of Care for Patients with Type 2 Diabetes Mellitus in the Netherlands and the United States: A Comparison of Two Quality Improvement Programs

    PubMed Central

    Valk, Gerlof D; Renders, Carry M; Kriegsman, Didi MW; Newton, Katherine M; Twisk, Jos WR; van Eijk, Jacques ThM; van der Wal, Gerrit; Wagner, Edward H

    2004-01-01

    Objective To assess differences in diabetes care and patient outcomes by comparing two multifaceted quality improvement programs in two different countries, and to increase knowledge of effective elements of such programs. Study Setting Primary care in the ExtraMural Clinic (EMC) of the Department of General Practice of the Vrije Universiteit in Amsterdam, the Netherlands, and the Group Health Cooperative (GHC), a group-model health maintenance organization (HMO) in western Washington State in the United States. Data were collected from 1992 to 1997. Study Design In this observational study two diabetes cohorts in which a quality improvement program was implemented were compared. Both programs included a medical record system, clinical practice guidelines, physician educational meetings, audit, and feedback. Only the Dutch program (EMC) included guidelines on the structure of diabetes care and a recall system. Only the GHC program included educational outreach visits, formation of multidisciplinary teams, and patient self-management support. Data Collection Included were 379 EMC patients, and 2,119 GHC patients with type 2 diabetes mellitus. Main process outcomes were: annual number of diabetes visits, and number of HbA1c and blood lipid measurements. Main patient outcomes were HbA1c and blood lipid levels. Multilevel analysis was used to adjust for dependency between repeated observations within one patient and for clustering of patients within general practices. Principal Findings In the EMC process outcomes and glycemic control improved more than at GHC, however, GHC had better baseline measures. There were no differences between programs on blood lipid control. During follow-up, intensification of pharmacotherapy was noted at both sites. Differences noted between programs were in line with differences in diabetes guidelines. Conclusions Following implementation of guidelines and organizational improvement efforts, change occurred primarily in the process outcomes, rather than in the patient outcomes. Although much effort was put into improving process and patient outcomes, both complex programs still showed only moderate effects. PMID:15230924

  4. Maternal characteristics and pregnancy outcomes after assisted reproductive technology by infertility diagnosis: ovulatory dysfunction versus tubal obstruction

    PubMed Central

    Grigorescu, Violanda; Zhang, Yujia; Kissin, Dmitry M.; Sauber-Schatz, Erin; Sunderam, Mithi; Kirby, Russell S.; Diop, Hafsatou; McKane, Patricia; Jamieson, Denise J.

    2015-01-01

    Objective To examine differences in maternal characteristics and pregnancy outcomes between women with ovulatory dysfunction (OD) and women with tubal obstruction (TO) who underwent assisted reproductive technology (ART). Design Retrospective cohort study. Setting Centers for Disease Control and Prevention. Patient(s) Exposed and nonexposed groups were selected from the 2000–2006 National ART Surveillance System linked with live-birth certificates from three states: Florida, Massachusetts, and Michigan. Intervention(s) None. Main Outcome Measure(s) Maternal characteristics and pregnancy outcomes, including newborn’s health status right after delivery (Apgar score, <7 vs. ≥7) as the study outcome of interest, were assessed among women with OD/polycystic ovary syndrome (PCOS) and TO who used ART. Result(s) A significantly higher prevalence of women with OD/PCOS were younger (<35 years of age; 65.7% vs. 48.9%), were white (85.4% vs. 74.4%), had higher education (29.4% vs. 15.6%), and experienced diabetes (8.8% vs. 5.3%) compared with those having TO. The odds of having a lower (<7) Apgar score at 5 minutes were almost twice as high among newborns of women with OD/PCOS compared with those with TO (crude odds ratio, 1.86; 95% confidence interval [CI], 1.31, 2.64; adjusted odds ratio, 1.90; 95% CI, 1.30, 2.77). Conclusion(s) Women with OD/PCOS who underwent ART have different characteristics and health issues (higher prevalence of diabetes) and infant outcomes (lower Apgar score) compared with women with TO. PMID:24484993

  5. Trends in Obstetric Intervention and Pregnancy Outcomes of Canadian Women With Diabetes in Pregnancy From 2004 to 2015

    PubMed Central

    Sabr, Yasser; Hutcheon, Jennifer A.; Donovan, Lois; Lyons, Janet; Burrows, Jason; Joseph, K. S.

    2017-01-01

    Context: Multiple consensus statements decree that women with diabetes mellitus should have comparable birth outcomes to women without diabetes mellitus; however, there is a scarcity of contemporary population-based studies on this issue. Objective: To examine temporal trends in obstetric interventions and perinatal outcomes in a population-based cohort of women with type 1, type 2, or gestational diabetes mellitus compared with a control population. Design: Cross-sectional study. Setting: National hospitalization data (Canada except Quebec) from 2004 to 2015. Patients: Pregnant women with type 1 (n = 7362), type 2 (n = 11,028), and gestational diabetes mellitus (n = 149,780) and women without diabetes mellitus (n = 2,688,231). Main Outcome Measures: Rates of obstetric intervention, maternal morbidity, and neonatal morbidity/mortality. Results: A consistent relationship was generally observed between diabetes mellitus subtype and obstetric outcomes, with women with type 1 diabetes mellitus having the highest rate of intervention and the highest rates of adverse perinatal outcomes followed by women with type 2 diabetes mellitus and women with gestational diabetes mellitus. Rates of severe preeclampsia were 1.2% among women without diabetes mellitus, 2.1% among women with gestational diabetes mellitus, 4.2% among women with type 2 diabetes mellitus, and 7.5% among women with type 1 diabetes mellitus (P < 0.001). The rate of neonatal morbidity ranged from 8.7% in women without diabetes mellitus to 11.0%, 17.4%, and 24.1% in women with gestational, type 2, and type 1 diabetes mellitus, respectively (P < 0.001). Conclusions: In a contemporary obstetric population, women with diabetes mellitus remain at increased risk of adverse pregnancy outcomes compared with women without diabetes mellitus. PMID:29308448

  6. Understanding the Influence of Race/Ethnicity, Gender, and Class on Inequalities in Academic and Non-Academic Outcomes among Eighth-Grade Students: Findings from an Intersectionality Approach

    PubMed Central

    Bécares, Laia; Priest, Naomi

    2015-01-01

    Socioeconomic, racial/ethnic, and gender inequalities in academic achievement have been widely reported in the US, but how these three axes of inequality intersect to determine academic and non-academic outcomes among school-aged children is not well understood. Using data from the US Early Childhood Longitudinal Study—Kindergarten (ECLS-K; N = 10,115), we apply an intersectionality approach to examine inequalities across eighth-grade outcomes at the intersection of six racial/ethnic and gender groups (Latino girls and boys, Black girls and boys, and White girls and boys) and four classes of socioeconomic advantage/disadvantage. Results of mixture models show large inequalities in socioemotional outcomes (internalizing behavior, locus of control, and self-concept) across classes of advantage/disadvantage. Within classes of advantage/disadvantage, racial/ethnic and gender inequalities are predominantly found in the most advantaged class, where Black boys and girls, and Latina girls, underperform White boys in academic assessments, but not in socioemotional outcomes. In these latter outcomes, Black boys and girls perform better than White boys. Latino boys show small differences as compared to White boys, mainly in science assessments. The contrasting outcomes between racial/ethnic and gender minorities in self-assessment and socioemotional outcomes, as compared to standardized assessments, highlight the detrimental effect that intersecting racial/ethnic and gender discrimination have in patterning academic outcomes that predict success in adult life. Interventions to eliminate achievement gaps cannot fully succeed as long as social stratification caused by gender and racial discrimination is not addressed. PMID:26505623

  7. Understanding the Influence of Race/Ethnicity, Gender, and Class on Inequalities in Academic and Non-Academic Outcomes among Eighth-Grade Students: Findings from an Intersectionality Approach.

    PubMed

    Bécares, Laia; Priest, Naomi

    2015-01-01

    Socioeconomic, racial/ethnic, and gender inequalities in academic achievement have been widely reported in the US, but how these three axes of inequality intersect to determine academic and non-academic outcomes among school-aged children is not well understood. Using data from the US Early Childhood Longitudinal Study-Kindergarten (ECLS-K; N = 10,115), we apply an intersectionality approach to examine inequalities across eighth-grade outcomes at the intersection of six racial/ethnic and gender groups (Latino girls and boys, Black girls and boys, and White girls and boys) and four classes of socioeconomic advantage/disadvantage. Results of mixture models show large inequalities in socioemotional outcomes (internalizing behavior, locus of control, and self-concept) across classes of advantage/disadvantage. Within classes of advantage/disadvantage, racial/ethnic and gender inequalities are predominantly found in the most advantaged class, where Black boys and girls, and Latina girls, underperform White boys in academic assessments, but not in socioemotional outcomes. In these latter outcomes, Black boys and girls perform better than White boys. Latino boys show small differences as compared to White boys, mainly in science assessments. The contrasting outcomes between racial/ethnic and gender minorities in self-assessment and socioemotional outcomes, as compared to standardized assessments, highlight the detrimental effect that intersecting racial/ethnic and gender discrimination have in patterning academic outcomes that predict success in adult life. Interventions to eliminate achievement gaps cannot fully succeed as long as social stratification caused by gender and racial discrimination is not addressed.

  8. Analysis of Covariance: Is It the Appropriate Model to Study Change?

    ERIC Educational Resources Information Center

    Marston, Paul T., Borich, Gary D.

    The four main approaches to measuring treatment effects in schools; raw gain, residual gain, covariance, and true scores; were compared. A simulation study showed true score analysis produced a large number of Type-I errors. When corrected for this error, this method showed the least power of the four. This outcome was clearly the result of the…

  9. Statin Selection in Qatar Based on Multi-indication Pharmacotherapeutic Multi-criteria Scoring Model, and Clinician Preference.

    PubMed

    Al-Badriyeh, Daoud; Fahey, Michael; Alabbadi, Ibrahim; Al-Khal, Abdullatif; Zaidan, Manal

    2015-12-01

    Statin selection for the largest hospital formulary in Qatar is not systematic, not comparative, and does not consider the multi-indication nature of statins. There are no reports in the literature of multi-indication-based comparative scoring models of statins or of statin selection criteria weights that are based primarily on local clinicians' preferences and experiences. This study sought to comparatively evaluate statins for first-line therapy in Qatar, and to quantify the economic impact of this. An evidence-based, multi-indication, multi-criteria pharmacotherapeutic model was developed for the scoring of statins from the perspective of the main health care provider in Qatar. The literature and an expert panel informed the selection criteria of statins. Relative weighting of selection criteria was based on the input of the relevant local clinician population. Statins were comparatively scored based on literature evidence, with those exceeding a defined scoring threshold being recommended for use. With 95% CI and 5% margin of error, the scoring model was successfully developed. Selection criteria comprised 28 subcriteria under the following main criteria: clinical efficacy, best publish evidence and experience, adverse effects, drug interaction, dosing time, and fixed dose combination availability. Outcome measures for multiple indications were related to effects on LDL cholesterol, HDL cholesterol, triglyceride, total cholesterol, and C-reactive protein. Atorvastatin, pravastatin, and rosuvastatin exceeded defined pharmacotherapeutic thresholds. Atorvastatin and pravastatin were recommended as first-line use and rosuvastatin as a nonformulary alternative. It was estimated that this would produce a 17.6% cost savings in statins expenditure. Sensitivity analyses confirmed the robustness of the evaluation's outcomes against input uncertainties. Incorporating a comparative evaluation of statins in Qatari practices based on a locally developed, transparent, multi-indication, multi-criteria scoring model has the potential to considerably reduce expenditures on statins. Atorvastatin and pravastatin should be the first-line statin therapies in the main Qatari health care provider, with rosuvastatin as an alternative. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

  10. Long term outcomes of new generation drug eluting stents versus coronary artery bypass grafting for multivessel and/or left main coronary artery disease. A Bayesian network meta-analysis of randomized controlled trials.

    PubMed

    Mina, George S; Watti, Hussam; Soliman, Demiana; Shewale, Anand; Atkins, Jessica; Reddy, Pratap; Dominic, Paari

    2018-01-05

    Most data guiding revascularization of multivessel disease (MVD) and/or left main disease (LMD) favor coronary artery bypass grafting (CABG) over percutaneous coronary intervention (PCI). However, those data are based on trials comparing CABG to bare metal stents (BMS) or old generation drug eluting stents (OG-DES). Hence, it is essential to outcomes of CABG to those of new generation drug eluting stents (NG-DES). We searched PUBMED and Cochrane database for trials evaluating revascularization of MVD and/or LMD with CABG and/or PCI. A Bayesian network meta-analysis was performed to calculate odds ratios (OR) and 95% credible intervals (CrI). Primary outcome was major adverse cardiovascular events (MACE) at 3-5 years. Secondary outcomes were mortality, cerebrovascular accidents (CVA), myocardial infarction (MI) and repeat revascularization. We included 10 trials with a total of 9287 patients. CABG was associated with lower MACE when compared to BMS or OG-DES. However, MACE was not significantly different between CABG and NG-DES (OR 0.79, CrI 0.45-1.40). Moreover, there were no significant differences between CABG and NG-DES in mortality (OR 0.78, CrI 0.45-1.37), CVA (OR 0.93 CrI 0.35-2.2) or MI (OR 0.6, CrI 0.17-2.0). On the other hand, CABG was associated with lower repeat revascularization (OR 0.55, CrI 0.36-0.84). Our study suggests that NG-DES is an acceptable alternative to CABG in patients with MVD and/or LMD. However, repeat revascularization remains to be lower with CABG than with PCI. Copyright © 2018. Published by Elsevier Inc.

  11. Seventeen-year Outcome of a Randomized Clinical Trial Comparing Laparoscopic and Conventional Nissen Fundoplication: A Plea for Patient Counseling and Clarification.

    PubMed

    Oor, Jelmer E; Roks, David J; Broeders, Joris A; Hazebroek, Eric J; Gooszen, Hein G

    2017-07-01

    To analyze long-term outcome of a randomized clinical trial comparing laparoscopic Nissen fundoplication (LNF) and conventional Nissen fundoplication (CNF) for the treatment of gastroesophageal reflux disease (GERD). LNF has replaced CNF, based on positive short and mid-term outcome. Studies with a follow-up of over 15 years are scarce, but are desperately needed for patient counselling. Between 1997 and 1999, 177 patients with proton pump inhibitor (PPI)-refractory GERD were randomized to CNF or LNF. Data regarding the presence of reflux symptoms, dysphagia, general health, PPI use, and need for surgical reintervention at 17 years are reported. A total of 111 patients (60 LNF, 51 CNF) were included. Seventeen years after LNF and CNF, 90% and 95% of the patients reported symptom relief, with no differences in GERD symptoms or dysphagia. Forty-three and 49% of the patients used PPIs (NS). Both groups demonstrated significant improvement in general health (77% vs 71%; NS) and quality of life (75.3 vs 74.7; NS). Surgical reinterventions were more frequent after CNF (18% vs 45%; P = 0.002), mainly due to incisional hernia corrections (3% vs 14%; P = 0.047). The effects of LNF and CNF on symptomatic outcome and general state of health remain for up to 17 years after surgery, with no differences between the 2 procedures. CNF carries a higher risk of surgical reintervention, mainly due to incisional hernia corrections. Patients should be informed that 17 years after Nissen fundoplication, 60% of the patients are off PPIs, and 16% require reoperation for recurrent GERD and/or dysphagia.

  12. Outcome of renal replacement treatment in patients with diabetes mellitus.

    PubMed Central

    McMillan, M A; Briggs, J D; Junor, B J

    1990-01-01

    OBJECTIVE--To compare the outcome of renal replacement treatment in patients with diabetes mellitus and in non-diabetic patients with end stage renal failure. DESIGN--Retrospective comparison of cases and matched controls. SETTING--Renal unit, Western Infirmary, Glasgow, providing both dialysis and renal transplantation. PATIENTS--82 Diabetic patients starting renal replacement treatment between 1979 and 1988, compared with 82 matched non-diabetic controls with renal failure and 39 different matched controls undergoing renal transplantation. MAIN OUTCOME MEASURES--Patient characteristics, history of smoking, prevalence of left ventricular hypertrophy and myocardial ischaemia at start of renal replacement treatment; survival of patients with renal replacement treatment and of patients and allografts with renal transplantation. RESULTS--The overall survival of the diabetic patients during the treatment was 83%, 59%, and 50% at one, three, and five years. Survival was significantly poorer in the diabetic patients than the controls (p less than 0.001). Particularly adverse features for outcome at the start of treatment were increasing age (p less than 0.01) and current cigarette smoking (relative risk (95% confidence interval) 2.28 (0.93 to 4.84), p less than 0.05). Deaths were mainly from cardiac and vascular causes. The incidence of peritonitis in patients on continuous ambulatory peritoneal dialysis was the same in diabetic patients and controls (49% in each group remained free of peritonitis after one year), and the survival of renal allografts was not significantly worse in diabetic patients (p less than 0.5). CONCLUSIONS--Renal replacement treatment may give good results in diabetic patients, although the outlook remains less favourable than for non-diabetic patients because of coexistent, progressive vascular disease, which is more severe in older patients. PMID:2207427

  13. Simultaneous bilateral cataract surgery: economic analysis; Helsinki Simultaneous Bilateral Cataract Surgery Study Report 2.

    PubMed

    Leivo, Tiina; Sarikkola, Anna-Ulrika; Uusitalo, Risto J; Hellstedt, Timo; Ess, Sirje-Linda; Kivelä, Tero

    2011-06-01

    To present an economic-analysis comparison of simultaneous and sequential bilateral cataract surgery. Helsinki University Eye Hospital, Helsinki, Finland. Economic analysis. Effects were estimated from data in a study in which patients were randomized to have bilateral cataract surgery on the same day (study group) or sequentially (control group). The main clinical outcomes were corrected distance visual acuity, refraction, complications, Visual Function Index-7 (VF-7) scores, and patient-rated satisfaction with vision. Health-care costs of surgeries and preoperative and postoperative visits were estimated, including the cost of staff, equipment, material, floor space, overhead, and complications. The data were obtained from staff measurements, questionnaires, internal hospital records, and accountancy. Non-health-care costs of travel, home care, and time were estimated based on questionnaires from a random subset of patients. The main economic outcome measures were cost per VF-7 score unit change and cost per patient in simultaneous versus sequential surgery. The study comprised 520 patients (241 patients included non-health-care and time cost analyses). Surgical outcomes and patient satisfaction were similar in both groups. Simultaneous cataract surgery saved 449 Euros (€) per patient in health-care costs and €739 when travel and paid home-care costs were included. The savings added up to €849 per patient when the cost of lost working time was included. Compared with sequential bilateral cataract surgery, simultaneous bilateral cataract surgery provided comparable clinical outcomes with substantial savings in health-care and non-health-care-related costs. No author has a financial or proprietary interest in any material or method mentioned. Copyright © 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  14. Motion Versus Fixed Distraction of the Joint in the Treatment of Ankle Osteoarthritis

    PubMed Central

    Saltzman, Charles L.; Hillis, Stephen L.; Stolley, Mary P.; Anderson, Donald D.; Amendola, Annunziato

    2012-01-01

    Background: Initial reports have shown the efficacy of fixed distraction for the treatment of ankle osteoarthritis. We hypothesized that allowing ankle motion during distraction would result in significant improvements in outcomes compared with distraction without ankle motion. Methods: We conducted a prospective randomized controlled trial comparing the outcomes for patients with advanced ankle osteoarthritis who were managed with anterior osteophyte removal and either (1) fixed ankle distraction or (2) ankle distraction permitting joint motion. Thirty-six patients were randomized to treatment with either fixed distraction or distraction with motion. The patients were followed for twenty-four months after frame removal. The Ankle Osteoarthritis Scale (AOS) was the main outcome variable. Results: Two years after frame removal, subjects in both groups showed significant improvement compared with the status before treatment (p < 0.02 for both groups). The motion-distraction group had significantly better AOS scores than the fixed-distraction group at twenty-six, fifty-two, and 104 weeks after frame removal (p < 0.01 at each time point). At 104 weeks, the motion-distraction group had an overall mean improvement of 56.6% in the AOS score, whereas the fixed-distraction group had a mean improvement of 22.9% (p < 0.01). Conclusion: Distraction improved the patient-reported outcomes of treatment of ankle osteoarthritis. Adding ankle motion to distraction showed an early and sustained beneficial effect on outcome. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. PMID:22637202

  15. Correlation of Site of Embryo Transfer with IVF Outcome: Analysis of 743 Cycles from a Single Center

    PubMed Central

    Singh, Neeta; Lata, Kusum; Malhotra, Neena; Vanamail, P.

    2017-01-01

    Objective: To investigate the influence of site of embryo transfer (ET) on reproductive outcome. Materials and Methods: A retrospective analysis of 743 ultrasound-guided ET in fresh in vitro fertilization (IVF) cycles from a single center over a period of 4 years was conducted. The distance between the fundal endometrial surface and the air bubble was measured, and accordingly, patients were divided into four groups (≤10 mm; >10 and ≤15 mm; >15 and 20 mm; >20 and <25 mm). Setting: Tertiary Assisted Reproductive Technology (ART) center. Patient(s): All patients enrolled in the IVF program undergoing ET. Intervention(s): Controlled ovarian hyperstimulation (OS), IVF, and ET. Main Outcome Measure(s): Cleavage rate and clinical pregnancy rate. Result(s): Clinical pregnancy rate was significantly more in groups 2 and 3 compared to the other groups. Logistic regression analysis showed that one unit increase in embryos transfer will enhance the pregnancy outcome about 3.7 (adjusted odds ratio) times with 95% confidence limits 2.6 to 5.4. Similarly, pregnancy outcome will be 3.1 (95% confidence limits: 1.5–6.4) times higher for distance group >15 and <20 mm compared to less than 10-mm distance group. Ectopic pregnancy rates were similar in all the four groups. Conclusion: The present study demonstrates that site of ET has significant difference on reproductive outcome. PMID:28904498

  16. In vitro fertilization outcomes in obese women under and above 35 years of age.

    PubMed

    Vural, F; Vural, B; Çakiroglu, Y

    2016-01-01

    To explore the impact of obesity on in vitro fertilization (IVF) outcomes and comparing the results with regards to age groups. This retrospective cohort recruited 780 women that underwent IVF. Women with polycystic ovarian syndrome (PCOS) were excluded from the study. Women under and above 35 years were categorized into three groups as normal weight, overweight, and obese. The main outcome measures were ovarian response, oocyte maturity, and clinical pregnancy rates. Despite oocyte count and fertilization rate that decreased in both younger and older obese women, this difference was not statistically significant. After age matched-normal weight controls, the clinical pregnancy rates were significantly decreased in older obese women. On the other hand, poor ovarian response observed significantly in young obese women without effect on pregnancy rates. These results suggested that obesity in young and old women has different outcomes and different steps of IVF process may be affected.

  17. Improved outcomes in pediatric epilepsy surgery: the UCLA experience, 1986-2008.

    PubMed

    Hemb, M; Velasco, T R; Parnes, M S; Wu, J Y; Lerner, J T; Matsumoto, J H; Yudovin, S; Shields, W D; Sankar, R; Salamon, N; Vinters, H V; Mathern, G W

    2010-06-01

    Epilepsy neurosurgery is a treatment option for children with refractory epilepsy. Our aim was to determine if outcomes improved over time. Pediatric epilepsy surgery patients operated in the first 11 years (1986-1997; pre-1997) were compared with the second 11 years (1998-2008; post-1997) for differences in presurgical and postsurgical variables. Despite similarities in seizure frequency, age at seizure onset, and age at surgery, the post-1997 series had more lobar/focal and fewer multilobar resections, and more patients with tuberous sclerosis complex and fewer cases of nonspecific gliosis compared with the pre-1997 group. Fewer cases had intracranial EEG studies in the post-1997 (0.8%) compared with the pre-1997 group (9%). Compared with the pre-1997 group, the post-1997 series had more seizure-free patients at 0.5 (83%, +16%), 1 (81%, +18%), 2 (77%, +19%), and 5 (74%, +29%) years, and more seizure-free patients were on medications at 0.5 (97%, +6%), 1 (88%, +9%), and 2 (76%, +29%), but not 5 (64%, +8%) years after surgery. There were fewer complications and reoperations in the post-1997 series compared with the pre-1997 group. Logistic regression identified post-1997 series and less aggressive medication withdrawal as the main predictors of becoming seizure-free 2 years after surgery. Improved technology and surgical procedures along with changes in clinical practice were likely factors linked with enhanced and sustained seizure-free outcomes in the post-1997 series. These findings support the general concept that clearer identification of lesions and complete resection are linked with better outcomes in pediatric epilepsy surgery patients.

  18. Clinical application of bone morphogenetic proteins for bone healing: a systematic review.

    PubMed

    Krishnakumar, Gopal Shankar; Roffi, Alice; Reale, Davide; Kon, Elizaveta; Filardo, Giuseppe

    2017-06-01

    This paper documents the existing evidence on bone morphogenetic proteins (BMPs) use for the treatment of bone fractures, non-union, and osteonecrosis, through a review of the clinical literature, underlying potential and limitations in terms of cost effectiveness and risk of complications. A systematic review was performed on the PubMed database using the following string: (bone morphogenetic proteins OR BMPs) and (bone repair OR bone regeneration) including papers from 2000 to 2016. The search focused on clinical trials dealing with BMPs application to favor bone regeneration in bone fractures, non-union, and osteonecrosis, in English language, with level of evidence I, II, III, and IV. Relevant data (type of study, number of patients, BMPs delivery material, dose, site, follow-up, outcome, and adverse events) were extracted and analyzed. Forty-four articles met the inclusion criteria: 10 randomized controlled trials (RCTs), 7 comparative studies, 18 case series, and 9 case reports. rhBMP-2 was documented mainly for the treatment of fractures, and rhBMP-7 mainly for non-unions and osteonecrosis. Mixed results were found among RCTs and comparative papers: 11 reported positive results for BMPs augmentation, 3 obtained no significant effects, and 2 showed negative results. The only study comparing the two BMPs showed a better outcome with rhBMP-2 for non-union treatment. Clinical evidence on BMPs use for the treatment of fractures, non-union, and osteonecrosis is still controversial, with the few available reports being mainly of low quality. While positive findings have been described in many studies, mixed results are still present in the literature in terms of efficacy and adverse events. The difficulties in drawing clear conclusions are also due to the studies heterogeneity, mainly in terms of different BMPs applied, with different concomitant treatments for each bone pathology. Therefore, further research with well-designed studies is needed in order to understand the real potential of this biological approach to favour bone healing.

  19. Pulmonary Vascular Input Impedance is a Combined Measure of Pulmonary Vascular Resistance and Stiffness and Predicts Clinical Outcomes Better than PVR Alone in Pediatric Patients with Pulmonary Hypertension

    PubMed Central

    Hunter, Kendall S.; Lee, Po-Feng; Lanning, Craig J.; Ivy, D. Dunbar; Kirby, K. Scott; Claussen, Lori R.; Chan, K. Chen; Shandas, Robin

    2011-01-01

    Background Pulmonary vascular resistance (PVR) is the current standard for evaluating reactivity in children with pulmonary arterial hypertension (PAH). However, PVR measures only the mean component of right ventricular afterload and neglects pulsatile effects. We recently developed and validated an method to measure pulmonary vascular input impedance, which revealed excellent correlation between the zero-harmonic impedance value and PVR, and suggested a correlation between higher harmonic impedance values and pulmonary vascular stiffness (PVS). Here we show that input impedance can be measured routinely and easily in the catheterization laboratory, that impedance provides PVR and PVS from a single measurement, and that impedance is a better predictor of disease outcomes compared to PVR. Methods Pressure and velocity waveforms within the main PA were measured during right-heart catheterization of patients with normal PA hemodynamics (n=14) and those with PAH undergoing reactivity evaluation (49 subjects; 95 conditions). A correction factor needed to transform velocity into flow was obtained by calibrating against cardiac output. Input impedance was obtained off-line by dividing Fourier-transformed pressure and flow waveforms. Results Exceptional correlation was found between the indexed zero harmonic of impedance and indexed PVR (y=1.095·x+1.381, R2=0.9620). Additionally, the modulus sum of the first two harmonics of impedance was found to best correlate with indexed pulse pressure over stroke volume (PP/SV) (y=13.39·x-0.8058, R2=0.7962). Amongst a subset of PAH patients (n=25), cumulative logistic regression between outcomes to total indexed impedance was better (RL2=0.4012) than between outcomes and indexed PVR (RL2=0.3131). Conclusions Input impedance can be consistently and easily obtained from PW Doppler and a single catheter pressure measurement, provides comprehensive characterization of the main components of RV afterload, and better predicts patient outcomes compared to PVR alone. PMID:18082509

  20. Pulmonary vascular input impedance is a combined measure of pulmonary vascular resistance and stiffness and predicts clinical outcomes better than pulmonary vascular resistance alone in pediatric patients with pulmonary hypertension.

    PubMed

    Hunter, Kendall S; Lee, Po-Feng; Lanning, Craig J; Ivy, D Dunbar; Kirby, K Scott; Claussen, Lori R; Chan, K Chen; Shandas, Robin

    2008-01-01

    Pulmonary vascular resistance (PVR) is the current standard for evaluating reactivity in children with pulmonary arterial hypertension (PAH). However, PVR measures only the mean component of right ventricular afterload and neglects pulsatile effects. We recently developed and validated a method to measure pulmonary vascular input impedance, which revealed excellent correlation between the zero harmonic impedance value and PVR and suggested a correlation between higher-harmonic impedance values and pulmonary vascular stiffness. Here we show that input impedance can be measured routinely and easily in the catheterization laboratory, that impedance provides PVR and pulmonary vascular stiffness from a single measurement, and that impedance is a better predictor of disease outcomes compared with PVR. Pressure and velocity waveforms within the main pulmonary artery were measured during right heart catheterization of patients with normal pulmonary artery hemodynamics (n = 14) and those with PAH undergoing reactivity evaluation (49 subjects, 95 conditions). A correction factor needed to transform velocity into flow was obtained by calibrating against cardiac output. Input impedance was obtained off-line by dividing Fourier-transformed pressure and flow waveforms. Exceptional correlation was found between the indexed zero harmonic of impedance and indexed PVR (y = 1.095x + 1.381, R2 = 0.9620). In addition, the modulus sum of the first 2 harmonics of impedance was found to best correlate with indexed pulse pressure over stroke volume (y = 13.39x - 0.8058, R2 = 0.7962). Among a subset of patients with PAH (n = 25), cumulative logistic regression between outcomes to total indexed impedance was better (R(L)2 = 0.4012) than between outcomes and indexed PVR (R(L)2 = 0.3131). Input impedance can be consistently and easily obtained from pulse-wave Doppler and a single catheter pressure measurement, provides comprehensive characterization of the main components of RV afterload, and better predicts patient outcomes compared with PVR alone.

  1. A comparison of outcomes for adults and children undergoing resection for inflammatory bowel disease: is there a difference?

    PubMed

    Mcmullin, Christine M; Morton, Jonathan; Vickramarajah, Saranya; Cameron, Ewen; Parkes, Miles; Torrente, Franco; Heuschkel, Robert; Carroll, Nicholas; Davies, R Justin

    2014-01-01

    Background. The incidence of inflammatory bowel disease (IBD) is increasing in the paediatric population. Since 2007, a single surgeon whose main practice is in the treatment of adults has performed surgery for IBD in adults and children within two dedicated multidisciplinary teams. Our aim was to assess and compare outcomes for adults and children following surgery for IBD. Methods. Analysis of a prospectively collected database was carried out to include all patients who had undergone resectional surgery for IBD between 2007 and 2012. Results. 48 adults and 30 children were included in the study. Median age for children was 14 years (range 8-16) and for adults was 33.5 years (range 17-64). Median BMI was 23 (range 18-38) and 19 (range 13-29.5) in adults and children, respectively (P < 0.001). Laparoscopic resection was performed in 27 (90%) children and 36 (75%) adults. Postoperative complication rates were comparable, 11 (23%) in adults versus 6 (20%) in children (P = 1.00). Conclusion. Resectional surgery for IBD in children has outcomes that compare favourably with the adult population, with the majority of cases being performed by a laparoscopic approach.

  2. Five-year outcomes of staged percutaneous coronary intervention in the SYNTAX study.

    PubMed

    Watkins, Stuart; Oldroyd, Keith G; Preda, Istvan; Holmes, David R; Colombo, Antonio; Morice, Marie-Claude; Leadley, Katrin; Dawkins, Keith D; Mohr, Friedrich W; Serruys, Patrick W; Feldman, Ted E

    2015-04-01

    The SYNTAX study compared PCI with TAXUS Express stents to CABG for the treatment of de novo 3-vessel and/or left main coronary disease. This study aimed to determine patient characteristics and five-year outcomes after a staged PCI strategy compared to single-session PCI. In the SYNTAX trial, staged procedures were discouraged but were allowed within 72 hours or, if renal insufficiency or contrast-induced nephropathy occurred, within 14 days (mean 9.8±18.1 days post initial procedure). A total of 125 (14%) patients underwent staged PCI. These patients had greater disease severity and/or required a more complex procedure. MACCE was significantly increased in staged patients (48.1% vs. 35.5%, p=0.004), as was the composite of death/stroke/MI (32.2% vs. 19%, p=0.0007). Individually, cardiac death and stroke occurred more frequently in the staged PCI group (p=0.03). Repeat revascularisation was significantly higher in staged patients (32.8% vs 24.8%, p=0.035), as was stent thrombosis (10.9% vs. 4.7%, p=0.005). There is a higher incidence of MACCE in patients undergoing staged compared to single-session PCI for 3-vessel and/or left main disease over the first five years of follow-up. However, these patients had more comorbidities and more diffuse disease.

  3. [Pneumonia associated with health care versus community acquired pneumonia: different entities, distinct approaches].

    PubMed

    Guimarães, C; Lares Santos, C; Costa, F; Barata, F

    2011-01-01

    Healthcare-associated pneumonia (HCAP) is now identified as a unique entity that differs from community-acquired pneumonia (CAP), and in many ways is similar to nosocomial pneumonia (NP). Patients with the diagnosis of CAP and HCAP admitted to our Pneumology Unit during one year were retrospectively analysed. The objective was to compare the characteristics and the approach of these two entities. 197 patients were included, 144 with CAP and 53 with HCAP. Sex, age, comorbilities, Pneumonia Severity Index (PSI) score, radiological involvement, bacteriology, treatment and outcomes were analysed in the 2 groups. Compared to CAP, HCAP was associated with more severe disease, a higher mortality rate and greater length of hospitalization. HCAP differed from CAP mainly in bacteriology and outcomes. Copyright © 2010 Sociedade Portuguesa de Pneumologia. Published by Elsevier España. All rights reserved.

  4. Group based diabetes self-management education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis.

    PubMed

    Steinsbekk, Aslak; Rygg, Lisbeth Ø; Lisulo, Monde; Rise, Marit B; Fretheim, Atle

    2012-07-23

    Diabetes self-management education (DSME) can be delivered in many forms. Group based DSME is widespread due to being a cheaper method and the added advantages of having patient meet and discuss with each other. assess effects of group-based DSME compared to routine treatment on clinical, lifestyle and psychosocial outcomes in type-2 diabetes patients. A systematic review with meta-analysis. Computerised bibliographic database were searched up to January 2008 for randomised controlled trials evaluating group-based DSME for adult type-2 diabetics versus routine treatment where the intervention had at least one session and =/>6 months follow-up. At least two reviewers independently extracted data and assessed study quality. In total 21 studies (26 publications, 2833 participants) were included. Of all the participants 4 out of 10 were male, baseline age was 60 years, BMI 31.6, HbA1c 8.23%, diabetes duration 8 years and 82% used medication. For the main clinical outcomes, HbA1c was significantly reduced at 6 months (0.44% points; P=0.0006, 13 studies, 1883 participants), 12 months (0.46% points; P=0.001, 11 studies, 1503 participants) and 2 years (0.87% points; P<0.00001, 3 studies, 397 participants) and fasting blood glucose levels were also significantly reduced at 12 months (1.26 mmol/l; P<0.00001, 5 studies, 690 participants) but not at 6 months. For the main lifestyle outcomes, diabetes knowledge was improved significantly at 6 months (SMD 0.83; P=0.00001, 6 studies, 768 participants), 12 months (SMD 0.85; P<0.00001, 5 studies, 955 participants) and 2 years (SMD 1.59; P=0.03, 2 studies, 355 participants) and self-management skills also improved significantly at 6 months (SMD 0.55; P=0.01, 4 studies, 534 participants). For the main psychosocial outcomes, there were significant improvement for empowerment/self-efficacy (SMD 0.28, P=0.01, 2 studies, 326 participants) after 6 months. For quality of life no conclusion could be drawn due to high heterogeneity. For the secondary outcomes there were significant improvements in patient satisfaction and body weight at 12 months for the intervention group. There were no differences between the groups in mortality rate, body mass index, blood pressure and lipid profile. Group-based DSME in people with type 2 diabetes results in improvements in clinical, lifestyle and psychosocial outcomes.

  5. ADA Title I allegations and the Mining, Quarrying, and Oil/Gas Extraction industry.

    PubMed

    Van Wieren, Todd A; Rhoades, Laura; McMahon, Brian T

    2017-01-01

    The majority of research about employment discrimination in the U.S. Mining, Quarrying, and Oil/Gas (MQOGE) industries has concentrated on gender and race, while little attention has focused on disability. To explore allegations of Americans with Disabilities Act (ADA) Title I discrimination made to the Equal Employment Opportunity Commission (EEOC) by individuals with disabilities against MQOGE employers. Key data available to this study included demographic characteristics of charging parties, size of employers, types of allegations, and case outcomes. Using descriptive analysis, allegation profiles were developed for MQOGE's three main sectors (i.e., Oil/Gas Extraction, Mining except Oil/Gas, and Support Activities). These three profiles where then comparatively analyzed. Lastly, regression analysis explored whether some of the available data could partially predict MQOGE case outcomes. The predominant characteristics of MQOGE allegations were found to be quite similar to the allegation profile of U.S. private-sector industry as a whole, and fairly representative of MQOGE's workforce demographics. Significant differences between MQOGE's three main sector profiles were noted on some important characteristics. Lastly, it was found that MQOGE case outcomes could be partially predicted via some of the available variables. The study's limitations were presented and recommendations were offered for further research.

  6. Expression of sperm PLCζ and clinical outcomes of ICSI-AOA in men affected by globozoospermia due to DPY19L2 deletion.

    PubMed

    Tavalaee, Marziyeh; Nomikos, Michail; Lai, F Anthony; Nasr-Esfahani, Mohammad Hossein

    2018-03-01

    Globozoospermia is characterized by the presence of 100% acrosomeless round-headed spermatozoa in an ejaculate. Failed fertilization after intracytoplasmic sperm injection (ICSI) is commonly reported for globozoospermic couples and can be overcome by artificial oocyte activation (AOA). Phospholipase C zeta (PLCζ) is one of the main sperm factors involved in oocyte activation and its low expression levels mainly account for fertilization failure. Deletion of the DPY19L2 gene is reported as a main genetic cause in over 70% of infertile men with globozoospermia. The current study assesses the expression profile of sperm PLCζ at RNA and protein levels in 32 DPY19L2 deletion-mediated globozoospermic men and reports corresponding clinical outcomes following ICSI with AOA. The expression of PLCζ relative to GAPDH at RNA (0.78 ± 0.16 versus 1.65 ± 0.24; P = 0.02) and protein (0.39 ± 0.12 versus 0.83 ± 0.13; P = 0.01) levels in globozoospermic men with DPY19L2 deletion was significantly lower compared with fertile men (n = 32). Fertilization rate in globozoospermic couples following ICSI-AOA was significantly lower compared with fertile men (53.14 ± 5.13% versus 87.64 ± 2.38%, P < 0.001). However, implantation (26.2%) and pregnancy (53.8%) rates were not jeopardized by DPY19L2 deletion in these couples. Copyright © 2017 Reproductive Healthcare Ltd. All rights reserved.

  7. Different outcomes of infection of chickens and ducks with a duck-origin H9N2 influenza A virus.

    PubMed

    Wang, J; Li, C C; Diao, Y X; Sun, X Y; Hao, D M; Liu, X; Ge, P P

    2014-01-01

    As the major aquatic and terrestrial hosts for avian influenza viruses (AIVs), ducks and chickens play a critical role in the evolution and spread of the H9N2 virus. However, the outcomes of infection of ducks and chickens with the H9N2 virus are not sufficiently documented. In this study, we compared the outcomes of infection of chickens and Peking ducks with a duck-origin H9N2 virus. The results showed that this virus caused more pronounced clinical signs and histological lesions in chickens. As for the virus shedding, chickens shed more virus in the trachea and less virus in the cloaca in levels of interferon (IFN) γ were found in the trachea of ducks compared with chickens, while comparison with ducks. As for cytokines, namely IFNs and interleukins (IL), higher higher levels of IFN-β, IFN-γ, IL-1β, and IL-6 were observed in the ileum of chickens compared with ducks. Eventually, serum hemagglutination-inhibition (HI) antibody titers were higher in chickens than in ducks. Taken together, ducks and chickens use different strategies in response to the H9N2 virus infection in tissues representing main replication sites of low-pathogenic AIVs. Given the different outcomes of the H9N2 virus infection in ducks and chickens, different measures should be taken in vaccination and treatment.

  8. Techniques of laparoscopic cholecystectomy: Nomenclature and selection.

    PubMed

    Haribhakti, Sanjiv P; Mistry, Jitendra H

    2015-01-01

    There are more than 50 different techniques of laparoscopic cholecystectomy (LC) available in literature mainly due to modifications by surgeons in aim to improve postoperative outcome and cosmesis. These modifications include reduction in port size and/or number than what is used in standard LC. There is no uniform nomenclature to describe these different techniques so that it is not possible to compare the outcomes of different techniques. We brief the advantages and disadvantages of each of these techniques and suggest the situation where particular technique would be useful. We also propose a nomenclature which is easy to remember and apply, so that any future comparison will be possible between the techniques.

  9. Contact investigation outcomes of Canadian-born adults with tuberculosis in Indigenous and non-Indigenous populations in Alberta.

    PubMed

    Eisenbeis, Lisa; Gao, Zhiwei; Heffernan, Courtney; Yacoub, Wadieh; Long, Richard; Verma, Geetika

    2016-06-27

    Contact investigations are a critical component of tuberculosis control in high-income countries. However, the relative success of conventional methods by population group and place of residence is unknown. This study compares outcomes of contact investigations of Canadian-born Indigenous tuberculosis cases living on- and off-reserve with other Canadian-born cases. In a retrospective analysis, Canadian-born adult culture-positive pulmonary TB cases (2001-2010) were identified. Characteristics of source cases and their contacts were compared by population group. Outcomes of contact investigations, including completion of recommended investigations and preventive therapy, were compared in multivariable analysis. Of 171 cases of tuberculosis identified, 49 (29%) were Indigenous on-reserve, 62 (36%) Indigenous off-reserve, and 60 (35%) non-Indigenous or Canadian-born, "other". Indigenous people had more contacts identified per case compared to non-Indigenous patients. Case population group and smear status were the main predictors of the success of contact investigations. Of those recommended preventive therapy, close contacts of Indigenous cases on-reserve had the highest rate of completion, at 54%, vs. 41% and 37% for close contacts of Indigenous living off-reserve and Canadian-born "other" respectively (p = 0.02). Contacts of Indigenous cases living off-reserve had the greatest delay in assessment and the lowest rates of completion of assessment and preventive therapy. In multivariable analysis, population group, smear status of source case and proximity of contact were predictors of preventive therapy acceptance and/or completion. Significant differences in outcomes of contact investigations were observed between population groups. The higher priority of contacts of smear-positive cases appears to influence efficiency of service delivery, regardless of population group. Jurisdictional differences in program delivery, resource availability and perceived risk of transmission likely influence outcomes of contact investigations.

  10. A Randomized Controlled Trial to Compare 2 Scalable Interventions for Lower Urinary Tract Symptom Prevention: Main Outcomes of the TULIP Study.

    PubMed

    Sampselle, Carolyn M; Newman, Diane K; Miller, Janis M; Kirk, Keri; DiCamillo, Mary Ann; Wagner, Todd H; Raghunathan, Trivellor E; Diokno, Ananias C

    2017-06-01

    We compared 2-year urinary incontinence and urgency scores of older women who attended a 2-hour bladder health class vs those who viewed a 20-minute abbreviated class video for the purpose of urinary incontinence prevention. A randomized, 2-arm, parallel design study was done to test the superiority of the 20-minute video over the 2-hour class. Outcomes at baseline, and 3, 12 and 24 months were the scores on questions 1 to 3 of ICIQ-SF (International Consultation on Incontinence Short Form) as the primary outcome and on IUSS (Indevus Urgency Severity Scale). Intent to treat analysis was done to compare the change from baseline in each intervention group across time and also with each other. Multiple imputation was used for missing data. A total of 647 women participated in the study. Mean age was 63 years and approximately 28% of the participants were African American, primarily from an urban setting. The 2 arms were balanced on body mass index at baseline, age, race/ethnicity, education, employment status, income and marital status. No differences in primary or secondary outcomes were demonstrated between the 2 groups from baseline to the 3, 12 or 24-month visits. The absence of significant differences in the outcome measures of ICIQ-SF and IUSS between the 2-hour class and the 20-minute video groups demonstrates that the 2 interventions were comparable. As urinary incontinence and urgency tend to rise annually in older women, instruction in bladder health self-care provided through either the 2-hour class or the 20-minute video format is a useful intervention to prevent urinary incontinence in older women. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  11. Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation.

    PubMed

    Camenzind, Edoardo; Wijns, William; Mauri, Laura; Boersma, Eric; Parikh, Keyur; Kurowski, Volkhard; Gao, Runlin; Bode, Christoph; Greenwood, John P; Gershlick, Anthony; O'Neill, William; Serruys, Patrick W; Jorissen, Brenda; Steg, P Gabriel

    2009-12-01

    Drug-eluting stents (DES) reduce restenosis rates compared to bare-metal stents. Most trials using DES enrolled selected patient and lesion subtypes, and primary endpoint focused on angiographic metrics or relatively short-term outcomes. When DES are used in broader types of lesions and patients, important differences may emerge in long-term outcomes between stent types, particularly the incidence of late stent thrombosis. PROTECT is a randomized, open-label trial comparing the long-term safety of the zotarolimus-eluting stent and the sirolimus-eluting stent. The trial has enrolled 8,800 patients representative of those seen in routine clinical practice, undergoing elective, unplanned, or emergency procedures in native coronary arteries in 196 centers in 36 countries. Indications for the procedure and selection of target vessel and lesion characteristics were at the operator's discretion. Procedures could be staged, but no more than 4 target lesions could be treated per patient. Duration of dual antiplatelet therapy was prespecified to achieve similar lengths of treatment in both study arms. The shortest predefined duration was 3 months, as per the manufacturer's instructions. The primary outcome measure is the composite rate of definite and probable stent thrombosis at 3 years, centrally adjudicated using Academic Research Consortium definitions. The main secondary end points are 3-year all-cause mortality, cardiac death, large nonfatal myocardial infarction, and all myocardial infarctions. This large, international, randomized, controlled trial will provide important information on comparative rates of stent thrombosis between 2 different DES systems and safety as assessed by patient-relevant long-term clinical outcomes.

  12. Assisted reproductive technology treatment in women with severe eating disorders: a national cohort study.

    PubMed

    Assens, Maria; Ebdrup, Ninna H; Pinborg, Anja; Schmidt, Lone; Hougaard, Charlotte O; Hageman, Ida

    2015-11-01

    This national retrospective cohort study investigates the prevalence of women with severe eating disorders in assisted reproductive technology (ART) treatment compared with an age-matched background population without ART treatment. It assesses the frequency distribution of the first and last eating disorder diagnosis before, during, and after ART treatment, and evaluates differences in obstetric outcomes between women with and without a severe eating disorder. Hospital-diagnosed eating disorders among 42,915 women in the Danish National ART cohort (DANAC), registered during 1994-2009 in the mandatory Psychiatric Central Research Register, were compared with a non-eating disorder ART cohort of 42,644 women and an age-matched background population of 215,290 women without a history of ART treatment for the main outcome measures prevalence of eating disorders, frequency distribution of diagnoses before/during/after ART treatment, as well as ART treatment and obstetric outcomes. In the ART cohort, 271 women (0.63%) had an eating disorder diagnosis compared with 0.73% in the background population (p = 0.025). The prevalence of ovulatory disorder was significantly higher in women with a severe eating disorder compared with the ART cohort without eating disorders. Obstetric outcomes were similar in ART-treated women with and without an eating disorder. Women with severe eating disorders were identified in the ART cohort, although significantly less often than in the age-matched background population. Women with severe eating disorders suffered more often from anovulatory infertility than the ART comparison cohort without this disease. Obstetric outcomes appeared reassuring in the ART cohort with eating disorders. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

  13. Provisional versus elective two-stent strategy for unprotected true left main bifurcation lesions: Insights from a FAILS-2 sub-study.

    PubMed

    Kawamoto, Hiroyoshi; Chieffo, Alaide; D'Ascenzo, Fabrizio; Jabbour, Richard J; Naganuma, Toru; Cerrato, Enrico; Ugo, Fabrizio; Pavani, Marco; Varbella, Ferdinando; Boccuzzi, Giacomo; Pennone, Mauro; Garbo, Roberto; Conrotto, Federico; Biondi-Zoccai, Giuseppe; D'Amico, Maurizio; Moretti, Claudio; Escaned, Javier; Gaita, Fiorenzo; Nakamura, Sunao; Colombo, Antonio

    2018-01-01

    This study sought to investigate the optimal percutaneous coronary intervention (PCI) strategy for true unprotected left main coronary artery (ULMCA) bifurcations. The FAILS-2 was a retrospective multi-center study including patients with ULMCA disease treated with second-generation drug-eluting stents. Of these, we compared clinical outcomes of a provisional strategy (PS; n=216) versus an elective two-stent strategy (E2S; n=161) for true ULMCA bifurcations. The primary endpoint was the incidence of major adverse cardiac events (MACEs) at 3-years. We further performed propensity-score adjustment for clinical outcomes. There were no significant differences between the groups in terms of patient and lesion characteristics. 9.7% of patients in the PS group crossed over to a provisional two-stent strategy. MACEs were not significantly different between groups (MACE at 3-year; PS 28.1% vs. E2S 28.9%, adjusted p=0.99). The rates of target lesion revascularization (TLR) on the circumflex artery (LCX) were numerically high in the E2S group (LCX-TLR at 3-years; PS 11.8% vs. E2S 16.6%, adjusted p=0.51). E2S was associated with a comparable MACE rate to PS for true ULMCA bifurcations. The rates of LCX-TLR tended to be higher in the E2S group although there was no statistical significance. This study sought to compare the clinical outcomes of a provisional strategy (PS) with an elective two-stent strategy (E2S) for the treatment of true unprotected left main coronary artery bifurcations. 377 Patients (PS 216 vs. E2S 161 patients) were evaluated, and 9.7% in the PS group crossed over to a two-stent strategy. E2S was associated with a similar major adverse cardiac event rate at 3-years when compared to the PS strategy (PS 28.1% vs. E2S 28.9%, p=0.99). However, the left circumflex artery TLR rate at 3-year tended to be higher in the E2S group (PS 11.8% vs. E2S 16.6%, p=0.51). Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Prediction of Outcome after Moderate and Severe Traumatic Brain Injury: External Validation of the IMPACT and CRASH Prognostic Models

    PubMed Central

    Roozenbeek, Bob; Lingsma, Hester F.; Lecky, Fiona E.; Lu, Juan; Weir, James; Butcher, Isabella; McHugh, Gillian S.; Murray, Gordon D.; Perel, Pablo; Maas, Andrew I.R.; Steyerberg, Ewout W.

    2012-01-01

    Objective The International Mission on Prognosis and Analysis of Clinical Trials (IMPACT) and Corticoid Randomisation After Significant Head injury (CRASH) prognostic models predict outcome after traumatic brain injury (TBI) but have not been compared in large datasets. The objective of this is study is to validate externally and compare the IMPACT and CRASH prognostic models for prediction of outcome after moderate or severe TBI. Design External validation study. Patients We considered 5 new datasets with a total of 9036 patients, comprising three randomized trials and two observational series, containing prospectively collected individual TBI patient data. Measurements Outcomes were mortality and unfavourable outcome, based on the Glasgow Outcome Score (GOS) at six months after injury. To assess performance, we studied the discrimination of the models (by AUCs), and calibration (by comparison of the mean observed to predicted outcomes and calibration slopes). Main Results The highest discrimination was found in the TARN trauma registry (AUCs between 0.83 and 0.87), and the lowest discrimination in the Pharmos trial (AUCs between 0.65 and 0.71). Although differences in predictor effects between development and validation populations were found (calibration slopes varying between 0.58 and 1.53), the differences in discrimination were largely explained by differences in case-mix in the validation studies. Calibration was good, the fraction of observed outcomes generally agreed well with the mean predicted outcome. No meaningful differences were noted in performance between the IMPACT and CRASH models. More complex models discriminated slightly better than simpler variants. Conclusions Since both the IMPACT and the CRASH prognostic models show good generalizability to more recent data, they are valid instruments to quantify prognosis in TBI. PMID:22511138

  15. Outcome of Vaginoplasty in Male-to-Female Transgenders: A Systematic Review of Surgical Techniques.

    PubMed

    Horbach, Sophie E R; Bouman, Mark-Bram; Smit, Jan Maerten; Özer, Müjde; Buncamper, Marlon E; Mullender, Margriet G

    2015-06-01

    Gender reassignment surgery is the keystone of the treatment of transgender patients. For male-to-female transgenders, this involves the creation of a neovagina. Many surgical methods for vaginoplasty have been opted. The penile skin inversion technique is the method of choice for most gender surgeons. However, the optimal surgical technique for vaginoplasty in transgender women has not yet been identified, as outcomes of the different techniques have never been compared. With this systematic review, we aim to give a detailed overview of the published outcomes of all currently available techniques for vaginoplasty in male-to-female transgenders. A PubMed and EMBASE search for relevant publications (1995-present), which provided data on the outcome of techniques for vaginoplasty in male-to-female transgender patients. Main outcome measures are complications, neovaginal depth and width, sexual function, patient satisfaction, and improvement in quality of life (QoL). Twenty-six studies satisfied the inclusion criteria. The majority of these studies were retrospective case series of low to intermediate quality. Outcome of the penile skin inversion technique was reported in 1,461 patients, bowel vaginoplasty in 102 patients. Neovaginal stenosis was the most frequent complication in both techniques. Sexual function and patient satisfaction were overall acceptable, but many different outcome measures were used. QoL was only reported in one study. Comparison between techniques was difficult due to the lack of standardization. The penile skin inversion technique is the most researched surgical procedure. Outcome of bowel vaginoplasty has been reported less frequently but does not seem to be inferior. The available literature is heterogeneous in patient groups, surgical procedure, outcome measurement tools, and follow-up. Standardized protocols and prospective study designs are mandatory for correct interpretation and comparability of data. © 2015 International Society for Sexual Medicine.

  16. Different labour outcomes in primiparous women that have been subjected to childhood sexual abuse or rape in adulthood: a case–control study in a clinical cohort

    PubMed Central

    Nerum, H; Halvorsen, L; Straume, B; Sørlie, T; Øian, P

    2013-01-01

    Objective To compare the duration and outcome of the first labour in women who have been subjected to childhood sexual abuse (CSA) and women who have been raped in adulthood (RA). Design Case–control study in a clinical cohort. Setting University Hospital of North Norway. Sample In all, 373 primiparas: 185 subjected to CSA, 47 to RA and 141 controls without a history of abuse. Methods Data on birth outcomes were retrieved from the patient files. Information on sexual abuse was reported in consultation with specialised midwives in the mental health team. Birth outcomes were analysed by multinominal regression analysis. Main outcome measures Vaginal births, delivery by caesarean section, operative vaginal delivery and duration of labour. Results As compared with controls, the RA group showed a significantly higher risk for caesarean section (adjusted OR 9.9, 95% CI 3.4–29.4) and operative vaginal delivery (adjusted OR 12.2, 95% CI 4.4–33.7). There were no significant differences between the CSA and the control group. The RA group displayed significantly longer duration of labour in all phases as compared with the control and CSA groups. Conclusions There were major differences in the duration of labour and birth outcomes in the two abuse groups. Despite a higher proportion of obstetric risk factors at onset of labour in the CSA group, women subjected to CSA had shorter labours and less risk for caesarean section and operative vaginal deliveries than women subjected to RA. The best care for birthing women subjected to sexual abuse needs to be explored in further studies. PMID:23157417

  17. Women hospitalized with atrial fibrillation: gender differences, trends and outcome from a 20-year registry in a Middle Eastern country (1991-2010).

    PubMed

    Salam, Amar M; AlBinali, Hajar A; Al-Mulla, Abdul Wahid; Asaad, Nidal; Singh, Rajvir; Al-Qahtani, Awad; Al Suwaidi, Jassim

    2013-09-30

    Most of the published research on atrial fibrillation (AF) is limited to studies in the developed world and included mainly Caucasian patients. Data about women with AF among other ethnicities is very limited. The aim of this study was to compare the clinical characteristics, treatment and outcome of women to men hospitalized with AF in a middle-eastern country. Retrospective analysis of prospective registry of all patients hospitalized with AF in Qatar from 1991 through 2010 was made. Clinical characteristics, management, and outcomes of AF patients were compared according to gender. During the 20-years period; 1417 women and 2432 men were hospitalized for AF. Women were 5 years older and more likely to have diabetes mellitus, hypertension, and chronic renal impairment and were also less likely to be current smokers and to have ischemic heart disease and impaired left ventricular function when compared to men. There was no gender preference in the use of anticoagulation. The prevalence of concomitant ischemic heart disease and hypertension increased, while the prevalence of valvular heart disease and heart failure decreased among patients hospitalized with AF over the study period. In-hospital mortality and stroke rates were comparable between the two groups. Women hospitalized with atrial fibrillation were older in age and had higher prevalence of co-morbid cardiovascular risk factors compared to men whereas, mortality and stroke rates were comparable. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  18. [Comparative oncologic and functional outcomes of prostate cancer surgery with other curative treatments].

    PubMed

    Soulié, M; Salomon, L

    2015-11-01

    Review of the comparative results of different treatment strategies (surgery, radiotherapy, ultrasound, surveillance) of prostate cancer, in which the main goal is the local control and the second target is the tolerance of the side effects of those treatments. Review of literature using Medline databases selected based on scientific relevance. Clinical keys centered on the oncological and functional outcomes of comparative series between different curative treatments. The numerous comparative series between surgery and other therapeutic modalities are essentially retrospective with significant methodological bias that is difficult to overcome in order to formulate the optimal thesis. However, there is a clear tendency toward surgery usually with young patients who have intermediate risk tumors without important comorbidity. In the absence of randomized comparative series with significant power, the oncological and functional results of the radical prostatectomy with or without adjuvant treatment seem at least the same, in a selected population of patients, compared with the combination of radiotherapy-hormonotherapy in terms of survival, without biochemical recurrence, disease-specific survival and overall survival, for the aggressive tumors necessitating curative local treatments. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  19. Benefits of using a hybrid problem-based learning curriculum to improve long-term learning acquisition in undergraduate biology education.

    PubMed

    Carrió, Mar; Agell, Laia; Baños, Josep Eladi; Moyano, Elisabeth; Larramona, Pilar; Pérez, Jorge

    2016-08-01

    Although problem-based learning (PBL) has been used for over 40 years, with many studies comparing the benefits of PBL versus other educational approaches, little attention has been paid to the effectiveness of hybrid PBL (H-PBL) curricula. Here we aimed to compare the learning outcomes of two groups of undergraduate biology students working towards a bachelor's degree: one group used an H-PBL approach, while the second used a lecture-based learning (LBL) approach. Specifically, the H-PBL group used a PBL module with interdisciplinary problems, which represented 20% of the entire curriculum. The main outcomes of evaluation were the long-term acquisition of factual knowledge and the problem-solving skills at the end of the bachelor's degree. The sample included 85 students, 39 in the H-PBL group and 46 in the LBL group. We found that an H-PBL curriculum can improve the students' learning outcomes such as long-term knowledge acquisition, problem solving skills and generic competences. © FEMS 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  20. Deafferentation in thalamic and pontine areas in severe traumatic brain injury.

    PubMed

    Laouchedi, M; Galanaud, D; Delmaire, C; Fernandez-Vidal, S; Messé, A; Mesmoudi, S; Oulebsir Boumghar, F; Pélégrini-Issac, M; Puybasset, L; Benali, H; Perlbarg, V

    2015-07-01

    Severe traumatic brain injury (TBI) is characterized mainly by diffuse axonal injuries (DAI). The cortico-subcortical disconnections induced by such fiber disruption play a central role in consciousness recovery. We hypothesized that these cortico-subcortical deafferentations inferred from diffusion MRI data could differentiate between TBI patients with favorable or unfavorable (death, vegetative state, or minimally conscious state) outcome one year after injury. Cortico-subcortical fiber density maps were derived by using probabilistic tractography from diffusion tensor imaging data acquired in 24 severe TBI patients and 9 healthy controls. These maps were compared between patients and controls as well as between patients with favorable (FO) and unfavorable (UFO) 1-year outcome to identify the thalamo-cortical and ponto-thalamo-cortical pathways involved in the maintenance of consciousness. Thalamo-cortical and ponto-thalamo-cortical fiber density was significantly lower in TBI patients than in healthy controls. Comparing FO and UFO TBI patients showed thalamo-cortical deafferentation associated with unfavorable outcome for projections from ventral posterior and intermediate thalamic nuclei to the associative frontal, sensorimotor and associative temporal cortices. Specific ponto-thalamic deafferentation in projections from the upper dorsal pons (including the reticular formation) was also associated with unfavorable outcome. Fiber density of cortico-subcortical pathways as measured from diffusion MRI tractography is a relevant candidate biomarker for early prediction of one-year favorable outcome in severe TBI. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  1. Ovarian reserve and subsequent ART outcomes following methotrexate therapy for ectopic pregnancy and pregnancy of unknown location

    PubMed Central

    Hill, Micah J.; Cooper, Janelle C.; Levy, Gary; Alford, Connie; Richter, Kevin S.; DeCherney, Alan H.; Katz, Charles; Levens, Eric D.; Wolff, Erin F.

    2013-01-01

    Objective It is unclear whether the stimulated state of the ovaries as part of ART results in an increased vulnerability to the effects of methotrexate. The objective of this study was to assess ovarian reserve following methotrexate treatment for ectopic pregnancy or pregnancy of unknown location after ART. Design Retrospective cohort study. Setting Large ART practice. Patients Methotrexate or surgery following ART. Interventions None. Main Outcome Measures Follicle stimulating hormone (FSH), antral follicle count (AFC), and oocyte yield were compared between subjects treated with methotrexate and surgery. Secondary outcomes were clinical pregnancy and live birth. Results There were 153 patients in the methotrexate group and 36 patients in the surgery group. Neither group demonstrated differences in ovarian reserve or oocyte yield comparing before and after treatment values. The change in ovarian reserve and oocyte yield after treatment were similar between the two groups. The number of doses of methotrexate was not correlated with changes in ovarian reserve, indicating no dose-dependent effect. Time between treatment and repeat ART was not correlated with outcomes. Live birth in subsequent cycles was similar in the two groups. Conclusions Ovarian reserve and subsequent ART cycle outcomes were reassuring following methotrexate and surgical management of ectopic pregnancy. An adverse impact of methotrexate was not detected in this large fertility cohort as has been previously described. PMID:24269042

  2. Impact of social challenges on gaining employment for veterans with posttraumatic stress disorder: an exploratory moderator analysis.

    PubMed

    Davis, Lori L; Pilkinton, Patricia; Poddar, Swati; Blansett, Catherine; Toscano, Richard; Parker, Pamela E

    2014-06-01

    To explore whether psychosocial challenges impact effects of vocational rehabilitation in Veterans with Posttraumatic Stress Disorder (PTSD). A post hoc exploratory analysis of possible moderators of treatment was conducted on outcomes from a randomized, controlled trial of Individual Placement and Support in Veterans with PTSD. When examining groups within each moderator, there was a greater IPS supportive employment benefit in gaining competitive employment for those with inadequate transportation (number needed to treat [NNT] = 1.5) and inadequate housing (NNT = 1.5) compared with the main finding of the pilot study (NNT = 2.07). Compared with the main finding of the pilot study, there was no greater advantage of IPS for those with adequate transportation (NNT = 2.4) or adequate housing (NNT = 2.4). Compared with the main finding in the pilot study, those without a family care burden had a greater benefit from IPS (NNT = 1.4) and those with family care burden had a reduced treatment effect (NNT = 3.3). These results are exploratory and are not intended to guide clinical decision-making, but rather offer a potentially useful strategy in the design of larger trials of IPS.

  3. Neonatal and maternal outcomes of successful manual rotation to correct malposition of the fetal head; A retrospective and prospective observational study

    PubMed Central

    Tempest, Nicola; McGuinness, Naomi; Lane, Steven; Hapangama, Dharani K.

    2017-01-01

    Objective To evaluate the neonatal and maternal outcomes associated with successful operative vaginal births assisted by manual rotation. Design Prospective and retrospective observational study. Setting Delivery suite in a tertiary referral teaching hospital in England. Population A cohort of 2,426 consecutive operative births, in the second stage of labour, complicated with malposition of the fetal head during 2006–2013. Methods Outcomes of all births successfully assisted by manual rotation followed by direct traction instruments were compared with other methods of operative birth for fetal malposition in the second stage of labour (rotational ventouse, Kielland forceps and caesarean section). Main outcome measures Associated neonatal outcomes (admission to the special care baby unit, low cord pH, low Apgar and shoulder dystocia) and maternal outcomes (massive obstetric haemorrhage (blood loss of >1500ml) and obstetric anal sphincter injury). Results Births successfully assisted with manual rotation followed by direct traction instruments, resulted in 10% (36/346) of the babies being admitted to the Special Care Baby Unit, 4.9% (17/349) shoulder dystocia, 2% (7/349) massive obstetric haemorrhage and 1.7% (6/349) obstetric anal sphincter injury, similar to other methods of rotational births. Conclusions Adverse neonatal and maternal outcomes associated with successful manual rotations followed by direct traction instruments were comparable to traditional methods of operative births. There is an urgent need to standardise the practice (guidance, training) and documentation of manual rotation followed by direct traction instrumental deliveries that will enable assessment of its efficacy and the absolute safety in achieving a vaginal birth. PMID:28489924

  4. Perinatal outcome of monochorionic and dichorionic twins after spontaneous and assisted conception: a retrospective cohort study.

    PubMed

    Hack, Karien E A; Vereycken, Marijn E M S; Torrance, Helen L; Koopman-Esseboom, Corine; Derks, Jan B

    2018-06-01

    The aim of this study was to compare pregnancy outcomes in twin pregnancies after assisted conception and spontaneous conception, according to chorionicity. Retrospective cohort study of 1305 twin pregnancies between 1995 and 2015. All spontaneous (n = 731) and assisted conception conceived (n = 574) twin pregnancies with antenatal care and delivery in University Medical Center Utrecht, the Netherlands, a tertiary obstetric care center were studied according to chorionicity. Maternal age and incidence of nulliparity were higher among the assisted conception twins. Hypertensive disorders also appeared to be more frequent in assisted conception pregnancies, which could largely be explained by the higher proportion of elderly nulliparous women in this group. Spontaneously conceived twins were born earlier than twins after assisted conception, with subsequent lower birthweights and more admissions to a neonatal intensive care unit with increased neonatal morbidity. Monochorionic twins had worse pregnancy outcomes compared with dichorionic twins, irrespective of mode of conception; monochorionic twins conceived by assisted reproduction had more neonatal morbidity (mainly respiratory distress syndrome and necrotizing enterocolitis) and late neonatal deaths compared with spontaneously conceived monochorionic twins. Spontaneously conceived twins have worse pregnancy outcome compared with twins after assisted conception, probably due to a lower incidence of monochorionicity in the assisted conception group. The already increased perinatal risks in monochorionic twins are even higher in monochorionic twins conceived after infertility treatments compared with spontaneously conceived monochorionic twins, which warrants extra attention to these high-risk pregnancies. © 2018 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).

  5. Short- and long-term clinical outcomes of use of beta-interferon or glatiramer acetate for people with clinically isolated syndrome: a systematic review of randomised controlled trials and network meta-analysis.

    PubMed

    Armoiry, X; Kan, A; Melendez-Torres, G J; Court, R; Sutcliffe, P; Auguste, P; Madan, J; Counsell, C; Clarke, A

    2018-05-01

    Beta-interferon (IFN-β) and glatiramer acetate (GA) have been evaluated in people with clinically isolated syndrome (CIS) with the aim to delay a second clinical attack and a diagnosis of clinically definite multiple sclerosis (CDMS). We systematically reviewed trials evaluating the short- and long-term clinical effectiveness of these drugs in CIS. We searched multiple electronic databases. We selected randomised controlled studies (RCTs) conducted in CIS patients and where the interventions were IFN-β and GA. Main outcomes were time to CDMS, and discontinuation due to adverse events (AE). We compared interventions using random-effect network meta-analyses (NMA). We also reported outcomes from long-term open-label extension (OLE) studies. We identified five primary studies. Four had open-label extensions following double-blind periods comparing outcomes between early vs delayed DMT. Short-term clinical results (double-blind period) showed that all drugs delayed CDMS compared to placebo. Indirect comparisons did not suggest superiority of any one active drug over another. We could not undertake a NMA for discontinuation due to AE. Long-term clinical results (OLE studies) showed that the risk of developing CDMS was consistently reduced across studies after early DMT treatment compared to delayed DMT (HR = 0.64, 95% CI 0.55, 0.74). No data supported the benefit of DMTs in reducing the time to, and magnitude of, disability progression. Meta-analyses confirmed that IFN-β and GA delay time to CDMS compared to placebo. In the absence of evidence that early DMTs can reduce disability progression, future research is needed to better identify patients most likely to benefit from long-term DMTs.

  6. A laparoscopic approach to CBD stones.

    PubMed

    Khanzada, Zubair; Morgan, Richard

    2013-12-01

    : This study aimed to evaluate single-stage surgical (laparoscopic or open) approach to the management of common bile duct (CBD) stones, as treatment of choice. Prospectively collected data to assess outcomes of CBD clearance, morbidity, mortality, and hospital stay, and compared with published data. Successful clearance of CBD stones was achieved in 96% cases, laparoscopic exploration successful in 83%. Retained stones were found in 4% cases and another 5% developed postoperative complications. Common length of stay in hospital was 2 days, although mean stay was 4 days. Seventy-three percent of cases were elective, 27% were emergencies. Conversion rate to open surgery was 14%, which was mainly in emergency cases. Postoperative mortality was 1.2%, not directly related to the procedure. Good outcomes can be achieved, comparing favorably with those of other modalities, when laparoscopic bile duct exploration is chosen as treatment for CBD stones; the best results can be anticipated in elective patients.

  7. Generation Y and the Integrated Plastic Surgery Residency Match: A Cross-sectional Study of the 2011 Match Outcomes

    PubMed Central

    Narayan, Deepak

    2013-01-01

    Background: Plastic surgery is the most competitive specialty in medicine. We sought to identify factors associated with the successful match of generation Y applicants into integrated plastic surgery residency. Methods: We utilized the most recent data from the Charting Outcomes in the Match published by the National Resident Matching Program in 2011. We had data on US senior or independent applicant status, Alpha Omega Alpha (AOA) status, attendance of top 40 medical schools, advanced degree status, and number of contiguous ranks within plastic surgery. Our main outcome measure was match status. Results: A total of 81 out of 197 applicants (41.1%) successfully matched into integrated plastic surgery in the 2011 main match. US seniors matched at a significantly higher rate compared to independent applicants (44.0% vs 24.1%, P = 0.044). Matched US seniors were more likely to have AOA membership compared to unmatched US seniors (45.9% vs 27.7%, P = 0.014) and attend a top 40 medical school (52.7% vs 35.1%, P = 0.022). There were no differences in terms of advanced degrees between matched and unmatched US seniors. Unmatched US seniors were more likely to have 3 or fewer contiguous ranks of plastic surgery residency programs than matched US seniors (86.2% vs 68.9%, P = 0.007). Conclusions: US senior status, AOA membership, and attendance at a top 40 medical school are predictors of matching into integrated plastic surgery. Program directors need to be aware of the background of the millennial applicants to recruit and maintain top residents. PMID:25289227

  8. The economics of employing a counsellor in general practice: analysis of data from a randomised controlled trial.

    PubMed Central

    Friedli, K; King, M B; Lloyd, M

    2000-01-01

    BACKGROUND: Counselling is currently adopted in many general practices, despite limited evidence of clinical and cost effectiveness. AIM: To compare direct and indirect costs of counsellors and general practitioners (GPs) in providing care to people with emotional problems. METHOD: We carried out a prospective, randomized controlled trial of non-directive counselling and routine general practice care in 14 general practices in north London. Counsellors adhered to a Rogerian model of counselling. The counselling sessions ranged from one to 12 sessions over 12 weeks. As reported elsewhere, there were no differences in clinical outcomes between the two groups. Therefore, we conducted a cost minimisation analysis. We present only the economic outcomes in this paper. Main outcome measures were cost data (service utilisation, travel, and work absence) at baseline, three months, and nine months. RESULTS: One hundred and thirty-six patients with emotional problems, mainly depression, took part. Seventy patients were randomised to the counsellors and 66 to the GPs. The average direct and indirect costs for the counsellor was 162.09 Pounds more per patient after three months compared with costs for the GP group; however, over the following six months the counsellor group was 87.00 Pounds less per patient than the GP group. Over the total nine-month period, the counsellor group remained more expensive per patient. CONCLUSIONS: Referral to counselling is no more clinically effective or expensive than GP care over a nine-month period in terms of direct plus indirect costs. However, further research is needed to establish indirect costs of introducing a counsellor into general practice. PMID:10897510

  9. CABG Surgery Remains the best Option for Patients with Left Main Coronary Disease in Comparison with PCI-DES: Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Sá, Michel Pompeu Barros Oliveira; Soares, Artur Freire; Miranda, Rodrigo Gusmão Albuquerque; Araújo, Mayara Lopes; Menezes, Alexandre Motta; Silva, Frederico Pires Vasconcelos; Lima, Ricardo Carvalho

    2017-01-01

    Objective To compare the safety and efficacy of coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) using drug-eluting stents (DES) in patients with unprotected left main coronary artery (ULMCA) disease. Methods MEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LILACS, Google Scholar and reference lists of relevant articles were searched for clinical studies that reported outcomes at 1-year follow-up after PCI with DES and CABG for the treatment of ULMCA stenosis. Five studies fulfilled our eligibility criteria and they included a total of 4.595 patients (2.298 for CABG and 2.297 for PCI with DES). Results At 1-year follow-up, there was no significant difference between CABG and DES groups concerning the risk for death (risk ratio [RR] 0.973, P=0.830), myocardial infarction (RR 0.694, P=0.148), stroke (RR 1.224, P=0.598), and major adverse cerebrovascular and cardiovascular events (RR 0.948, P=0.680). The risk for target vessel revascularization (TVR) was significantly lower in the CABG group compared to the DES group (RR 0.583, P<0.001). It was observed no publication bias regarding the outcomes, but only the outcome TVR was free from substantial statistical heterogeneity of the effects. In the meta-regression, there was evidence that the factor "female gender" modulated the effect regarding myocardial infarction rates, favoring the CABG strategy. Conclusion CABG surgery remains the best option of treatment for patients with ULMCA disease, with lower TVR rates. PMID:29211222

  10. Need for Supplemental Oxygen at Discharge in Infants with Bronchopulmonary Dysplasia Is Not Associated with Worse Neurodevelopmental Outcomes at 3 Years Corrected Age

    PubMed Central

    Lodha, Abhay; Sauvé, Reg; Bhandari, Vineet; Tang, Selphee; Christianson, Heather; Bhandari, Anita; Amin, Harish; Singhal, Nalini

    2014-01-01

    Objectives To determine if chronic oxygen dependency (discharge home on supplemental oxygen) in children with bronchopulmonary dysplasia (BPD; defined as requirement for supplemental O2 at 36 weeks postmenstrual age) predicts neurodevelopmental disability rates and growth outcomes at 36 months corrected age (CA). Study Design Longitudinal cohort study. Setting Southern Alberta regional center located at high altitude. Participants Preterm infants weighing ≤1250 grams with no BPD, BPD, and BPD with chronic oxygen dependency. Main outcome measures Neurodevelopmental and growth outcomes. Results Of 1563 preterm infants admitted from 1995–2007, 1212 survived. Complete follow-up data were available for 1030 (85%) children. Children in BPD and BPD with chronic oxygen dependency groups had significantly lower birth weights, gestational ages, prolonged mechanical ventilation and oxygen supplementation and received more postnatal steroids, compared to those without BPD. Children with BPD and BPD with chronic oxygen dependency were more likely to be below the 5th centile in weight and height compared to those without BPD but there was little difference between the BPD and BPD with chronic oxygen dependency groups. After controlling for confounding variables, children who had BPD and BPD with chronic oxygen dependency had higher odds of neurodevelopmental disability compared to those without BPD [OR (odds ratio) 1.9 (95%CI 1.1 to 3.5) and OR 1.8 (1.1 to 2.9), respectively], with no significant difference between BPD and BPD with chronic oxygen dependency [OR 0.9 (95% CI 0.6 to 1.5)]. Conclusions BPD and BPD with chronic oxygen dependency in children predicts abnormal neurodevelopmental outcomes at 36 months CA. However, the neurodevelopmental disability rates were not significantly higher in BPD with chronic oxygen dependency children compared to children with BPD only. Compared to those without BPD, growth is impaired in children with BPD and BPD with chronic oxygen dependency, but no difference between the latter two groups. PMID:24646665

  11. Predicting Trans-epithelial Phototherapeutic Keratectomy Outcomes Using Fourier-Domain Optical Coherence Tomography

    PubMed Central

    Cleary, Catherine; Li, Yan; Tang, Maolong; Gendy, Nehal Samy El; Huang, David

    2014-01-01

    Purpose To use Fourier-domain optical coherence tomography (FD-OCT) to predict trans-epithelial phototherapeutic keratectomy (TE-PTK) outcomes. Methods Prospective case series. Subjects with anterior stromal corneal opacities underwent excimer laser PTK combined with PRK using the VISX S4 excimer laser (AMO, Inc., Santa Ana, CA). Pre- and postoperative FD-OCT images were used to develop a simulation algorithm to predict treatment outcomes. Main Outcome Measures Pre- and postoperative uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA). Postoperative corneal thickness and manifest refraction spherical equivalent (MRSE) were analyzed using multivariate linear regression. Results Nine eyes of 8 patients were treated. Nominal ablation depth was 75 – 177 μm centrally and 62 –185 μm peripherally. Measured PTK ablation depths were 20% higher centrally and 26% higher peripherally, compared to laser settings. Postoperatively, mean UDVA was 20/41 (range 20/25 – 20/80) compared to 20/103 (range 20/60 – 20/400) preoperatively. Mean CDVA was 20/29 (range 20/15 – 20/60) compared to 20/45 (range 20/30 – 20/80) preoperatively. MRSE was +1.38±2.37 D compared to −2.59±2.83D (mean±SD). Mean astigmatism magnitude was 1.14±0.83D compared to 1.40±1.18D preoperatively. Postoperative MRSE correlated strongly with ablation settings, central and peripheral epithelial thickness (r=0.99, p<0.00001 ). Central island remained difficult to predict and limited visual outcomes in some cases. Conclusion OCT measurements of opacity depth and 3D ablation simulation provide valuable guidance PTK planning. Post-PTK refraction may be predicted with a regression formula which uses OCT epithelial thickness measurements. Laser ablation rates described in this study only apply to the VisX laser. PMID:24452208

  12. Implementation of the Nutrition Care Process and International Dietetics and Nutrition Terminology in a single-center hemodialysis unit: comparing paper vs electronic records.

    PubMed

    Rossi, Megan; Campbell, Katrina Louise; Ferguson, Maree

    2014-01-01

    There is little doubt surrounding the benefits of the Nutrition Care Process and International Dietetics and Nutrition Terminology (IDNT) to dietetics practice; however, evidence to support the most efficient method of incorporating these into practice is lacking. The main objective of our study was to compare the efficiency and effectiveness of an electronic and a manual paper-based system for capturing the Nutrition Care Process and IDNT in a single in-center hemodialysis unit. A cohort of 56 adult patients receiving maintenance hemodialysis were followed for 12 months. During the first 6 months, patients received the usual standard care, with documentation via a manual paper-based system. During the following 6-month period (Months 7 to 12), nutrition care was documented by an electronic system. Workload efficiency, number of IDNT codes used related to nutrition-related diagnoses, interventions, monitoring and evaluation using IDNT, nutritional status using the scored Patient-Generated Subjective Global Assessment Tool of Quality of Life were the main outcome measures. Compared with paper-based documentation of nutrition care, our study demonstrated that an electronic system improved the efficiency of total time spent by the dietitian by 13 minutes per consultation. There were also a greater number of nutrition-related diagnoses resolved using the electronic system compared with the paper-based documentation (P<0.001). In conclusion, the implementation of an electronic system compared with a paper-based system in a population receiving hemodialysis resulted in significant improvements in the efficiency of nutrition care and effectiveness related to patient outcomes. Copyright © 2014 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  13. A review of the Australian healthcare system: A policy perspective

    PubMed Central

    Sambasivan, Murali

    2018-01-01

    This article seeks to review the Australian healthcare system and compare it to similar systems in other countries to highlight the main issues and problems. A literature search for articles relating to the Australian and other developed countries’ healthcare systems was conducted by using Google and the library of Victoria University, Melbourne. Data from the websites of the Commonwealth of Australia, the Australian Institute of Health and Welfare, the Australian Productivity Commission, the Organisation for Economic Co-operation and Development and the World Bank have also been used. Although care within the Australian healthcare system is among the best in the world, there is a need to change the paradigm currently being used to measure the outcomes and allocate resources. The Australian healthcare system is potentially dealing with two main problems: (a) resource allocation, and (b) performance and patient outcomes improvements. An interdisciplinary research approach in the areas of performance measurement, quality and patient outcomes improvement could be adopted to discover new insights, by using the policy implementation error/efficiency and bureaucratic capacity. Hospital managers, executives and healthcare management practitioners could use an interdisciplinary approach to design new performance measurement models, in which financial performance, quality, healthcare and patient outcomes are blended in, for resource allocation and performance improvement. This article recommends that public policy implementation error and the bureaucratic capacity models be applied to healthcare to optimise the outcomes for the healthcare system in Australia. In addition, it highlights the need for evaluation of the current reimbursement method, freedom of choice to patients and a regular scrutiny of the appropriateness of care. PMID:29686869

  14. A review of the Australian healthcare system: A policy perspective.

    PubMed

    Dixit, Sunil K; Sambasivan, Murali

    2018-01-01

    This article seeks to review the Australian healthcare system and compare it to similar systems in other countries to highlight the main issues and problems. A literature search for articles relating to the Australian and other developed countries' healthcare systems was conducted by using Google and the library of Victoria University, Melbourne. Data from the websites of the Commonwealth of Australia, the Australian Institute of Health and Welfare, the Australian Productivity Commission, the Organisation for Economic Co-operation and Development and the World Bank have also been used. Although care within the Australian healthcare system is among the best in the world, there is a need to change the paradigm currently being used to measure the outcomes and allocate resources. The Australian healthcare system is potentially dealing with two main problems: (a) resource allocation, and (b) performance and patient outcomes improvements. An interdisciplinary research approach in the areas of performance measurement, quality and patient outcomes improvement could be adopted to discover new insights, by using the policy implementation error/efficiency and bureaucratic capacity. Hospital managers, executives and healthcare management practitioners could use an interdisciplinary approach to design new performance measurement models, in which financial performance, quality, healthcare and patient outcomes are blended in, for resource allocation and performance improvement. This article recommends that public policy implementation error and the bureaucratic capacity models be applied to healthcare to optimise the outcomes for the healthcare system in Australia. In addition, it highlights the need for evaluation of the current reimbursement method, freedom of choice to patients and a regular scrutiny of the appropriateness of care.

  15. Dependability of results in conference abstracts of randomized controlled trials in ophthalmology and author financial conflicts of interest as a factor associated with full publication.

    PubMed

    Saldanha, Ian J; Scherer, Roberta W; Rodriguez-Barraquer, Isabel; Jampel, Henry D; Dickersin, Kay

    2016-04-26

    Discrepancies between information in conference abstracts and full publications describing the same randomized controlled trial have been reported. The association between author conflicts of interest and the publication of randomized controlled trials is unclear. The objective of this study was to use randomized controlled trials in ophthalmology to evaluate (1) the agreement in the reported main outcome results by comparing abstracts and corresponding publications and (2) the association between the author conflicts of interest and publication of the results presented in the abstracts. We considered abstracts describing results of randomized controlled trials presented at the 2001-2004 Association for Research in Vision and Ophthalmology conferences as eligible for our study. Through electronic searching and by emailing abstract authors, we identified the earliest publication (journal article) containing results of each abstract's main outcome through November 2013. We categorized the discordance between the main outcome results in the abstract and its paired publication as qualitative (a difference in the direction of the estimated effect) or as quantitative. We used the Association for Research in Vision and Ophthalmology categories for conflicts of interest: financial interest, employee of business with interest, consultant to business with interest, inventor/developer with patent, and receiving ≥ 1 gift from industry in the past year. We calculated the relative risks (RRs) of publication associated with the categories of conflicts of interest for abstracts with results that were statistically significant, not statistically significant, or not reported. We included 513 abstracts, 230 (44.8 %) of which reached publication. Among the 86 pairs with the same main outcome domain at the same time point, 47 pairs (54.7 %) had discordant results: qualitative discordance in 7 pairs and quantitative discordance in 40 pairs. Quantitative discordance was indicated as < 10, 10-20, > 20 %, and unclear in 14, 5, 14, and 7 pairs, respectively. First authors reporting of one or more conflicts of interest was associated with a greater likelihood of publication (RR = 1.31; 95 % CI = 1.04 to 1.64) and a shorter time-to-publication (log-rank p = 0.026). First author conflicts of interests that were associated with publication were financial support (RR = 1.50; 95 % CI = 1.19 to 1.90) and one or more gifts (RR = 1.42; 95 % CI = 1.05 to 1.92). The association between conflicts of interest and publication remained, irrespective of the statistical significance of the results. More than half the abstract/publication pairs exhibited some amount of discordance in the main outcome results, calling into question the dependability of conference abstracts. Regardless of the main outcome results, the conflicts of interests of the abstract's first author were associated with publication.

  16. Intraoperative ultrasound guidance in breast-conserving surgery shows superiority in oncological outcome, long-term cosmetic and patient-reported outcomes: Final outcomes of a randomized controlled trial (COBALT).

    PubMed

    Volders, J H; Haloua, M H; Krekel, N M A; Negenborn, V L; Kolk, R H E; Lopes Cardozo, A M F; Bosch, A M; de Widt-Levert, L M; van der Veen, H; Rijna, H; Taets van Amerongen, A H M; Jóźwiak, K; Meijer, S; van den Tol, M P

    2017-04-01

    The multicenter randomized controlled COBALT trial demonstrated that ultrasound-guided breast-conserving surgery (USS) results in a significant reduction of margin involvement (3.1% vs. 13%) and excision volumes compared to palpation-guided surgery (PGS). The aim of the present study was to determine long term oncological and patient-reported outcomes including quality of life (QoL), together with their progress over time. 134 patients with T1-T2 breast cancer were randomized to USS (N = 65) or PGS (N = 69). Cosmetic outcomes were assessed with the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software, panel-evaluation and patient self-evaluation on a 4-point Likert-scale. QoL was measured using the EORTC QLQ-C30/-BR23 questionnaire. No locoregional recurrences were reported after mean follow-up of 41 months. Seven patients (5%) developed distant metastatic disease (USS 6.3%, PGS 4.4%, p = 0.466), of whom six died of disease (95.5% overall survival). USS achieved better cosmetic outcomes compared to PGS, with poor outcomes of 11% and 21% respectively, a result mainly attributable to mastectomies due to involved margins following PGS. There was no difference after 1 and 3 years in cosmetic outcome. Dissatisfied patients included those with larger excision volumes, additional local therapies and worse QoL. Patients with poor/fair cosmetic outcomes scored significantly lower on aspects of QoL, including breast-symptoms, body image and sexual enjoyment. By significantly reducing positive margin status and lowering resection volumes, USS improves the rate of good cosmetic outcomes and increases patient-satisfaction. Considering the large impact of cosmetic outcome on QoL, USS has great potential to improve QoL following breast-conserving therapy. Copyright © 2016 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

  17. Techniques of laparoscopic cholecystectomy: Nomenclature and selection

    PubMed Central

    Haribhakti, Sanjiv P.; Mistry, Jitendra H.

    2015-01-01

    There are more than 50 different techniques of laparoscopic cholecystectomy (LC) available in literature mainly due to modifications by surgeons in aim to improve postoperative outcome and cosmesis. These modifications include reduction in port size and/or number than what is used in standard LC. There is no uniform nomenclature to describe these different techniques so that it is not possible to compare the outcomes of different techniques. We brief the advantages and disadvantages of each of these techniques and suggest the situation where particular technique would be useful. We also propose a nomenclature which is easy to remember and apply, so that any future comparison will be possible between the techniques. PMID:25883450

  18. Impact of early oseltamivir treatment on outcome in critically ill patients with 2009 pandemic influenza A.

    PubMed

    Rodríguez, Alejandro; Díaz, Emili; Martín-Loeches, Ignacio; Sandiumenge, Alberto; Canadell, Laura; Díaz, Juan J; Figueira, Juan C; Marques, Asunción; Alvarez-Lerma, Francisco; Vallés, Jordi; Baladín, Bárbara; García-López, Fernando; Suberviola, Borja; Zaragoza, Rafael; Trefler, Sandra; Bonastre, Juan; Blanquer, José; Rello, Jordi

    2011-05-01

    The impact of oseltamivir on mortality in critically ill patients with 2009 pandemic influenza A (2009 H1N1) is not clear. The main objective of this study was to investigate the relationship between the timing of antiviral administration and intensive care unit (ICU) outcomes. Prospective, observational study of a cohort of ICU patients with confirmed 2009 H1N1 infection. Clinical data, treatment and outcome were compared between patients receiving early treatment (ET) with oseltamivir, initiated within 2 days, and patients administered late treatment (LT), initiated after this timepoint. Multivariate analysis and propensity score were used to determine the effect of oseltamivir on ICU mortality. Six hundred and fifty-seven patients were enrolled. Four hundred and four (61.5%) patients required mechanical ventilation (MV; mortality 32.6%). Among them, 385 received effective antiviral therapy and were included in the study group. All patients received oseltamivir for a median duration of 10 days (interquartile range 8-14 days). Seventy-nine (20.5%) ET patients were compared with 306 LT patients. The two groups were comparable in terms of main clinical variables. ICU length of stay (22.7 ± 16.7 versus 18.4 ± 14.2 days; P = 0.03), hospital length of stay (34.0 ± 20.3 versus 27.2 ± 18.2 days; P = 0.001) and MV days (17.4 ± 15.2 versus 14.0 ± 12.4; P = 0.04) were higher in the LT group. ICU mortality was also higher in LT (34.3%) than in ET (21.5%; OR = 1.9; 95% CI 1.06-3.41). A multivariate model identified ET (OR = 0.44; 95% CI 0.21-0.87) as an independent variable associated with reduced ICU mortality. These results were confirmed by propensity score analysis (OR = 0.44; 95% CI 0.22-0.90; P < 0.001). Our findings suggest that early oseltamivir administration was associated with favourable outcomes among critically ill ventilated patients with 2009 H1N1 virus infection.

  19. Outcomes of mandated treatment for women with histories of abuse and co-occurring disorders.

    PubMed

    Clark, Colleen; Young, M Scott

    2009-12-01

    Although there is much momentum for behavioral health policies supporting mandated treatment, there is little evidence supporting its safety and effectiveness for individuals with complex issues. The authors used a national study of women with co-occurring psychiatric, substance use disorders and histories of trauma to compare mandated and voluntary treatment by examining psychiatric, substance use, and trauma-related outcomes following treatment. This quasi-experimental study included 2,726 women, with measures completed at baseline, 6-month, and 12-month follow-up. Two-way analyses of covariance examined the main and interactive effects of coercive status (mandated vs. voluntary) and condition (integrated treatment vs. services as usual) on psychiatric distress, trauma-related symptoms, and substance use outcomes. Women did better with integrated treatment and with mandated treatment regardless of treatment condition for psychiatric, trauma, and substance use outcomes at both follow-ups. Further research clarifying unintended side effects and change mechanisms of mandated treatment is needed to inform policy decisions.

  20. Is testosterone replacement therapy in males with hypogonadism cost-effective? An analysis in Sweden.

    PubMed

    Arver, Stefan; Luong, Ba; Fraschke, Anina; Ghatnekar, Ola; Stanisic, Sanja; Gultyev, Dmitry; Müller, Elvira

    2014-01-01

    Testosterone replacement therapy (TRT) has been recommended for the treatment of primary and secondary hypogonadism. However, long-term implications of TRT have not been investigated extensively. The aim of this analysis was to evaluate health outcomes and costs associated with life-long TRT in patients suffering from Klinefelter syndrome and late-onset hypogonadism (LOH). A Markov model was developed to assess cost-effectiveness of testosterone undecanoate (TU) depot injection treatment compared with no treatment. Health outcomes and associated costs were modeled in monthly cycles per patient individually along a lifetime horizon. Modeled health outcomes included development of type 2 diabetes, depression, cardiovascular and cerebrovascular complications, and fractures. Analysis was performed for the Swedish health-care setting from health-care payer's and societal perspective. One-way sensitivity analyses evaluated the robustness of results. The main outcome measures were quality-adjusted life-years (QALYs) and total cost in TU depot injection treatment and no treatment cohorts. In addition, outcomes were also expressed as incremental cost per QALY gained for TU depot injection therapy compared with no treatment (incremental cost-effectiveness ratio [ICER]). TU depot injection compared to no-treatment yielded a gain of 1.67 QALYs at an incremental cost of 28,176 EUR (37,192 USD) in the Klinefelter population. The ICER was 16,884 EUR (22,287 USD) per QALY gained. Outcomes in LOH population estimated benefits of TRT at 19,719 EUR (26,029 USD) per QALY gained. Results showed to be considerably robust when tested in sensitivity analyses. Variation of relative risk to develop type 2 diabetes had the highest impact on long-term outcomes in both patient groups. This analysis suggests that lifelong TU depot injection therapy of patients with hypogonadism is a cost-effective treatment in Sweden. Hence, it can support clinicians in decision making when considering appropriate treatment strategies for patients with testosterone deficiency. © 2013 International Society for Sexual Medicine.

  1. Neuromodulation integrating rTMS and neurofeedback for the treatment of autism spectrum disorder: an exploratory study.

    PubMed

    Sokhadze, Estate M; El-Baz, Ayman S; Tasman, Allan; Sears, Lonnie L; Wang, Yao; Lamina, Eva V; Casanova, Manuel F

    2014-12-01

    Autism spectrum disorder (ASD) is a pervasive developmental disorder characterized by deficits in social interaction, language, stereotyped behaviors, and restricted range of interests. In previous studies low frequency repetitive transcranial magnetic stimulation (rTMS) has been used, with positive behavioral and electrophysiological results, for the experimental treatment in ASD. In this study we combined prefrontal rTMS sessions with electroencephalographic (EEG) neurofeedback (NFB) to prolong and reinforce TMS-induced EEG changes. The pilot trial recruited 42 children with ASD (~14.5 years). Outcome measures included behavioral evaluations and reaction time test with event-related potential (ERP) recording. For the main goal of this exploratory study we used rTMS-neurofeedback combination (TMS-NFB, N = 20) and waitlist (WTL, N = 22) groups to examine effects of 18 sessions of integrated rTMS-NFB treatment or wait period) on behavioral responses, stimulus and response-locked ERPs, and other functional and clinical outcomes. The underlying hypothesis was that combined TMS-NFB will improve executive functions in autistic patients as compared to the WTL group. Behavioral and ERP outcomes were collected in pre- and post-treatment tests in both groups. Results of the study supported our hypothesis by demonstration of positive effects of combined TMS-NFB neurotherapy in active treatment group as compared to control WTL group, as the TMS-NFB group showed significant improvements in behavioral and functional outcomes as compared to the WTL group.

  2. Neuromodulation integrating rTMS and neurofeedback for the treatment of autism spectrum disorder: An exploratory study

    PubMed Central

    Sokhadze, Estate M.; El-Baz, Ayman S.; Tasman, Allan; Sears, Lonnie L.; Wang, Yao; Lamina, Eva V.; Casanova, Manuel F.

    2014-01-01

    Autism spectrum disorder (ASD) is a pervasive developmental disorder characterized by deficits in social interaction, language, stereotyped behaviors, and restricted range of interests. In previous studies low frequency repetitive transcranial magnetic stimulation (rTMS) has been used, with positive behavioral and electrophysiological results, for the experimental treatment in ASD. In this study we combined prefrontal rTMS sessions with electroencephalographic (EEG) neurofeedback (NFB) to prolong and reinforce TMS-induced EEG changes. The pilot trial recruited 42 children with ASD (~14.5 yrs). Outcome measures included behavioral evaluations and reaction time test with event-related potential (ERP) recording. For the main goal of this exploratory study we used rTMS-neurofeedback combination (TMS-NFB, N=20) and waitlist (WTL, N=22) groups to examine effects of 18 sessions of integrated rTMS-NFB treatment or wait period) on behavioral responses, stimulus and response-locked ERPs, and other functional and clinical outcomes. The underlying hypothesis was that combined TMS-NFB will improve executive functions in autistic patients as compared to the waitlist group. Behavioral and ERP outcomes were collected in pre- and post-treatment tests in both groups. Results of the study supported our hypothesis by demonstration of positive effects of combined TMS-NFB neurotherapy in active treatment group as compared to control waitlist group, as the TMS-NFB group showed significant improvements in behavioral and functional outcomes as compared to the waitlist group. PMID:25267414

  3. Chronic stress and sexual function in women

    PubMed Central

    Hamilton, Lisa Dawn; Meston, Cindy M.

    2014-01-01

    Introduction Chronic stress is known to have negative effects on reproduction, but little is known about how it affects the sexual response cycle. The present study examined the relationship between chronic stress and sexual arousal and the mechanisms that mediate this relationship. Aim To test the relationship between chronic stress and sexual arousal and identify mechanisms that may explain this relationship. We predicted that women experiencing high levels of chronic stress would show lower levels of genital arousal & DHEAS and higher levels of cortisol and cognitive distraction compared to women with average levels of stress. Methods Women who were categorized as high in chronic stress (high stress group, n = 15) or average in chronic stress (average stress group; n = 15) provided saliva samples and watched an erotic film while having their genital and psychological arousal measured. Main Outcome Measures Main outcome measures were vaginal pulse amplitude, psychological arousal, salivary cortisol, salivary DHEAS, and heart rate and compared them between women with high and average levels of chronic stress. Results Women in the high stress group had lower levels of genital, but not psychological arousal, had higher levels of cortisol, and reported more distraction during the erotic film than women in the average stress group. The main predictor of decreased genital sexual arousal was participants’ distraction scores. Conclusions High levels of chronic stress were related to lower levels of genital sexual arousal. Both psychological (distraction) and hormonal (increased cortisol) factors were related to the lower levels of sexual arousal seen in women high in chronic stress, but distraction was the only significant predictor when controlling for other variables. PMID:23841462

  4. Measuring and decomposing inequity in self-reported morbidity and self-assessed health in Thailand.

    PubMed

    Yiengprugsawan, Vasoontara; Lim, Lynette Ly; Carmichael, Gordon A; Sidorenko, Alexandra; Sleigh, Adrian C

    2007-12-18

    In recent years, interest in the study of inequalities in health has not stopped at quantifying their magnitude; explaining the sources of inequalities has also become of great importance. This paper measures socioeconomic inequalities in self-reported morbidity and self-assessed health in Thailand, and the contributions of different population subgroups to those inequalities. The Health and Welfare Survey 2003 conducted by the Thai National Statistical Office with 37,202 adult respondents is used for the analysis. The health outcomes of interest derive from three self-reported morbidity and two self-assessed health questions. Socioeconomic status is measured by adult-equivalent monthly income per household member. The concentration index (CI) of ill health is used as a measure of socioeconomic health inequalities, and is subsequently decomposed into contributing factors. The CIs reveal inequality gradients disadvantageous to the poor for both self-reported morbidity and self-assessed health in Thailand. The magnitudes of these inequalities were higher for the self-assessed health outcomes than for the self-reported morbidity outcomes. Age and sex played significant roles in accounting for the inequality in reported chronic illness (33.7 percent of the total inequality observed), hospital admission (27.8 percent), and self-assessed deterioration of health compared to a year ago (31.9 percent). The effect of being female and aged 60 years or older was by far the strongest demographic determinant of inequality across all five types of health outcome. Having a low socioeconomic status as measured by income quintile, education and work status were the main contributors disadvantaging the poor in self-rated health compared to a year ago (47.1 percent) and self-assessed health compared to peers (47.4 percent). Residence in the rural Northeast and rural North were the main regional contributors to inequality in self-reported recent and chronic illness, while residence in the rural Northeast was the major contributor to the tendency of the poor to report lower levels of self-assessed health compared to peers. The findings confirm that substantial socioeconomic inequalities in health as measured by self-reported morbidity and self-assessed health exist in Thailand. Decomposition analysis shows that inequalities in health status are associated with particular demographic, socioeconomic and geographic population subgroups. Vulnerable subgroups which are prone to both ill health and relative poverty warrant targeted policy attention.

  5. Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis

    PubMed Central

    Maule, Milena; Ceccarelli, Manuela; Fea, Antonio Maria

    2017-01-01

    Background MIGS have been developed as a surgical alternative for glaucomatous patients. Purpose To analyze the change in intraocular pressure (IOP) and glaucoma medications using different MIGS devices (Trabectome, iStent, Excimer Laser Trabeculotomy (ELT), iStent Supra, CyPass, XEN, Hydrus, Fugo Blade, Ab interno canaloplasty, Goniscopy-assisted transluminal trabeculotomy) as a solo procedure or in association with phacoemulsification. Methods Randomized control trials (RCT) and non-RCT (non randomized comparative studies, NRS, and before-after studies) were included. Studies with at least one year of follow-up in patients affected by primary open angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma were considered. Risk of Bias assessment was performed using the Cochrane Risk of Bias and the ROBINS-I tools. The main outcome was the effect of MIGS devices compared to medical therapy, cataract surgery, other glaucoma surgeries and other MIGS on both IOP and use of glaucoma medications 12 months after surgery. Outcomes measures were the mean difference in the change of IOP and glaucoma medication compared to baseline at one and two years and all ocular adverse events. The current meta-analysis is registered on PROSPERO (reference n° CRD42016037280). Results Over a total of 3,069 studies, nine RCT and 21 case series with a total of 2.928 eyes were included. Main concerns about risk of bias in RCTs were lack of blinding, allocation concealment and attrition bias while in non-RCTs they were represented by patients’ selection, masking of participants and co-intervention management. Limited evidence was found based on both RCTs and non RCTs that compared MIGS surgery with medical therapy or other MIGS. In before-after series, MIGS surgery seemed effective in lowering both IOP and glaucoma drug use. MIGS showed a good safety profile: IOP spikes were the most frequent complications and no cases of infection or BCVA loss due to glaucoma were reported. Conclusions Although MIGS seem efficient in the reduction of the IOP and glaucoma medication and show good safety profile, this evidence is mainly derived from non-comparative studies and further, good quality RCTs are warranted. PMID:28850575

  6. Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis.

    PubMed

    Lavia, Carlo; Dallorto, Laura; Maule, Milena; Ceccarelli, Manuela; Fea, Antonio Maria

    2017-01-01

    MIGS have been developed as a surgical alternative for glaucomatous patients. To analyze the change in intraocular pressure (IOP) and glaucoma medications using different MIGS devices (Trabectome, iStent, Excimer Laser Trabeculotomy (ELT), iStent Supra, CyPass, XEN, Hydrus, Fugo Blade, Ab interno canaloplasty, Goniscopy-assisted transluminal trabeculotomy) as a solo procedure or in association with phacoemulsification. Randomized control trials (RCT) and non-RCT (non randomized comparative studies, NRS, and before-after studies) were included. Studies with at least one year of follow-up in patients affected by primary open angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma were considered. Risk of Bias assessment was performed using the Cochrane Risk of Bias and the ROBINS-I tools. The main outcome was the effect of MIGS devices compared to medical therapy, cataract surgery, other glaucoma surgeries and other MIGS on both IOP and use of glaucoma medications 12 months after surgery. Outcomes measures were the mean difference in the change of IOP and glaucoma medication compared to baseline at one and two years and all ocular adverse events. The current meta-analysis is registered on PROSPERO (reference n° CRD42016037280). Over a total of 3,069 studies, nine RCT and 21 case series with a total of 2.928 eyes were included. Main concerns about risk of bias in RCTs were lack of blinding, allocation concealment and attrition bias while in non-RCTs they were represented by patients' selection, masking of participants and co-intervention management. Limited evidence was found based on both RCTs and non RCTs that compared MIGS surgery with medical therapy or other MIGS. In before-after series, MIGS surgery seemed effective in lowering both IOP and glaucoma drug use. MIGS showed a good safety profile: IOP spikes were the most frequent complications and no cases of infection or BCVA loss due to glaucoma were reported. Although MIGS seem efficient in the reduction of the IOP and glaucoma medication and show good safety profile, this evidence is mainly derived from non-comparative studies and further, good quality RCTs are warranted.

  7. Verbal memory functioning moderates psychotherapy treatment response for PTSD-Related nightmares.

    PubMed

    Scott, J Cobb; Harb, Gerlinde; Brownlow, Janeese A; Greene, Jennifer; Gur, Ruben C; Ross, Richard J

    2017-04-01

    Posttraumatic stress disorder (PTSD) is associated with cognitive deficits in attention, executive control, and memory, although few studies have investigated the relevance of cognitive difficulties for treatment outcomes. We examined whether cognitive functioning and history of traumatic brain injury (TBI) were associated with response to cognitive-behavioral therapy (CBT) for PTSD-related sleep problems. In a randomized controlled trial of Imagery Rehearsal (IR) added to components of CBT for Insomnia (IR + cCBT-I) compared to cCBT-I alone for PTSD-related recurrent nightmares, 94 U.S. veterans completed a battery of cognitive tests. TBI was assessed via structured clinical interview. Mixed-effects models examined main effects of cognitive functioning and interactions with time on primary sleep and nightmare outcomes. Significant verbal immediate memory by time interactions were found for nightmare distress, nightmare frequency, and sleep quality, even after controlling for overall cognitive performance and depression. TBI exhibited main effects on outcomes but no interactions with time. Findings indicated that individuals with lower verbal memory performance were less likely to respond to treatment across two sleep interventions. Veterans with TBI displayed greater symptoms but no altered trajectories of treatment response. Together with prior literature, findings suggest that verbal memory functioning may be important to consider in PTSD treatment implementation. Published by Elsevier Ltd.

  8. The effect of customization and use of a fetal growth standard on the association between birthweight percentile and adverse perinatal outcome.

    PubMed

    Sovio, Ulla; Smith, Gordon C S

    2018-02-01

    It has been proposed that correction of offspring weight percentiles (customization) might improve the prediction of adverse pregnancy outcome; however, the approach is not accepted universally. A complication in the interpretation of the data is that the main method for calculation of customized percentiles uses a fetal growth standard, and multiple analyses have compared the results with birthweight-based standards. First, we aimed to determine whether women who deliver small-for-gestational-age infants using a customized standard differed from other women. Second, we aimed to compare the association between birthweight percentile and adverse outcome using 3 different methods for percentile calculation: (1) a noncustomized actual birthweight standard, (2) a noncustomized fetal growth standard, and (3) a fully customized fetal growth standard. We analyzed data from the Pregnancy Outcome Prediction study, a prospective cohort study of nulliparous women who delivered in Cambridge, UK, between 2008 and 2013. We used a composite adverse outcome, namely, perinatal morbidity or preeclampsia. Receiver operating characteristic curve analysis was used to compare the 3 methods of calculating birthweight percentiles in relation to the composite adverse outcome. We confirmed previous observations that delivering an infant who was small for gestational age (<10th percentile) with the use of a fully customized fetal growth standard but who was appropriate for gestational age with the use of a noncustomized actual birthweight standard was associated with higher rates of adverse outcomes. However, we also observed that the mothers of these infants were 3-4 times more likely to be obese and to deliver preterm. When we compared the risk of adverse outcome from logistic regression models that were fitted to the birthweight percentiles that were derived by each of the 3 predefined methods, the areas under the receiver operating characteristic curves were similar for all 3 methods: 0.56 (95% confidence interval, 0.54-0.59) fully customized, 0.56 (95% confidence interval, 0.53-0.59) noncustomized fetal weight standard, and 0.55 (95% confidence interval, 0.53-0.58) noncustomized actual birthweight standard. When we classified the top 5% of predicted risk as high risk, the methods that used a fetal growth standard showed attenuation after adjustment for gestational age, whereas the birthweight standard did not. Further adjustment for the maternal characteristics, which included weight, attenuated the association with the customized standard, but not the other 2 methods. The associations after full adjustment were similar when we compared the 3 approaches. The independent association between birthweight percentile and adverse outcome was similar when we compared actual birthweight standards and fetal growth standards and compared customized and noncustomized standards. Use of fetal weight standards and customized percentiles for maternal characteristics could lead to stronger associations with adverse outcome through confounding by preterm birth and maternal obesity. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Induction of labor or serial antenatal fetal monitoring in postterm pregnancy: a randomized controlled trial.

    PubMed

    Heimstad, Runa; Skogvoll, Eirik; Mattsson, Lars-Ake; Johansen, Ole Jakob; Eik-Nes, Sturla H; Salvesen, Kjell A

    2007-03-01

    To compare induction of labor at gestational age 41 weeks with expectant management in regard to neonatal morbidity. Secondary aims were to assess the effect of these managements on mode of delivery and maternal complications. Between September 2002 and July 2004, postterm women with singleton cephalic presentation and no prelabor rupture of membranes were randomly assigned to induction of labor at 289 days or antenatal fetal surveillance every third day until spontaneous labor. Main outcome measures were neonatal morbidity, operative delivery rates, and maternal complications. Five hundred eight women were randomly assigned, 254 in each group. No differences of clinical importance were observed in women in whom labor was induced compared with women who were expectantly managed with regard to the following outcomes: neonates whose 5-minute Apgar score was less than 7 (three neonates in the induction group compared with four in the monitoring group, P=.72); neonates whose umbilical cord pH was less than 7 (three compared with two, P=.69); prevalence of cesarean delivery (28 compared with 33, P=.50); or prevalence of operative vaginal delivery (32 compared with 27, P=.49). In the induction group more women had precipitate labors (33 compared with 12, P<.01; number needed to treat was 13), and the duration of second stage of labor was more often less than 15 minutes (94 compared with 56, P<.01; number needed to treat was 7). No differences were found between the induced and monitored groups regarding neonatal morbidity or mode of delivery, and the outcomes were generally good. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00385229. I.

  10. Stress management in dental students: a systematic review

    PubMed Central

    Alzahem, Abdullah M; Van der Molen, Henk T; Alaujan, Arwa H; De Boer, Benjamin J

    2014-01-01

    This study compared the effectiveness of stress management programs in dental education by systematic review of the literature. The number of studies concerning stress management programs for dental students is limited compared with studies discussing sources of stress. Several types of programs for stress management have been reported, and differ in their duration, content, and outcomes. Two main strategies have been used to help stressed students, ie, decreasing the number of stressors and increasing the ability to cope with stress. The first strategy includes several components, such as reducing fear of failure and workload pressure due to examinations and requirements. The second strategy includes coping techniques, such as deep breathing exercises. Although positive effects have been reported for most of the programs, these have mainly been evaluated using subjective self-report measures. There is a need for more research to identify the most effective stress management program. PMID:24904226

  11. Systematic review of the use of honey as a wound dressing

    PubMed Central

    Moore, Owen A; Smith, Lesley A; Campbell, Fiona; Seers, Kate; McQuay, Henry J; Moore, R Andrew

    2001-01-01

    Objective To investigate topical honey in superficial burns and wounds though a systematic review of randomised controlled trials. Data sources Cochrane Library, MEDLINE, EMBASE, PubMed, reference lists and databases were used to seek randomised controlled trials. Seven randomised trials involved superficial burns, partial thickness burns, moderate to severe burns that included full thickness injury, and infected postoperative wounds. Review methods Studies were randomised trials using honey, published papers, with a comparator. Main outcomes were relative benefit and number-needed-to-treat to prevent an outcome relating to wound healing time or infection rate. Results One study in infected postoperative wounds compared honey with antiseptics plus systemic antibiotics. The number needed to treat with honey for good wound healing compared with antiseptic was 2.9 (95% confidence interval 1.7 to 9.7). Five studies in patients with partial thickness or superficial burns involved less than 40% of the body surface. Comparators were polyurethane film, amniotic membrane, potato peel and silver sulphadiazine. The number needed to treat for seven days with honey to produce one patient with a healed burn was 2.6 (2.1 to 3.4) compared with any other treatment and 2.7 (2.0 to 4.1) compared with potato and amniotic membrane. For some or all outcomes honey was superior to all these treatments. Time for healing was significantly shorter for honey than all these treatments. The quality of studies was low. Conclusion Confidence in a conclusion that honey is a useful treatment for superficial wounds or burns is low. There is biological plausibility. PMID:11405898

  12. Group based diabetes self-management education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis

    PubMed Central

    2012-01-01

    Background Diabetes self-management education (DSME) can be delivered in many forms. Group based DSME is widespread due to being a cheaper method and the added advantages of having patient meet and discuss with each other. assess effects of group-based DSME compared to routine treatment on clinical, lifestyle and psychosocial outcomes in type-2 diabetes patients. Methods A systematic review with meta-analysis. Computerised bibliographic database were searched up to January 2008 for randomised controlled trials evaluating group-based DSME for adult type-2 diabetics versus routine treatment where the intervention had at least one session and =/>6 months follow-up. At least two reviewers independently extracted data and assessed study quality. Results In total 21 studies (26 publications, 2833 participants) were included. Of all the participants 4 out of 10 were male, baseline age was 60 years, BMI 31.6, HbA1c 8.23%, diabetes duration 8 years and 82% used medication. For the main clinical outcomes, HbA1c was significantly reduced at 6 months (0.44% points; P = 0.0006, 13 studies, 1883 participants), 12 months (0.46% points; P = 0.001, 11 studies, 1503 participants) and 2 years (0.87% points; P < 0.00001, 3 studies, 397 participants) and fasting blood glucose levels were also significantly reduced at 12 months (1.26 mmol/l; P < 0.00001, 5 studies, 690 participants) but not at 6 months. For the main lifestyle outcomes, diabetes knowledge was improved significantly at 6 months (SMD 0.83; P = 0.00001, 6 studies, 768 participants), 12 months (SMD 0.85; P < 0.00001, 5 studies, 955 participants) and 2 years (SMD 1.59; P = 0.03, 2 studies, 355 participants) and self-management skills also improved significantly at 6 months (SMD 0.55; P = 0.01, 4 studies, 534 participants). For the main psychosocial outcomes, there were significant improvement for empowerment/self-efficacy (SMD 0.28, P = 0.01, 2 studies, 326 participants) after 6 months. For quality of life no conclusion could be drawn due to high heterogeneity. For the secondary outcomes there were significant improvements in patient satisfaction and body weight at 12 months for the intervention group. There were no differences between the groups in mortality rate, body mass index, blood pressure and lipid profile. Conclusions Group-based DSME in people with type 2 diabetes results in improvements in clinical, lifestyle and psychosocial outcomes. PMID:22824531

  13. Outcomes for street children and youth under multidisciplinary care in a drop-in centre in Tegucigalpa, Honduras.

    PubMed

    Souza, Renato; Porten, Klaudia; Nicholas, Sarala; Grais, Rebecca

    2011-11-01

    There is little evidence to describe the feasibility and outcomes of services for the care of street children and youth in low-income countries. To describe the outcomes of a multidisciplinary case management approach delivered in a drop-in centre for street children and youth. A longitudinal study of street children and youth followed in an urban drop-in centre. Four hundred (400) street children and youth received a multidisciplinary case management therapeutic package based on the community reinforcement approach. The main outcomes were changes in psychological distress, substance abuse and social situation scores. The median follow-up time for the cohort was 18 months. There were reductions in the levels of psychological distress (p = 0.0001) and substance abuse (p ≤ 0.0001) in the cohort as well as an improvement in the social situation of street children and youth (p = 0.0001). There was a main effect of gender (p < 0.001) and a significant interaction of gender over time (p < 0.001) on improvements in levels of psychological distress. Survival analysis showed that the probability of remaining on substances at 12 months was 0.76 (95% CI: 0.69-0.81) and 0.51 (95% CI: 0.42-0.59) at 24 months. At 12 months, fewer female patients remained using substances compared to male (p < 0.01). To be most effective, programmes and strategies for children and youth in street situations in developing countries should target both their health and social needs.

  14. Radar observations of asteroid 216 kleopatra

    PubMed

    Ostro; Hudson; Nolan; Margot; Scheeres; Campbell; Magri; Giorgini; Yeomans

    2000-05-05

    Radar observations of the main-belt, M-class asteroid 216 Kleopatra reveal a dumbbell-shaped object with overall dimensions of 217 kilometers by 94 kilometers by 81 kilometers (+/-25%). The asteroid's surface properties are consistent with a regolith having a metallic composition and a porosity comparable to that of lunar soil. Kleopatra's shape is probably the outcome of an exotic sequence of collisional events, and much of its interior may have an unconsolidated rubble-pile structure.

  15. Visual Prognosis and Ocular Complications in Herpetic versus HLA-B27- or Ankylosing Spondylitis-associated Anterior Uveitis.

    PubMed

    Hoeksema, Lisette; Los, Leonoor I

    2016-06-01

    To investigate the visual prognosis and ocular complications in patients with herpetic versus HLA-B27 associated anterior uveitis (AU). This was a retrospective, observational study conducted at the ophthalmology department of the University Medical Center of Groningen. Sixty-two herpetic and 113 HLA-B27-associated AU patients were included. The main outcome measures were visual acuity and ocular complications. Visual acuity over time was significantly lower in herpetic as compared to HLA-B27 AU, mainly due to corneal scarring. The incidence rate of any ocular complication was higher in herpetic AU compared to HLA-B27-associated AU (0.140/EY versus 0.076/EY, p = <0.001), which was mainly due to glaucoma (0.033/EY versus 0.004/EY, p < 0.001) and cataract (0.059/EY versus 0.023/EY, p < 0.001). The most prominent finding was a worse visual prognosis in herpetic AU, which is probably related to higher prevalence of corneal scarring and glaucoma. In addition, herpetic AU patients have more ocular complications overall.

  16. Trochleoplasty: Indications and Technique.

    PubMed

    Nolan, John E; Schottel, Patrick C; Endres, Nathan K

    2018-05-09

    Trochlear dysplasia is a well-described risk factor for patellar instability. Trochleoplasty has emerged as a procedure within the surgical armamentarium for patellar instability, yet its role is unclear. A variety of trochleoplasty procedures have emerged. The purpose of this review is to clarify indications for trochleoplasty, outline the technical steps involved in performing common trochleoplasties and report the published outcomes and potential complications of these procedures. Patellar instability with severe trochlear dysplasia is the main indication for trochleoplasty. Three types of trochleoplasty have emerged: (1) lateral facet elevation; (2) sulcus deepening; and (3) recession wedge. Deepening and recession wedge trochleoplasties are the most commonly performed. Trochleoplasty is a surgical option for addressing patellar instability in patients with severe trochlear dysplasia. Deepening and recession wedge trochleoplasties that address Dejour B and D dysplastic trochleas are the most studied, with both short- and midterm outcomes reported. Long-term outcomes are lacking and comparative studies are needed.

  17. Child maltreatment and violent delinquency: disentangling main effects and subgroup effects.

    PubMed

    Mersky, Joshua P; Reynolds, Arthur J

    2007-08-01

    This study employs data from the Chicago Longitudinal Study (CLS) to investigate the relation between child maltreatment and the incidence and frequency of violent delinquency. The authors also examine if effects vary between physically abused and neglected children and if select indicators (sex, cumulative risk, public aid receipt) moderate the connections between maltreatment and violent outcomes. The CLS follows a cohort of 1,539 low-income, minority children who attended public kindergarten programs in 1985-1986. The primary sample includes 1,404 participants for whom maltreatment and delinquency status were verified. Maltreatment is significantly associated with all violent outcomes investigated. Effects are comparable for physically abused and neglected children. Results indicate that public assistance, particularly persistent receipt, moderates the association between maltreatment and multiple outcomes. Findings support the hypothesized connection between maltreatment and violent delinquency while highlighting certain subgroups that may be at elevated risk. Implications for research design and program development are discussed.

  18. Intensive behavioral therapy for agoraphobia.

    PubMed

    Knuts, Inge J E; Esquivel, Gabriel; Overbeek, Thea; Schruers, Koen R J

    2015-03-15

    We investigated the efficacy of an intensive 1-week behavioral therapy program focusing on agoraphobia for panic disorder patients with agoraphobia (PDA). The study design was a case-control study. Main outcome measure was the agoraphobia score of the Fear Questionnaire (FQ-AGO). The outcomes on the FQ-AGO of a 1-week intensive therapy (96 patients) and a twice-weekly therapy (98 patients) were compared. Agoraphobia improved significantly in both groups, 1 week and 3 months after therapy. Effect size for changes in the 1-week intensive therapy on the FQ-AGO was 0.75. Limitations are use of antidepressants, no placebo group, and no long term follow-up. Behavioral therapy for agoraphobia can be shortened significantly if intensified without affecting therapy outcome, thus allowing patients a more rapid return to work and resumption of daily activities. Copyright © 2014 Elsevier B.V. All rights reserved.

  19. Fixation of comminuted midshaft clavicle fractures with bone fragments separated by soft tissue using a novel double ligature technique

    PubMed Central

    Ju, Wei-Na; Wang, Cheng-Xue; Wang, Tie-Jun; Qi, Bao-Chang

    2017-01-01

    Abstract Rationale: Clavicle fractures are common, and mostly occur in the midshaft. Methods for operative treatment of midshaft clavicle fractures are evolving, as they improve clinical outcomes compared with traditional conservative management. However, fixation of comminuted midshaft clavicle fractures with bone fragments separated by soft tissue remains a challenge. Patient concerns: Here, we present a case of comminuted midshaft clavicle fracture with a bone fragment separated from the main fracture by soft tissue. Diagnosis: Left comminuted midshaft clavicle fracture. Interventions: We treated this patient with a novel double ligature technique using absorbable suturing. Outcomes: In the past 7 years, we have treated >50 patients with this technique. We have achieved good clinical outcomes with no complications. Lessons: We recommend widespread use of our novel double ligature technique for treating comminuted midshaft clavicle fractures with bone fragments separated by soft tissue. PMID:29137088

  20. Successful Pregnancy Using the NxStage Home Hemodialysis System

    PubMed Central

    Brahmbhatt, Yasmin; Ikeme, Arinze; Bhogal, Navjyot; Berghella, Vincenzo

    2016-01-01

    Pregnancy in the setting of the uremic milieu of renal disease has a lower success rate than in the normal population and is a rare event. While intensified renal replacement therapy (RRT) during pregnancy can lead to improved outcomes, most studies have focused on nocturnal hemodialysis as the main RRT in pregnancy. Although thousands of patients use the home NxStage System One short daily hemodialysis (SDHD) machine in the United States, pregnancy outcomes with this therapy are unknown. The NxStage System One uses low-volume dialysate and hence small and middle molecule clearance may differ compared to conventional therapies and affect pregnancy outcomes. We report a case of a successful conception and pregnancy using the home NxStage system. The NxStage system may provide an alternative to the more routinely used NHD or standard SDHD therapies for women of childbearing age. PMID:26949554

  1. Patients presenting to an outpatient sport medicine clinic with concussion

    PubMed Central

    Ouellet, Jérôme; Boisvert, Leslie; Fischer, Lisa

    2016-01-01

    Abstract Objective To describe the characteristics of patients who presented to outpatient sport and exercise medicine clinics with concussion. Design Retrospective chart review of electronic medical records. Setting Three specialized sport and exercise medicine clinics in London, Ont. Participants A total of 283 patients presenting with concussion. Main outcome measures Data collected included demographic variables (age and sex), sport participation at the time of injury, previous medical history (including history of concussion), Post-Concussion Symptom Scale (PCSS) scores, and return-to-play (RTP) variables (delay and outcome). Results The mean age of patients presenting for care was 17.6 years; 70.9% of patients were younger than 18 years of age (considered pediatric patients); 58.8% of patients were male; and 31.7% of patients had a previous history of concussion. The main sports associated with injury were hockey (40.0%), soccer (12.6%), and football (11.7%). Return to play was granted to 50.9% of patients before the 3-week mark and 80.2% of patients before 8 weeks. Total PCSS scores (maximum score was 132) and neck scores (part of the PCSS, maximum score was 6) were significantly higher in adults compared with pediatric patients (36.2 vs 27.6, P = .02, and 1.8 vs 1.2, P = .02, respectively). A significant difference was seen in RTP, with pediatric patients returning earlier than adults did (P = .04). This difference was not seen when comparing males with females (P = .07). Longer duration of follow-up did not influence RTP outcomes. Previous history of concussion was associated with restriction from contact or collision sports (P < .001). Conclusion Given the age and sex variability found in this study, as well as in previous published reports, it is important to manage each patient individually using current best available practice strategies to optimize long-term outcomes.

  2. Similarity between generic and brand-name antihypertensive drugs for primary prevention of cardiovascular disease: evidence from a large population-based study.

    PubMed

    Corrao, Giovanni; Soranna, Davide; Merlino, Luca; Mancia, Giuseppe

    2014-10-01

    Although generic and earlier brand-name counterparts are bioequivalent, their equivalence in preventing relevant clinical outcomes is of concern. To compare effectiveness of generic and brand-name antihypertensive drugs for preventing the onset of cardiovascular (CV) outcomes. A population-based, nested case-control study was carried out by including the cohort of 78 520 patients from Lombardy (Italy) aged 18 years or older who were newly treated with antihypertensive drugs during 2005. Cases were the 2206 patients who experienced a hospitalization for CV disease from initial prescription until 2011. One control for each case was randomly selected from the same cohort that generated cases. Logistic regression was used to model the CV risk associated with starting on and/or continuing with generic or brand-name agents. There was no evidence that patients who started on generics experienced different CV risk than those on brand-name product (OR 0·86; 95% CI 0·63-1·17). Patients at whom generics were main dispensed had not significantly difference in CV outcomes than those mainly on brand-name agents (OR 1·19; 95% CI 0·86-1·63). Compared with patients who kept initial brand-name therapy, those who experienced brand-to-generic or generic-to-brand switches, and those always on generics, did not show differential CV risks, being the corresponding ORs (and 95% CIs), 1·18 (0·96-1·47), 0·87 (0·63-1·21) and 1·08 (0·80-1·46). Our findings do not support the notion that brand-name antihypertensive agents are superior to generics for preventing CV outcomes in the real-world clinical practice. © 2014 Stichting European Society for Clinical Investigation Journal Foundation.

  3. Implementation of a cardiac PET stress program: comparison of outcomes to the preceding SPECT era.

    PubMed

    Knight, Stacey; Min, David B; Le, Viet T; Meredith, Kent G; Dhar, Ritesh; Biswas, Santanu; Jensen, Kurt R; Mason, Steven M; Ethington, Jon-David; Lappe, Donald L; Muhlestein, Joseph B; Anderson, Jeffrey L; Knowlton, Kirk U

    2018-05-03

    Cardiac positron emission testing (PET) is more accurate than single photon emission computed tomography (SPECT) at identifying coronary artery disease (CAD); however, the 2 modalities have not been thoroughly compared in a real-world setting. We conducted a retrospective analysis of 60-day catheterization outcomes and 1-year major adverse cardiovascular events (MACE) after the transition from a SPECT- to a PET-based myocardial perfusion imaging (MPI) program. MPI patients at Intermountain Medical Center from January 2011-December 2012 (the SPECT era, n = 6,777) and January 2014-December 2015 (the PET era, n = 7,817) were studied. Outcomes studied were 60-day coronary angiography, high-grade obstructive CAD, left main/severe 3-vessel disease, revascularization, and 1-year MACE-revascularization (MACE-revasc; death, myocardial infarction [MI], or revascularization >60 days). Patients were 64 ± 13 years old; 54% were male and 90% were of European descent; and 57% represented a screening population (no prior MI, revascularization, or CAD). During the PET era, compared with the SPECT era, a higher percentage of patients underwent coronary angiography (13.2% vs. 9.7%, P < 0.0001), had high-grade obstructive CAD (10.5% vs. 6.9%, P < 0.0001), had left main or severe 3-vessel disease (3.0% vs. 2.3%, P = 0.012), and had coronary revascularization (56.7% vs. 47.1%, P = 0.0001). Similar catheterization outcomes were seen when restricted to the screening population. There was no difference in 1-year MACE-revasc (PET [5.8%] vs. SPECT [5.3%], P = 0.31). The PET-based MPI program resulted in improved identification of patients with high-grade obstructive CAD, as well as a larger percentage of revascularization, thus resulting in fewer patients undergoing coronary angiography without revascularization. This observational study was funded using internal departmental funds.

  4. Co-colonisation with Aspergillus fumigatus and Pseudomonas aeruginosa is associated with poorer health in cystic fibrosis patients: an Irish registry analysis.

    PubMed

    Reece, Emma; Segurado, Ricardo; Jackson, Abaigeal; McClean, Siobhán; Renwick, Julie; Greally, Peter

    2017-04-21

    Pulmonary infection is the main cause of death in cystic fibrosis (CF). Aspergillus fumigatus (AF) and Pseudomonas aeruginosa (PA) are the most prevalent fungal and bacterial pathogens isolated from the CF airway, respectively. Our aim was to determine the effect of different colonisation profiles of AF and PA on the clinical status of patients with CF. A retrospective analysis of data from the Cystic Fibrosis Registry of Ireland from 2013 was performed to determine the effect of intermittent and persistent colonisation with AF or PA or co-colonisation with both microorganisms on clinical outcome measures in patients with CF. Key outcomes measured included forced expiratory volume in one second (FEV 1 ), number of hospitalisations, respiratory exacerbations and antimicrobials prescribed, and complications of CF, including CF related diabetes (CFRD) and allergic bronchopulmonary aspergillosis (ABPA). The prevalence of AF and PA colonisation were 11% (5% persistent, 6% intermittent) and 31% (19% persistent, 12% intermittent) in the Irish CF population, respectively. Co-colonisation with both pathogens was associated with a 13.8% reduction in FEV 1 (p = 0.016), higher levels of exacerbations (p = 0.042), hospitalisations (p = 0.023) and antimicrobial usage (p = 0.014) compared to non-colonised patients and these clinical outcomes were comparable to those persistently colonised with PA. Intermittent and persistent AF colonisation were not associated with poorer clinical outcomes or ABPA. Patients with persistent PA had a higher prevalence of CFRD diagnosis (p = 0.012). CF patients co-colonised with AF and PA had poor clinical outcomes comparable to patients persistently colonised with PA, emphasising the clinical significance of co-colonisation with these microorganisms.

  5. Baseline peripheral blood leukocytosis: Biological marker predicts outcome in oropharyngeal cancer, regardless of HPV-status.

    PubMed

    Gouw, Zeno A R; Paul de Boer, Jan; Navran, Arash; van den Brekel, Michiel W M; Sonke, Jan-Jakob; Al-Mamgani, Abrahim

    2018-03-01

    To study the prognostic value of abnormalities in baseline complete blood count in patients with oropharyngeal cancer (OPC) treated with (chemo) radiation. The prognostic value of baseline complete blood count on outcome in 234 patients with OPC treated between 2010 and 2015 was examined in multivariate analysis together with other conventional prognostic variables including HPV-status, tumor stage, tumor and nodal size. The 3-year overall survival (OS), disease-free survival (DFS), locoregional control (LRC), and distant control (DC) of the whole group were 74%, 64%, 79%, and 88%, respectively. Leukocytosis and HPV-status were the only significant prognosticators for OS and DFS at the multivariate analysis. Patients without leukocytosis had a significantly better DC compared to those with leukocytosis (92% and 70%, respectively, p < 0.001). Patients with HPV-negative OPC had significantly worse LRC compared to HPV-positive patients (67% and 90%, respectively, p < 0.001). The 3-year OS in HPV-positive group with leukocytosis compared to those without leukocytosis were 69% and 95%, respectively (p < 0.001). The figures for HPV-negative patients were 41% vs. 61%, respectively (p = 0.010). This is the first study to date reporting the independent impact of leukocytosis and HPV-status on outcome of patients with OPC. The poor outcome of patients with leukocytosis is mainly caused by the worse DC. The significant impact of leukocytosis on outcome was even more pronounced in HPV-positive patients. These biomarkers could help identifying patients with poor prognosis at baseline requiring intensification of local and/or systemic treatment while treatment de-intensification might be offered to the low-risk group. Copyright © 2018 Elsevier Ltd. All rights reserved.

  6. Effects of Tailored and ACT-Influenced Internet-Based CBT for Eating Disorders and the Relation Between Knowledge Acquisition and Outcome: A Randomized Controlled Trial.

    PubMed

    Strandskov, Sandra Weineland; Ghaderi, Ata; Andersson, Hedvig; Parmskog, Nicole; Hjort, Emelie; Wärn, Anna Svanberg; Jannert, Maria; Andersson, Gerhard

    2017-09-01

    This is the first trial to investigate the outcome of tailored and ACT-influenced, cognitive behavioral Internet treatment for eating disorder psychopathology, and the relation between knowledge acquisition and outcome. This study utilized a randomized controlled design, with computer-based allocation to treatment or waiting list control group. Participants were recruited via advertisements in social media and newspapers in Sweden. Participants fulfilling the criteria for bulimia nervosa (BN), or Eating Disorder Not Otherwise Specified (EDNOS), with a BMI above 17.5, were enrolled in the study (N = 92). The treatment group received an Internet-based, ACT-influenced CBT intervention, developed by the authors, for eating disorders. The treatment lasted 8 weeks, and was adapted to the participant's individual needs. A clinician provided support. The main outcome measures were eating disorder symptoms and body shape dissatisfaction. Intent-to-treat analysis showed that the treatment group (n = 46) improved significantly on eating disorder symptoms and body dissatisfaction, compared with the waiting list control group (n = 46), with small to moderate effect sizes (between group effects, d = 0.35-0.64). More than a third of the participants in the treatment group (36.6%), compared to 7.1% in the waiting list control condition, made clinically significant improvements. Results showed a significant increase in knowledge in the treatment group compared to the waiting list control group (between group effect, d = 1.12), but we found no significant correlations between knowledge acquisition and outcome (r= -0.27 to -r = 0.23). The results provide preliminary support for Internet-based, tailored, and ACT-influenced treatment, based on CBT for participants with eating disorder psychopathology. Copyright © 2017. Published by Elsevier Ltd.

  7. Impact of medication reconciliation and review and counselling, on adverse drug events and healthcare resource use.

    PubMed

    Al-Hashar, Amna; Al-Zakwani, Ibrahim; Eriksson, Tommy; Sarakbi, Alaa; Al-Zadjali, Badriya; Al Mubaihsi, Saif; Al Zaabi, Mohammed

    2018-05-12

    Background Adverse drug events from preventable medication errors can result in patient morbidity and mortality, and in cost to the healthcare system. Medication reconciliation can improve communication and reduce medication errors at transitions in care. Objective Evaluate the impact of medication reconciliation and counselling intervention delivered by a pharmacist for medical patients on clinical outcomes 30 days after discharge. Setting Sultan Qaboos University Hospital, Muscat, Oman. Methods A randomized controlled study comparing standard care with an intervention delivered by a pharmacist and comprising medication reconciliation on admission and discharge, a medication review, a bedside medication counselling, and a take-home medication list. Medication discrepancies during hospitalization were identified and reconciled. Clinical outcomes were evaluated by reviewing electronic health records and telephone interviews. Main outcome measures Rates of preventable adverse drug events as primary outcome and healthcare resource utilization as secondary outcome at 30 days post discharge. Results A total of 587 patients were recruited (56 ± 17 years, 57% female); 286 randomized to intervention; 301 in the standard care group. In intervention arm, 74 (26%) patients had at least one discrepancy on admission and 100 (35%) on discharge. Rates of preventable adverse drug events were significantly lower in intervention arm compared to standard care arm (9.1 vs. 16%, p = 0.009). No significant difference was found in healthcare resource use. Conclusion The implementation of an intervention comprising medication reconciliation and counselling by a pharmacist has significantly reduced the rate of preventable ADEs 30 days post discharge, compared to the standard care. The effect of the intervention on healthcare resource use was insignificant. Pharmacists should be included in decentralized, patient-centred roles. The findings should be interpreted in the context of the study's limitations.

  8. Potential Utility of the SYNTAX Score 2 in Patients Undergoing Left Main Angioplasty

    PubMed Central

    Madeira, Sérgio; Raposo, Luís; Brito, João; Rodrigues, Ricardo; Gonçalves, Pedro; Teles, Rui; Gabriel, Henrique; Machado, Francisco; Almeida, Manuel; Mendes, Miguel

    2016-01-01

    Background The revascularization strategy of the left main disease is determinant for clinical outcomes. Objective We sought to 1) validate and compare the performance of the SYNTAX Score 1 and 2 for predicting major cardiovascular events at 4 years in patients who underwent unprotected left main angioplasty and 2) evaluate the long-term outcome according to the SYNTAX score 2-recommended revascularization strategy. Methods We retrospectively studied 132 patients from a single-centre registry who underwent unprotected left main angioplasty between March 1999 and December 2010. Discrimination and calibration of both models were assessed by ROC curve analysis, calibration curves and the Hosmer-Lemeshow test. Results Total event rate was 26.5% at 4 years.The AUC for the SYNTAX Score 1 and SYNTAX Score 2 for percutaneous coronary intervention, was 0.61 (95% CI: 0.49-0.73) and 0.67 (95% CI: 0.57-0.78), respectively. Despite a good overall adjustment for both models, the SYNTAX Score 2 tended to underpredict risk. In the 47 patients (36%) who should have undergone surgery according to the SYNTAX Score 2, event rate was numerically higher (30% vs. 25%; p=0.54), and for those with a higher difference between the two SYNTAX Score 2 scores (Percutaneous coronary intervention vs. Coronary artery by-pass graft risk estimation greater than 5.7%), event rate was almost double (40% vs. 22%; p=0.2). Conclusion The SYNTAX Score 2 may allow a better and individualized risk stratification of patients who need revascularization of an unprotected left main coronary artery. Prospective studies are needed for further validation. PMID:27007223

  9. Development of the Veterans Healthcare Administration (VHA) Ophthalmic Surgical Outcome Database (OSOD) project and the role of ophthalmic nurse reviewers.

    PubMed

    Lara-Smalling, Agueda; Cakiner-Egilmez, Tulay; Miller, Dawn; Redshirt, Ella; Williams, Dale

    2011-01-01

    Currently, ophthalmic surgical cases are not included in the Veterans Administration Surgical Quality Improvement Project data collection. Furthermore, there is no comprehensive protocol in the health system for prospectively measuring outcomes for eye surgery in terms of safety and quality. There are 400,000 operative cases in the system per year. Of those, 48,000 (12%) are ophthalmic surgical cases, with 85% (41,000) of those being cataract cases. The Ophthalmic Surgical Outcome Database Pilot Project was developed to incorporate ophthalmology into VASQIP, thus evaluating risk factors and improving cataract surgical outcomes. Nurse reviewers facilitate the monitoring and measuring of these outcomes. Since its inception in 1778, the Veterans Administration (VA) Health System has provided comprehensive healthcare to millions of deserving veterans throughout the U.S. and its territories. Historically, the quality of healthcare provided by the VA has been the main focus of discussion because it did not meet a standard of care comparable to that of the private sector. Information regarding quality of healthcare services and outcomes data had been unavailable until 1986, when Congress mandated the VA to compare its surgical outcomes to those of the private sector (PL-99-166). 1 Risk adjustment of VA surgical outcomes began in 1987 with the Continuous Improvement in Cardiac Surgery Program (CICSP) in which cardiac surgical outcomes were reported and evaluated. 2 Between 1991 and 1993, the National VA Surgical Risk Study (NVASRS) initiated a validated risk-adjustment model for predicting surgical outcomes and comparative assessment of the quality of surgical care in 44 VA medical centers. 3 The success of NVASRS encouraged the VA to establish an ongoing program for monitoring and improving the quality of surgical care, thus developing the National Surgical Quality Improvement Program (NSQIP) in 1994. 4 According to a prospective study conducted between 1991-1997 in 123 VA medical centers by Khuri et al., the 30-day mortality and morbidity rates for major surgeries had decreased by 9% and 30%, respectively. 5 Recently renamed the VA Surgical Quality Improvement Program (VASQIP) in 2010, the quality of surgical outcomes has continued to improve among all documented surgical specialties. Ophthalmic surgery is presumed to have a very low mortality rate and therefore has not been included in the VASQIP database.

  10. Economic evaluation of multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: A randomized controlled trial.

    PubMed

    Vos-Vromans, Desirée; Evers, Silvia; Huijnen, Ivan; Köke, Albère; Hitters, Minou; Rijnders, Nieke; Pont, Menno; Knottnerus, André; Smeets, Rob

    2017-01-01

    A multi-centre RCT has shown that multidisciplinary rehabilitation treatment (MRT) is more effective in reducing fatigue over the long-term in comparison with cognitive behavioural therapy (CBT) for patients with chronic fatigue syndrome (CFS), but evidence on its cost-effectiveness is lacking. To compare the cost-effectiveness of MRT versus CBT for patients with CFS from a societal perspective. A multi-centre randomized controlled trial comparing MRT with CBT was conducted among 122 patients with CFS diagnosed using the 1994 criteria of the Centers for Disease Control and Prevention and aged between 18 and 60 years. The societal costs (healthcare costs, patient and family costs, and costs for loss of productivity), fatigue severity, quality of life, quality-adjusted life-year (QALY), and cost-effectiveness ratios (ICERs) were measured over a follow-up period of one year. The main outcome of the cost-effectiveness analysis was fatigue measured by the Checklist Individual Strength (CIS). The main outcome of the cost-utility analysis was the QALY based on the EuroQol-5D-3L utilities. Sensitivity analyses were performed, and uncertainty was calculated using the cost-effectiveness acceptability curves and cost-effectiveness planes. The data of 109 patients (57 MRT and 52 CBT) were analyzed. MRT was significantly more effective in reducing fatigue at 52 weeks. The mean difference in QALY between the treatments was not significant (0.09, 95% CI: -0.02 to 0.19). The total societal costs were significantly higher for patients allocated to MRT (a difference of €5,389, 95% CI: 2,488 to 8,091). MRT has a high probability of being the most cost effective, using fatigue as the primary outcome. The ICER is €856 per unit of the CIS fatigue subscale. The results of the cost-utility analysis, using the QALY, indicate that the CBT had a higher likelihood of being more cost-effective. The probability of being more cost-effective is higher for MRT when using fatigue as primary outcome variable. Using QALY as the primary outcome, CBT has the highest probability of being more cost-effective. ISRCTN77567702.

  11. Quality of Life Outcomes after Primary Treatment for Clinically Localised Prostate Cancer: A Systematic Review.

    PubMed

    Lardas, Michael; Liew, Matthew; van den Bergh, Roderick C; De Santis, Maria; Bellmunt, Joaquim; Van den Broeck, Thomas; Cornford, Philip; Cumberbatch, Marcus G; Fossati, Nicola; Gross, Tobias; Henry, Ann M; Bolla, Michel; Briers, Erik; Joniau, Steven; Lam, Thomas B; Mason, Malcolm D; Mottet, Nicolas; van der Poel, Henk G; Rouvière, Olivier; Schoots, Ivo G; Wiegel, Thomas; Willemse, Peter-Paul M; Yuan, Cathy Yuhong; Bourke, Liam

    2017-12-01

    Current evidence-based management for clinically localised prostate cancer includes active surveillance, surgery, external beam radiotherapy (EBRT) and brachytherapy. The impact of these treatment modalities on quality of life (QoL) is uncertain. To systematically review comparative studies investigating disease-specific QoL outcomes as assessed by validated cancer-specific patient-reported outcome measures with at least 1 yr of follow-up after primary treatment for clinically localised prostate cancer. MEDLINE, EMBASE, AMED, PsycINFO, and Cochrane Library were searched to identify relevant studies. Studies were critically appraised for the risk of bias. A narrative synthesis was undertaken. Of 11486 articles identified, 18 studies were eligible for inclusion, including three randomised controlled trials (RCTs; follow-up range: 60-72 mo) and 15 nonrandomised comparative studies (follow-up range: 12-180 mo) recruiting a total of 13604 patients. Two RCTs recruited small cohorts and only one was judged to have a low risk of bias. The quality of evidence from observational studies was low to moderate. For a follow-up of up to 6 yr, active surveillance was found to have the lowest impact on cancer-specific QoL, surgery had a negative impact on urinary and sexual function when compared with active surveillance and EBRT, and EBRT had a negative impact on bowel function when compared with active surveillance and surgery. Data from one small RCT reported that brachytherapy has a negative impact on urinary function 1 yr post-treatment, but no significant urinary toxicity was reported at 5 yr. This is the first systematic review comparing the impact of different primary treatments on cancer-specific QoL for men with clinically localised prostate cancer, using validated cancer-specific patient-reported outcome measures only. There is robust evidence that choice of primary treatment for localised prostate cancer has distinct impacts on patients' QoL. This should be discussed in detail with patients during pretreatment counselling. Our review of the current evidence suggests that for a period of up to 6 yr after treatment, men with localised prostate cancer who were managed with active surveillance reported high levels of quality of life (QoL). Men treated with surgery reported mainly urinary and sexual problems, while those treated with external beam radiotherapy reported mainly bowel problems. Men eligible for brachytherapy reported urinary problems up to a year after therapy, but then their QoL returned gradually to as it was before treatment. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  12. Cost-effectiveness models for chronic obstructive pulmonary disease: cross-model comparison of hypothetical treatment scenarios.

    PubMed

    Hoogendoorn, Martine; Feenstra, Talitha L; Asukai, Yumi; Borg, Sixten; Hansen, Ryan N; Jansson, Sven-Arne; Samyshkin, Yevgeniy; Wacker, Margarethe; Briggs, Andrew H; Lloyd, Adam; Sullivan, Sean D; Rutten-van Mölken, Maureen P M H

    2014-07-01

    To compare different chronic obstructive pulmonary disease (COPD) cost-effectiveness models with respect to structure and input parameters and to cross-validate the models by running the same hypothetical treatment scenarios. COPD modeling groups simulated four hypothetical interventions with their model and compared the results with a reference scenario of no intervention. The four interventions modeled assumed 1) 20% reduction in decline in lung function, 2) 25% reduction in exacerbation frequency, 3) 10% reduction in all-cause mortality, and 4) all these effects combined. The interventions were simulated for a 5-year and lifetime horizon with standardization, if possible, for sex, age, COPD severity, smoking status, exacerbation frequencies, mortality due to other causes, utilities, costs, and discount rates. Furthermore, uncertainty around the outcomes of intervention four was compared. Seven out of nine contacted COPD modeling groups agreed to participate. The 5-year incremental cost-effectiveness ratios (ICERs) for the most comprehensive intervention, intervention four, was €17,000/quality-adjusted life-year (QALY) for two models, €25,000 to €28,000/QALY for three models, and €47,000/QALY for the remaining two models. Differences in the ICERs could mainly be explained by differences in input values for disease progression, exacerbation-related mortality, and all-cause mortality, with high input values resulting in low ICERs and vice versa. Lifetime results were mainly affected by the input values for mortality. The probability of intervention four to be cost-effective at a willingness-to-pay value of €50,000/QALY was 90% to 100% for five models and about 70% and 50% for the other two models, respectively. Mortality was the most important factor determining the differences in cost-effectiveness outcomes between models. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  13. The professional nursing practice environment and nurse-reported job outcomes in two European countries: a survey of nurses in Finland and the Netherlands.

    PubMed

    Hinno, Saima; Partanen, Pirjo; Vehviläinen-Julkunen, Katri

    2012-03-01

    The working environment of nurses is receiving international interest, because there is a growing consensus that identifying opportunities for improving working conditions in hospitals is essential to maintain adequate staffing, high-quality care, nurses' job satisfaction and hence their retention. Thus, the aim of this study was to investigate the relationship between nurse work environment characteristics and nurse-reported job outcomes in hospital settings in Finland and the Netherlands and to compare these results. A comparative cross-sectional nurse survey was conducted. Data were collected from the two countries randomly sampling the countries' National Nurses Association' membership databases. In this paper, the results from Registered Nurses working in hospital settings are used. In total, 869 hospital nurses participated: 535 from Finland and 334 from the Netherlands with the response rate of 44.9 and 33.4%, respectively. Fifty-five items from the Nursing Work Index-Revised were used as a main tool for the practice environment. Exploratory factor analysis was used to identify a set of internally consistent subscales. Further, logistic regression analysis and T-tests were used. Three practice environment characteristics were identified: adequacy of resources, supportiveness of management and assurance of care quality via collaborative relationships. Favourable evaluations of the adequacy of resources and supportiveness of management were positively correlated with nurse-assessed quality of care and job-related positive feelings and negatively correlated with intentions to leave a unit, organization or the entire profession. In neither of the participating countries were adverse incidents affecting nurses related to nurses' evaluations of their current professional practice environment. Compared with Finland, in the Netherlands, RN appears to evaluate the majority of work environment characteristics more positively; nevertheless, to some extent, the results were uniform as adequacy of resources and supportiveness of management were main predictors for nurse-reported job outcomes considered. © 2011 The Authors. Scandinavian Journal of Caring Sciences © 2011 Nordic College of Caring Science.

  14. Effect of Weight Loss with or without Exercise on Inflammatory Markers and Adipokines in Postmenopausal Women: The SHAPE-2 Trial, A Randomized Controlled Trial.

    PubMed

    van Gemert, Willemijn A; May, Anne M; Schuit, Albertine J; Oosterhof, Blanche Y M; Peeters, Petra H; Monninkhof, Evelyn M

    2016-05-01

    We investigated the effect of equivalent weight loss, by a hypocaloric diet or mainly exercise, on inflammatory markers and adipokines in overweight postmenopausal women. Women were randomized to a diet (n = 97), mainly exercise (n = 98), or control group (n = 48). Goal of both interventions was to lose 5 to 6 kg bodyweight by a hypocaloric diet or an exercise program (4 hours/week) combined with a small caloric intake restriction. Outcomes after 16 weeks included serum high-sensitive C-reactive protein (hsCRP), IL6, adiponectin, and leptin. Both intervention groups achieved the target weight loss. Controls remained weight stable. Compared with control, hsCRP decreased with mainly exercise [treatment effect ratio (TER) = 0.64] and borderline statistically significant with diet (TER = 0.77). There was a suggestively larger effect of exercise, directly compared with diet (TER = 0.83). Leptin decreased with both interventions: mainly exercise (TER = 0.55) and diet (TER = 0.59), versus control. Effects attenuated and lost significance after adjusting for change in body fat percentage, and to a lesser extent when adjusting for fitness. No effects were seen on IL6 and adiponectin. A 16-week randomized intervention inducing comparable weight loss by a hypocaloric diet or mainly exercise, resulted in favorable effects on serum hsCRP and leptin. We found a possible more beneficial effect on hsCRP with mainly exercise versus diet. These effects of exercise were established by changes in body fat percentage and physical fitness. A modest amount of weight loss in postmenopausal women reduces hsCRP and leptin levels which might be associated with a lower breast cancer risk. Cancer Epidemiol Biomarkers Prev; 25(5); 799-806. ©2016 AACR. ©2016 American Association for Cancer Research.

  15. Cleft characteristics and treatment outcomes in hemifacial microsomia compared to non-syndromic cleft lip/palate.

    PubMed

    Dentino, K M; Valstar, A; Padwa, B L

    2016-06-01

    The goal of this study was to describe the clinical characteristics and treatment outcomes of patients with hemifacial microsomia (HFM) and cleft lip/palate (CL/P), and to compare them to a historic cohort of patients with non-syndromic CL/P treated at the same centre. A retrospective review of patients with HFM and CL/P was performed; the main outcome measures assessed were cleft type/side, surgical outcome, midfacial retrusion, and speech. Twenty-six patients (13 male, 13 female; mean age 22.7±14.9, range 1-52 years) with cleft lip with/without cleft palate (CL±P) were identified: three with cleft lip (12%), two with cleft lip and alveolus and an intact secondary palate (8%), and 21 with cleft lip and palate (CLP) (81%; 15 unilateral and six bilateral). Four patients (19%) had a palatal fistula after palatoplasty. Twelve of 22 patients aged >5 years (55%) had midfacial retrusion and two (9%) required a pharyngeal flap for velopharyngeal insufficiency (VPI). Fisher's exact test demonstrated a higher frequency of complete labial clefting (P=0.004), CLP (P=0.009), midfacial retrusion (P=0.0009), and postoperative palatal fistula (P=0.03) in HFM compared to non-syndromic CL±P. There was no difference in VPI prevalence. This study revealed that patients with HFM and CL±P have more severe forms of orofacial clefting than patients with non-syndromic CL±P. Patients with HFM and CL±P have more severe midfacial retrusion and a higher palatal fistula rate compared to patients with non-syndromic CL±P. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  16. Advances of human bone marrow-derived mesenchymal stem cells in the treatment of cartilage defects: a systematic review.

    PubMed

    Gopal, Kaliappan; Amirhamed, Haji Alizadeh; Kamarul, Tunku

    2014-06-01

    Mesenchymal stem cell (MSC)-based therapies represent a new option for treating damaged cartilage. However, the outcomes following its clinical application have seldom been previously compared. The present paper presents the systematic review of current literatures on MSC-based therapy for cartilage repair in clinical applications. Ovid, Scopus, PubMed, ISI Web of Knowledge and Google Scholar online databases were searched using several keywords, which include "cartilage" and "stem cells". Only studies using bone marrow-derived MSC (BM-MSC) to treat cartilage defects clinically were included in this review. The clinical outcomes were compared, and the quality of the tissue repair was analysed where possible. Of the 996 articles, only six (n = 6) clinical studies have described the use of BM-MSC in clinical applications. Two studies were cohort observational trials, three were case series, and one was a case report. In the two comparative trials, BM-MSCs produced superior repair to cartilage treatment without cells and have comparable outcomes to autologous chondrocyte implantation. The case series and case-control studies have demonstrated that use of BM-MSCs resulted in better short- to long-term clinical outcomes with minimal complications. In addition, histological analyses in two studies have resulted in good repair tissue formation at the damaged site, composed mainly of hyaline-like cartilage. Although results of the respective studies are highly indicative that BM-MSC-based therapy is superior, due to the differences in methods and selection criteria used, it was not possible to make direct comparison between the studies. In conclusion, published studies do suggest that BM-MSCs could provide superior cartilage repair. However, due to limited number of reports, more robust studies might be required before a definitive conclusion can be drawn.

  17. Term Elective Induction of Labor and Perinatal Outcomes in Obese Women: Retrospective Cohort Study

    PubMed Central

    Lee, Vanessa R.; Darney, Blair G.; Snowden, Jonathan M.; Main, Elliott K.; Gilbert, William; Chung, Judith; Caughey, Aaron B.

    2015-01-01

    Objective To compare perinatal outcomes between elective induction of labor (eIOL) and expectant management in obese women. Design Retrospective cohort study. Setting Deliveries in California in 2007. Population Term, singleton, vertex, nonanomalous deliveries among obese women (n=74,725). Methods Women who underwent eIOL at 37 weeks were compared with women who were expectantly managed at that gestational age. Similar comparisons were made at 38, 39, and 40 weeks. Results were stratified by parity. Chi-square tests and multivariable logistic regression were used for statistical comparison. Main Outcome Measures Method of delivery, severe perineal lacerations, postpartum hemorrhage, chorioamnionitis, macrosomia, shoulder dystocia, brachial plexus injury, respiratory distress syndrome. Results The odds of cesarean delivery were lower among nulliparous women with eIOL at 37 weeks (odds ratio [OR] 0.55, 95% confidence interval [CI] 0.34–0.90) and 39 weeks (OR 0.77, 95% CI 0.63–0.95) compared to expectant management. Among multiparous women with a prior vaginal delivery, eIOL at 37 (OR 0.39, 95% CI 0.24–0.64), 38 (OR 0.65, 95% CI 0.51–0.82), and 39 weeks (OR 0.67, 95% CI 0.56–0.81) was associated with lower odds of cesarean. Additionally, eIOL at 38, 39, and 40 weeks was associated with lower odds of macrosomia. There were no differences in the odds of operative vaginal delivery, lacerations, brachial plexus injury, or respiratory distress syndrome. Conclusions In obese women, term eIOL may decrease the risk of cesarean delivery, particularly in multiparas, without increasing the risks of other adverse outcomes when compared with expectant management. Tweetable Abstract Elective induction of labor in obese women does not increase risk of cesarean or other perinatal morbidities. PMID:26840780

  18. Percutaneous laser disc decompression versus conventional microdiscectomy in sciatica: a randomized controlled trial.

    PubMed

    Brouwer, Patrick A; Brand, Ronald; van den Akker-van Marle, M Elske; Jacobs, Wilco C H; Schenk, Barry; van den Berg-Huijsmans, Annette A; Koes, Bart W; van Buchem, M A; Arts, Mark P; Peul, Wilco C

    2015-05-01

    Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991. However, no randomized trial comparing PLDD to conventional treatment has been performed. In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery. This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-to-treat protocol with full institutional review board approval. One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included. The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patient's report of perceived recovery. Patients were randomly allocated to PLDD (n=57) or conventional surgery (n=58). Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands. The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 (-0.1; [95% confidence interval (CI), -2.3 to 2.1]) and 52 weeks (-1.1; 95% CI, -3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42-0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year. At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Low-Carbohydrate Diet for the Treatment of Gestational Diabetes Mellitus

    PubMed Central

    Moreno-Castilla, Cristina; Hernandez, Marta; Bergua, Merce; Alvarez, Maria C.; Arce, Maria A.; Rodriguez, Karen; Martinez-Alonso, Montserrat; Iglesias, Montserrat; Mateu, Magdalena; Santos, Maria D.; Pacheco, Linda R.; Blasco, Yolanda; Martin, Eva; Balsells, Nuria; Aranda, Nuria; Mauricio, Didac

    2013-01-01

    OBJECTIVE Medical nutrition therapy based on the control of the amount and distribution of carbohydrates (CHO) is the initial treatment for gestational diabetes mellitus (GDM), but there is a need for randomized controlled trials comparing different dietary strategies. The purpose of this study was to test the hypothesis that a low-CHO diet for the treatment of GDM would lead to a lower rate of insulin treatment with similar pregnancy outcomes compared with a control diet. RESEARCH DESIGN AND METHODS A total of 152 women with GDM were included in this open, randomized controlled trial and assigned to follow either a diet with low-CHO content (40% of the total diet energy content as CHO) or a control diet (55% of the total diet energy content as CHO). CHO intake was assessed by 3-day food records. The main pregnancy outcomes were also assessed. RESULTS The rate of women requiring insulin was not significantly different between the treatment groups (low CHO 54.7% vs. control 54.7%; P = 1). Daily food records confirmed a difference in the amount of CHO consumed between the groups (P = 0.0001). No differences were found in the obstetric and perinatal outcomes between the treatment groups. CONCLUSIONS Treatment of women with GDM using a low-CHO diet did not reduce the number of women needing insulin and produced similar pregnancy outcomes. In GDM, CHO amount (40 vs. 55% of calories) did not influence insulin need or pregnancy outcomes. PMID:23564917

  20. Leveraging prognostic baseline variables to gain precision in randomized trials

    PubMed Central

    Colantuoni, Elizabeth; Rosenblum, Michael

    2015-01-01

    We focus on estimating the average treatment effect in a randomized trial. If baseline variables are correlated with the outcome, then appropriately adjusting for these variables can improve precision. An example is the analysis of covariance (ANCOVA) estimator, which applies when the outcome is continuous, the quantity of interest is the difference in mean outcomes comparing treatment versus control, and a linear model with only main effects is used. ANCOVA is guaranteed to be at least as precise as the standard unadjusted estimator, asymptotically, under no parametric model assumptions and also is locally semiparametric efficient. Recently, several estimators have been developed that extend these desirable properties to more general settings that allow any real-valued outcome (e.g., binary or count), contrasts other than the difference in mean outcomes (such as the relative risk), and estimators based on a large class of generalized linear models (including logistic regression). To the best of our knowledge, we give the first simulation study in the context of randomized trials that compares these estimators. Furthermore, our simulations are not based on parametric models; instead, our simulations are based on resampling data from completed randomized trials in stroke and HIV in order to assess estimator performance in realistic scenarios. We provide practical guidance on when these estimators are likely to provide substantial precision gains and describe a quick assessment method that allows clinical investigators to determine whether these estimators could be useful in their specific trial contexts. PMID:25872751

  1. Effect of a national primary care pay for performance scheme on emergency hospital admissions for ambulatory care sensitive conditions: controlled longitudinal study

    PubMed Central

    Harrison, Mark J; Dusheiko, Mark; Sutton, Matt; Gravelle, Hugh; Doran, Tim

    2014-01-01

    Objective To estimate the impact of a national primary care pay for performance scheme, the Quality and Outcomes Framework in England, on emergency hospital admissions for ambulatory care sensitive conditions (ACSCs). Design Controlled longitudinal study. Setting English National Health Service between 1998/99 and 2010/11. Participants Populations registered with each of 6975 family practices in England. Main outcome measures Year specific differences between trend adjusted emergency hospital admission rates for incentivised ACSCs before and after the introduction of the Quality and Outcomes Framework scheme and two comparators: non-incentivised ACSCs and non-ACSCs. Results Incentivised ACSC admissions showed a relative reduction of 2.7% (95% confidence interval 1.6% to 3.8%) in the first year of the Quality and Outcomes Framework compared with ACSCs that were not incentivised. This increased to a relative reduction of 8.0% (6.9% to 9.1%) in 2010/11. Compared with conditions that are not regarded as being influenced by the quality of ambulatory care (non-ACSCs), incentivised ACSCs also showed a relative reduction in rates of emergency admissions of 2.8% (2.0% to 3.6%) in the first year increasing to 10.9% (10.1% to 11.7%) by 2010/11. Conclusions The introduction of a major national pay for performance scheme for primary care in England was associated with a decrease in emergency admissions for incentivised conditions compared with conditions that were not incentivised. Contemporaneous health service changes seem unlikely to have caused the sharp change in the trajectory of incentivised ACSC admissions immediately after the introduction of the Quality and Outcomes Framework. The decrease seems larger than would be expected from the changes in the process measures that were incentivised, suggesting that the pay for performance scheme may have had impacts on quality of care beyond the directly incentivised activities. PMID:25389120

  2. Postoperative costs associated with outcomes after cardiac surgery with extracorporeal circulation: role of antithrombin levels.

    PubMed

    Muedra, Vicente; Llau, Juan V; Llagunes, José; Paniagua, Pilar; Veiras, Sonia; Fernández-López, Antonio R; Diago, Carmen; Hidalgo, Francisco; Gil, Jesús; Valiño, Cristina; Moret, Enric; Gómez, Laura; Pajares, Azucena; de Prada, Blanca

    2013-04-01

    To study the impact on postoperative costs of a patient's antithrombin levels associated with outcomes after cardiac surgery with extracorporeal circulation. An analytic decision model was designed to estimate costs and clinical outcomes after cardiac surgery in a typical patient with low antithrombin levels (<63.7%) compared with a patient with normal antithrombin levels (≥63.7%). The data used in the model were obtained from a literature review and subsequently validated by a panel of experts in cardiothoracic anesthesiology. Multi-institutional (14 Spanish hospitals). Consultant anesthesiologists. A sensitivity analysis of extreme scenarios was carried out to assess the impact of the major variables in the model results. The average cost per patient was €18,772 for a typical patient with low antithrombin levels and €13,881 for a typical patient with normal antithrombin levels. The difference in cost was due mainly to the longer hospital stay of a patient with low antithrombin levels compared with a patient with normal levels (13 v 10 days, respectively, representing a €4,596 higher cost) rather than to costs related to the management of postoperative complications (€215, mostly owing to transfusions). Sensitivity analysis showed a high variability range of approximately ±55% of the base case cost between the minimum and maximum scenarios, with the hospital stay contributing more significantly to the variation. Based on this analytic decision model, there could be a marked increase in the postoperative costs of patients with low antithrombin activity levels at the end of cardiac surgery, mainly ascribed to a longer hospitalization. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Ortho-geriatric service--a literature review comparing different models.

    PubMed

    Kammerlander, C; Roth, T; Friedman, S M; Suhm, N; Luger, T J; Kammerlander-Knauer, U; Krappinger, D; Blauth, M

    2010-12-01

    In the fast-growing geriatric population, we are confronted with both osteoporosis, which makes fixation of fractures more and more challenging, and several comorbidities, which are most likely to cause postoperative complications. Several models of shared care for these patients are described, and the goal of our systematic literature research was to point out the differences of the individual models. A systematic electronic database search was performed, identifying articles that evaluate in a multidisciplinary approach the elderly hip fracture patients, including at least a geriatrician and an orthopedic surgeon focused on in-hospital treatment. The different investigations were categorized into four groups defined by the type of intervention. The main outcome parameters were pooled across the studies and weighted by sample size. Out of 656 potentially relevant citations, 21 could be extracted and categorized into four groups. Regarding the main outcome parameters, the group with integrated care could show the lowest in-hospital mortality rate (1.14%), the lowest length of stay (7.39 days), and the lowest mean time to surgery (1.43 days). No clear statement could be found for the medical complication rates and the activities of daily living due to their inhomogeneity when comparing the models. The review of these investigations cannot tell us the best model, but there is a trend toward more recent models using an integrated approach. Integrated care summarizes all the positive features reported in the various investigations like integration of a Geriatrician in the trauma unit, having a multidisciplinary team, prioritizing the geriatric fracture patients, and developing guidelines for the patients' treatment. Each hospital implementing a special model for geriatric hip fracture patients should collect detailed data about the patients, process of care, and outcomes to be able to participate in audit processes and avoid peerlessness.

  4. Decreased visual acuity resulting from glistening and sub-surface nano-glistening formation in intraocular lenses: A retrospective analysis of 5 cases

    PubMed Central

    Matsushima, Hiroyuki; Nagata, Mayumi; Katsuki, Yoko; Ota, Ichiro; Miyake, Kensaku; Beiko, George H.H.; Grzybowski, Andrzej

    2015-01-01

    Background To report on five patients with decreased visual acuity due to glistening and severe sub-surface nano-glistening (SSNG) formation within their intraocular lenses (IOLs). Design Case reports and analysis of extracted IOLs. Participants and samples We report improved visual acuity when IOLs with severe glistening and SSNG were exchanged for clear IOLs in five patients. Methods Case reports. Main outcome measures The main outcome measure was visual acuity. The secondary outcome measure was light transmission. Explanted IOLs were subjected to investigation. Pre- and postoperative slit lamp images of the anterior eye and microscopic images of the extracted IOLs were taken and compared. Light transmission of the IOL was measured using a double beam type spectrophotometer. An integrated value of the percentage light transmittance in the visible light spectrum was calculated. Results We report on five patients whose visual acuity improved when IOLs were exchanged because of severe glistening and SSNG. All of the affected IOLs were MA60BM (Alcon, Forth Wroth Texas, USA) and the original implantation had occurred over a range of 6–15 years prior to the IOL exchange. Light transmission was decreased in all affected lenses compared to a similar control IOL. Conclusions Although only a few reports of cases in which glistening and SSNG have progressed to the level of decreased visual function have been published, the likelihood is that this phenomena will increase as the severity and incidence of these inclusions have been shown to increase with time. Appropriate evaluations of visual function in such patients are needed and consideration should be given to IOL exchange in symptomatic patients. PMID:26586975

  5. Association Between In Vitro Susceptibility to Natamycin and Voriconazole and Clinical Outcomes in Fungal Keratitis

    PubMed Central

    Sun, Catherine Q.; Lalitha, Prajna; Prajna, N. Venkatesh; Karpagam, Rajarathinam; Geetha, Manoharan; O’Brien, Kieran S.; Oldenburg, Catherine E.; Ray, Kathryn J.; McLeod, Stephen D.; Acharya, Nisha R.; Lietman, Thomas M.

    2014-01-01

    Purpose To assess the association between minimum inhibitory concentration (MIC) and clinical outcomes in a fungal keratitis clinical trial. Design Experimental study using data from a randomized comparative trial. Participants Of the 323 patients enrolled in the trial, we were able to obtain MIC values from 221 patients with monocular fungal keratitis. Methods The Mycotic Ulcer Treatment Trial I (MUTT I) was a randomized, double-masked clinical trial comparing clinical outcomes of monotherapy with topical natamycin versus voriconazole for the treatment of fungal keratitis. Speciation and determination of MIC to natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute guidelines. The relationship between MIC and clinical outcome was assessed. Main Outcome Measures The primary outcome was 3-month best spectacle-corrected visual acuity. Secondary outcomes included 3-month infiltrate/scar size, corneal perforation and/or therapeutic penetrating keratoplasty (TPK), and time to re-epithelialization. Results A 2-fold increase in MIC was associated with a larger 3-month infiltrate/scar size (0.21 mm, 95% confidence interval [CI] 0.10–0.31, P <0.001) and increased odds of perforation (odds ratio [OR] 1.32, 95% CI 1.04–1.69, P=0.02). No correlation was found between MIC and 3-month visual acuity. For natamycin-treated cases, an association was found between higher natamycin MIC with larger 3-month infiltrate/scar size (0.29 mm, 95% CI 0.15–0.43, P<0.001) and increased perforations (OR 2.41, 95% CI 1.46–3.97, P<0.001). Among voriconazole-treated cases, the voriconazole MIC did not correlate with any of the measured outcomes in the study. Conclusion Decreased susceptibility to natamycin was associated with increased infiltrate/scar size and increased odds of perforation. There was no association between susceptibility to voriconazole and outcome. PMID:24746358

  6. Edifoligide and long-term outcomes after coronary artery bypass grafting: PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) 5-year results.

    PubMed

    Lopes, Renato D; Williams, Judson B; Mehta, Rajendra H; Reyes, Eric M; Hafley, Gail E; Allen, Keith B; Mack, Michael J; Peterson, Eric D; Harrington, Robert A; Gibson, C Michael; Califf, Robert M; Kouchoukos, Nicholas T; Ferguson, T Bruce; Lorenz, Todd J; Alexander, John H

    2012-09-01

    Edifoligide, an E2F transcription factor decoy, does not prevent vein graft failure or adverse clinical outcomes at 1 year in patients undergoing coronary artery bypass grafting (CABG). We compared the 5-year clinical outcomes of patients in PREVENT IV treated with edifoligide and placebo to identify predictors of long-term clinical outcomes. A total of 3,014 patients undergoing CABG with at least 2 planned vein grafts were enrolled. Kaplan-Meier curves were generated to compare the long-term effects of edifoligide and placebo. A Cox proportional hazards model was constructed to identify factors associated with 5-year post-CABG outcomes. The main outcome measures were death, myocardial infarction (MI), repeat revascularization, and rehospitalization through 5 years. Five-year follow-up was complete in 2,865 patients (95.1%). At 5 years, patients randomized to edifoligide and placebo had similar rates of death (11.7% and 10.7%, respectively), MI (2.3% and 3.2%), revascularization (14.1% and 13.9%), and rehospitalization (61.6% and 62.5%). The composite outcome of death, MI, or revascularization occurred at similar frequency in patients assigned to edifoligide and placebo (26.3% and 25.5%, respectively; hazard ratio 1.03 [95% CI 0.89-1.18], P = .721). Factors associated with death, MI, or revascularization at 5 years included peripheral and/or cerebrovascular disease, time on cardiopulmonary bypass, lung disease, diabetes mellitus, and congestive heart failure. Up to a quarter of patients undergoing CABG will have a major cardiac event or repeat revascularization procedure within 5 years of surgery. Edifoligide does not affect outcomes after CABG; however, common identifiable baseline and procedural risk factors are associated with long-term outcomes after CABG. Copyright © 2012 Mosby, Inc. All rights reserved.

  7. A photometric survey of outer belt asteroids

    NASA Technical Reports Server (NTRS)

    Dimartino, M.; Gonano-Beurer, M.; Mottola, Stefano; Neukum, G.

    1992-01-01

    Since 1989, we have been conducting a research program devoted to the study of the Trojans and outer belt asteroids (Hilda and Cybele groups), in order to characterize their rotational properties and shapes. As an outcome of several observational campaigns, we determined rotational periods and lightcurve amplitudes for 23 distant asteroids, using both CCD and photoelectric photometry. In this paper, we compare the rotational properties of main belt asteroids and Trojans, based on the preliminary results of this survey.

  8. Vitex agnus castus for premenstrual syndrome and premenstrual dysphoric disorder: a systematic review.

    PubMed

    Cerqueira, Raphael O; Frey, Benicio N; Leclerc, Emilie; Brietzke, Elisa

    2017-12-01

    The objective of this study was to evaluate whether Vitex agnus castus is a safe and effective treatment for PMS and premenstrual dysphoric disorder (PMDD) and to discuss the implications of these findings for clinical practice. A systematic review of literature was conducted using PubMed and Scielo databases. The inclusion criteria were randomized controlled trials (RCT) using V. agnus castus in individuals with PMS or PMDD that compared this intervention with placebo or an active comparator and included a description of blinding and dropouts/withdrawals. The search was conducted by two independent investigators who reached consensus on the included trials. A total of eight RCTs were included in this study. Most studies focused on PMS, and the diagnostic criteria of PMS and PMDD changed over the years. Three different preparations of V. agnus castus (VAC) were tested, and there was significant variability in the measurement of treatment outcomes between the studies. Nevertheless, all eight studies were positive for VAC in the treatment of PMS or PMDD and VAC was overall well tolerated. Main limitations were differences in definition of diagnostic criteria, the instruments used as main outcome measures, and different preparations of VAC extracts limit the comparison of results between studies. In conclusion, the RCTs using VAC for treatment of PMS/PMDD suggested that the VAC extract is a safe and efficacious alternative to be considered for the treatment of PMS/PMDD symptoms.

  9. Short-term variations in bone remodeling markers of an oral contraception formulation containing 3 mg of drospirenone plus 30 microg of ethinyl estradiol: observational study in young postadolescent women.

    PubMed

    Paoletti, Anna Maria; Orrù, Marisa; Lello, Stefano; Floris, Stefano; Ranuzzi, Francesca; Etzi, Rossella; Zedda, Pierina; Guerriero, Stefano; Fratta, Stefania; Sorge, Roberto; Mallarini, Giorgio; Melis, Gian Benedetto

    2004-10-01

    The clinical study of treated subjects and nontreated controls was made in healthy eumenorrheic young postadolescent women volunteers in the Department of Obstetrics and Gynaecology at Cagliari University, to investigate whether an oral contraceptive (OC) containing drospirenone (3 mg) plus ethinyl estradiol (30 microg) (DRSP+EE) can affect bone metabolism. Control group (n = 26) and OC group (n = 28) women did not differ in age, body mass index, waist-to-hip ratio and main outcome measures [urinary levels of deoxypyridinoline and pyridinoline, serum levels of osteocalcin, bone specific alkaline phosphatase (bSAP), total testosterone (total-T), sex hormone-binding globulin (SHBG), progesterone and bone mineral density (BMD) at the heel]. The control group was studied at the luteal phase (LP) during both the first and the sixth menstrual cycle; the OC group was studied during the first cycle at the LP, and on days 16-18 of the sixth cycle of DRSP+EE treatment. At the sixth cycle, in the control group, the main outcome measures did not change compared to baseline. In the OC group, deoxypyridinoline, pyridinoline, osteocalcin, bSAP, total-T and progesterone levels were reduced, whereas SHBG levels were increased. The BMD was unchanged compared to baseline. The results suggest that 6-month DRSP+EE treatment decreases bone turnover. Copyright 2004 Elsevier Inc.

  10. Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease: Results From the EXCEL Trial.

    PubMed

    Baron, Suzanne J; Chinnakondepalli, Khaja; Magnuson, Elizabeth A; Kandzari, David E; Puskas, John D; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Taggart, David P; Morice, Marie-Claude; Lembo, Nicholas J; Brown, W Morris; Banning, Adrian; Simonton, Charles A; Kappetein, A Pieter; Sabik, Joseph F; Serruys, Patrick W; Stone, Gregg W; Cohen, David J

    2017-12-26

    The EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial compared outcomes in patients with unprotected left main coronary artery disease (LMCAD) treated with coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) using everolimus-eluting stents. Whereas rates of death, stroke, and myocardial infarction were similar at 36 months, event timing and repeat revascularization rates differed by treatment group. To understand the effects of revascularization strategy from the patient's perspective, a prospective quality of life (QoL) substudy was performed alongside the EXCEL trial. Between September 2010 and March 2014, 1,905 patients with LMCAD were randomized to undergo CABG or PCI, of whom 1,788 participated in the QoL substudy. QoL was assessed at baseline and 1, 12, and 36 months using the Seattle Angina Questionnaire, the 12-Item Short Form Health Survey, the Rose Dyspnea Scale, the Patient Health Questionnaire-8, and the EQ-5D. Differences between PCI and CABG were assessed using longitudinal random-effect growth curve models. Over 36 months, both PCI and CABG were associated with significant improvements in QoL compared with baseline. At 1 month, PCI was associated with better QoL than CABG. By 12 months though, these differences were largely attenuated, and by 36 months, there were no significant QoL differences between PCI and CABG. Among selected patients with LMCAD, both PCI and CABG result in similar QoL improvement through 36 months, although a greater early benefit is seen with PCI. Taken together with the 3-year clinical results of EXCEL, these findings suggest that PCI and CABG provide similar intermediate-term outcomes for patients with LMCAD. (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  11. International variation in the definition of ‘main condition’ in ICD-coded health data

    PubMed Central

    Quan, H.; Moskal, L.; Forster, A.J.; Brien, S.; Walker, R.; Romano, P.S.; Sundararajan, V.; Burnand, B.; Henriksson, G.; Steinum, O.; Droesler, S.; Pincus, H.A.; Ghali, W.A.

    2014-01-01

    Hospital-based medical records are abstracted to create International Classification of Disease (ICD) coded discharge health data in many countries. The ‘main condition’ is not defined in a consistent manner internationally. Some countries employ a ‘reason for admission’ rule as the basis for the main condition, while other countries employ a ‘resource use’ rule. A few countries have recently transitioned from one of these approaches to the other. The definition of ‘main condition’ in such ICD data matters when it is used to define a disease cohort to assign diagnosis-related groups and to perform risk adjustment. We propose a method of harmonizing the international definition to enable researchers and international organizations using ICD-coded health data to aggregate or compare hospital care and outcomes across countries in a consistent manner. Inter-observer reliability of alternative harmonization approaches should be evaluated before finalizing the definition and adopting it worldwide. PMID:24990594

  12. Comparing two types of macrolide antibiotics for the purpose of assessing population-based drug interactions

    PubMed Central

    Fleet, Jamie L; Shariff, Salimah Z; Bailey, David G; Gandhi, Sonja; Juurlink, David N; Nash, Danielle M; Mamdani, Muhammad; Gomes, Tara; Patel, Amit M; Garg, Amit X

    2013-01-01

    Objective Clarithromycin strongly inhibits enzyme cytochrome P450 3A4, preventing the metabolism of some other drugs, while azithromycin is a weak inhibitor. Accordingly, blood concentrations of other drugs increase with clarithromycin coprescription leading to adverse events. These macrolide antibiotics also differ on other properties that may impact outcomes. In this study, we compared outcomes in two groups of macrolide antibiotic users in the absence of potentially interacting drugs. Design Population-based retrospective cohort study. Setting Ontario, Canada, from 2003 to 2010. Patients Patients (mean 74 years) prescribed clarithromycin (n=52 251) or azithromycin (referent group, n=46 618). Main outcomes The primary outcomes were hospital admission within 30 days of a new antibiotic prescription with any of the 12 conditions examined separately (acute kidney injury, acute myocardial infarction, neuroimaging (proxy for delirium), hypotension, syncope, hyperkalaemia, hyponatraemia, hyperglycaemia, arrhythmia, ischaemic stroke, gastrointestinal bleeding and sepsis). The secondary outcome was mortality. Results The baseline characteristics of the two groups, including patient demographics, comorbid conditions, infection type and prescribing physician specialty, were nearly identical. The median daily dose was 1000 mg for clarithromycin and 300 mg for azithromycin and the median duration of dispensing antibiotics was 10 and 5 days, respectively. There was no difference between the groups in the risk of hospitalisation for any condition studied (relative risk ranged from 0.67 to 1.23). Compared with azithromycin, clarithromycin was associated with a slightly higher risk of all-cause mortality (0.46% vs 0.37%, relative risk 1.25, 95% CI 1.03 to 1.52). Conclusions Clarithromycin can be used to assess drug interactions in population-based studies with azithromycin serving as a control group. However, any differences in mortality observed between the two antibiotic groups in the setting of other drug use may be partially attributable to factors beyond the inhibition of drug metabolising enzymes and transporters, as the difference for this outcome was significant. PMID:23847265

  13. Interpregnancy weight changes and impact on pregnancy outcome in a cohort of women with a macrosomic first delivery: a prospective longitudinal study

    PubMed Central

    Crosby, David A; Walsh, Jennifer M; Segurado, Ricardo; McAuliffe, Fionnuala M

    2017-01-01

    Objective To determine the median interpregnancy maternal weight change between first and second pregnancies, and second and third pregnancies and to assess the impact of this weight change on pregnancy outcome in a cohort of women with a macrosomic first delivery. Study design Prospective longitudinal study conducted over three pregnancies from 2007 to 2015. Setting Tertiary referral maternity hospital, Dublin, Ireland. Participants Women were recruited if their first baby weighed >4.0 kg. Methods The pregnancy outcomes in the second and third pregnancies were analysed separately. Data were also analysed for both interpregnancy intervals comparing outcomes for those who gained any weight, or more weight than the median, with those who did not. Main outcome measures Recurrent fetal macrosomia ≥4.0 kg and gestational diabetes mellitus. Results There were 280 women who delivered a third baby between 2011 and 2015. There were no differences in pregnancy outcomes for the second pregnancy in women who gained interpregnancy weight compared with those who did not and those who gained more interpregnancy weight than the median compared with those who did not. There was a statistically significant increase in birth weight ≥4.0 kg (54.0% vs 39.6% p=0.03) in those women who gained any weight between the second and third pregnancies. In those women who gained more interpregnancy weight than the median (1.70 kg) between a second and third pregnancy, there was a significant increase in the rate of gestational diabetes (6.5% vs 1.4%, p=0.03). Conclusions This longitudinal study demonstrates that within this cohort maternal interpregnancy weight change between a second and third pregnancy is associated with an increase in birth weight ≥4.0 kg. Additionally, a gain of more weight than the median (1.70 kg) is associated with a higher rate of gestational diabetes. PMID:28588113

  14. Cost-effectiveness of planned birth in a birth centre compared with alternative planned places of birth: results of the Dutch Birth Centre study

    PubMed Central

    Hermus, Marieke, MAA; Boesveld, Inge, IC; Franx, Arie; van der Pal-de Bruin, Karin, KM; Steegers, Eric, EAP; van den Akker-van Marle, EIske, ME

    2017-01-01

    Objectives To estimate the cost-effectiveness of a planned birth in a birth centre compared with alternative planned places of birth for low-risk women. In addition, a distinction has been made between different types of locations and integration profiles of birth centres. Design Economic evaluation based on a prospective cohort study. Setting 21 Dutch birth centres, 46 hospital locations where midwife-led birth was possible and 110 midwifery practices where home birth was possible. Participants 3455 low-risk women under the care of a community midwife at the start of labour in the Netherlands within the study period 1 July 2013 to 31 December 2013. Main outcome measures Costs and health outcomes of birth for different planned places of birth. Healthcare costs were measured from start of labour until 7 days after birth. The health outcomes were assessed by the Optimality Index-NL2015 (OI) and a composite adverse outcomes score. Results The total adjusted mean costs for births planned in a birth centre, in a hospital and at home under the care of a community midwife were €3327, €3330 and €2998, respectively. There was no difference between the score on the OI for women who planned to give birth in a birth centre and that of women who planned to give birth in a hospital. Women who planned to give birth at home had better outcomes on the OI (higher score on the OI). Conclusions We found no differences in costs and health outcomes for low-risk women under the care of a community midwife with a planned birth in a birth centre and in a hospital. For nulliparous and multiparous low-risk women, planned birth at home was the most cost-effective option compared with planned birth in a birth centre. PMID:28893750

  15. Joint ultrasound baseline abnormalities predict a specific long-term clinical outcome in systemic lupus erythematosus patients.

    PubMed

    Corzo, P; Salman-Monte, T C; Torrente-Segarra, V; Polino, L; Mojal, S; Carbonell-Abelló, J

    2017-06-01

    Objective To describe long-term clinical and serological outcome in all systemic lupus erythematosus (SLE) domains in SLE patients with hand arthralgia (HA) and joint ultrasound (JUS) inflammatory abnormalities, and to compare them with asymptomatic SLE patients with normal JUS. Methods SLE patients with HA who presented JUS inflammatory abnormalities ('cases') and SLE patients without HA who did not exhibit JUS abnormalities at baseline ('controls') were included. All SLE clinical and serological domain involvement data were collected. End follow-up clinical activity and damage scores (systemic lupus erythematosus disease activity index (SLEDAI), Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR)) were recorded. JUS inflammatory abnormalities were defined based on the Proceedings of the Seventh International Consensus Conference on Outcome Measures in Rheumatology Clinical Trials (OMERACT-7) definitions. Statistical analyses were carried out to compare 'cases' and 'controls'. Results A total of 35 patients were recruited. The 'cases', n = 18/35, had a higher incidence of musculoskeletal involvement (arthralgia and/or arthritis) through the follow-up period (38.9% vs 0%, p = 0.008) and received more hydroxychloroquine (61.1% vs 25.0%, p = 0.034) and methotrexate (27.8% vs 0%, p = 0.046) compared to 'controls', n = 17/35. Other comparisons did not reveal any statistical differences. Conclusions We found SLE patients with arthralgia who presented JUS inflammatory abnormalities received more hydroxychloroquine and methotrexate, mainly due to persistent musculoskeletal involvement over time. JUS appears to be a useful technique for predicting worse musculoskeletal outcome in SLE patients.

  16. Surgical management of gastroesophageal reflux disease (GERD) in children: A systematic review.

    PubMed

    Jancelewicz, Tim; Lopez, Monica E; Downard, Cynthia D; Islam, Saleem; Baird, Robert; Rangel, Shawn J; Williams, Regan F; Arnold, Meghan A; Lal, Dave; Renaud, Elizabeth; Grabowski, Julia; Dasgupta, Roshni; Austin, Mary; Shelton, Julia; Cameron, Danielle; Goldin, Adam B

    2017-08-01

    The goal of this systematic review by the American Pediatric Surgical Association Outcomes and Evidence-Based Practice Committee was to derive recommendations from the medical literature regarding the surgical treatment of pediatric gastroesophageal reflux disease (GERD). Five questions were addressed by searching the MEDLINE, Cochrane, Embase, Central, and National Guideline Clearinghouse databases using relevant search terms. Consensus recommendations were derived for each question based on the best available evidence. There was insufficient evidence to formulate recommendations for all questions. Fundoplication does not affect the rate of hospitalization for aspiration pneumonia, apnea, or reflux-related symptoms. Fundoplication is effective in reducing all parameters of esophageal acid exposure without altering esophageal motility. Laparoscopic fundoplication may be comparable to open fundoplication with regard to short-term clinical outcomes. Partial fundoplication and complete fundoplication are comparable in effectiveness for subjective control of GERD. Fundoplication may benefit GERD patients with asthma, but may not improve outcomes in patients with neurologic impairment or esophageal atresia. Overall GERD recurrence rates are likely below 20%. High-quality evidence is lacking regarding the surgical management of GERD in the pediatric population. Definitive conclusions regarding the effectiveness of fundoplication are limited by patient heterogeneity and lack of a standardized outcomes reporting framework. Systematic review of level 1-4 studies. Level 1-4 (mainly level 3-4). Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Randomised trial comparing hysterectomy with endometrial ablation for dysfunctional uterine bleeding: psychiatric and psychosocial aspects.

    PubMed Central

    Alexander, D. A.; Naji, A. A.; Pinion, S. B.; Mollison, J.; Kitchener, H. C.; Parkin, D. E.; Abramovich, D. R.; Russell, I. T.

    1996-01-01

    OBJECTIVE: To compare in psychiatric and psychosocial terms the outcome of hysterectomy and endometrial ablation for the treatment of dysfunctional uterine bleeding. DESIGN: Prospective randomised controlled trial. SETTING--Obstetrics and gynaecology department of a large teaching hospital. SUBJECTS: 204 women with dysfunctional bleeding for whom hysterectomy would have been the preferred treatment were recruited over 24 months and randomly allocated to hysterectomy (99 women) or to hysteroscopic surgery (transcervical resection (52 women) or laser ablation (53 women). MAIN OUTCOME MEASURES: Mental state, martial relationship, psychosocial and sexual adjustment in assessments conducted before the operation and one month, six months, and 12 months later. RESULTS: Both treatments significantly reduced the anxiety and depression present before the operation, and there were no differences in mental health between the groups at 12 months. Hysterectomy did not lead to postoperative psychiatric illness. Sexual interest after the operation did not vary with treatment. Overall, 46 out of 185 (25%) women reported a loss sexual interest and 50 out of 185 (27%) reported increased sexual interest. Marital relationships were unaffected by surgery. Personality and duration of dysfunctional uterine bleeding played no significant part in determining outcome. CONCLUSIONS: Hysteroscopic surgery and hysterectomy have a similar effect on psychiatric and psychosocial outcomes. There is no evidence that hysterectomy leads to postoperative psychiatric illness. PMID:8611783

  18. Long-term effects of transference interpretation in dynamic psychotherapy of personality disorders.

    PubMed

    Høglend, P; Dahl, H-S; Hersoug, A G; Lorentzen, S; Perry, J C

    2011-10-01

    Only a few treatment studies of personality disorders (PD) patients are on longer-term psychotherapy, general outcome measures are used, and follow-up periods are usually short. More studies of long-term therapies, using outcome measures of core psychopathology, are needed. This study is a dismantling randomized controlled clinical trial, specifically designed to study long-term effects of transference interpretation. Forty-six patients with mainly cluster C personality disorders were randomly assigned to 1 year of dynamic psychotherapy with or without transference interpretations. The outcome measures were remission from PD, improvement in interpersonal functioning, and use of mental health resources in the 3-year period after treatment termination. After therapy with transference interpretation PD-patients improved significantly more in core psychopathology and interpersonal functioning, the drop-out rate was reduced to zero, and use of health services was reduced to 50%, compared to therapy without this ingredient. Three years after treatment termination, 73% no longer met diagnostic criteria for any PD in the transference group, compared to 44% in the comparison group. PD-patients with co-morbid disorders improved in both treatment arms in this study. However, transference interpretation improved outcome substantially more. Long-term psychotherapy that includes transference interpretation is an effective treatment for cluster C personality disorders and milder cluster B personality disorders. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

  19. Is intracytoplasmic morphologically selected sperm injection (IMSI) beneficial in the first ART cycle? a multicentric randomized controlled trial.

    PubMed

    Leandri, R D; Gachet, A; Pfeffer, J; Celebi, C; Rives, N; Carre-Pigeon, F; Kulski, O; Mitchell, V; Parinaud, J

    2013-09-01

    Intracytoplasmic morphologically selected sperm injection (IMSI), by selecting spermatozoa at high magnification improves the outcome of intracytoplasmic sperm injection (ICSI) mainly after several failures. However, only few monocentric randomized studies are available and they do not analyse results as a function of sperm characteristics. In 255 couples attempting their first assisted reproductive technology (ART) attempt for male infertility (motile sperm count <1×10⁶ after sperm selection, but at least 3×10⁶ spermatozoa per ejaculate to allow a detailed analysis of sperm characteristics), a prospective randomized trial was performed to compare the clinical outcomes of IMSI and ICSI and to evaluate the influence of sperm characteristics on these outcomes. IMSI did not provide any significant improvement in the clinical outcomes compared with ICSI neither for implantation (24% vs. 23%), nor clinical pregnancy (31% vs. 33%) nor live birth rates (27% vs. 30%). Moreover, the results of IMSI were similar to the ICSI ones whatever the degree of sperm DNA fragmentation, nuclear immaturity and sperm morphology. These results show that IMSI instead of ICSI has no advantage in the first ART attempts. However, this does not rule out IMSI completely and more randomized trials must be performed especially regarding patients carrying severe teratozoospermia, or high sperm DNA fragmentation levels or having previous ICSI failures. © 2013 American Society of Andrology and European Academy of Andrology.

  20. A Randomized Trial of Two Behavioral Interventions to Improve Outcomes Following Inpatient Detoxification for Alcohol Dependence

    PubMed Central

    Blondell, Richard D.; Frydrych, Lynne M.; Jaanimägi, Urmo; Ashrafioun, Lisham; Homish, Gregory G.; Foschio, Elisa M.; Bashaw, Heather L.

    2011-01-01

    To determine if the addition of a behavioral intervention during alcohol detoxification would facilitate initiation of subsequent care, we randomized 150 detoxification patients to receive: treatment as usual (TAU), a Motivation Enhancement Therapy (MET) intervention, or a Peer-delivered Twelve Step Facilitation (P-TSF) intervention. The main outcome was the initiation of any type of subsequent care (i.e., professional treatment or self-help) within 30 and 90 days of discharge. Other outcomes included: alcohol and drug use, completion of subsequent professional treatment, and readmission for detoxification. The mean age of the participants was 45 years; 65% were men, and 84% were white. At the 30-day follow-up, there was no significant difference among the groups in the rate of initiation of any type of subsequent care (82%, 74%, and 82% respectively, p = 0.617); however, the MET group had significantly more patients initiate subsequent inpatient treatment by the 90-day follow-up compared to the P-TSF group (31% and 61%, p = 0.007) and a greater proportion of MET participants completed subsequent inpatient treatment compared to both TAU and P-TSF. There were no differences in drinking-related outcomes (e.g., number of days before first drink, percent days abstinent) between the groups. We conclude that MET during detoxification may provide additional benefits in terms of initiating and maintaining patients in aftercare inpatient treatment programs. PMID:21491295

  1. Microdose follicular flare: a viable alternative for normal responding patients undergoing in vitro fertilization?

    PubMed Central

    Levens, Eric D.; Whitcomb, Brian W.; Kort, Jonathan D.; Materia-Hoover, Donna; Larsen, Frederick W.

    2009-01-01

    Objective To compare cycle outcomes among normal responding patients ≤30 years receiving microdose follicular flare (MDF) and long-luteal agonist (LL). Design Retrospective cohort study. Setting Military-based ART center. Patients First, autologous ART cycles among 499 women ≤30 years old from 01/1999 to 12/2005. Interventions Following OCP administration prior to cycle start, patients were non-randomly assigned to either LL or MDF for LH surge suppression. LL received 1 mg/d leuprolide acetate (LA) on cycle day 21, which was reduced to 0.25 mg/day 10–14 days later. MDF received LA (40 μg BID) beginning 3 days after discontinuing OCPs. Both groups received a combination of hMG and rFSH. Main Outcome Measures Primary outcomes were implantation, clinical pregnancy and live birth rates; in cycle variables included peak E2, oocytes retrieved, oocyte maturity, and fertilization rate. Results Multivariable models controlling for confounding by treatment indication found no significant differences between groups in implantation (MDF:36%; LL:38%), clinical pregnancy (MDF:53%; LL:56%), and live birth rates (MDF:47%; LL:50%). No differences were observed in peak E2, oocytes retrieved, oocyte maturity, fertilization rate, or embryos transferred. Conclusions MDF use among normal responding ART patients produced no differences in cycle outcome when compared to LL. Resultantly, MDF may be a viable alternative for normal responding patients. PMID:18249365

  2. Outcomes of robotic versus laparoscopic surgery for mid and low rectal cancer after neoadjuvant chemoradiation therapy and the effect of learning curve

    PubMed Central

    Huang, Yu-Min; Huang, Yan Jiun; Wei, Po-Li

    2017-01-01

    Abstract Randomized controlled trials have demonstrated that laparoscopic surgery for rectal cancer is safe and can accelerate recovery without compromising oncological outcomes. However, such a surgery is technically demanding, limiting its application in nonspecialized centers. The operational features of a robotic system may facilitate overcoming this limitation. Studies have reported the potential advantages of robotic surgery. However, only a few of them have featured the application of this surgery in patients with advanced rectal cancer undergoing neoadjuvant chemoradiation therapy (nCRT). From January 2012 to April 2015, after undergoing nCRT, 40 patients with mid or low rectal cancer were operated using the robotic approach at our institution. Another 38 patients who were operated using the conventional laparoscopic approach were matched to patients in the robotic group by sex, age, the body mass index, and procedure. All operations were performed by a single surgical team. The clinicopathological characteristics and short-term outcomes of these patients were compared. To assess the effect of the learning curve on the outcomes, patients in the robotic group were further subdivided into 2 groups according to the sequential order of their procedures, with an equal number of patients in each group. Their outcome measures were compared. The robotic and laparoscopic groups were comparable with regard to pretreatment characteristics, rectal resection type, and pathological examination result. After undergoing nCRT, more patients in the robotic group exhibited clinically advanced diseases. The complication rate was similar between the 2 groups. The operation time and the time to the resumption of a soft diet were significantly prolonged in the robotic group. Further analysis revealed that the difference was mainly observed in the first robotic group. No significant difference was observed between the second robotic and laparoscopic groups. Although the robotic approach may offer potential advantages for rectal surgery, comparable short-term outcomes may be achieved when laparoscopic surgery is performed by experienced surgeons. However, our results suggested a shorter learning curve for robotic surgery for rectal cancer, even in patients who exhibited more advanced disease after undergoing nCRT. PMID:28984767

  3. Alcohol consumption for simulated driving performance: A systematic review.

    PubMed

    Rezaee-Zavareh, Mohammad Saeid; Salamati, Payman; Ramezani-Binabaj, Mahdi; Saeidnejad, Mina; Rousta, Mansoureh; Shokraneh, Farhad; Rahimi-Movaghar, Vafa

    2017-06-01

    Alcohol consumption can lead to risky driving and increase the frequency of traffic accidents, injuries and mortalities. The main purpose of our study was to compare simulated driving performance between two groups of drivers, one consumed alcohol and the other not consumed, using a systematic review. In this systematic review, electronic resources and databases including Medline via Ovid SP, EMBASE via Ovid SP, PsycINFO via Ovid SP, PubMed, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINHAL) via EBSCOhost were comprehensively and systematically searched. The randomized controlled clinical trials that compared simulated driving performance between two groups of drivers, one consumed alcohol and the other not consumed, were included. Lane position standard deviation (LPSD), mean of lane position deviation (MLPD), speed, mean of speed deviation (MSD), standard deviation of speed deviation (SDSD), number of accidents (NA) and line crossing (LC) were considered as the main parameters evaluating outcomes. After title and abstract screening, the articles were enrolled for data extraction and they were evaluated for risk of biases. Thirteen papers were included in our qualitative synthesis. All included papers were classified as high risk of biases. Alcohol consumption mostly deteriorated the following performance outcomes in descending order: SDSD, LPSD, speed, MLPD, LC and NA. Our systematic review had troublesome heterogeneity. Alcohol consumption may decrease simulated driving performance in alcohol consumed people compared with non-alcohol consumed people via changes in SDSD, LPSD, speed, MLPD, LC and NA. More well-designed randomized controlled clinical trials are recommended. Copyright © 2017. Production and hosting by Elsevier B.V.

  4. A systematic review and cost analysis of robot-assisted hysterectomy in malignant and benign conditions.

    PubMed

    Tapper, Anna-Maija; Hannola, Mikko; Zeitlin, Rainer; Isojärvi, Jaana; Sintonen, Harri; Ikonen, Tuija S

    2014-06-01

    In order to assess the effectiveness and costs of robot-assisted hysterectomy compared with conventional techniques we reviewed the literature separately for benign and malignant conditions, and conducted a cost analysis for different techniques of hysterectomy from a hospital economic database. Unlimited systematic literature search of Medline, Cochrane and CRD databases produced only two randomized trials, both for benign conditions. For the outcome assessment, data from two HTA reports, one systematic review, and 16 original articles were extracted and analyzed. Furthermore, one cost modelling and 13 original cost studies were analyzed. In malignant conditions, less blood loss, fewer complications and a shorter hospital stay were considered as the main advantages of robot-assisted surgery, like any mini-invasive technique when compared to open surgery. There were no significant differences between the techniques regarding oncological outcomes. When compared to laparoscopic hysterectomy, the main benefit of robot-assistance was a shorter learning curve associated with fewer conversions but the length of robotic operation was often longer. In benign conditions, no clinically significant differences were reported and vaginal hysterectomy was considered the optimal choice when feasible. According to Finnish data, the costs of robot-assisted hysterectomies were 1.5-3 times higher than the costs of conventional techniques. In benign conditions the difference in cost was highest. Because of expensive disposable supplies, unit costs were high regardless of the annual number of robotic operations. Hence, in the current distribution of cost pattern, economical effectiveness cannot be markedly improved by increasing the volume of robotic surgery. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. Comparison of retrograde intrarenal surgery versus a single-session percutaneous nephrolithotomy for lower-pole stones with a diameter of 15 to 30 mm: A propensity score-matching study.

    PubMed

    Jung, Gyoo Hwan; Jung, Jae Hyun; Ahn, Tae Sik; Lee, Joong Sub; Cho, Sung Yong; Jeong, Chang Wook; Lee, Seung Bae; Kim, Hyeon Hoe; Oh, Seung-June

    2015-07-01

    To investigate surgical outcomes between retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) groups for a main stone sized 15 to 30 mm and located in the lower-pole calyx. Patients who underwent PNL or RIRS for a main stone sized 15 to 30 mm and located in the lower-pole calyx were retrospectively reviewed. Each patient in the RIRS group was matched to one in the PNL group on the basis of calculated propensity scores by use of age, sex, body mass index, previous treatment history, stone site, maximum stone size, and stone volume. We compared perioperative outcomes between the unmatched and matched groups. Patients underwent PNL (n=87, 66.4%) or RIRS (n=44, 33.6%). After matching, 44 patients in each group were included. Mean patient age was 54.4 ± 13.7 years. Perioperative hemoglobin drop was significantly higher and the hospital stay was longer in the PNL group than in the RIRS group. The operative time was significantly longer in the RIRS group than in the PNL group. Stone-free rates were higher and complications rates were lower in the RIRS group than in the PNL group without statistical significance. The presence of a stone located in the lower-anterior minor calyx was a predictor of stone-free status. RIRS and single-session PNL for patients with a main stone of 15 to 30 mm located in the lower-pole calyx showed comparable surgical results. However, RIRS can be performed more safely than PNL with less bleeding. Stones in the lower-anterior minor calyx should be carefully removed during these procedures.

  6. Comparison of retrograde intrarenal surgery versus a single-session percutaneous nephrolithotomy for lower-pole stones with a diameter of 15 to 30 mm: A propensity score-matching study

    PubMed Central

    Jung, Gyoo Hwan; Jung, Jae Hyun; Ahn, Tae Sik; Lee, Joong Sub; Cho, Sung Yong; Jeong, Chang Wook; Lee, Seung Bae; Kim, Hyeon Hoe

    2015-01-01

    Purpose To investigate surgical outcomes between retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) groups for a main stone sized 15 to 30 mm and located in the lower-pole calyx. Materials and Methods Patients who underwent PNL or RIRS for a main stone sized 15 to 30 mm and located in the lower-pole calyx were retrospectively reviewed. Each patient in the RIRS group was matched to one in the PNL group on the basis of calculated propensity scores by use of age, sex, body mass index, previous treatment history, stone site, maximum stone size, and stone volume. We compared perioperative outcomes between the unmatched and matched groups. Results Patients underwent PNL (n=87, 66.4%) or RIRS (n=44, 33.6%). After matching, 44 patients in each group were included. Mean patient age was 54.4±13.7 years. Perioperative hemoglobin drop was significantly higher and the hospital stay was longer in the PNL group than in the RIRS group. The operative time was significantly longer in the RIRS group than in the PNL group. Stone-free rates were higher and complications rates were lower in the RIRS group than in the PNL group without statistical significance. The presence of a stone located in the lower-anterior minor calyx was a predictor of stone-free status. Conclusions RIRS and single-session PNL for patients with a main stone of 15 to 30 mm located in the lower-pole calyx showed comparable surgical results. However, RIRS can be performed more safely than PNL with less bleeding. Stones in the lower-anterior minor calyx should be carefully removed during these procedures. PMID:26175872

  7. Multicausal analysis on water deterioration processes present in a drinking water treatment system.

    PubMed

    Wang, Li; Ma, Fang; Pang, Changlong; Firdoz, Shaik

    2013-03-01

    The fluctuation of water turbidity has been studied during summer in the settling tanks of a drinking water treatment plant. Results from the multiple cause-effect model indicated that five main pathways interactively influenced thequalityof tank water. During rain, turbidity levels increased mainly as a result of decreasing pH and anaerobic reactions (partial effect = 68%). Increasing water temperature combined with dissolved oxygen concentration (partial effect = 64%) was the key parameterforcontrolling decreases in water turbidity during nighttime periods after a rainy day. The dominant factor influencing increases in turbidity during sunny daytime periods was algal blooms (partial effect = 86%). However, short-circuiting waves (partial effect = 77%) was the main cause for increased nighttime water turbidity after a sunny day. The trade offbetween regulatory pathways was responsible for environmental changes, and the outcome was determined by the comparative strengths of each pathway.

  8. Preventing patient-to-worker violence in hospitals: outcome of a randomized controlled intervention

    PubMed Central

    Arnetz, Judith E.; Hamblin, Lydia; Russell, Jim; Upfal, Mark J.; Luborsky, Mark; Janisse, James; Essenmacher, Lynnette

    2016-01-01

    Objective To evaluate the effects of a randomized controlled intervention on the incidence of patient-to-worker (Type II) violence and related injury in hospitals. Methods Forty-one units across 7 hospitals were randomized into intervention (n=21) and control (n=20) groups. Intervention units received unit-level violence data to facilitate development of an action plan for violence prevention; no data were presented to control units. Main outcomes were rates of violent events and injuries across study groups over time. Results Six months post-intervention, incident rate ratios of violent events were significantly lower on intervention units compared to controls (IRR 0.48, 95% CI 0.29-0.80). At 24 months, the risk for violence-related injury was lower on intervention units, compared to controls (IRR 0.37, 95% CI 0.17-0.83). Conclusion This data-driven, worksite-based intervention was effective in decreasing risks of patient-to-worker violence and related injury. PMID:28045793

  9. Maine Technical College System Annual Report, 1996.

    ERIC Educational Resources Information Center

    Fitzsimmons, John

    Focusing on the 1995-96 academic year, this report discusses programs and outcomes for the seven colleges in the Maine Technical College System (MTCS). Following a message from the System President, general outcomes for the MTCS are described. This section indicates that systemwide enrollment in fall 1995 was 4,475, representing a 24% increase…

  10. Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial.

    PubMed

    Borgen, Iren; Garnweidner-Holme, Lisa Maria; Jacobsen, Anne Flem; Bjerkan, Kirsti; Fayyad, Seraj; Joranger, Pål; Lilleengen, Anne Marie; Mosdøl, Annhild; Noll, Josef; Småstuen, Milada Cvancarova; Terragni, Laura; Torheim, Liv Elin; Lukasse, Mirjam

    2017-03-27

    The promotion of a healthy diet, physical activity and measurement of blood glucose levels are essential components in the care for women with gestational diabetes mellitus (GDM). Smartphones offer a new way to promote health behaviour. The main aim is to investigate if the use of the Pregnant+ app, in addition to standard care, results in better blood glucose levels compared with current standard care only, for women with GDM. This randomised controlled trial will include 230 pregnant women with GDM followed up at 5 outpatient departments (OPD) in the greater Oslo Region. Women with a 2-hour oral glucose tolerance test (OGTT) ≥9 mmol/L, who own a smartphone, understand Norwegian, Urdu or Somali and are <33 weeks pregnant, are invited. The intervention group receives the Pregnant+ app and standard care. The control group receives standard care only. Block randomisation is performed electronically. Data are collected using self-reported questionnaires and hospital records. Data will be analysed according to the intention-to-treat principle. Groups will be compared using linear regression for the main outcome and χ 2 test for categorical data and Student's t-test or Mann-Whitney-Wilcoxon test for skewed distribution. The main outcome is the glucose level measured at the 2-hour OGTT 3 months postpartum. Secondary outcomes are a change in health behaviour and knowledge about GDM, quality of life, birth weight, mode of delivery and complications for mother and child. The study is exempt from regional ethics review due to its nature of quality improvement in patient care. Our study has been approved by the Norwegian Social Science Data Services and the patient privacy protections boards governing over the recruitment sites. Findings will be presented in peer-reviewed journals and at conferences. NCT02588729, Post-results. 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/.

  11. Treatment outcomes in patients with migraine: an ex-post-facto comparison of two in-patient facilities.

    PubMed

    Weidenhammer, W; Linde, K; Melchart, D

    2004-08-01

    In two hospitals we performed an open, prospective observational study on patients with chronic headache as a measure of internal quality assurance using identical methods. Available data were subordinately analysed in order to compare both studies. Are the patient samples of both hospitals comparable? If not, which form of statistical adjustment is recommended? Are there differences in the outcome measures of both facilities? The outcomes were defined as differences between baseline values and values at discharge from hospital, respectively 6 months after. Frequency of headache attacks, intensity of pain, intensity of general complaints as well as of concomitant symptoms, and quality of life were determined in advance as dependent variables. To compare both patient groups univariate analysis of variance without and with inclusion of covariates were used. For calculating propensity scores (conditional probability of belonging to one of two groups) a logistic regression with the same covariates serving as independent variables was performed. 426 patients with the main diagnosis "Migraine" and complete data sets concerning the covariates were selected for analysis. 87% of patients are female, the mean age is 45.5 +/- 11.7 years (range 14-73 yrs). 4 out of 11 potential covariates show statistically significant differences between the patients of both hospitals. Correct classification of patients by means of the propensity score succeeds in 67%. Comparing the outcomes at discharge from hospital, significant differences between both groups exist which are, with one exception, not affected by controlling for covariates. 6 months after discharge two of the initial differences between both patient groups are no longer present. These findings are independent from the statistical technique of risk adjustment. Because of the observed differences between both patient groups it is recommended to adjust data by regression analysis in order to enhance comparability. The choice for one of the two proposed techniques is secondary. With respect to the analyses clear differences between both hospitals exist in short-term outcomes, disappearing 6 months later. Copyright 2004 S. Karger GmbH, Freiburg

  12. An overview of morbidity, mortality and long-term outcome of late preterm birth.

    PubMed

    Dong, Ying; Yu, Jia-Lin

    2011-08-01

    Preterm birth rate continues to rise around the world mainly at the expense of late preterm newborns, recently defined as births between the gestational age of 34 weeks and 36-6/7 weeks. Late preterm infants are considered to have significantly more short-term and longterm adverse outcomes than term infants. Articles concerning morbidity, mortality and long-term outcomes of late preterm infants were retrieved from PubMed/MEDLINE published during the period of 2000-2010. Late preterm infants are the fastest growing subgroup of neonates, comprising the majority of all preterm births. Compared with term infants, they have significantly higher risk of morbidity, mortality and adverse long-term outcomes well beyond infancy into adulthood. However, epidemiology and etiology of late preterm births, the magnitude of their morbidity, the long-term life quality, and public health impact have not been well studied. The growing number of late preterm neonates substantiates the importance to better understand and medically approach this special preterm subgroup. A long-term evaluation, monitoring and follow-up of late preterm infants are needed to optimize neonatal care and improve human health status.

  13. Comparison of mild and microdose GnRH agonist flare protocols on IVF outcome in poor responders.

    PubMed

    Karimzadeh, Mohammad Ali; Mashayekhy, Mehri; Mohammadian, Farnaz; Moghaddam, Fatemeh Mansoori

    2011-05-01

    To compare the IVF outcome of clomiphene citrate/gonadotropin/antagonist (mild protocol) and microdose GnRH agonist flare protocols for poor responders undergoing in vitro fertilization. 159 poor responder patients were randomized and ovarian stimulation was performed with clomiphene citrate, gonadotropin and antagonist (group I) or microdose GnRH agonist flare (group II) protocols. Main outcome was clinical pregnancy rate and secondary outcomes were doses of gonadotropin administration and duration of stimulation. There were no significant differences in age, causes of infertility, basal FSH, BMI, duration of infertility, E(2) level on the day of hCG injection in both groups. Although the cancellation, fertilization, and clinical pregnancy rates were similar in both groups, the endometrial thickness, number of retrieved oocytes, mature oocytes and implantation rate were significantly higher in mild protocol. The doses of gonadotropin administration and duration of stimulation were significantly lower in mild protocol. We recommend mild protocol in assisted reproductive technology cycles for poor responders based on our results regarding less doses of used gonadotropin and a shorter duration of stimulation.

  14. Obstetric and perinatal outcomes in IVF versus ICSI-conceived pregnancies at a tertiary care center--a pilot study.

    PubMed

    Nouri, Kazem; Ott, Johannes; Stoegbauer, Lucia; Pietrowski, Detlef; Frantal, Sophie; Walch, Katharina

    2013-08-31

    Although most pregnancies after IVF result in normal healthy outcomes, an increased risk for a number of obstetric and neonatal complications, compared to naturally conceived pregnancies, has been reported. While there are many studies that compare pregnancies after assisted reproductive techniques with spontaneously conceived pregnancies, fewer data are available that evaluate the differences between IVF and ICSI-conceived pregnancies. The aim of our present study was, therefore, to compare obstetric and perinatal outcomes in pregnancies conceived after in vitro fertilization (IVF) versus intracytoplasmatic sperm injection (ICSI). Three-hundred thirty four women who had become pregnant after an IVF or ICSI procedure resulted in a total of 530 children referred between 2003 und 2009 to the Department of Obstetrics and Gynecology of the Medical University of Vienna, a tertiary care center, and were included in this retrospective cohort study. We assessed maternal and fetal parameters in both groups (IVF and ICSI). The main study outcomes were preterm delivery, the need for neonatal intensive care, and congenital malformations. Moreover, we compared the course of pregnancy between both groups and the occurrence of complications that led to maternal hospitalization during pregnancy. There were 80 children conceived via ICSI and 450 children conceived via IVF.Mean gestational age was significantly lower in the ICSI group (p = 0.001). After ICSI, the birth weight (p = 0.008) and the mean APGAR values after 1 minute and after 10 minutes were lower compared to that of the IVF group (p = 0.016 and p = 0.047, respectively). Moreover, ICSI-conceived children had to be hospitalized more often at a neonatal intensive care unit (p = 0.004). There was no difference in pH of the umbilical artery or in major congenital malformations between the two groups. Pregnancy complications (i.e., premature rupture of membranes, cervical insufficiency, and premature uterine contractions) and the need for maternal hospitalization during pregnancy were found significantly more often after IVF (p = 0.0016 and p = 0.0095, respectively), compared to the ICSI group. When comparing IVF versus ICSI-conceived pregnancies at a tertiary care center, we found the course of pregnancy to be more complicated after IVF, whereas the primary fetal outcome seemed to be better in this group than after ICSI treatment.

  15. Obstetric and perinatal outcomes in IVF versus ICSI-conceived pregnancies at a tertiary care center - a pilot study

    PubMed Central

    2013-01-01

    Background Although most pregnancies after IVF result in normal healthy outcomes, an increased risk for a number of obstetric and neonatal complications, compared to naturally conceived pregnancies, has been reported. While there are many studies that compare pregnancies after assisted reproductive techniques with spontaneously conceived pregnancies, fewer data are available that evaluate the differences between IVF and ICSI-conceived pregnancies. The aim of our present study was, therefore, to compare obstetric and perinatal outcomes in pregnancies conceived after in vitro fertilization (IVF) versus intracytoplasmatic sperm injection (ICSI). Methods Three-hundred thirty four women who had become pregnant after an IVF or ICSI procedure resulted in a total of 530 children referred between 2003 und 2009 to the Department of Obstetrics and Gynecology of the Medical University of Vienna, a tertiary care center, and were included in this retrospective cohort study. We assessed maternal and fetal parameters in both groups (IVF and ICSI). The main study outcomes were preterm delivery, the need for neonatal intensive care, and congenital malformations. Moreover, we compared the course of pregnancy between both groups and the occurrence of complications that led to maternal hospitalization during pregnancy. Results There were 80 children conceived via ICSI and 450 children conceived via IVF. Mean gestational age was significantly lower in the ICSI group (p = 0.001). After ICSI, the birth weight (p = 0.008) and the mean APGAR values after 1 minute and after 10 minutes were lower compared to that of the IVF group (p = 0.016 and p = 0.047, respectively). Moreover, ICSI-conceived children had to be hospitalized more often at a neonatal intensive care unit (p = 0.004). There was no difference in pH of the umbilical artery or in major congenital malformations between the two groups. Pregnancy complications (i.e., premature rupture of membranes, cervical insufficiency, and premature uterine contractions) and the need for maternal hospitalization during pregnancy were found significantly more often after IVF (p = 0.0016 and p = 0.0095, respectively), compared to the ICSI group. Conclusions When comparing IVF versus ICSI-conceived pregnancies at a tertiary care center, we found the course of pregnancy to be more complicated after IVF, whereas the primary fetal outcome seemed to be better in this group than after ICSI treatment. PMID:24004836

  16. The Association of Frailty With Outcomes and Resource Use After Emergency General Surgery: A Population-Based Cohort Study.

    PubMed

    McIsaac, Daniel I; Moloo, Husein; Bryson, Gregory L; van Walraven, Carl

    2017-05-01

    Older patients undergoing emergency general surgery (EGS) experience high rates of postoperative morbidity and mortality. Studies focused primarily on elective surgery indicate that frailty is an important predictor of adverse outcomes in older surgical patients. The population-level effect of frailty on EGS is poorly described. Therefore, our objective was to measure the association of preoperative frailty with outcomes in a population of older patients undergoing EGS. We created a population-based cohort study using linked administrative data in Ontario, Canada, that included community-dwelling individuals aged >65 years having EGS. Our main exposure was preoperative frailty, as defined by the Johns Hopkins Adjusted Clinical Groups frailty-defining diagnoses indicator. The Adjusted Clinical Groups frailty-defining diagnoses indicator is a binary variable that uses 12 clusters of frailty-defining diagnoses. Our main outcome measures were 1-year all-cause mortality (primary), intensive care unit admission, length of stay, institutional discharge, and costs of care (secondary). Of 77,184 patients, 19,779 (25.6%) were frail. Death within 1 year occurred in 6626 (33.5%) frail patients compared with 11,366 (19.8%) nonfrail patients. After adjustment for sociodemographic and surgical confounders, this resulted in a hazard ratio of 1.29 (95% confidence interval [CI] 1.25-1.33). The risk of death for frail patients varied significantly across the postoperative period and was particularly high immediately after surgery (hazard ratio on postoperative day 1 = 23.1, 95% CI 22.3-24.1). Frailty was adversely associated with all secondary outcomes, including a 5.82-fold increase in the adjusted odds of institutional discharge (95% CI 5.53-6.12). After EGS, frailty is associated with increased rates of mortality, institutional discharge, and resource use. Strategies that might improve perioperative outcomes in frail EGS patients need to be developed and tested.

  17. Unmatched U.S. Allopathic Seniors in the 2015 Main Residency Match: A Study of Applicant Behavior, Interview Selection, and Match Outcome.

    PubMed

    Liang, Mei; Curtin, Laurie S; Signer, Mona M; Savoia, Maria C

    2017-07-01

    The application and interview behaviors of unmatched U.S. allopathic medical school senior students (U.S. seniors) participating in the 2015 National Resident Matching Program (NRMP) Main Residency Match were studied in conjunction with their United States Medical Licensing Examination (USMLE) Step 1 scores and ranking preferences to understand their effects on Match outcome. USMLE Step 1 score and preferred specialty information were reviewed for U.S. seniors who responded to the 2015 NRMP Applicant Survey. Unmatched U.S. seniors were categorized as "strong," "solid," "marginal," or "weak" based on the perceived competitiveness of their Step 1 scores compared with U.S. seniors who matched in the same preferred specialty. The numbers of applications sent, interviews obtained, and programs ranked also were examined by Match outcome. Strong unmatched U.S. seniors submitted significantly more applications to achieve and attend approximately the same number of interviews as strong matched U.S. seniors. Strong unmatched seniors ranked fewer programs than their matched counterparts. As a group, unmatched U.S. seniors were less likely than their matched counterparts to rank a mix of competitive and less competitive programs and more likely to rank programs based on their perceived likelihood of matching. A small number of unmatched U.S. seniors would have matched if they had ranked programs that ranked them. U.S. seniors' Match outcomes may be affected by applicant characteristics that negatively influence their selection for interviews, and their difficulties may be exacerbated by disadvantageous ranking behaviors.

  18. Normal stress-only myocardial single photon emission computed tomography predicts good outcome in patients with coronary artery stenoses between 40 and 70.

    PubMed

    Jiang, Zhixin; Liu, Yangqing; Xin, Chaofan; Zhou, Yanli; Wang, Cheng; Zhao, Zhongqiang; Li, Chunxiang; Li, Dianfu

    2016-09-01

    Normal stress myocardial single photon emission computed tomography (SPECT) usually indicates good physiologic function of all coronary lesions, and also indicates a good outcome. We hypothesize that it can still predict good outcome in patients with coronary stenoses between 40 and 70%. A group of patients who underwent stress myocardial SPECT after coronary angiography were consecutively recruited in our center. Patients were eligible if they had one or more coronary stenoses between 40 and 70%. Patients with coronary stenoses greater than 50% diameter of left main or greater than 70% diameter of nonleft main epicardial vessels, and left ventricular ejection fraction less than 50% were excluded. The outcome was defined as major adverse events, including cardiac death, nonfatal myocardial infarction, and revascularization. Patients' survival curves were constructed accorded to the method of Kaplan and Meier and compared using the log-rank test. A study cohort of 77 patients was enrolled. According to the summed stress score, 43 patients were assigned to the perfusion defect group and 34 patients were assigned to the perfusion normal group. The follow-up duration was 6.4±0.3 years. In the perfusion normal group, only one of 34 (2.9%) patients developed major adverse events. In the perfusion defect group, six of 43 (14%) developed major adverse events, P-value of 0.041. It is safe to defer a percutaneous coronary intervention in patients with coronary stenoses between 40 and 70% and normal stress myocardial SPECT.

  19. A randomized trial of enema versus polyethylene glycol 3350 for fecal disimpaction in children presenting to an emergency department.

    PubMed

    Miller, Melissa K; Dowd, Mary Denise; Friesen, Craig A; Walsh-Kelly, Christine M

    2012-02-01

    This study aimed to compare efficacy of enema versus polyethylene glycol (PEG) 3350 for pediatric fecal impaction treatment. We conducted a prospective, randomized comparison of treatments of fecal impaction in children in a pediatric emergency department (ED). Treatment arms were a single milk and molasses enema in the ED or PEG 3350 for 3 days outpatient. Telephone follow-up was done on days 1, 3, and 5. The primary outcome was main symptom improvement. Additional outcomes were stool frequency, consistency, and ease of stool passage. Treatment failures (home enema, ED return, or hospital admission) were tracked. Seventy-nine subjects participated (39 PEG; 40 enema). At day 1, PEG subjects were less likely to have improved main symptom (odds ratio [OR], 0.3; 95% confidence interval [CI], 0.1-0.8) but no difference in other outcomes. Half (54%) in enema arm were reported as upset by ED therapy, whereas no children in PEG arm were upset (P < 0.05). At day 3, more patients in enema arm reported ideal stool consistency (74% vs 38%; P < 0.05). At day 5, no difference between groups was noted. Most treatment failures were in PEG arm (83%; P = 0.08). This pilot study suggests that disimpaction by enema may be superior to PEG for immediate relief of symptoms. Larger trials are needed to assess any advantage.

  20. Inequalities in multiple health outcomes by education, sex, and race in 93 US counties: why we should measure them all.

    PubMed

    Asada, Yukiko; Whipp, Alyce; Kindig, David; Billard, Beverly; Rudolph, Barbara

    2014-06-13

    Regular reporting of health inequalities is essential to monitoring progress of efforts to reduce health inequalities. While reporting of population health became increasingly common, reporting of a subpopulation group breakdown of each indicator of the health of the population is rarely a standard practice. This study reports education-, sex-, and race-related inequalities in four health outcomes in each of the selected 93 counties in the United States in a systematic and comparable manner. This study is a cross-sectional analysis of large, publicly available data, 2008, 2009, and 2010 Behavioral Risk Factor Surveillance System (BRFSS) Selected Metropolitan/Micropolitan Area Risk Trends (SMART) and 2008, 2009, and 2010 United States Birth Records from the National Vital Statistics System. The study population is American adults older than 25 years of age residing in the selected 93 counties, representing about 30% of the US population, roughly equally covering all geographic regions of the country. Main outcome measures are: (1) Attribute (group characteristic)-specific inequality: education-, sex-, or race-specific inequality in each of the four health outcomes (poor or fair health, poor physical health days, poor mental health days, and low birthweight) in each county; (2) Overall inequality: the average of these three attribute-specific inequalities for each health outcome in each county; and (3) Summary inequality in total morbidity: the weighted average of the overall inequalities across the four health outcomes in each county. The range of inequality across the counties differed considerably by health outcome; inequality in poor or fair health had the widest range and the highest median among inequalities in all health outcomes. In more than 70% of the counties, education-specific inequality was the largest in all health outcomes except for low birthweight. It is feasible to extend population health reporting to include reporting of a subpopulation group breakdown of each indicator of the health of the population at a small jurisdictional level using publicly available data. No single group characteristic or health outcome represents the whole picture of health inequalities in a population. Examining multiple group characteristics and outcomes in a comparable manner is essential in reporting health inequalities.

  1. Neurosurgeon academic impact is associated with clinical outcomes after clipping of ruptured intracranial aneurysms

    PubMed Central

    Ibrahim, George M.; Wang, Justin; Guha, Daipayan; Mamdani, Muhammad; Schweizer, Tom A.; Macdonald, R. Loch

    2017-01-01

    Background Surgeon-dependent factors such as experience and volume are associated with patient outcomes. However, it is unknown whether a surgeon’s research productivity could be related to outcomes. The main aim of this study is to investigate the association between the surgeon’s academic productivity and clinical outcomes following neurosurgical clipping of ruptured aneurysms. Methods We performed a post-hoc analysis of 3567 patients who underwent clipping of ruptured intracranial aneurysms in the randomized trials of tirilazad mesylate from 1990 to 1997. These trials included 162 centers and 156 surgeons from 21 countries. Primary and secondary outcomes were: Glasgow outcome scale score and mortality, respectively. Total publications, H-index, and graduate degrees were used as academic indicators for each surgeon. The association between outcomes and academic factors were assessed using a hierarchical logistic regression analysis, adjusting for patient covariates. Results Academic profiles were available for 147 surgeons, treating a total of 3307 patients. Most surgeons were from the USA (62, 42%), Canada (18, 12%), and Germany (15, 10%). On univariate analysis, the H-index correlated with better functional outcomes and lower mortality rates. In the multivariate model, patients under the care of surgeons with higher H-indices demonstrated improved neurological outcomes (p = 0.01) compared to surgeons with lower H-indices, without any significant difference in mortality. None of the other academic indicators were significantly associated with outcomes. Conclusion Although prognostication following surgery for ruptured intracranial aneurysms primarily depends on clinical and radiological factors, the academic impact of the operating neurosurgeon may explain some heterogeneity in surgical outcomes. PMID:28727832

  2. Neurosurgeon academic impact is associated with clinical outcomes after clipping of ruptured intracranial aneurysms.

    PubMed

    Alotaibi, Naif M; Ibrahim, George M; Wang, Justin; Guha, Daipayan; Mamdani, Muhammad; Schweizer, Tom A; Macdonald, R Loch

    2017-01-01

    Surgeon-dependent factors such as experience and volume are associated with patient outcomes. However, it is unknown whether a surgeon's research productivity could be related to outcomes. The main aim of this study is to investigate the association between the surgeon's academic productivity and clinical outcomes following neurosurgical clipping of ruptured aneurysms. We performed a post-hoc analysis of 3567 patients who underwent clipping of ruptured intracranial aneurysms in the randomized trials of tirilazad mesylate from 1990 to 1997. These trials included 162 centers and 156 surgeons from 21 countries. Primary and secondary outcomes were: Glasgow outcome scale score and mortality, respectively. Total publications, H-index, and graduate degrees were used as academic indicators for each surgeon. The association between outcomes and academic factors were assessed using a hierarchical logistic regression analysis, adjusting for patient covariates. Academic profiles were available for 147 surgeons, treating a total of 3307 patients. Most surgeons were from the USA (62, 42%), Canada (18, 12%), and Germany (15, 10%). On univariate analysis, the H-index correlated with better functional outcomes and lower mortality rates. In the multivariate model, patients under the care of surgeons with higher H-indices demonstrated improved neurological outcomes (p = 0.01) compared to surgeons with lower H-indices, without any significant difference in mortality. None of the other academic indicators were significantly associated with outcomes. Although prognostication following surgery for ruptured intracranial aneurysms primarily depends on clinical and radiological factors, the academic impact of the operating neurosurgeon may explain some heterogeneity in surgical outcomes.

  3. Decompression Surgery Alone Versus Decompression Plus Fusion in Symptomatic Lumbar Spinal Stenosis: A Swiss Prospective Multicenter Cohort Study With 3 Years of Follow-up.

    PubMed

    Ulrich, Nils H; Burgstaller, Jakob M; Pichierri, Giuseppe; Wertli, Maria M; Farshad, Mazda; Porchet, François; Steurer, Johann; Held, Ulrike

    2017-09-15

    Retrospective analysis of a prospective, multicenter cohort study. To estimate the added effect of surgical fusion as compared to decompression surgery alone in symptomatic lumbar spinal stenosis patients with spondylolisthesis. The optimal surgical management of lumbar spinal stenosis patients with spondylolisthesis remains controversial. Patients of the Lumbar Stenosis Outcome Study with confirmed DLSS and spondylolisthesis were enrolled in this study. The outcomes of this study were Spinal Stenosis Measure (SSM) symptoms (score range 1-5, best-worst) and function (1-4) over time, measured at baseline, 6, 12, 24, and 36 months follow-up. In order to quantify the effect of fusion surgery as compared to decompression alone and number of decompressed levels, we used mixed effects models and accounted for the repeated observations in main outcomes (SSM symptoms and SSM function) over time. In addition to individual patients' random effects, we also fitted random slopes for follow-up time points and compared these two approaches with Akaike's Information Criterion and the chi-square test. Confounders were adjusted with fixed effects for age, sex, body mass index, diabetes, Cumulative Illness Rating Scale musculoskeletal disorders, and duration of symptoms. One hundred thirty-one patients undergoing decompression surgery alone (n = 85) or decompression with fusion surgery (n = 46) were included in this study. In the multiple mixed effects model the adjusted effect of fusion compared with decompression alone surgery on SSM symptoms was 0.06 (95% confidence interval: -0.16-0.27) and -0.07 (95% confidence interval: -0.25-0.10) on SSM function, respectively. Among the patients with degenerative lumbar spinal stenosis and spondylolisthesis our study confirms that in the two groups, decompression alone and decompression with fusion, patients distinctively benefited from surgical treatment. When adjusted for confounders, fusion surgery was not associated with a more favorable outcome in both SSM scores as compared to decompression alone surgery. 3.

  4. Single-site Laparoscopic Colorectal Surgery Provides Similar Clinical Outcomes Compared to Standard Laparoscopic Surgery: An Analysis of 626 Patients

    PubMed Central

    Sangster, William; Messaris, Evangelos; Berg, Arthur S.; Stewart, David B.

    2015-01-01

    BACKGROUND Compared to standard laparoscopy, single-site laparoscopic colorectal surgerymay potentially offer advantages by creating fewer surgical incisions and providing a multi-functional trocar. Previous comparisons, however, have been limited by small sample sizes and selection bias. OBJECTIVE To compare 60-day outcomes between standard laparoscopic and single-site laparoscopic colorectal surgery patients undergoing elective and urgent surgeries. DESIGN This was an unselected retrospective cohort study comparing patients who underwent elective and unplanned standard laparoscopic or single-site laparoscopic colorectal resections for benign and malignant disease between 2008 and 2014. Outcomes were compared using univariate analyses. SETTING This study was conducted at a single institution. PATIENTS A total of 626 consecutive patients undergoing laparoscopic colorectal surgery were included. MAIN OUTCOME MEASURES Morbidity and mortality within 60 postoperative days. RESULTS 318 (51%) and 308 (49%) patients underwent standard laparoscopic and single-site laparoscopic procedures, respectively. No significant difference was noted in mean operative time (Standard laparoscopy 182.1 ± 81.3 vs. Single-site laparoscopy 177±86.5, p=0.30) and postoperative length of stay (Standard laparoscopy 4.8±3.4 vs. Single-site laparoscopy 5.5 ± 6.9, p=0.14). Conversions to laparotomy and 60-day readmissions were also similar for both cohorts across all procedures performed. A significant difference was identified in the number of patients who developed postoperative complications (Standard laparoscopy 19.2% vs. Single-site laparoscopy 10.7%, p=0.004), especially with respect to surgical-site infections (Standard laparoscopy 11.3% vs. Single-site laparoscopy 5.8%, p=0.02). LIMITATIONS This was a retrospective, single institution study. CONCLUSIONS Single-site laparoscopic colorectal surgery demonstrates similar results to standard laparoscopic colorectal surgery in regards to operative time, length of stay and readmissions. Single-site laparoscopic colorectal surgery may provide advantages in limiting the development of certain complications such as superficial surgical-site infections. PMID:26252848

  5. Self-expanding metallic stent as a bridge to surgery in the treatment of left colon cancer obstruction: Cost-benefit analysis and oncologic results.

    PubMed

    Flor-Lorente, Blas; Báguena, Gloria; Frasson, Matteo; García-Granero, Alvaro; Cervantes, Andrés; Sanchiz, Vicente; Peña, Andres; Espí, Alejandro; Esclapez, Pedro; García-Granero, Eduardo

    2017-03-01

    The use of a self-expanding metallic stent as a bridge to surgery in acute malignant left colonic obstruction has been suggested as an alternative treatment to emergency surgery. The aim of the present study was to compare the morbi-mortality, cost-benefit and long-term oncological outcomes of both therapeutic options. This is a prospective, comparative, controlled, non-randomized study (2005-2010) performed in a specialized unit. The study included 82 patients with left colon cancer obstruction treated by stent as a bridge to surgery (n=27) or emergency surgery (n=55) operated with local curative intention. The main outcome measures (postoperative morbi-mortaliy, cost-benefit, stoma rate and long-term oncological outcomes) were compared based on an "intention-to-treat" analysis. There were no significant statistical differences between the two groups in terms of preoperative data and tumor characteristics. The technically successful stenting rate was 88.9% (11.1% perforation during stent placement) and clinical success was 81.4%. No difference was observed in postoperative morbi-mortality rates. The primary anastomosis rate was higher in the bridge to surgery group compared to the emergency surgery group (77.8% vs. 56.4%; P=.05). The mean costs in the emergency surgery group resulted to be €1,391.9 more expensive per patient than in the bridge to surgery group. There was no significant statistical difference in oncological long-term outcomes. The use of self-expanding metalllic stents as a bridge to surgery is a safe option in the urgent treatment of obstructive left colon cancer, with similar short and long-term results compared to direct surgery, inferior mean costs and a higher rate of primary anastomosis. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  6. Surgical outcomes in patients with cutaneous malignant melanoma in Europe - a systematic literature review.

    PubMed

    Costa Svedman, F; Spanopoulos, D; Taylor, A; Amelio, J; Hansson, J

    2017-04-01

    There is limited comparative evidence of the outcomes of different types of surgical management in patients with malignant melanoma in Europe. To address that gap we conducted a systematic literature review to summarize studies reporting outcomes of surgical procedures in patients with malignant melanoma in Europe. Medline was searched for European studies published in English, between 2004 and 2014 reporting surgical outcomes in adults with cutaneous malignant melanoma. We identified 23 studies that evaluated 18 332 patients treated surgically between 1979 and 2009 from 11 European countries. Most of the studies (21/23) were observational; the two remaining studies were randomized controlled trials (RCTs). Studies compared the effect of a range of surgical interventions on a range of clinical outcomes, more commonly overall survival (OS) and disease-free survival (DFS)/recurrence-free survival (RFS). Wider excisions were not associated with improved survival in patients with melanoma thickness ≥2 mm in both studies (RCTs), however, recent results based on long-term follow-up data associate 3 cm excision margins (vs. 1 cm) with favourable survival outcomes. There was some evidence that complete lymph node dissection after positive sentinel lymph node offers survival benefits over therapeutic lymph node dissection. Sentinel lymph node biopsy was not shown to be associated with significant OS benefits, however, it was overly related with higher rates of DFS/RFS. This review highlights the difficulties of making comparisons between different types of surgical procedures for malignant melanoma. As surgery remains the main treatment, this is an important field, and further evidence, particularly from RCTs, is needed. © 2016 European Academy of Dermatology and Venereology.

  7. Heterotopic ossification and clinical outcome in nonconstrained cervical arthroplasty 2 years after surgery: the Norwegian Cervical Arthroplasty Trial (NORCAT).

    PubMed

    Sundseth, Jarle; Jacobsen, Eva Astrid; Kolstad, Frode; Sletteberg, Ruth O; Nygaard, Oystein P; Johnsen, Lars Gunnar; Pripp, Are Hugo; Andresen, Hege; Fredriksli, Oddrun Anita; Myrseth, Erling; Zwart, John A

    2016-07-01

    Heterotopic ossification is a phenomenon in cervical arthroplasty. Previous reports have mainly focused on various semiconstrained devices and only a few publications have focused on ossification around devices that are nonconstrained. The purpose of this study was to assess the occurrence of heterotopic ossification around a nonconstrained cervical device and how it affects clinical outcome 2 years after surgery. Thirty-seven patients were included from a larger cohort of a randomized controlled trial (NORCAT) which compared single-level cervical arthroplasty with fusion. The occurrence of heterotopic ossification was assessed with a CT scan and two neuroradiologists determined its degree. For grading, we used the Mehren/Suchomel classification system (grade 0-4). The patients were divided by level of ossification, low grade (0-2) or high grade (3-4), and clinical outcomes were compared. Self-rated disability for neck and arm pain (Neck Disability Index), health-related quality of life (the Short Form-36 and EuroQol-5D), and pain (the Numeric Rating Scale 11) were used as clinical outcome measures. Heterotopic ossification was encountered in all patients 2 years after surgery. Complete fusion (grade 4) was found in 16 % of participants, and high-grade ossification (grade 3-4) occurred in 62 %. The remaining patients were classified as having low-grade ossification (grade 2). There were no differences in the clinical outcomes of patients with low- and high-grade ossification. High-grade heterotopic ossification and spontaneous fusion 2 years after surgery were seen in a significant number of patients. However, the degree of ossification did not influence the clinical outcome.

  8. Intralesional cryotherapy versus excision and corticosteroids or brachytherapy for keloid treatment: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Keloids are a burden for patients due to physical, aesthetic and social complaints and treatment remains a challenge because of therapy resistance and high recurrence rates. The main goal of treatment is to improve the quality of life (QoL); this implies that, apart from surgical outcomes, patient-reported outcome measures (PROMs) need to be taken into account. Decision making in keloid treatment is difficult due to heterogeneity of the condition and the lack of comparative studies. Methods/Design This is a multicentre, randomised controlled open trial that compares 1) intralesional cryotherapy versus excision and corticosteroids for primary keloids, and 2) intralesional cryotherapy versus excision and brachytherapy for therapy-resistant keloids. The primary outcome is the Patient and Observer Scar Assessment Scale (POSAS), a 12-item scale (with score 12 indicating the best and 120 indicating the worst scar imaginable). A difference of six points on the total score is considered to be of clinical importance. Secondary outcomes are recurrence rates, volume reduction, Skindex-29 scores, SF-36 scores and complication rates. Primary and secondary outcome measurements are taken at baseline, and at 2, 12, 26 and 52 weeks postoperatively. For analysis, a linear mixed model is used. A total of 176 patients will be included over a period of 2.5 years. The protocol is approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam and follows good clinical practice guidelines. Discussion The outcomes of this study will improve evidence-based decision making for the treatment of keloids, as well as patient education. Trial registration Dutch Trial Register NTR4151. PMID:24354714

  9. Final visual acuity results in the early treatment for retinopathy of prematurity study.

    PubMed

    Good, William V; Hardy, Robert J; Dobson, Velma; Palmer, Earl A; Phelps, Dale L; Tung, Betty; Redford, Maryann

    2010-06-01

    To compare visual acuity at 6 years of age in eyes that received early treatment for high-risk prethreshold retinopathy of prematurity (ROP) with conventionally managed eyes. Infants with symmetrical, high-risk prethreshold ROP (n = 317) had one eye randomized to earlier treatment at high-risk prethreshold disease and the other eye managed conventionally, treated if ROP progressed to threshold severity. For asymmetric cases (n = 84), the high-risk prethreshold eye was randomized to either early treatment or conventional management. The main outcome measure was ETDRS visual acuity measured at 6 years of age by masked testers. Retinal structure was assessed as a secondary outcome. Analysis of all subjects with high-risk prethreshold ROP showed no statistically significant benefit for early treatment (24.3% vs 28.6% [corrected] unfavorable outcome; P = .15). Analysis of 6-year visual acuity results according to the Type 1 and 2 clinical algorithm showed a benefit for Type 1 eyes (25.1% vs 32.8%; P = .02) treated early but not Type 2 eyes (23.6% vs 19.4%; P = .37). Early-treated eyes showed a significantly better structural outcome compared with conventionally managed eyes (8.9% vs 15.2% unfavorable outcome; P < .001), with no greater risk of ocular complications. Early treatment for Type 1 high-risk prethreshold eyes improved visual acuity outcomes at 6 years of age. Early treatment for Type 2 high-risk prethreshold eyes did not. Application to Clinical Practice Type 1 eyes, not Type 2 eyes, should be treated early. These results are particularly important considering that 52% of Type 2 high-risk prethreshold eyes underwent regression of ROP without requiring treatment. Trial Registration clinicaltrials.gov Identifier: NCT00027222.

  10. Fragility non-hip fracture patients are at risk.

    PubMed

    Gosch, M; Druml, T; Nicholas, J A; Hoffmann-Weltin, Y; Roth, T; Zegg, M; Blauth, M; Kammerlander, C

    2015-01-01

    Fragility fractures are a growing worldwide health care problem. Hip fractures have been clearly associated with poor outcomes. Fragility fractures of other bones are common reasons for hospital admission and short-term disability, but specific long-term outcome studies of non-hip fragility fractures are rare. The aim of our trial was to evaluate the 1-year outcomes of non-hip fragility fracture patients. This study is a retrospective cohort review of 307 consecutive older inpatient non-hip fracture patients. Patient data for analysis included fracture location, comorbidity prevalence, pre-fracture functional status, osteoporosis treatments and sociodemographic characteristics. The main outcomes evaluated were 1-year mortality and post-fracture functional status. As compared to the expected mortality, the observed 1-year mortality was increased in the study group (17.6 vs. 12.2 %, P = 0.005). After logistic regression, three variables remained as independent risk factors for 1-year mortality among non-hip fracture patients: malnutrition (OR 3.3, CI 1.5-7.1), Charlson comorbidity index (CCI) (OR 1.3, CI 1.1-1.5) and the Parker Mobility Score (PMS) (OR 0.85, CI 0.74-0.98). CCI and PMS were independent risk factors for a high grade of dependency after 1 year. Management of osteoporosis did not significantly improve after hospitalization due to a non-hip fragility fracture. The outcomes of older non-hip fracture patients are comparable to the poor outcomes of older hip fracture patients, and appear to be primarily related to comorbidities, pre-fracture function and nutritional status. The low rate of patients on osteoporosis medications likely reflects the insufficient recognition of the importance of osteoporosis assessment and treatment in non-hip fracture patients. Increased clinical and academic attention to non-hip fracture patients is needed.

  11. Which is Superior, Doppler Velocimetry or Non-stress Test or Both in Predicting the Perinatal Outcome of High-Risk Pregnancies.

    PubMed

    Subramanian, Vijaya; Venkat, Janani; Dhanapal, Mohana

    2016-10-01

    To analyze which is superior, Doppler velocimetry or non-stress test or both by means of categorization into four groups and comparing the prediction of perinatal outcome in high-risk pregnancies like anemia, hypertensive disorders of pregnancies. This was a prospective study conducted at the Department of Obstetrics and Gynaecology, ISO KGH, Madras Medical College, Chennai, in the year 2014. Two hundred high-risk pregnancies like anemia, hypertensive disorders of pregnancy were included in the study. They were examined systematically, and Doppler velocimetry and non-stress test were done. The main vessels studied by Doppler were umbilical artery and middle cerebral artery, and the indices were calculated. The results of the non-stress test were interpreted as reactive and non-reactive. Based on the results of Doppler and non-stress test, the 200 cases were categorized into four groups and the results were analyzed. Among the 200 cases of high-risk pregnancies, those with a normal Doppler study and a reactive non-stress test had good perinatal outcome. When both were abnormal, there was a higher percentage of adverse outcome as compared to that of either Doppler alone being abnormal or non-stress test alone being non-reactive. It was also found that abnormal Doppler but with a reactive non-stress test had the advantage of prolonging the pregnancy and bringing a better outcome indicating that non-stress test is surely a good test of well-being. When Doppler was normal, but non-stress test was non-reactive, there was an increase in the rate of cesarean section. Each method of fetal surveillance reflects different aspect of maternal and fetal pathophysiology. Hence, combining these will help to bring out better perinatal outcome.

  12. Revascularization for Left Main and Multivessel Coronary Artery Disease: Current Status and Future Prospects after the EXCEL and NOBLE Trials

    PubMed Central

    2018-01-01

    Revascularization of severe left main and multivessel coronary artery disease has been shown to improve survival in both stable ischemic heart disease and acute coronary syndrome. While revascularization with coronary artery bypass surgery for these disease entities carries class I recommendation in most current guidelines, recent trials has shown potential comparable survival and cardiovascular outcomes between percutaneous and surgical interventions in patients with less complex coronary anatomy. Despite the conflicting results observed in the most recent left main revascularization trials, Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease (EXCEL) and Nordic-Baltic-British left main revascularization (NOBLE), both treatment strategies remain important for the management of left main disease (LMD) and multivessel disease (MVD) reflecting on the importance of heart team discussion. This review is focused on revascularization of LMD and MVD in patients who are not presenting with ST-segment elevation myocardial infarction, encompassing the evidence from historic and contemporary trials which shaped up current practices. This review discusses the heart team approach to guide decision making, including special populations that are not represented in clinical trials. PMID:29856140

  13. Revascularization for Left Main and Multivessel Coronary Artery Disease: Current Status and Future Prospects after the EXCEL and NOBLE Trials.

    PubMed

    Al-Hijji, Mohammed; El Sabbagh, Abdallah; Holmes, David R

    2018-06-01

    Revascularization of severe left main and multivessel coronary artery disease has been shown to improve survival in both stable ischemic heart disease and acute coronary syndrome. While revascularization with coronary artery bypass surgery for these disease entities carries class I recommendation in most current guidelines, recent trials has shown potential comparable survival and cardiovascular outcomes between percutaneous and surgical interventions in patients with less complex coronary anatomy. Despite the conflicting results observed in the most recent left main revascularization trials, Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease (EXCEL) and Nordic-Baltic-British left main revascularization (NOBLE), both treatment strategies remain important for the management of left main disease (LMD) and multivessel disease (MVD) reflecting on the importance of heart team discussion. This review is focused on revascularization of LMD and MVD in patients who are not presenting with ST-segment elevation myocardial infarction, encompassing the evidence from historic and contemporary trials which shaped up current practices. This review discusses the heart team approach to guide decision making, including special populations that are not represented in clinical trials. Copyright © 2018. The Korean Society of Cardiology.

  14. Outcomes of elective induction of labour compared with expectant management: population based study

    PubMed Central

    Ferguson, Evelyn; Duffy, Andrew; Ford, Ian; Chalmers, James; Norman, Jane E

    2012-01-01

    Objective To determine neonatal outcomes (perinatal mortality and special care unit admission) and maternal outcomes (mode of delivery, delivery complications) of elective induction of labour compared with expectant management. Design Retrospective cohort study using an unselected population database. Setting Consultant and midwife led obstetric units in Scotland 1981-2007. Participants 1 271 549 women with singleton pregnancies of 37 weeks or more gestation. Interventions Outcomes of elective induction of labour (induction of labour with no recognised medical indication) at 37, 38, 39, 40, and 41 weeks’ gestation compared with those of expectant management (continuation of pregnancy to either spontaneous labour, induction of labour or caesarean section at a later gestation). Main outcome measures Extended perinatal mortality, mode of delivery, postpartum haemorrhage, obstetric anal sphincter injury, and admission to a neonatal or special care baby unit. Outcomes were adjusted for age at delivery, parity, year of birth, birth weight, deprivation category, and, where appropriate, mode of delivery. Results At each gestation between 37 and 41 completed weeks, elective induction of labour was associated with a decreased odds of perinatal mortality compared with expectant management (at 40 weeks’ gestation 0.08% (37/44 764) in the induction of labour group versus 0.18% (627/350 643) in the expectant management group; adjusted odds ratio 0.39, 99% confidence interval 0.24 to 0.63), without a reduction in the odds of spontaneous vertex delivery (at 40 weeks’ gestation 79.9% (35 775/44 778) in the induction of labour group versus 73.7% (258 665/350 791) in the expectant management group; adjusted odds ratio 1.26, 1.22 to 1.31). Admission to a neonatal unit was, however, increased in association with elective induction of labour at all gestations before 41 weeks (at 40 weeks’ gestation 8.0% (3605/44 778) in the induction of labour group compared with 7.3% (25 572/350 791) in the expectant management group; adjusted odds ratio 1.14, 1.09 to 1.20). Conclusion Although residual confounding may remain, our findings indicate that elective induction of labour at term gestation can reduce perinatal mortality in developed countries without increasing the risk of operative delivery. PMID:22577197

  15. How do aggregated patient-reported outcome measures data stimulate health care improvement? A realist synthesis

    PubMed Central

    Dalkin, Sonia; Gibbons, Elizabeth; Wright, Judy; Valderas, Jose Maria; Meads, David; Black, Nick

    2017-01-01

    Objectives Internationally, there has been considerable debate about the role of data in supporting quality improvement in health care. Our objective was to understand how, why and in what circumstances the feedback of aggregated patient-reported outcome measures data improved patient care. Methods We conducted a realist synthesis. We identified three main programme theories underlying the use of patient-reported outcome measures as a quality improvement strategy and expressed them as nine ‘if then’ propositions. We identified international evidence to test these propositions through searches of electronic databases and citation tracking, and supplemented our synthesis with evidence from similar forms of performance data. We synthesized this evidence through comparing the mechanisms and impact of patient-reported outcome measures and other performance data on quality improvement in different contexts. Results Three programme theories were identified: supporting patient choice, improving accountability and enabling providers to compare their performance with others. Relevant contextual factors were extent of public disclosure, use of financial incentives, perceived credibility of the data and the practicality of the results. Available evidence suggests that patients or their agents rarely use any published performance data when selecting a provider. The perceived motivation behind public reporting is an important determinant of how providers respond. When clinicians perceived that performance indicators were not credible but were incentivized to collect them, gaming or manipulation of data occurred. Outcome data do not provide information on the cause of poor care: providers needed to integrate and interpret patient-reported outcome measures and other outcome data in the context of other data. Lack of timeliness of performance data constrains their impact. Conclusions Although there is only limited research evidence to support some widely held theories of how aggregated patient-reported outcome measures data stimulate quality improvement, several lessons emerge from interventions sharing the same programme theories to help guide the increasing use of these measures. PMID:29260592

  16. WITHDRAWN: Interventions for treating hallux valgus (abductovalgus) and bunions.

    PubMed

    Ferrari, Jill; Higgins, Julian Pt; Prior, Trevor D

    2009-04-15

    Hallux valgus is classified as an abnormal deviation of the great toe (hallux) towards the midline of the foot. To identify and evaluate the evidence from randomised trials of interventions used to correct hallux valgus. We searched the Cochrane Bone, Joint and Muscle Trauama Group trials register (2003/1), the Cochrane Central Register of Controlled Trials (The Cochrane Library issue 1, 2003), MEDLINE (January 1966 to March 2003) and EMBASE (1980 to January 2003). No language restrictions were applied. Hand searching of specific foot journals was also undertaken.Date of the most recent search: 31st March 2003. Randomised or quasi-randomised trials of both conservative and surgical treatments of hallux valgus. Excluded were studies comparing areas of surgery not specific to the control of the deformity such as use of anaesthetics or tourniquet placement. Methodological quality of trials which met the inclusion criteria was independently assessed by two reviewers. Data extraction was undertaken by two reviewers. The trials were grouped according to the interventions being compared, but the dissimilarity in the comparisons prevented pooling of results. The methodological quality of the 21 included trials was generally poor and trial sizes were small.Three trials involving 332 participants evaluated conservative treatments versus no treatment. There was no evidence of a difference in outcomes between treatment and no treatment.One good quality trial involving 140 participants compared surgery to conservative treatment. Evidence was shown of an improvement in all outcomes in patients receiving chevron osteotomy compared with those receiving orthoses. The same trial also compared surgery to no treatment in 140 participants. Evidence was shown of an improvement in all outcomes in patients receiving chevron osteotomy compared with those receiving no treatment.Two trials involving 133 people with hallux valgus compared Keller's arthroplasty with other surgical techniques. In general, there was no advantage or disadvantage using Keller's over the other techniques. When the distal osteotomy was compared to Keller's arthroplasty, the osteotomy showed evidence of improving the intermetatarsal angle and preserving joint range of motion. The arthroplasty was found to have less of an impact on walking ability compared to the arthrodesis.Six trials involving 309 participants compared chevron (and chevron-type) osteotomy with other techniques. The chevron osteotomy offered no advantages in these trials. For some outcomes, other techniques gave better results. Two of these trials (94 participants) compared a type of proximal osteotomy to a proximal chevron osteotomy and found no evidence of a difference in outcomes between techniques.Three trials involving 157 participants compared outcomes between original operations and surgeon's adaptations. There was no advantage found for any of the adaptations.Three trials involving 71 people with hallux valgus compared new methods of fixation to traditional methods. There was no evidence that the new methods of fixation were detrimental to the outcome of the patients.Four trials involving 162 participants evaluated methods of post-operative rehabilitation. The use of continuous passive motion appeared to give an improved range of motion and earlier recovery following surgery. Early weightbearing or the use of a crepe bandage were not found to be detrimental to final outcome. Only a few studies had considered conservative treatments. The evidence from these suggested that orthoses and night splints did not appear to be any more beneficial in improving outcomes than no treatment. Surgery (chevron osteotomy) was shown to be beneficial compared to orthoses or no treatment, but when compared to other osteotomies, no technique was shown to be superior to any other. Only one trial had compared an osteotomy to an arthroplasty. There was limited evidence to suggest that the osteotomy gave the better outcomes. It was notable that the numbers of participants in some trials remaining dissatisfied at follow-up were consistently high (25 to 33%), even when the hallux valgus angle and pain had improved. A few of the more recent trials used assessment scores that combine several aspects of the patients outcomes. These scoring systems are useful to the clinician when comparing techniques but are of dubious relevance to the patient if they do not address their main concern and such scoring systems are frequently unvalidated. Only one study simply asked the patient if they were better than before the treatment. Final outcomes were most frequently measured at one year, with a few trials maintaining follow-up for 3 years. Such time-scales are minimal given that the patients will be on their feet for at least another 20-30 years after treatment. Future research should include patient-focused outcomes, standardised assessment criteria and longer surveillance periods, more usefully in the region of 5-10 years.

  17. Interventions for treating hallux valgus (abductovalgus) and bunions.

    PubMed

    Ferrari, J; Higgins, J P T; Prior, T D

    2004-01-01

    Hallux valgus is classified as an abnormal deviation of the great toe (hallux) towards the midline of the foot. To identify and evaluate the evidence from randomised trials of interventions used to correct hallux valgus. We searched the Cochrane Musculoskeletal Injuries Group trials register (2003/1), the Cochrane Central Register of Controlled Trials (The Cochrane Library issue 1, 2003), MEDLINE (January 1966 to March 2003) and EMBASE (1980 to January 2003). No language restrictions were applied. Hand searching of specific foot journals was also undertaken. Date of the most recent search: 31st March 2003. Randomised or quasi-randomised trials of both conservative and surgical treatments of hallux valgus. Excluded were studies comparing areas of surgery not specific to the control of the deformity such as use of anaesthetics or tourniquet placement. Methodological quality of trials which met the inclusion criteria was independently assessed by two reviewers. Data extraction was undertaken by two reviewers. The trials were grouped according to the interventions being compared, but the dissimilarity in the comparisons prevented pooling of results. The methodological quality of the 21 included trials was generally poor and trial sizes were small. Three trials involving 332 participants evaluated conservative treatments versus no treatment. There was no evidence of a difference in outcomes between treatment and no treatment. One good quality trial involving 140 participants compared surgery to conservative treatment. Evidence was shown of an improvement in all outcomes in patients receiving chevron osteotomy compared with those receiving orthoses. The same trial also compared surgery to no treatment in 140 participants. Evidence was shown of an improvement in all outcomes in patients receiving chevron osteotomy compared with those receiving no treatment. Two trials involving 133 people with hallux valgus compared Keller's arthroplasty with other surgical techniques. In general, there was no advantage or disadvantage using Keller's over the other techniques. When the distal osteotomy was compared to Keller's arthroplasty, the osteotomy showed evidence of improving the intermetatarsal angle and preserving joint range of motion. The arthroplasty was found to have less of an impact on walking ability compared to the arthrodesis. Six trials involving 309 participants compared chevron (and chevron-type) osteotomy with other techniques. The chevron osteotomy offered no advantages in these trials. For some outcomes, other techniques gave better results. Two of these trials (94 participants) compared a type of proximal osteotomy to a proximal chevron osteotomy and found no evidence of a difference in outcomes between techniques. Three trials involving 157 participants compared outcomes between original operations and surgeon's adaptations. There was no advantage found for any of the adaptations. Three trials involving 71 people with hallux valgus compared new methods of fixation to traditional methods. There was no evidence that the new methods of fixation were detrimental to the outcome of the patients. Four trials involving 162 participants evaluated methods of post-operative rehabilitation. The use of continuous passive motion appeared to give an improved range of motion and earlier recovery following surgery. Early weightbearing or the use of a crepe bandage were not found to be detrimental to final outcome. Only a few studies had considered conservative treatments. The evidence from these suggested that orthoses and night splints did not appear to be any more beneficial in improving outcomes than no treatment. Surgery (chevron osteotomy) was shown to be beneficial compared to orthoses or no treatment, but when compared to other osteotomies, no technique was shown to be superior to any other. Only one trial had compared an osteotomy to an arthroplasty. There was limited evidence to suggest that the osteotomy gat the osteotomy gave the better outcomes. It was notable that the numbers of participants in some trials remaining dissatisfied at follow-up were consistently high (25 to 33%), even when the hallux valgus angle and pain had improved. A few of the more recent trials used assessment scores that combine several aspects of the patients outcomes. These scoring systems are useful to the clinician when comparing techniques but are of dubious relevance to the patient if they do not address their main concern and such scoring systems are frequently unvalidated. Only one study simply asked the patient if they were better than before the treatment. Final outcomes were most frequently measured at one year, with a few trials maintaining follow-up for 3 years. Such time-scales are minimal given that the patients will be on their feet for at least another 20-30 years after treatment. Future research should include patient-focused outcomes, standardised assessment criteria and longer surveillance periods, more usefully in the region of 5-10 years.

  18. Experiences and outcomes of maternal Ramadan fasting during pregnancy: results from a sub-cohort of the Born in Bradford birth cohort study.

    PubMed

    Petherick, Emily S; Tuffnell, Derek; Wright, John

    2014-09-26

    Observing the fast during the holy month of Ramadan is one of the five pillars of Islam. Although pregnant women and those with pre-existing illness are exempted from fasting many still choose to fast during this time. The fasting behaviours of pregnant Muslim women resident in Western countries remain largely unexplored and relationships between fasting behaviour and offspring health outcomes remain contentious. This study was undertaken to assess the prevalence, characteristics of fasting behaviours and offspring health outcomes in Asian and Asian British Muslim women within a UK birth cohort. Prospective cohort study conducted at the Bradford Royal Infirmary UK from October to December 2010 comprising 310 pregnant Muslim women of Asian or Asian British ethnicity that had a live singleton birth at the Bradford Royal Infirmary. The main outcome of the study was the decision to fast or not during Ramadan. Secondary outcomes were preterm births and mean birthweight. Logistic regression analyses were used to investigate the relationship between covariables of interest and women's decision to fast or not fast. Logistic regression was also used to investigate the relationship between covariables and preterm birth as well as low birth weight. Mutually adjusted analysis showed that the odds of any fasting were higher for women with an obese BMI at booking compared to women with a normal BMI, (OR 2.78 (95% C.I. 1.29-5.97)), for multiparous compared to nulliparous women(OR 3.69 (95% C.I. 1.38-9.86)), and for Bangladeshi origin women compared to Pakistani origin women (OR 3.77 (95% C.I. 1.04-13.65)). Odds of fasting were lower in women with higher levels of education (OR 0.40 (95% C.I. 0.18-0.91)) and with increasing maternal age (OR 0.87 (95% C.I. 0.80-0.94). No associations were observed between fasting and health outcomes in the offspring. Pregnant Muslim women residing in the UK who fasted during Ramadan differed by social, demographic and lifestyle characteristics compared to their non-fasting peers. Fasting was not found to be associated with adverse birth outcomes in this sample although these results require confirmation using reported fasting data in a larger sample before the safety of fasting during pregnancy can be established.

  19. Birth outcomes among Arab Americans in Michigan before and after the terrorist attacks of September 11, 2001.

    PubMed

    El-Sayed, Abdulrahman; Hadley, Craig; Galea, Sandro

    2008-01-01

    To assess whether the incidence of adverse birth outcomes among Arab Americans in Michigan changed after September 11, 2001. Birth data were collected on all births in Michigan from September 11, 2000, to March 11, 2001, and from September 11, 2001, to March 11, 2002. Self-reported ancestry and a name algorithm were used to determine Arab American ethnicity. Unadjusted and adjusted logistic regression analysis was used to assess the relationship between birth before/after September 11 and birth outcomes. Main outcome measures were low birth weight (LBW), very low birth weight (VLBW), and preterm birth (PTB). We observed no association between birth before/after September 11 and risk of adverse birth outcomes among Arab Americans in Michigan by using either the name algorithm or self-reported ancestry to determine Arab American ethnicity. Arab name was significantly associated with lower risk of VLBW and PTB in adjusted and unadjusted models. Arab ancestry was significantly associated with lower risk of VLBW and PTB in adjusted and unadjusted models and significantly associated with lower risk of LBW in an unadjusted model. In contrast to previous findings in California, we observed no difference in adverse birth outcomes before and after the events of September 11, 2001, among Arab Americans in Michigan. Arab American ethnicity is associated with lower risk of adverse birth outcomes compared to other racial/ethnic groups.

  20. Patients with Revision Modern Megaprostheses of the Distal Femur Have Improved Disease-Specific and Health-Related Outcomes Compared to Those with Primary Replacements.

    PubMed

    Heyberger, Clémence; Auberger, Guillaume; Babinet, Antoine; Anract, Philippe; Biau, David J

    2017-12-21

    We asked whether there would be any difference between primary and revision modern cemented fixed hinge megaprosthesis of the distal femur in function and activity-related outcomes following treatment of a bone tumor. An identical custom-made fixed hinge cemented megaprosthesis with a hydroxyapatite collar was used in all cases. The main outcomes were joint-specific function, disease-specific activity, and health-related quality of life. Implant survival was also evaluated. Patients in the revision group performed slightly better than patients in the primary group on disease-specific (Toronto Extremity Salvage Score, p  = 0.033; Musculoskeletal Tumor Society, p  = 0.072) and health-related outcomes (Short Form 36 [SF-36] physical component, p  = 0.085; SF-36 mental component, p  = 0.069) but not on joint-specific outcomes (Knee Society Score, p  = 0.94). The cumulative probabilities of revision for any reason were 14.5% (7-25%) at 5 years with no statistically significant difference between primary and revision procedures ( p  = 0.77). In conclusion, patients undergoing a revision have similar joint-specific functional outcome but improved disease-specific and health-related outcomes. Implant survival are similar between groups. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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

    PubMed

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

    2017-12-01

    The primary hypothesis of the ROMA trial is that in patients undergoing primary isolated non-emergent coronary artery bypass grafting, the use of 2 or more arterial grafts compared with a single arterial graft (SAG) is associated with a reduction in the composite outcome of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in these patients, the use of 2 or more arterial grafts compared with a SAG is associated with improved survival. The ROMA trial is a prospective, unblinded, randomized event-driven multicentre trial comprising at least 4300 subjects. Patients younger than 70 years with left main and/or multivessel disease will be randomized to a SAG or multiple arterial grafts to the left coronary system in a 1:1 fashion. Permuted block randomization stratified by the centre and the type of second arterial graft will be used. The primary outcome will be a composite of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary outcome will be all-cause mortality. The primary safety outcome will be a composite of death from any cause, any stroke and any myocardial infarction. In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the SAG group, saphenous vein grafts will be used for all non-left anterior descending target vessels. For patients randomized to the multiple arterial graft group, the main target vessel of the lateral wall will be grafted with either a radial artery or a second internal thoracic artery. Additional grafts for the multiple arterial graft group can be saphenous veins or supplemental arterial conduits. To detect a 20% relative reduction in the primary outcome, with 90% power at 5% alpha and assuming a time-to-event analysis, the sample size must include 845 events (and 3650 patients). To detect a 20% relative reduction in the secondary outcome, with 80% power at 5% alpha, the sample size must include 631 events (and 3650 patients). To be conservative, the sample size will be set at 4300 patients. The primary outcome will be tested according to the intention-to-treat principle. The primary analysis will be a Cox proportional hazards regression model, with the treatment arm included as a covariate. If non-proportional hazards are observed, alternatives to Cox proportional hazards regression will be explored. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  2. Does pulse oximeter use impact health outcomes? A systematic review

    PubMed Central

    English, Mike; Shepperd, Sasha

    2016-01-01

    Objective Do newborns, children and adolescents up to 19 years have lower mortality rates, lower morbidity and shorter length of stay in health facilities where pulse oximeters are used to inform diagnosis and treatment (excluding surgical care) compared with health facilities where pulse oximeters are not used? Design Studies were obtained for this systematic literature review by systematically searching the Database of Abstracts of Reviews of Effects, Cochrane, Medion, PubMed, Web of Science, Embase, Global Health, CINAHL, WHO Global Health Library, international health organisation and NGO websites, and study references. Patients Children 0–19 years presenting for the first time to hospitals, emergency departments or primary care facilities. Interventions Included studies compared outcomes where pulse oximeters were used for diagnosis and/or management, with outcomes where pulse oximeters were not used. Main outcome measures: mortality, morbidity, length of stay, and treatment and management changes. Results The evidence is low quality and hypoxaemia definitions varied across studies, but the evidence suggests pulse oximeter use with children can reduce mortality rates (when combined with improved oxygen administration) and length of emergency department stay, increase admission of children with previously unrecognised hypoxaemia, and change physicians’ decisions on illness severity, diagnosis and treatment. Pulse oximeter use generally increased resource utilisation. Conclusions As international organisations are investing in programmes to increase pulse oximeter use in low-income settings, more research is needed on the optimal use of pulse oximeters (eg, appropriate oxygen saturation thresholds), and how pulse oximeter use affects referral and admission rates, length of stay, resource utilisation and health outcomes. PMID:26699537

  3. Maine Technical College System 1993/1994 Annual Report.

    ERIC Educational Resources Information Center

    Maine Technical Coll. System, Augusta.

    Focusing on data from the 1993-94 academic year, this report discusses programs and outcomes for the seven colleges in the Maine Technical College System (MTCS). Following a message from the System President, general outcomes for the MTCS are described. This section indicates that systemwide enrollment in 1993-94 was 4,305, representing a 19%…

  4. Assessment of a Hospital Palliative Care Unit (HPCU) for Cancer Patients; A Conceptual Framework.

    PubMed

    Rouhollahi, Mohammad Reza; Saghafinia, Masoud; Zandehdel, Kazem; Motlagh, Ali Ghanbari; Kazemian, Ali; Mohagheghi, Mohammad Ali; Tahmasebi, Mamak

    2015-01-01

    The first hospital palliative care unit (HPCU) in Iran (FARS-HPCU) has been established in 2008 in the Cancer Institute, which is the largest referral cancer center in the country. We attempted to assess the performance of the HPCU based on a comprehensive conceptual framework. The main aim of this study was to develop a conceptual framework for assessment of the HPCU performances through designing a value chain in line with the goals and the main processes (core and support). We collected data from a variety of sources, including international guidelines, international best practices, and expert opinions in the country and compared them with national policies and priorities. We also took into consideration the trend of the HPCU development in the Cancer Institute of Iran. Through benchmarking the gap area with the performance standards, some recommendations for better outcome are proposed. The framework for performance assessment consisted of 154 process indicators (PIs), based on which the main stakeholders of the HPCU (including staff, patients, and families) offered their scoring. The outcome revealed the state of the processes as well as the gaps. Despite a significant improvement in many processes and indicators, more development in the comprehensive and integrative aspects of FARS-HPCU performance is required. Consideration of all supportive and palliative requirements of the patients through interdisciplinary and collaborative approaches is recommended.

  5. A cost analysis of introducing an infectious disease specialist-guided antimicrobial stewardship in an area with relatively low prevalence of antimicrobial resistance.

    PubMed

    Lanbeck, Peter; Ragnarson Tennvall, Gunnel; Resman, Fredrik

    2016-07-27

    Antimicrobial stewardship programs have been widely introduced in hospitals as a response to increasing antimicrobial resistance. Although such programs are commonly used, the long-term effects on antimicrobial resistance as well as societal economics are uncertain. We performed a cost analysis of an antimicrobial stewardship program introduced in Malmö, Sweden in 20 weeks 2013 compared with a corresponding control period in 2012. All direct costs and opportunity costs related to the stewardship intervention were calculated for both periods. Costs during the stewardship period were directly compared to costs in the control period and extrapolated to a yearly cost. Two main analyses were performed, one including only comparable direct costs (analysis one) and one including comparable direct and opportunity costs (analysis two). An extra analysis including all comparable direct costs including costs related to length of hospital stay (analysis three) was performed, but deemed as unrepresentative. According to analysis one, the cost per year was SEK 161 990 and in analysis two the cost per year was SEK 5 113. Since the two cohorts were skewed in terms of size and of infection severity as a consequence of the program, and since short-term patient outcomes have been demonstrated to be unchanged by the intervention, the costs pertaining to patient outcomes were not included in the analysis, and we suggest that analysis two provides the most correct cost calculation. In this analysis, the main cost drivers were the physician time and nursing time. A sensitivity analysis of analysis two suggested relatively modest variation under changing assumptions. The total yearly cost of introducing an infectious disease specialist-guided, audit-based antimicrobial stewardship in a department of internal medicine, including direct costs and opportunity costs, was calculated to be as low as SEK 5 113.

  6. The treatment of perfectionism within the eating disorders: a pilot study.

    PubMed

    Goldstein, Mandy; Peters, Lorna; Thornton, Christopher E; Touyz, Stephen W

    2014-05-01

    The aim of this pilot study was to investigate the impact of the direct treatment of perfectionism on the outcome of perfectionism and eating disorder pathology. Sixty-one participants, attending day hospital treatment, participated in a randomised controlled study, in which treatment as usual (TAU) was compared with TAU combined with a clinician-lead cognitive behavioural treatment for perfectionism (TAU+P). Linear mixed model analysis revealed no significant interaction effects but significant main effects for time on variables measuring eating pathology and perfectionism. Outcomes supported the effectiveness of overall treatment but suggested that adding direct treatment of perfectionism did not enhance treatment. The results are discussed in relation to the existing literature on the treatment of perfectionism. Copyright © 2014 John Wiley & Sons, Ltd and Eating Disorders Association.

  7. The etiology and determinants of hospital closure.

    PubMed

    Longo, D R; Sohn, M W; Shortell, S M

    1996-01-01

    This article examines the etiology of hospital closure and the correlates of hospital closure and the extent of similarity in this organizational outcome between pre- and post-Prospective Payment System (PPS) implementation. It also replicates a study from an earlier time period. Findings support the study's main hypotheses: in more stringent and turbulent markets, institutional and strategic variables are more important determinants of hospital closure. Merger acquisitions are found to be similar to both system acquisitions and autonomous hospitals. Standard Metropolitan Statistical Area (SMSA) status and regulation show an effect on hospital closure and merger acquisition. While many similarities exist when compared to the replicated study and findings prior to PPS implementation, it appears that sufficient differences exist to support the hypothesis that the PPS has an impact upon hospital organizational outcome.

  8. Digital versus analogue preoperative planning of total hip arthroplasties: a randomized clinical trial of 210 total hip arthroplasties.

    PubMed

    The, Bertram; Verdonschot, Nico; van Horn, Jim R; van Ooijen, Peter M A; Diercks, Ron L

    2007-09-01

    The objective of this randomized clinical trial was to compare the clinical and technical results of digital preoperative planning for primary total hip arthroplasties with analogue planning. Two hundred and ten total hip arthroplasties were randomized. All plans were constructed on standardized radiographs by the surgeon who performed the arthroplasty the next day. The main outcome was accuracy of the preoperative plan. Secondary outcomes were operation time and a radiographic assessment of the arthroplasty. Digital preoperative plans were more accurate in planning the cup (P < .05) and scored higher on the postoperative radiologic assessment of cemented cup (P = .03) and stem (P < .01) components. None of the other comparisons reached statistical significance. We conclude that digital plans slightly outperform analogue plans.

  9. Provisional vs. two-stent technique for unprotected left main coronary artery disease after ten years follow up: A propensity matched analysis.

    PubMed

    D'Ascenzo, Fabrizio; Iannaccone, Mario; Giordana, Francesca; Chieffo, Alaide; Connor, Stephen O; Napp, L Christian; Chandran, SujaySubash; de la Torre Hernández, José María; Chen, Shao-Liang; Varbella, Ferdinando; Omedè, Pierluigi; Taha, Salma; Meliga, Emanuele; Kawamoto, Hiroyoshi; Montefusco, Antonio; Chong, Mervyn; Garot, Philippe; Sin, Lin; Gasparetto, Valeria; Abdirashid, Mohamed; Cerrato, Enrico; Biondi-Zoccai, Giuseppe; Gaita, Fiorenzo; Escaned, Javier; Hiddick Smith, David; Lefèvre, Thierry; Colombo, Antonio; Sheiban, Imad; Moretti, Claudio

    2016-05-15

    There is uncertainty on which stenting approach confers the best long-term outlook for unprotected left main (ULM) bifurcation disease. This is a non-randomized, retrospective study including all consecutive patients with 50% stenosis of the left main involving at least 1 of the arteries stemming from the left main treated with drug-eluting stents (DES) in 9 European centers between 2002 and 2004. Patients were divided into two groups: those treated with provisional stentings vs. those treated with two stent strategy. The outcomes of interest were 10-year rates of target lesion revascularization (TLR), major adverse cardiac events (MACE), and their components (cardiovascular death, myocardial infarction [MI], or repeat revascularization), along with stent thrombosis (ST). A total of 285 patients were included, 178 (62.5%) in the provisional stenting group and 87 (37.5%) in the two stent group. After 10 years, no differences in TLR were found at unadjusted analysis (19% vs 25%, p>0.05) nor after propensity score matching (25% vs 28%, p>0.05). Similar rates of MACE (60% vs 66%, p>0.05), death (34% vs 43%, p>0.05), MI (9% vs 14%, p>0.05) and ST were also disclosed at propensity-based analysis. Even after 10 year follow-up, patients treated with provisional stenting on left main showed comparable rates of target lesion revascularization compared to two stent strategy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  10. A core outcome set for clinical trials in acute diarrhoea.

    PubMed

    Karas, Jacek; Ashkenazi, Shai; Guarino, Alfredo; Lo Vecchio, Andrea; Shamir, Raanan; Vandenplas, Yvan; Szajewska, Hania

    2015-04-01

    Core outcome sets are the baseline for what should be measured in clinical research and, thus, should serve as a guide for what should be collected and reported. The Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials, established in 2012, agreed that consensus on a core set of outcomes with agreed-upon definitions that should be measured and reported in clinical trials was needed. To achieve this goal, six working groups (WGs) were setup, including WG on acute diarrhoea, whose main goal was to develop a core outcome set for trials in acute diarrhoea. The first step identified how published outcomes related to acute diarrhoea were reported. The second focused on the methodology for determining which outcomes to measure in clinical trials. The third employed a two-phase questionnaire study using the Delphi technique to define clinically important outcomes to clinicians and parents. For therapeutic studies, the five most important outcome measures were diarrhoea duration, degree of dehydration, need for hospitalisation (or duration of hospitalisation for inpatients), the proportion of patients recovered by 48 h and adverse effects. The prophylactic core outcome set included prevention of diarrhoea, prevention of dehydration, prevention of hospitalisation and adverse effects. The outcome sets for therapy and prevention can be recommended for use in future trials of patients with gastroenteritis. Their envisioned goal is to decrease study heterogeneity and to ease the comparability of studies. WG's next step is to determine how to measure the outcomes included in the core set. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  11. [The use of synthetic mesh implants in surgical treatment of pelvic organ prolapse].

    PubMed

    Pastorčáková, M; Huser, M; Belkov, A I; Ventruba, P

    2014-04-01

    Pelvic organ prolapse (POP) surgical treatment went through major changes thanks to availability and wider expansion of mesh implants (MI). This work is focused on critical analysis of outcomes of these surgical procedures and recommendation prescription for their uses in application pelvic surgery. There was made analysis of published outcomes and experience with MI use in POP surgical treatment. OUTCOMES were analysed separately for each pelvic bottom section. Main criteria were surgical complications and treatment effectivity based on objective measurable parameters and subjective patients evaluation. There are formalized suitable indications and conditions for individual pelvic bottom sections for safe MI use in reconstructive POP surgery. On the basis of objective data authors also define specific situations when MI use doesn't bring any benefit and it is not recommended. Mesh implants have their definite place in POP surgical treatment. Implants with right indication and right surgical technique in comparison with classic surgical procedures have significantly lower recurrence risk with comparable or higher surgical complication rate.

  12. [Endonasal versus trans-canalicular endoscopic dacriocystorhinostomy using diode laser. Surgical techniques and outcomes].

    PubMed

    Piédrola Maroto, David; Franco Sánchez, Javier; Reyes Eldblom, Robin; Monje Vega, Elena; Conde Jiménez, Manuel; Ortiz Rueda, Manuel

    2008-01-01

    To evaluate the benefits and disadvantages of the endoscopic endonasal versus transcanalicular approaches using diode laser, and to compare their clinical outcomes. A total of 127 patients were operated on, 80 of them with the endonasal approach (Group I) and 47 with the transcanalicular technique (Group II). Epiphora improved completely in 67 patients in Group I (83.7 %) while the other 13 (16.2 %) continued to present the same symptoms. In Group II, a successful result was achieved in 39 patients (82.9 %) and 8 (17 %) of them had to be re-operated because of the persistence of epiphora. The surgical outcomes are similar with both laser techniques. The main advantages of using diode laser are that it does not require general anaesthesia, the lower intra- and peri-operative morbidity, the lack of nasal packing and the greater ease of performing additional interventions if it fails. The only real disadvantage of laser procedures is the high cost.

  13. The Social Consequences of Poverty: An Empirical Test on Longitudinal Data.

    PubMed

    Mood, Carina; Jonsson, Jan O

    Poverty is commonly defined as a lack of economic resources that has negative social consequences, but surprisingly little is known about the importance of economic hardship for social outcomes. This article offers an empirical investigation into this issue. We apply panel data methods on longitudinal data from the Swedish Level-of-Living Survey 2000 and 2010 (n = 3089) to study whether poverty affects four social outcomes-close social relations (social support), other social relations (friends and relatives), political participation, and activity in organizations. We also compare these effects across five different poverty indicators. Our main conclusion is that poverty in general has negative effects on social life. It has more harmful effects for relations with friends and relatives than for social support; and more for political participation than organizational activity. The poverty indicator that shows the greatest impact is material deprivation (lack of cash margin), while the most prevalent poverty indicators-absolute income poverty, and especially relative income poverty-appear to have the least effect on social outcomes.

  14. Carbetocin versus oxytocin for prevention of post-partum haemorrhage at caesarean section in the United Kingdom: An economic impact analysis.

    PubMed

    van der Nelson, Helen A; Draycott, Tim; Siassakos, Dimitrios; Yau, Christopher W H; Hatswell, Anthony J

    2017-03-01

    To determine the economic impact of the introduction of carbetocin for the prevention of postpartum haemorrhage (PPH) at caesarean section, compared to oxytocin. The model is a decision tree conducted from a UK National Health Service perspective. 1500 caesarean sections (both elective and emergency) were modelled over a 12 month period. Efficacy data was taken from a published Cochrane meta-analysis, and costs from NHS Reference costs, the British National Formulary and the NHS electronic Medicines Information Tool. A combination of hospital audit data and expert input from an advisory board of clinicians was used to inform resource use estimates. The main outcome measures were the incidence of PPH and total cost over a one year time horizon, as a result of using carbetocin compared to oxytocin for prevention of PPH at caesarean section. The use of carbetocin compared to oxytocin for prevention of PPH at caesarean section was associated with a reduction of 30 (88 vs 58) PPH events (>500ml blood loss), and a cost saving of £27,518. In probabilistic sensitivity analysis, carbetocin had a 91.5% probability of producing better outcomes, and a 69.4% chance of being dominant (both cheaper and more effective) compared to oxytocin. At list price, the introduction of carbetocin appears to provide improved clinical outcomes along with cost savings, though this is subject to uncertainty regarding the underlying data in efficacy, resource use, and cost. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

  15. Lower kidney allograft survival in African-Americans compared to Hispanic-Americans with lupus.

    PubMed

    Gonzalez-Suarez, M L; Contreras, G

    2017-10-01

    Background and objective African-Americans and Hispanic-Americans with lupus are the two most common minority groups who receive kidney transplants in the USA. It is unknown if African-Americans and Hispanic-Americans with lupus have similar outcomes after kidney transplantation. In this study, we assessed whether African-Americans compared to Hispanic-Americans have worse kidney allograft survival after risk factors of rejection and other prognostic factors were matched between both groups. Methods Out of 1816 African-Americans and 901 Hispanic-Americans with lupus, who received kidney transplants between 1987 and 2006 and had complete records in the UNOS program, 478 pairs were matched in 16 baseline predictors and follow-up time employing a predicted probability of group membership. The primary outcome was kidney allograft survival. Main secondary outcomes were rejection, allograft failure attributed to rejection, and mortality. Results Matched pairs were predominantly women (81%) with the mean age of 36 years. 96% were on dialysis before transplantation. 89% of recipients received kidneys from deceased donors and 15.5% from expanded criteria donors. 12% of recipients had zero HLA mismatch. African-Americans compared to Hispanic-Americans had lower cumulative allograft survival during 12-year follow-up ( p < 0.001). African-Americans compared to Hispanic-Americans had higher rates of rejection (10.4 vs 6.73 events/100 patients-years; p = 0.0002) and allograft failure attributed to rejection (6.31 vs 3.99; p = 0.0023). However, African-Americans and Hispanic-Americans had similar mortality rates (2.71 vs 2.31; p = 0.4269). Conclusions African-Americans compared to Hispanic-Americans with lupus had lower kidney allograft survival when recognized risk factors of rejection were matched between groups.

  16. Impact of totally laparoscopic combined management of colorectal cancer with synchronous hepatic metastases on severity of complications: a propensity-score-based analysis.

    PubMed

    Ratti, Francesca; Catena, Marco; Di Palo, Saverio; Staudacher, Carlo; Aldrighetti, Luca

    2016-11-01

    Thanks to widespread diffusion of minimally invasive approach in the setting of both colorectal and hepatic surgeries, the interest in combined resections for colorectal cancer and synchronous liver metastases (SCLM) by totally laparoscopic approach (TLA) has increased. Aim of this study was to compare outcome of combined resections for SCLM performed by TLA or by open approach, in a propensity-score-based study. All 25 patients undergoing combined TLA for SCLM at San Raffaele Hospital in Milano were compared in a case-matched analysis with 25 out of 91 patients undergoing totally open approach (TOA group). Groups were matched with 1:2 ratio using propensity scores based on covariates representing disease severity. Main endpoints were postoperative morbidity and long-term outcome. The Modified Accordion Severity Grading System was used to quantify complications. The groups resulted comparable in terms of patients and disease characteristics. The TLA group, as compared to the TOA group, had lower blood loss (350 vs 600 mL), shorter postoperative stay (9 vs 12 days), lower postoperative morbidity index (0.14 vs 0.20) and severity score for complicated patients (0.60 vs 0.85). Colonic anastomosis leakage had the highest fractional complication burden in both groups. In spite of comparable long-term overall survival, the TLA group had better recurrence-free survival. TLA for combined resections is feasible, and its indications can be widened to encompass a larger population of patients, provided its benefits in terms of reduced overall risk and severity of complications, rapid functional recovery and favorable long-term outcomes.

  17. Association between funding, risk of bias, and outcome of randomised controlled trials in oral and maxillofacial surgery.

    PubMed

    Oomens, M A E M; Lazzari, S; Heymans, M W; Forouzanfar, T

    2016-01-01

    The influence of funding on the main outcome of a random control trial (RCT) is important, as it could potentially lead to bias towards industry, and results that are too optimistic. We investigated the association between funding, the published outcome, and the risk of bias in trials in oral and maxillofacial surgery (OMFS) published from January 2000 to May 2013 listed in PubMed. The methods used were scored using the risk of bias items given in a Delphi List. Sources of funding were recorded and categorised five ways: not funded, funded by industry, not funded by industry, supported by industry, and source of funds not clear. A total of 390 RCT met the inclusion criteria, and there was a correlation between funding and favourable main outcomes, although this was not significant. There was no correlation between the risk of bias and favourable results of the main outcome of a trial, or between the risk of bias and the reported source of funding in post-hoc analysis. We were unable to show a significant correlation between funding and a higher likelihood of a favourable result for the primary outcome in RCT in OMFS. We also failed to show a significant correlation between the risk of bias of a trial and its main outcome. In contrast, the source of funding proved to affect the risk of bias of a trial significantly, although not in post-hoc analysis. Funded trials were better organised, and so had a lower risk of bias. Copyright © 2015 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  18. Efficacy of water preloading before main meals as a strategy for weight loss in primary care patients with obesity: RCT.

    PubMed

    Parretti, Helen M; Aveyard, Paul; Blannin, Andrew; Clifford, Susan J; Coleman, Sarah J; Roalfe, Andrea; Daley, Amanda J

    2015-09-01

    To investigate the efficacy of water preloading before meals as a weight loss strategy for adults with obesity. A two-group randomized controlled trial was conducted in Birmingham, England. Eighty-four adults with obesity were recruited from general practices. All participants were given a face-to-face weight management consultation at baseline (30 min) and a follow-up telephone consultation at 2 weeks (10 min). At baseline, participants were randomized to either drinking 500 ml of water 30 min before their main meals or an attention control group where participants were asked to imagine their stomach was full before meals. The primary outcome was weight change at 12-week follow-up. Several measures of adherence were also used, including 24 h total urine collections. 41 participants were randomized to the intervention group and 43 to the comparator group. The water preloading group lost -1.3 kg (95% CI -2.4 to -0.1, P = 0.028) more than comparators at follow up. Adjusting for ethnicity, deprivation, age, and gender resulted in the intervention group losing -1.2 kg (95% CI -2.4 to 0.07, P = 0.063) more than the comparator. There is preliminary evidence that water preloading before main meals leads to a moderate weight loss at follow up. ISRCTN33238158. © 2015 The Obesity Society.

  19. [Measuring the impact of nursing on health: a literature review].

    PubMed

    Ausili, Davide

    2013-01-01

    Measuring nursing contribution to health services' outcomes represents a primary issue for nursing research internationally. The aim of this literature review was to outline main research lines studying the effect of nursing practice on health. A search of the literature was performed asking health and nursing-specific major database and consulting websites of authoritative nursing associations and scientific societies. Four main nursing research lines were found in literature and they concerned, nurse staffing and patient and staff-related outcomes; level of nursing care needed to achieve attended outcomes in hospitals; practice environments and patient and staff-related outcomes; the use of nursing terminologies and classifications to describe nursing-specific and nursing sensitive outcomes. Although researchers report the need to strengthen available evidences, recommendations suggest to empower nurses and nursing in clinical, educational, organizational and policy-making settings in order to draw toward the best health outcomes for communities.

  20. Impact of a Videoconference Educational Intervention on Physical Restraint and Antipsychotic Use in Nursing Homes: Results From the ECHO-AGE Pilot Study.

    PubMed

    Gordon, Stephen E; Dufour, Alyssa B; Monti, Sara M; Mattison, Melissa L P; Catic, Angela G; Thomas, Cindy P; Lipsitz, Lewis A

    2016-06-01

    US nursing homes care for increasing numbers of residents with dementia and associated behavioral problems. They often lack access to specialized clinical expertise relevant to managing these problems. Project ECHO-AGE provides this expertise through videoconference sessions between frontline nursing home staff and clinical experts at an academic medical center. We hypothesized that ECHO-AGE would result in less use of physical and chemical restraints and other quality improvements in participating facilities. A 2:1 matched-cohort study comparing quality of care outcomes between ECHO-AGE facilities and matched controls for the period July 2012 to December 2013. Eleven nursing homes in Massachusetts and Maine. Nursing home staff and a hospital-based team of geriatrician, geropsychiatrist, and neurologist discussed anonymized residents with dementia. Biweekly online video case discussions and brief didactic sessions focused on the management of dementia and behavior disorders. The primary outcome variables were percentage of residents receiving antipsychotic medications and the percentage of residents who were physically restrained. Secondary outcomes included 9 other quality of care metrics from MDS 3.0. Residents in ECHO-AGE facilities were 75% less likely to be physically restrained compared with residents in control facilities over the 18-month intervention period (OR = 0.25, P = .05). Residents in ECHO-AGE facilities were 17% less likely to be prescribed antipsychotic medication compared with residents in control facilities (OR = 0.83, P = .07). Other outcomes were not significantly different. Preliminary evidence suggests that participation in Project ECHO-AGE reduces rates of physical restraint use and may reduce rates of antipsychotic use among long-term nursing home residents. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. All rights reserved.

  1. Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial.

    PubMed

    Causarano, Natalie; Platt, Jennica; Baxter, Nancy N; Bagher, Shaghayegh; Jones, Jennifer M; Metcalfe, Kelly A; Hofer, Stefan O P; O'Neill, Anne C; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

    2015-05-01

    Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals. We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction. We conducted a pilot randomized controlled trial (RCT) where participants were randomly assigned to the intervention with routine education or routine education alone. The outcomes evaluated were decisional conflict, decision self-efficacy, satisfaction with information, perceived involvement in care, and uptake of reconstruction following surgical consultation. Trial feasibility and acceptability were evaluated, and effect sizes were calculated to determine the primary outcome for the full-scale RCT. Of the 41 patients enrolled, recruitment rate was 72 %, treatment fidelity was 98 %, and retention rate was 95 %. The Cohen's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education (0.69, 95 % CI = 0.02-1.42), while the effect sizes of increase in decision self-efficacy (0.05, 95 % CI = -0.60-0.71) and satisfaction with information (0.11, 95 % CI = -0.53-0.76) were small. A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction (14/20 or 70 %) compared to the intervention group (8/21 or 38 %) P = 0.06. A pre-consultation educational group intervention improves patients' shared decision-making quality compared to routine preoperative patient education. A full-scale definitive RCT is warranted based on high feasibility outcomes, and the primary outcome for the main trial will be decisional conflict.

  2. Mode of childbirth and neonatal outcome after external cephalic version: A prospective cohort study.

    PubMed

    Rosman, A N; Vlemmix, F; Ensing, S; Opmeer, B C; Te Hoven, S; Velzel, J; de Hundt, M; van den Berg, S; Rota, H; van der Post, J A M; Mol, B W J; Kok, M

    2016-08-01

    to assess the mode of childbirth and adverse neonatal outcomes in women with a breech presentation with or without an external cephalic version attempt, and to compare the mode of childbirth among women with successful ECV to women with a spontaneous cephalic presentation. prospective matched cohort study. 25 clusters (hospitals and its referring midwifery practices) in the Netherlands. Data of the Netherlands perinatal registry for the matched cohort. singleton pregnancies from January 2011 to August 2012 with a fetus in breech presentation and a childbirth from 36 weeks gestation onwards. Spontaneous cephalic presentations (selected from national registry 2009 and 2010) were matched in a 2:1 ratio to cephalic presentations after a successful version attempt. Matching criteria were maternal age, parity, gestational age at childbirth and fetal gender. Main outcomes were mode of childbirth and neonatal outcomes. of 1613 women eligible for external cephalic version, 1169 (72.5%) received an ECV attempt. The overall caesarean childbirth rate was significantly lower compared to women who did not receive a version attempt (57% versus 87%; RR 0.66 (0.62-0.70)). Women with a cephalic presentation after ECV compared to women with a spontaneous cephalic presentation had a decreased risk for instrumental vaginal childbirth (RR 0.52 (95% CI 0.29-0.94)) and an increased risk of overall caesarean childbirth (RR 1.7 (95%CI 1.2-2.5)). women who had a successful ECV are at increased risk for a caesarean childbirth but overall, ECV is an important tool to reduce the caesarean rate. ECV is an important tool to reduce the caesarean section rates. Copyright © 2016. Published by Elsevier Ltd.

  3. Overview of the Publications From the Anthroposophic Medicine Outcomes Study (AMOS): A Whole System Evaluation Study

    PubMed Central

    Kiene, Helmut; Ziegler, Renatus; Tröger, Wilfried; Meinecke, Christoph; Schnürer, Christof; Vögler, Hendrik; Glockmann, Anja; Kienle, Gunver Sophia

    2014-01-01

    Anthroposophic medicine is a physician-provided complementary therapy system that was founded by Rudolf Steiner and Ita Wegman. Anthroposophic therapy includes special medicinal products, artistic therapies, eurythmy movement exercises, and special physical therapies. The Anthroposophic Medicine Outcomes Study (AMOS) was a prospective observational multicenter study of 1631 outpatients starting anthroposophic therapy for anxiety disorders, asthma, attention deficit hyperactivity disorder, depression, low back pain, migraine, and other chronic indications under routine conditions in Germany. AMOS incorporated two features proposed for the evaluation of integrative therapy systems: (1) a sequential approach, starting with the whole therapy system (use, safety, outcomes, perceived benefit), addressing comparative effectiveness and proceeding to the major system components (physician counseling, anthroposophic medicinal products, art therapy, eurythmy therapy, rhythmical massage therapy) and (2) a mix of different research methods to build an information synthesis, including pre-post analyses, prospective comparative analyses, economic analyses, and safety analyses of individual patient data. AMOS fostered two methodological innovations for the analysis of single-arm therapy studies (combined bias suppression, systematic outcome comparison with corresponding cohorts in other studies) and the first depression cost analysis worldwide comparing primary care patients treated for depression vs depressed patients treated for another disorder vs nondepressed patients. A total of 21 peer-reviewed publications from AMOS have resulted. This article provides an overview of the main research questions, methods, and findings from these publications: anthroposophic treatment was safe and was associated with clinically relevant improvements in symptoms and quality of life without cost increase; improvements were found in all age, diagnosis, and therapy modality groups and were retained at 48-month follow-up; nonrespondent bias, natural recovery, regression to the mean, and adjunctive therapies together could explain a maximum of 37% of the improvement. PMID:24753995

  4. Overview of the Publications From the Anthroposophic Medicine Outcomes Study (AMOS): A Whole System Evaluation Study.

    PubMed

    Hamre, Harald Johan; Kiene, Helmut; Ziegler, Renatus; Tröger, Wilfried; Meinecke, Christoph; Schnürer, Christof; Vögler, Hendrik; Glockmann, Anja; Kienle, Gunver Sophia

    2014-01-01

    Anthroposophic medicine is a physician-provided complementary therapy system that was founded by Rudolf Steiner and Ita Wegman. Anthroposophic therapy includes special medicinal products, artistic therapies, eurythmy movement exercises, and special physical therapies. The Anthroposophic Medicine Outcomes Study (AMOS) was a prospective observational multicenter study of 1631 outpatients starting anthroposophic therapy for anxiety disorders, asthma, attention deficit hyperactivity disorder, depression, low back pain, migraine, and other chronic indications under routine conditions in Germany. AMOS INCORPORATED TWO FEATURES PROPOSED FOR THE EVALUATION OF INTEGRATIVE THERAPY SYSTEMS: (1) a sequential approach, starting with the whole therapy system (use, safety, outcomes, perceived benefit), addressing comparative effectiveness and proceeding to the major system components (physician counseling, anthroposophic medicinal products, art therapy, eurythmy therapy, rhythmical massage therapy) and (2) a mix of different research methods to build an information synthesis, including pre-post analyses, prospective comparative analyses, economic analyses, and safety analyses of individual patient data. AMOS fostered two methodological innovations for the analysis of single-arm therapy studies (combined bias suppression, systematic outcome comparison with corresponding cohorts in other studies) and the first depression cost analysis worldwide comparing primary care patients treated for depression vs depressed patients treated for another disorder vs nondepressed patients. A total of 21 peer-reviewed publications from AMOS have resulted. This article provides an overview of the main research questions, methods, and findings from these publications: anthroposophic treatment was safe and was associated with clinically relevant improvements in symptoms and quality of life without cost increase; improvements were found in all age, diagnosis, and therapy modality groups and were retained at 48-month follow-up; nonrespondent bias, natural recovery, regression to the mean, and adjunctive therapies together could explain a maximum of 37% of the improvement.

  5. Characteristics and outcome of spontaneous bacterial meningitis in patients with cancer compared to patients without cancer.

    PubMed

    Pomar, Virginia; Benito, Natividad; López-Contreras, Joaquin; Coll, Pere; Gurguí, Mercedes; Domingo, Pere

    2017-05-01

    In cancer patients, who are frequently immunocompromised, bacterial meningitis (BM) can be a severe complication, with a different presentation, etiology, and course, compared to patients without cancer. Our objective is to compare the characteristics and outcomes of BM in patients with and without cancer. A single-center, prospective observational cohort study, conducted between 1982 and 2012, in a tertiary university hospital in Barcelona (Spain). The main outcome measure is in-hospital mortality. We evaluated 659 episodes of BM; 97 (15%) had active cancer. Patients with malignancies were older (median 63 (interquartile range [IQR] 24) vs 52 [IQR 42] years, P < .001) and more often had a Charlson comorbidity score of ≥3 (51% vs 11%, P < .001). The classic meningitis triad (35% vs 50%, P = .05), fever (91% vs 96%, P = .03), neck stiffness (58% vs 78%, P < .001), headache (63% vs 77%) P = .003), and rash (7% vs 30%, P < .001) were less frequent. There was a longer interval between admission and antibiotic therapy (median 5 [IQR 14] vs 3 [IQR 6] hours, P < .001). Listeria meningitis was the commonest cause of BM (29%) and was more frequent in cancer than noncancer (8%, P < .001) patients, whereas meningococcal meningitis was much less frequent (4% vs 36%, P < .001). Overall mortality was higher in patients with cancer (31% vs 16%, P < .001), although cancer was not associated with an unfavorable outcome in the multivariate analysis (odds ratio 1.825, P = .07). Patients with meningitis and cancer are older and have more subtle clinical manifestations than patients without cancer. Listeria monocytogenes is the predominant pathogen and mortality is higher in cancer patients.

  6. Motivational Interviewing or Reminders for Glaucoma Medication Adherence? Results of a Multi-Site Randomized Controlled Trial

    PubMed Central

    Schmiege, Sarah J.; Mansberger, Steven L.; Sheppler, Christina; Kammer, Jeffrey; Fitzgerald, Timothy; Kahook, Malik Y.

    2017-01-01

    Objective Nonadherence reduces glaucoma treatment efficacy. Motivational interviewing (MI) is a well-studied adherence intervention, but has not been tested in glaucoma. Reminder interventions also may improve adherence. Design 201 patients with glaucoma or ocular hypertension were urn-randomized to receive MI delivered by an ophthalmic technician (OT), usual care, or a minimal behavioral intervention (reminder calls). Main Outcome Measures Outcomes included electronic monitoring with Medication Event Monitoring System (MEMS) bottles, two self-report adherence measures, patient satisfaction, and clinical outcomes. Multilevel modeling was used to test differences in MEMS results by group over time; ANCOVA was used to compare groups on other measures. Results Reminder calls increased adherence compared to usual care based on MEMS, p = .005, and self-report, p = .04. MI had a nonsignificant effect but produced higher satisfaction than reminder calls, p = .007. Treatment fidelity was high on most measures, with observable differences in behavior between groups. All groups had high baseline adherence that limited opportunities for change. Conclusion Reminder calls, but not MI, led to better adherence than usual care. Although a large literature supports MI, reminder calls might be a cost-effective intervention for patients with high baseline adherence. Replication is needed with less adherent participants. PMID:27701902

  7. An in silico approach helped to identify the best experimental design, population, and outcome for future randomized clinical trials.

    PubMed

    Bajard, Agathe; Chabaud, Sylvie; Cornu, Catherine; Castellan, Anne-Charlotte; Malik, Salma; Kurbatova, Polina; Volpert, Vitaly; Eymard, Nathalie; Kassai, Behrouz; Nony, Patrice

    2016-01-01

    The main objective of our work was to compare different randomized clinical trial (RCT) experimental designs in terms of power, accuracy of the estimation of treatment effect, and number of patients receiving active treatment using in silico simulations. A virtual population of patients was simulated and randomized in potential clinical trials. Treatment effect was modeled using a dose-effect relation for quantitative or qualitative outcomes. Different experimental designs were considered, and performances between designs were compared. One thousand clinical trials were simulated for each design based on an example of modeled disease. According to simulation results, the number of patients needed to reach 80% power was 50 for crossover, 60 for parallel or randomized withdrawal, 65 for drop the loser (DL), and 70 for early escape or play the winner (PW). For a given sample size, each design had its own advantage: low duration (parallel, early escape), high statistical power and precision (crossover), and higher number of patients receiving the active treatment (PW and DL). Our approach can help to identify the best experimental design, population, and outcome for future RCTs. This may be particularly useful for drug development in rare diseases, theragnostic approaches, or personalized medicine. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Individually tailored internet-based cognitive behaviour therapy for older adults with anxiety and depression: a randomised controlled trial.

    PubMed

    Silfvernagel, Kristin; Westlinder, Anna; Andersson, Stina; Bergman, Kajsa; Diaz Hernandez, Rosario; Fallhagen, Line; Lundqvist, Ida; Masri, Nicole; Viberg, Linda; Forsberg, Marie-Louise; Lind, Maria; Berger, Thomas; Carlbring, Per; Andersson, Gerhard

    2018-07-01

    Mixed anxiety and depression is common among older adults. The aim of the study was to compare the effects of an eight-week-long tailored internet-supported cognitive behaviour therapy (ICBT) programme and to compare against the provision of weekly general support. A second aim was to investigate if pre-treatment cognitive flexibility and self-reported cognitive problems would predict outcome. We included 66 older adults (aged over 60 years) with mixed anxiety/depression following media recruitment and randomised them into treatment and control groups. We also included a one-year follow-up. As a measure of executive function, we used the Wisconsin Card Sorting Test (perseverative errors) and the Cognitive Failures Questionnaire during the pre-treatment phase. Results showed a moderate between-group effect on the main outcome measure, the Beck Anxiety Inventory (BAI) (d= .50), favouring the treatment group. Nearly half (45.5%) of that group were classified as responders. One person (3%) in the treatment group deteriorated. There were significant correlations between perseverative errors and outcome (on the BAI r = -.45), but not among self-reported cognitive function. We conclude that guided, tailored ICBT may be effective for some older adults and that the role of cognitive function needs to be investigated further.

  9. Effects of Preoperative Simulation on Minimally Invasive Hybrid Lumbar Interbody Fusion.

    PubMed

    Rieger, Bernhard; Jiang, Hongzhen; Reinshagen, Clemens; Molcanyi, Marek; Zivcak, Jozef; Grönemeyer, Dietrich; Bosche, Bert; Schackert, Gabriele; Ruess, Daniel

    2017-10-01

    The main focus of this study was to evaluate how preoperative simulation affects the surgical work flow, radiation exposure, and outcome of minimally invasive hybrid lumbar interbody fusion (MIS-HLIF). A total of 132 patients who underwent single-level MIS-HLIF were enrolled in a cohort study design. Dose area product was analyzed in addition to surgical data. Once preoperative simulation was established, 66 cases (SIM cohort) were compared with 66 patients who had previously undergone MIS-HLIF without preoperative simulation (NO-SIM cohort). Dose area product was reduced considerably in the SIM cohort (320 cGy·cm 2 NO-SIM cohort: 470 cGy·cm 2 ; P < 0.01). Surgical time was shorter for the SIM cohort (155 minutes; NO-SIM cohort, 182 minutes; P < 0.05). SIM cohort had a better outcome in Numeric Rating Scale back at 6 months follow-up compared with the NO-SIM cohort (P < 0.05). Preoperative simulation reduced radiation exposure and resulted in less back pain at the 6 months follow-up time point. Preoperative simulation provided guidance in determining the correct cage height. Outcome controls enabled the surgeon to improve the procedure and the software algorithm. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Group differences in risk across three domains using an expanded measure of sexual orientation.

    PubMed

    Loosier, Penny S; Dittus, Patricia J

    2010-12-01

    The purpose of this study was to highlight associations between sexual orientation and risk outcomes in late adolescence and early adulthood using an expanded measure of sexual orientation. Recent data indicate higher levels of risk behavior in a newly identified population, mostly heterosexuals, as compared to heterosexuals. Comparisons among groups using an expanded measure of sexual orientation such as this, however, often do not include all possible groups or may restrict comparisons between groups. Data were derived from the National Longitudinal Study of Adolescent Health (Add Health); participants identified as heterosexual, mostly heterosexual, bisexual, mostly gay, or gay. Main risk outcomes were parental mistreatment, home displacement, thoughts of suicide, depressive symptoms, frequency of drinking, and delinquency. A priori planned comparisons examined differences between: (a) heterosexual vs. mostly heterosexual, (b) gay vs. mostly gay, (c) mostly heterosexual vs. bisexual, (d) mostly gay vs. bisexual, (e) mostly heterosexual vs. mostly gay, (f) heterosexual vs. gay, (g) heterosexual vs. bisexual, and (h) gay vs. bisexual. Mostly heterosexual youth were at significantly greater risk than heterosexual youth on all outcomes but did not differ from bisexual or mostly gay youth. Heterosexuals were at lower risk as compared to mostly heterosexuals and bisexuals. This study provides further evidence of differential risk associations for sexual minorities.

  11. Outcomes after implementing the enhanced recovery after surgery protocol for patients undergoing tuberculous empyema operations.

    PubMed

    Xia, Zhaohua; Qiao, Kun; Wang, Haijiang; Ning, Xinzhong; He, Jianxing

    2017-07-01

    Enhanced recovery after surgery (ERAS) protocols provide recommendations for care in various surgical fields. However, there is scarce information on the application of these protocols in tuberculous empyema surgery. The purpose of this research is to evaluate the outcomes of ERAS recommendations for patients who received tuberculous empyema surgery. A retrospective analysis was performed on patients who underwent tuberculous empyema surgery in our hospital from March 2011 to March 2016. The patients were divided into an ERAS group and a conventional control group. The main outcome measure was the postoperative median length of stay (including readmissions). Principles related to ERAS were documented, and the postoperative median hospital stay was analyzed statistically between the two groups. A total of 92 patients underwent 93 consecutive tuberculous empyema surgical treatments. The postoperative fasting time, chest tube duration, and length of stay were shorter in the ERAS group compared with the control group. The volume of chest tube drainage in the ERAS group was significantly smaller than that of the control group. No statistical differences were observed in the postoperative complications and reasons for readmission between the two groups. Application of ERAS recommendations in patients receiving tuberculous empyema operations decreased the length of stay and chest tube drainage compared to the control group.

  12. Pharmacoepidemiology for nephrologists: do proton pump inhibitors cause chronic kidney disease?

    PubMed Central

    Tomlinson, Laurie A.; Fogarty, Damian G.; Douglas, Ian; Nitsch, Dorothea

    2017-01-01

    Abstract Pharmacoepidemiology studies are increasingly used for research into safe prescribing in chronic kidney disease (CKD). Typically, patients prescribed a drug are compared with patients who are not on the drug and outcomes are compared to draw conclusions about the drug effects. This review article aims to provide the reader with a framework to critically appraise such research. A key concern in pharmacoepidemiology studies is confounding, in that patients who have worse health status are prescribed more drugs or different agents and their worse outcomes are attributed to the drugs not the health status. It may be challenging to adjust for this using statistical methods unless a comparison group with a similar health status but who are prescribed a different (comparison) drug(s) is identified. Another challenge in pharmacoepidemiology is outcome misclassification, as people who are more ill engage more often with the health service, leading to earlier diagnosis in people who are frequent attenders. Finally, using replication cohorts with the same methodology in the same type of health system does not ensure that findings are more robust. We use two recent papers that investigated the association of proton pump inhibitor drugs with CKD as a device to review the main pitfalls of pharmacoepidemiology studies and how to attempt to mitigate against potential biases that can occur. PMID:28201528

  13. Psychopathology and resident status - comparing asylum seekers, refugees, illegal migrants, labor migrants, and residents.

    PubMed

    Heeren, Martina; Wittmann, Lutz; Ehlert, Ulrike; Schnyder, Ulrich; Maier, Thomas; Müller, Julia

    2014-05-01

    This study aimed to describe, compare, and predict mental health outcomes of different migrant groups and native residents in Switzerland. Asylum seekers (n=65); refugees holding permanent protection visas (n=34); illegal migrants (n=21); labor migrants (n=26); and residents (n=56) completed an assessment by questionnaire. Main outcome variables were symptoms of posttraumatic stress, anxiety and depression. It was tested whether resident status predicted psychopathology over and above the influence of control variables including social desirability, traumatic event types and post-migration resources. Asylum seekers (54.0%) and refugees (41.4%) fulfilled criteria of PTSD most frequently. Clinically relevant symptoms of anxiety and depression were most frequently reported by asylum seekers (84.6% and 63.1%, resp.) and illegal migrants (both 47.6%). Resident status contributed to psychopathology over and above the influence of control variables. Overall, asylum seekers, refugees, and illegal migrants showed high psychiatric morbidity. Differences in resident status appear to be specifically associated with mental health outcomes. This association persists even when controlling for social desirability, post-migration resources and traumatic events. This emphasizes the importance of current socio-political living conditions for mental health, even with respect to the psychopathological sequelae of past traumatic experiences. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Perioperative surgical outcome of conventional and robot-assisted total laparoscopic hysterectomy.

    PubMed

    van Weelden, W J; Gordon, B B M; Roovers, E A; Kraayenbrink, A A; Aalders, C I M; Hartog, F; Dijkhuizen, F P H L J

    2017-01-01

    To evaluate surgical outcome in a consecutive series of patients with conventional and robot assisted total laparoscopic hysterectomy. A retrospective cohort study was performed among patients with benign and malignant indications for a laparoscopic hysterectomy. Main surgical outcomes were operation room time and skin to skin operating time, complications, conversions, rehospitalisation and reoperation, estimated blood loss and length of hospital stay. A total of 294 patients were evaluated: 123 in the conventional total laparoscopic hysterectomy (TLH) group and 171 in the robot TLH group. After correction for differences in basic demographics with a multivariate linear regression analysis, the skin to skin operating time was a significant 18 minutes shorter in robot assisted TLH compared to conventional TLH (robot assisted TLH 92m, conventional TLH 110m, p0.001). The presence or absence of previous abdominal surgery had a significant influence on the skin to skin operating time as did the body mass index and the weight of the uterus. Complications were not significantly different. The robot TLH group had significantly less blood loss and lower rehospitalisation and reoperation rates. This study compares conventional TLH with robot assisted TLH and shows shorter operating times, less blood loss and lower rehospitalisation and reoperation rates in the robot TLH group.

  15. Influence of macrosocial policies on women's health and gender inequalities in health.

    PubMed

    Borrell, Carme; Palència, Laia; Muntaner, Carles; Urquía, Marcelo; Malmusi, Davide; O'Campo, Patricia

    2014-01-01

    Gender inequalities in health have been widely described, but few studies have examined the upstream sources of these inequalities in health. The objectives of this review are 1) to identify empirical papers that assessed the effect of gender equality policies on gender inequalities in health or on women's health by using between-country (or administrative units within a country) comparisons and 2) to provide an example of published evidence on the effects of a specific policy (parental leave) on women's health. We conducted a literature search covering the period from 1970 to 2012, using several bibliographical databases. We assessed 1,238 abstracts and selected 19 papers that considered gender equality policies, compared several countries or different states in 1 country, and analyzed at least 1 health outcome among women or compared between genders. To illustrate specific policy effects, we also selected articles that assessed associations between parental leave and women's health. Our review partially supports the hypothesis that Nordic social democratic welfare regimes and dual-earner family models best promote women's health. Meanwhile, enforcement of reproductive policies, mainly studied across US states, is associated with better mental health outcomes, although less with other outcomes. Longer paid maternity leave was also generally associated with better mental health and longer duration of breastfeeding.

  16. Manchester Triage System: main flowcharts, discriminators and outcomes of a pediatric emergency care 1

    PubMed Central

    Amthauer, Camila; da Cunha, Maria Luzia Chollopetz

    2016-01-01

    ABSTRACT Objetive: to characterize the care services performed through risk rating by the Manchester Triage System, identifying demographics (age, gender), main flowcharts, discriminators and outcomes in pediatric emergency Method: cross-sectional quantitative study. Data on risk classification were obtained through a search of computerized registration data from medical records of patients treated in the pediatric emergency within one year. Descriptive statistics with absolute and relative frequencies was used for the analysis. Results: 10,921 visits were conducted in the pediatric emergency, mostly male (54.4%), aged between 29 days and two years (44.5%). There was a prevalence of the urgent risk category (43.6%). The main flowchart used in the care was worried parents (22.4%) and the most prevalent discriminator was recent event (15.3%). The hospitalization outcome occurred in 10.4% of care performed in the pediatric emergency, however 61.8% of care needed to stay under observation and / or being under the health team care in the pediatric emergency. Conclusion: worried parents was the main flowchart used and recent events the most prevalent discriminator, comprising the hospitalization outcomes and permanency in observation in the pediatric emergency before discharge from the hospital. PMID:27579934

  17. Comparison of 39 post-traumatic tibia bone transports performed with and without the use of an intramedullary rod: the long-term outcomes.

    PubMed

    Liodakis, Emmanouil; Kenawey, Mohamed; Krettek, Christian; Wiebking, Ulrich; Hankemeier, Stefan

    2011-09-01

    Bone transport can be performed with an external fixator alone or with the monorail technique which entails the combination of a fixator and an intramedullary nail. The purpose of this study was to compare the complication rates and long-term outcomes of these methods. Two groups of patients, the external fixator (n = 21) and the monorail group (n = 18), were compared. The average follow-up period was 7.9 ± 5.6 years and the mean defect length 8.3 ± 3.1 cm. Healing was achieved in 19 (90%) and 13 (72%) of the fixator and monorail patients, respectively. Six patients underwent amputations because of persistent infections (two in the fixator and four in the monorail group). The rate of deformities was significantly higher in the fixator group (p = 0.049). No statistically significant difference was found when comparing categories of the SF-36 test or the ability to work or do sports. The main advantages of the monorail method are reduction of the external fixation time and the lower rate of deformities. However, the authors recommend segmental transport with external fixator in patients with chronic infections.

  18. Differences across health care systems in outcome and cost-utility of surgical and conservative treatment of chronic low back pain: a study protocol

    PubMed Central

    Melloh, Markus; Röder, Christoph; Elfering, Achim; Theis, Jean-Claude; Müller, Urs; Staub, Lukas P; Aghayev, Emin; Zweig, Thomas; Barz, Thomas; Kohlmann, Thomas; Wieser, Simon; Jüni, Peter; Zwahlen, Marcel

    2008-01-01

    Background There is little evidence on differences across health care systems in choice and outcome of the treatment of chronic low back pain (CLBP) with spinal surgery and conservative treatment as the main options. At least six randomised controlled trials comparing these two options have been performed; they show conflicting results without clear-cut evidence for superior effectiveness of any of the evaluated interventions and could not address whether treatment effect varied across patient subgroups. Cost-utility analyses display inconsistent results when comparing surgical and conservative treatment of CLBP. Due to its higher feasibility, we chose to conduct a prospective observational cohort study. Methods This study aims to examine if 1. Differences across health care systems result in different treatment outcomes of surgical and conservative treatment of CLBP 2. Patient characteristics (work-related, psychological factors, etc.) and co-interventions (physiotherapy, cognitive behavioural therapy, return-to-work programs, etc.) modify the outcome of treatment for CLBP 3. Cost-utility in terms of quality-adjusted life years differs between surgical and conservative treatment of CLBP. This study will recruit 1000 patients from orthopaedic spine units, rehabilitation centres, and pain clinics in Switzerland and New Zealand. Effectiveness will be measured by the Oswestry Disability Index (ODI) at baseline and after six months. The change in ODI will be the primary endpoint of this study. Multiple linear regression models will be used, with the change in ODI from baseline to six months as the dependent variable and the type of health care system, type of treatment, patient characteristics, and co-interventions as independent variables. Interactions will be incorporated between type of treatment and different co-interventions and patient characteristics. Cost-utility will be measured with an index based on EQol-5D in combination with cost data. Conclusion This study will provide evidence if differences across health care systems in the outcome of treatment of CLBP exist. It will classify patients with CLBP into different clinical subgroups and help to identify specific target groups who might benefit from specific surgical or conservative interventions. Furthermore, cost-utility differences will be identified for different groups of patients with CLBP. Main results of this study should be replicated in future studies on CLBP. PMID:18534034

  19. Economic evaluation of multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: A randomized controlled trial

    PubMed Central

    Köke, Albère; Hitters, Minou; Rijnders, Nieke; Pont, Menno

    2017-01-01

    Background A multi-centre RCT has shown that multidisciplinary rehabilitation treatment (MRT) is more effective in reducing fatigue over the long-term in comparison with cognitive behavioural therapy (CBT) for patients with chronic fatigue syndrome (CFS), but evidence on its cost-effectiveness is lacking. Aim To compare the cost-effectiveness of MRT versus CBT for patients with CFS from a societal perspective. Methods A multi-centre randomized controlled trial comparing MRT with CBT was conducted among 122 patients with CFS diagnosed using the 1994 criteria of the Centers for Disease Control and Prevention and aged between 18 and 60 years. The societal costs (healthcare costs, patient and family costs, and costs for loss of productivity), fatigue severity, quality of life, quality-adjusted life-year (QALY), and cost-effectiveness ratios (ICERs) were measured over a follow-up period of one year. The main outcome of the cost-effectiveness analysis was fatigue measured by the Checklist Individual Strength (CIS). The main outcome of the cost-utility analysis was the QALY based on the EuroQol-5D-3L utilities. Sensitivity analyses were performed, and uncertainty was calculated using the cost-effectiveness acceptability curves and cost-effectiveness planes. Results The data of 109 patients (57 MRT and 52 CBT) were analyzed. MRT was significantly more effective in reducing fatigue at 52 weeks. The mean difference in QALY between the treatments was not significant (0.09, 95% CI: -0.02 to 0.19). The total societal costs were significantly higher for patients allocated to MRT (a difference of €5,389, 95% CI: 2,488 to 8,091). MRT has a high probability of being the most cost effective, using fatigue as the primary outcome. The ICER is €856 per unit of the CIS fatigue subscale. The results of the cost-utility analysis, using the QALY, indicate that the CBT had a higher likelihood of being more cost-effective. Conclusions The probability of being more cost-effective is higher for MRT when using fatigue as primary outcome variable. Using QALY as the primary outcome, CBT has the highest probability of being more cost-effective. Trial registration ISRCTN77567702. PMID:28574985

  20. Long-Term Outcomes and Discard Rate of Kidneys by Decade of Extended Criteria Donor Age

    PubMed Central

    Messina, Maria; Diena, Davide; Dellepiane, Sergio; Guzzo, Gabriella; Lo Sardo, Luca; Fop, Fabrizio; Segoloni, Giuseppe P.; Amoroso, Antonio; Magistroni, Paola

    2017-01-01

    Background and objectives Extended criteria donors represent nowadays a main resource for kidney transplantation, and recovery criteria are becoming increasingly inclusive. However, the limits of this approach are not clear as well as the effects of extreme donor ages on long-term kidney transplantation outcomes. To address these issues, we performed a retrospective study on extended criteria donor kidney transplantation. Design, setting, participants, & measurements In total, 647 consecutive extended criteria donor kidney transplantations performed over 11 years (2003–2013) were included. Donor, recipient, and procedural variables were classified according to donor age decades (group A, 50–59 years old [n=91]; group B, 60–69 years old [n=264]; group C, 70–79 years old [n=265]; and group D, ≥80 years old [n=27]). Organs were allocated in single- or dual-kidney transplantation after a multistep evaluation including clinical and histologic criteria. Long-term outcomes and main adverse events were analyzed among age groups and in either single- or dual-kidney transplantation. Kidney discard rate incidence and causes were evaluated. Results Median follow-up was 4.9 years (25th; 75th percentiles: 2.7; 7.6 years); patient and graft survival were comparable among age groups (5-year patient survival: group A, 87.8%; group B, 88.1%; group C, 88.0%; and group D, 90.1%; P=0.77; graft survival: group A, 74.0%; group B, 74.2%; group C, 75.2%; and group D, 65.9%; P=0.62) and between dual-kidney transplantation and single-kidney transplantation except for group D, with a better survival for dual-kidney transplantation (P=0.04). No difference was found analyzing complications incidence or graft function over time. Kidney discard rate was similar in groups A, B, and C (15.4%, 17.7%, and 20.1%, respectively) and increased in group D (48.2%; odds ratio, 5.1 with A as the reference group; 95% confidence interval, 2.96 to 8.79). Conclusions Discard rate and long-term outcomes are similar among extended criteria donor kidney transplantation from donors ages 50–79 years old. Conversely, discard rate was strikingly higher among kidneys from octogenarian donors, but appropriate selection provides comparable long-term outcomes, with better graft survival for dual-kidney transplantation. PMID:27979977

  1. Long-Term Outcomes and Discard Rate of Kidneys by Decade of Extended Criteria Donor Age.

    PubMed

    Messina, Maria; Diena, Davide; Dellepiane, Sergio; Guzzo, Gabriella; Lo Sardo, Luca; Fop, Fabrizio; Segoloni, Giuseppe P; Amoroso, Antonio; Magistroni, Paola; Biancone, Luigi

    2017-02-07

    Extended criteria donors represent nowadays a main resource for kidney transplantation, and recovery criteria are becoming increasingly inclusive. However, the limits of this approach are not clear as well as the effects of extreme donor ages on long-term kidney transplantation outcomes. To address these issues, we performed a retrospective study on extended criteria donor kidney transplantation. In total, 647 consecutive extended criteria donor kidney transplantations performed over 11 years (2003-2013) were included. Donor, recipient, and procedural variables were classified according to donor age decades (group A, 50-59 years old [n=91]; group B, 60-69 years old [n=264]; group C, 70-79 years old [n=265]; and group D, ≥80 years old [n=27]). Organs were allocated in single- or dual-kidney transplantation after a multistep evaluation including clinical and histologic criteria. Long-term outcomes and main adverse events were analyzed among age groups and in either single- or dual-kidney transplantation. Kidney discard rate incidence and causes were evaluated. Median follow-up was 4.9 years (25th; 75th percentiles: 2.7; 7.6 years); patient and graft survival were comparable among age groups (5-year patient survival: group A, 87.8%; group B, 88.1%; group C, 88.0%; and group D, 90.1%; P=0.77; graft survival: group A, 74.0%; group B, 74.2%; group C, 75.2%; and group D, 65.9%; P=0.62) and between dual-kidney transplantation and single-kidney transplantation except for group D, with a better survival for dual-kidney transplantation (P=0.04). No difference was found analyzing complications incidence or graft function over time. Kidney discard rate was similar in groups A, B, and C (15.4%, 17.7%, and 20.1%, respectively) and increased in group D (48.2%; odds ratio, 5.1 with A as the reference group; 95% confidence interval, 2.96 to 8.79). Discard rate and long-term outcomes are similar among extended criteria donor kidney transplantation from donors ages 50-79 years old. Conversely, discard rate was strikingly higher among kidneys from octogenarian donors, but appropriate selection provides comparable long-term outcomes, with better graft survival for dual-kidney transplantation. Copyright © 2017 by the American Society of Nephrology.

  2. A randomized, controlled phase I/II study to evaluate the safety and efficacy of MGV354 for ocular hypertension or glaucoma.

    PubMed

    Stacy, Rebecca; Huttner, Kenneth; Watts, Jen; Peace, James; Wirta, David; Walters, Tom; Sall, Kenneth; Seaman, John; Ni, Xiao; Prasanna, Ganesh; Mogi, Muneto; Adams, Christopher; Yan, Jing-He; Wald, Michael; He, Yunsheng; Newton, Ronald; Kolega, Randall; Grosskreutz, Cynthia

    2018-05-23

    To assess the clinical safety, tolerability, and efficacy of topically administered MGV354, a soluble guanylate cyclase (sGC) activator, in patients with ocular hypertension (OH) or glaucoma DESIGN: Double-masked, randomized, and vehicle-controlled study METHODS: Parts 1 and 2 evaluated safety and tolerability to identify the maximum tolerated dose (MTD) of once daily MGV354 in 32 healthy volunteers (Part 1) and 16 patients with OH or glaucoma (Part 2) at a single clinical site. Part 3 was a multi-site trial that evaluated IOP-lowering efficacy of the MTD administered nightly for one week in 50 patients with minimum IOP of 24mm Hg at 8 AM, with a main outcome measure of mean diurnal IOP at Day 8 compared to baseline (ClinicalTrials.gov NCT02743780). There was no difference in favor of MGV354 for IOP lowering; change from Baseline to Day 8 in mean diurnal IOP was -0.6 mmHg for MGV354-treated patients and -1.1 mmHg for Vehicle-treated patients in Part 3, with a confidence interval of -0.7 to 1.7. The most common adverse events reported after MGV354 administration were conjunctival and ocular hyperemia. Overall, MGV354 0.1% demonstrated no statistically significant effect compared to Vehicle in lowering IOP based upon the study's main outcome measure. MGV354 produced ocular hyperemia consistent with its pharmacology. Copyright © 2018 Elsevier Inc. All rights reserved.

  3. Epidemiology, morbidity and mortality from fall-related injuries in the United Arab Emirates

    PubMed Central

    2014-01-01

    Background Unintentional falls are a major cause of morbidity and mortality with a significant burden on victims, families, and societies. We aimed to study the mechanism, risk factors, and outcome of hospitalized patients with fall-related injuries in order to propose preventive measures. Methods Fall-related injured patients who were admitted to Al Ain Hospital, United Arab Emirates (UAE) for more than 24 hours or who died after arrival to the hospital, were studied over 3 years. Demography, location and time of injury, affected body regions, hospital and ICU stay, and outcome were analyzed. Results 882 patients were studied, 82% were males, and 22% were less than 19 years old. Majority were from the Indian subcontinent. The most common location for fall injuries was work. Patients injured at work were older and mainly non-UAE nationals (p < 0.0001) when compared with those injured at home. Patients falling from height, when compared with those falling from same level, were older (p = 0.017), had more males (p < 0.001), were mainly from the Indian subcontinent (p < 0.001), had higher ISS (p = 0.011) and longer total hospital stay (p < 0.001). Conclusions Falls are a major health problem in the UAE. Falls at work can be prevented by safety education tailored to different ethnic groups, and proper legislation and regulation. Environmental modification using evidence-based architectural design may prevent falls among vulnerable risk groups. PMID:25178823

  4. Comparación de costos y resultados sanitarios de usuarios con neumonia adquirida en comunidad atendidos en domicilio o en hospitalización tradicional: estudio exploratorio de 40 casos.

    PubMed

    Macaya, Mario Carvajal; Ridulfo, Alberto Hernández; Ramírez-Santana, Muriel

    2015-12-01

    Economic evaluations of health technologies and health interventions are considered in many countries as the fourth barrier for adopting new services or drugs; followed by safety, efficacy and quality. The validity and reliability of the results will depend on the perspective of the study, timeframe of the analysis, discount rate, the model used and the costs involved. This study aims to assess the cost effectiveness of home care treatment in users with diagnosis of uncomplicated community acquired pneumonia compared with traditional hospitalization at inpatient wards. The hypothesis is that home based care would be more cost effective compared to traditional hospitalization. The study perspective was from the health provider. Microcosting was used to determine the costs of both treatment modalities in a sample of 20 users treated with each modality during 2013 at main Hospitals of Coquimbo Region, Chile. The main outcome of effectiveness was the number of inpatient care days saved. Additionally, number of infections associated to health care (IAHC) and type of discharge were measured. The study concludes that there is a better cost effectiveness relationship for the home care modality, with fewer days of treatment, at lower costs and without risk of IAHC. However, further studies are needed in order to achieve accurate results. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  5. Association between Breastfeeding and Childhood Obesity: Analysis of a Linked Longitudinal Study of Rural Appalachian Fifth-Grade Children.

    PubMed

    Umer, Amna; Hamilton, Candice; Britton, Cris M; Mullett, Martha D; John, Collin; Neal, William; Lilly, Christa L

    2015-08-01

    Although breastfeeding is associated with improving numerous health outcomes for the child, its role in reducing childhood obesity is contested. Despite this controversy, both the CDC and the US Department of Health and Human Services promote breastfeeding as one of the strategies for reducing childhood obesity. Rural Appalachia has one of the highest rates of childhood obesity and low rates of breastfeeding, compared to rest of the nation. The aim of this study was to examine the association between breastfeeding and childhood obesity at 11 years in the rural Appalachian state of West Virginia (WV). The study used linked data from two cross-sectional data sets to examine this relationship longitudinally in fifth-grade WV children. The main outcome variable was BMI adjusted percent (BMI%) and the main exposure was defined as occurrence of breastfeeding. Mean BMI% of children who were not breastfed was significantly higher, compared to children who were breastfed. The result of the multiple regression analysis showed that breastfeeding significantly predicted BMI% of children after controlling for maternal education, health insurance, family history of hypercholesterolemia and diabetes, child's asthma status, and birth weight of the infant. Our results are consistent with other studies that have shown a significant, but small, inverse association between breastfeeding and childhood obesity. Findings from this study suggest the need to improve breastfeeding rates in the rural Appalachian state of WV as one of the potential strategies to prevent obesity during childhood and adolescence.

  6. The properties of residual water molecules in ionic liquids: a comparison between direct and inverse Kirkwood-Buff approaches.

    PubMed

    Kobayashi, Takeshi; Reid, Joshua E S J; Shimizu, Seishi; Fyta, Maria; Smiatek, Jens

    2017-07-26

    We study the properties of residual water molecules at different mole fractions in dialkylimidazolium based ionic liquids (ILs), namely 1-ethyl-3-methylimidazolium tetrafluoroborate (EMIM/BF 4 ) and 1-butyl-3-methylimidazolium tetrafluoroborate (BMIM/BF 4 ) by means of atomistic molecular dynamics (MD) simulations. The corresponding Kirkwood-Buff (KB) integrals for the water-ion and ion-ion correlation behavior are calculated by a direct evaluation of the radial distribution functions. The outcomes are compared to the corresponding KB integrals derived by an inverse approach based on experimental data. Our results reveal a quantitative agreement between both approaches, which paves a way towards a more reliable comparison between simulation and experimental results. The simulation outcomes further highlight that water even at intermediate mole fractions has a negligible influence on the ion distribution in the solution. More detailed analysis on the local/bulk partition coefficients and the partial structure factors reveal that water molecules at low mole fractions mainly remain in the monomeric state. A non-linear increase of higher order water clusters can be found at larger water concentrations. For both ILs, a more pronounced water coordination around the cations when compared to the anions can be observed, which points out that the IL cations are mainly responsible for water pairing mechanisms. Our simulations thus provide detailed insights in the properties of dialkylimidazolium based ILs and their effects on water binding.

  7. Impact of clinical pharmacist intervention in anticoagulation clinic in Sudan.

    PubMed

    Ahmed, Nahid Osman; Osman, Bashier; Abdelhai, Yassein Mohamed; El-Hadiyah, Tariq Muhammed Hashim

    2017-08-01

    Background Many trials have compared anticoagulation management provided by a pharmacist led anticoagulation clinic versus usual physician care showing the role for clinical pharmacist in the management of anticoagulant therapy, and demonstrating excellent outcomes. In Sudan, there is no published research evaluating the role of pharmacist in providing pharmaceutical care for patients taking warfarin. Objective The objective of the study is to assess the role of clinical pharmacist intervention in warfarin patients compared to usual medical care. Setting This study was conducted in Ahmed Gasim cardiac surgery and renal transplant center warfarin clinic. Methods One hundred thirty-five patients were randomly selected from adult patients on warfarin therapy The history of INR records, and adverse effects for the past year, were recorded. Then patients' warfarin dose adjustments according to INR, was done by the clinical pharmacist for one year. Patients received continuous verbal education and written information about warfarin. Main outcome measure The primary outcome for this study was the INR control, while the secondary outcomes were the bleeding events and hospitalization due to warfarin. Results After the clinical pharmacist intervention there was significant (P < 0.01) improvement in INR control and a significant (P < 0.05) reduction in incidence of bleeding after clinical pharmacist intervention. Hospitalization due to warfarin related complications (bleeding, high INR, low INR) was also significantly (P < 0.001) reduced. Conclusion Clinical pharmacists intervention in warfarin therapy improve INR control, reduce bleeding and hospitalization due to warfarin complications.

  8. Novel topical BoNTA (CosmeTox, toxin type A) cream used to treat hyperfunctional wrinkles of the face, mouth, and neck.

    PubMed

    Chajchir, I; Modi, P; Chajchir, A

    2008-09-01

    This study aimed to compare the effect of the stabilized novel topical botulinum neurotoxin type A (BoNTA) cream (CosmeTox) and a placebo cream on subjects, to compare clinician-reported outcomes, and to assess the safety and utility of the novel topical BoNTA cream for treating the entire upper face, chin, and neck areas. This study randomized 40 female subjects to receive either topical BoNTA (CosmeTox) cream (2 U/ml) or an identical placebo cream (without BoNTA) on the face, chin, and neck areas. The subjects were followed for 12 weeks. The main outcome measures were the Facial Line Outcomes questionnaire scores and results from the Self-Perception of Age instrument, which assesses age of appearance relative to actual age. The BoNTA topical cream (CosmeTox) treatment produced significant improvements in the Facial Lines Outcome scores, which were maintained throughout the study period and lasted more than 3 months. The BoNTA topical cream treatment also reduced the age of appearance for a majority of subjects. The placebo had no effect on any measure. No serious adverse events occurred during the entire study period. Topical treatment with the stabilized BoNTA cream (CosmeTox) to the entire upper facial lines resulted in significantly improved facial features and age appearance, as measured by the subjects and clinicians. The BoNTA cream (CosmeTox) resulted in a significantly younger, more satisfying, relaxed appearance.

  9. A comparison of two novel antipsychotics in first episode non-affective psychosis: one-year outcome on symptoms, motor side effects and cognition.

    PubMed

    Malla, Ashok; Norman, Ross; Scholten, Derek; Townsend, Laurel; Manchanda, Rahul; Takhar, Jatinder; Haricharan, Raj

    2004-12-15

    The main objective of this study was to compare 1-year outcome on symptoms, extrapyramidal side effects (EPS) , positive and negative symptoms, and domains of cognition in first episode psychosis (FEP) patients. Drug-naive FEP patients, who were similar on a number of characteristics likely to affect outcome, were treated with only one antipsychotic (risperidone or olanzapine) for at least 1 year and compared at baseline and after 1 year of treatment. Differences in outcome were assessed using an analysis of co-variance with change scores between initial assessment and after 1 year of treatment on levels of psychotic, disorganization and psychomotor poverty symptoms, EPS (parkinsonism, akathesia and dyskineisa) and domains of cognition as the dependent variable, respective baseline scores as covariates, and drug group as the independent variable. While patients in both groups showed substantial improvement, there were no significant differences in the magnitude of change in reality distortion, disorganization and psychomotor poverty symptoms. Trends in change in EPS favouring olanzapine and on some domains of cognition (processing speed and executive functions) favouring risperidone failed to reach statistical significance. The failure to confirm previous claims of greater improvement on either risperidone or olanzapine in patients with a first episode of psychosis may be the result of methodological bias introduced by unequal dosing between the two drugs or the use of chronically ill and treatment-refractory patients in previous studies.

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

    PubMed Central

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

    2016-01-01

    Background: Providing community-based mental health services is crucial and is an agreed plan between the Iranian Mental Health Office and the Regional Committee for the Eastern Mediterranean (affiliated with WHO). The aim of this study was to determine the effectiveness of home-visit clinical case-management services on the hospitalization rate and other clinical outcomes in patients with severe mental illness. Methods: A total of 182 patients were randomly allocated into three groups, namely, home-visit (n=60), telephone follow-up (n=61) and as-usual care (n=61) groups. Trained nurses as clinical case-managers provided home-visit services and the telephone follow-up tasks. Hospitalization rate as a measure of recurrence, as well as burden, knowledge, general health condition of caregivers with positive/negative symptoms, satisfaction, quality of life, and social skills of the consumers were assessed as the main and secondary outcomes, respectively. Results: Most clinical variables were improved in both intervention groups compared with the control group. During the one year follow-up, the rate of rehospitalization for the telephone follow-up and as-usual groups were respectively 1.5 and 2.5 times higher than the home-visit group. Conclusion: Trained clinical case-managers are capable of providing continuous care services to patients with severe mental illness. The telephone follow-up services could also have beneficiary outcome for the consumers, their caregivers, and the health system network. PMID:26722141

  11. Flavonoid-Rich Apple Improves Endothelial Function in Individuals at Risk for Cardiovascular Disease: A Randomized Controlled Clinical Trial.

    PubMed

    Bondonno, Nicola P; Bondonno, Catherine P; Blekkenhorst, Lauren C; Considine, Michael J; Maghzal, Ghassan; Stocker, Roland; Woodman, Richard J; Ward, Natalie C; Hodgson, Jonathan M; Croft, Kevin D

    2018-02-01

    The cardioprotective effects of apples are primarily attributed to flavonoids, found predominantly in the skin. This study aimed to determine if acute and/or chronic (4 weeks) ingestion of flavonoid-rich apples improves endothelial function, blood pressure (BP), and arterial stiffness in individuals at risk for cardiovascular diseases (CVD). In this randomized, controlled cross-over trial, acute and 4 week intake of apple with skin (high flavonoid apple, HFA) is compared to intake of apple flesh only (low flavonoid apple, LFA) in 30 participants. The primary outcome is endothelial function assessed using flow-mediated dilation (FMD) of the brachial artery, while main secondary outcomes are 24 h ambulatory BP and arterial stiffness. Other outcomes include fasting serum glucose and lipoprotein profile, plasma heme oxygenase-1 (Hmox-1), F 2 -isoprostanes, flavonoid metabolites, and plasma and salivary nitrate (NO 3 - ) and nitrite (NO 2 - ) concentrations. Compared to LFA control, the HFA results in a significant increase in FMD acutely (0.8%, p < 0.001) and after 4 weeks chronic intake (0.5%, p < 0.001), and in plasma flavonoid metabolites (p < 0.0001). Other outcomes are not altered significantly. A lower risk of CVD with higher apple consumption could be mediated by the beneficial effect of apple skin on endothelial function, both acutely and chronically. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  12. The impact of social deprivation on the response to a randomised controlled trial of a weight management intervention (BeWEL) for people at increased risk of colorectal cancer.

    PubMed

    Fisher, A; Craigie, A M; Macleod, M; Steele, R J C; Anderson, A S

    2018-06-01

    Although 45% of colorectal cancer (CRC) cases may be avoidable through appropriate lifestyle and weight management, health promotion interventions run the risk of widening health inequalities. The BeWEL randomised controlled trial assessed the impact of a diet and activity programme in overweight adults who were diagnosed with a colorectal adenoma, demonstrating a significantly greater weight loss at 12 months in intervention participants than in controls. The present study aimed to compare BeWEL intervention outcomes by participant deprivation status. The intervention group of the BeWEL trial (n = 163) was classified by the Scottish Index of Multiple Deprivation (SIMD) quintiles into 'more deprived' (SIMD 1-2, n = 58) and 'less deprived' (SIMD 3-5, n = 105). Socio-economic and lifestyle variables were compared at baseline to identify potential challenges to intervention adherence in the more deprived. Between group differences at 12 months in primary outcome (change in body weight) and secondary outcomes (cardiovascular risk factors, diet, physical activity, knowledge of CRC risk and psychosocial variables) were assessed by deprivation status. At baseline, education (P = 0.001), income (P < 0.001), spending on physical activity (P = 0.003) and success at previous weight loss attempts (P = 0.007) were significantly lower in the most deprived. At 12 months, no between group differences by deprivation status were detected for changes in primary and main secondary outcomes. Despite potential barriers faced by the more deprived participants, primary and most secondary outcomes were comparable between groups, indicating that this intervention is unlikely to worsen health inequalities and is equally effective across socio-economic groups. © 2017 The Authors. Journal of Human Nutrition and Dietetics published by John Wiley & Sons Ltd on behalf of British Dietetic Association.

  13. Model-based analysis of costs and outcomes of non-invasive prenatal testing for Down's syndrome using cell free fetal DNA in the UK National Health Service.

    PubMed

    Morris, Stephen; Karlsen, Saffron; Chung, Nancy; Hill, Melissa; Chitty, Lyn S

    2014-01-01

    Non-invasive prenatal testing (NIPT) for Down's syndrome (DS) using cell free fetal DNA in maternal blood has the potential to dramatically alter the way prenatal screening and diagnosis is delivered. Before NIPT can be implemented into routine practice, information is required on its costs and benefits. We investigated the costs and outcomes of NIPT for DS as contingent testing and as first-line testing compared with the current DS screening programme in the UK National Health Service. We used a pre-existing model to evaluate the costs and outcomes associated with NIPT compared with the current DS screening programme. The analysis was based on a hypothetical screening population of 10,000 pregnant women. Model inputs were taken from published sources. The main outcome measures were number of DS cases detected, number of procedure-related miscarriages and total cost. At a screening risk cut-off of 1∶150 NIPT as contingent testing detects slightly fewer DS cases, has fewer procedure-related miscarriages, and costs the same as current DS screening (around UK£280,000) at a cost of £500 per NIPT. As first-line testing NIPT detects more DS cases, has fewer procedure-related miscarriages, and is more expensive than current screening at a cost of £50 per NIPT. When NIPT uptake increases, NIPT detects more DS cases with a small increase in procedure-related miscarriages and costs. NIPT is currently available in the private sector in the UK at a price of £400-£900. If the NHS cost was at the lower end of this range then at a screening risk cut-off of 1∶150 NIPT as contingent testing would be cost neutral or cost saving compared with current DS screening. As first-line testing NIPT is likely to produce more favourable outcomes but at greater cost. Further research is needed to evaluate NIPT under real world conditions.

  14. Fracture risk by HIV infection status in perinatally HIV-exposed children.

    PubMed

    Siberry, George K; Li, Hong; Jacobson, Denise

    2012-03-01

    The objective of this study was to examine the incidence of fractures in HIV-infected children and comparable HIV-exposed, uninfected (HEU) children in a multicenter, prospective cohort study (PACTG 219/219C) in the United States. The main outcome was first fracture during the risk period. Nine fractures occurred in 7 of 1326 HIV-infected and 2 of 649 HEU children, corresponding to incidence rates of 1.2 per 1000 person-years and 1.1 per 1000 person-years, respectively. The incidence rate ratio was 1.1 (95% CI 0.2, 5.5). There was no evidence of a substantially increased risk of fracture in HIV-infected compared to HEU children.

  15. Has the difference in mortality between percutaneous coronary intervention and coronary artery bypass grafting in people with heart disease and diabetes changed over the years? A systematic review and meta-regression

    PubMed Central

    Herbison, Peter; Wong, Cheuk-Kit

    2015-01-01

    Objectives To examine the difference in outcome between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), to see if it has changed over the years in diabetics deemed eligible for both treatments; and to contrast the long-term mortality findings with those in non-diabetics. Design Meta-analyses using data from randomised controlled trials found by searches on MEDLINE, EMBASE and the Cochrane Controlled Trials Register, from their inception until March 2015. Setting Studies had to be randomised controlled trials comparing PCI with CABG. Participants Those taking part in the studies had to have multivessel cardiac or left main artery cardiac disease and be deemed eligible for both treatments. Interventions PCI or CABG. Primary and secondary outcomes The primary outcome was all cause mortality. Secondary outcomes were a composite of mortality, stroke and myocardial infarction; cardiovascular death; and MACCE (Major Adverse Cardiac or Cerebrovascular Event). The longest follow-up was used in the analysis. Results Among 14 studies (4868 diabetics) reported over three decades, meta-regression shows no relationship between the year of publication and the difference in long term all cause mortality between PCI and CABG. CABG has maintained an approximately 30% mortality advantage compared to PCI. The other outcomes used showed the same lack of change over the years. These findings held true among insulin-requiring and non-insulin-requiring diabetics. However, among non-diabetics included in the 14 studies, there was no difference in mortality outcome between PCI and CABG. Conclusions The difference in outcome between PCI and CABG in diabetics has not narrowed from the beginning—with balloon angioplasty to current PCI—with the second generation of drug eluting stents. In contrast to the non-diabetics, there is a persistent 30% benefit in all cause mortality favouring CABG in diabetics, and this should be a major factor in treatment recommendation. PMID:26719324

  16. REFOCUS Trial: protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams.

    PubMed

    Slade, Mike; Bird, Victoria; Le Boutillier, Clair; Williams, Julie; McCrone, Paul; Leamy, Mary

    2011-11-23

    There is a consensus about the importance of 'recovery' in mental health services, but the evidence base is limited. A two centre, cluster randomised controlled trial. Participants are community-based mental health teams, and service users aged 18-65 years with a primary clinical diagnosis of psychosis. In relation to the REFOCUS Manual researchintorecovery.com/refocus, which describes a 12-month, pro-recovery intervention based on the REFOCUS Model, the objectives are: (1) To establish the effectiveness of the intervention described in the REFOCUS Manual; (2) To validate the REFOCUS Model; (3) To establish and optimise trial parameters for the REFOCUS Manual; and (4) To understand the relationship between clinical outcomes and recovery outcomes. The hypothesis for the main study is that service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) compared to service users receiving care from control teams. The hypothesis for the secondary study is that black service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) and client satisfaction (as measured by the CSQ) compared to Black service users receiving care from control teams. The intervention comprises treatment as usual plus two components: recovery-promoting relationships and working practices. The control condition is treatment as usual. The primary outcme is the Process of Recovery Questionnaire (QPR). Secondary outcomes are satisfaction, Goal setting - Personal Primary Outcome, hope, well-being, empowerment, and quality of life. Primary outcomes for the secondary study will be QPR and satisfaction. Cost data will be estimated, and clinical outcomes will also be reported (symptomatology, need, social disability, functioning). 29 teams (15 intervention and 14 control) will be randomised. Within each team, 15 services users will be randomly chosen, giving a total sample of 435 service users (225 in intervention and 210 in control). Power for the main study: 336 service users will give power to detect a medium effect size of 0.4 (alpha 0.05, power = 0.8) on both QPR sub-scales. Power for the secondary study: 89 participants will give power to detect an effect size of 0.67 on both QPR sub-scales and on CSQ. A range of approaches are used to minimise bias, although service users and clinicians cannot be blinded. This cluster-RCT will evaluate a pro-recovery intervention in community mental health teams. ISRCTN: ISRCTN02507940.

  17. REFOCUS Trial: protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams

    PubMed Central

    2011-01-01

    Background There is a consensus about the importance of 'recovery' in mental health services, but the evidence base is limited. Methods/Design A two centre, cluster randomised controlled trial. Participants are community-based mental health teams, and service users aged 18-65 years with a primary clinical diagnosis of psychosis. In relation to the REFOCUS Manual researchintorecovery.com/refocus, which describes a 12-month, pro-recovery intervention based on the REFOCUS Model, the objectives are: (1) To establish the effectiveness of the intervention described in the REFOCUS Manual; (2) To validate the REFOCUS Model; (3) To establish and optimise trial parameters for the REFOCUS Manual; and (4) To understand the relationship between clinical outcomes and recovery outcomes. The hypothesis for the main study is that service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) compared to service users receiving care from control teams. The hypothesis for the secondary study is that black service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) and client satisfaction (as measured by the CSQ) compared to Black service users receiving care from control teams. The intervention comprises treatment as usual plus two components: recovery-promoting relationships and working practices. The control condition is treatment as usual. The primary outcme is the Process of Recovery Questionnaire (QPR). Secondary outcomes are satisfaction, Goal setting - Personal Primary Outcome, hope, well-being, empowerment, and quality of life. Primary outcomes for the secondary study will be QPR and satisfaction. Cost data will be estimated, and clinical outcomes will also be reported (symptomatology, need, social disability, functioning). 29 teams (15 intervention and 14 control) will be randomised. Within each team, 15 services users will be randomly chosen, giving a total sample of 435 service users (225 in intervention and 210 in control). Power for the main study: 336 service users will give power to detect a medium effect size of 0.4 (alpha 0.05, power = 0.8) on both QPR sub-scales. Power for the secondary study: 89 participants will give power to detect an effect size of 0.67 on both QPR sub-scales and on CSQ. A range of approaches are used to minimise bias, although service users and clinicians cannot be blinded. Discussion This cluster-RCT will evaluate a pro-recovery intervention in community mental health teams. Trial registration ISRCTN: ISRCTN02507940 PMID:22112008

  18. [Health measurement instruments in patients with vertigo].

    PubMed

    Pérez, N; Garmendia, I; Martín, E; Boleas, M S; García-Tapia, R

    2000-01-01

    Compare disability and handicap in patients with dizziness by means of two questionnaires. Prospective study. 337 patients seen for non-acute dizziness from peripheral or central origin in a tertiary referral setting. Spanish version of the Dizziness Handicap Inventory test and UCLA-Dizziness Questionnaire after transcultural adaptation following the method of translation-back-translation. We obtained a good correlation between the frequency of dizzy spells and quality of health as perceived by the patient; also there was good correlation between the intensity of each spell and limitation for performance of daily activities. Quality of life is mainly related to handicap in these patients. Vertigo, as a non-fatal health outcome, can be studied following the two main conceptual frameworks of Impairment, Disabilities and Handicap and Health-Related Quality of Life.

  19. International variation in the definition of 'main condition' in ICD-coded health data.

    PubMed

    Quan, H; Moskal, L; Forster, A J; Brien, S; Walker, R; Romano, P S; Sundararajan, V; Burnand, B; Henriksson, G; Steinum, O; Droesler, S; Pincus, H A; Ghali, W A

    2014-10-01

    Hospital-based medical records are abstracted to create International Classification of Disease (ICD) coded discharge health data in many countries. The 'main condition' is not defined in a consistent manner internationally. Some countries employ a 'reason for admission' rule as the basis for the main condition, while other countries employ a 'resource use' rule. A few countries have recently transitioned from one of these approaches to the other. The definition of 'main condition' in such ICD data matters when it is used to define a disease cohort to assign diagnosis-related groups and to perform risk adjustment. We propose a method of harmonizing the international definition to enable researchers and international organizations using ICD-coded health data to aggregate or compare hospital care and outcomes across countries in a consistent manner. Inter-observer reliability of alternative harmonization approaches should be evaluated before finalizing the definition and adopting it worldwide. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  20. Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154

    PubMed Central

    Peul, Wilco C; van Houwelingen, Hans C; van der Hout, Wilbert B; Brand, Ronald; Eekhof, Just AH; Tans, Joseph ThJ; Thomeer, Ralph TWM; Koes, Bart W

    2005-01-01

    Background The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). Methods/design Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years. Discussion Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery. PMID:15707491

  1. Induction of labour for improving birth outcomes for women at or beyond term

    PubMed Central

    Gülmezoglu, A Metin; Crowther, Caroline A; Middleton, Philippa; Heatley, Emer

    2014-01-01

    Background As a pregnancy continues beyond term the risks of babies dying inside the womb or in the immediate newborn period increase. Whether a policy of labour induction at a predetermined gestational age can reduce this increased risk is the subject of this review. Objectives To evaluate the benefits and harms of a policy of labour induction at term or post-term compared with awaiting spontaneous labour or later induction of labour. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (31 March 2012). Selection criteria Randomised controlled trials conducted in women at or beyond term. The eligible trials were those comparing a policy of labour induction with a policy of awaiting spontaneous onset of labour. Cluster-randomised trials and cross-over trials are not included. Quasi-random allocation schemes such as alternation, case record numbers or open random-number lists were not eligible. Data collection and analysis Two review authors independently assessed trials for inclusion. Two review authors independently assessed trial quality and extracted data. Data were checked for accuracy. Outcomes are analysed in two main categories: gestational age and cervix status. Main results We included 22 trials reporting on 9383 women. The trials were generally at moderate risk of bias. Compared with a policy of expectant management, a policy of labour induction was associated with fewer (all-cause) perinatal deaths: risk ratio (RR) 0.31, 95% confidence interval (CI) 0.12 to 0.88; 17 trials, 7407 women. There was one perinatal death in the labour induction policy group compared with 13 perinatal deaths in the expectant management group. The number needed to treat to benefit (NNTB) with induction of labour in order to prevent one perinatal death was 410 (95% CI 322 to 1492). For the primary outcome of perinatal death and most other outcomes, no differences between timing of induction subgroups were seen; the majority of trials adopted a policy of induction at 41 completed weeks (287 days) or more. Fewer babies in the labour induction group had meconium aspiration syndrome (RR 0.50, 95% CI 0.34 to 0.73; eight trials, 2371 infants) compared with a policy of expectant management. There was no statistically significant difference between the rates of neonatal intensive care unit (NICU) admission for induction compared with expectant management (RR 0.90, 95% CI 0.78 to 1.04; 10 trials, 6161 infants). For women in the policy of induction arms of trials, there were significantly fewer caesarean sections compared with expectant management in 21 trials of 8749 women (RR 0.89, 95% CI 0.81 to 0.97). Authors’ conclusions A policy of labour induction compared with expectant management is associated with fewer perinatal deaths and fewer caesarean sections. Some infant morbidities such as meconium aspiration syndrome were also reduced with a policy of post-term labour induction although no significant differences in the rate of NICU admission were seen. However, the absolute risk of perinatal death is small. Women should be appropriately counselled in order to make an informed choice between scheduled induction for a post-term pregnancy or monitoring without induction (or delayed induction). PMID:22696345

  2. Pregnancy outcome after induction of labor in women with previous cesarean section.

    PubMed

    Ashwal, Eran; Hiersch, Liran; Melamed, Nir; Ben-Zion, Maya; Brezovsky, Alex; Wiznitzer, Arnon; Yogev, Yariv

    2015-03-01

    As conflicting data exist concerning the safety of induction of labor (IoL) in women with previous single lower segment cesarean section (CS), we aimed to assess pregnancy outcome following IoL in such patient population. All singleton pregnancies with previous single CS which underwent IoL during 2008-2012 were included (study group). Their pregnancy outcome was compared to those pregnancies with previous single CS that admitted with spontaneous onset of labor (control group). Overall, 1898 pregnancies were eligible, of them, 259 underwent IoL, and 1639 were admitted with spontaneous onset of labor. Parity, gestational age at delivery and birthweight were similar. Women in the study group were more likely to undergo CS mainly due to labor dystocia (8.1 versus 3.7%, p < 0.01). The rate of CS due to non-reassuring fetal heart rate was similar. No difference was found in the rate of uterine rupture/dehiscence. Short-term neonatal outcome was similar between the groups. On multivariable logistic regression analysis, IoL was not independently associated with uterine rupture (OR 1.33, 95% C.I 0.46-3.84, p = 0.59). Our data suggest that IoL in women with one previous low segment CS neither increases the risk of uterine rupture nor adversely affects immediate neonatal outcome.

  3. The effect of increasing the supply of skilled health providers on pregnancy and birth outcomes: evidence from the midwives service scheme in Nigeria.

    PubMed

    Okeke, Edward; Glick, Peter; Chari, Amalavoyal; Abubakar, Isa Sadeeq; Pitchforth, Emma; Exley, Josephine; Bashir, Usman; Gu, Kun; Onwujekwe, Obinna

    2016-08-23

    Limited availability of skilled health providers in developing countries is thought to be an important barrier to achieving maternal and child health-related MDG goals. Little is known, however, about the extent to which scaling-up supply of health providers will lead to improved pregnancy and birth outcomes. We study the effects of the Midwives Service Scheme (MSS), a public sector program in Nigeria that increased the supply of skilled midwives in rural communities on pregnancy and birth outcomes. We surveyed 7,104 women with a birth within the preceding five years across 12 states in Nigeria and compared changes in birth outcomes in MSS communities to changes in non-MSS communities over the same period. The main measured effect of the scheme was a 7.3-percentage point increase in antenatal care use in program clinics and a 5-percentage point increase in overall use of antenatal care, both within the first year of the program. We found no statistically significant effect of the scheme on skilled birth attendance or on maternal delivery complications. This study highlights the complexity of improving maternal and child health outcomes in developing countries, and shows that scaling up supply of midwives may not be sufficient on its own.

  4. Concurrent bariatric operations and association with perioperative outcomes: registry based cohort study.

    PubMed

    Liu, Jason B; Ban, Kristen A; Berian, Julia R; Hutter, Matthew M; Huffman, Kristopher M; Liu, Yaoming; Hoyt, David B; Hall, Bruce L; Ko, Clifford Y

    2017-09-26

    Objective  To determine whether perioperative outcomes differ between patients undergoing concurrent compared with non-concurrent bariatric operations in the USA. Design  Retrospective, propensity score matched cohort study. Setting  Hospitals in the US accredited by the American College of Surgeons' metabolic and bariatric surgery accreditation and quality improvement program. Participants  513 167 patients undergoing bariatric operations between 1 January 2014 and 31 December 2016. Main outcome measures  The primary outcome measure was a composite of 30 day death, morbidity, readmission, reoperation, anastomotic or staple line leak, and bleeding events. Operative duration and lengths of stay were also assessed. Operations were defined as concurrent if they overlapped by 60 or more minutes or in their entirety. Results  In this study of 513 167 operations, 739 (29.5%) surgeons at 483 (57.8%) hospitals performed 6087 (1.2%) concurrent operations. The most frequently performed concurrent bariatric operations were sleeve gastrectomy (n=3250, 53.4%) and Roux-en-Y gastric bypass (n=1601, 26.3%). Concurrent operations were more often performed at large academic medical centers with higher operative volumes and numbers of trainees and by higher volume surgeons. Compared with non-concurrent operations, concurrent operations lasted a median of 34 minutes longer (P<0.001) and resulted in 0.3 days longer average length of stay (P<0.001). Perioperative adverse events were not observed to more likely occur in concurrent compared with non-concurrent operations (7.5% v 7.4%; relative risk 1.02, 95% confidence interval 0.90 to 1.15; P=0.84). Conclusions  Concurrent bariatric operations occurred infrequently, but when they did, there was no observable increased risk for adverse perioperative outcomes compared with non-concurrent operations. These results, however, do not argue against improved and more meaningful disclosure of concurrent surgery practices. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  5. Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies.

    PubMed

    Evoniuk, Gary; Mansi, Bernadette; DeCastro, Barbara; Sykes, Jennie

    2017-04-21

    Objectives  To determine whether the outcome of drug studies influenced submission and/or acceptance rates for publication in peer reviewed medical journals. Design  A six year retrospective review of publication status by study outcome for all human drug research studies conducted by a single industry sponsor (GlaxoSmithKline) that completed from 1 January 2009 to 30 June 2014 and were therefore due for manuscript submission (per the sponsor's policy) to peer reviewed journals within 18 months of study completion-that is, 31 December 2015. In addition, manuscripts from studies completing after 30 June 2014 were included irrespective of outcome if they were submitted before 31 December 2015. Setting  Studies conducted by a single industry sponsor (GlaxoSmithKline) Studies reviewed  1064 human drug research studies. Main outcome measures  All studies were assigned a publication status at 26 February 2016 including (as applicable): study completion date, date of first primary manuscript submission, number of submissions, journal decision(s), and publication date. All studies were also classified with assessors blinded to publication status as "positive" (perceived favorable outcome for the drug under study), "negative" (perceived unfavorable outcome for the drug under study), mixed, or non-comparative based on the presence and outcome of the primary outcome measure(s) for each study. "Negative" studies included safety studies in which the primary outcome was achieved but was adverse for the drug under study. For the total cohort and each of the four study outcomes, measures included descriptive statistics for study phase, time from study completion to submission and publication, and number and outcome (accepted/rejected) of publication submissions. Results  Of the 1064 studies (phase I-IV, interventional and non-interventional) included, 321 had study outcomes classified as positive, 155 as negative, 52 as mixed, and 536 as non-comparative. At the time of publication cut-off date (26 February 2016), 904 (85%) studies had been submitted for publication as full manuscripts and 751 (71%) had been successfully published or accepted, with 100 (9%) still under journal review. An additional 77 (7%) studies were conference abstracts and were not included in submission or publication rates. Submission rates by study outcome were 79% for the 321 studies with positive outcomes, 92% for the 155 with negative outcomes, 94% for the 52 with mixed outcomes, and 85% for the 536 non-comparative studies; while rates of publication at the cut-off date were 66%, 77%, 77%, and 71%, respectively. Median time from study completion to submission was 537 days (interquartile range 396-638 days) and 823 days (650-1063 days) from completion to publication, with similar times observed across study outcomes. First time acceptance rates were 56% for studies with positive outcomes and 48% for studies with negative outcomes. Over 10% of studies across all categories required three or more submissions to achieve successful publication. At the time of analysis, 83 studies had not been submitted for publication, including 49 bioequivalence studies with positive outcomes and 33 non-comparative studies. Most studies (98%, 1041/1064) had results posted to one or more public registers, including all studies subject to FDAAA (Food and Drug Administration Amendments Act) requirements for posting to www.clinicaltrials.gov Conclusions  Over the period studied, there was no evidence of submission or publication bias: 92% of studies with negative outcomes were submitted for publication by the cut-off date versus 79% of those with positive outcomes. Publication rates were slightly higher for studies with a negative (that is, unfavorable) outcome compared with a positive outcome, despite a slightly lower rate of acceptance at first submission. Many studies required multiple submission attempts before they were accepted for publication. Analyses focusing solely on publication rates do not take into account unsuccessful efforts to publish. Sponsors and journal editors should share similar information to contribute to better understanding of issues and barriers to full transparency. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  6. Comparison of zero-profile anchored spacer versus plate-cage construct in treatment of cervical spondylosis with regard to clinical outcomes and incidence of major complications: a meta-analysis

    PubMed Central

    Liu, Weijun; Hu, Ling; Wang, Junwen; Liu, Ming; Wang, Xiaomei

    2015-01-01

    Purpose Meta-analysis was conducted to evaluate whether zero-profile anchored spacer (Zero-P) could reduce complication rates, while maintaining similar clinical outcomes compared to plate-cage construct (PCC) in the treatment of cervical spondylosis. Methods All prospective and retrospective comparative studies published up to May 2015 that compared the clinical outcomes of Zero-P versus PCC in the treatment of cervical spondylosis were acquired by a comprehensive search in PubMed and EMBASE. Exclusion criteria were non-English studies, noncomparative studies, hybrid surgeries, revision surgeries, and surgeries with less than a 12-month follow-up period. The main end points including Japanese Orthopedic Association (JOA) and Neck Disability Index (NDI) scores, cervical lordosis, fusion rate, subsidence, and dysphagia were analyzed. All studies were analyzed with the RevMan 5.2.0 software. Publication biases of main results were examined using Stata 12.0. Results A total of 12 studies were included in the meta-analysis. No statistical difference was observed with regard to preoperative or postoperative JOA and NDI scores, cervical lordosis, and fusion rate. The Zero-P group had a higher subsidence rate than the PCC group (P<0.05, risk difference =0.13, 95% confidence interval [CI] 0.00–0.26). However, the Zero-P group had a significantly lower postoperative dysphagia rate than the PCC group within the first 2 weeks (P<0.05, odds ratio [OR] =0.64, 95% CI 0.45–0.91), at the 6th month [P<0.05, OR =0.20, 95% CI 0.04–0.90], and at the final follow-up time [P<0.05, OR =0.13, 95% CI 0.04–0.45]. Conclusion Our meta-analysis suggested that surgical treatments of single or multiple levels of cervical spondylosis using Zero-P and PCC were similar in terms of JOA score, NDI score, cervical lordosis, and fusion rate. Although the Zero-P group had a higher subsidence rate than the PCC group, Zero-P had a lower postoperative dysphagia rate and might have a lower adjacent-level ossification rate. PMID:26445543

  7. Comparison of zero-profile anchored spacer versus plate-cage construct in treatment of cervical spondylosis with regard to clinical outcomes and incidence of major complications: a meta-analysis.

    PubMed

    Liu, Weijun; Hu, Ling; Wang, Junwen; Liu, Ming; Wang, Xiaomei

    2015-01-01

    Meta-analysis was conducted to evaluate whether zero-profile anchored spacer (Zero-P) could reduce complication rates, while maintaining similar clinical outcomes compared to plate-cage construct (PCC) in the treatment of cervical spondylosis. All prospective and retrospective comparative studies published up to May 2015 that compared the clinical outcomes of Zero-P versus PCC in the treatment of cervical spondylosis were acquired by a comprehensive search in PubMed and EMBASE. Exclusion criteria were non-English studies, noncomparative studies, hybrid surgeries, revision surgeries, and surgeries with less than a 12-month follow-up period. The main end points including Japanese Orthopedic Association (JOA) and Neck Disability Index (NDI) scores, cervical lordosis, fusion rate, subsidence, and dysphagia were analyzed. All studies were analyzed with the RevMan 5.2.0 software. Publication biases of main results were examined using Stata 12.0. A total of 12 studies were included in the meta-analysis. No statistical difference was observed with regard to preoperative or postoperative JOA and NDI scores, cervical lordosis, and fusion rate. The Zero-P group had a higher subsidence rate than the PCC group (P<0.05, risk difference =0.13, 95% confidence interval [CI] 0.00-0.26). However, the Zero-P group had a significantly lower postoperative dysphagia rate than the PCC group within the first 2 weeks (P<0.05, odds ratio [OR] =0.64, 95% CI 0.45-0.91), at the 6th month [P<0.05, OR =0.20, 95% CI 0.04-0.90], and at the final follow-up time [P<0.05, OR =0.13, 95% CI 0.04-0.45]. Our meta-analysis suggested that surgical treatments of single or multiple levels of cervical spondylosis using Zero-P and PCC were similar in terms of JOA score, NDI score, cervical lordosis, and fusion rate. Although the Zero-P group had a higher subsidence rate than the PCC group, Zero-P had a lower postoperative dysphagia rate and might have a lower adjacent-level ossification rate.

  8. Achievement for All: improving psychosocial outcomes for students with special educational needs and disabilities.

    PubMed

    Humphrey, Neil; Lendrum, Ann; Barlow, Alexandra; Wigelsworth, Michael; Squires, Garry

    2013-04-01

    Students with special educational needs and disabilities (SEND) are at a greatly increased risk of experiencing poor psychosocial outcomes. Developing effective interventions that address the cause of these outcomes has therefore become a major policy priority in recent years. We report on a national evaluation of the Achievement for All (AfA) programme that was designed to improve outcomes for students with SEND through: (1) academic assessment, tracking and intervention, (2) structured conversations with parents, and (3) developing provision to improve wider outcomes (e.g. positive relationships). Using a quasi-experimental, pre-test-post-test control group design, we assessed the impact of AfA on teacher ratings of the behaviour problems, positive relationships and bullying of students with SEND over an 18-month period. Participants were 4758 students with SEND drawn from 323 schools across England. Our main impact analysis demonstrated that AfA had a significant impact on all three response variables when compared to usual practice. Hierarchical linear modelling of data from the intervention group highlighted a range of school-level contextual factors and implementation activities and student-level individual differences that moderated the impact of AfA on our study outcomes. The implications of our findings are discussed, and study strengths and limitations are noted. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

  9. Sensory Recovery Outcome after Digital Nerve Repair in Relation to Different Reconstructive Techniques: Meta-Analysis and Systematic Review

    PubMed Central

    Wolf, Petra; Harder, Yves; Kern, Yasmin; Paprottka, Philipp M.; Machens, Hans-Günther; Lohmeyer, Jörn A.

    2013-01-01

    Good clinical outcome after digital nerve repair is highly relevant for proper hand function and has a significant socioeconomic impact. However, level of evidence for competing surgical techniques is low. The aim is to summarize and compare the outcomes of digital nerve repair with different methods (end-to-end and end-to-side coaptations, nerve grafts, artificial conduit-, vein-, muscle, and muscle-in-vein reconstructions, and replantations) to provide an aid for choosing an individual technique of nerve reconstruction and to create reference values of standard repair for nonrandomized clinical studies. 87 publications including 2,997 nerve repairs were suitable for a precise evaluation. For digital nerve repairs there was practically no particular technique superior to another. Only end-to-side coaptation had an inferior two-point discrimination in comparison to end-to-end coaptation or nerve grafting. Furthermore, this meta-analysis showed that youth was associated with an improved sensory recovery outcome in patients who underwent digital replantation. For end-to-end coaptations, recent publications had significantly better sensory recovery outcomes than older ones. Given minor differences in outcome, the main criteria in choosing an adequate surgical technique should be gap length and donor site morbidity caused by graft material harvesting. Our clinical experience was used to provide a decision tree for digital nerve repair. PMID:23984064

  10. Substance use outcomes 5½ years past baseline for partnership-based, family-school preventive interventions

    PubMed Central

    Spoth, Richard L.; Randall, G. Kevin; Trudeau, Linda; Shin, Chungyeol; Redmond, Cleve

    2008-01-01

    This article reports adolescent substance use outcomes of universal family and school preventive interventions 5½ years past baseline. Participants were 1677 7th grade students from schools (N = 36) randomly assigned to the school-based Life Skills Training plus the Strengthening Families Program: For Parents and Youth 10–14 (LST + SFP 10–14), LST-alone, or a control condition. Self-reports were collected at baseline, 6 months later following the interventions, then yearly through the 12th grade. Measures included initiation—alcohol, cigarette, marijuana, and drunkenness, along with a Substance Initiation Index (SII)—and measures of more serious use—frequency of alcohol, cigarette, and marijuana use, drunkenness frequency, monthly poly-substance use, and advanced poly-substance use. Analyses ruled out differential attrition. For all substance initiation outcomes, one or both intervention groups showed significant, positive point-in-time differences at 12th grade and/or significant growth trajectory outcomes when compared with the control group. Although no main effects for the more serious substance use outcomes were observed, a higher-risk subsample demonstrated significant, positive 12th grade point-in-time and/or growth trajectory outcomes for one or both intervention groups on all measures. The observed pattern of results likely reflects a combination of predispositions of the higher-risk subsample, the timing of the interventions, and baseline differences between experimental conditions favoring the control group. PMID:18434045

  11. Blastocyst development rate impacts outcome in cryopreserved blastocyst transfer cycles

    PubMed Central

    Levens, Eric D.; Whitcomb, Brian W.; Hennessy, Sasha; James, Aidita N.; Yauger, Belinda J.; Larsen, Frederick W.

    2008-01-01

    Structured Abstract Objective To assess cycle outcome among day 5 and day 6 cryopreserved frozen-thawed blastocyst embryo transfers (FBET). Design Retrospective cohort study. Setting Military-based ART center. Patients One hundred seventy-two non-donor, programmed cryopreserved embryo cycles. Interventions Fully expanded blastocysts on day 5 were cryopreserved on day 5 and those achieving this state on day 6 were cryopreserved on day 6. Leuprolide acetate was given for ovulation inhibition and endometrial supplementation was by oral and vaginal estradiol. Progesterone in oil was administered and blastocyst transfer occurred in the morning of the 6th day of progesterone. Main Outcome Measures Implantation, pregnancy and live birth rates. Results Fresh and frozen cycle characteristics were similar between groups. Day 5 FBET had significantly higher implantation rates (32.2% vs. 19.2%; p=0.01) which remained significant even when adjusting for co-variates (OR: 1.91; 95%CI: 1.00, 3.67). Live birth rates trended towards improvement after adjusting for co-variates (OR: 1.18; 95%CI: 0.61, 2.30). Conclusions Cryopreserved day 5 blastocysts have higher implantation rates and trend toward improved pregnancy outcomes compared to cryopreserved day 6 blastocysts. This suggests that embryo development rate may, in part, predict implantation and subsequent FBET outcomes although embryos not achieving the blastocyst stage until day 6 still demonstrate acceptable outcomes. PMID:18178191

  12. Cost-effectiveness of therapist-guided internet-delivered cognitive behaviour therapy for paediatric obsessive–compulsive disorder: results from a randomised controlled trial

    PubMed Central

    Lenhard, Fabian; Ssegonja, Richard; Andersson, Erik; Feldman, Inna; Mataix-Cols, David; Serlachius, Eva

    2017-01-01

    Objectives To evaluate the cost-effectiveness of a therapist-guided internet-delivered cognitive behaviour therapy (ICBT) intervention for adolescents with obsessive–compulsive disorder (OCD) compared with untreated patients on a waitlist. Design Single-blinded randomised controlled trial. Setting A research clinic within the regular child and adolescent mental health service in Stockholm, Sweden. Participants Sixty-seven adolescents (12–17 years) with a Diagnostic and Statistical Manual of Mental Disorders Fifth Edition diagnosis of OCD. Interventions Either a 12-week, therapist-guided ICBT intervention or a wait list condition of equal duration. Primary outcome measures Cost data were collected at baseline and after treatment, including healthcare use, supportive resources, prescription drugs, prescription-free drugs, school absence and productivity loss, as well as the cost of ICBT. Health outcomes were defined as treatment responder rate and quality-adjusted life years gain. Bootstrapped mixed model analyses were conducted comparing incremental costs and health outcomes between the groups from the societal and healthcare perspectives. Results Compared with waitlist control, ICBT generated substantial societal cost savings averaging US$−144.98 (95% CI −159.79 to –130.16) per patient. The cost reductions were mainly driven by reduced healthcare use in the ICBT group. From the societal perspective, the probability of ICBT being cost saving compared with waitlist control was approximately 60%. From the healthcare perspective, the cost per additional responder to ICBT compared with waitlist control was approximately US$78. Conclusions The results suggest that therapist-guided ICBT is a cost-effective treatment and results in societal cost savings, compared with patients who do not receive evidence-based treatment. Since, at present, most patients with OCD do not have access to evidence-based treatments, the results have important implications for the increasingly strained national and healthcare budgets. Future studies should compare the cost-effectiveness of ICBT with regular face-to-face CBT. Trial registration number NCT02191631. PMID:28515196

  13. Satisfaction of healthy pregnant women receiving short message service via mobile phone for prenatal support: A randomized controlled trial.

    PubMed

    Jareethum, Rossathum; Titapant, Vitaya; Chantra, Tienthai; Sommai, Viboonchart; Chuenwattana, Prakong; Jirawan, Chatchainoppakhun

    2008-04-01

    The main objective was to compare the satisfaction levels of antenatal care between healthy pregnant women who received short message service (SMS) via mobile phone for prenatal support, and those who did not. The second objective was to compare the confidence, anxiety levels and also pregnancy outcomes. A randomized controlled trial. 68 healthy pregnant women who attended the antenatal clinic and delivered at Siriraj Hospital, who met the inclusion criterias between May 2007 and October 2007, were enrolled and randomly allocated into two random groups. The study group received two SMS messages per week from 28 weeks of gestation until giving birth. The other group was pregnant women who did not receive SMS. Both groups had the same antenatal and perinatal care. The satisfaction, confidence and anxiety scores were evaluated using a questionnaire at the postpartum ward. The pregnancy outcomes were also compared in these two groups. The satisfaction levels of the women who received prenatal support in SMS messages, were significantly higher than those of who did not receive the messages both in the antenatal period (9.25 vs. 8.00, p < 0.001) and during labor (9.09 vs. 7.90, p = 0.007). In the SMS using group, the confidence level was'higher (8.91 vs. 7.79, p = 0.001) and the anxiety level was lower (2.78 vs. 4.93, p = 0.002) than the control group n the antenatal period, however no diference in pregnancy outcomes were found. The present study shows the higher satisfaction level of pregnant women who received SMS via mobile phone during their antenatal service when compared with the general antenatal care group. The study also show the higher confidence level and lower anxiety level in the antenatal period but no difference in pregnancy outcomes.

  14. Dehydration and Performance on Clinical Concussion Measures in Collegiate Wrestlers

    PubMed Central

    Weber, Amanda Friedline; Mihalik, Jason P.; Register-Mihalik, Johna K.; Mays, Sally; Prentice, William E.; Guskiewicz, Kevin M.

    2013-01-01

    Context: The effects of dehydration induced by wrestling-related weight-cutting tactics on clinical concussion outcomes, such as neurocognitive function, balance performance, and symptoms, have not been adequately studied. Objective: To evaluate the effects of dehydration on the outcome of clinical concussion measures in National Collegiate Athletic Association Division I collegiate wrestlers. Design: Repeated-measures design. Setting: Clinical research laboratory. Patients or Other Participants: Thirty-two Division I healthy collegiate male wrestlers (age = 20.0 ± 1.4 years; height = 175.0 ± 7.5 cm; baseline mass = 79.2 ± 12.6 kg). Intervention(s): Participants completed preseason concussion baseline testing in early September. Weight and urine samples were also collected at this time. All participants reported to prewrestling practice and postwrestling practice for the same test battery and protocol in mid-October. They had begun practicing weight-cutting tactics a day before prepractice and postpractice testing. Differences between these measures permitted us to evaluate how dehydration and weight-cutting tactics affected concussion measures. Main Outcome Measures: Sport Concussion Assessment Tool 2 (SCAT2), Balance Error Scoring System, Graded Symptom Checklist, and Simple Reaction Time scores. The Simple Reaction Time was measured using the Automated Neuropsychological Assessment Metrics. Results: The SCAT2 measurements were lower at prepractice (P = .002) and postpractice (P < .001) when compared with baseline. The BESS error scores were higher at postpractice when compared with baseline (P = .015). The GSC severity scores were higher at prepractice (P = .011) and postpractice (P < .001) than at baseline and at postpractice when than at prepractice (P = .003). The number of Graded Symptom Checklist symptoms reported was also higher at prepractice (P = .036) and postpractice (P < .001) when compared with baseline, and at postpractice when compared with prepractice (P = .003). Conclusions: Our results suggest that it is important for wrestlers to be evaluated in a euhydrated state to ensure that dehydration is not influencing the outcome of the clinical measures. PMID:23672379

  15. Comparing the effectiveness of using generic and specific search terms in electronic databases to identify health outcomes for a systematic review: a prospective comparative study of literature search methods

    PubMed Central

    MacLean, Alice; Sweeting, Helen; Hunt, Kate

    2012-01-01

    Objective To compare the effectiveness of systematic review literature searches that use either generic or specific terms for health outcomes. Design Prospective comparative study of two electronic literature search strategies. The ‘generic’ search included general terms for health such as ‘adolescent health’, ‘health status’, ‘morbidity’, etc. The ‘specific’ search focused on terms for a range of specific illnesses, such as ‘headache’, ‘epilepsy’, ‘diabetes mellitus’, etc. Data sources The authors searched Medline, Embase, the Cumulative Index to Nursing and Allied Health Literature, PsycINFO and the Education Resources Information Center for studies published in English between 1992 and April 2010. Main outcome measures Number and proportion of studies included in the systematic review that were identified from each search. Results The two searches tended to identify different studies. Of 41 studies included in the final review, only three (7%) were identified by both search strategies, 21 (51%) were identified by the generic search only and 17 (41%) were identified by the specific search only. 5 of the 41 studies were also identified through manual searching methods. Studies identified by the two ELS differed in terms of reported health outcomes, while each ELS uniquely identified some of the review's higher quality studies. Conclusions Electronic literature searches (ELS) are a vital stage in conducting systematic reviews and therefore have an important role in attempts to inform and improve policy and practice with the best available evidence. While the use of both generic and specific health terms is conventional for many reviewers and information scientists, there are also reviews that rely solely on either generic or specific terms. Based on the findings, reliance on only the generic or specific approach could increase the risk of systematic reviews missing important evidence and, consequently, misinforming decision makers. However, future research should test the generalisability of these findings. PMID:22734117

  16. Ultrastructural analysis of different-made staplers' staples.

    PubMed

    Gentilli, S; Portigliotti, L; Aronici, M; Ferrante, D; Surico, D; Milanesio, M; Gianotti, V; Gatti, G; Addante, A; Garavoglia, M

    2012-10-01

    Recently, Chinese-made mechanical staplers with lower price respect to American-made ones have been introduced in clinical practice. In literature, small case series compare the clinical outcomes of different staplers concluding that the new stapler devices perform as well as the American ones. The aim of this study is to compare with an ultrastructural analysis the staples of different staplers in order to verify the existence of differences that might explain significant price disparity and condition clinical outcomes. Each stapler was subjected to morphological analysis, energy dispersive X-Ray spectroscopy, metal release assessment followed by inductively coupled plasma mass spectroscopy. P-values were considered statistically significant when <0.05. Autosuture staples have square section whereas the other American one and Chinese made staples have round sections. Roughness index and chips presence before and after ageing tests were comparable for all samples except for Ethicon Endo-Surgery stapler. Energy dispersive X-Ray spectroscopy showed that all staplers are made of pure Titanium but Ethicon Endo-Surgery staples are made with an alloy. Metal release analysis release statistically significant differences between samples in simulated body fluid 20 days solution (P=0.002) and in Aquaregia at 14 days solution. Discussion. Stapling devices have became routinely used in gastrointestinal surgery mainly because of operative time reduction. Recently, new Chinese-made mechanical staplers, with significantly lower prices, have been introduced in clinical practice. In literature, there are some studies that compare clinical outcomes of American-made and Chinese-made staplers on small groups of patients but doesn't exist any work which consider structural differences between traditional and new devices. In our study, for the first time, we propose a comparison between two American-made staplers and three Chinese-made staplers which evaluate morphology, metal composition and chemical staples release. Our study suggest that there are some ultrastructural differences between commercially available staplers with no correlation to price disparity. More studies are needed to confirm our results and to verify if our findings could condition clinical outcomes.

  17. The Relationship between Parent Expectations and Postschool Outcomes of Adolescents with Disabilities

    ERIC Educational Resources Information Center

    Doren, Bonnie; Gau, Jeff M.; Lindstrom, Lauren E.

    2012-01-01

    A secondary analysis was conducted of the National Longitudinal Transition Study-2 to examine (a) main effects of parents' school and postschool outcome expectations on the actual outcomes achieved, (b) demographic moderators, and (c) adolescent autonomy as a mediator of parent expectations and outcomes. Parent expectations were found to…

  18. Using Propensity Score Methods to Approximate Factorial Experimental Designs to Analyze the Relationship between Two Variables and an Outcome

    ERIC Educational Resources Information Center

    Dong, Nianbo

    2015-01-01

    Researchers have become increasingly interested in programs' main and interaction effects of two variables (A and B, e.g., two treatment variables or one treatment variable and one moderator) on outcomes. A challenge for estimating main and interaction effects is to eliminate selection bias across A-by-B groups. I introduce Rubin's causal model to…

  19. Excluded from social security: rejections of disability pension applications in Norway 1998-2004.

    PubMed

    Galaasen, Anders Mølster; Bruusgaard, Dag; Claussen, Bjørgulf

    2012-03-01

    Admission to disability pension (DP) in Norway, like most other countries, requires a medical condition as the main cause of income reduction. Still, a widespread assumption is that much of the recruitment to the programme is rather due to non-medical, mainly labour market factors. In this article, we study the grey zones between acceptance and rejection of DP applications, in light of the concept of marginalisation. From the total Norwegian population, aged 18-66 in 1998, we included all first-time applications for DP between 1998 and 2004. Logistic regressions of both application and application outcome were then performed, controlling for a range of socioeconomic variables and medical diagnosis. Medical diagnosis had the strongest impact on application outcome, together with the applicant's age. High rejection risk was found among applicants with complex musculoskeletal diagnoses, and also for complex psychiatric diagnoses as compared to well-defined ones. Persons having previously received social assistance more often applied for a DP and more often were rejected. The same is true, though on a lesser scale, for people with a weak affiliation to the labour market. The DP programme in Norway is to a large degree medically oriented, not only judicially but also in practice. Nevertheless, non-medical factors have a bearing on both application rates and application outcome. The control system seems to work in a way that excludes the most marginalised applicants, thus possibly contributing to further marginalisation of already disadvantaged groups.

  20. An orthogeriatric collaborative intervention program for fragility fractures: a retrospective cohort study.

    PubMed

    Leung, Andraay Hon-Chi; Lam, Tsz-Ping; Cheung, Wing-Hoi; Chan, Tan; Sze, Pan-Ching; Lau, Thomas; Leung, Kwok-Sui

    2011-11-01

    This retrospective cohort study aims to investigate the impact of regular pre- and postoperative geriatric input into the management of geriatric patients with hip fracture, with specific interests in morbidity and mortality. Patients with hip fracture (n = 548) older than 60 years were identified within a 2-year period. In the first year, the patients (n = 270) were managed mainly by orthopedics and this group constituted the control group. In the second year, this group of patients (orthogeriatric group, n = 278) had reviews by orthopedic surgeons and geriatricians (physicians specializing in medicine for the elderly), within 48 hours of admission and regularly thereafter. The main outcomes measured included demographics, length of hospital stay, postoperative complications, mortality, and functional outcomes. Data were collected from records of acute and rehabilitation admissions, and outpatient consultations. The admission to operation time for those in the orthogeriatric group was shorter by 17% (p = 0.02). The percentage of patients deceased at 12 months postoperative was 11.5% for the orthogeriatric group and 20.4% for the conventional group (p = 0.02). A higher percentage of patients in the orthogeriatric group remained independent for daily living activities (24.5%) when compared with the conventional group (23.7%; p = 0.02). In addition to existing evidence that postoperative orthogeriatric collaboration improves mortality and functional outcomes in older patients with hip fractures, this study suggests that allowing preoperative geriatric input in this model of care can produce even more superior results.

  1. Factors affecting the incidence and outcome of Trueperella pyogenes mastitis in cows

    PubMed Central

    ISHIYAMA, Dai; MIZOMOTO, Tomoko; UEDA, Chise; TAKAGI, Nobuyuki; SHIMIZU, Noriko; MATSUURA, Yu; MAKUUCHI, Yuto; WATANABE, Aiko; SHINOZUKA, Yasunori; KAWAI, Kazuhiro

    2017-01-01

    The main factors affecting the outcome of Trueperella pyogenes (T. pyogenes) mastitis were examined through a survey of diagnostic data and interviews relating to the occurrence of T. pyogenes mastitis in 83 quarters from 82 Holstein cows between August 2012 and April 2014. Ultimately, one cow was sold during the examination, and 82 quarters from 81 cows were used for analysis on prognosis. T. pyogenes mastitis occurred year round in both lactating and dry cows. The incidence of T. pyogenes mastitis did not significantly differ by month or show seasonality in either lactating or dry cows. Therefore, the occurrence of T. pyogenes mastitis also differed from that of summer mastitis. The 1-month survival rate of infected cows was 64.6% (53/82), and the recovery rate of quarters with T. pyogenes mastitis was 14.6% (12/82). Bivariate logistic regression analysis was performed with survival and culling of infected cows as objective variables and with recovery and non-recovery of quarters with T. pyogenes mastitis as objective variables. The severe cases were significantly culled (odds ratio, 16.30) compared to mild cases, and the status of quarters didn’t recover (odds ratio, 6.50). The results suggest that mild to moderate symptom severity at the time of onset are the main factors affecting outcomes in cows and recovery of quarters infected with T. pyogenes mastitis. Further, high level of NAGase activity also suggested the potential use as an indicator of culling of cows with T. pyogenes mastitis. PMID:28163273

  2. [Trends in world science and practice of pain treatment].

    PubMed

    Osipova, N A

    2014-01-01

    In recent days there are two main conceptions of the treatment of strong pain. The first conception is a system multimodal analgesia and the second is a multidisciplinary therapy including invasive techniques (local nervous blockades, neuroaxial blockades, neurostimulating or drug therapy with implanted systems etc.), physical, manual, and psychological effecting on peripheral and central nervous system. A physician (anaesthesiologist, oncologist, neurologist etc.) treats the pain according to interests of a patient. Multidisciplinary pain treatment, which is recommended by the American Pain Association, requires the use of special equipment for effecting on nervous system of the patient and contains conflict of interests of managers, medical workers, equipment providing companies and other parts of the multidisciplinary process. Therefore there is a risk that commercial benefit can get a main role in the process of pain treatment, but not interests of the patient. The "industrial" approach in the pain treatment is connected with many negative outcomes such as a minimizing of the role of pain science, increasing of complications risks due to invasive techniques of the pain relief etc. Therefore an objective analysis of pain treatment outcomes is needed Helsinki Declaration of a patient safety in surgery approved by European Society of Anaesthesiology in June, 2010 requires an accounting system of critical incidents, complications and assessment of outcomes in perioperative anaesthesiological practice. The same study is very actual for Russia especially to compare a safety of the system multimodal anaesthesia/analgesia and epidural blockades in major surgery.

  3. Outcomes of fetuses with small head circumference on second-trimester ultrasonography.

    PubMed

    Deloison, Benjamin; Chalouhi, Gihad E; Bernard, Jean-Pierre; Ville, Yves; Salomon, Laurent J

    2012-09-01

    We examined the outcomes of pregnancies in which the fetal head circumference (HC) was below the 5(th) centile at the routine second-trimester scan. We retrospectively analysed outcomes of 18,377 women according to HC Z scores at second-trimester ultrasound examination between 2001 and 2008. We collected all major malformations, intrauterine deaths and other abnormal outcomes. Six hundred seventy-four fetuses (3.7%) had an HC below the 5(th) centile. Twenty-one major malformations were noted, consisting mainly of neurological abnormalities (3.1%). There were seven intra uterine fetal death (1.3%). Of all the fetuses, 26% were lost to follow-up. Outcome and neurological development was normal in 467 cases, based on neonatal examination and/or parent or general practitioner reports. Major abnormalities were noted in respectively 26.2%, 3.0% and 1.1% of fetuses with Z scores < -2.5, -2.5 to -2.0, and -2 to -1.645, compared with 0.3% of fetuses with normal HC (p < 10(-4)). A head circumference below the 5(th) centile at second-trimester scan is associated with various abnormalities, especially neurological disorders. The outcome was worse when the HC was smaller. An HC Z score below -2.5 was strongly associated with neurological and chromosomal abnormalities. Conversely, an HC Z score below -1.645 but above -2, excluding cases with prenatally diagnosed malformations, seems to be reassuring for favorable neonatal outcome. © 2012 John Wiley & Sons, Ltd.

  4. Public and private pregnancy care in Reggio Emilia Province: an observational study on appropriateness of care and delivery outcomes

    PubMed Central

    2014-01-01

    Background In industrialized countries, improvements have been made in both maternal and newborn health. While attention to antenatal care is increasing, excessive medicalization is also becoming more common. The aim of this study is to compare caesarean section (CS) frequency and ultrasound scan utilization in a public model of care involving both midwives and obstetricians with a private model in which care is provided by obstetricians only. Methods Design: Observational population-based study. Setting: Reggio Emilia Province. Population: 5957 women resident in the province who delivered between October 2010 and November 2011. Main outcome measures: CS frequency and ultrasound scan utilization, stillbirths, and other negative perinatal outcomes. Women in the study were searched in the public family and reproductive health clinic medical records to identify those cared for in the public system. Outcomes of the two antenatal care models were compared through multivariate logistic regression adjusting for maternal characteristics and, for CS only, by stratifying by Robson’s Group. Results Compared to women cared for in private services (N = 3,043), those in public service (N = 2,369) were younger, less educated, more frequently non-Italian, and multiparous. The probability of CS was slightly higher for women cared for by private obstetricians than for those cared for in the public system (31.8% vs. 27.1%; adjusted odds ratio: 1.10; 95% CI: 0.93–1.29): The probability of having more than 3 ultrasound scans was higher in private care (89.6% vs. 49.8%; adjusted odds ratio: 5.11; 95% CI: 4.30–6.08). CS frequency was higher in private care for all Robson’s classes except women who underwent CS during spontaneous labour. Among negative perinatal outcomes only a higher risk of pre-term birth was observed for pregnancies cared for in private services. Conclusions The public model provides less medicalized and more guidelines-oriented care than does the private model, with no increase in negative perinatal outcomes. PMID:24533853

  5. A national evaluation of clinical and economic outcomes in open versus laparoscopic colorectal surgery.

    PubMed

    Keller, Deborah S; Delaney, Conor P; Hashemi, Lobat; Haas, Eric M

    2016-10-01

    Surgical value is based on optimizing clinical and financial outcomes. The clinical benefits of laparoscopic surgery are well established; however, many patients are still not offered a laparoscopic procedure. Our objective was to compare the modern clinical and financial outcomes of laparoscopic and open colorectal surgery. The Premier Perspective database identified patients undergoing elective colorectal resections from January 1, 2013 to December 31, 2013. Cases were stratified by operative approach into laparoscopic and open cohorts. Groups were controlled on all demographics, diagnosis, procedural, hospital characteristics, surgeon volume, and surgeon specialty and then compared for clinical and financial outcomes. The main outcome measures were length of stay (LOS), complications, readmission rates, and cost by surgical approach. A total of 6343 patients were matched and analyzed in each cohort. The most common diagnosis was diverticulitis (p = 0.0835) and the most common procedure a sigmoidectomy (p = 0.0962). The LOS was significantly shorter in laparoscopic compared to open (mean 5.78 vs. 7.80 days, p < 0.0001). The laparoscopic group had significantly lower readmission (5.82 vs. 7.68 %, p < 0.0001), complication (32.60 vs. 42.28 %, p < 0.0001), and mortality rates (0.52 vs. 1.28 %, p < 0.0001). The total cost was significantly lower in laparoscopic than in open (mean $17,269 vs. $20,552, p < 0.0001). By category, laparoscopy was significantly more cost-effective for pharmacy (p < 0.0001), room and board (p < 0.0001), recovery room (p = 0.0058), ICU (p < 0.0001), and laboratory and imaging services (both p < 0.0001). Surgical supplies (p < 0.0001), surgery (p < 0.0001), and anesthesia (p = 0.0053) were higher for the laparoscopic group. Laparoscopy is more cost-effective and produces better patient outcomes than open colorectal surgery. Minimally invasive colorectal surgery is now the standard that should be offered to patients, providing value to both patient and provider.

  6. Treatment of alcohol use disorder and co-occurring PTSD.

    PubMed

    Taylor, Mandrill; Petrakis, Ismene; Ralevski, Elizabeth

    2017-07-01

    Alcohol use disorder (AUD) is a serious psychiatric disorder with medical, psychiatric, and social consequences. In individuals with comorbid post-traumatic stress disorder (PTSD), treatment outcomes are notably worse in comparison with treatment outcomes associated with either disorder occurring alone. There is a growing literature evaluating treatments, both pharmacotherapy and psychotherapy focused, in individuals with co-occurring AUD and PTSD. The main objective of this review was to evaluate pharmacotherapy and psychotherapy studies that were specifically designed to evaluate the treatment of individuals with comorbid AUD and PTSD. MEDLINE and PUBMED databases were searched with no specific time period. Studies focusing on SUD treatments were excluded. Because the number of random clinical trial (RCT) studies was small, all publications (including open label, single case, and secondary analyses) were included. Sixteen studies met criteria and were organized based on whether they evaluated the efficacy of pharmacotherapy, psychotherapy, or both. Pharmacological interventions with either AUD or PTSD agents were mainly effective in reducing drinking outcomes; only one study using sertraline found that the active study medication was superior to placebo in reducing PTSD symptoms. Psychotherapies were not superior to a comparative treatment in reducing drinking outcomes. Only 1 study showed reduction in PTSD symptoms in a small sample of completers. The single RCT that evaluated the efficacy of naltrexone in combination with psychotherapies (prolonged exposure or supportive counseling) found that naltrexone in combination with prolonged exposure was better for drinking outcomes at follow-up. Although these studies represent a good start in terms of research in treatment interventions of co-occurring AUD and PTSD, the studies are very limited, most lack adequate power, and the majority suffer from inadequate control groups. In particular, there is a strong need to develop and evaluate the combined medication and psychological-based treatment interventions for those with comorbid AUD and PTSD.

  7. Temporal changes in management and outcome of septic shock in patients with malignancies in the intensive care unit.

    PubMed

    Pène, Frédéric; Percheron, Stéphanie; Lemiale, Virginie; Viallon, Vivian; Claessens, Yann-Erick; Marqué, Sophie; Charpentier, Julien; Angus, Derek C; Cariou, Alain; Chiche, Jean-Daniel; Mira, Jean-Paul

    2008-03-01

    Septic shock is a severe, often terminal, complication of malignancy. For patients without malignancy, outcome from septic shock has improved with new advances in care. We wished to explore whether outcome from septic shock has similarly improved for cancer patients, with regard to implementation of recent adjuvant therapies. An 8-yr retrospective observational study. A 24-bed medical intensive care unit in a university hospital. Patients were 238 consecutive cancer patients (solid tumors or hematologic malignancies) with septic shock admitted to the intensive care unit within two consecutive 4-yr periods: 1998-2001 and 2002-2005. None. Septic shock occurred in 90 patients in 1998-2001 and 148 in 2002-2005. Management of septic shock between the two periods mostly differed by emergence of adjuvant therapies of sepsis (mainly low-dose glucocorticoids) and intensive insulin therapy and a more frequent use of renal replacement therapy in the recent period. Short-term survival rates were significantly higher during 2002-2005 compared with the previous 4-yr period: 28-day, intensive care unit, and hospital survival rates were 47.3% vs. 27.8% (p = .003), 41.2% vs. 26.7% (p = .02), and 36.5% vs. 21.1% (p = .01), respectively. After adjustment, intensive care unit admission between 2002 and 2005 was an independent favorable prognostic factor for short-term outcome. Improved survival was mainly observed in patients who did not require renal replacement therapy during their stay in the intensive care unit (hospital survival 65% in 2002-2005 vs. 21.4% in 1998-2001, p < .001). Improved outcome in critically ill cancer patients extended to the subgroup of patients with septic shock. This might be ascribed both to a better selection of patients and to improvements in the care and management, including new therapeutic strategies for sepsis.

  8. Outcomes for primary kidney transplantation from donation after Citizens' death in China: a single center experience of 367 cases.

    PubMed

    Xue, Wujun; Tian, Puxun; Xiang, Heli; Ding, Xiaoming; Pan, Xiaoming; Yan, Hang; Hou, Jun; Feng, Xinshun; Liu, Linjuan; Ding, Chenguang; Tian, Xiaohui; Li, Yang; Zheng, Jin

    2017-04-04

    The cases of donation after brain death followed by circulatory death (DBCD) and donation after cardiac death (DCD) have been increased year by year in China. Further research is needed to understand in the outcomes and risk factors of delayed graft function (DGF) in order to minimize the risk of DGF and ameliorate its potential impact on long-term outcomes. This study was to explore the differences in outcomes between DBCD and DCD transplant and the main risk factors for DGF in DBCD. Retrospective analysis of the clinical data of 367donations after citizens' death kidney transplant procedures (donors and recipients) between July 2012 and August 2015 at our center. During the study period, the donation success rate was 25.3%. 164 cases of DBCD and 35 cases of DCD had been implemented and 367 kidneys were transplanted. The incidence of DGF in DBCD group were significantly lower than that of DCD group (12.0% vs. 27.0%, p = 0.002). The 1-year percent freedom from acute rejection (AR) was significantly higher in DBCD group compared with it of DCD group (94% vs. 82%, p = 0.036). Multivariate logistic regression analysis of the kidney transplants revealed that the high risk factors for DGF after renal transplantation in DBCD were history of hypertension (Odds Ratio [OR] = 5.88, 95% CI: 1.90 to 18.2, p = 0.002), low blood pressure (BP < 80 mmHg) (OR = 4.86, 95% CI: 1.58 to 14.9, p = 0.006) and serum creatinine of donor (OR = 1.09, 95% CI: 1.03 to 1.16, p = 0.003) before donation. The outcomes of DBCD could be better than DCD in DGF and AR. The main risk factors for DGF in DBCD kidney transplants are donors with a history of hypertension, low blood pressure, and serum creatinine of donor before donation.

  9. Retransplantation in Late Hepatic Artery Thrombosis: Graft Access and Transplant Outcome.

    PubMed

    Buchholz, Bettina M; Khan, Shakeeb; David, Miruna D; Gunson, Bridget K; Isaac, John R; Roberts, Keith J; Muiesan, Paolo; Mirza, Darius F; Tripathi, Dhiraj; Perera, M Thamara P R

    2017-08-01

    Definitive treatment for late hepatic artery thrombosis (L-HAT) is retransplantation (re-LT); however, the L-HAT-associated disease burden is poorly represented in allocation models. Graft access and transplant outcome of the re-LT experience between 2005 and 2016 was reviewed with specific focus on the L-HAT cohort in this single-center retrospective study. Ninety-nine (5.7%) of 1725 liver transplantations were re-LT with HAT as the main indication (n = 43; 43%) distributed into early (n = 25) and late (n = 18) episodes. Model for end-stage liver disease as well as United Kingdom model for end-stage liver disease did not accurately reflect high disease burden of graft failure associated infections such as hepatic abscesses and biliary sepsis in L-HAT. Hence, re-LT candidates with L-HAT received low prioritization and waited longest until the allocation of an acceptable graft (median, 103 days; interquartile range, 28-291 days), allowing for progression of biliary sepsis. Balance of risk score and 3-month mortality score prognosticated good transplant outcome in L-HAT but, contrary to the prediction, the factual 1-year patient survival after re-LT was significantly inferior in L-HAT compared to early HAT, early non-HAT and late non-HAT (65% vs 82%, 92% and 95%) which was mainly caused by sepsis and multiorgan failure driving 3-month mortality (28% vs 11%, 16% and 0%). Access to a second graft after a median waitlist time of 6 weeks achieved the best short- and long-term outcome in re-LT for L-HAT (3-month mortality, 13%; 1-year survival, 77%). Inequity in graft access and peritransplant sepsis are fundamental obstacles for successful re-LT in L-HAT. Offering a graft for those in need at the best window of opportunity could facilitate earlier engrafting with improved outcomes.

  10. Assessing cosmetic results after breast conserving surgery.

    PubMed

    Cardoso, Maria João; Oliveira, Helder; Cardoso, Jaime

    2014-07-01

    "Taking less treating better" has been one of the major improvements of breast cancer surgery in the last four decades. The application of this principle translates into equivalent survival of breast cancer conserving treatment (BCT) when compared to mastectomy, with a better cosmetic outcome. While it is relatively easy to evaluate the oncological results of BCT, the cosmetic outcome is more difficult to measure due to the lack of an effective and consensual procedure. The assessment of cosmetic outcome has been mainly subjective, undertaken by a panel of expert observers or/and by patient self-assessment. Unfortunately, the reproducibility of these methods is low. Objective methods have higher values of reproducibility but still lack the inclusion of several features considered by specialists in BCT to be fundamental for cosmetic outcome. The recent addition of volume information obtained with 3D images seems promising. Until now, unfortunately, no method is considered to be the standard of care. This paper revises the history of cosmetic evaluation and guides us into the future aiming at a method that can easily be used and accepted by all, caregivers and caretakers, allowing not only the comparison of results but the improvement of performance. © 2014 Wiley Periodicals, Inc.

  11. Is Textbook Outcome a valuable composite measure for short-term outcomes of gastrointestinal treatments in the Netherlands using hospital information system data? A retrospective cohort study

    PubMed Central

    Salet, Nèwel; Bremmer, Rolf H; Verhagen, Marc A M T; Ekkelenkamp, Vivian E; Hansen, Bettina E; de Jonge, Pieter J F; de Man, Rob A

    2018-01-01

    Objective To develop a feasible model for monitoring short-term outcome of clinical care trajectories for hospitals in the Netherlands using data obtained from hospital information systems for identifying hospital variation. Study design Retrospective analysis of collected data from hospital information systems combined with clinical indicator definitions to define and compare short-term outcomes for three gastrointestinal pathways using the concept of Textbook Outcome. Setting 62 Dutch hospitals. Participants 45 848 unique gastrointestinal patients discharged in 2015. Main outcome measure A broad range of clinical outcomes including length of stay, reintervention, readmission and doctor–patient counselling. Results Patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) for gallstone disease (n=4369), colonoscopy for inflammatory bowel disease (IBD; n=19 330) and colonoscopy for colorectal cancer screening (n=22 149) were submitted to five suitable clinical indicators per treatment. The percentage of all patients who met all five criteria was 54%±9% (SD) for ERCP treatment. For IBD this was 47%±7% of the patients, and for colon cancer screening this number was 85%±14%. Conclusion This study shows that reusing data obtained from hospital information systems combined with clinical indicator definitions can be used to express short-term outcomes using the concept of Textbook Outcome without any excess registration. This information can provide meaningful insight into the clinical care trajectory on the level of individual patient care. Furthermore, this concept can be applied to many clinical trajectories within gastroenterology and beyond for monitoring and improving the clinical pathway and outcome for patients. PMID:29496668

  12. Psychosocial profile of institutionalised street children in Alexandria, Egypt: a comparative study with school children.

    PubMed

    Attia, Medhat S; Tayel, Kholoud Y; Shata, Zeinab N; Othman, Sally S

    2017-09-01

    The phenomenon of street children in Egypt constitutes a public health concern. This study aimed to investigate the characteristics of institutionalised street children in Alexandria, to compare the prevalence of substance abuse and conduct disorder between street children and school children, and to identify predictors of these mental health outcomes among street children. Institutionalised street children (n = 102) participated in a cross-sectional comparative study with a matched group of school children (n = 156). An interviewing questionnaire was used to assess demographic characteristics and substance use. Conduct disorder was measured using the Revised Ontario Child Health study scale. Poverty, family breakdown, and domestic violence were the main reasons for street children having left home. Street children recorded significantly higher rates of substance use (9.8%) and conduct disorder (35.3%) compared to school children. In street children, smoking was a significant predictor of substance use and conduct disorder. Other predictors of conduct disorder included physical illness and having 5 to 7 siblings. Substance abuse and conduct disorder were present among institutionalised street children at higher rates than school children. Absence of basic life needs and disrupted families constituted the main reasons for leaving home. Interventions at the governmental and non-governmental levels are needed.

  13. Disparity in ST-segment Elevation Myocardial Infarction Practices and Outcomes in Arabian Gulf Countries (Gulf COAST Registry)

    PubMed Central

    Zubaid, Mohammad; Rashed, Wafa; Alsheikh-Ali, Alawi A.; Garadah, Taysir; Alrawahi, Najib; Ridha, Mustafa; Akbar, Mousa; Alenezi, Fahad; Alhamdan, Rashed; Almahmeed, Wael; Ouda, Hussam; Al-Mulla, Arif; Baslaib, Fahad; Shehab, Abdulla; Alnuaimi, Abdulla; Amin, Haitham

    2017-01-01

    Objectives: The objective of this study is to describe contemporary management and 1-year outcomes of patients hospitalized with ST-segment elevation myocardial infarction (STEMI) in Arabian Gulf countries. Methods: Data of patients admitted to 29 hospitals in four Gulf countries [Bahrain, Kuwait, Oman, United Arab Emirates (UAE)] with the diagnosis of STEMI were analyzed from Gulf locals with acute coronary syndrome (ACS) events (Gulf COAST) registry. This was a longitudinal, observational registry of consecutive citizens, admitted with ACS from January 2012 to January 2013. Patient management and outcomes were analyzed and compared between the four countries. Results: A total of 1039 STEMI patients were enrolled in Gulf COAST Registry. The mean age was 58 years, and there was a high prevalence of diabetes (47%). With respect to reperfusion, 10% were reperfused with primary percutaneous coronary intervention, 66% with fibrinolytic therapy and 24% were not reperfused. Only one-third of patients who received fibrinolytic therapy had a door-to-needle time of 30 min or less. The in-hospital mortality rate was 7.4%. However, we noted a significant regional variability in mortality rate (3.8%-11.9%). In adjusted analysis, patients from Oman were 4 times more likely to die in hospital as compared to patients from Kuwait. Conclusions: In the Gulf countries, fibrinolytic therapy is the main reperfusion strategy used in STEMI patients. Most patients do not receive this therapy according to timelines outlined in recent practice guidelines. There is a significant discrepancy in outcomes between the countries. Quality improvement initiatives are needed to achieve better adherence to management guidelines and close the gap in outcomes. PMID:28706594

  14. Are generic and brand-name statins clinically equivalent? Evidence from a real data-base.

    PubMed

    Corrao, Giovanni; Soranna, Davide; Arfè, Andrea; Casula, Manuela; Tragni, Elena; Merlino, Luca; Mancia, Giuseppe; Catapano, Alberico L

    2014-10-01

    Use of generic drugs can help contain drug spending. However, there is concern among patients and physicians that generic drugs may be clinically inferior to brand-name ones. This study aimed to compare patients treated with generic and brand-name statins in terms of therapeutic interruption and cardiovascular (CV) outcomes. 13,799 beneficiaries of the health care system of Lombardy, Italy, aged 40 years or older who were newly treated with generic or brand-name simvastatin during 2008, were followed until 2011 for the occurrence of two outcomes: 1) therapeutic discontinuation and 2) hospitalization for CV events. Hazard ratios (HR) associated with use of generic or brand-name at starting therapy (intention-to-treat analysis) and during follow-up (as-treated analysis) were estimated by fitting proportional hazard Cox models. A Monte-Carlo sensitivity analysis was performed to account for unmeasured confounders. Patients who started on generic did not experience a different risk of discontinuation (HR: 0.98; 95% CI 0.94 to 1.02) nor of CV outcomes (HR: 0.98; 95% CI 0.79 to 1.22) from those starting on brand-name. Patients who spent >75% of time of follow-up with statin available on generics did not experience a different risk of discontinuation (HR: 0.94; 95% CI 0.87 to 1.01), nor of CV outcomes (HR: 1.06; 95% CI 0.83 to 1.34), compared with those who mainly or only used brand-name statin. Our findings do not support the notion that in the real world clinical practice brand-name statins are superior to generics for keeping therapy and preventing CV outcomes. Copyright © 2014. Published by Elsevier B.V.

  15. Probiotics for respiratory tract infections in children attending day care centers-a systematic review.

    PubMed

    Laursen, Rikke Pilmann; Hojsak, Iva

    2018-05-12

    Probiotics have been suggested to have a preventive effect on respiratory tract infections (RTIs), but limited evidence exist on strain-specific effects. The main aim of this systematic review and meta-analysis was to evaluate strain-specific probiotic effects on RTIs in children attending day care. We included 15 RCTs with 5121 children in day care settings (aged 3 months to 7 years), but due to high diversity in reported outcomes, different number of RCTs were available for evaluated outcomes. Twelve RCTs (n = 4527) reported results which could be compared in at least one outcome of the meta-analysis. Compared to placebo, Lactobacillus rhamnosus GG (LGG) significantly reduced duration of RTIs (three RCTs, n = 1295, mean difference - 0.78 days, 95% confidence interval (CI) - 1.46; - 0.09), whereas no effect was found on other evaluated outcomes. Based on the results from two studies (n = 343), Bifidobacterium animalis subsp. lactis BB-12 showed no effect on duration of RTIs or on absence from day care. Meta-analyses on other strains or their combination were not possible due to limited data and different outcome measures. LGG is modestly effective in decreasing the duration of RTIs. More RCTs investigating specific probiotic strains or their combinations in prevention of RTIs are needed. What is known: • Previously published systematic reviews have suggested that probiotics may have a preventive effect on respiratory infections, but limited data exist on strain specific effects. What is new: • This systematic review showed that use of Lactobacillus rhamnosus GG modestly reduces the duration of respiratory tract infections.

  16. Triple antithrombotic therapy versus dual antiplatelet therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

    PubMed

    Kang, Dong Oh; Yu, Cheol Woong; Kim, Hee Dong; Cho, Jae Young; Joo, Hyung Joon; Choi, Rak Kyong; Park, Jin Sik; Lee, Hyun Jong; Kim, Je Sang; Park, Jae Hyung; Hong, Soon Jun; Lim, Do-Sun

    2015-08-01

    The optimal antithrombotic regimen in patients with atrial fibrillation (AF) undergoing drug-eluting stent (DES) implantation for complex coronary artery disease is unclear. We compared the net clinical outcomes of triple antithrombotic therapy (TAT; aspirin, thienopyridine, and warfarin) and dual antiplatelet therapy (DAPT; aspirin and thienopyridine) in AF patients who had undergone DES implantation. A total of 367 patients were enrolled and analyzed retrospectively; 131 patients (35.7%) received TAT and 236 patients (64.3%) received DAPT. DAPT and warfarin were maintained for a minimum of 12 and 24 months, respectively. The primary endpoint was the 2-year net clinical outcomes, a composite of major bleeding and major adverse cardiac and cerebral events (MACCE). Propensity score-matching analysis was carried out in 99 patient pairs. The 2-year net clinical outcomes of the TAT group were worse than those of the DAPT group (34.3 vs. 21.1%, P=0.006), which was mainly due to the higher incidence of major bleeding (16.7 vs. 4.6%, P<0.001), without any significant increase in MACCE (22.1 vs. 17.7%, P=0.313). In the multivariate analysis, TAT was an independent predictor of worse net clinical outcomes (odds ratio 1.63, 95% confidence interval 1.06-2.50) and major bleeding (odds ratio 3.54, 95% confidence interval 1.65-7.58). After propensity score matching, the TAT group still had worse net clinical outcomes and a higher incidence of major bleeding compared with the DAPT group. In AF patients undergoing DES implantation, prolonged administration of TAT may be harmful due to the substantial increase in the risk for major bleeding without any reduction in MACCE.

  17. Implementing core NICE guidelines for osteoarthritis in primary care with a model consultation (MOSAICS): a cluster randomised controlled trial.

    PubMed

    Dziedzic, K S; Healey, E L; Porcheret, M; Afolabi, E K; Lewis, M; Morden, A; Jinks, C; McHugh, G A; Ryan, S; Finney, A; Main, C; Edwards, J J; Paskins, Z; Pushpa-Rajah, A; Hay, E M

    2018-01-01

    To determine the effectiveness of a model osteoarthritis consultation, compared with usual care, on physical function and uptake of National Institute for Health and Care Excellence (NICE) osteoarthritis recommendations, in adults ≥45 years consulting with peripheral joint pain in UK general practice. Two-arm cluster-randomised controlled trial with baseline health survey. Eight general practices in England. 525 adults ≥45 years consulting for peripheral joint pain, amongst 28,443 population survey recipients. Four intervention practices delivered the model osteoarthritis consultation to patients consulting with peripheral joint pain; four control practices continued usual care. The primary clinical outcome of the trial was the SF-12 physical component score (PCS) at 6 months; the main secondary outcome was uptake of NICE core recommendations by 6 months, measured by osteoarthritis quality indicators. A Linear Mixed Model was used to analyse clinical outcome data (SF-12 PCS). Differences in quality indicator outcomes were assessed using logistic regression. 525 eligible participants were enrolled (mean age 67.3 years, SD 10.5; 59.6% female): 288 from intervention and 237 from control practices. There were no statistically significant differences in SF-12 PCS: mean difference at the 6-month primary endpoint was -0.37 (95% CI -2.32, 1.57). Uptake of core NICE recommendations by 6 months was statistically significantly higher in the intervention arm compared with control: e.g., increased written exercise information, 20.5% (7.9, 28.3). Whilst uptake of core NICE recommendations was increased, there was no evidence of benefit of this intervention, as delivered in this pragmatic randomised trial, on the primary outcome of physical functioning at 6 months. ISRCTN06984617. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  18. The need for cost-effectiveness analyses of antimicrobial stewardship programmes: A structured review.

    PubMed

    Coulter, Sonali; Merollini, Katharina; Roberts, Jason A; Graves, Nicholas; Halton, Kate

    2015-08-01

    The cost effectiveness of antimicrobial stewardship (AMS) programmes was reviewed in hospital settings of Organisation for Economic Co-operation and Development (OECD) countries, and limited to adult patient populations. In each of the 36 studies, the type of AMS strategy and the clinical and cost outcomes were evaluated. The main AMS strategy implemented was prospective audit with intervention and feedback (PAIF), followed by the use of rapid technology, including rapid polymerase chain reaction (PCR)-based methods and matrix-assisted laser desorption/ionisation time-of-flight (MALDI-TOF) technology, for the treatment of bloodstream infections. All but one of the 36 studies reported that AMS resulted in a reduction in pharmacy expenditure. Among 27 studies measuring changes to health outcomes, either no change was reported post-AMS, or the additional benefits achieved from these outcomes were not quantified. Only two studies performed a full economic evaluation: one on a PAIF-based AMS intervention; and the other on use of rapid technology for the selection of appropriate treatment for serious Staphylococcus aureus infections. Both studies found the interventions to be cost effective. AMS programmes achieved a reduction in pharmacy expenditure, but there was a lack of consistency in the reported cost outcomes making it difficult to compare between interventions. A failure to capture complete costs in terms of resource use makes it difficult to determine the true cost of these interventions. There is an urgent need for full economic evaluations that compare relative changes both in clinical and cost outcomes to enable identification of the most cost-effective AMS strategies in hospitals. Copyright © 2015 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

  19. Save the patient a trip. Outcome difference between conservatively treated patients with traumatic brain injury in a nonspecialized intensive care unit vs a specialized neurosurgical intensive care unit in the Sultanate of Oman.

    PubMed

    Al-Kashmiri, Ammar M; Al-Shaqsi, Sultan Z; Al-Kharusi, Adil S; Al-Tamimi, Laila A

    2015-06-01

    Traumatic brain injury (TBI) continues to be the main cause of death among trauma patients. Accurate diagnosis and timely surgical interventions are critical steps in reducing the mortality from this disease. For patients who have no surgically reversible head injury pathology, the decision to transfer to a dedicated neurosurgical unit is usually controversial. To compare the outcome of patients with severe TBI treated conservatively in a specialized neurosurgical intensive care unit (ICU) and those treated conservatively at a general ICU in the Sultanate of Oman. Retrospective cohort study. This is a retrospective study of patients with severe TBI admitted to Khoula Hospital ICU (specialized neurosurgical ICU) and Nizwa Hospital ICU (general ICU) in Oman in 2013. Surgically treated patients were excluded. Data extracted included demographics, injury details, interventions, and outcomes. The outcome variables included mortality, length of stay, length of ICU days, and ventilated days. There were 100 patients with severe TBI treated conservatively at Khoula Hospital compared with 74 patients at Nizwa Hospital. Basic demographics were similar between the 2 groups. No significant difference was found in mortality, length of stay, ICU days, and ventilation days. There is no difference in outcome between patients with TBI treated conservatively in a specialized neurosurgical ICU and those treated in a general nonspecialized ICU in Oman in 2013. Therefore, unless neurosurgical intervention is warranted or expected, patients with TBI may be managed in a general ICU, saving the risk and expense of a transfer to a specialized neurosurgical ICU. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Immediate radical trachelectomy versus neoadjuvant chemotherapy followed by conservative surgery for patients with stage IB1 cervical cancer with tumors 2cm or larger: A literature review and analysis of oncological and obstetrical outcomes.

    PubMed

    Pareja, Rene; Rendón, Gabriel J; Vasquez, Monica; Echeverri, Lina; Sanz-Lomana, Carlos Millán; Ramirez, Pedro T

    2015-06-01

    Radical trachelectomy is the treatment of choice in women with early-stage cervical cancer wishing to preserve fertility. Radical trachelectomy can be performed with a vaginal, abdominal, or laparoscopic/robotic approach. Vaginal radical trachelectomy (VRT) is generally not offered to patients with tumors 2cm or larger because of a high recurrence rate. There are no conclusive recommendations regarding the safety of abdominal radical trachelectomy (ART) or laparoscopic radical trachelectomy (LRT) in such patients. Several investigators have used neoadjuvant chemotherapy in patients with tumors 2 to 4cm to reduce tumor size so that fertility preservation may be offered. However, to our knowledge, no published study has compared outcomes between patients with cervical tumors 2cm or larger who underwent immediate radical trachelectomy and those who underwent neoadjuvant chemotherapy followed by radical trachelectomy. We conducted a literature review to compare outcomes with these 2 approaches. Our main endpoints for evaluation were oncological and obstetrical outcomes. The fertility preservation rate was 82.7%, 85.1%, 89%; and 91.1% for ART (tumors larger than >2cm), ART (all sizes), NACT followed by surgery and VRT (all sizes); respectively. The global pregnancy rate was 16.2%, 24% and 30.7% for ART, VRT, and NACT followed by surgery; respectively. The recurrence rate was 3.8%, 4.2%, 6%, 7.6% and 17% for ART (all sizes), VRT (all sizes), ART (tumors>2cm), NACT followed by surgery, and VRT (tumors>2cm). These outcomes must be considered when offering a fertility sparing technique to patients with a tumor larger than 2cm. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Biodiesel versus diesel exposure: Enhanced pulmonary inflammation, oxidative stress, and differential morphological changes in the mouse lung

    PubMed Central

    Yanamala, Naveena; Hatfield, Meghan K.; Farcas, Mariana T.; Schwegler-Berry, Diane; Hummer, Jon A.; Shurin, Michael R.; Birch, M. Eileen; Gutkin, Dmitriy W.; Kisin, Elena; Kagan, Valerian E.; Bugarski, Aleksandar D.; Shvedova, Anna A.

    2015-01-01

    The use of biodiesel (BD) or its blends with petroleum diesel (D) is considered to be a viable approach to reduce occupational and environmental exposures to particulate matter (PM). Due to its lower particulate mass emissions compared to D, use of BD is thought to alleviate adverse health effects. Considering BD fuel is mainly composed of unsaturated fatty acids, we hypothesize that BD exhaust particles could induce pronounced adverse outcomes, due to their ability to readily oxidize. The main objective of this study was to compare the effects of particles generated by engine fueled with neat BD and neat petroleum-based D. Biomarkers of tissue damage and inflammation were significantly elevated in lungs of mice exposed to BD particulates. Additionally, BD particulates caused a significant accumulation of oxidatively modified proteins and an increase in 4-hydroxynonenal. The up-regulation of inflammatory cytokines/chemokines/growth factors was higher in lungs upon BD particulate exposure. Histological evaluation of lung sections indicated presence of lymphocytic infiltrate and impaired clearance with prolonged retention of BD particulate in pigment laden macrophages. Taken together, these results clearly indicate that BD exhaust particles could exert more toxic effects compared to D. PMID:23886933

  2. The development of a Simplified, Effective, Labour Monitoring-to-Action (SELMA) tool for Better Outcomes in Labour Difficulty (BOLD): study protocol.

    PubMed

    Souza, João Paulo; Oladapo, Olufemi T; Bohren, Meghan A; Mugerwa, Kidza; Fawole, Bukola; Moscovici, Leonardo; Alves, Domingos; Perdona, Gleici; Oliveira-Ciabati, Livia; Vogel, Joshua P; Tunçalp, Özge; Zhang, Jim; Hofmeyr, Justus; Bahl, Rajiv; Gülmezoglu, A Metin

    2015-05-26

    The partograph is currently the main tool available to support decision-making of health professionals during labour. However, the rate of appropriate use of the partograph is disappointingly low. Apart from limitations that are associated with partograph use, evidence of positive impact on labour-related health outcomes is lacking. The main goal of this study is to develop a Simplified, Effective, Labour Monitoring-to-Action (SELMA) tool. The primary objectives are: to identify the essential elements of intrapartum monitoring that trigger the decision to use interventions aimed at preventing poor labour outcomes; to develop a simplified, monitoring-to-action algorithm for labour management; and to compare the diagnostic performance of SELMA and partograph algorithms as tools to identify women who are likely to develop poor labour-related outcomes. A prospective cohort study will be conducted in eight health facilities in Nigeria and Uganda (four facilities from each country). All women admitted for vaginal birth will comprise the study population (estimated sample size: 7,812 women). Data will be collected on maternal characteristics on admission, labour events and pregnancy outcomes by trained research assistants at the participating health facilities. Prediction models will be developed to identify women at risk of intrapartum-related perinatal death or morbidity (primary outcomes) throughout the course of labour. These predictions models will be used to assemble a decision-support tool that will be able to suggest the best course of action to avert adverse outcomes during the course of labour. To develop this set of prediction models, we will use up-to-date techniques of prognostic research, including identification of important predictors, assigning of relative weights to each predictor, estimation of the predictive performance of the model through calibration and discrimination, and determination of its potential for application using internal validation techniques. This research offers an opportunity to revisit the theoretical basis of the partograph. It is envisioned that the final product would help providers overcome the challenging tasks of promptly interpreting complex labour information and deriving appropriate clinical actions, and thus increase efficiency of the care process, enhance providers' competence and ultimately improve labour outcomes. Please see related articles ' http://dx.doi.org/10.1186/s12978-015-0027-6 ' and ' http://dx.doi.org/10.1186/s12978-015-0028-5 '.

  3. Analyses of group sequential clinical trials.

    PubMed

    Koepcke, W

    1989-12-01

    In the first part of this article the methodology of group sequential plans is reviewed. After introducing the basic definition of such plans the main properties are shown. At the end of this section three different plans (Pocock, O'Brien-Fleming, Koepcke) are compared. In the second part of the article some unresolved issues and recent developments in the application of group sequential methods to long-term controlled clinical trials are discussed. These include deviation from the assumptions, life table methods, multiple-arm clinical trials, multiple outcome measures, and confidence intervals.

  4. [Accidents at work and occupational diseases trend in agriculture insurance management. The contribution of INAIL data's for the knowledge of a worrying phenomenon].

    PubMed

    Calandriello, Luigi; Goggiamani, Angela; Ienzi, Emanuela; Naldini, Silvia; Orsini, Dario

    2013-01-01

    The author's describe accidents at work and occupational diseases outcome's measure in Agricolture insurance management acquired through statistical approach based on data processing provided by INAIL Bank data. Accident's incidence in Agricolture is compared to main insurance managements, using frequency index of accidents appearance selected on line of work and type of consequence. Concerning occupational diseases the authors describes the complaints and compensation with the comparison referring the analysis to statistical general data. The data define a worrying phenomenon.

  5. Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 5 years follow-up from the randomized DEDICATION trial (Drug Elution and Distal Protection in Acute Myocardial Infarction).

    PubMed

    Holmvang, Lene; Kelbæk, Henning; Kaltoft, Anne; Thuesen, Leif; Lassen, Jens Flensted; Clemmensen, Peter; Kløvgaard, Lene; Engstrøm, Thomas; Bøtker, Hans E; Saunamäki, Kari; Krusell, Lars R; Jørgensen, Erik; Tilsted, Hans-Henrik; Christiansen, Evald H; Ravkilde, Jan; Køber, Lars; Kofoed, Klaus Fuglsang; Terkelsen, Christian J; Helqvist, Steffen

    2013-06-01

    This study sought to compare the long-term effects of drug-eluting stent (DES) compared with bare-metal stent (BMS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) trial evaluated the outcome after DES compared with BMS implantation in patients with STEMI undergoing primary percutaneous coronary intervention. Patients with a high-grade stenosis/occlusion of a native coronary artery presenting with symptoms <12 h and ST-segment elevation were enrolled after giving informed consent. Patients were randomly assigned to receive a DES or a BMS in the infarct-related lesion. Patients were followed for at least 5 years, and clinical endpoints were evaluated from population registries and hospital charts. The main endpoint was the occurrence of the first major adverse cardiac event (MACE), defined as cardiac death, nonfatal recurrent myocardial infarction, and target lesion revascularization. Complete clinical status was available in 623 patients (99.5%) at 5 years follow-up. The combined MACE rate was insignificantly lower in the DES group (16.9% vs. 23%), mainly driven by a lower need of repeat revascularization (p = 0.07). Whereas the number of deaths from all causes tended to be higher in the DES group (16.3% vs. 12.1%, p = 0.17), cardiac mortality was significantly higher (7.7% vs. 3.2%, p = 0.02). The 5-year stent thrombosis rates were generally low and similar between the DES and the BMS groups. No cardiac deaths occurring within 1 month could be clearly ascribed to stent thrombosis, whereas stent thrombosis was involved in 78% of later-occurring deaths. The 5-year MACE rate was insignificantly different, but the cardiac mortality was higher after DES versus BMS implantation in patients with STEMI. Stent thrombosis was the main cause of late cardiac deaths. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  6. Cannabis-associated arterial disease.

    PubMed

    Desbois, Anne Claire; Cacoub, Patrice

    2013-10-01

    The aim of this study was to describe the different arterial complications reported in cannabis smokers. This study was a literature review. Cannabis use was found to be associated with stroke, myocardial infarction, and lower limb arteritis. Arterial disease involved especially young men. There was a very strong temporal link between arterial complications and cannabis use for stroke and myocardial infarction episodes. Patient outcome was closely correlated with cannabis withdrawal and relapses associated with cannabis rechallenge. Cannabis use was associated with particular characteristics of arterial disease. The increased risk of myocardial infarction onset occurred within 1 hour of smoking marijuana compared with periods of non-use. Strokes occurred mainly in the posterior cerebral circulation. Compared with cohorts of thromboangiitis obliterans patients, those with cannabis-associated limb arteritis were younger, more often male, and had more frequent unilateral involvement of the lower limbs at clinical presentation. Cannabis use is associated with arterial disease such as stroke, myocardial infarction, and limbs arteritis. It appears essential to investigate cannabis use in young patients presenting with such arterial manifestations, as outcome is closely correlated with cannabis withdrawal. Copyright © 2013 Elsevier Inc. All rights reserved.

  7. Simulating memory outcome before right selective amygdalohippocampectomy.

    PubMed

    Patrikelis, Panayiotis; Lucci, Giuliana; Siatouni, Anna; Zalonis, Ioannis; Sakas, Damianos E; Gatzonis, Stylianos

    2013-01-01

    In this paper we present the case of a left-sided speech dominant patient with right medial temporal sclerosis (RMTS) and pharmacoresistant epilepsy who showed improved verbal memory during intracarotid amobarbital test (IAT) at his right hemisphere as compared with his own performance before the drug injection (baseline), as well as after right selective amygdalohippocampectomy. We suggest that the defective verbal memory shown by this patient is due to abnormal activity of his right hippocampus that interfered with the function of his left hippocampus. This hypothesis was demonstrated by the fact that disconnection of the two hippocampi, either by anesthetisation or by resection of the right hippocampus, disengaged the left hippocampus and, consequently improved its function. This paper main objective is twofold: first to contribute to the field of neuropsychology of epilepsy surgery by emphasising on postoperative memory outcomes in right medial temporal lobe epilepsy (RMTLE) patients, particularly those undergoing amygdalohippocampectomy, as the pattern of memory changes after resection of the right temporal lobe is less clear; second, by focusing on memory performance asymmetries during IAT, and comparatively considering them with neuropsychological memory performance, because of their possible prognostic-simulating value.

  8. Inequalities in multiple health outcomes by education, sex, and race in 93 US counties: Why we should measure them all

    PubMed Central

    2014-01-01

    Introduction Regular reporting of health inequalities is essential to monitoring progress of efforts to reduce health inequalities. While reporting of population health became increasingly common, reporting of a subpopulation group breakdown of each indicator of the health of the population is rarely a standard practice. This study reports education-, sex-, and race-related inequalities in four health outcomes in each of the selected 93 counties in the United States in a systematic and comparable manner. Methods This study is a cross-sectional analysis of large, publicly available data, 2008, 2009, and 2010 Behavioral Risk Factor Surveillance System (BRFSS) Selected Metropolitan/Micropolitan Area Risk Trends (SMART) and 2008, 2009, and 2010 United States Birth Records from the National Vital Statistics System. The study population is American adults older than 25 years of age residing in the selected 93 counties, representing about 30% of the US population, roughly equally covering all geographic regions of the country. Main outcome measures are: (1) Attribute (group characteristic)-specific inequality: education-, sex-, or race-specific inequality in each of the four health outcomes (poor or fair health, poor physical health days, poor mental health days, and low birthweight) in each county; (2) Overall inequality: the average of these three attribute-specific inequalities for each health outcome in each county; and (3) Summary inequality in total morbidity: the weighted average of the overall inequalities across the four health outcomes in each county. Results The range of inequality across the counties differed considerably by health outcome; inequality in poor or fair health had the widest range and the highest median among inequalities in all health outcomes. In more than 70% of the counties, education-specific inequality was the largest in all health outcomes except for low birthweight. Conclusions It is feasible to extend population health reporting to include reporting of a subpopulation group breakdown of each indicator of the health of the population at a small jurisdictional level using publicly available data. No single group characteristic or health outcome represents the whole picture of health inequalities in a population. Examining multiple group characteristics and outcomes in a comparable manner is essential in reporting health inequalities. PMID:24927805

  9. Effectiveness of footwear and foot orthoses for calcaneal apophysitis: a 12-month factorial randomised trial.

    PubMed

    James, Alicia M; Williams, Cylie M; Haines, Terry P

    2016-10-01

    Calcaneal apophysitis, is a relatively common cause of heel pain in children. Very few randomised studies have evaluated treatment options. This trial compared the effectiveness of currently employed treatment options for the relief of pain and disability associated with calcaneal apophysitis. Factorial 2×2 randomised comparative effectiveness trial with 1, 2, 6 and 12-month follow-up. Participants were recruited from the caseload of podiatrists at Monash health and Peninsula Health. Children aged 8-14 years with clinically diagnosed calcaneal apophysitis. Treatment factor 1: two different types of in-shoe orthoses: a heel raise or prefabricated orthoses. Treatment factor 2: footwear replacement or no footwear replacement. Our primary outcome was functional disability, the secondary outcomes were pain and ankle dorsiflexion range. A total of 133 children and their parents responded to the recruitment advertisement, 124 participated in the trial.At the 1 and 2-month follow-up points, there was a main effect of the shoe insert (heel raise) in only the physical domain for the Oxford ankle foot questionnaire (p=0.04). At the 6 and 12-month follow-up points, there was no main effect or interaction effect for any outcome measure. This trial indicates at the 2-month time point there is a relative advantage in the use of heel raises over prefabricated orthoses for the treatment for calcaneal apophysitis. At 12 months there was no relative advantage to any one of the investigated treatment choices over another. Therefore, if a physical impact is experienced for greater than 2 months, the selection of treatment choice may defer to clinical judgement, cost-minimisation and or patient preference. ACTRN12609000696291. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  10. Cost-effectiveness of screening and treatment for bacterial vaginosis in early pregnancy among women at low risk for preterm birth.

    PubMed

    Kekki, Minnamaija; Kurki, Tapio; Kotomäki, Teija; Sintonen, Harri; Paavonen, Jorma

    2004-01-01

    Bacterial vaginosis (BV) is an important risk factor for preterm birth. BV is detected in 10-30% of pregnant women and is often asymptomatic. Treatment of BV during pregnancy seems to reduce the risk of preterm delivery among high-risk women. We performed a cost-effectiveness analysis of screening and treatment for BV in early pregnancy among asymptomatic women at low risk for preterm delivery. A decision tree was built with two arms. For the screening (and treatment) arm the probabilities were derived from our earlier randomized trial on screening and treatment for BV, consisting of BV-positive women treated with intravaginal clindamycin cream or placebo and also of BV-negative pregnant women. The probabilities of outcomes among these women were collected from antenatal clinic records and hospital records, and for the no-screening arm mainly from the Finnish Perinatal Statistics. The outcomes considered were preterm delivery, mode of delivery, peripartum infections and postpartum complications. The unit costs associated with these outcomes were mainly based on disease-related groups (DRGs). No-screening was compared with two screening programs (one with clindamycin, the other with metronidazole treatment) and subjected to sensitivity analyses. There was no significant difference between screening and no-screening strategies in the costs and in the rate of preterm deliveries but the screening strategy produced significantly fewer peripartum infections and postpartum complications. Sensitivity analyses suggested that the screening strategy may become cost-saving if the rate of preterm deliveries exceeds 3%. Screening and treatment for BV in early pregnancy may not reduce costs compared to no-screening in a population at low risk for preterm birth but would produce, at the same cost, more health benefits in terms of fewer peripartum infections and postpartum complications. However, it may be cost-saving if the rate of preterm deliveries is higher than 3%.

  11. Everyday functioning of male adolescents who later died by suicide: Results of a pilot case-control study using mixed-method analysis.

    PubMed

    Buhnick-Atzil, Ortal; Rubinstein, Katya; Tuval-Mashiach, Rivka; Fischer, Sharon; Fruchter, Eyal; Large, Matthew; Weiser, Mark

    2015-02-01

    Previous research has shown a link between difficulties in everyday functioning and suicidality in adolescence. The majority of research in this field focuses on suicidal ideation and attempts, rather than on completed suicide. The main goal of this study is to better characterize everyday functioning among young men who later completed suicide. Based on previous literature, we hypothesized that the functioning of adolescents who died by suicide would be poor, compared to controls. The current study is a record-driven study, which examined summaries of screening interviews performed by the Israeli Defense Forces (IDF) of 20 male adolescents who later completed suicide, compared with 20 matched living controls. The current study is a pilot stage of a larger project. The study used unique data, collected as part of the IDF pre-induction process, in the months or years before the tragic outcome. The data were extracted by two psychologists, blinded to the participants׳ suicide or non-suicide outcome, using mixed-method technique, combining qualitative and quantitative analysis. The main findings indicated that, in comparison with controls, male adolescents who later died by suicide were described as having more interpersonal difficulties, were more likely to be involved in violent behavior, had more difficulties in dealing with problems in everyday functioning and had an avoidant conflict resolution style. Functional difficulties are apparent in a wide range of behavioral domains in adolescents who later complete suicide. These findings indicate a need for interventions that might assist young persons, and it is possible that such assistance might reduce the likelihood of suicide. However, because suicide is a rare outcome and these behavioral traits are common in adolescence, the presence of such traits might not be useful in identifying people at risk of suicide. Copyright © 2014 Elsevier B.V. All rights reserved.

  12. Surrogacy: outcomes for surrogate mothers, children and the resulting families-a systematic review.

    PubMed

    Söderström-Anttila, Viveca; Wennerholm, Ulla-Britt; Loft, Anne; Pinborg, Anja; Aittomäki, Kristiina; Romundstad, Liv Bente; Bergh, Christina

    2016-01-01

    Surrogacy is a highly debated method mainly used for treating women with infertility caused by uterine factors. This systematic review summarizes current levels of knowledge of the obstetric, medical and psychological outcomes for the surrogate mothers, the intended parents and children born as a result of surrogacy. PubMed, Cochrane and Embase databases up to February 2015 were searched. Cohort studies and case series were included. Original studies published in English and the Scandinavian languages were included. In case of double publications, the latest study was included. Abstracts only and case reports were excluded. Studies with a control group and case series (more than three cases) were included. Cohort studies, but not case series, were assessed for methodological quality, in terms of risk of bias. We examined a variety of main outcomes for the surrogate mothers, children and intended mothers, including obstetric outcome, relationship between surrogate mother and intended couple, surrogate's experiences after relinquishing the child, preterm birth, low birthweight, birth defects, perinatal mortality, child psychological development, parent-child relationship, and disclosure to the child. The search returned 1795 articles of which 55 met the inclusion criteria. The medical outcome for the children was satisfactory and comparable to previous results for children conceived after fresh IVF and oocyte donation. The rate of multiple pregnancies was 2.6-75.0%. Preterm birth rate in singletons varied between 0 and 11.5% and low birthweight occurred in between 0 and 11.1% of cases. At the age of 10 years there were no major psychological differences between children born after surrogacy and children born after other types of assisted reproductive technology (ART) or after natural conception. The obstetric outcomes for the surrogate mothers were mainly reported from case series. Hypertensive disorders in pregnancy were reported in between 3.2 and 10% of cases and placenta praevia/placental abruption in 4.9%. Cases with hysterectomies have also been reported. Most surrogate mothers scored within the normal range on personality tests. Most psychosocial variables were satisfactory, although difficulties related to handing over the child did occur. The psychological well-being of children whose mother had been a surrogate mother between 5 and 15 years earlier was found to be good. No major differences in psychological state were found between intended mothers, mothers who conceived after other types of ART and mothers whose pregnancies were the result of natural conception. Most studies reporting on surrogacy have serious methodological limitations. According to these studies, most surrogacy arrangements are successfully implemented and most surrogate mothers are well-motivated and have little difficulty separating from the children born as a result of the arrangement. The perinatal outcome of the children is comparable to standard IVF and oocyte donation and there is no evidence of harm to the children born as a result of surrogacy. However, these conclusions should be interpreted with caution. To date, there are no studies on children born after cross-border surrogacy or growing up with gay fathers. © The Author 2015. 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.

  13. Efficacy of the treatment of transarterial chemoembolization combined with radiotherapy for hepatocellular carcinoma with portal vein tumor thrombus: A propensity score analysis.

    PubMed

    Li, Xiao-Long; Guo, Wei-Xing; Hong, Xiao-Dong; Yang, Liang; Wang, Kang; Shi, Jie; Li, Nan; Wu, Meng-Chao; Cheng, Shu-Qun

    2016-10-01

    The survival outcome of patients with unresectable hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT) who received transarterial chemoembolization (TACE) combined with radiotherapy (RT) remains unclear. A total of 112 and 735 HCC patients with PVTT undergoing TACE combined with RT and TACE alone, respectively, were evaluated. One hundred and eight pairs of matched patients were selected from each treatment arm by using a propensity score matching (PSM) analysis. Of the whole study population, TACE combined with RT showed significant survival benefits compared with TACE in all patients (median survival, 11.0 vs 4.8 months; P < 0.001), especially in patients with PVTT involving the right/left portal vein (median survival, 12.5 vs 5.2 months; P < 0.001) and main portal vein trunk (median survival, 8.9 vs 4.3 months; P < 0.001). After one-to-one PSM, 108 pairs of matched patients were selected for further analysis. In the propensity model, the median survival time was 10.9 versus 4.1 months (P < 0.001) in all patients, 12.5 versus 4.4 months (P = 0.002) in patients with PVTT involving the right/left portal vein and 8.9 versus 4.0 months (P < 0.001) in patients with PVTT involving the main portal vein trunk. The treatment, maximum lesion diameter and main trunk PVTT were the independent prognostic factors for survival at uni- and multivariate analysis. TACE combined with RT provides a significantly better survival outcome than TACE for unresectable HCC patients with PVTT, especially for patients with PVTT involving the right/left portal vein or main trunk. © 2016 The Japan Society of Hepatology.

  14. The French health care system: liberal universalism.

    PubMed

    Steffen, Monika

    2010-06-01

    This article analyzes the reforms introduced over the last quarter century into the French health care system. A particular public-private combination, rooted in French history and institutionalized through a specific division of the policy field between private doctors and public hospitals, explains the system's core characteristics: universal access, free choice, high quality, and a weak capacity for regulation. The dual architecture of this unique system leads to different reform strategies and outcomes in its two main parts. While the state has leverage in the hospital sector, it has failed repeatedly in attempts to regulate the ambulatory care sector. The first section of this article sets out the main characteristics and historical landmarks that continue to affect policy framing and implementation. Section 2 focuses on the evolution in financing and access, section 3 on management and governance in the (private) ambulatory care sector, and section 4 on the (mainly public) hospital sector. The conclusion compares the French model with those developed in the comparative literature and sets out the terms of the dilemma: a state-run social health insurance that lacks both the legitimacy of Bismarckian systems and the leverages of state-run systems. The French system therefore pursues contradictory policy goals, simultaneously developing universalism and liberalism, which explains both the direct state intervention and its limits.

  15. Impact of locus of control on clinical outcomes in renal dialysis.

    PubMed

    Dec, Elaine

    2006-01-01

    This study focused on the relationship between patients' locus of control and their ability to improve selected clinical outcomes related to kidney dialysis. The main hypothesis of this study stated that patients who viewed themselves as having control over their situation would be more successful at improving targeted clinical outcomes than those who believed someone other than themselves had control over their situation. The study found that interventions aimed at increasing awareness of who has control and reducing the aspect of chance had a more significant positive impact on outcomes than did pure cognitive or educational interventions geared mainly toward emotional issues or educational deficits. Interventions that work with the dominant locus of control to increase awareness of where control lies appeared to be more effective in assisting the patients to improve their targeted clinical outcomes rather than are interventions to change the locus of control between internal and powerful others (external).

  16. Short- and long-term outcomes after enucleation of pancreatic tumors: An evidence-based assessment.

    PubMed

    Zhou, Yanming; Zhao, Min; Wu, Lupeng; Ye, Feng; Si, Xiaoying

    Enucleation of pancreatic tumors is rarely performed. The aim of this study was to evaluate the published evidence for its short- and long-term outcomes. PubMed (MEDLINE) and EMBASE databases were searched from 1990 to March 2016. Studies including at least ten patients who underwent enucleation of pancreatic lesions were included. Data on the outcomes were synthesized and meta-analyzed where appropriate. Twenty-seven studies involving 1316 patients were included in the systematic review. The postoperative mortality was 0.3%, and the postoperative morbidity was 50.3%, mainly represented by pancreatic fistula (38.1%). Endocrine insufficiency, exocrine insufficiency and tumor recurrence was observed in 2.4%, 1.1% and 2.3% of the patients respectively. Compared with typical resection, the operation time, blood loss, length of hospital stay, and the incidence of endocrine and exocrine insufficiency were all significantly reduced after enucleation. The occurrence of pancreatic fistula was significantly higher in enucleation group, but overall morbidity, the reoperation rate and mortality were comparable between the two groups. There was no significant difference in disease recurrence between the two groups. Compared with central pancreatectomy, enucleation had a shorter operation time, lower blood loss, less morbidity, and better pancreatic function. Compared with open enucleation, minimally invasive enucleation had a shorter operation time and a shorter length of hospital stay. Enucleation is an appropriate surgical procedure in selected patients with benign or low-malignant lesions of the pancreas. The benefits of minimally invasive approach need to be validated in further investigations with larger groups of patients. Copyright © 2016 IAP and EPC. Published by Elsevier B.V. All rights reserved.

  17. Gulf war illness—better, worse, or just the same? A cohort study

    PubMed Central

    Hotopf, Matthew; David, Anthony S; Hull, Lisa; Nikalaou, Vasilis; Unwin, Catherine; Wessely, Simon

    2003-01-01

    Objectives Firstly, to describe changes in the health of Gulf war veterans studied in a previous occupational cohort study and to compare outcome with comparable non-deployed military personnel. Secondly, to determine whether differences in prevalence between Gulf veterans and controls at follow up can be explained by greater persistence or greater incidence of disorders. Design Occupational cohort study in the form of a postal survey. Participants Military personnel who served in the 1991 Persian Gulf war; personnel who served on peacekeeping duties to Bosnia; military personnel who were deployed elsewhere (“Era” controls). All participants had responded to a previous survey. Setting United Kingdom. Main outcome measures Self reported fatigue measured on the Chalder fatigue scale; psychological distress measured on the general health questionnaire, physical functioning and health perception on the SF-36; and a count of physical symptoms. Results Gulf war veterans experienced a modest reduction in prevalence of fatigue (48.8% at stage 1, 43.4% at stage 2) and psychological distress (40.0% stage 1, 37.1% stage 2) but a slight worsening of physical functioning on the SF-36 (90.3 stage 1, 88.7 stage 2). Compared with the other cohorts Gulf veterans continued to experience poorer health on all outcomes, although physical functioning also declined in Bosnia veterans. Era controls showed both lower incidence of fatigue than Gulf veterans, and both comparison groups showed less persistence of fatigue compared with Gulf veterans. Conclusions Gulf war veterans remain a group with many symptoms of ill health. The excess of illness at follow up is explained by both higher incidence and greater persistence of symptoms. PMID:14670878

  18. Outcomes Evaluation of a Weekly Nurse Practitioner-Managed Symptom Management Clinic for Patients With Head and Neck Cancer Treated With Chemoradiotherapy

    PubMed Central

    Mason, Heidi; DeRubeis, Mary Beth; Foster, Jared C.; Taylor, Jeremy M.G.; Worden, Francis P.

    2016-01-01

    Purpose/Objectives To determine whether improved monitoring through close follow-up with a nurse practitioner (NP) could enhance treatment compliance and decrease frequency of hospitalizations. Design Retrospective chart review. Setting An academic National Cancer Institute–designated comprehensive cancer center. Sample 151 patients aged 45–65 years diagnosed with stage III or IV oropharyngeal cancer. Methods Patients were nonrandomized to one of two groups: a prechemotherapy clinic group and a weekly NP-led clinic group. After examination of descriptive statistics, multiple linear and logistic regressions were used to compare groups across patient outcomes. Main Research Variables Hospitalization, chemotherapy dose deviations, and chemotherapy treatment completion. Findings The average number of visits during traditional treatment was three and, after initiation of the NP-led clinic, the number was six. The hospitalization rate was 28% in the traditional clinic group compared to 12% in the NP-led group. The rate of chemotherapy dose deviations was 48% in the traditional clinic group compared to 6% in the NP-led clinic group. Forty-six percent of patients in the traditional clinic group received the full seven scheduled doses of chemotherapy compared to 90% of patients seen in the NP-led clinic group. Conclusions A weekly NP-led symptom management clinic reduces rates of hospitalization and chemotherapy dose deviations and increases chemotherapy completion in patients receiving intensive chemoradiotherapy for oropharyngeal cancer. Implications for Nursing Patients receiving chemoradiotherapy benefit from close monitoring for toxicities by NPs to successfully complete their treatment and avoid hospitalization. Knowledge Translation Early interventions to manage toxicities in patients with head and neck cancer can improve outcomes. NPs are in a key position to manage these toxicities and, when symptoms are controlled, costs are reduced. PMID:24007925

  19. Stapled hemorrhoidopexy, an innovative surgical procedure for hemorrhoidal prolapse: cost-utility analysis.

    PubMed

    Ribarić, Goran; Kofler, Justus; Jayne, David G

    2011-08-15

    To undertake full economic evaluation of stapled hemorrhoidopexy (PPH) to establish its cost-effectiveness and investigate whether PPH can become cost-saving compared to conventional excisional hemorrhoidectomy (CH). A cost-utility analysis in hospital and health care system (UK) was undertaken using a probabilistic, cohort-based decision tree to compare the use of PPH with CH. Sensitivity analyses allowed showing outcomes in regard to the variations in clinical practice of PPH procedure. The participants were patients undergoing initial surgical treatment of third and fourth degree hemorrhoids within a 1-year time-horizon. Data on clinical effectiveness were obtained from a systematic review of the literature. Main outcome measures were the cost per procedure at the hospital level, total direct costs from the health care system perspective, quality adjusted life years (QALY) gained and incremental cost per QALY gained. A decrease in operating theater time and hospital stay associated with PPH led to a cost saving compared to CH of GBP 27 (US $43.11, €30.50) per procedure at the hospital level and to an incremental cost of GBP 33 (US $52.68, €37.29) after one year from the societal perspective. Calculation of QALYs induced an incremental QALY of 0.0076 and showed an incremental cost-effective ratio (ICER) of GBP 4316 (US $6890.47, €4878.37). Taking into consideration recent literature on clinical outcomes, PPH becomes cost saving compared to CH for the health care system. PPH is a cost-effective procedure with an ICER of GBP 4136 and it seems that an innovative surgical procedure could be cost saving in routine clinical practice.

  20. Unilateral or bilateral laparoscopic ovarian drilling in polycystic ovary syndrome: a meta-analysis of randomized trials.

    PubMed

    Abu Hashim, Hatem; Foda, Osama; El Rakhawy, Mohamed

    2018-04-01

    This systematic review and meta-analysis aimed to compare the effectiveness of unilateral vs. bilateral laparoscopic ovarian drilling (ULOD vs. BLOD) for improving fertility outcomes in infertile women with clomiphene-resistant polycystic ovary syndrome (PCOS) as well as its effect on ovarian reserve. Searches were conducted on PubMed, ScienceDirect, ClinicalTrials.gov, and CENTRAL databases from January 1984 to January 2017. Only randomized trials comparing ULOD with BLOD were included. The PRISMA Statement was followed. Main outcomes were ovulation and clinical pregnancy rates per woman randomized. Secondary outcomes were; live birth and miscarriage rates as well as postoperative serum anti-mullerian hormone (AMH) concentration and antral follicle count (AFC). Quality assessment was performed by the Cochrane Collaboration risk of bias tool. Eight eligible trials (484 women) were analyzed. No significant difference was found in rates of ovulation (OR 0.73; 95% CI 0.47-1.11), clinical pregnancy (OR 0.56; 95% CI 0.22-1.41), live birth (OR 0.77; 95% CI 0.28-2.10), or miscarriage (OR 0.90; 95% CI 0.33-2.84) when ULOD was compared with BLOD. The reduction in AMH was comparable between the two procedures (MD 0.64 ng/ml; 95% CI - 0.08 to 1.36). A significantly higher AFC at 6-month follow-up was found with dose-adjusted ULOD (MD 2.20; 95% CI 1.01-3.39). After carefully weighing up the well-known benefits of BLOD against a potential risk to ovarian reserve, clinicians could be advised to offer the fixed-dose ULOD to their infertile patients with clomiphene-resistant PCOS. This is concordant with the "primum non nocere" principal if LOD will be envisaged.

  1. The relationship of undernutrition/psychosocial factors and developmental outcomes of children in extreme poverty in Ethiopia.

    PubMed

    Worku, Berhanu Nigussie; Abessa, Teklu Gemechu; Wondafrash, Mekitie; Vanvuchelen, Marleen; Bruckers, Liesbeth; Kolsteren, Patrick; Granitzer, Marita

    2018-02-09

    Extreme poverty is severe deprivation of basic needs and services. Children living in extreme poverty may lack adequate parental care and face increased developmental and health risks. However, there is a paucity of literature on the combined influences of undernutrition and psychosocial factors (such as limited play materials, playground, playtime, interactions of children with their peers and mother-child interaction) on children's developmental outcomes. The main objective of this study was, therefore, to ascertain the association of developmental outcomes and psychosocial factors after controlling nutritional indices. A community-based cross-sectional study design was used to compare the developmental outcomes of extremely poor children (N = 819: 420 girls and 399 boys) younger than 5 years versus age-matched reference children (N = 819: 414 girls and 405 boys) in South-West Ethiopia. Using Denver II-Jimma, development in personal-social, language, fine and gross motor skills were assessed, and social-emotional skills were evaluated using the Ages and Stages Questionnaires: Social-Emotional (ASQ: SE). Nutritional status was derived from the anthropometric method. Independent samples t-test was used to detect mean differences in developmental outcomes between extremely poor and reference children. Multiple linear regression analysis was employed to identify nutritional and psychosocial factors associated with the developmental scores of children in extreme poverty. Children in extreme poverty performed worse in all the developmental domains than the reference children. Among the 819 extremely poor children, 325 (39.7%) were stunted, 135 (16.5%) were underweight and 27 (3.3%) were wasted. The results also disclosed that stunting and underweightness were negatively associated with all the developmental skills. After taking into account the effects of stunting and being underweight on the developmental scores, it was observed that limited play activities, limited child-to-child interactions and mother-child relationships were negatively related mainly to gross motor and language performances of children in extreme poverty. Undernutrition and psychosocial factors were negatively related to the developmental outcomes, independently, of children living in extreme poverty. Intervention, for these children, should integrate home-based play-assisted developmental stimulation and nutritional rehabilitation.

  2. Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression.

    PubMed

    Roseman, Leor; Nutt, David J; Carhart-Harris, Robin L

    2017-01-01

    Introduction: It is a basic principle of the "psychedelic" treatment model that the quality of the acute experience mediates long-term improvements in mental health. In the present paper we sought to test this using data from a clinical trial assessing psilocybin for treatment-resistant depression (TRD). In line with previous reports, we hypothesized that the occurrence and magnitude of Oceanic Boundlessness (OBN) (sharing features with mystical-type experience) and Dread of Ego Dissolution (DED) (similar to anxiety) would predict long-term positive outcomes, whereas sensory perceptual effects would have negligible predictive value. Materials and Methods: Twenty patients with treatment resistant depression underwent treatment with psilocybin (two separate sessions: 10 and 25 mg psilocybin). The Altered States of Consciousness (ASC) questionnaire was used to assess the quality of experiences in the 25 mg psilocybin session. From the ASC, the dimensions OBN and DED were used to measure the mystical-type and challenging experiences, respectively. The Self-Reported Quick Inventory of Depressive Symptoms (QIDS-SR) at 5 weeks served as the endpoint clinical outcome measure, as in later time points some of the subjects had gone on to receive new treatments, thus confounding inferences. In a repeated measure ANOVA, Time was the within-subject factor (independent variable), with QIDS-SR as the within-subject dependent variable in baseline, 1-day, 1-week, 5-weeks. OBN and DED were independent variables. OBN-by-Time and DED-by-Time interactions were the primary outcomes of interest. Results: For the interaction of OBN and DED with Time (QIDS-SR as dependent variable), the main effect and the effects at each time point compared to baseline were all significant ( p = 0.002 and p = 0.003, respectively, for main effects), confirming our main hypothesis. Furthermore, Pearson's correlation of OBN with QIDS-SR (5 weeks) was specific compared to perceptual dimensions of the ASC ( p < 0.05). Discussion: This report further bolsters the view that the quality of the acute psychedelic experience is a key mediator of long-term changes in mental health. Future therapeutic work with psychedelics should recognize the essential importance of quality of experience in determining treatment efficacy and consider ways of enhancing mystical-type experiences and reducing anxiety. Trial Registration: ISRCTN, number ISRCTN14426797, http://www.isrctn.com/ISRCTN14426797.

  3. Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression

    PubMed Central

    Roseman, Leor; Nutt, David J.; Carhart-Harris, Robin L.

    2018-01-01

    Introduction: It is a basic principle of the “psychedelic” treatment model that the quality of the acute experience mediates long-term improvements in mental health. In the present paper we sought to test this using data from a clinical trial assessing psilocybin for treatment-resistant depression (TRD). In line with previous reports, we hypothesized that the occurrence and magnitude of Oceanic Boundlessness (OBN) (sharing features with mystical-type experience) and Dread of Ego Dissolution (DED) (similar to anxiety) would predict long-term positive outcomes, whereas sensory perceptual effects would have negligible predictive value. Materials and Methods: Twenty patients with treatment resistant depression underwent treatment with psilocybin (two separate sessions: 10 and 25 mg psilocybin). The Altered States of Consciousness (ASC) questionnaire was used to assess the quality of experiences in the 25 mg psilocybin session. From the ASC, the dimensions OBN and DED were used to measure the mystical-type and challenging experiences, respectively. The Self-Reported Quick Inventory of Depressive Symptoms (QIDS-SR) at 5 weeks served as the endpoint clinical outcome measure, as in later time points some of the subjects had gone on to receive new treatments, thus confounding inferences. In a repeated measure ANOVA, Time was the within-subject factor (independent variable), with QIDS-SR as the within-subject dependent variable in baseline, 1-day, 1-week, 5-weeks. OBN and DED were independent variables. OBN-by-Time and DED-by-Time interactions were the primary outcomes of interest. Results: For the interaction of OBN and DED with Time (QIDS-SR as dependent variable), the main effect and the effects at each time point compared to baseline were all significant (p = 0.002 and p = 0.003, respectively, for main effects), confirming our main hypothesis. Furthermore, Pearson's correlation of OBN with QIDS-SR (5 weeks) was specific compared to perceptual dimensions of the ASC (p < 0.05). Discussion: This report further bolsters the view that the quality of the acute psychedelic experience is a key mediator of long-term changes in mental health. Future therapeutic work with psychedelics should recognize the essential importance of quality of experience in determining treatment efficacy and consider ways of enhancing mystical-type experiences and reducing anxiety. Trial Registration: ISRCTN, number ISRCTN14426797, http://www.isrctn.com/ISRCTN14426797 PMID:29387009

  4. Randomised controlled feasibility trial of a web-based weight management intervention with nurse support for obese patients in primary care

    PubMed Central

    2014-01-01

    Background There is a need for cost-effective weight management interventions that primary care can deliver to reduce the morbidity caused by obesity. Automated web-based interventions might provide a solution, but evidence suggests that they may be ineffective without additional human support. The main aim of this study was to carry out a feasibility trial of a web-based weight management intervention in primary care, comparing different levels of nurse support, to determine the optimal combination of web-based and personal support to be tested in a full trial. Methods This was an individually randomised four arm parallel non-blinded trial, recruiting obese patients in primary care. Following online registration, patients were randomly allocated by the automated intervention to either usual care, the web-based intervention only, or the web-based intervention with either basic nurse support (3 sessions in 3 months) or regular nurse support (7 sessions in 6 months). The main outcome measure (intended as the primary outcome for the main trial) was weight loss in kg at 12 months. As this was a feasibility trial no statistical analyses were carried out, but we present means, confidence intervals and effect sizes for weight loss in each group, uptake and retention, and completion of intervention components and outcome measures. Results All randomised patients were included in the weight loss analyses (using Last Observation Carried Forward). At 12 months mean weight loss was: usual care group (n = 43) 2.44 kg; web-based only group (n = 45) 2.30 kg; basic nurse support group (n = 44) 4.31 kg; regular nurse support group (n = 47) 2.50 kg. Intervention effect sizes compared with usual care were: d = 0.01 web-based; d = 0.34 basic nurse support; d = 0.02 regular nurse support. Two practices deviated from protocol by providing considerable weight management support to their usual care patients. Conclusions This study demonstrated the feasibility of delivering a web-based weight management intervention supported by practice nurses in primary care, and suggests that the combination of the web-based intervention with basic nurse support could provide an effective solution to weight management support in a primary care context. Trial registration Current Controlled Trials ISRCTN31685626. PMID:24886516

  5. The influence of body mass index to in-vitro fertilisation treatment outcome, risk of miscarriage and pregnancy outcome.

    PubMed

    Thum, M Y; El-Sheikhah, A; Faris, R; Parikh, J; Wren, M; Ogunyemi, T; Gafar, A; Abdalla, H

    2007-10-01

    The aim of this work was to evaluate the effects of extreme body mass index (BMI) on assisted reproductive treatment outcome and pregnancy outcome. This is a descriptive cohort study that evaluated 8,145 consecutive in-vitro fertilisation/intracytoplasmic sperm injection-embryo transfer (IVF/ICSI-ET) cycles in which BMI were known, from July 1997 to June 2005 in an inner London major fertility clinic. The data were collected prospectively and analysed retrospectively on women undergoing IVF/ICSI and ET. Patients' weight and height were established prior to treatment. IVF/ICSI treatment was then started using either a long or an antagonist protocol. Patients were divided into five groups: Group A (BMI < 19); Group B (BMI between 19 and 25.9); Group C (BMI between 26 and 30.9); Group D (BMI between 31 and 35.9); Group E (BMI > 36). The main outcomes measured were number of eggs collected, fertilisation rate, number of embryos available for transfer, pregnancy rate (PR), live-birth rate (LBR) and miscarriage rate (MR). The results showed no significant difference in the average number of days taking follicle stimulating hormone (FSH) for ovarian stimulation, the average amount of gonadotrophin used for stimulation, number of eggs collected and fertilisation rate. The pregnancy rate, miscarriage rate and the live-birth rate were not statistically different between all groups. However, in group E the miscarriage rate was significantly higher and the LBR was statistically lower compared with group B. We concluded that extreme BMI did not affect the super-ovulation outcome fertilisation rate and pregnancy rate. Women with a BMI > 35 had a higher miscarriage rate and hence a lower live-birth rate, but a reasonable pregnancy and live-birth rate can be achieved. For women with a BMI < 20 there was no difference in assisted reproduction treatment (ART) outcome and pregnancy outcome when compared with women with a normal BMI. This information should be used to advise patients who wish to embark on ART with extreme BMI.

  6. Establishing Long-Term Efficacy in Chronic Disease: Use of Recursive Partitioning and Propensity Score Adjustment to Estimate Outcome in MS

    PubMed Central

    Goodin, Douglas S.; Jones, Jason; Li, David; Traboulsee, Anthony; Reder, Anthony T.; Beckmann, Karola; Konieczny, Andreas; Knappertz, Volker

    2011-01-01

    Context Establishing the long-term benefit of therapy in chronic diseases has been challenging. Long-term studies require non-randomized designs and, thus, are often confounded by biases. For example, although disease-modifying therapy in MS has a convincing benefit on several short-term outcome-measures in randomized trials, its impact on long-term function remains uncertain. Objective Data from the 16-year Long-Term Follow-up study of interferon-beta-1b is used to assess the relationship between drug-exposure and long-term disability in MS patients. Design/Setting To mitigate the bias of outcome-dependent exposure variation in non-randomized long-term studies, drug-exposure was measured as the medication-possession-ratio, adjusted up or down according to multiple different weighting-schemes based on MS severity and MS duration at treatment initiation. A recursive-partitioning algorithm assessed whether exposure (using any weighing scheme) affected long-term outcome. The optimal cut-point that was used to define “high” or “low” exposure-groups was chosen by the algorithm. Subsequent to verification of an exposure-impact that included all predictor variables, the two groups were compared using a weighted propensity-stratified analysis in order to mitigate any treatment-selection bias that may have been present. Finally, multiple sensitivity-analyses were undertaken using different definitions of long-term outcome and different assumptions about the data. Main Outcome Measure Long-Term Disability. Results In these analyses, the same weighting-scheme was consistently selected by the recursive-partitioning algorithm. This scheme reduced (down-weighted) the effectiveness of drug exposure as either disease duration or disability at treatment-onset increased. Applying this scheme and using propensity-stratification to further mitigate bias, high-exposure had a consistently better clinical outcome compared to low-exposure (Cox proportional hazard ratio = 0.30–0.42; p<0.0001). Conclusions Early initiation and sustained use of interferon-beta-1b has a beneficial impact on long-term outcome in MS. Our analysis strategy provides a methodological framework for bias-mitigation in the analysis of non-randomized clinical data. Trial Registration Clinicaltrials.gov NCT00206635 PMID:22140424

  7. Cross-cultural comparison of the Scoliosis Research Society Outcomes Instrument between American and Japanese idiopathic scoliosis patients: are there differences?

    PubMed

    Watanabe, Kei; Lenke, Lawrence G; Bridwell, Keith H; Hasegawa, Kazuhiro; Hirano, Toru; Endo, Naoto; Cheh, Gene; Kim, Yongjung J; Hensley, Marsha; Stobbs, Georgia; Koester, Linda

    2007-11-15

    A comparative study. To report a preliminary evaluation of the Scoliosis Research Society Outcomes Instrument (SRS-24) and determine whether differences in baseline scores exist between American and Japanese patients with idiopathic scoliosis. Because the SRS outcomes instrument was primarily introduced for the American population, baseline scores in the Japanese population might differ from the American population. A comparative study using the SRS instrument between American and Japanese patients with idiopathic scoliosis has not been reported. Two comparable groups of 100 idiopathic scoliosis patients before spinal fusion were separated into American (A) and Japanese (J). There were no statistically significant differences between the groups for gender (A: 9 men/91 women vs. J: 13 men/87 women), age (A: 15.0 +/- 2.4 vs. J: 14.9 +/- 3.8), main curve location (A: 77 thoracic/23 lumbar, J: 76 thoracic/24 lumbar), main curve Cobb angle (A: 50.5 +/- 5.2 vs. J: 51.1 +/- 8.7), and thoracic kyphosis (A: 20.9 +/- 14.3 vs. J: 19.9 +/- 12.1) (P > 0.05, for all comparisons). Patients were evaluated using the first section of the SRS-24 which was divided into 4 domains: total pain, general self-image, general function, and activity. SRS-24 scores were statistical compared in individual domains and questions using the Mann-Whitney U test. American patients had significantly lower scores in pain (P < 0.0001, A: 3.7 +/- 0.8 vs. J: 4.3 +/- 0.4), function (P < 0.01, A: 3.9 +/- 0.6 vs. J: 4.2 +/- 0.5), and activity (P < 0.0001, A: 4.5 +/- 0.8 vs. J: 4.9 +/- 0.3) domains compared with Japanese patients. Japanese patients had significantly lower scores in the self-image (P < 0.0001, A: 4.0 +/- 0.7 vs. J: 3.5 +/- 0.5) domain. With regard to individual questions, there were significant differences in the scores between the 2 groups for all questions except 5 and 13 (P < 0.05, for all comparisons). SRS-24 scores in the Japanese idiopathic scoliosis population differed from that of the American population. Japanese patients had less back pain, a negative self-image regarding back deformity, higher general physical function, and daily activity. It is highly probable that patient's perceptions differ due to cultural differences, which affect SRS-24 scores so a cross-cultural comparison of the SRS instrument content is necessary in the future.

  8. Therapist strategies early in therapy associated with good or poor outcomes among clients with low proactive agency.

    PubMed

    von der Lippe, Anna Louise; Oddli, Hanne Weie; Halvorsen, Margrethe Seeger

    2017-09-10

    Within a mixed methods program of research the present study aimed at expanding knowledge about interactions in the initial therapeutic collaboration by combining focus on client interpersonal style and therapist contribution. The study involves in-depth analyses of therapist-client interactions in the initial two sessions of good and poor outcome therapies. Based on interpersonal theory and previous research, the Inventory of Interpersonal Problems (IIP-64-C) was used to define poor outcome cases, that is, low proactive agency cases. To compare good and poor outcome cases matched on this interpersonal pattern, cases were drawn from two different samples; nine poor outcome cases from a large multi-site outpatient clinic study and nine good outcome cases from a process-outcome study of highly experienced therapists. Qualitative analysis of therapist behaviors resulted in 2 main categories, fostering client's proactive agentic involvement in change work and discouraging client's proactive agentic involvement in change work, 8 categories and 22 sub-categories. The findings revealed distinct and cohesive differences in therapist behaviors between the two outcome groups, and point to the particular therapist role of fostering client agency through engagement in a shared work on change when clients display strong unassertiveness and low readiness for change. Clinical or Methodological Significance Summary: The present analysis combines focus on client interpersonal style, therapist strategies/process and outcome. The categories generated from the present grounded theory analysis may serve as a foundation for identifying interactions that are associated with agentic involvement in future process research and practice, and hence we have formulated principles/strategies that were identified by the analysis.

  9. Urinary tract infection in children after cardiac surgery: Incidence, causes, risk factors and outcomes in a single-center study.

    PubMed

    Kabbani, Mohamed S; Ismail, Sameh R; Fatima, Anis; Shafi, Rehana; Idris, Julinar A; Mehmood, Akhter; Singh, Reetam K; Elbarabry, Mahmoud; Hijazi, Omar; Hussein, Mohamed A

    2016-01-01

    Nosocomial urinary tract infection (UTI) increases hospitalization, cost and morbidity. In this cohort study, we aimed to determine the incidence, risk factors, etiology and outcomes of UTIs in post-operative cardiac children. To this end, we studied all post-operative patients admitted to the Pediatric Cardiac Intensive Care Unit (PCICU) in 2012, and we divided the patients into two groups: the UTI (UTI group) and the non-UTI (control group). We compared both groups for multiple peri-operative risk factors. We included 413 children in this study. Of these, 29 (7%) had UTIs after cardiac surgery (UTI group), and 384 (93%) were free from UTIs (control group). All UTI cases were catheter-associated UTIs (CAUTIs). A total of 1578 urinary catheter days were assessed in this study, with a CAUTI density rate of 18 per 1000 catheter days. Multivariate logistic regression analysis demonstrated the following risk factors for CAUTI development: duration of urinary catheter placement (p<0.001), presence of congenital abnormalities of kidney and urinary tract (CAKUT) (p<0.0041) and the presence of certain syndromes (Down, William, and Noonan) (p<0.02). Gram-negative bacteria accounted for 63% of the CAUTI. The main causes of CAUTI were Klebsiella (27%), Candida (24%) and Escherichia coli (21%). Resistant organisms caused 34% of CAUTI. Two patients (7%) died in the UTI group compared with the one patient (0.3%) who died in the control group (p<0.05). Based on these findings, we concluded that an increased duration of the urinary catheter, the presence of CAKUT, and the presence of syndromes comprised the main risk factors for CAUTI. Gram-negative organisms were the main causes for CAUTI, and one-third of them found to be resistant in this single-center study. Copyright © 2016 King Saud Bin Abdulaziz University for Health Sciences. Published by Elsevier Ltd. All rights reserved.

  10. Dynamic Assessment and Response to Intervention

    PubMed Central

    Grigorenko, Elena L.

    2013-01-01

    This article compares and contrasts the main features of dynamic testing and assessment (DT/A) and response to intervention (RTI). The comparison is carried out along the following lines: (a) historical and empirical roots of both concepts, (b) premises underlying DT/A and RTI, (c) terms used in these concepts, (d) use of these concepts, (e) evidence in support of DT/A and RTI, and (f) expectations associated with each of the concepts. The main outcome of this comparison is a conclusion that both approaches belong to one family of methodologies in psychology and education whose key feature is in blending assessment and intervention in one holistic activity. Because DT/A has been around much longer than RTI, it makes sense for the proponents of RTI to consider both the accomplishments and frustrations that have accumulated in the field of DT/A. PMID:19073895

  11. Optimization of educational paths for higher education

    NASA Astrophysics Data System (ADS)

    Tarasyev, Alexandr A.; Agarkov, Gavriil; Medvedev, Aleksandr

    2017-11-01

    In our research, we combine the theory of economic behavior and the methodology of increasing efficiency of the human capital to estimate the optimal educational paths. We provide an optimization model for higher education process to analyze possible educational paths for each rational individual. The preferences of each rational individual are compared to the best economically possible educational path. The main factor of the individual choice, which is formed by the formation of optimal educational path, deals with higher salaries level in the chosen economic sector after graduation. Another factor that influences on the economic profit is the reduction of educational costs or the possibility of the budget support for the student. The main outcome of this research consists in correction of the governmental policy of investment in human capital based on the results of educational paths optimal control.

  12. Outcome of cataract surgery at one year in Kenya, the Philippines and Bangladesh.

    PubMed

    Lindfield, R; Kuper, H; Polack, S; Eusebio, C; Mathenge, W; Wadud, Z; Rashid, A M; Foster, A

    2009-07-01

    To assess the change in vision following cataract surgery in Kenya, Bangladesh and the Philippines and to identify causes and predictors of poor outcome. Cases were identified through surveys, outreach and clinics. They underwent preoperative visual acuity measurement and ophthalmic examination. Cases were re-examined 8-15 months after cataract surgery. Information on age, gender, poverty and literacy was collected at baseline. 452 eyes of 346 people underwent surgery. 124 (27%) eyes had an adverse outcome. In Kenya and the Philippines, the main cause of adverse outcome was refractive error (37% and 49% respectively of all adverse outcomes) then comorbid ocular disease (26% and 27%). In Bangladesh, this was comorbid disease (58%) then surgical complications (21%). There was no significant association between adverse outcome and gender, age, literacy, poverty or preoperative visual acuity. Adverse outcomes following cataract surgery were frequent in the three countries. Main causes were refractive error and preoperative comorbidities. Many patients are not attaining the outcomes available with modern surgery. Focus should be on correcting refractive error, through operative techniques or postoperative refraction, and on a system for assessing comorbidities and communicating risk to patients. These are only achievable with a commitment to ongoing surgical audit.

  13. Operative outcomes of adult living donor liver transplantation and deceased donor liver transplantation: a systematic review and meta-analysis.

    PubMed

    Wan, Ping; Yu, Xin; Xia, Qiang

    2014-04-01

    Living donor liver transplantation (LDLT) has emerged as an alternative to deceased donor liver transplantation (DDLT) because of the increasing number of patients waiting for liver transplantation (LT). However, whether it can achieve operative outcomes similar to those achieved with DDLT for adult patients remains controversial. We conducted this meta-analysis to compare the operative outcomes of LDLT and DDLT recipients. A literature search was performed to identify clinical controlled studies comparing LDLT and DDLT that were published before October 2013. Four perioperative outcomes [duration of the recipient operation (DRO), red blood cell (RBC) transfusion requirement, length of the hospital stay, and cold ischemia time (CIT)] and 5 postoperative complication outcomes (biliary complications, vascular complications, intra-abdominal bleeding, perioperative death, and retransplantation) were the main outcomes assessed. Nineteen studies with a total of 5450 patients were included in the meta-analysis. In comparison with DDLT, LDLT was associated with a significantly longer DRO and a shorter CIT. We found that biliary complications [odds ratio (OR) = 3.08, 95% confidence interval (CI) = 1.97-4.81, P < 0.001], vascular complications (OR = 2.16, 95% CI = 1.32-3.54, P = 0.002), and retransplantation (OR = 1.76, 95% CI = 1.09-2.83, P = 0.02) occurred more frequently for LDLT recipients, and the subgroup analysis indicated that the biliary complication rate decreased dramatically with greater LDLT experience. No significant difference was observed in RBC transfusion requirements, the lengths of hospital stays, intra-abdominal bleeding rates, or perioperative mortality between LDLT and DDLT recipients. In conclusion, LDLT is associated with a higher rate of surgical complications after transplantation. A reduction of postoperative complication rates can be achieved as centers gain greater experience with LDLT. However, LDLT is still an excellent alternative to DDLT because it facilitates access to LT. © 2014 American Association for the Study of Liver Diseases.

  14. Treatment patterns, symptom reduction, quality of life, and resource use associated with lubiprostone in irritable bowel syndrome constipation subtype.

    PubMed

    Solem, Caitlyn T; Patel, Haridarshan; Mehta, Sonam; Mody, Reema; Macahilig, Cynthia; Gao, Xin

    2016-05-01

    Objectives Real-world patient outcomes data is scarce concerning the high disease burden of IBS-C. The aim of this study was to compare patient-reported symptom control, health-related quality of life (HRQoL), resource utilization, and treatment satisfaction of lubiprostone vs non-lubiprostone treatment for irritable bowel syndrome-constipation (IBS-C). Research design and methods An observational, retrospective US chart review and computer-assisted telephone patient survey was conducted March to August 2013 recruiting women over 18 years old with physician-confirmed IBS-C who had initiated new treatment from inadequate relief of previous treatments and who had been on the new treatment ≥3 months. Multiple IBS-C treatments were permitted. IBS-C severity, time since diagnosis, age, and race were controlled using inverse probability of treatment weighting. Weighted outcomes were compared using t-tests (continuous outcomes) and chi-squared tests (categorical outcomes). Main outcomes measures Instruments included Patient Assessment of Constipation Symptoms (PAC-SYM) and IBS quality of life (IBS-QoL). A single item assessed current treatment satisfaction. Results Of 162 patients (mean age 45.9 [SD 15.3] years old, 71% white, 61.1% with moderate IBS-C), 76 switched to lubiprostone and 86 to non-lubiprostone. Groups were similar in clinical and demographic characteristics and previous 30 day IBS-C treatment. After weighting, all PAC-SYM scores were lower for lubiprostone (P < 0.05). All IBS-QoL subscales were higher for lubiprostone including overall, dysphoria, social reaction, sexual, and relationship scores (P < 0.05.) More lubiprostone patients reported positive treatment satisfaction (92.3% vs 71.0%, P < 0.001). Conclusions In IBS-C patients with inadequate response to previous therapies, lubiprostone improved patient-reported symptom control, treatment satisfaction, and HRQoL. Key limitations include lack of measurement of patient-reported outcomes at treatment start and potential data gaps in chart documentation.

  15. The Effect of Advancing Age on Total Joint Replacement Outcomes

    PubMed Central

    Noiseux, Nicolas; Linson, Eric; Cram, Peter

    2015-01-01

    Objective: To describe age-related differences in outcomes among older adults undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). Design: Retrospective study. Participants: A total of 1792 patients who underwent primary THA or TKA at the University of Iowa Hospitals and Clinics between 2010 and 2013 were identified in the University HealthSystem Consortium Database and University of Iowa Orthopedics Joint Replacement Registry. Main Outcome Measures: Hospital length of stay (LOS), 30-day readmission rate, in-hospital mortality, number of days admitted to intensive care unit (ICU discharge disposition), in-hospital complications (pulmonary embolism, deep vein thrombosis, wound infection, hemorrhage, sepsis, or myocardial infarction), quality of life (measured using Short-Form 36 [SF-36]), discharge disposition (home, home with home health, nursing home, inpatient rehabilitation, transfer to another acute care hospital, and dead), and total patient level observed hospital cost (based on hospital charge information from each revenue code and estimated labor costs). Outcomes were compared in patients stratified by age and categorized by decade (ie, ≤50, 51-60, 61-70, 71-80, and ≥81). Results: A total of 871 THAs and 921 TKAs were performed. The mean age of our cohort was 60.5 years and 56.1% were women. In-hospital complication rates and ICU utilization progressively increased with increasing age. There was also a higher likelihood of skilled nursing facility placement and longer LOS. There was no increase in 30-day readmissions, mortality, or total cost. Improvements in patient reported outcomes (SF-36) scores were similar for all age-groups. Conclusions: Compared to younger patients, older THA and TKA recipients were more likely to experience postoperative complications, admission to the ICU, discharge to a skilled care facility, and had longer hospital LOS. Improvements in patient-related outcomes were similar across all age-groups. These findings may be helpful when counseling older patients regarding elective total joint arthroplasty. PMID:26328232

  16. Acute Kidney Injury in Pediatric Severe Sepsis, An Independent Risk Factor for Death and New Disability

    PubMed Central

    Fitzgerald, Julie C.; Basu, Rajit; Akcan-Arikan, Ayse; Izquierdo, Ledys M.; Piñeres Olave, Byron E.; Hassinger, Amanda B.; Szczepanska, Maria; Deep, Akash; Williams, Duane; Sapru, Anil; Roy, Jason A.; Nadkarni, Vinay M.; Thomas, Neal J.; Weiss, Scott L.; Furth, Susan

    2017-01-01

    Objective The prevalence of septic acute kidney injury (AKI) and impact on functional status of pediatric intensive care unit (PICU) survivors are unknown. We utilized data from an international prospective severe sepsis study to elucidate functional outcomes of children suffering septic AKI. Design Secondary analysis of patients in the Sepsis PRevalence, OUtcomes, and Therapies (SPROUT) point prevalence study. AKI was defined on the study day using Kidney Disease Improving Global Outcomes definitions. Patients with no AKI or stage 1 AKI (“No/mild AKI”) were compared to those with stage 2 or 3 AKI (“Severe AKI”). The primary outcome was a composite of death or new moderate disability at discharge defined as a Pediatric Overall Performance Category score of 3 or higher, and increased by 1 from baseline. Setting 128 PICUs in 26 countries. Patients Children with severe sepsis in the SPROUT study. Interventions None Measurements and Main Results One hundred two (21%) of 493 patients had Severe AKI. More than twice as many patients with Severe AKI died or developed new moderate disability compared to those with No/mild AKI (64% vs. 30%, p<0.001). Severe AKI was independently associated with death or new moderate disability (adjusted OR 2.5, 95% CI 1.5, 4.2; p=0.001) after adjustment for age, region, baseline disability, malignancy, invasive mechanical ventilation, albumin administration, and the pediatric logistic organ dysfunction score. Conclusions In a multi-national cohort of critically ill children with severe sepsis and high mortality rates, septic AKI is independently associated with further increased death or new disability. PMID:27513354

  17. Short-term outcomes of the transvaginal minimal mesh procedure for pelvic organ prolapse.

    PubMed

    Takazawa, Naoko; Fujisaki, Akiko; Yoshimura, Yasukuni; Tsujimura, Akira; Horie, Shigeo

    2018-03-01

    This study aimed to evaluate the clinical outcomes and complications of transvaginal minimal mesh repair without using commercially available kits for treatment of pelvic organ prolapse (POP). This retrospective cohort study involved 91 women who underwent surgical management of POP with originally designed small mesh between July 2014 and August 2015. This mesh is 56% smaller than the mesh widely used in Japan, and it has only two arms delivered into each right and left sacrospinous ligament. The main study outcome was the anatomic cure rate defined as recurrence of POP quantification (POP-Q) stage II or more. We also assessed changes in the overactive bladder symptom score (OABSS) and prolapse quality of life questionnaire (P-QOL) and evaluated adverse events. Finally, we compared patient backgrounds between the patients with and without recurrence. Prolapse recurred in 10 of 91 patients (11.0%), and all patients with recurrence were diagnosed as POP-Q stage II. As adverse events, only mesh erosion occurred in two (2.2%) and pelvic pain in one (1.1%) of the 91 patients. The OABSS and P-QOL were significantly improved by the operation. When we compared patient backgrounds between the patients with and without recurrence, body mass index was the only factor influencing affecting recurrence. Transvaginal minimal mesh repair resulted in successful outcomes with low mesh-related complications and anatomic recurrence at one year. Furthermore, significant improvement in QOL was offered by this procedure. Our minimal mesh technique should be considered as one treatment option for the management of POP.

  18. Short-term outcomes of the transvaginal minimal mesh procedure for pelvic organ prolapse

    PubMed Central

    Takazawa, Naoko; Fujisaki, Akiko; Yoshimura, Yasukuni; Tsujimura, Akira

    2018-01-01

    Purpose This study aimed to evaluate the clinical outcomes and complications of transvaginal minimal mesh repair without using commercially available kits for treatment of pelvic organ prolapse (POP). Materials and Methods This retrospective cohort study involved 91 women who underwent surgical management of POP with originally designed small mesh between July 2014 and August 2015. This mesh is 56% smaller than the mesh widely used in Japan, and it has only two arms delivered into each right and left sacrospinous ligament. The main study outcome was the anatomic cure rate defined as recurrence of POP quantification (POP-Q) stage II or more. We also assessed changes in the overactive bladder symptom score (OABSS) and prolapse quality of life questionnaire (P-QOL) and evaluated adverse events. Finally, we compared patient backgrounds between the patients with and without recurrence. Results Prolapse recurred in 10 of 91 patients (11.0%), and all patients with recurrence were diagnosed as POP-Q stage II. As adverse events, only mesh erosion occurred in two (2.2%) and pelvic pain in one (1.1%) of the 91 patients. The OABSS and P-QOL were significantly improved by the operation. When we compared patient backgrounds between the patients with and without recurrence, body mass index was the only factor influencing affecting recurrence. Conclusions Transvaginal minimal mesh repair resulted in successful outcomes with low mesh-related complications and anatomic recurrence at one year. Furthermore, significant improvement in QOL was offered by this procedure. Our minimal mesh technique should be considered as one treatment option for the management of POP. PMID:29520390

  19. Maintenance Medication for Opiate Addiction: The Foundation of Recovery

    PubMed Central

    Bart, Gavin

    2012-01-01

    Illicit use of opiates is the fastest growing substance use problem in the United States and the main reason for seeking addiction treatment services for illicit drug use throughout the world. It is associated with significant morbidity and mortality related to HIV, hepatitis C, and overdose. Treatment for opiate addiction requires long-term management. Behavioral interventions alone have extremely poor outcomes, with more than 80% of patients returning to drug use. Similarly poor results are seen with medication assisted detoxification. This article provides a topical review of the three medications approved by the FDA for long-term treatment of opiate dependence: the opioid agonist methadone, the opioid partial agonist buprenorphine, and the opioid antagonist naltrexone. Basic mechanisms of action and treatment outcomes are described for each medication. Results indicate that maintenance medication provides the best opportunity for patients to achieve recovery from opiate addiction. Extensive literature and systematic reviews show that maintenance treatment with either methadone or buprenorphine is associated with retention in treatment, reduction in illicit opiate use, decreased craving, and improved social function. Oral naltrexone is ineffective in treating opiate addiction but recent studies using extended release naltrexone injections have shown promise. While no direct comparisons between extended release naltrexone injections and either methadone or buprenorphine exist, indirect comparison of retention shows inferior outcome compared to methadone and buprenorphine. Further work is needed to compare directly each medication and determine individual factors that can assist in medication selection. Until such time, selection of medication should be based on informed choice following a discussion of outcomes, risks, and benefits of each medication. PMID:22873183

  20. A comparison of clinical features of coronary artery spasm with and without thyrotoxicosis.

    PubMed

    Lee, Soo Youn; Yu, Cheol Woong; Choi, Young Jin; Choi, Rak Kyeong; Park, Jin Sik; Lee, Hyun Jong; Kim, Je Sang; Jang, Ho Jun; Jang, Duck Hyun; Chae, Myung Joon; Shim, Won Heum; Ro, Young Moo

    2014-03-01

    Several reports have suggested that thyrotoxicosis may induce severe coronary artery spasm (CAS). However, there are few data regarding the differences in clinical characteristics of CAS with and without thyrotoxicosis. The aim of our study is to compare the clinical features of CAS with and without thyrotoxicosis. We evaluated 430 consecutive patients with CAS [patients with thyrotoxicosis (N=32, group I) and those without (N=398, group II)] at a single institute between January 2001 and June 2011. We compared clinical presentations, angiographic findings, and adverse outcomes (a composite outcome of cardiac death, myocardial infarction, or rehospitalization due to cardiac cause) of both groups. There was higher incidence of acute myocardial infarction at initial presentation in group I (15.6 vs. 5.8%, P=0.04). CAS with thyrotoxicosis was more diffuse (59.4 vs. 39.3%, P=0.03), more medically intractable (9.4 vs. 0%, P=0.001), and more frequently involved the left main vessel (25.0 vs.0.8%, P=0.001) than CAS without thyrotoxicosis. During the follow-up period (median 43 months), there were no significant differences between the two groups in terms of the risk of adverse outcomes (hazard ratio for CAS with thyrotoxicosis, 1.029; 95% confidence interval, 0.347-3.054). Clinical and angiographic presentations of CAS with thyrotoxicosis were more severe than CAS without thyrotoxicosis, but clinical outcomes were similar in both groups. Optimal vasodilator therapy is essential for the management of CAS with thyrotoxicosis. Thyroid function test should be mandatory for all patients with CAS.

  1. Long-term outcome of older patients with newly diagnosed de novo acute promyelocytic leukemia treated with ATRA plus anthracycline-based therapy.

    PubMed

    Martínez-Cuadrón, D; Montesinos, P; Vellenga, E; Bernal, T; Salamero, O; Holowiecka, A; Brunet, S; Gil, C; Benavente, C; Ribera, J M; Pérez-Encinas, M; De la Serna, J; Esteve, J; Rubio, V; González-Campos, J; Escoda, L; Amutio, M E; Arnan, M; Arias, J; Negri, S; Lowënberg, B; Sanz, M A

    2018-01-01

    Treatment outcome in older patients with acute promyelocytic leukemia (APL) is lower compared with younger patients, mainly because of a higher induction death rate and postremission non-relapse mortality (NRM). This prompted us to design a risk- and age-adapted protocol (Programa Español de Tratamientos en Hematología (PETHEMA)/HOVON LPA2005), with dose reduction of consolidation chemotherapy. Patients aged ⩾60 years reported to the PETHEMA registry and were treated with all-trans retinoic acid (ATRA) plus anthracycline-based regimens according to three consecutive PETHEMA trials that were included. We compared the long-term outcomes of the LPA2005 trial with the preceding PETHEMA trials using non-age-adapted schedules (LPA96&LPA99). From 1996 to 2012, 389 older patients were registered, of whom 268 patients (69%) were eligible. Causes of ineligibility were secondary APL (19%), and unfit for chemotherapy (11%). Median age was 67 years, without relevant differences between LPA2005 and LPA96&LPA99 cohorts. Overall, 216 patients (81%) achieved complete remission with no differences between trials. The 5-year NRM, cumulative incidence of relapse, disease-free survival and overall survival in the LPA2005 vs the LPA96&99 were 5 vs 18% (P=0.15), 7 vs 12% (P=0.23), 87 vs 69% (P=0.04) and 74 vs 60% (P=0.06). A less intensive front-line regimen with ATRA and anthracycline monochemotherapy resulted in improved outcomes in older APL patients.

  2. Short-term outcome of retrograde tibiotalocalcaneal arthrodesis with a curved intramedullary nail.

    PubMed

    Mückley, Thomas; Klos, Kajetan; Drechsel, Thomas; Beimel, Claudia; Gras, Florian; Hofmann, Gunther O

    2011-01-01

    The aim of this study was to investigate the potential clinical benefit of tibiotalocalcaneal arthrodesis (TTCA) with an intramedullary nail with a valgus curve, two compression options, and angle-stable locking. Patients who had undergone TTCA at two tertiary hospitals were eligible. Patients who had undergone TTCA before the beginning of the study were evaluated retrospectively, then all following patients were examined prospectively. There were 59 TTCAs; 55 patients were available for analysis. Twenty-eight were evaluated retrospectively, 27 prospectively. Main Outcome Measures were an SF-36, Mazur-, and AOFAS ankle-hindfoot rating scores and radiographic examination. Bony union was obtained in 53 patients. Fifty-one patients were satisfied with the outcome. Fifty-one patients had marked subjective improvement in mobility. The mean AOFAS score of the 55 patients at the latest followup was 66.8 (range, 38 to 86). The mean Mazzur score was 68.0 (range, 30 to 83). In the prospective group, the scores were significantly improved: AOFAS score by an average of 39.6 points (p<0.001); Mazur score by an average of 43 points (p<0.001); SF-36 physical component summary score (p<0.001) and mental component summary score also improved (p<0.048). Radiology showed good hindfoot alignment. The complication rate was 25%. Compared with the literature, the data obtained in this study show a good outcome and a high rate of bony union, with comparable complication rates. Patient satisfaction was good. However, the patients still had limitations. The clinical benefit of the nail used was confirmed.

  3. Efficacy of a Virtual Reality Commercial Gaming Device in Upper Limb Recovery after Stroke: A Randomized, Controlled Study.

    PubMed

    Kong, Keng-He; Loh, Yong-Joo; Thia, Ernest; Chai, Audrey; Ng, Chwee-Yin; Soh, Yan-Ming; Toh, Shirlene; Tjan, Soon-Yin

    2016-10-01

    To compare the efficacy of a virtual reality commercial gaming device, Nintendo wii (NW) with conventional therapy and customary care in facilitating upper limb recovery after stroke. Randomized, controlled, single-blinded study. Tertiary rehabilitation center. 105 subjects admitted to in inpatient rehabilitation program within 6 weeks of stroke onset. Subjects were randomly assigned to one of three groups of upper limb exercises: (1) NW gaming; (2) conventional therapy; (3) control. NW gaming and conventional therapy were provided fourtimes a week for 3 weeks. The main outcome measure was Fugl-Meyer assessment (FMA) of upper limb function. Secondary outcome measures included Action Research Arm Test, Functional Independence Measure, and Stroke Impact Scale. These measures were assessed at baseline, completion of intervention (week 3) and at 4 weeks and 8 weeks after completion of intervention. The primary outcome measure was the change in FMA scores at completion of intervention. The mean age was 57.5±9.8 years, and subjects were enrolled at a mean of 13.7±8.9 days after stroke. The mean baseline FMA score was 16.4±14.2. There was no difference in FMA scores between all 3 groups at the end of intervention, and at 4 and 8 weeks after completion of intervention. Similar findings were also noted for the secondary outcome measures. Twelve sessions of augmented upper limb exercises via NW gaming or conventional therapy over a 3-week period was not effective in enhancing upper limb motor recovery compared to control.

  4. Initial Operative Experience and Short Term Hearing Preservation Results with a Mid-Scala Cochlear Implant Electrode Array

    PubMed Central

    Svrakic, Maja; Roland, J. Thomas; McMenomey, Sean O.; Svirsky, Mario A.

    2016-01-01

    OBJECTIVE To describe our initial operative experience and hearing preservation results with the Advanced Bionics (AB) Mid Scala Electrode (MSE) STUDY DESIGN Retrospective review. SETTING Tertiary referral center. PATIENTS Sixty-three MSE implants in pediatric and adult patients were compared to age- and gender-matched 1j electrode implants from the same manufacturer. All patients were severe to profoundly deaf. INTERVENTION Cochlear implantation with either the AB 1j electrode or the AB MSE. MAIN OUTCOME MEASURES The MSE and 1j electrode were compared in their angular depth of insertion (aDOI) and pre- to post-operative change in hearing thresholds. Hearing preservation was analyzed as a function of aDOI. Secondary outcome measures included operative time, incidence of abnormal intraoperative impedance and telemetry values, and incidence of postsurgical complications. RESULTS Depth of insertion was similar for both electrodes, but was more consistent for the MSE array and more variable for the 1j array. Patients with MSE electrodes had better hearing preservation. Thresholds shifts at four audiometric frequencies ranging from 250 to 2,000 Hz were 10 dB, 7 dB, 2 dB and 6 dB smaller for the MSE electrode than for the 1j (p<0.05). Hearing preservation at low frequencies was worse with deeper insertion, regardless of array. Secondary outcome measures were similar for both electrodes. CONCLUSIONS The MSE electrode resulted in more consistent insertion depth and somewhat better hearing preservation than the 1j electrode. Differences in other surgical outcome measures were small or unlikely to have a meaningful effect. PMID:27755356

  5. Initial experience of single-port laparoscopic surgery for sigmoid colon cancer.

    PubMed

    Park, Sun Jin; Lee, Kil Yeon; Kang, Byung Mo; Choi, Sung Il; Lee, Suk Hwan

    2013-03-01

    Single-port laparoscopic surgery has attracted attention in the field of minimally invasive colorectal surgery. We hypothesized that an experienced laparoscopic surgeon could perform single-port surgery for colon cancer eligible for conventional laparoscopic anterior resection. Our aim was to analyze our initial experience and immediate surgical outcomes of single-port anterior resection. A total of 37 consecutive patients with presumed sigmoid colonic cancer underwent single-port anterior resection with standard laparoscopic instruments between May 2009 and June 2010. Each operation was performed by one of two experienced colorectal surgeons. A cohort of patients who had undergone conventional laparoscopic surgery (CLS) for the same duration a year earlier (August 2007 to September 2008) was used as a historical control. Patient demographics and perioperative outcomes were analyzed and compared with those of CLS. There were no significant differences in mean estimated blood loss, mean length of the resection margin, or morbidity between the two groups, but operative time for the single-port group was significantly shorter (118 ± 41 vs. 140 ± 42 min; p = 0.017). Single-port laparoscopic surgery was successfully performed in 78.4% (29/37) of the patients treated in 2010, and CLS was successfully completed in all of the patients treated the previous year (p = 0.000). The main causes of single-port surgery failure were adhesion and tumor location. Single-port anterior resection is a feasible and safe procedure with immediate outcomes comparable to those of conventional laparoscopy. Further studies are required to determine the feasibility of single-port surgery for colonic tumors outside the sigmoid colon and the long-term outcome.

  6. Live birth rates and safety profile using dydrogesterone for luteal phase support in assisted reproductive techniques

    PubMed Central

    Nadarajah, Ravichandran; Rajesh, Hemashree; Wong, Ker Yi; Faisal, Fazlin; Yu, Su Ling

    2017-01-01

    INTRODUCTION Assisted reproductive techniques (ARTs) result in a deficient luteal phase, requiring the administration of intramuscular, intravaginal or oral exogenous progesterone. Dydrogesterone, an oral retroprogesterone with good bioavailability, has been used in assisted reproductive cycles with outcomes that are comparable to those of vaginal or intramuscular progesterone. However, there are limited reviews on its use for luteal phase support in ARTs, in terms of pregnancy outcomes and associated fetal anomalies. This study aimed to review the live birth rates and associated fetal anomalies of women who were given dydrogesterone for luteal phase support in assisted reproductive cycles at a tertiary hospital in Singapore. METHODS This retrospective descriptive study included 1,050 women who underwent in vitro fertilisation/intracytoplasmic sperm injection at the Centre for Assisted Reproduction of Singapore General Hospital between 2000 and 2011. The women were given dydrogesterone for luteal phase support. The main outcome measures were rates of pregnancy, live birth, miscarriage and fetal anomalies. RESULTS The pregnancy and live birth rates were 34.7% and 27.7%, respectively. Among those who achieved pregnancy, 17.0% miscarried, 0.8% had ectopic pregnancies and 0.3% had molar pregnancies. Fetal anomalies were detected in 1.9% of pregnancies, all of which were terminated by choice. CONCLUSION Since the outcomes of dydrogesterone are comparable to those of intramuscular and vaginal progesterone, it is a reasonable option to provide luteal phase support for women who are uncomfortable with injections or vaginal insertions. Randomised controlled studies are needed to determine the optimal dosage of dydrogesterone for luteal phase support in ARTs. PMID:27090598

  7. Food Sources of Energy and Macronutrient Intakes among Infants from 6 to 12 Months of Age: The Growing Up in Singapore Towards Healthy Outcomes (GUSTO) Study.

    PubMed

    Lim, Shan-Xuan; Toh, Jia-Ying; van Lee, Linde; Han, Wee-Meng; Shek, Lynette Pei-Chi; Tan, Kok-Hian; Yap, Fabian; Godfrey, Keith M; Chong, Yap-Seng; Chong, Mary Foong-Fong

    2018-03-10

    Adequate nutrition during complementary feeding is important for the growth, development and well-being of children. We aim to examine the energy and macronutrient intake composition and their main food sources in a mother-offspring cohort study in Singapore. The diets of infants were assessed by 24 h dietary recalls or food diaries collected from mothers when their offspring were 6 (n = 760), 9 (n = 893) and 12 (n = 907) months of age. Food sources of energy and macronutrients were determined using the population proportion methodology. Energy intakes per day (kcal; mean (standard deviation, SD)) of these infants were 640 (158) at 6 months, 675 (173) at 9 months, and 761 (208) at 12 months. Infant formula, breastmilk and infant cereals were the top three food sources of energy and macronutrient intakes in infants through the period 6 to 12 months. Other main energy and carbohydrate sources at 9 and 12 months of age were rice porridge, infant biscuits and fresh fruits, while fish, red meat and eggs were the other main protein and total fat sources. Breast-fed and mixed-fed infants had a more varied diet as compared to formula-fed infants. Formula-fed infants had consistently higher protein and lower total fat consumption compared to those who were breastfed. An understanding of these main food sources during complementary feeding can inform local dietary recommendations and policies.

  8. Food Sources of Energy and Macronutrient Intakes among Infants from 6 to 12 Months of Age: The Growing Up in Singapore Towards Healthy Outcomes (GUSTO) Study

    PubMed Central

    Lim, Shan-Xuan; Toh, Jia-Ying; Han, Wee-Meng; Shek, Lynette Pei-Chi; Yap, Fabian; Chong, Yap-Seng; Chong, Mary Foong-Fong

    2018-01-01

    Adequate nutrition during complementary feeding is important for the growth, development and well-being of children. We aim to examine the energy and macronutrient intake composition and their main food sources in a mother–offspring cohort study in Singapore. The diets of infants were assessed by 24 h dietary recalls or food diaries collected from mothers when their offspring were 6 (n = 760), 9 (n = 893) and 12 (n = 907) months of age. Food sources of energy and macronutrients were determined using the population proportion methodology. Energy intakes per day (kcal; mean (standard deviation, SD)) of these infants were 640 (158) at 6 months, 675 (173) at 9 months, and 761 (208) at 12 months. Infant formula, breastmilk and infant cereals were the top three food sources of energy and macronutrient intakes in infants through the period 6 to 12 months. Other main energy and carbohydrate sources at 9 and 12 months of age were rice porridge, infant biscuits and fresh fruits, while fish, red meat and eggs were the other main protein and total fat sources. Breast-fed and mixed-fed infants had a more varied diet as compared to formula-fed infants. Formula-fed infants had consistently higher protein and lower total fat consumption compared to those who were breastfed. An understanding of these main food sources during complementary feeding can inform local dietary recommendations and policies. PMID:29534442

  9. Surgical outcomes after application of a liquid adhesive ocular bandage to clear corneal incisions during cataract surgery.

    PubMed

    Uy, Harvey S; Kenyon, Kenneth R

    2013-11-01

    To compare the anatomic and refractive outcomes in eyes having phacoemulsification with 1 of 3 clear corneal incision (CCI) closure methods. Ambulatory surgical center, Makati, Philippines. Prospective randomized clinical trial. Patients having phacoemulsification cataract surgery had wound closure using no additional treatment (control), a single 10-0 nylon suture, or a liquid adhesive ocular bandage (Ocuseal). The main outcome measures were wound-edge closure rates, surgically induced astigmatism (SIA), foreign-body sensation, and intraocular pressure (IOP) 1, 3, 5, 7, and 14 days postoperatively. The study evaluated 90 eyes. There was a significant improvement in wound-edge closure rates in the suture group and the ocular bandage group compared with the control group (P<.001). A significant increase in SIA occurred in the sutured group but not in the control or ocular bandage groups (P<.001). The ocular bandage group had significantly less foreign-body sensation than the control and suture groups (P<.001). There were no significant differences in IOP between the groups (P=.515). The liquid adhesive ocular bandage resulted in improved wound-edge closure, reduced SIA, and diminished foreign-body sensation. Suturing was associated with improved wound-edge closure but increased SIA and foreign-body sensation. Unsutured incisions led to delayed wound-edge closure and increased foreign-body sensation. Copyright © 2013 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  10. Effect of clomifene citrate plus metformin and clomifene citrate plus placebo on induction of ovulation in women with newly diagnosed polycystic ovary syndrome: randomised double blind clinical trial

    PubMed Central

    Moll, Etelka; Bossuyt, Patrick M M; Korevaar, Johanna C; Lambalk, Cornelis B; van der Veen, Fulco

    2006-01-01

    Objective To compare the effectiveness of clomifene citrate plus metformin and clomifene citrate plus placebo in women with newly diagnosed polycystic ovary syndrome. Design Randomised clinical trial. Setting Multicentre trial in 20 Dutch hospitals. Participants 228 women with polycystic ovary syndrome. Interventions Clomifene citrate plus metformin or clomifene citrate plus placebo. Main outcome measure The primary outcome measure was ovulation. Secondary outcome measures were ongoing pregnancy, spontaneous abortion, and clomifene resistance. Results 111 women were allocated to clomifene citrate plus metformin (metformin group) and 114 women were allocated to clomifene citrate plus placebo (placebo group). The ovulation rate in the metformin group was 64% compared with 72% in the placebo group, a non-significant difference (risk difference - 8%, 95% confidence interval - 20% to 4%). There were no significant differences in either rate of ongoing pregnancy (40% v 46%; - 6%, - 20% to 7%) or rate of spontaneous abortion (12% v 11%; 1%, - 7% to 10%). A significantly larger proportion of women in the metformin group discontinued treatment because of side effects (16% v 5%; 11%, 5% to 16%). Conclusion Metformin is not an effective addition to clomifene citrate as the primary method of inducing ovulation in women with polycystic ovary syndrome. Trial registration Current Controlled Trials ISRCTN55906981 [controlled-trials.com]. PMID:16769748

  11. Effects of pregabalin on brain edema, neurologic and histologic outcomes in experimental traumatic brain injury.

    PubMed

    Shamsi Meymandi, Manzumeh; Soltani, Zahra; Sepehri, Gholamreza; Amiresmaili, Sedigheh; Farahani, Fatemeh; Moeini Aghtaei, Mohammadmehdi

    2018-05-03

    Brain edema and increased intracranial pressure (ICP) are among the main causes of neurological disturbance and mortality following traumatic brain injury (TBI). Since pregabalin neuroprotective effects have been shown, this study was performed to evaluate the possible neuroprotective effects of pregabalin in experimental TBI of male rats. Adult male Wistar rats were divided into 4 groups: sham, vehicle, pregabalin 30 mg/kg and pregabalin 60 mg/kg. TBI was induced in vehicle and pregabalin groups by Marmarou method. Pregabalin was administered 30 min after TBI. Sham and vehicle groups received saline. Brain water and Evans blue content and histopathological changes were evaluated 24, 5 and 24 h after TBI, respectively. The ICP and neurological outcomes (veterinary coma scale, VCS) were recorded before, 1 h and 24 h post TBI. The results showed a significant reduction in brain water content and ICP, and a significant increase in VCS of pregabalin group (60 mg/kg) as compared to vehicle group (P < 0.05). Also, pregabalin reduced brain edema and apoptosis score as compared to vehicle group. Post TBI pregabalin administration revealed a delayed but significant improvement in ICP and neurological outcomes in experimental TBI. The underlying mechanism(s) was not determined and needs further investigation. Copyright © 2018 Elsevier Inc. All rights reserved.

  12. Women in the Persian Gulf: lack of gender differences in long-term health effects of service in United Kingdom Armed Forces in the 1991 Persian Gulf War.

    PubMed

    Unwin, Catherine; Hotopf, Matthew; Hull, Lisa; Ismail, Khalida; David, Anthony; Wessely, Simon

    2002-05-01

    A cross-sectional postal survey was conducted to evaluate the health of a random sample of United Kingdom Armed Forces personnel who were deployed to the 1990-1991 Persian Gulf conflict compared with nondeployed controls and controls deployed to Bosnia. The health of service women was examined and compared with that of United Kingdom service men. The main outcome measures were physical symptoms and ailments, functional capacity on the 36-item Short-Form Health Survey, the 12-item General Health Questionnaire, the Centers for Disease Control and Prevention multisymptom criteria for Gulf War illness, and post-traumatic stress reactions. There were 645 (65.3%) valid responses. The women from the Gulf cohort reported each symptom and the majority of health outcomes more frequently than either control group. No gender differences were found for 32 of the 50 symptoms assessed. Of the remaining 18 symptoms, women reported significantly more than men for only 6 of them, and there were no gender differences in 5 of the 6 principal health outcome measures. Women deployed to the Persian Gulf had similar rates of ill health as their male counterparts. Nothing was found to suggest that, other than for gender-specific health effects, any special considerations need to be made on health grounds for service women in any future deployments.

  13. Efficacy and safety of topical Trikatu preparation in, relieving mosquito bite reactions: a randomized controlled trial.

    PubMed

    Maenthaisong, Ratree; Chaiyakunapruk, Nathorn; Tiyaboonchai, Waree; Tawatsin, Apiwat; Rojanawiwat, Archawin; Thavara, Usavadee

    2014-02-01

    Trikatu is composed of dried fruits of Piper nigrum L and Piper retrofractum Vahl, and dried rhizomes of Zingiber officinale R. Although this preparation has been used to relieve pruritis, pain, and inflammation for a long time, there is no clinical evidence to confirm its efficacy and safety. Therefore, we performed a double-blind, within person-randomized controlled study of 30 healthy volunteers to determine efficacy and safety of topical Trikatu on mosquito bite reactions. All subjects were bitten by Aedes aegypti laboratory mosquitoes on their forearms and they were randomly assigned arms to apply either Trikatu or reference product on the mosquito bite papule. The main outcome was the difference of papule size reduction at 30 min, measured by a caliper, between the Trikatu and reference arms. Pruritis, redness, pain, and patient satisfaction were assessed at 15, 30, 60, 180, and 360 min as secondary outcomes. There were no significant differences between treatment and reference arms on any outcome at any time of measurement. Trikatu did not show additional effects for relieving mosquito bite reaction as compared with the reference product containing camphor, menthol, and eucalyptus. For further study, it is very important to consider a proper selection of subjects, comparator product, and concentration of extract when Trikatu preparation is investigated. Copyright © 2013 Elsevier Ltd. All rights reserved.

  14. Use of health services among international migrant children - a systematic review.

    PubMed

    Markkula, Niina; Cabieses, Baltica; Lehti, Venla; Uphoff, Eleonora; Astorga, Sofia; Stutzin, Francisca

    2018-05-16

    Migrant children have specific health needs, and may face difficulties in accessing health care, but not enough is known about their health service use. This study aims to describe patterns of use of health services of international migrant children and differences to respective native populations. Electronic databases PubMed and Web of Science, references of identified publications, and websites of relevant international agencies were searched. We included observational studies published between 2006 and 2016 that reported use of formal health services by migrant children (0-18 years), including first and second generation migrants. Data on study characteristics, study theme, main outcome and study quality were extracted. One hundred seven full texts were included in the review. Of the studies that reported comparable outcomes, half (50%) indicated less use of healthcare by migrants compared with non-migrants; 25% reported no difference, 18% reported greater use, and 7% did not report this outcome. There was variation by theme, so that the proportion of conclusions "less use" was most common in the categories "general access to care", "primary care" and "oral health", whereas in the use of emergency rooms or hospitalisations, the most common conclusion was "greater use". Migrant children appear to use different types of healthcare services less than native populations, with the exception of emergency and hospital services. PROSPERO systematic review registration number: CRD42016039876 .

  15. A review of the application of propensity score methods yielded increasing use, advantages in specific settings, but not substantially different estimates compared with conventional multivariable methods

    PubMed Central

    Stürmer, Til; Joshi, Manisha; Glynn, Robert J.; Avorn, Jerry; Rothman, Kenneth J.; Schneeweiss, Sebastian

    2006-01-01

    Objective Propensity score analyses attempt to control for confounding in non-experimental studies by adjusting for the likelihood that a given patient is exposed. Such analyses have been proposed to address confounding by indication, but there is little empirical evidence that they achieve better control than conventional multivariate outcome modeling. Study design and methods Using PubMed and Science Citation Index, we assessed the use of propensity scores over time and critically evaluated studies published through 2003. Results Use of propensity scores increased from a total of 8 papers before 1998 to 71 in 2003. Most of the 177 published studies abstracted assessed medications (N=60) or surgical interventions (N=51), mainly in cardiology and cardiac surgery (N=90). Whether PS methods or conventional outcome models were used to control for confounding had little effect on results in those studies in which such comparison was possible. Only 9 out of 69 studies (13%) had an effect estimate that differed by more than 20% from that obtained with a conventional outcome model in all PS analyses presented. Conclusions Publication of results based on propensity score methods has increased dramatically, but there is little evidence that these methods yield substantially different estimates compared with conventional multivariable methods. PMID:16632131

  16. Randomised controlled trial of specialist nurse intervention in heart failure

    PubMed Central

    Blue, Lynda; Lang, Elanor; McMurray, John J V; Davie, Andrew P; McDonagh, Theresa A; Murdoch, David R; Petrie, Mark C; Connolly, Eugene; Norrie, John; Round, Caroline E; Ford, Ian; Morrison, Caroline E

    2001-01-01

    Objectives To determine whether specialist nurse intervention improves outcome in patients with chronic heart failure. Design Randomised controlled trial. Setting Acute medical admissions unit in a teaching hospital. Participants 165 patients admitted with heart failure due to left ventricular systolic dysfunction. The intervention started before discharge and continued thereafter with home visits for up to 1 year. Main outcome measures Time to first event analysis of death from all causes or readmission to hospital with worsening heart failure. Results 31 patients (37%) in the intervention group died or were readmitted with heart failure compared with 45 (53%) in the usual care group (hazard ratio=0.61, 95% confidence interval 0.33 to 0.96).Compared with usual care, patients in the intervention group had fewer readmissions for any reason (86 v 114, P=0.018), fewer admissions for heart failure (19 v 45, P<0.001) and spent fewer days in hospital for heart failure (mean 3.43 v 7.46 days, P=0.0051). Conclusions Specially trained nurses can improve the outcome of patients admitted to hospital with heart failure. What is already known on this topicStudies have suggested that nurse intervention may reduce readmission in patients with heart failureWhat this study addsHome based intervention from nurses reduces readmissions for worsening heart failureRegular contact to review treatment and patient education are likely to contribute to this effect PMID:11576977

  17. Danish Gulf War Veterans Revisited: No Evidence of Increased Sickness Absence or Reduced Labor Market Outcome After Deployment to the Persian Gulf.

    PubMed

    Nissen, Lars Ravnborg; Stoltenberg, Christian; Nielsen, Anni B Sternhagen; Vedtofte, Mia S; Marott, Jacob L; Gyntelberg, Finn; Guldager, Bernadette

    2016-11-01

    To examine the assumption that postdeployment incidence of sickness and other absence from work are higher among Gulf War Veterans compared with nonveterans. A prospective registry study including a cohort of 721 Danish Gulf War Veterans and a control cohort of 3,629 nonveterans selected from the general Danish population. Outcome measures were up to 23 years postdeployment incidence of (1) long-term sickness absence and (2) long-term all types of absence from work. Long term with regard to sickness and other absence was defined as exceeding 8 weeks. The association between outcomes and information on deployment history was studied using time-to-event analysis. The index date was the return date from the last deployment to the Gulf. The follow-up period was the time from index date until April 27, 2014. As the main finding, no difference was found between veterans and nonveterans in the incidence rate of long-term sickness absence. After an initial short period (3 months) with elevated incidence rate of long-term absence from work among veterans, there was no difference between the cohorts. Among Danish Gulf War Veterans, no postdeployment increased risk of long-term sickness absence or long-term absence from work was found as compared with nonveterans. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

  18. Supplementation with Guanidinoacetic Acid in Women with Chronic Fatigue Syndrome.

    PubMed

    Ostojic, Sergej M; Stojanovic, Marko; Drid, Patrik; Hoffman, Jay R; Sekulic, Damir; Zenic, Natasa

    2016-01-29

    A variety of dietary interventions has been used in the management of chronic fatigue syndrome (CFS), yet no therapeutic modality has demonstrated conclusive positive results in terms of effectiveness. The main aim of this study was to evaluate the effects of orally administered guanidinoacetic acid (GAA) on multidimensional fatigue inventory (MFI), musculoskeletal soreness, health-related quality of life, exercise performance, screening laboratory studies, and the occurrence of adverse events in women with CFS. Twenty-one women (age 39.3 ± 8.8 years, weight 62.8 ± 8.5 kg, height 169.5 ± 5.8 cm) who fulfilled the 1994 Centers for Disease Control and Prevention criteria for CFS were randomized in a double-blind, cross-over design, from 1 September 2014 through 31 May 2015, to receive either GAA (2.4 grams per day) or placebo (cellulose) by oral administration for three months, with a two-month wash-out period. No effects of intervention were found for the primary efficacy outcome (MFI score for general fatigue), and musculoskeletal pain at rest and during activity. After three months of intervention, participants receiving GAA significantly increased muscular creatine levels compared with the placebo group (36.3% vs. 2.4%; p < 0.01). Furthermore, changes from baseline in muscular strength and aerobic power were significantly greater in the GAA group compared with placebo (p < 0.05). Results from this study indicated that supplemental GAA can positively affect creatine metabolism and work capacity in women with CFS, yet GAA had no effect on main clinical outcomes, such as general fatigue and musculoskeletal soreness.

  19. Medicaid Coverage of Methadone Maintenance and the Use of Opioid Agonist Therapy Among Pregnant Women in Specialty Treatment.

    PubMed

    Bachhuber, Marcus A; Mehta, Pooja K; Faherty, Laura J; Saloner, Brendan

    2017-12-01

    Opioid agonist therapy (OAT) is the standard of care for pregnant women with opioid use disorder (OUD). Medicaid coverage policies may strongly influence OAT use in this group. To examine the association between Medicaid coverage of methadone maintenance and planned use of OAT in the publicly funded treatment system. Retrospective cross-sectional analysis of treatment admissions in 30 states extracted from the Treatment Episode Data Set (2013 and 2014). Medicaid-insured pregnant women with OUD (n=3354 treatment admissions). The main outcome measure was planned use of OAT on admission. The main exposure was state Medicaid coverage of methadone maintenance. Using multivariable logistic regression models adjusting for sociodemographic, substance use, and treatment characteristics, we compared the probability of planned OAT use in states with Medicaid coverage of methadone maintenance versus states without coverage. A total of 71% of pregnant women admitted to OUD treatment were 18-29 years old, 85% were white non-Hispanic, and 56% used heroin. Overall, 74% of admissions occurred in the 18 states with Medicaid coverage of methadone maintenance and 53% of admissions involved planned use of OAT. Compared with states without Medicaid coverage of methadone maintenance, admissions in states with coverage were significantly more likely to involve planned OAT use (adjusted difference: 32.9 percentage points, 95% confidence interval, 19.2-46.7). Including methadone maintenance in the Medicaid benefit is essential to increasing OAT among pregnant women with OUD and should be considered a key policy strategy to enhance outcomes for mothers and newborns.

  20. Reporting and dealing with missing quality of life data in RCTs: has the picture changed in the last decade?

    PubMed

    Fielding, S; Ogbuagu, A; Sivasubramaniam, S; MacLennan, G; Ramsay, C R

    2016-12-01

    Missing data are a major problem in the analysis of data from randomised trials affecting power and potentially producing biased treatment effects. Specifically focussing on quality of life outcomes, we aimed to report the amount of missing data, whether imputation was used and what methods and was the missing mechanism discussed from four leading medical journals and compare the picture to our previous review nearly a decade ago. A random selection (50 %) of all RCTS published during 2013-2014 in BMJ, JAMA, Lancet and NEJM was obtained. RCTs reported in research letters, cluster RCTs, non-randomised designs, review articles and meta-analysis were excluded. We included 87 RCTs in the review of which 35 % the amount of missing primary QoL data was unclear, 31 (36 %) used imputation. Only 23 % discussed the missing data mechanism. Nearly half used complete case analysis. Reporting was more unclear for secondary QoL outcomes. Compared to the previous review, multiple imputation was used more prominently but mainly in sensitivity analysis. Inadequate reporting and handling of missing QoL data in RCTs are still an issue. There is a large gap between statistical methods research relating to missing data and the use of the methods in applications. A sensitivity analysis should be undertaken to explore the sensitivity of the main results to different missing data assumptions. Medical journals can help to improve the situation by requiring higher standards of reporting and analytical methods to deal with missing data, and by issuing guidance to authors on expected standard.

  1. Haemodialysis-membrane biocompatibility and mortality of patients with dialysis-dependent acute renal failure: a prospective randomised multicentre trial. International Multicentre Study Group.

    PubMed

    Jörres, A; Gahl, G M; Dobis, C; Polenakovic, M H; Cakalaroski, K; Rutkowski, B; Kisielnicka, E; Krieter, D H; Rumpf, K W; Guenther, C; Gaus, W; Hoegel, J

    1999-10-16

    There is controversy as to whether haemodialysis-membrane biocompatibility (ie, the potential to activate complement and neutrophils) influences mortality of patients with acute renal failure. We did a prospective randomised multicentre trial in patients with dialysis-dependent acute renal failure treated with two different types of low-flux membrane. 180 patients with acute renal failure were randomly assigned bioincompatible Cuprophan (n=90) or polymethyl-methacrylate (n=90) membranes. The main outcome was survival 14 days after the end of therapy (treatment success). Odds ratios for survival were calculated and the two groups were compared by Fisher's exact test. Analyses were based on patients treated according to protocol (76 Cuprophan, 84 polymethyl methacrylate). At the start of dialysis, the groups did not differ significantly in age, sex, severity of illness (as calculated by APACHE II scores), prevalence of oliguria, or biochemical measures of acute renal failure. 44 patients (58% [95% CI 46-69]) assigned Cuprophan membranes and 50 patients (60% [48-70]) assigned polymethyl-methacrylate membranes survived. The odds ratio for treatment failure on Cuprophan compared with polymethyl-methacrylate membranes was 1.07 (0.54-2.11; p=0.87). No difference between Cuprophan and polymethyl-methacrylate membranes was detected when the analysis was adjusted for age and APACHE II score. 18 patients in the Cuprophan group and 20 in the polymethyl-methacrylate group had clinical complications of therapy (mainly hypotension). There were no differences in outcome for patients with dialysis-dependent acute renal failure between those treated with Cuprophan membranes and those treated with polymethyl-methacrylate membranes.

  2. New-generation stents compared with coronary bypass surgery for unprotected left main disease: A word of caution.

    PubMed

    Benedetto, Umberto; Taggart, David P; Sousa-Uva, Miguel; Biondi-Zoccai, Giuseppe; Di Franco, Antonino; Ohmes, Lucas B; Rahouma, Mohamed; Kamel, Mohamed; Caputo, Massimo; Girardi, Leonard N; Angelini, Gianni D; Gaudino, Mario

    2018-05-01

    With the advent of bare metal stents and drug-eluting stents, percutaneous coronary intervention has emerged as an alternative to coronary artery bypass grafting surgery for unprotected left main disease. However, whether the evolution of stents technology has translated into better results after percutaneous coronary intervention remains unclear. We aimed to compare coronary artery bypass grafting with stents of different generations for left main disease by performing a Bayesian network meta-analysis of available randomized controlled trials. All randomized controlled trials with at least 1 arm randomized to percutaneous coronary intervention with stents or coronary artery bypass grafting for left main disease were included. Bare metal stents and drug-eluting stents of first- and second-generation were compared with coronary artery bypass grafting. Poisson methods and Bayesian framework were used to compute the head-to-head incidence rate ratio and 95% credible intervals. Primary end points were the composite of death/myocardial infarction/stroke and repeat revascularization. Nine randomized controlled trials were included in the final analysis. Six trials compared percutaneous coronary intervention with coronary artery bypass grafting (n = 4654), and 3 trials compared different types of stents (n = 1360). Follow-up ranged from 6 months to 5 years. Second-generation drug-eluting stents (incidence rate ratio, 1.3; 95% credible interval, 1.1-1.6), but not bare metal stents (incidence rate ratio, 0.63; 95% credible interval, 0.27-1.4), and first-generation drug-eluting stents (incidence rate ratio, 0.85; 95% credible interval, 0.65-1.1) were associated with a significantly increased risk of death/myocardial infarction/stroke when compared with coronary artery bypass grafting. When compared with coronary artery bypass grafting, the highest risk of repeat revascularization was observed for bare metal stents (hazard ratio, 5.1; 95% confidence interval, 2.1-14), whereas first-generation drug-eluting stents (incidence rate ratio, 1.8; 95% confidence interval, 1.4-2.4) and second-generation drug-eluting stents (incidence rate ratio, 1.8; 95% confidence interval, 1.4-2.4) were comparable. The introduction of new-generation drug-eluting stents did not translate into better outcomes for percutaneous coronary intervention when compared with coronary artery bypass grafting. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  3. Perinatal Outcomes in Pregnant Women Users of Illegal Drugs.

    PubMed

    Oliveira, Tenilson Amaral; Bersusa, Ana Aparecida Sanches; Santos, Tatiana Fiorelli Dos; Aquino, Márcia Maria Auxiliadora de; Mariani Neto, Corintio

    2016-04-01

    Objective The purpose of this study was to evaluate the perinatal outcomes in pregnant women who use illicit drugs. Methods A retrospective observational study of patients who, at the time of delivery, were sent to or who spontaneously sought a public maternity hospital in the eastern area of São Paulo city. We compared the perinatal outcomes of two distinct groups of pregnant women - illicit drugs users and non-users - that gave birth in the same period and analyzed the obstetric and neonatal variables. We used Student's t-test to calculate the averages among the groups, and the Chi-square test or Fisher's exact test to compare categorical data from each group. Results We analyzed 166 women (83 users and 83 non-users) in both groups with a mean of age of 26 years. Ninety-five percent of the drug users would use crack or pure cocaine alone or associated with other psychoactive substances during pregnancy. Approximately half of the users group made no prenatal visit, compared with 2.4% in the non-users group (p < 0.001). Low birth weight (2,620 g versus 3,333 g on average, p < 0.001) and maternal syphilis (15.7% versus 0%, p < 0.001) were associated with the use of these illicit drugs. Conclusions The use of illicit drugs, mainly crack cocaine, represents an important perinatal risk. Any medical intervention in this population should combine adherence to prenatal care with strategies for reducing maternal exposure to illicit drugs. Thieme Publicações Ltda Rio de Janeiro, Brazil.

  4. Outcomes of kidney transplantation in Alport syndrome compared with other forms of renal disease.

    PubMed

    Kelly, Yvelynne P; Patil, Anish; Wallis, Luke; Murray, Susan; Kant, Saumitra; Kaballo, Mohammed A; Casserly, Liam; Doyle, Brendan; Dorman, Anthony; O'Kelly, Patrick; Conlon, Peter J

    2017-11-01

    Alport syndrome is an inherited renal disease characterized by hematuria, renal failure, hearing loss and a lamellated glomerular basement membrane. Patients with Alport syndrome who undergo renal transplantation have been shown to have patient and graft survival rates similar to or better than those of patients with other renal diseases. In this national case series, based in Beaumont Hospital Dublin, we studied the cohort of patients who underwent renal transplantation over the past 33 years, recorded prospectively in the Irish Renal Transplant Registry, and categorized them according to the presence or absence of Alport syndrome. The main outcomes assessed were patient and renal allograft survival. Fifty-one patients diagnosed with Alport syndrome in Beaumont Hospital received 62 transplants between 1982 and 2014. The comparison group of non-Alport patients comprised 3430 patients for 3865 transplants. Twenty-year Alport patient survival rate was 70.2%, compared to 44.8% for patients with other renal diseases (p = .01). Factors associated with patient survival included younger age at transplantation as well as differences in recipient sex, donor age, cold ischemia time, and episodes of acute rejection. Twenty-year graft survival was 46.8% for patients with Alport syndrome compared to 30.2% for those with non-Alport disease (p = .11). Adjusting for baseline differences between the groups, patients with end-stage kidney disease (ESKD) due to Alport syndrome have similar patient and graft survival to those with other causes of ESKD. This indicates that early diagnosis and management can lead to favorable outcomes for this patient cohort.

  5. What is the impact of shift work on the psychological functioning and resilience of nurses? An integrative review.

    PubMed

    Tahghighi, Mozhdeh; Rees, Clare S; Brown, Janie A; Breen, Lauren J; Hegney, Desley

    2017-09-01

    To synthesize existing research to determine if nurses who work shifts have poorer psychological functioning and resilience than nurses who do not work shifts. Research exploring the impact of shift work on the psychological functioning and resilience of nurses is limited compared with research investigating the impact of shifts on physical outcomes. Integrative literature review. Relevant databases were searched from January 1995-August 2016 using the combination of keywords: nurse, shift work; rotating roster; night shift; resilient; hardiness; coping; well-being; burnout; mental health; occupational stress; compassion fatigue; compassion satisfaction; stress; anxiety; depression. Two authors independently performed the integrative review processes proposed by Whittemore and Knafl and a quality assessment using the mixed-methods appraisal tool by Pluye et al. A total of 37 articles were included in the review (32 quantitative, 4 qualitative and 1 mixed-methods). Approximately half of the studies directly compared nurse shift workers with non-shift workers. Findings were grouped according to the following main outcomes: (1) general psychological well-being/quality of life; (2) Job satisfaction/burnout; (3) Depression, anxiety and stress; and (4) Resilience/coping. We did not find definitive evidence that shift work is associated with poorer psychological functioning in nurses. Overall, the findings suggest that the impact of shift work on nurse psychological functioning is dependent on several contextual and individual factors. More studies are required which directly compare the psychological outcomes and resilience of nurse shift workers with non-shift workers. © 2017 John Wiley & Sons Ltd.

  6. The comparative effectiveness of mail order pharmacy use vs. local pharmacy use on LDL-C control in new statin users.

    PubMed

    Schmittdiel, Julie A; Karter, Andrew J; Dyer, Wendy; Parker, Melissa; Uratsu, Connie; Chan, James; Duru, O Kenrik

    2011-12-01

    Mail order pharmacies are commonly used to deliver CVD risk factor medications. Previous studies have shown that mail order pharmacy use is associated with greater medication adherence; however, no studies have examined whether mail order pharmacy use is related to improved CVD risk factor outcomes. To examine the comparative effectiveness of mail order pharmacy vs. local pharmacy use on LDL-C control in new statin users. Observational cohort study. 100,298 adult Kaiser Permanente Northern California (KPNC) members who were new users of statins between January 1, 2005 and December 31, 2007. The main outcome measure was LDL-C control in the 3-15 month period after statin therapy was initiated. After adjustment for patient, clinical, and census-block characteristics, and for potential unmeasured differences between mail order and local KPNC pharmacy users with instrumental variables analysis, 85.0% of patients who used the mail order pharmacy to deliver their statin at any time achieved target LDL-C levels compared with 74.2% of patients who only used the local KPNC pharmacy to dispense the statin (p < 0.001). Greater adjusted rates of LDL-C control in mail order pharmacy users were seen across all gender and race/ethnicity subgroups. Mail order pharmacy use was positively associated with LDL-C control in new statin users. Future research should continue to explore the relationship between mail order pharmacy use and outcomes, and address how to appropriately target mail order services to patients most likely to benefit without compromising patient choice, care, and safety.

  7. Non-pharmacological care for patients with generalized osteoarthritis: design of a randomized clinical trial

    PubMed Central

    2010-01-01

    Background Non-pharmacological treatment (NPT) is a useful treatment option in the management of hip or knee osteoarthritis. To our knowledge however, no studies have investigated the effect of NPT in patients with generalized osteoarthritis (GOA). The primary aim of this study is to compare the effectiveness of two currently existing health care programs with different intensity and mode of delivery on daily functioning in patients with GOA. The secondary objective is to compare the cost-effectiveness of both interventions. Methods/Design In this randomized, single blind, clinical trial with active controls, we aim to include 170 patients with GOA. The experimental intervention consist of six self-management group sessions provided by a multi-disciplinary team (occupational therapist, physiotherapist, dietician and specialized nurse). The active control group consists of two group sessions and four sessions by telephone, provided by a specialized nurse and physiotherapist. Both therapies last six weeks. Main study outcome is daily functioning during the first year after the treatment, assessed on the Health Assessment Questionnaire. Secondary outcomes are health related quality of life, specific complaints, fatigue, and costs. Illness cognitions, global perceived effect and self-efficacy, will also be assessed for a responder analysis. Outcome assessments are performed directly after the intervention, after 26 weeks and after 52 weeks. Discussion This article describes the design of a randomized, single blind, clinical trial with a one year follow up to compare the costs and effectiveness of two non-pharmacological interventions with different modes of delivery for patients with GOA. Trial registration Dutch Trial Register NTR2137 PMID:20594308

  8. Robotic Liver Resection: A Case-Matched Comparison.

    PubMed

    Kingham, T Peter; Leung, Universe; Kuk, Deborah; Gönen, Mithat; D'Angelica, Michael I; Allen, Peter J; DeMatteo, Ronald P; Laudone, Vincent P; Jarnagin, William R; Fong, Yuman

    2016-06-01

    In recent years, increasingly sophisticated tools have allowed for more complex robotic surgery. Robotic hepatectomy, however, is still in its infancy. Our goals were to examine the adoption of robotic hepatectomy and to compare outcomes between open and robotic liver resections. The robotic hepatectomy experience of 64 patients was compared to a modern case-matched series of 64 open hepatectomy patients at the same center. Matching was according to benign/malignant diagnosis and number of segments resected. Patient data were obtained retrospectively. The main outcomes and measures were operative time, estimated blood loss, conversion rate (robotic to open), Pringle maneuver use, single non-anatomic wedge resection rate, resection margin size, complication rates (infectious, hepatic, pulmonary, cardiac), hospital stay length, ICU stay length, readmission rate, and 90-day mortality rate. Sixty-four robotic hepatectomies were performed in 2010-2014. Forty-one percent were segmental and 34 % were wedge resections. There was a 6 % conversion rate, a 3 % 90-day mortality rate, and an 11 % morbidity rate. Compared to 64 matched patients who underwent open hepatectomy (2004-2012), there was a shorter median OR time (p = 0.02), lower median estimated blood loss (p < 0.001), and shorter median hospital stay (p < 0.001). Eleven of the robotic cases were isolated resections of tumors in segments 2, 7, and 8. Robotic hepatectomy is safe and effective. Increasing experience in more centers will allow definition of which hepatectomies can be performed robotically, and will enable optimization of outcomes and prospective examination of the economic cost of each approach.

  9. Efficacy and tolerability of EPs 7630 in children and adolescents with acute bronchitis - a randomized, double-blind, placebo-controlled multicenter trial with a herbal drug preparation from Pelargonium sidoides roots.

    PubMed

    Kamin, W; Maydannik, V; Malek, F A; Kieser, M

    2010-03-01

    The study aim was to demonstrate the efficacy and to investigate the tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides roots, in the treatment of patients (1 - 18 years) with acute bronchitis outside the strict indication for antibiotics. A total of 200 patients were randomized to receive either active drug containing EPs 7630 (1 - 6 years: 3 x 10 drops/d; > 6 - 12 years: 3 x 20 drops/d; > 12 - 18 years: 3 x 30 drops/d) or placebo for 7 consecutive days. change in the total score of bronchitis-specific symptoms (BSS) from Day 0 to Day 7. Main secondary outcome measures: treatment outcome, patients' satisfaction with treatment, onset of effect, bed rest. From baseline to Day 7, the mean BSS score improved significantly more for EPs 7630 compared with placebo (3.4 +/- 1.8 vs. 1.2 +/- 1.8 points, p < 0.0001). On Day 7, treatment outcome was significantly better (p < 0.0001), satisfaction with treatment more pronounced (77.6% vs. 25.8%, p < 0.0001), onset of effect faster, and time of bed rest shorter as compared with placebo. Tolerability was similarly good in both groups. All adverse events were assessed as non-serious. EPs 7630 was shown to be efficacious and safe in the treatment of acute bronchitis in children and adolescents outside the strict indication for antibiotics with patients treated with EPs 7630 perceiving a more favorable course of the disease and a good tolerability as compared with placebo.

  10. Manipulative therapy in addition to usual medical care accelerates recovery of shoulder complaints at higher costs: economic outcomes of a randomized trial.

    PubMed

    Bergman, Gert J D; Winter, Jan C; van Tulder, Maurits W; Meyboom-de Jong, Betty; Postema, Klaas; van der Heijden, Geert J M G

    2010-09-06

    Shoulder complaints are common in primary care and have unfavourable long term prognosis. Our objective was to evaluate the clinical effectiveness of manipulative therapy of the cervicothoracic spine and the adjacent ribs in addition to usual medical care (UMC) by the general practitioner in the treatment of shoulder complaints. This economic evaluation was conducted alongside a randomized trial in primary care. Included were 150 patients with shoulder complaints and a dysfunction of the cervicothoracic spine and adjacent ribs. Patients were treated with UMC (NSAID's, corticosteroid injection or referral to physical therapy) and were allocated at random (yes/no) to manipulative therapy (manipulation and mobilization). Patient perceived recovery, severity of main complaint, shoulder pain, disability and general health were outcome measures. Data about direct and indirect costs were collected by means of a cost diary. Manipulative therapy as add-on to UMC accelerated recovery on all outcome measures included. At 26 weeks after randomization, both groups reported similar recovery rates (41% vs. 38%), but the difference between groups in improvement of severity of the main complaint, shoulder pain and disability sustained. Compared to the UMC group the total costs were higher in the manipulative group (€1167 vs. €555). This is explained mainly by the costs of the manipulative therapy itself and the higher costs due sick leave from work. The cost effectiveness ratio showed that additional manipulative treatment is more costly but also more effective than UMC alone. The cost-effectiveness acceptability curve shows that a 50%-probability of recovery with AMT within 6 months after initiation of treatment is achieved at €2876. Manipulative therapy in addition to UMC accelerates recovery and is more effective than UMC alone on the long term, but is associated with higher costs. INTERNATIONAL STANDARD RANDOMIZED CONTROLLED TRIAL NUMBER REGISTER: ISRCTN11216.

  11. IKZF1 deletion is an independent predictor of outcome in pediatric acute lymphoblastic leukemia treated according to the ALL-BFM 2000 protocol.

    PubMed

    Dörge, Petra; Meissner, Barbara; Zimmermann, Martin; Möricke, Anja; Schrauder, André; Bouquin, Jean-Pierre; Schewe, Denis; Harbott, Jochen; Teigler-Schlegel, Andrea; Ratei, Richard; Ludwig, Wolf-Dieter; Koehler, Rolf; Bartram, Claus R; Schrappe, Martin; Stanulla, Martin; Cario, Gunnar

    2013-03-01

    IKZF1 gene deletions have been associated with a poor outcome in pediatric precursor B-cell acute lymphoblastic leukemia. To assess the prognostic relevance of IKZF1 deletions for patients treated on Berlin-Frankfurt-Münster Study Group trial ALL-BFM 2000, we screened 694 diagnostic acute lymphoblastic leukemia samples by Multiplex Ligation-dependent Probe Amplification. Patients whose leukemic cells bore IKZF1 deletions had a lower 5-year event-free survival (0.69±0.05 vs. 0.85±0.01; P<0.0001) compared to those without, mainly due to a higher cumulative incidence of relapses (0.21±0.04 vs. 0.10±0.01; P=0.001). Although IKZF1 deletions were significantly associated with the P2RY8-CRLF2 rearrangement, their prognostic value was found to be independent from this association. Thus, IKZF1 deletion is an independent predictor of treatment outcome and a strong candidate marker for integration in future treatment stratification strategies on ALL-BFM protocols. Clinicaltrials.gov identifier: NCT00430118.

  12. Measuring outcome from vestibular rehabilitation, part II: refinement and validation of a new self-report measure.

    PubMed

    Morris, Anna E; Lutman, Mark E; Yardley, Lucy

    2009-01-01

    A prototype self-report measure of vestibular rehabilitation outcome is described in a previous paper. The objectives of the present work were to identify the most useful items and assess their psychometric properties. Stage 1: One hundred fifty-five participants completed a prototype 36-item Vestibular Rehabilitation Benefit Questionnaire (VRBQ). Statistical analysis demonstrated its subscale structure and identified redundant items. Stage 2: One hundred twenty-four participants completed a refined 22-item VRBQ and three established questionnaires (Dizziness Handicap Inventory, DHI; Vertigo Symptom Scale short form, VSS-sf; Medical Outcomes Study short form 36, SF-36) in a longitudinal study. Statistical analysis revealed four internally consistent subscales of the VRBQ: Dizziness, Anxiety, Motion-Provoked Dizziness, and Quality of Life. Correlations with the DHI, VSS-sf, and SF-36 support the validity of the VRBQ, and effect size estimates suggest that the VRBQ is more responsive than comparable questionnaires. Twenty participants completed the VRBQ twice in a 24-hour period, indicating excellent test-retest reliability. The VRBQ appears to be a concise and psychometrically robust questionnaire that addresses the main aspects of dizziness impact.

  13. Risk Associated with Pulse Pressure on Out-of-Office Blood Pressure Measurement

    PubMed Central

    Gu, Yu-Mei; Aparicio, Lucas S.; Liu, Yan-Ping; Asayama, Kei; Hansen, Tine W.; Niiranen, Teemu J.; Boggia, José; Thijs, Lutgarde; Staessen, Jan A.

    2014-01-01

    Background Longitudinal studies have demonstrated that the risk of cardiovascular disease increases with pulse pressure (PP). However, PP remains an elusive cardiovascular risk factor with findings being inconsistent between studies. The 2013 ESH/ESC guideline proposed that PP is useful in stratification and suggested a threshold of 60 mm Hg, which is 10 mm Hg higher compared to that in the 2007 guideline; however, no justification for this increase was provided. Methodology Published thresholds of PP are based on office blood pressure measurement and often on arbitrary categorical analyses. In the International Database on Ambulatory blood pressure in relation to Cardiovascular Outcomes (IDACO) and the International Database on HOme blood pressure in relation to Cardiovascular Outcome (IDHOCO), we determined outcome-driven thresholds for PP based on ambulatory or home blood pressure measurement, respectively. Results The main findings were that for people aged <60 years, PP did not refine risk stratification, whereas in older people the thresholds were 64 and 76 mm Hg for the ambulatory and home PP, respectively. However, PP provided little added predictive value over and beyond classical risk factors. PMID:26587443

  14. Predicting international medical graduate success on college certification examinations

    PubMed Central

    Schabort, Inge; Mercuri, Mathew; Grierson, Lawrence E.M.

    2014-01-01

    Abstract Objective To determine predictors of international medical graduate (IMG) success in accordance with the priorities highlighted by the Thomson and Cohl judicial report on IMG selection. Design Retrospective assessment using regression analyses to compare the information available at the time of resident selection with those trainees’ national certification examination outcomes. Setting McMaster University in Hamilton, Ont. Participants McMaster University IMG residents who completed the program between 2005 and 2011. Main outcome measures Associations between IMG professional experience or demographic characteristics and examination outcomes. Results The analyses revealed that country of study and performance on the Medical Council of Canada Evaluating Examination are among the predictors of performance on the College of Family Physicians of Canada and the Royal College of Physicians and Surgeons of Canada certification examinations. Of interest, the analyses also suggest discipline-specific relationships between previous professional experience and examination success. Conclusion This work presents a useful technique for further improving our understanding of the performance of IMGs on certification examinations in North America, encourages similar interinstitutional analyses, and provides a foundation for the development of tools to assist with IMG education. PMID:25316762

  15. Intrathecal application of the nimodipine slow-release microparticle system eg-1962 for prevention of delayed cerebral ischemia and improvement of outcome after aneurysmal subarachnoid hemorrhage.

    PubMed

    Etminan, Nima; Macdonald, R Loch; Davis, Cara; Burton, Kevin; Steiger, Hans-Jakob; Hänggi, Daniel

    2015-01-01

    The effective reduction of delayed cerebral ischemia (DCI), a main contributor for poor outcome following aneurysmal subarachnoid hemorrhage (SAH), remains challenging. Previous clinical trials on systemic pharmaceutical treatment of SAH mostly failed to improve outcome, probably because of insensitive pharmaceutical targets and outcome measures, small sample size, insufficient subarachnoid drug concentrations and also detrimental, systemic effects of the experimental treatment per se. Interestingly, in studies that are more recent, intrathecal administration of nicardipine pellets following surgical aneurysm repair was suggested to have a beneficial effect on DCI and neurological outcome. However, this positive effect remained restricted to patients who were treated surgically for a ruptured aneurysm. Because of the favorable results of the preclinical data on DCI and neurological outcome in the absence of neurotoxicity or systemic side effects, we are initiating clinical trials. The PROMISE (Prolonged Release nimOdipine MIcro particles after Subarachnoid hemorrhage) trial is designed as an unblinded, nonrandomized, single-center, single-dose, dose-escalation safety and tolerability phase 1 study in patients surgically treated for aSAH and will investigate the effect of intracisternal EG-1962 administration. The NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) trial is a phase 1/2a multicenter, controlled, randomized, open-label, dose-escalation, safety, tolerability, and pharmacokinetic study comparing EG-1962 and nimodipine in patients with aneurysmal SAH.

  16. Income received during treatment does not affect response to contingency management treatments in cocaine-dependent outpatients

    PubMed Central

    Andrade, Leonardo F.; Petry, Nancy M.

    2013-01-01

    Background Prior studies find no effect of baseline income on response to contingency management (CM) interventions. However, income among substance disordered patients is variable, particularly at treatment entry. This study investigated the impact of during-treatment income, a more proximal estimate of economic resources at the time that CM is in effect, on response to standard treatment or the standard treatment plus CM. Method These secondary analyses included 418 cocaine dependent participants initiating community intensive outpatient treatment. We examined whether differences were present in pretreatment and during-treatment overall income, as well as specific income sources. We then conducted a series of regression models to investigate the impact of during-treatment income on treatment outcome. Results Participants’ during-treatment income was significantly lower compared to pretreatment income, and this difference was largely attributable to decreases in earned income, illegal income, and support from friends and family. Neither the main effect of income, nor the interaction of income and treatment condition, was significantly associated with treatment outcome. CM, however, was a significant predictor of improved treatment outcome relative to standard treatment. Income sources and some demographic characteristics were also significant predictors of outcomes; public assistance income was associated with improved outcomes and illegal income was associated with poorer outcomes. Conclusions These results suggest that substance abusers benefit from CM regardless of their income level, and these data add to the growing literature supporting the generalizability of CM across a variety of patient characteristics. PMID:23631869

  17. Two tales of cardiovascular risks—middle-aged women living in Sweden and Scotland: a cross-sectional comparative study

    PubMed Central

    Wennerholm, Carina; Bromley, Catherine; Johansson, AnnaKarin; Nilsson, Staffan; Frank, John; Faresjö, Tomas

    2017-01-01

    Objectives To compare cardiovascular risk factors as well as rates of cardiovascular diseases in middle-aged women from urban areas in Scotland and Sweden. Design Comparative cross-sectional study. Setting Data from the general population in urban areas of Scotland and the general population in two major Swedish cities in southeast Sweden, south of Stockholm. Participants Comparable data of middle-aged women (40–65 years) from the Scottish Health Survey (n=6250) and the Swedish QWIN study (n=741) were merged together into a new dataset (n=6991 participants). Main outcome measure We compared middle-aged women in urban areas in Sweden and Scotland regarding risk factors for cardiovascular disease (CVD), CVD diagnosis, anthropometrics, psychological distress and lifestyle. Results In almost all measurements, there were significant differences between the countries, favouring the Swedish women. Scottish women demonstrated a higher frequency of alcohol consumption, smoking, obesity, low vegetable consumption, a sedentary lifestyle and also more psychological distress. For doctor-diagnosed coronary heart disease, there were also significant differences, with a higher prevalence among the Scottish women. Conclusions This is one of the first studies that clearly shows that Scottish middle-aged women are particularly affected by a worse profile of CVD risks. The profound differences in CVD risk and outcome frequency in the two populations are likely to have arisen from differences in the two groups of women's social, cultural, political and economic environments. PMID:28790040

  18. Development and Evaluation of a Multimedia CD-ROM for Exercise During Pregnancy and Postpartum

    PubMed Central

    Hausenblas, Heather A.; Brewer, Britton W.; Van Raalte, Judy L.; Cook, Brian; Downs, Danielle Symons; Weis, Carol Ann; Nigg, Claudio; Cruz, Amelia

    2008-01-01

    Objective To meet the need for an interactive product on exercise during pregnancy and postpartum, we developed and evaluated a personally-tailored multimedia CD-ROM. Methods Pregnant and postpartum women, who were randomly assigned to either the experimental group (PregXercise™ CD-ROM) or the control group (CD-ROM with neutral content), navigated through the CD-ROM for 1 hour. Main outcomes were exercise self-efficacy and knowledge. Results In analyses of covariance, compared with the control group, the experimental group had significant increases in self-efficacy and knowledge. Conclusion The multimedia CD-ROM delivering information about exercise motivation, guidelines, and prescription was effective in improving exercise self-efficacy and knowledge. Practice Implications Our preliminary results illustrate that healthcare professionals and researchers may use interactive multimedia for improving exercise behavior and related outcomes with pregnant and postpartum women. PMID:18068940

  19. 50 years of rational‐emotive and cognitive‐behavioral therapy: A systematic review and meta‐analysis

    PubMed Central

    Cotet, Carmen; Matu, Silviu; Mogoase, Cristina; Stefan, Simona

    2017-01-01

    Objective Rational emotive behavior therapy (REBT), introduced by Albert Ellis in the late 1950s, is one of the main pillars of cognitive‐behavioral therapy. Existing reviews on REBT are overdue by 10 years or more. We aimed to summarize the effectiveness and efficacy of REBT since its beginnings and investigate the alleged mechanisms of change. Method Systematic search identified 84 articles, out of which 68 provided data for between‐group analyses and 39 for within‐group analyses. Results We found a medium effect size of REBT compared to other interventions on outcomes (d = 0.58) and on irrational beliefs (d = 0.70), at posttest. For the within‐group analyses, we obtained medium effects for both outcomes (d = 0.56) and irrational beliefs (d = 0.61). Several significant moderators emerged. Conclusion REBT is a sound psychological intervention. Directions for future studies are outlined, stemming from the limitations of existing ones. PMID:28898411

  20. Fixation of comminuted midshaft clavicle fractures with bone fragments separated by soft tissue using a novel double ligature technique: A case report.

    PubMed

    Ju, Wei-Na; Wang, Cheng-Xue; Wang, Tie-Jun; Qi, Bao-Chang

    2017-11-01

    Clavicle fractures are common, and mostly occur in the midshaft. Methods for operative treatment of midshaft clavicle fractures are evolving, as they improve clinical outcomes compared with traditional conservative management. However, fixation of comminuted midshaft clavicle fractures with bone fragments separated by soft tissue remains a challenge. Here, we present a case of comminuted midshaft clavicle fracture with a bone fragment separated from the main fracture by soft tissue. Left comminuted midshaft clavicle fracture. We treated this patient with a novel double ligature technique using absorbable suturing. In the past 7 years, we have treated >50 patients with this technique. We have achieved good clinical outcomes with no complications. We recommend widespread use of our novel double ligature technique for treating comminuted midshaft clavicle fractures with bone fragments separated by soft tissue.

  1. Oropharyngeal dysphagia in myotonic dystrophy type 1: a systematic review.

    PubMed

    Pilz, Walmari; Baijens, Laura W J; Kremer, Bernd

    2014-06-01

    A systematic review was conducted to investigate the pathophysiology of and diagnostic procedures for oropharyngeal dysphagia in myotonic dystrophy (MD). The electronic databases Embase, PubMed, and The Cochrane Library were used. The search was limited to English, Dutch, French, German, Spanish, and Portuguese publications. Sixteen studies met the inclusion criteria. Two independent reviewers assessed the methodological quality of the included articles. Swallowing assessment tools, the corresponding protocols, the studies' outcome measurements, and main findings are summarized and presented. The body of literature on pathophysiology of swallowing in dysphagic patients with MD type 1 remains scant. The included studies are heterogeneous with respect to design and outcome measures and hence are not directly comparable. More importantly, most studies had methodological problems. These are discussed in detail and recommendations for further research on diagnostic examinations for swallowing disorders in patients with MD type 1 are provided.

  2. Evidence-based outcomes for mesh-based surgery for pelvic organ prolapse.

    PubMed

    Mettu, Jayadev R; Colaco, Marc; Badlani, Gopal H

    2014-07-01

    In light of all the recent controversy regarding the use of synthetic mesh for pelvic organ prolapse, we did a retrospective review of the evidence-based outcomes and complications for its use. A total of 18 of the most recent studies in the last 5 years were selected. Studies selected were prospective randomized or quasi-randomized controlled trials that included surgical operations for pelvic organ prolapse for this review. Additionally, Cochrane review and meta-analysis of outcomes and complication were also analyzed. In terms of outcomes, the definition of successful surgery is currently being debated. Synthetic mesh provides superior anatomical and subjective cure rates compared with native tissue repair. Success rates varied greatly depending on the nature of prolapse and surgical approach. Furthermore, recurrence rates for mesh-based surgery are significantly lower than that for native tissue repair. The main unique complication of mesh is exposure and was reported in a mean of 11.4% of patients, with 6.8% of patients requiring surgical partial excision of mesh. Mesh significantly improves anatomical outcomes with sacrocolpopexy and vaginal repair. Mesh does create the unique complication which can be reduced with training and proper patient selection. Further development of better materials is vital rather than reverting to tissue-based repair. Ultimately, the decision to use mesh should be based upon a patient's personal goals and preferences after an informed conversation with her physician.

  3. Short- and long-term outcomes of AL amyloidosis patients admitted into intensive care units.

    PubMed

    Guinault, Damien; Canet, Emmanuel; Huart, Antoine; Jaccard, Arnaud; Ribes, David; Lavayssiere, Laurence; Venot, Marion; Cointault, Olivier; Roussel, Murielle; Nogier, Marie-Béatrice; Pichereau, Claire; Lemiale, Virginie; Arnulf, Bertrand; Attal, Michel; Chauveau, Dominique; Azoulay, Elie; Faguer, Stanislas

    2016-09-01

    Amyloidosis is a rare and threatening condition that may require intensive care because of amyloid deposit-related organ dysfunction or therapy-related adverse events. Although new multiple myeloma drugs have dramatically improved outcomes in AL amyloidosis, the outcomes of AL patients admitted into intensive care units (ICUs) remain largely unknown. Admission has been often restricted to patients with low Mayo Clinic staging and/or with a complete or very good immunological response at admission. In a retrospective multicentre cohort of 66 adult AL (n = 52) or AA (n = 14) amyloidosis patients, with similar causes of admission to an ICU, the 28-d and 6-month survival rates of AA patients were significantly higher compared to AL patients (93% vs. 60%, P = 0·03; 71% vs. 45%, P = 0·02, respectively). In AL patients, the simplified Index of Gravity Score (IGS2) was the only independent predictive factor for death by day 28, whereas the Mayo-Clinic classification stage had no influence. In Cox's multivariate regression model, only cardiac arrest and on-going chemotherapy at ICU admission significantly predicted death at 6 months. Short-term outcomes of AL patients admitted into an ICU were mainly related to the severity of the acute medical condition, whereas on-going chemotherapy for active amyloidosis impacted on long-term outcomes. © 2016 John Wiley & Sons Ltd.

  4. Can we alter pregnancy outcome by adjusting progesterone treatment at mid-luteal phase: a randomized controlled trial.

    PubMed

    Aslih, Nardin; Ellenbogen, Adrian; Shavit, Tal; Michaeli, Medeia; Yakobi, Devora; Shalom-Paz, Einat

    2017-08-01

    Our study aimed to determine whether mid-luteal serum P concentrations can serve as a predictive factor for in vitro fertilization (IVF) outcomes and whether increasing P dosage for patients with low levels at mid-luteal phase may improve pregnancy rates. It was a prospective, randomized controlled study. A total of 146 patients undergoing IVF treatment were prospectively enrolled and received routine luteal phase support (LPS) regimen of Endometrin® (progesterone) 200 mg/day. Serum P levels were measured 7 days after embryo transfer (ET). Considering a cutoff level of 15 ng/ml on this day, patients with higher levels continued the same dosage until pregnancy test (control group). Patients with lower levels were randomly allocated to continue Endometrin® 200 mg/day (Group A) or to increase Endometrin® dosage to 300 mg/day (Group B). The Main Outcome Measures were pregnancy rates. Both biochemical and clinical pregnancy and live birth rates were comparable between all groups regardless of P level on day 7 of luteal phase and regardless of dose adjustment. ROC analysis determined that mid-luteal P levels of 17 ng/ml can be a better predictor of cycle outcome. In conclusion raising the P dose at mid-luteal phase to 300 mg daily did not improve cycle outcomes.

  5. Short dental implants in patients with oral lichen planus: a long-term follow-up.

    PubMed

    Anitua, E; Piñas, L; Escuer-Artero, V; Fernández, R S; Alkhraisat, M H

    2018-04-01

    Oral lichen planus is associated with the Koebner phenomenon, and trauma may exacerbate oral lesions. Short dental implants, as alternatives to bony augmentation, would reduce the number of interventions and their morbidity. However, we know of no studies that have analysed the long-term outcomes of short implants in patients with oral lichen planus. We have therefore designed a retrospective study of such patients treated with short implants (≤8.5mm long), with survival of implants as the main outcome. The secondary outcomes were marginal bone loss and the development of complications. We calculated the implants' survival and compared the outcomes statistically between erosive and reticular oral lichen planus. Sixty-six short implants were placed in 23 patients with a mean (SD) age of 58 (7) years. The mean (SD) peri-implant bone loss was 0.96 (0.89) mm mesially and 0.99 (1.1) mm distally. Sixty-five of the 66 implants survived with a mean (SD) follow-up of 68 (32) months, and there were no significant differences between erosive and reticular disease. Stable long-term outcomes can be expected for short implants placed in patients with oral lichen planus, and graftless rehabilitation of missing teeth could be possible in these patients if short implants were used. Copyright © 2018 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  6. Outcomes of overseas kidney transplantation in chronic haemodialysis patients in Taiwan.

    PubMed

    Hsu, Chih-Cheng; Lee, Cheng-Hua; Hwang, Shang-Jyh; Huang, Shi-Wei; Yang, Wu-Chang; Chang, Yu-Kang; Tsai, Daniel Fu-Chang; Kuo, Ken N

    2011-03-01

    Overseas kidney transplantation has often been reported to have unsatisfactory outcomes. This study aims to compare post-transplantation outcomes between overseas and domestic kidney transplant (KT) recipients in Taiwan. The Taiwanese National Health Insurance Research Database was used to identify 310 domestic and 643 overseas KT recipients, who survived for longer than 1 month after the transplantation, in a cohort of 45,453 chronic haemodialysis patients in 1997-2002. Cox proportional hazards models were used to assess risks of mortality and graft failure. The 1, 3 and 5 year survival rates for domestic KT recipients were 96.5%, 93.3% and 91.6%, respectively, while those for overseas KT recipients were 94.9%, 87.9% and 77.1%, respectively (P = 0.015). For the overseas group, those who received a KT before 2001 had significantly higher hazard ratios of mortality and graft failure (2.85 and 1.71, respectively). However, for those receiving a KT in 2001-2002, no significant outcome difference could be found between overseas and domestic recipients. The risk disparity between overseas and domestic KT recipients is mainly attributable to when the transplantation was performed. In attempting to dissuade potential recipients from organ trafficking, merely emphasizing the previously acknowledged poor outcomes no longer suffices as a valid reason. © 2011 The Authors. Nephrology © 2011 Asian Pacific Society of Nephrology.

  7. Male chromosomal polymorphisms reduce cumulative live birth rate for IVF couples.

    PubMed

    Ni, Tianxiang; Li, Jing; Chen, Hong; Gao, Yuan; Gao, Xuan; Yan, Junhao; Chen, Zi-Jiang

    2017-08-01

    Chromosomal polymorphisms are associated with infertility, but their effects on assisted reproductive outcomes are still quite conflicting, especially after IVF treatment. This study evaluated the role of chromosomal polymorphisms of different genders in IVF pregnancy outcomes. Four hundred and twenty-five infertile couples undergoing IVF treatment were divided into three groups: 214 couples with normal chromosomes (group A, control group), 86 couples with female polymorphisms (group B), and 125 couples with male polymorphisms (group C). The pregnancy outcomes after the first and cumulative transfer cycles were analyzed, and the main outcome measures were live birth rate (LBR) after the first transfer cycle and cumulative LBR after a complete IVF cycle. Comparison of pregnancy outcomes after the first transfer cycle within group A, group B, and group C demonstrated a similar LBR as well as other rates of implantation, clinical pregnancy, early miscarriage, and ongoing pregnancy (P > 0.05). However, the analysis of cumulative pregnancy outcomes indicated that compared with group A, group C had a significantly lower LBR per cycle (80.4 vs 68.00%), for a rate ratio of 1.182 (95% CI 1.030 to 1.356, P = 0.01) and a significantly higher cumulative early miscarriage rate (EMR) among clinical pregnancies (7.2 vs 14.7%), for a rate ratio of 0.489 (95% CI 0.248 to 0.963, P = 0.035). Couples with chromosomal polymorphisms in only male partners have poor pregnancy outcomes after IVF treatment manifesting as high cumulative EMR and low LBR after a complete cycle.

  8. No increased risk of major congenital anomalies or adverse pregnancy or neonatal outcomes following letrozole use in assisted reproductive technology.

    PubMed

    Tatsumi, T; Jwa, S C; Kuwahara, A; Irahara, M; Kubota, T; Saito, H

    2017-01-01

    Does letrozole use increase the risk of major congenital anomalies and adverse pregnancy and neonatal outcomes in fresh, single-embryo transfer? Letrozole significantly decreases the risk of miscarriage and does not increase the risk of major congenital anomalies or adverse pregnancy or neonatal outcomes compared with natural cycles in patients undergoing ART. Letrozole is the most commonly used aromatase inhibitor for mild ovarian stimulation in ART. However, its safety in terms of pregnancy and neonatal outcomes is unclear. This retrospective cohort study used data from the Japanese national ART registry from 2011 to 2013. A total of 3136 natural cycles and 792 letrozole-induced cycles associated with fresh, single-embryo transfer and resulting in a clinical pregnancy were included in the analysis. The main pregnancy outcomes were miscarriage, ectopic pregnancy and still birth, and the neonatal outcomes were preterm delivery, low birth weight, small/large for gestational age and major congenital anomalies. Terminated pregnancies were included in the analysis of major congenital anomalies. Odds ratios (ORs) and 95% CIs were calculated using multivariate logistic regression analysis adjusted for maternal age and calendar year. The risk of miscarriage was significantly lower in women administered letrozole (adjusted OR [aOR], 0.37, 95% CI, 0.30-0.47, P < 0.001). There was no significant difference in the overall risk of major congenital anomalies between the two groups (natural cycle 1.5% vs letrozole 1.9%, aOR, 1.24, 95% CI, 0.64-2.40, P = 0.52), and no increased risk for any specific organ system. Subgroup analysis demonstrated that the risk of major congenital anomalies was not increased in patients who underwent either in vitro fertilization or ICSI, or in those who received early cleavage stage or blastocyst embryo transfer. All other pregnancy and neonatal outcomes were comparable between the two groups. Despite the large sample size, we were only able to rule out the possibility that letrozole might cause large increases in birth-defect risks in ART patients. The results suggest that letrozole stimulation reduces the risk of miscarriage, with no increase in the risk of major congenital anomalies or adverse pregnancy or neonatal outcomes compared with natural cycles in women undergoing ART. Letrozole may thus be a safe option for mild ovarian stimulation. None. Not applicable. © 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.

  9. Dose-Related Effect of Extracorporeal Shock Wave Therapy for Plantar Fasciitis

    PubMed Central

    Lee, Su-Jin; Kang, Jung-Ho; Kim, Ja-Young; Kim, Jin-Hong; Jung, Kwang-Ik

    2013-01-01

    Objective To examine the dose-related effect of extracorporeal shock wave therapy (ESWT) for plantar fasciitis. Methods Sixty patients with plantar fasciitis despite conservative treatment were enrolled. The patients were divided into a low-energy group (group L: n=30, 1,000 shocks/session, energy flux density [EFD] per shock 0.08 mJ/mm2) and a medium-energy group (group M: n=30, 1,000 shocks/session, EFD 0.16 mJ/mm2). The main outcome measures were visual analogue scale (VAS), Roles and Maudsley (RM) score, and thickness of plantar fascia (PF). To compare the effects between each group, follow-up was carried out 1 week after 3 and 6 sessions, and 1 and 3 months after ESWT. Results Significant VAS and RM score improvement, and PF thickness reduction were observed in both groups (p<0.01). After 3 sessions of ESWT, group M showed significant improvement in the VAS and RM score than group L, whereas after 3 additional sessions applied in group L, the main outcomes were no longer significantly different in both groups (p>0.05). Conclusion Therapeutic effect might disclose a dose-related relationship; therefore, EFD and the times of the session are considerable factors when treating with ESWT. PMID:23869336

  10. Work-related reproductive, musculoskeletal and mental disorders among working women--history, current issues and future research directions.

    PubMed

    Kishi, Reiko; Kitahara, Teruyo; Masuchi, Ayumi; Kasai, Setsuko

    2002-04-01

    According to the recent changes of working environments and socio-economical conditions, the proportion of working women are increasing in Japan. Characteristics of occupational workload and stress of Japanese working women are consistent with those in many industrialized countries except man-dominant culture. In this review we describe the history, current issues, and future research directions on occupational health of working women, especially focused on reproductive health, work-related musculo-skeletal disorders (WMSDs), and mental disorders. In the reproductive health survey, traditionally main concern was about pregnancy outcomes, then fecundity studies, such as time to pregnancy, became topics recently. Future research will be shifted to outcomes not only during pregnancy but also disorders of hormonal balance and climacterium or health conditions after menopause. WMSDs are reviewed on mainly gender difference and its causative factors. Historically, mental health of working women in Japan has focused on the job stress of nurses. We compare results with a lot of recent researches in Europe and U.S.A., where interaction between occupational stress and family roles were studied. It is not easy to predict the prospective status of female workers in Japan, but social, workplace and familial supports will enhance their health promotion.

  11. Perioperative Events and Complications in Minimally Invasive Live Donor Nephrectomy: A Systematic Review and Meta-Analysis.

    PubMed

    Kortram, Kirsten; Ijzermans, Jan N M; Dor, Frank J M F

    2016-11-01

    Minimally invasive live donor nephrectomy has become a fully implemented and accepted procedure. Donors have to be well educated about all risks and details during the informed consent process. For this to be successful, more information regarding short-term outcome is necessary. A literature search was performed; all studies discussing short-term complications after minimally invasive live donor nephrectomy were included. Outcomes evaluated were intraoperative and postoperative complications, conversions, operative and warm ischemia times, blood loss, length of hospital stay, pain score, convalescence, quality of life, and costs. One hundred ninety articles were included in the systematic review, 41 in the meta-analysis. Conversion rate was 1.1%. Intraoperative complication rate was 2.3%, mainly bleeding (1.5%). Postoperative complications occurred in 7.3% of donors, including infectious complications (2.6%), of which mainly wound infection (1.6%) and bleeding (1.0%). Reported mortality rate was 0.01%. All minimally invasive techniques were comparable with regard to complication or conversion rate. The used techniques for minimally invasive live donor nephrectomy are safe and associated with low complication rates and minimal risk of mortality. These data may be helpful to develop a standardized, donor-tailored informed consent procedure for live donor nephrectomy.

  12. Effect of transcendental meditation on employee stress, depression, and burnout: a randomized controlled study.

    PubMed

    Elder, Charles; Nidich, Sanford; Moriarty, Francis; Nidich, Randi

    2014-01-01

    Workplace stress and burnout are pervasive problems, affecting employee performance and personal health. To evaluate the effects of the Transcendental Meditation program on psychological distress and burnout among staff at a residential therapeutic school for students with severe behavioral problems. A total of 40 secondary schoolteachers and support staff at the Bennington School in Vermont, a therapeutic school for children with behavioral problems, were randomly assigned to either practice of the Transcendental Meditation program or a wait-list control group. The Transcendental Meditation course was provided by certified instructors. Outcome measures were assessed at baseline and four months, and included perceived stress, depression, and burnout. A multivariate analysis of covariance was used to determine overall effects. Analysis of the 4-month intervention data indicated a significant improvement in the main outcomes of the study resulting from practice of the Transcendental Meditation program compared with controls (Wilks Λ [3,28] = 0.695; p = 0.019). Results of univariate F tests indicated a significant reduction of all main outcome measures: perceived stress (F[1,32] = 13.42; p = < 0.001); depression (F[1,32] = 6.92; p = 0.013); and overall teacher burnout (F[1,32] = 6.18; p = 0.018). Effect sizes ranged from 0.40 to 0.94. The Transcendental Meditation program was effective in reducing psychological distress in teachers and support staff working in a therapeutic school for students with behavioral problems. These findings have important implications for employees’ job performance as well as their mental and physical health.

  13. Long-term risk of mental health problems in women experiencing preterm birth: a longitudinal study of 29 mothers.

    PubMed

    Misund, Aud R; Nerdrum, Per; Bråten, Stein; Pripp, Are Hugo; Diseth, Trond H

    2013-10-31

    Several studies have reported significantly higher stress levels, both short and long terms, among mothers giving preterm birth compared with mothers giving birth at term. Stress, however, is a psychological phenomenon that may present as anxiety, depression and/or trauma reactions. In this study, the long-term mental health outcomes and the prevalence of anxiety, depression and trauma reactions in women experiencing preterm birth were explored. Interactional, main effect variables and predictors were identified. Twenty-nine mothers of 35 premature children born before the 33rd week of pregnancy were assessed within 2 weeks postpartum (T0), 2 weeks after hospitalization (T1), 6 months post-term (T2), and 18 months post-term (T3). The standardized psychometric methods Impact of Event Scale (IES), General Health Questionnaire (GHQ) and State Anxiety Inventory (STAI-X1) assessed the maternal mental health outcomes. The maternal mental health problems except state anxiety decreased from T0 to T1, but remained high and stable at T3. The prevalence of posttraumatic stress reactions (PTSR) and posttraumatic stress disorder (PTSD) at T0 and T3 was 52% and 23%, respectively. We identified the time period between T0 and T1 to have a significant main effect on mental health outcomes. The predictors of higher levels of mental health problems were preeclampsia, previous psychological treatment, age, trait anxiety and infant's postnatal intraventricular haemorrhage. Bleeding in pregnancy predicted lower levels of mental health problems. The prevalence of maternal mental health problems remained high, emphasizing the importance of effective interventions.

  14. Evaluation of outreach clinics held by specialists in general practice in England

    PubMed Central

    Bond, M.; Bowling, A.; Abery, A.; McClay, M.; Dickinson, E.

    2000-01-01

    OBJECTIVES—To measure the processes of care, health benefits and costs of outreach clinics held by hospital specialists in primary care settings.
DESIGN—The study was designed as a case-referent (comparative) study in which the features of 19 outreach clinics (cases) were compared with matched outpatient clinics (controls). The measuring instruments were self administered questionnaires. Patients were followed up at six months to reassess health status. The specialties included in the study were cardiology, ENT, general medicine, general surgery, gynaecology and rheumatology.
SETTING—Specialist outreach clinics in general practice in England, with matched outpatient clinic controls.
SUBJECTS—Consecutive patient attenders in the outreach and outpatient clinics, their specialists, the outreach patients' general practitioners, practice managers and trust accountants. Patients' response rate at baseline: 78% (1420).
MAIN OUTCOME MEASURES—Patient satisfaction, doctors' attitudes, processes and health outcomes, costs.
RESULTS—Outreach patients were more satisfied with the processes of their care than outpatients, their access to specialist care was better than that for outpatients and they were more likely to be discharged. Doctors reported that the main advantages of the outreach clinic were improved patient access to specialists and convenience for patients, in comparison with outpatients, and most GPs and specialists felt the outreach clinic was "worthwhile". At six month follow up, the health status of the outreach sample had significantly improved more than that of the outpatients on all eight sub-scales of the HSQ-12, but this was probably because of their better starting point at baseline. The impact of outreach on health outcomes was small. The NHS costs of outreach were significantly higher than outpatients. An increase in outreach clinic size would reduce cost per patient, but would lead to the loss of most of the clinics' benefits.
CONCLUSIONS—While the process of care was of higher quality in outreach than in outpatients, and the efficiency of care was also greater in the latter, the effect on patients' health outcomes was small. Responsiveness to patients' views and preferences is an essential component of good quality service provision. However, the greater cost of outreach raises the issue of whether improvements in the quality and efficiency of health care, without a substantial impact on health outcomes, is money well spent in a publicly funded health service. On the other hand, the real costs of outreach in comparison with outpatients clinics can probably only be truly estimated in a longitudinal study with a resource based costing model derived from documented patient attendances and treatment costs over time in relation to longer term outcome (for example, at a two year end point).


Keywords: outreach clinics; general practice PMID:10715749

  15. A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT): a study protocol

    PubMed Central

    Norrie, John; Lawton, Julia; Norman, Jane E; Scotland, Graham; McPherson, Gladys C; McDonald, Alison; Forrest, Mark; Hudson, Jemma; Brewin, Jane; Peace, Mathilde; Clarkson, Cynthia; Brook-Smith, Sheonagh; Morrow, Susan; Hallowell, Nina; Hodges, Laura; Carruthers, Kathryn F

    2017-01-01

    Introduction A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP). Methods and analysis The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice. Ethics and dissemination Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals. Trial registration number ISCRTN88609453; Pre-results. PMID:28928192

  16. Long-term outcomes following laparoscopic adjustable gastric banding: postoperative psychological sequelae predict outcome at 5-year follow-up.

    PubMed

    Scholtz, Samantha; Bidlake, Louise; Morgan, John; Fiennes, Alberic; El-Etar, Ashraf; Lacey, John Hubert; McCluskey, Sara

    2007-09-01

    NICE guidelines state that patients with psychological contra-indications should not be considered for bariatric surgery, including Laparoscopic Adjustable Gastric Banding (LAGB) surgery as treatment of morbid obesity, although no consistent correlation between psychiatric illness and long-term outcome in LAGB has been established. This is to our knowledge the first study to evaluate long-term outcomes in LAGB for a full range of DSM-IV defined psychiatric and eating disorders, and forms part of a research portfolio developed by the authors aimed at defining psychological predictors of bariatric surgery in the short-, medium- and long-term. Case notes of 37 subjects operated on between April 1997 and June 2000, who had undergone structured clinical interview during pre-surgical assessment to yield diagnoses of mental and eating disorders according to DSM-IV criteria were analyzed according to a set of operationally defined criteria. Statistical analysis was carried out to compare those with a poor outcome and those considered to have a good outcome in terms of psychiatric profile. In this group of mainly female, Caucasian subjects, ranging in age from 27 to 60 years, one-third were diagnosed with a mental disorder according to DSM-IV criteria. The development of postoperative DSM-IV defined binge eating disorder (BED) or depression strongly predicted poor surgical outcome, but pre-surgical psychiatric factors alone did not. Although pre-surgical psychiatric assessment alone cannot predict outcome, an absence of preoperative psychiatric illness should not reassure surgeons who should be mindful of postoperative psychiatric sequelae, particularly BED. The importance of providing an integrated biopsychosocial model of care in bariatric teams is highlighted.

  17. A meta-analysis on gender differences in negotiation outcomes and their moderators.

    PubMed

    Mazei, Jens; Hüffmeier, Joachim; Freund, Philipp Alexander; Stuhlmacher, Alice F; Bilke, Lena; Hertel, Guido

    2015-01-01

    This meta-analysis investigates gender differences in economic negotiation outcomes. As suggested by role congruity theory, we assume that the behaviors that increase economic negotiation outcomes are more congruent with the male as compared with the female gender role, thereby presenting challenges for women's negotiation performance and reducing their outcomes. Importantly, this main effect is predicted to be moderated by person-based, situation-based, and task-based influences that make effective negotiation behavior more congruent with the female gender role, which should in turn reduce or even reverse gender differences in negotiation outcomes. Using a multilevel modeling approach, this meta-analysis includes 123 effect sizes (overall N = 10,888, including undergraduate and graduate students as well as businesspeople). Studies were included when they enabled the calculation of an effect size reflecting gender differences in achieved economic negotiation outcomes. As predicted, men achieved better economic outcomes than women on average, but gender differences strongly depended on the context: Moderator analysis revealed that gender differences favoring men were reduced when negotiators had negotiation experience, when they received information about the bargaining range, and when they negotiated on behalf of another individual. Moreover, gender differences were reversed under conditions of the lowest predicted role incongruity for women. In conclusion, gender differences in negotiations are contextually bound and can be subject to change. Future research is needed that investigates the underlying mechanisms of new moderators revealed in the current research (e.g., experience). Implications for theoretical explanations of gender differences in negotiation outcomes, for gender inequalities in the workplace, and for future research are discussed. PsycINFO Database Record (c) 2015 APA, all rights reserved.

  18. Secondary patella resurfacing in painful non-resurfaced total knee arthroplasties : A study of survival and clinical outcome from the Norwegian Arthroplasty Register (1994-2011).

    PubMed

    Leta, Tesfaye H; Lygre, Stein Håkon L; Skredderstuen, Arne; Hallan, Geir; Gjertsen, Jan-Erik; Rokne, Berit; Furnes, Ove

    2016-04-01

    In Norway, 19 % of revisions of non-resurfaced total knee arthroplasties done for knee pain between 1994 and 2011 were Secondary Patella Resurfacing (SPR). It is, however, unclear whether SPR actually resolves the pain. The aim was to investigate prostheses survival and clinical outcomes following SPR. A total of 308 knees (301 patients) with SPR were used to assess implant survival, and a sub-cohort (n = 114 out of 301 patients) with Patient Reported Outcome Measures (PROMs) data were used to assess the clinical outcomes. The EuroQol (EQ-5D), the Knee Injury and Osteoarthritis Outcome Score, and Visual Analogue Scales on satisfaction and pain were used to collect PROM data. Outcomes were analysed by Kaplan-Meier, Cox regression, and multiple linear regression. The five- and ten-year Kaplan-Meier survival percentages were 91 % and 87 %, respectively. Overall, 35 knees were re-revised at a median follow-up of eight years and pain alone (10 knees) was the main cause of re-revision. Younger patients (<60 years) had nearly nine times higher risk of re-revision compared to older patients (>70 years) (RR = 8.6; p < 0.001). Mean EQ-5D index score had improved from 0.41 (SD 0.21) preoperative to 0.56 (SD 0.25) postoperative following SPR. A total of 63 % of patients with PROM data were satisfied with the outcomes of SPR. The long-term prostheses survival following SPR was satisfactory, although not as good as for primary knee replacement. Patients' health related quality of life improved significantly following SPR. Still, more than a third of patients with PROMs data were dissatisfied with the outcomes of the SPR procedure.

  19. Organizational Climate, Services, and Outcomes in Child Welfare Systems

    ERIC Educational Resources Information Center

    Glisson, Charles; Green, Philip

    2011-01-01

    Objective: This study examines the association of organizational climate, casework services, and youth outcomes in child welfare systems. Building on preliminary findings linking organizational climate to youth outcomes over a 3-year follow-up period, the current study extends the follow-up period to 7 years and tests main, moderating and…

  20. A Participative Approach to Evaluation of Graduates' Professional Outcomes

    ERIC Educational Resources Information Center

    Clerici, Renata; Castiglioni, Maria; Grion, Valentina; Zago, Giuseppe; Da Re, Lorenza

    2014-01-01

    This work discusses the professional outcomes of University of Padova graduates in academic year 2007/08. Its aim was to carry out an overall assessment of higher education professional outcomes, involving all the main actors of the learning process, students, teachers and tutors, in a perspective of participatory evaluation, to improve teaching…

  1. The association of funding source on effect size in randomized controlled trials: 2013-2015 - a cross-sectional survey and meta-analysis.

    PubMed

    Falk Delgado, Alberto; Falk Delgado, Anna

    2017-03-14

    Trials financed by for-profit organizations have been associated with favorable outcomes of new treatments, although the effect size of funding source impact on outcome is unknown. The aim of this study was to estimate the effect size for a favorable outcome in randomized controlled trials (RCTs), stratified by funding source, that have been published in general medical journals. Parallel-group RCTs published in The Lancet, New England Journal of Medicine, and JAMA between 2013 and 2015 were identified. RCTs with binary primary endpoints were included. The primary outcome was the OR of patients' having a favorable outcome in the intervention group compared with the control group. The OR of a favorable outcome in each trial was calculated by the number of positive events that occurred in the intervention and control groups. A meta-analytic technique with random effects model was used to calculate summary OR. Data were stratified by funding source as for-profit, mixed, and nonprofit. Prespecified sensitivity, subgroup, and metaregression analyses were performed. Five hundred nine trials were included. The OR for a favorable outcome in for-profit-funded RCTs was 1.92 (95% CI 1.72-2.14), which was higher than mixed source-funded RCTs (OR 1.34, 95% CI 1.25-1.43) and nonprofit-funded RCTs (OR 1.32, 95% CI 1.26-1.39). The OR for a favorable outcome was higher for both clinical and surrogate endpoints in for-profit-funded trials than in RCTs with other funding sources. Excluding drug trials lowered the OR for a favorable outcome in for-profit-funded RCTs. The OR for a favorable surrogate outcome in drug trials was higher in for-profit-funded trials than in nonprofit-funded trials. For-profit-funded RCTs have a higher OR for a favorable outcome than nonprofit- and mixed source-funded RCTs. This difference is associated mainly with the use of surrogate endpoints in for-profit-financed drug trials.

  2. Social experiential deprivation in autism spectrum disorders: A possible prognostic factor?

    PubMed

    Kaku, Sowmyashree Mayur; Basheer, Salah; Venkatasubramanian, Ganesan; Bharath, Rose Dawn; Girimaji, Satish Chandra; Srinath, Shoba

    2017-04-01

    Autism spectrum disorders (ASD) are well known to be influenced by various environmental factors. Among these influencers, social experiential deprivation (SED) in infancy is one of them which is not well reported. We explored factors contributing to SED in 11 young children diagnosed to have ASD and compared them to 24 children without SED also having ASD. Intervention mainly addressing factors causing SED for 6 months demonstrated that children with SED had a better outcome at follow up. Could SED be a possible prognostic factor in children with ASD? Copyright © 2017 Elsevier B.V. All rights reserved.

  3. A comparison of Wisconsin Neonatal Intensive Care Units with National data on outcomes and practices

    PubMed Central

    Hagen, Erika W.; Sadek-Badawi, Mona; Albanese, Aggie; Palta, Mari

    2009-01-01

    Context: Improvements in neonatal care over the past three decades have resulted in increased survival of infants at lower birthweights and gestational ages. However, outcomes and practices vary considerably between hospitals. Objective: To describe maternal and infant characteristics, NICU practices, morbidity, and mortality in Wisconsin neonatal intensive care units (NICU) and to compare outcomes in Wisconsin to the National Institute of Child Health and Human Development network of large academic medical center NICUs. Design and Setting: The Newborn Lung Project Statewide Cohort is a prospective observational study of all very low birthweight (≤ 1500 grams) infants admitted during 2003 and 2004 to the 16 level III NICUs in Wisconsin. Anonymous data were collected for all admitted infants (N=1463). Main outcome measures: Major neonatal morbidities, including bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, and retinopathy of prematurity were evaluated. Results: The overall incidence of bronchopulmonary dysplasia was 24% (range 8-56% between NICUs); intraventricular hemorrhage incidence was 23% (9-41%); the incidence of necrotizing enterocolitis was 7% (0-21%); and the incidence of grade III or higher retinopathy of prematurity was 10% (0-35%). Conclusion: The incidence rates of major neonatal morbidities in Wisconsin were similar to those of a national network of academic NICUs. PMID:19180870

  4. Implementation of Telemedicine and Stroke Network in thrombolytic administration: comparison between walk-in and referred patients.

    PubMed

    Dharmasaroja, Pornpatr A; Muengtaweepongsa, Sombat; Kommarkg, Urai

    2010-08-01

    The purpose of this study was to evaluate the efficacy and safety of implementation of telemedicine and the Thammasat Stroke Network model in treating acute ischemic stroke patients with intravenous thrombolysis. Telemedicine (telephone consultation and tele-radiology) has been used in acute ischemic stroke management since June, 2007. The Thammasat Stroke Network (TSN) was effectively organized in March, 2008. Thammasat Hospital served as a "hub" hospital, with 25 "spoke" hospitals in the TSN. The main outcome measures included favorable outcome of the patients treated with intravenous tissue plasminogen activator (tPA) at 3 months and symptomatic intracerebral hemorrhage by comparison between walk-in patients and the patients who were referred by the TSN. There were 14 patients (14 out of 170 acute ischemic stroke patients, 8%) and 110 patients (110 out of 406 patients, 27%) receiving tPA, before and after implementation of TSN, respectively. Walk-in patients (66 patients) had significant shorter onset-to-treatment duration as compared with referred patients (58 patients) (130 vs. 170 min, P < 0.0001). However, there was no significant difference in favorable outcome (48 vs. 42%, P = 0.538) and rate of symptomatic intracerebral hemorrhage (3 vs. 2%, P = 0.637). Implementation of telemedicine and TSN markedly increased tPA administrations, without compromising favorable and safety outcomes.

  5. An Exploratory Evaluation of the Family Meal Intervention for Adolescent Anorexia Nervosa.

    PubMed

    Herscovici, Cecile Rausch; Kovalskys, Irina; Orellana, Liliana

    2017-06-01

    Although weight restoration is a crucial factor in the recovery of anorexia nervosa (AN), there is scarce evidence regarding which components of treatment promote it. In this paper, the author reports on an effort to utilize research methods in her own practice, with the goal of evaluating if the family meal intervention (FMI) had a positive effect on increasing weight gain or on improving other general outcome measures. Twenty-three AN adolescents aged 12-20 years were randomly assigned to two forms of outpatient family therapy (with [FTFM] and without [FT]) using the FMI, and treated for a 6-month duration. Their outcome was compared at the end of treatment (EOT) and at a 6-month posttreatment follow-up (FU). The main outcome measure was weight recovery; secondary outcome measures were the Morgan Russell Global Assessment Schedule (MRHAS), amenorrhea, general psychological symptoms, and eating disorder symptoms. The majority of the patients in both groups improved significantly at EOT, and these changes were sustained through FU. Given its primarily clinical nature, findings of this investigation project preclude any conclusion. Although the FMI did not appear to convey specific benefits in causing weight gain, clinical observation suggests the value of a flexible stance in implementation of the FMI for the severely undernourished patient with greater psychopathology. © 2015 Family Process Institute.

  6. Is urgent coronary artery bypass grafting a safe option in octogenarians? A developing country perspective.

    PubMed

    Luqman, Zubair; Ansari, Junaid; Siddiqui, Fahad Javaid; Sami, Shahid Ahmed

    2009-09-01

    Life expectancy has increased during recent decades leading to a growing number of older population. The objective of this study was to evaluate the outcomes of coronary artery bypass grafting (CABG) in octogenarians and to compare the outcomes of the emergent CABG with elective surgery. Prospectively collected data from 31 consecutive octogenarian patients who underwent CABG between 1 January 2006 and 31 December 2008 were analyzed. Main outcomes of interest included mortality, length of ICU stay, length of hospital stay, priority of surgery, postoperative complications and functional status on follow-up. Fifteen patients were operated on an urgent basis. Patients operated on an urgent basis were in NYHA class III or IV preoperatively (P=0.0016). There were no significant differences in operative and postoperative variables. There were three in-hospital deaths and 23 patients (82%) were alive on follow-up and 19 were in functional class I or II. Quality of life assessment was performed using Seattle Angina Questionnaire and patients reported remarkable improvement in quality of life. Overall, 90% patients were not or slightly disabled in their daily activity. Satisfaction with their current quality of life was reported by 95% of patients. CABG may be performed in octogenarians with remarkable outcomes and improvement in quality of life.

  7. The Differential Outcomes Procedure Enhances Adherence to Treatment: A Simulated Study with Healthy Adults

    PubMed Central

    Molina, Michael; Plaza, Victoria; Fuentes, Luis J.; Estévez, Angeles F.

    2015-01-01

    Memory for medical recommendations is a prerequisite for good adherence to treatment, and therefore to ameliorate the negative effects of the disease, a problem that mainly affects people with memory deficits. We conducted a simulated study to test the utility of a procedure (the differential outcomes procedure, DOP) that may improve adherence to treatment by increasing the patient’s learning and retention of medical recommendations regarding medication. The DOP requires the structure of a conditional discriminative learning task in which correct choice responses to specific stimulus–stimulus associations are reinforced with a particular reinforcer or outcome. In two experiments, participants had to learn and retain in their memory the pills that were associated with particular disorders. To assess whether the DOP improved long-term retention of the learned disorder/pill associations, participants were asked to perform two recognition memory tests, 1 h and 1 week after completing the learning phase. The results showed that compared with the standard non-differential outcomes procedure, the DOP produced better learning and long-term retention of the previously learned associations. These findings suggest that the DOP can be used as a useful complementary technique in intervention programs targeted at increasing adherence to clinical recommendations. PMID:26913010

  8. Part-Time Physicians…Prevalent, Connected, and Satisfied

    PubMed Central

    Levine, Rachel B.; Manwell, Linda Baier; Mundt, Marlon P.; Linzer, Mark

    2008-01-01

    Objective The health care workforce is evolving and part-time practice is increasing. The objective of this work is to determine the relationship between part-time status, workplace conditions, and physician outcomes. Design Minimizing error, maximizing outcome (MEMO) study surveyed generalist physicians and their patients in the upper Midwest and New York City. Measurements and Main Results Physician survey of stress, burnout, job satisfaction, work control, intent to leave, and organizational climate. Patient survey of satisfaction and trust. Responses compared by part-time and full-time physician status; 2-part regression analyses assessed outcomes associated with part-time status. Of 751 physicians contacted, 422 (56%) participated. Eighteen percent reported part-time status (n = 77, 31% of women, 8% of men, p < .001). Part-time physicians reported less burnout (p < .01), higher satisfaction (p < .001), and greater work control (p < .001) than full-time physicians. Intent to leave and assessments of organizational climate were similar between physician groups. A survey of 1,795 patients revealed no significant differences in satisfaction and trust between part-time and full-time physicians. Conclusions Part-time is a successful practice style for physicians and their patients. If favorable outcomes influence career choice, an increased demand for part-time practice is likely to occur. PMID:18214623

  9. The National Early Warning Score (NEWS) for outcome prediction in emergency department patients with community-acquired pneumonia: results from a 6-year prospective cohort study

    PubMed Central

    Sbiti-Rohr, Diana; Kutz, Alexander; Christ-Crain, Mirjam; Thomann, Robert; Zimmerli, Werner; Hoess, Claus; Henzen, Christoph; Mueller, Beat; Schuetz, Philipp

    2016-01-01

    Objective To investigate the accuracy of the National Early Warning Score (NEWS) to predict mortality and adverse clinical outcomes for patients with community-acquired pneumonia (CAP) compared to standard risk scores such as the pneumonia severity index (PSI) and CURB-65. Design Secondary analysis of patients included in a previous randomised-controlled trial with a median follow-up of 6.1 years. Settings Patients with CAP included on admission to the emergency departments (ED) of 6 tertiary care hospitals in Switzerland. Participants A total of 925 patients with confirmed CAP were included. NEWS, PSI and CURB-65 scores were calculated on admission to the ED based on admission data. Main outcome measure Our primary outcome was all-cause mortality within 6 years of follow-up. Secondary outcomes were adverse clinical outcome defined as intensive care unit (ICU) admission, empyema and unplanned hospital readmission all occurring within 30 days after admission. We used regression models to study associations of baseline risk scores and outcomes with the area under the receiver operating curve (AUC) as a measure of discrimination. Results 6-year overall mortality was 45.1% (n=417) with a stepwise increase with higher NEWS categories. For 30 day and 6-year mortality prediction, NEWS showed only low discrimination (AUC 0.65 and 0.60) inferior compared to PSI and CURB-65. For prediction of ICU admission, NEWS showed moderate discrimination (AUC 0.73) and improved the prognostic accuracy of a regression model, including PSI (AUC from 0.66 to 0.74, p=0.001) and CURB-65 (AUC from 0.64 to 0.73, p=0.015). NEWS was also superior to PSI and CURB-65 for prediction of empyema, but did not well predict rehospitalisation. Conclusions NEWS provides additional prognostic information with regard to risk of ICU admission and complications and thereby improves traditional clinical-risk scores in the management of patients with CAP in the ED setting. Trial registration number ISRCTN95122877; Post-results. PMID:27683509

  10. Video Ratings of Surgical Skill and Late Outcomes of Bariatric Surgery

    PubMed Central

    Scally, Christopher P.; Varban, Oliver A.; Carlin, Arthur M.; Birkmeyer, John D.; Dimick, Justin B.

    2018-01-01

    Importance Measures of surgeons’ skill have been associated with variations in short-term outcomes after laparoscopic gastric bypass. However, the impact of surgical skill on long-term outcomes after bariatric surgery is unknown. Objective To study the association between surgical skill and long-term outcomes of bariatric surgery Design Surgeons were ranked on their skill level through blinded peer video review, and sorted into quartiles of skill. Outcomes of bariatric surgery were then examined at the patient level across skill levels. Setting The Michigan Bariatric Surgical Collaborative, a prospective clinical registry of 40 hospitals performing bariatric surgery in the state of Michigan Participants 20 surgeons performing bariatric surgery who submitted videos for anonymous peer ratings; patients undergoing surgery with these surgeons for whom one year follow-up data postoperatively was available. Exposure Surgeon skill level. Main Outcome Measures Excess body weight loss at one year; resolution of medical comorbidities (hypertension, sleep apnea, diabetes, hyperlipidemia), functional status, patient satisfaction. Results Peer ratings of surgical skill varied from 2.6 to 4.8 on a 5-point scale. There was no difference between the best (top 25%) and worst (bottom 25%) performance quartiles when comparing excess body weight loss (67.2% excess body weight loss vs 68.5%, p=.89) at one year. There were no differences in resolution of sleep apnea (62.6% vs 62.0%, p=.77), hypertension (47.1% vs 45.4%, p=.73), or hyperlipidemia (52.3% vs 63.4%, p=.45). Surgeons with the lowest skill rating had patients with higher rates of diabetes resolution (78.8%) when compared to the high-skill group (72.8%, p=0.01). Conclusions and Relevance In contrast to its impact on early complications, surgical skill did not impact postoperative weight loss or resolution of medical comorbidities at one year after laparoscopic gastric bypass. These findings suggest that long-term outcomes after bariatric surgery may be less dependent on a surgeon’s operative skill and instead be driven by other factors. Operative technique was not assessed in this analysis and should be considered in future studies. PMID:27074114

  11. Mental health and developmental outcomes for children born after ART: a comparative prospective study on child gender and treatment type.

    PubMed

    Punamäki, Raija-Leena; Tiitinen, Aila; Lindblom, Jallu; Unkila-Kallio, Leila; Flykt, Marjo; Vänskä, Mervi; Poikkeus, Piia; Tulppala, Maija

    2016-01-01

    Do children born after assisted reproductive techniques (ART; IVF/ICSI) display more mental health issues or social and cognitive developmental problems at 7-8 years than naturally conceived (NC) controls, and does child gender play a role? ART children do not differ with regard to mental health or social and cognitive developmental problems when compared with controls, but some gender-specific differences do exist. Systematic reviews have not found any evidence of delays in neurocognitive or sensorimotor development in ART children. However findings on the effect of the type of ART treatment (IVF versus ICSI) on the offspring's physical and mental development have not been uniform. Knowledge of the role of child gender in ART research is scarce. This prospective follow-up study compares mental health and social and cognitive developmental problems between 7-8-year-old ART and NC children, controlling for the father's age, length of the parents' partnership, mother's parity, child's gestational age, and the need of neonatal intensive care unit (NICU). Further, within the ART group, we analysed whether the treatment type (IVF versus ICSI) and the child's gender are associated with the mental health and developmental outcomes. In this study, 255 singleton ART children (IVF and ICSI) were compared with 278 NC children on parent-reported internalizing and externalizing symptoms, and social (social skills and peer relations) and cognitive development (executive functioning, perception, memory, and language). Within the ART group, 164 IVF and 76 ICSI children were compared on the same outcomes. Statistics included analyses of covariates (ANCOVA) with group main effects, group and gender interaction effects, and Bonferroni post hoc tests. ART and NC children did not differ generally in terms of their internalizing and externalizing symptoms or in the number of social and cognitive developmental problems (Group main effects, P > 0.05), but gender-specific group differences existed. The ART boys showed lower levels of cognitive problems than the NC boys, whereas ART girls showed higher levels of cognitive problems than the NC girls (Group × Gender-interaction effects with Bonferroni post hoc tests on mother-reports, P < 0.01). Further, unlike in the NC group, where boys showed more externalizing symptoms and social and cognitive developmental problems than girls (Group × Gender-interaction effects with Bonferroni post hoc tests for both parents' reports, P < 0.05), gender differences were not found in the ART group. Within the ART group, IVF and ICSI children did not differ in terms of mental health or developmental outcomes, and no significant gender differences emerged. The information on children's mental health and development was based on parental reports only. The dropout rate between the child's first year and the school age assessments was very high for fathers (57.4%) and substantial for mothers (30.1%), and the participating group was biased for older age of both parents and for better education of the fathers. The findings indicate the importance of considering child gender in learning about multiple developmental outcomes among children born after ART. This study was supported by the Academy of Finland (#11232276), the Emil Aaltonen Foundation, The Family Federation of Finland, Helsinki University Central Hospital Research Funds, and the National Graduate School of Psychology. None of authors has any competing interests to declare. © The Author 2015. 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.

  12. Cost effectiveness analysis of immunotherapy in patients with grass pollen allergic rhinoconjunctivitis in Germany.

    PubMed

    Westerhout, K Y; Verheggen, B G; Schreder, C H; Augustin, M

    2012-01-01

    An economic evaluation was conducted to assess the outcomes and costs as well as cost-effectiveness of the following grass-pollen immunotherapies: OA (Oralair; Stallergenes S.A., Antony, France) vs GRZ (Grazax; ALK-Abelló, Hørsholm, Denmark), and ALD (Alk Depot SQ; ALK-Abelló) (immunotherapy agents alongside symptomatic medication) and symptomatic treatment alone for grass pollen allergic rhinoconjunctivitis. The costs and outcomes of 3-year treatment were assessed for a period of 9 years using a Markov model. Treatment efficacy was estimated using an indirect comparison of available clinical trials with placebo as a common comparator. Estimates for immunotherapy discontinuation, occurrence of asthma, health state utilities, drug costs, resource use, and healthcare costs were derived from published sources. The analysis was conducted from the insurant's perspective including public and private health insurance payments and co-payments by insurants. Outcomes were reported as quality-adjusted life years (QALYs) and symptom-free days. The uncertainty around incremental model results was tested by means of extensive deterministic univariate and probabilistic multivariate sensitivity analyses. In the base case analysis the model predicted a cost-utility ratio of OA vs symptomatic treatment of €14,728 per QALY; incremental costs were €1356 (95%CI: €1230; €1484) and incremental QALYs 0.092 (95%CI: 0.052; 0.140). OA was the dominant strategy compared to GRZ and ALD, with estimated incremental costs of -€1142 (95%CI: -€1255; -€1038) and -€54 (95%CI: -€188; €85) and incremental QALYs of 0.015 (95%CI: -0.025; 0.056) and 0.027 (95%CI: -0.022; 0.075), respectively. At a willingness-to-pay threshold of €20,000, the probability of OA being the most cost-effective treatment was predicted to be 79%. Univariate sensitivity analyses show that incremental outcomes were moderately sensitive to changes in efficacy estimates. The main study limitation was the requirement of an indirect comparison involving several steps to assess relative treatment effects. The analysis suggests OA to be cost-effective compared to GRZ and ALD, and a symptomatic treatment. Sensitivity analyses showed that uncertainty surrounding treatment efficacy estimates affected the model outcomes.

  13. Clinical effectiveness and cost-effectiveness of parenting interventions for children with severe attachment problems: a systematic review and meta-analysis.

    PubMed

    Wright, Barry; Barry, Melissa; Hughes, Ellen; Trépel, Dominic; Ali, Shehzad; Allgar, Victoria; Cottrill, Lucy; Duffy, Steven; Fell, Jenny; Glanville, Julie; Glaser, Danya; Hackney, Lisa; Manea, Laura; McMillan, Dean; Palmer, Stephen; Prior, Vivien; Whitton, Clare; Perry, Amanda; Gilbody, Simon

    2015-07-01

    Services have variable practices for identifying and providing interventions for 'severe attachment problems' (disorganised attachment patterns and attachment disorders). Several government reports have highlighted the need for better parenting interventions in at-risk groups. This report was commissioned to evaluate the clinical effectiveness and cost-effectiveness of parenting interventions for children with severe attachment problems (the main review). One supplementary review explored the evaluation of assessment tools and a second reviewed 10-year outcome data to better inform health economic aspects of the main review. A total of 29 electronic databases were searched with additional mechanisms for identifying a wide pool of references using the Cochrane methodology. Examples of databases searched include PsycINFO (1806 to January week 1, 2012), MEDLINE and MEDLINE In-Process & Other Non-Indexed Citations (1946 to December week 4, 2011) and EMBASE (1974 to week 1, 2012). Searches were carried out between 6 and 12 January 2012. Papers identified were screened and data were extracted by two independent reviewers, with disagreements arbitrated by a third independent reviewer. Quality assessment tools were used, including quality assessment of diagnostic accuracy studies - version 2 and the Cochrane risk of bias tool. Meta-analysis of randomised controlled trials (RCTs) of parenting interventions was undertaken. A health economics analysis was conducted. The initial search returned 10,167 citations. This yielded 29 RCTs in the main review of parenting interventions to improve attachment patterns, and one involving children with reactive attachment disorder. A meta-analysis of eight studies seeking to improve outcome in at-risk populations showed statistically significant improvement in disorganised attachment. The interventions saw less disorganised attachment at outcome than the control (odds ratio 0.47, 95% confidence interval 0.34 to 0.65; p < 0.00001). Much of this focused around interventions improving maternal sensitivity, with or without video feedback. In our first supplementary review, 35 papers evaluated an attachment assessment tool demonstrating validity or psychometric data. Only five reported test-retest data. Twenty-six studies reported inter-rater reliability, with 24 reporting a level of 0.7 or above. Cronbach's alphas were reported in 12 studies for the comparative tests (11 with α > 0.7) and four studies for the reference tests (four with α > 0.7). Three carried out concurrent validity comparing the Strange Situation Procedure (SSP) with another assessment tool. These had good sensitivity but poor specificity. The Disturbances of Attachment Interview had good sensitivity and specificity with the research diagnostic criteria (RDC) for attachment disorders. In our supplementary review of 10-year outcomes in cohorts using a baseline reference standard, two studies were found with disorganised attachment at baseline, with one finding raised psychopathology in adolescence. Budget impact analysis of costs was estimated because a decision model could not be justifiably populated. This, alongside other findings, informed research priorities. There are relatively few UK-based clinical trials. A 10-year follow-up, while necessary for our health economists for long-term sequelae, yielded a limited number of papers. Maternal sensitivity interventions show good outcomes in at-risk populations, but require further research with complex children. The SSP and RDC for attachment disorders remain the reference standards for identification until more concurrent and predictive validity research is conducted. A birth cohort with sequential attachment measures and outcomes across different domains is recommended with further, methodologically sound randomised controlled intervention trials. The main area identified for future work was a need for good-quality RCTs in at-risk groups such as those entering foster care or adoption. This study is registered as PROSPERO CRD42011001395. The National Institute for Health Research Health Technology Assessment programme.

  14. Griseofulvin versus terbinafine in the treatment of tinea capitis: a meta-analysis of randomized, clinical trials.

    PubMed

    Fleece, David; Gaughan, John P; Aronoff, Stephen C

    2004-11-01

    Tinea capitis, a common pediatric infection in the United States, is caused mainly by Trichophyton species and affects many urban children. Although the current treatment of choice is oral griseofulvin, terbinafine has been shown to be variably effective in several comparative, randomized trials. The purpose of this study was to perform a meta-analysis of randomized, clinical trials comparing the efficacies of oral terbinafine and oral griseofulvin for the treatment of childhood tinea capitis. The Medline database was searched for randomized, clinical studies comparing griseofulvin and terbinafine for the treatment of tinea capitis. Acceptance criteria included oral administration of griseofulvin for at least 6 weeks and the identification of a pathogenic dermatophyte from the scalp at the time of enrollment in the study. Scalp culture status at least 8 weeks after enrollment was used as the outcome. The common odds ratio (OR) with 95% confidence intervals (CIs), the Cochran-Mantel-Haenszel test for significance, and the Breslow-Day test for homogeneity were calculated. Six articles that satisfied all inclusion criteria were identified. These studies were combined by using outcomes at 12 to 16 weeks after enrollment. The common OR was 0.86 (95% CI: 0.57-1.27). When the 5 studies that identified Trichophyton species as the predominant pathogen were combined, using outcomes 12 weeks after enrollment, the results nearly favored terbinafine (OR: 0.65 [95% CI: 0.42-1.01]). For outcomes at 8 weeks after enrollment, no difference was found between the agents (OR: 0.84 [95% CI: 0.54-1.32]). Consclusions.A 2- to 4-week course of terbinafine is at least as effective as a 6- to 8-week course of griseofulvin for the treatment of Trichophyton infections of the scalp. Griseofulvin is likely to be superior to terbinafine for the rare cases caused by Microsporum species.

  15. A novel stent inflation protocol improves long-term outcomes compared with rapid inflation/deflation deployment method.

    PubMed

    Vallurupalli, Srikanth; Kasula, Srikanth; Kumar Agarwal, Shiv; Pothineni, Naga Venkata K; Abualsuod, Amjad; Hakeem, Abdul; Ahmed, Zubair; Uretsky, Barry F

    2017-08-01

    High-pressure inflation for coronary stent deployment is universally performed. However, the duration of inflation is variable and does not take into account differences in lesion compliance. We developed a standardized "pressure optimization protocol" (POP) using inflation pressure stability rather than an arbitrary inflation time or angiographic balloon appearance for stent deployment. Whether this approach improves long-term outcomes is unknown. 792 patients who underwent PCI using either rapid inflation/deflation (n = 376) or POP (n = 416) between January 2009 and March 2014 were included. Exclusion criteria included PCI for acute myocardial infarction, in-stent restenosis, chronic total occlusion, left main, and saphenous vein graft lesions. Primary endpoint was target vessel failure [TVF = combined end point of target vessel revascularization (TVR), myocardial infarction, and cardiac death]. Outcomes were analyzed in the entire cohort and in a propensity analysis. Stent implantation using POP with a median follow-up of 1317 days was associated with lower TVF compared with rapid inflation/deflation (10.1 vs. 17.8%, P < 0.0001). This difference was driven by a decrease in TVR (7 vs. 10.6%, P = 0.0016) and cardiac death (2.9 vs. 5.8%, P = 0.017) while there was no difference in myocardial infarction (1 vs. 1.9%, P = 0.19). In the Cox regression model, deployment using POP was the only independent predictor of reduced TVF (HR 0.43; 0.29-0.64; P < 0.0001). In the propensity analysis (330 patients per group) TVF remained lower with POP vs. rapid inflation/deflation (10 vs. 18%, P < 0.0001). Stent deployment using POP led to reduced TVF compared to rapid I/D. These results recommend this method to improve long-term outcomes. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  16. A Comparison of Outcomes Following Laparoscopic and Open Hysterectomy With or Without Lymphadenectomy for Presumed Early-Stage Endometrial Cancer: Results From the Medical Research Council ASTEC Trial.

    PubMed

    Kyrgiou, Maria; Swart, Anne-Marie; Qian, Wendi; Warwick, Jane

    2015-10-01

    Laparoscopic hysterectomy (LH) is increasingly used for the management of endometrial malignancy. Its benefits may be particularly pronounced as these women are more likely to be older or obese. The aim of this study was to determine whether outcomes for LH are comparable to the open hysterectomy (OH). This was a prospective cohort study nested within the multicenter ASTEC (A Study in the Treatment of Endometrial Cancer) randomized controlled trial (1998-2005). Women with presumed early endometrial cancer were included. Laparoscopic hysterectomy was compared with OH with or without systematic lymphadenectomy. Overall survival, time to first recurrence, complication rates, and surgical outcomes were the main outcome measures. Of 1408 women, 1309 (93%) received OH, and 99 (7%) had LH. LH was associated with longer operating time (median, LH 105 minutes [interquartile range (IQR), 60-150] vs OH 80 minutes [IQR, 60-95]; P < 0.001) but 50% shorter hospital stay (median, LH 4 days [IQR, 3-5] vs OH 6 days [IQR, 5-7]). The number of harvested lymph nodes was similar (median, LH 13 [IQR, 10-16] vs OH 12 [IQR, 11-13]; P = 0.67). LH had fewer intraoperative and postoperative adverse events (9% difference, LH 21% vs OH 30%; borderline significance; P = 0.07). The rate of conversion to laparotomy for the LH group was high (27%). The median follow-up was 37 months. After adjusting for significant prognostic factors, the hazard ratio for overall survival in those who underwent LH compared with those who underwent OH was 0.67 (95% confidence interval, 0.31-1.43) (P = 0.30). Laparoscopic hysterectomy for early endometrial cancer is safe. Although it requires longer operating time it is associated with shorter hospital stay and favorable morbidity profile. Further studies are required to assess the long-term safety.

  17. Neurodevelopmental Outcomes of Infants Born at <29 Weeks of Gestation Admitted to Canadian Neonatal Intensive Care Units Based on Location of Birth.

    PubMed

    Amer, Reem; Moddemann, Diane; Seshia, Mary; Alvaro, Ruben; Synnes, Anne; Lee, Kyong-Soon; Lee, Shoo K; Shah, Prakesh S

    2018-05-01

    To compare mortality and neurodevelopmental outcomes of outborn and inborn preterm infants born at <29 weeks of gestation admitted to Canadian neonatal intensive care units (NICUs). Data were obtained from the Canadian Neonatal Network and Canadian Neonatal Follow-up Network databases for infants born at <29 weeks of gestation admitted to NICUs from April 2009 to September 2011. Rates of death, severe neurodevelopmental impairment (NDI), and overall NDI were compared between outborn and inborn infants at 18-21 months of age, corrected for prematurity. Of 2951 eligible infants, 473 (16%) were outborn. Mean birth weight (940 ± 278 g vs 897 + 237 g), rates of treatment with antenatal steroids (53.9% vs 92.9%), birth weight small for gestational age (5.3% vs 9.4%), and maternal college education (43.7% vs 53.9%) differed between outborn and inborn infants, respectively (all P values <.01). The median Score for Neonatal Acute Physiology-II (P = .01) and Apgar score at 5 minutes (P < .01) were higher in inborn infants. Severe brain injury was more common among outborn infants (25.3% vs 14.7%, P < .01). Outborn infants had higher odds of death or severe NDI (aOR 1.7, 95% CI 1.3-2.2), death or overall NDI (aOR 1.6, 95% CI 1.2-2.2), death (aOR 2.1, 95% CI 1.5-3.0), and cerebral palsy (aOR 1.9, 95% CI 1.1-3.3). The composite outcomes of death or neurodevelopmental impairment were significantly higher in outborn compared with inborn infants admitted to Canadian NICUs. Adverse outcomes were mainly attributed to increased mortality and cerebral palsy in outborn neonates. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Lung Transplant Outcomes in Systemic Sclerosis with Significant Esophageal Dysfunction. A Comprehensive Single-Center Experience

    PubMed Central

    Schwab, Kristin; Saggar, Rajeev; Duffy, Erin; Elashoff, David; Tseng, Chi-Hong; Weigt, Sam; Charan, Deepshikha; Abtin, Fereidoun; Johannes, Jimmy; Derhovanessian, Ariss; Conklin, Jeffrey; Ghassemi, Kevin; Khanna, Dinesh; Siddiqui, Osama; Ardehali, Abbas; Hunter, Curtis; Kwon, Murray; Biniwale, Reshma; Lo, Michelle; Volkmann, Elizabeth; Torres Barba, David; Belperio, John A.; Mahrer, Thomas; Furst, Daniel E.; Kafaja, Suzanne; Clements, Philip; Shino, Michael; Gregson, Aric; Kubak, Bernard; Lynch, Joseph P.; Ross, David

    2016-01-01

    Rationale: Consideration of lung transplantation in patients with systemic sclerosis (SSc) remains guarded, often due to the concern for esophageal dysfunction and the associated potential for allograft injury and suboptimal post–lung transplantation outcomes. Objectives: The purpose of this study was to systematically report our single-center experience regarding lung transplantation in the setting of SSc, with a particular focus on esophageal dysfunction. Methods: We retrospectively reviewed all lung transplants at our center from January 1, 2000 through August 31, 2012 (n = 562), comparing the SSc group (n = 35) to the following lung transplant diagnostic subsets: all non-SSc (n = 527), non-SSc diffuse fibrotic lung disease (n = 264), and a non-SSc matched group (n = 109). We evaluated post–lung transplant outcomes, including survival, primary graft dysfunction, acute rejection, bronchiolitis obliterans syndrome, and microbiology of respiratory isolates. In addition, we defined severe esophageal dysfunction using esophageal manometry and esophageal morphometry criteria on the basis of chest computed tomography images. For patients with SSc referred for lung transplant but subsequently denied (n = 36), we queried the reason(s) for denial with respect to the concern for esophageal dysfunction. Measurements and Main Results: The 1-, 3-, and 5-year post–lung transplant survival for SSc was 94, 77, and 70%, respectively, and similar to the other groups. The remaining post–lung transplant outcomes evaluated were also similar between SSc and the other groups. Approximately 60% of the SSc group had severe esophageal dysfunction. Pre–lung transplant chest computed tomography imaging demonstrated significantly abnormal esophageal morphometry for SSc when compared with the matched group. Importantly, esophageal dysfunction was the sole reason for lung transplant denial in a single case. Conclusions: Relative to other lung transplant indications, our SSc group experienced comparable survival, primary graft dysfunction, acute rejection, bronchiolitis obliterans syndrome, and microbiology of respiratory isolates, despite the high prevalence of severe esophageal dysfunction. Esophageal dysfunction rarely precluded active listing for lung transplantation. PMID:27078625

  19. Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivative for root coverage: a RCT using 3D digital measuring methods. Part II. Volumetric studies on healing dynamics and gingival dimensions.

    PubMed

    Rebele, Stephan F; Zuhr, Otto; Schneider, David; Jung, Ronny E; Hürzeler, Markus B

    2014-06-01

    The aim of this randomized clinical trial (RCT) was to compare the clinical performance of the tunnel technique with subepithelial connective tissue graft (TUN) versus a coronally advanced flap with enamel matrix derivative (CAF) in the treatment of gingival recession defects. The use of innovative 3D digital measuring methods allowed to study healing dynamics at connective tissue (CT)-grafted sites and to evaluate the influence of the thickness of the root covering soft tissues on the outcome of surgical root coverage. Twenty-four patients contributed a total of 47 Miller class I or II recessions for scientific evaluation. Precise study models collected at baseline and follow-up examinations were optically scanned and virtually superimposed for digital evaluation of clinical outcome measures including mean marginal soft tissue thickness (THK). Healing dynamics were measured in a defined region of interest at CT-grafted sites where volume differences between time points were calculated. At 12 months, recession reduction as well as mean root coverage were significantly better at CT-grafted sites treated in the TUN group (1.94 mm and 98.4% respectively) compared to the non-augmented sites of the CAF group (1.17 mm and 71.8% respectively) and statistical analysis revealed a positive correlation of THK (1.63 mm TUN versus 0.91 mm CAF, p < 0.0001) to both these variables. Soft tissue healing following surgical root coverage with CT-grafting was mainly accomplished after 6 months, with around two-thirds of the augmented volume being maintained after 12 months. The TUN resulted in thicker gingiva and better clinical outcomes compared to CAF. Increased gingival thickness was associated with better surgical outcomes in terms of recession reduction and root coverage. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. Comparison of Pediatric Severe Sepsis Managed in U.S. and European ICUs

    PubMed Central

    Giuliano, John S.; Markovitz, Barry P.; Brierley, Joe; Levin, Richard; Williams, Gary; Lum, Lucy Chai See; Dorofaeff, Tavey; Cruces, Pablo; Bush, Jenny L.; Keele, Luke; Nadkarni, Vinay M.; Thomas, Neal J.; Fitzgerald, Julie C.; Weiss, Scott L.

    2017-01-01

    Objectives Pediatric severe sepsis remains a significant global health problem without new therapies despite many multicenter clinical trials. We compared children managed with severe sepsis in European and U.S. PICUs to identify geographic variation, which may improve the design of future international studies. Design We conducted a secondary analysis of the Sepsis PRevalence, OUtcomes, and Therapies study. Data about PICU characteristics, patient demographics, therapies, and outcomes were compared. Multivariable regression models were used to determine adjusted differences in morbidity and mortality. Setting European and U.S. PICUs. Patients Children with severe sepsis managed in European and U.S. PICUs enrolled in the Sepsis PRevalence, OUtcomes, and Therapies study. Interventions None. Measurements and Main Results European PICUs had fewer beds (median, 11 vs 24; p < 0.001). European patients were younger (median, 1 vs 6 yr; p < 0.001), had higher severity of illness (median Pediatric Index of Mortality −3, 5.0 vs 3.8; p = 0.02), and were more often admitted from the ward (37% vs 24%). Invasive mechanical ventilation, central venous access, and vasoactive infusions were used more frequently in European patients (85% vs 68%, p = 0.002; 91% vs 82%, p = 0.05; and 71% vs 50%; p < 0.001, respectively). Raw morbidity and mortality outcomes were worse for European compared with U.S. patients, but after adjusting for patient characteristics, there were no significant differences in mortality, multiple organ dysfunction, disability at discharge, length of stay, or ventilator/vasoactive-free days. Conclusions Children with severe sepsis admitted to European PICUs have higher severity of illness, are more likely to be admitted from hospital wards, and receive more intensive care therapies than in the United States. The lack of significant differences in morbidity and mortality after adjusting for patient characteristics suggests that the approach to care between regions, perhaps related to PICU bed availability, needs to be considered in the design of future international clinical trials in pediatric severe sepsis. PMID:27124566

  1. Maternal care and birth outcomes among ethnic minority women in Finland

    PubMed Central

    Malin, Maili; Gissler, Mika

    2009-01-01

    Background Care during pregnancy and labour is of great importance in every culture. Studies show that people of migrant origin have barriers to obtaining accessible and good quality care compared to people in the host society. The aim of this study is to compare the access to and use of maternity services, and their outcomes among ethnic minority women having a singleton birth in Finland. Methods The study is based on data from the Finnish Medical Birth Register in 1999–2001 linked with the information of Statistics Finland on woman's country of birth, citizenship and mother tongue. Our study data included 6,532 women of foreign origin (3.9% of all singletons) giving singleton birth in Finland during 1999–2001 (compared to 158,469 Finnish origin singletons). Results Most women have migrated during the last fifteen years, mainly from Russia, Baltic countries, Somalia and East Europe. Migrant origin women participated substantially in prenatal care. Interventions performed or needed during pregnancy and childbirth varied between ethnic groups. Women of African and Somali origin had most health problems resulted in the highest perinatal mortality rates. Women from East Europe, the Middle East, North Africa and Somalia had a significant risk of low birth weight and small for gestational age newborns. Most premature newborns were found among women from the Middle East, North Africa and South Asia. Primiparous women from Africa, Somalia and Latin America and Caribbean had most caesarean sections while newborns of Latin American origin had more interventions after birth. Conclusion Despite good general coverage of maternal care among migrant origin women, there were clear variations in the type of treatment given to them or needed by them. African origin women had the most health problems during pregnancy and childbirth and the worst perinatal outcomes indicating the urgent need of targeted preventive and special care. These study results do not confirm either healthy migrant effect or epidemiological paradox according to which migrant origin women have considerable good birth outcomes. PMID:19298682

  2. Caseload midwifery compared to standard or private obstetric care for first time mothers in a public teaching hospital in Australia: a cross sectional study of cost and birth outcomes.

    PubMed

    Tracy, Sally K; Welsh, Alec; Hall, Bev; Hartz, Donna; Lainchbury, Anne; Bisits, Andrew; White, Jan; Tracy, Mark B

    2014-01-24

    In many countries midwives act as the main providers of care for women throughout pregnancy, labour and birth. In our large public teaching hospital in Australia we restructured the way midwifery care is offered and introduced caseload midwifery for one third of women booked at the hospital. We then compared the costs and birth outcomes associated with caseload midwifery compared to the two existing models of care, standard hospital care and private obstetric care. We undertook a cross sectional study examining the risk profile, birth outcomes and cost of care for women booked into one of the three available models of care in a tertiary teaching hospital in Australia between July 1st 2009 December 31st 2010. To control for differences in population or case mix we described the outcomes for a cohort of low risk first time mothers known as the 'standard primipara'. Amongst the 1,379 women defined as 'standard primipara' there were significant differences in birth outcome. These first time 'low risk' mothers who received caseload care were more likely to have a spontaneous onset of labour and an unassisted vaginal birth 58.5% in MGP compared to 48.2% for Standard hospital care and 30.8% with Private obstetric care (p < 0.001). They were also significantly less likely to have an elective caesarean section 1.6% with MGP versus 5.3% with Standard care and 17.2% with private obstetric care (p < 0.001). From the public hospital perspective, over one financial year the average cost of care for the standard primipara in MGP was $3903.78 per woman. This was $1375.45 less per woman than those receiving Private obstetric care and $1590.91 less than Standard hospital care per woman (p < 0.001). Similar differences in cost were found in favour of MGP for all women in the study who received caseload care. Cost reduction appears to be achieved through reorganising the way care is delivered in the public hospital system with the introduction of Midwifery Group Practice or caseload care. The study also highlights the unexplained clinical variation that exists between the three models of care in Australia.

  3. Caseload midwifery compared to standard or private obstetric care for first time mothers in a public teaching hospital in Australia: a cross sectional study of cost and birth outcomes

    PubMed Central

    2014-01-01

    Background In many countries midwives act as the main providers of care for women throughout pregnancy, labour and birth. In our large public teaching hospital in Australia we restructured the way midwifery care is offered and introduced caseload midwifery for one third of women booked at the hospital. We then compared the costs and birth outcomes associated with caseload midwifery compared to the two existing models of care, standard hospital care and private obstetric care. Methods We undertook a cross sectional study examining the risk profile, birth outcomes and cost of care for women booked into one of the three available models of care in a tertiary teaching hospital in Australia between July 1st 2009 December 31st 2010. To control for differences in population or case mix we described the outcomes for a cohort of low risk first time mothers known as the 'standard primipara'. Results Amongst the 1,379 women defined as 'standard primipara' there were significant differences in birth outcome. These first time ‘low risk’ mothers who received caseload care were more likely to have a spontaneous onset of labour and an unassisted vaginal birth 58.5% in MGP compared to 48.2% for Standard hospital care and 30.8% with Private obstetric care (p < 0.001). They were also significantly less likely to have an elective caesarean section 1.6% with MGP versus 5.3% with Standard care and 17.2% with private obstetric care (p < 0.001). From the public hospital perspective, over one financial year the average cost of care for the standard primipara in MGP was $3903.78 per woman. This was $1375.45 less per woman than those receiving Private obstetric care and $1590.91 less than Standard hospital care per woman (p < 0.001). Similar differences in cost were found in favour of MGP for all women in the study who received caseload care. Conclusions Cost reduction appears to be achieved through reorganising the way care is delivered in the public hospital system with the introduction of Midwifery Group Practice or caseload care. The study also highlights the unexplained clinical variation that exists between the three models of care in Australia. PMID:24456576

  4. Effects of acupuncture and computer-assisted cognitive training for post-stroke attention deficits: study protocol for a randomized controlled trial.

    PubMed

    Huang, Jia; McCaskey, Michael A; Yang, Shanli; Ye, Haicheng; Tao, Jing; Jiang, Cai; Schuster-Amft, Corina; Balzer, Christian; Ettlin, Thierry; Schupp, Wilfried; Kulke, Hartwig; Chen, Lidian

    2015-12-02

    A majority of stroke survivors present with cognitive impairments. Attention disturbance, which leads to impaired concentration and overall reduced cognitive functions, is strongly associated with stroke. The clinical efficacy of acupuncture with Baihui (GV20) and Shenting (GV24) as well as computer-assisted cognitive training in stroke and post-stroke cognitive impairment have both been demonstrated in previous studies. To date, no systematic comparison of these exists and the potential beneficial effects of a combined application are yet to be examined. The main objective of this pilot study is to evaluate the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The second objective is to test the effects of a combined cognitive intervention that incorporates computer-assisted cognitive training and acupuncture (ACoTrain). An international multicentre, single-blinded, randomised controlled pilot trial will be conducted. In a 1:1:1 ratio, 60 inpatients with post-stroke cognitive dysfunction will be randomly allocated into either the acupuncture group, the computer-assisted cognitive training group, or the ACoTrain group in addition to their individual rehabilitation programme. The intervention period of this pilot trial will last 4 weeks (30 minutes per day, 5 days per week, Monday to Friday). The primary outcome is the test battery for attentional performance. The secondary outcomes include the Trail Making Test, Test des Deux Barrages, National Institute of Health Stroke Scale, and Modified Barthel Index for assessment of daily life competence, and the EuroQol Questionnaire for health-related quality of life. This trial mainly focuses on evaluating the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The results of this pilot trial are expected to provide new insights on how Eastern and Western medicine can complement one another and improve the treatment of cognitive impairments in early stroke rehabilitation. Including patients with different cultural backgrounds allows a more generalisable interpretation of the results but also poses risks of performance bias. Using standardised and well-described assessments, validated for each region, is pivotal to allow pooling of the data. Clinical Trails.gov ID: NCT02324959 (8 December 2014).

  5. Design and rationale for a randomised comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: the EXCEL trial.

    PubMed

    Kappetein, Arie Pieter; Serruys, Patrick W; Sabik, Joseph F; Leon, Martin B; Taggart, David P; Morice, Marie-Claude; Gersh, Bernard J; Pocock, Stuart J; Cohen, David J; Wallentin, Lars; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Simonton, Charles A; Stone, Gregg W

    2016-09-18

    Coronary artery bypass graft (CABG) surgery is the standard of care for revascularisation of patients with left main coronary artery disease (LMCAD). Recent studies have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) may provide comparable outcomes in selected patients with LMCAD without extensive CAD. We therefore designed a trial to investigate whether PCI with XIENCE cobalt-chromium everolimus-eluting stents (CoCr-EES) would result in non-inferior or superior clinical outcomes to CABG in selected patients with LMCAD. The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is a prospective, open-label, multicentre, international study of 1,900 randomised subjects. Patients with significant LMCAD with a SYNTAX score ≤32 and local Heart Team consensus that the subject is appropriate for revascularisation by both PCI and CABG are consented and randomised 1:1 to undergo PCI using CoCr-EES or CABG. All patients undergo follow-up for five years. The primary endpoint is the three-year composite rate of death, stroke or myocardial infarction, assessed at a median follow-up of at least three years (with at least two-year follow-up in all patients), powered for sequential non-inferiority and superiority testing. The EXCEL study will define the contemporary roles of CABG and PCI using XIENCE CoCr-EES in patients with LMCAD disease with low and intermediate SYNTAX scores.

  6. A comparison of community and trophic structure in five marine ecosystems based on energy budgets and system metrics

    NASA Astrophysics Data System (ADS)

    Gaichas, Sarah; Skaret, Georg; Falk-Petersen, Jannike; Link, Jason S.; Overholtz, William; Megrey, Bernard A.; Gjøsæter, Harald; Stockhausen, William T.; Dommasnes, Are; Friedland, Kevin D.; Aydin, Kerim

    2009-04-01

    Energy budget models for five marine ecosystems were compared to identify differences and similarities in trophic and community structure. We examined the Gulf of Maine and Georges Bank in the northwest Atlantic Ocean, the combined Norwegian/Barents Seas in the northeast Atlantic Ocean, and the eastern Bering Sea and the Gulf of Alaska in the northeast Pacific Ocean. Comparable energy budgets were constructed for each ecosystem by aggregating information for similar species groups into consistent functional groups. Several ecosystem indices (e.g., functional group production, consumption and biomass ratios, cumulative biomass, food web macrodescriptors, and network metrics) were compared for each ecosystem. The comparative approach clearly identified data gaps for each ecosystem, an important outcome of this work. Commonalities across the ecosystems included overall high primary production and energy flow at low trophic levels, high production and consumption by carnivorous zooplankton, and similar proportions of apex predator to lower trophic level biomass. Major differences included distinct biomass ratios of pelagic to demersal fish, ranging from highest in the combined Norwegian/Barents ecosystem to lowest in the Alaskan systems, and notable differences in primary production per unit area, highest in the Alaskan and Georges Bank/Gulf of Maine ecosystems, and lowest in the Norwegian ecosystems. While comparing a disparate group of organisms across a wide range of marine ecosystems is challenging, this work demonstrates that standardized metrics both elucidate properties common to marine ecosystems and identify key distinctions useful for fisheries management.

  7. Drug delivery technologies for autoimmune disease.

    PubMed

    Phillips, Brett E; Giannoukakis, Nick

    2010-11-01

    Targeting autoimmune disease poses two main challenges. The first is to identify unique targets to suppress directly or indirectly autoreactive cells exclusively. The second is to penetrate target tissues to deliver specifically drugs to desired cells that can achieve a therapeutic outcome. Herein, the range of drug delivery methods available and under development and how they can be useful to treat autoimmune diseases are discussed. Polymer delivery methods, as well as biological methods that include fusion proteins, targeted antibodies, recombinant viruses and cell products are compared. Readers will gain insight into the progression of clinical trials for different technologies and drug delivery methods useful for targeting and modulating the function of autoreactive immune cells. Several tissue-specific polymer-based and biologic drug delivery systems are now in Phase II/III clinical trials. Although these trials are focused mainly on cancer treatment, lessons from these trials can guide the use of the same agents for autoimmunity therapeutics.

  8. [Achievements and problems of modern trials of antihypertensive drugs].

    PubMed

    Kobalava, Zh D; Kotovskaia, Iu V

    2011-01-01

    Most important value of lowering of substantially elevated arterial pressure (AP) for improvement of outcomes in patients with arterial hypertension (AH) was convincingly confirmed by large truly placebo controlled randomized clinical trials (RCT) with the use of mainly diuretics, and/or beta-adrenoblockers in the 60-80ths. Later comparative RCT confirmed equal antihypertensive efficacy of 5 main drug classes relative to AP level in brachial artery. In this review we discuss merit of auxiliary class-specific properties of antihypertensive agents potentially affecting prognosis besides AP lowering. We also discuss problems related to decline of significance of quantitative criteria of AH and consideration of AP level in general context of cardiovascular risk; problems of external validity of RCT; extrapolation of RCT results obtained in patients with complicated AH and very high cardiovascular risk on young patients with uncomplicated AH; significance of hard and surrogate end points.

  9. PubMed Central

    Maziade, Jean; Théorêt, Johanne

    2004-01-01

    OBJECTIVE: To describe the patients residents see in one hospital's family medicine unit and to determine whether these patients resemble family medicine patients in other Quebec hospitals. DESIGN: Descriptive study. SETTING: Urban teaching hospital. PARTICIPANTS: Patients 20 years and older who were admitted to the family medicine unit at Hôpital du St-Sacrement between April 1, 1999, and March 31, 2000, were compared with all patients admitted in general medicine to Quebec hospitals during this period. MAIN OUTCOME MEASURES: Sex, age, main diagnosis, secondary diagnoses, types of diseases, length of stay, number of consultations and specialties involved, referral after hospitalization. RESULTS: Patients hospitalized in this unit were older, had more secondary diagnoses, and stayed in hospital slightly longer than patients hospitalized in general medicine in Quebec as a whole. Residents were, therefore, exposed to patients who were more medically complex. CONCLUSION: Patients to whom residents were exposed resemble patients they will see in future hospital practice. PMID:15648384

  10. Comparison of the two most commonly used treatments for pyoderma gangrenosum: results of the STOP GAP randomised controlled trial

    PubMed Central

    Ormerod, Anthony D; Craig, Fiona E; Mitchell, Eleanor; Greenlaw, Nicola; Norrie, John; Mason, James M; Walton, Shernaz; Johnston, Graham A; Williams, Hywel C

    2015-01-01

    Objective To determine whether ciclosporin is superior to prednisolone for the treatment of pyoderma gangrenosum, a painful, ulcerating skin disease with a poor evidence base for management. Design Multicentre, parallel group, observer blind, randomised controlled trial. Setting 39 UK hospitals, recruiting from June 2009 to November 2012. Participants 121 patients (73 women, mean age 54 years) with clinician diagnosed pyoderma gangrenosum. Clinical diagnosis was revised in nine participants after randomisation, leaving 112 participants in the analysis set (59 ciclosporin; 53 prednisolone). Intervention Oral prednisolone 0.75 mg/kg/day compared with ciclosporin 4 mg/kg/day, to a maximum dose of 75 and 400 mg/day, respectively. Main outcome measures The primary outcome was speed of healing over six weeks, captured using digital images and assessed by blinded investigators. Secondary outcomes were time to healing, global treatment response, resolution of inflammation, self reported pain, quality of life, number of treatment failures, adverse reactions, and time to recurrence. Outcomes were assessed at baseline and six weeks and when the ulcer had healed (to a maximum of six months). Results Of the 112 participants, 108 had complete primary outcome data at baseline and six weeks (57 ciclosporin; 51 prednisolone). Groups were balanced at baseline. The mean (SD) speed of healing at six weeks was −0.21 (1.00) cm2/day in the ciclosporin group compared with −0.14 (0.42) cm2/day in the prednisolone group. The adjusted mean difference showed no between group difference (0.003 cm2/day, 95% confidence interval −0.20 to 0.21; P=0.97). By six months, ulcers had healed in 28/59 (47%) participants in the ciclosporin group compared with 25/53 (47%) in the prednisolone group. In those with healed ulcers, eight (30%) receiving ciclosporin and seven (28%) receiving prednisolone had a recurrence. Adverse reactions were similar for the two groups (68% ciclosporin and 66% prednisolone), but serious adverse reactions, especially infections, were more common in the prednisolone group. Conclusion Prednisolone and ciclosporin did not differ across a range of objective and patient reported outcomes. Treatment decisions for individual patients may be guided by the different side effect profiles of the two drugs and patient preference. Trial registration Current Controlled Trials ISRCTN35898459. PMID:26071094

  11. Sickle cell disease in pregnancy: trend and pregnancy outcomes at a tertiary hospital in Tanzania.

    PubMed

    Muganyizi, Projestine S; Kidanto, Hussein

    2013-01-01

    SCD in pregnancy is associated with increased adverse fetal and maternal outcomes. In Tanzania where the frequency of sickle cell trait is 13% there has been scanty data on SCD in pregnancy. With progressive improvement in childhood survival the burden of SCD in pregnancy will increase. We analyzed all deliveries at Muhimbili National Hospital (MNH) from 1999 to 2011. Fetal and maternal outcomes of SCD deliveries were compared with non-SCD. Data were analyzed using IBM SPSS statistics version 19. Chi square and Fisher Exact tests were used to compare proportions and the independent t-test for continuous data. To predict risks of adverse effects, odds ratios were determined using multivariate logistic regression. A p-value<0.05 was considered significant. In total, 157,473 deliveries occurred at MNH during the study period, of which 149 were SCD (incidence of 95 SCD per 100,000 deliveries). The incidence of SCD had increased from 76 per 100,000 deliveries in the 1999-2002 period to over 100 per 100,000 deliveries in recent years. The mean maternal age at delivery was lower in SCD (24.0±5.5 years) than in non-SCD deliveries (26.2±6.0 years), p<0.001. Compared with non-SCD (2.9±0.7 Kg), SCD deliveries had less mean birth-weight (2.6±0.6 Kg), p<0.001. SCD were more likely than non-SCD to deliver low APGAR score at 5 minutes (34.5% Vs 15.0%, OR = 3.0, 95%CI: 2.1-4.2), stillbirths (25.7% Vs 7.5%, OR = 4.0, 95%CI: 2.8-5.8). There was excessive risk of maternal deaths in SCD compared to non-SCD (11.4% Vs 0.4%, OR = 29, 95%CI: 17.3-48.1). The leading cause of deaths in SCD was infections in wholly 82% in contrast to only 32% in non-SCD. In conclusion SCD in pregnancy is an emerging problem at MNH with increased adverse fetal outcomes and excessive maternal mortality mainly due to infections.

  12. Measures of quality, costs and equity in primary health care instruments developed to analyse and compare primary care in 35 countries.

    PubMed

    Schäfer, Willemijn L A; Boerma, Wienke G W; Kringos, Dionne S; De Ryck, Evelyne; Greß, Stefan; Heinemann, Stephanie; Murante, Anna Maria; Rotar-Pavlic, Danica; Schellevis, François G; Seghieri, Chiara; Van den Berg, Michael J; Westert, Gert P; Willems, Sara; Groenewegen, Peter P

    2013-01-01

    The Quality and Costs of Primary Care in Europe (QUALICOPC) study aims to analyse and compare how primary health care systems in 35 countries perform in terms of quality, costs and equity. This article answers the question 'How can the organisation and delivery of primary health care and its outcomes be measured through surveys of general practitioners (GPs) and patients?' It will also deal with the process of pooling questions and the subsequent development and application of exclusion criteria to arrive at a set of appropriate questions for a broad international comparative study. The development of the questionnaires consisted of four phases: a search for existing validated questionnaires, the classification and selection of relevant questions, shortening of the questionnaires in three consensus rounds and the pilot survey. Consensus was reached on the basis of exclusion criteria (e.g. the applicability for international comparison). Based on the pilot survey, comprehensibility increased and the number of questions was further restricted, as the questionnaires were too long. Four questionnaires were developed: one for GPs, one for patients about their experiences with their GP, another for patients about what they consider important, and a practice questionnaire. The GP questionnaire mainly focused on the structural aspects (e.g. economic conditions) and care processes (e.g. comprehensiveness of services of primary care). The patient experiences questionnaire focused on the care processes and outcomes (e.g. how do patients experience access to care?). The questionnaire about what patients consider important was complementary to the experiences questionnaire, as it enabled weighing the answers from the latter. Finally, the practice questionnaire included questions on practice characteristics. The QUALICOPC researchers have developed four questionnaires to characterise the organisation and delivery of primary health care and to compare and analyse the outcomes. Data collected with these instruments will allow us not only to show in detail the variation in process and outcomes of primary health care, but also to explain the differences from features of the (primary) health care system.

  13. Game theory based models to analyze water conflicts in the Middle Route of the South-to-North Water Transfer Project in China.

    PubMed

    Wei, Shouke; Yang, Hong; Abbaspour, Karim; Mousavi, Jamshid; Gnauck, Albrecht

    2010-04-01

    This study applied game theory based models to analyze and solve water conflicts concerning water allocation and nitrogen reduction in the Middle Route of the South-to-North Water Transfer Project in China. The game simulation comprised two levels, including one main game with five players and four sub-games with each containing three sub-players. We used statistical and econometric regression methods to formulate payoff functions of the players, economic valuation methods (EVMs) to transform non-monetary value into economic one, cost-benefit Analysis (CBA) to compare the game outcomes, and scenario analysis to investigate the future uncertainties. The validity of game simulation was evaluated by comparing predictions with observations. The main results proved that cooperation would make the players collectively better off, though some player would face losses. However, players were not willing to cooperate, which would result in a prisoners' dilemma. Scenarios simulation results displayed that players in water scare area could not solve its severe water deficit problem without cooperation with other players even under an optimistic scenario, while the uncertainty of cooperation would come from the main polluters. The results suggest a need to design a mechanism to reduce the risk of losses of those players by a side payment, which provides them with economic incentives to cooperate. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

  14. Optimization of finite difference forward modeling for elastic waves based on optimum combined window functions

    NASA Astrophysics Data System (ADS)

    Jian, Wang; Xiaohong, Meng; Hong, Liu; Wanqiu, Zheng; Yaning, Liu; Sheng, Gui; Zhiyang, Wang

    2017-03-01

    Full waveform inversion and reverse time migration are active research areas for seismic exploration. Forward modeling in the time domain determines the precision of the results, and numerical solutions of finite difference have been widely adopted as an important mathematical tool for forward modeling. In this article, the optimum combined of window functions was designed based on the finite difference operator using a truncated approximation of the spatial convolution series in pseudo-spectrum space, to normalize the outcomes of existing window functions for different orders. The proposed combined window functions not only inherit the characteristics of the various window functions, to provide better truncation results, but also control the truncation error of the finite difference operator manually and visually by adjusting the combinations and analyzing the characteristics of the main and side lobes of the amplitude response. Error level and elastic forward modeling under the proposed combined system were compared with outcomes from conventional window functions and modified binomial windows. Numerical dispersion is significantly suppressed, which is compared with modified binomial window function finite-difference and conventional finite-difference. Numerical simulation verifies the reliability of the proposed method.

  15. Progression of aging in Mexico: the Mexican Health and Aging Study (MHAS) 2012.

    PubMed

    Wong, Rebeca; Michaels-Obregón, Alejandra; Palloni, Alberto; Gutiérrez-Robledo, Luis Miguel; González-González, César; López-Ortega, Mariana; Téllez-Rojo, Martha María; Mendoza-Alvarado, Laura Rosario

    2015-01-01

    To describe the third wave of the Mexican Health and Aging Study (MHAS), completed in 2012, and present preliminary results. Descriptive analyses by gender and age group of demographic and socioeconomic characteristics, health conditions and health behaviors, as well as social support and life satisfaction measures are presented. In addition, external validations are presented by comparing MHAS 2012 indicators with other national data sources. For the panel of older adults in the sample, the rate of health care insurance coverage increased greatly between 2001 and 2012, a significantly higher change in rural compared to urban areas. The results for 2012 are consistent with the previous two waves for the main indicators of health and physical disability prevalence, risk factors,and behaviors. The MHAS offers a unique opportunity to study aging in Mexico, as well as to complete cross-national comparisons. The cumulative number of deaths in the cohort should support the study of mortality and its association with health outcomes and behaviors over the life cycle. In addition, the sub-samples of objective markers will enable methodological research on self-reports and associations of biomarkers in old age with similar health outcomes and behaviors.

  16. Progression of aging in Mexico: the Mexican Health and Aging Study (MHAS) 2012

    PubMed Central

    Wong, Rebeca; Michaels-Obregón, Alejandra; Palloni, Alberto; Gutiérrez-Robledo, Luis Miguel; González-González, César; López-Ortega, Mariana; Téllez-Rojo, Martha María; Mendoza-Alvarado, Laura Rosario

    2015-01-01

    Objective To describe the third wave of the Mexican Health and Aging Study (MHAS), completed in 2012, and present preliminary results. Materials and methods Descriptive analyses by gender and age group of demographic and socioeconomic characteristics, health conditions and health behaviors, as well as social support and life satisfaction measures are presented. In addition, external validations are presented by comparing MHAS 2012 indicators with other national data sources. Results For the panel of older adults in the sample, the rate of health care insurance coverage increased greatly between 2001 and 2012, a significantly higher change in rural compared to urban areas. The results for 2012 are consistent with the previous two waves for the main indicators of health and physical disability prevalence, risk factors, and behaviors. Conclusions The MHAS offers a unique opportunity to study aging in Mexico, as well as to complete cross-national comparisons. The cumulative number of deaths in the cohort should support the study of mortality and its association with health outcomes and behaviors over the life cycle. In addition, the sub-samples of objective markers will enable methodological research on self-reports and associations of biomarkers in old age with similar health outcomes and behaviors. PMID:26172238

  17. Outcome of referrals for deceased organ donation to the government organ procurement organization.

    PubMed

    Suguitan, G A; Cabanayan-Casasola, C B; Danguilan, R A; Jaro, J M A

    2014-05-01

    The Human Organ Preservation Effort is a government organ procurement organization that pioneered the Deceased Organ Donation Program in the Philippines. Deceased organ donation comprises only 20% of kidney transplantation in the Philippines in the last 3 years. Various measures were implemented to improve deceased organ donor referrals and organ retrieval. To compare outcome of deceased organ donor referrals from 2002 to 2008 and 2009 to 2012 in the Philippines. This retrospective study reviewed the deceased organ donor referrals from 2002 to 2008 and 2009 to 2012. There were 437 referrals for potential deceased organ donors from 2009 to 2012, compared to 434 referrals from 2002 to 2008. Referrals were mainly trauma victims (76%) followed by those with cerebrovascular accidents (12%). In the recent cohort, 81% were approached and 60% consented for donation, but only 23% were retrieved and transplanted. Among those not retrieved, the majority (19%) were medically unsuitable and 6% retracted their consent. Although there was an increasing trend of organ donation referrals in the last 4 years, only 25% were procured. The reasons for nonprocurement should be addressed. Copyright © 2014 Elsevier Inc. All rights reserved.

  18. Clinical outcome of combined conjunctival autograft transplantation and amniotic membrane transplantation in pterygium surgery

    PubMed Central

    Malla, Tejsu; Jiang, Jing; Hu, Kai

    2018-01-01

    AIM To compare long-term outcome of primary and recurrent pterygium surgery with three different techniques: combined conjunctival autograft and overlay amniotic membrane transplantation (CAT with AMT), conjunctival autograft transplantation (CAT) alone and amniotic membrane transplantation (AMT) alone. METHODS In this retrospective study, 142 eyes of 142 pterygium patients (104 primary, 38 recurrent) who underwent CAT (group A), AMT (group B) or CAT with AMT (group C) respectively following surgical excision were reviewed and compared based on the recurrences and post-operative complications. RESULTS The number of recurrence post-surgery were 17 (9 from primary, 8 from recurrent; the same description below), 18 (10, 8) and 2 (1, 1) in groups A, B, and C respectively; dry eyes were 22 (16, 6), 27 (18, 9) and 7 (3, 4); conjunctival inflammations were 30 (17, 13), 27 (16, 11) and 11 (6, 5). Patients in group C (either primary or recurrent or both) mainly showed significantly better results than those in group A or B (P<0.05) regarding above-mentioned clinical effects. CONCLUSION Combined CAT and overly AMT have significantly lower rates of recurrence and postoperative complications for primary and recurrent pterygium surgery than CAT or AMT alone. PMID:29600172

  19. The Effect of Principal's Leadership Style on School Environment and Outcome

    ERIC Educational Resources Information Center

    Al-Safran, Eissa; Brown, David; Wiseman, Alexander

    2014-01-01

    The main objective of this study was to investigate the effect of principal's leadership style on school outcome. This study focused on the indirect relationship between the leadership style and the school environment. An additional objective was to investigate the impact of culture on leadership style as related to school environment and outcome.…

  20. Privileging Practice: Facing the Challenge of Integrated Working for Outcomes for Children

    ERIC Educational Resources Information Center

    Canavan, John; Coen, Liam; Dolan, Pat; Whyte, Liam

    2009-01-01

    Integrated working for outcomes is complex and challenging in theory and practice. Yet, outcomes and integrated working are central to the policy goals for children and families in Ireland. In this article, the authors present two main arguments: first, that reflective practice offers a useful general methodology for engaging with the theoretical…

  1. Student Outcomes: Investigating Competency-Based Curriculum in Adult Basic Education. Research Report No. 5.

    ERIC Educational Resources Information Center

    Hazell, Pat

    The outcomes attained by Australian adults enrolled in competency-based Certificate in Adult Foundation Education (CAFE) courses were examined. Special attention was paid to the outcomes achieved by students in the two lowest of the CAFE program's four levels. The main data sources were as follows: literature review; enrollment data from the…

  2. Cost-effectiveness of Chlamydia Vaccination Programs for Young Women

    PubMed Central

    Chesson, Harrell W.; Gift, Thomas L.; Brunham, Robert C.; Bolan, Gail

    2015-01-01

    We explored potential cost-effectiveness of a chlamydia vaccine for young women in the United States by using a compartmental heterosexual transmission model. We tracked health outcomes (acute infections and sequelae measured in quality-adjusted life-years [QALYs]) and determined incremental cost-effectiveness ratios (ICERs) over a 50-year analytic horizon. We assessed vaccination of 14-year-old girls and catch-up vaccination for 15–24-year-old women in the context of an existing chlamydia screening program and assumed 2 prevaccination prevalences of 3.2% by main analysis and 3.7% by additional analysis. Estimated ICERs of vaccinating 14-year-old girls were $35,300/QALY by main analysis and $16,200/QALY by additional analysis compared with only screening. Catch-up vaccination for 15–24-year-old women resulted in estimated ICERs of $53,200/QALY by main analysis and $26,300/QALY by additional analysis. The ICER was most sensitive to prevaccination prevalence for women, followed by cost of vaccination, duration of vaccine-conferred immunity, and vaccine efficacy. Our results suggest that a successful chlamydia vaccine could be cost-effective. PMID:25989525

  3. Patterns and associations between DAPT cessation and 2-year clinical outcomes in left main/proximal LAD versus other PCI: Results from the Patterns of Non-Adherence to Dual Antiplatelet Therapy in Stented Patients (PARIS) registry.

    PubMed

    Chandrasekhar, Jaya; Baber, Usman; Sartori, Samantha; Aquino, Melissa; Tomey, Matthew; Kruckoff, Mitchell; Moliterno, David; Henry, Timothy D; Weisz, Giora; Gibson, C Michael; Iakovou, Ioannis; Kini, Annapoorna; Faggioni, Michela; Vogel, Birgit; Farhan, Serdar; Colombo, Antonio; Steg, P Gabriel; Witzenbichler, Bernhard; Chieffo, Alaide; Cohen, David; Stuckey, Thomas; Ariti, Cono; Pocock, Stuart; Dangas, George; Mehran, Roxana

    2017-09-15

    Percutaneous coronary intervention (PCI) of the left main (LM) or proximal left anterior descending artery (pLAD) is considered high-risk as these segments subtend substantial left ventricular myocardial area. We assessed the patterns and associations between dual antiplatelet therapy (DAPT) cessation and 2-year outcomes in LM/pLAD vs. other PCI from the all-comer PARIS registry. Two-year major adverse cardiovascular events (MACE) were a composite of cardiac death, myocardial infarction, definite/probable stent thrombosis or target lesion revascularization. DAPT cessation was predefined as physician-guided permanent discontinuation, temporary interruption, or non-recommended disruption due to non-compliance or bleeding. Of the study population (n=5018), 25.0% (n=1252) underwent LM/pLAD PCI and 75.0% (n=3766) PCI to other segments. Compared to others, LM/pLAD patients presented with fewer comorbidities, less frequent acute coronary syndromes but more multivessel and bifurcation disease treated with greater stent lengths. Two-year adjusted risk of MACE (11.4% vs. 11.6%; HR 1.10, 95% CI 0.90-1.34, p=0.36) was similar between LM/pLAD vs. other patients. DAPT discontinuation was significantly higher (43.3% vs. 39.4%, p=0.01) in LM/pLAD patients with borderline significance for lower disruption (10.0% vs. 14.7%, p=0.059) compared to other patients. DAPT discontinuation was not associated with higher risk of MACE in LM/pLAD (HR 0.65, 95% CI 0.34-1.25) or other PCI groups (HR 0.67, 95% CI 0.47-0.95). LM/pLAD PCI was not an independent predictor of 2-year MACE. Compared to other PCI, patients undergoing LM/pLAD PCI had higher rates of physician recommended DAPT discontinuation, however, discontinuation did not result in greater adverse events. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Combined exercise is more effective than aerobic exercise in the improvement of fall risk factors: a randomized controlled trial in community-dwelling older men.

    PubMed

    Sousa, Nelson; Mendes, Romeu; Silva, André; Oliveira, José

    2017-04-01

    To compare the long-term effects of two community-based exercise programs on fall risk factors, such as balance, postural control, mobility and leg strength, in community-dwelling older men. Single-blinded randomized controlled trial, comparing three groups, with follow-ups at eight, 16, 24 and 32 weeks. Older men independent-living residing in Maia city, Portugal. A total of 66 older men (aged 69.0 ±4.9 years) were randomly assigned to an aerobic exercise group ( n = 22), a combined aerobic and resistance exercise group ( n = 22) or a control group ( n = 22). Both community-based exercise programs consisted of three sessions each week for 32 consecutive weeks and were planned for moderate-to-vigorous intensity. The control group had no exercise intervention. Main outcomes were measured by the Timed Up and Go Test, functional reach test, 30-second chair stand test and 6-minute walk test, on five different occasions. Repeated measures of analysis of covariance revealed significant main effects between time × group interaction in all outcomes over time (Timed Up and Go Test: p < 0.001; functional reach test: p = 0.002; 30-second chair stand: p = 0.001; 6-minute walk test: p < 0.001). Both exercise groups reported improvements; however, better performance was identified in the combined aerobic and resistance exercise group compared with the aerobic exercise group (-20.3% vs. -9.1% on the Timed Up and Go Test, +27.5% vs. +10.9% on the functional reach test, +20.8% vs. +7.3% on 30-second chair stand, +10.9% vs. +3.5% on 6-minute walk test). Adding resistance exercise to aerobic exercise improves factors associated with an increased risk of falls. However, both exercise regimes, combined or aerobic alone, are more effective than no exercise in the reduction of fall risk factors. ClinicalTrials.org #NCT01874132.

  5. Pregnancy and neonatal outcomes following letrozole use in frozen-thawed single embryo transfer cycles.

    PubMed

    Tatsumi, T; Jwa, S C; Kuwahara, A; Irahara, M; Kubota, T; Saito, H

    2017-06-01

    Are pregnancy and neonatal outcomes following letrozole use comparable with natural and HRT cycles in patients undergoing single frozen-thawed embryo transfer (FET)? Letrozole use was significantly associated with higher rates of clinical pregnancy, clinical pregnancy with fetal heart beat and live birth, and with a lower rate of miscarriage, compared with natural and HRT cycles. Letrozole is the most commonly used aromatase inhibitor for mild ovarian stimulation in ART. However, the effect of letrozole on pregnancy and neonatal outcomes in FET are not well known. A retrospective cohort study was conducted using data from the Japanese national ART registry between 2012 and 2013. A total of 110 722 single FET cycles with letrozole (n = 2409), natural (n = 41 470) or HRT cycles (n = 66 843) were included. The main outcomes were the rates of clinical pregnancy, clinical pregnancy with fetal heart beat, miscarriage and live birth. Adjusted odds ratios and relative risks (RRs) were calculated using a generalized estimating equation adjusting for correlations within clinics. The rates of clinical pregnancy, clinical pregnancy with fetal heart beat, and live birth were significantly higher, while the rate of miscarriage was significantly lower in the letrozole group compared with the natural and HRT groups. In blastocyst stage transfers, the adjusted RRs for clinical pregnancy with fetal heart beat of letrozole compared with natural and HRT cycles were 1.48 (95% CI: 1.41-1.55) and 1.62 (95% CI: 1.54-1.70), respectively. Similarly, the adjusted RRs of letrozole for miscarriage compared with natural and HRT cycles were 0.91 (95% CI: 0.88-0.93) and 0.84 (95% CI: 0.82-0.87), respectively. Neonatal outcomes were mostly similar in letrozole, natural and HRT cycles. Important limitations of this study included the lack of information concerning the reasons for selecting the specific FET method, parity, the number of previous ART failures, embryo quality and the dose and duration of letrozole intake. These results suggest that letrozole use may improve clinical pregnancy, clinical pregnancy with fetal heart beat, and live births and reduce the risk of miscarriage in patients undergoing single FET cycles. No external funding was used for this study. There are no conflicts of interest. Not applicable. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

  6. Comparison of graduate-entry and direct school leaver student performance on an applied dental knowledge test.

    PubMed

    Ali, K; Zahra, D; Tredwin, C

    2017-11-01

    To compare the academic performance of graduate-entry and direct school leavers in an undergraduate dental programme. This study examined the results of students in applied dental knowledge (ADK) progress tests conducted during two academic years. A mixed model analysis of variance (ANOVA) was conducted to compare the performance of graduate-entry and direct school leavers. ADK was treated as a repeated measures variable, and the outcome variable of interest was percentage score on the ADK. The results show statistically significant main effects for ADK [F (1,113) = 61.58, P < 0.001, η 2 p = 0.35], Cohort [F (1,113) = 88.57, P < 0.001, η 2 p = 0.44] and Entry [F (1,113) = 11.31, P = 0.001, η 2 p = 0.09]. That is, students do better on each subsequent test (main effect of ADK), students in later years of the programme perform better than those in earlier years (main effect of cohort), and graduate-entry students outperform direct school leavers. This is the first study to explore the differences in the academic performance of graduate-entry and direct school leavers in an undergraduate dental programme. The results show that the academic performance of graduate students was better than the direct school leavers in years 2 and 3. Further research is required to compare the performance of students longitudinally across the entire duration of undergraduate dental programmes and evaluate whether this difference persists throughout. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. Self-Reported Recovery from 2-Week 12-Hour Shift Work Schedules: A 14-Day Follow-Up.

    PubMed

    Merkus, Suzanne L; Holte, Kari Anne; Huysmans, Maaike A; van de Ven, Peter M; van Mechelen, Willem; van der Beek, Allard J

    2015-09-01

    Recovery from fatigue is important in maintaining night workers' health. This study compared the course of self-reported recovery after 2-week 12-hour schedules consisting of either night shifts or swing shifts (i.e., 7 night shifts followed by 7 day shifts) to such schedules consisting of only day work. Sixty-one male offshore employees-20 night workers, 16 swing shift workers, and 25 day workers-rated six questions on fatigue (sleep quality, feeling rested, physical and mental fatigue, and energy levels; scale 1-11) for 14 days after an offshore tour. After the two night-work schedules, differences on the 1(st) day (main effects) and differences during the follow-up (interaction effects) were compared to day work with generalized estimating equations analysis. After adjustment for confounders, significant main effects were found for sleep quality for night workers (1.41, 95% confidence interval 1.05-1.89) and swing shift workers (1.42, 95% confidence interval 1.03-1.94) when compared to day workers; their interaction terms were not statistically significant. For the remaining fatigue outcomes, no statistically significant main or interaction effects were found. After 2-week 12-hour night and swing shifts, only the course for sleep quality differed from that of day work. Sleep quality was poorer for night and swing shift workers on the 1(st) day off and remained poorer for the 14-day follow-up. This showed that while working at night had no effect on feeling rested, tiredness, and energy levels, it had a relatively long-lasting effect on sleep quality.

  8. How Important Are Health Care Expenditures for Life Expectancy? A Comparative, European Analysis.

    PubMed

    van den Heuvel, Wim J A; Olaroiu, Marinela

    2017-03-01

    The relationship between health care expenditures and health care outcomes, such as life expectancy and mortality, is complex. Research outcomes show different and contradictory results on this relationship. How and why health care expenditures affect health outcomes is not clear. A causal link between the two is not proven. Without such knowledge, effects of increase/decrease in health care expenses on health outcomes may be overestimated/underestimated. This study analyzes the relationship between life expectancy at birth and expenditures on health care, taking into account expenditures of social production and education, as well as the quantity and quality of health care provisions and lifestyles. This is a cross-sectional study, analyzing national data of 31 European countries. First, the bivariate correlation between the dependent variable and independent variables are calculated and described. Next a forward linear regression analysis is applied. The data are derived from standardized, comparative data bases as available in the Organisation for Economic Co-operation and Development and Eurostat. Health care expenditures are assessed as a percentage of the Gross Domestic Product (GDP). Health care expenditures are not the main determinant of life expectancy at birth, but social protection expenditures are. The regression analysis shows that in countries that spend a high percentage of their GDP on social protection, that have fewer curative beds and low infant mortality, whose citizens report fewer unmet health care needs and drink less alcohol, citizens have a significant longer life expectancy. To realize high life expectancy of citizens, policy measures have to be directed on investment in social protection expenditures, on improving quality of care, and on promoting a healthy life style. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  9. Regression Rates Following the Treatment of Aggressive Posterior Retinopathy of Prematurity with Bevacizumab Versus Laser: 8-Year Retrospective Analysis

    PubMed Central

    Nicoară, Simona D.; Ştefănuţ, Anne C.; Nascutzy, Constanta; Zaharie, Gabriela C.; Toader, Laura E.; Drugan, Tudor C.

    2016-01-01

    Background Retinopathy is a serious complication related to prematurity and a leading cause of childhood blindness. The aggressive posterior form of retinopathy of prematurity (APROP) has a worse anatomical and functional outcome following laser therapy, as compared with the classic form of the disease. The main outcome measures are the APROP regression rate, structural outcomes, and complications associated with intravitreal bevacizumab (IVB) versus laser photocoagulation in APROP. Material/Methods This is a retrospective case series that includes infants with APROP who received either IVB or laser photocoagulation and had a follow-up of at least 60 weeks (for the laser photocoagulation group) and 80 weeks (for the IVB group). In the first group, laser photocoagulation of the retina was carried out and in the second group, 1 bevacizumab injection was administered intravitreally. The following parameters were analyzed in each group: sex, gestational age, birth weight, postnatal age and postmenstrual age at treatment, APROP regression, sequelae, and complications. Statistical analysis was performed using Microsoft Excel and IBM SPSS (version 23.0). Results The laser photocoagulation group consisted of 6 premature infants (12 eyes) and the IVB group consisted of 17 premature infants (34 eyes). Within the laser photocoagulation group, the evolution was favorable in 9 eyes (75%) and unfavorable in 3 eyes (25%). Within the IVB group, APROP regressed in 29 eyes (85.29%) and failed to regress in 5 eyes (14.71%). These differences are statistically significant, as proved by the McNemar test (P<0.001). Conclusions The IVB group had a statistically significant better outcome compared with the laser photocoagulation group, in APROP in our series. PMID:27062023

  10. Health profile of deaf Canadians

    PubMed Central

    Woodcock, Kathryn; Pole, Jason D.

    2007-01-01

    OBJECTIVE To profile the health of deaf and hard-of-hearing Canadians inrelation to the population as a whole. DESIGN Using data from the Canada Community Health Survey 1.1, across-sectional survey conducted by Statistics Canada with a total of 131 535 respondents, a series of logistic regression models was fitted to estimate the odds, compared with the general population, of respondents classified as having hearing problems reporting the presence of various chronic health outcomes; of their utilizing the health care system; of their engaging in certain health promotion activities; and of their reporting certain perceptions about their overall health. For each odds ratio, 95% confidence intervals are provided. All analyses were adjusted for age and sex with some analyses being restricted to appropriate age ranges or having further adjustments made, depending on the outcomes. MAIN OUTCOME MEASURES In addition to indications of deafness or hearing loss, this study examined health care utilization, several commonly accepted health outcomes, engagement in health promotion activities, and perceptions of overall health. RESULTS Approximately 4% of respondents in the cross-sectional survey were considered to have hearing problems. The prevalence of hearing problems increased withage, with males having a slightly higher prevalence of hearing problems compared with females (4.52% versus 3.53%). Respondents classified as having hearing problems, whether hearing loss or deafness, were more likely to report adverse health conditions and low levels of physical activity, and to experience higher rates of depression. Respondents classified as having hearing problems were not more likely to smoke or to drink excessively. CONCLUSION Communication is essential to both health promotion and health care delivery. Deafness—both the disability and the culture—creates barriers to communication. Individual practitioners can and should consider the communication needs of individual patients with hearing loss or deafness to avoid barriers to optimal health. PMID:18077753

  11. Corticosteroids for Bacterial Keratitis

    PubMed Central

    Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; Glidden, David V.; Ray, Kathryn J.; Hong, Kevin C.; Oldenburg, Catherine E.; Lee, Salena M.; Zegans, Michael E.; McLeod, Stephen D.; Lietman, Thomas M.; Acharya, Nisha R.

    2013-01-01

    Objective To determine whether there is a benefit in clinical outcomes with the use of topical corticosteroids as adjunctive therapy in the treatment of bacterial corneal ulcers. Methods Randomized, placebo-controlled, double-masked, multicenter clinical trial comparing prednisolone sodium phosphate, 1.0%, to placebo as adjunctive therapy for the treatment of bacterial corneal ulcers. Eligible patients had a culture-positive bacterial corneal ulcer and received topical moxifloxacin for at least 48 hours before randomization. Main Outcome Measures The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months from enrollment. Secondary outcomes included infiltrate/scar size, reepithelialization, and corneal perforation. Results Between September 1, 2006, and February 22, 2010, 1769 patients were screened for the trial and 500 patients were enrolled. No significant difference was observed in the 3-month BSCVA (−0.009 logarithm of the minimum angle of resolution [logMAR]; 95% CI, −0.085 to 0.068; P = .82), infiltrate/scar size (P = .40), time to reepithelialization (P = .44), or corneal perforation (P > .99). A significant effect of corticosteroids was observed in subgroups of baseline BSCVA (P = .03) and ulcer location (P = .04). At 3 months, patients with vision of counting fingers or worse at baseline had 0.17 logMAR better visual acuity with corticosteroids (95% CI, −0.31 to −0.02; P = .03) compared with placebo, and patients with ulcers that were completely central at baseline had 0.20 logMAR better visual acuity with corticosteroids (−0.37 to −0.04; P = .02). Conclusions We found no overall difference in 3-month BSCVA and no safety concerns with adjunctive corticosteroid therapy for bacterial corneal ulcers. Application to Clinical Practice Adjunctive topical corticosteroid use does not improve 3-month vision in patients with bacterial corneal ulcers. PMID:21987582

  12. Internet-based stress management for distressed managers: results from a randomised controlled trial

    PubMed Central

    Dagöö, Jesper; Fjellström, Ida; Niemi, Linnea; Hansson, Katja; Zeraati, Forough; Ziuzina, Masha; Geraedts, Anna; Ljótsson, Brjánn; Carlbring, Per; Andersson, Gerhard

    2018-01-01

    Objective The aim of this randomised controlled trial (RCT) was to evaluate the efficacy of a guided internet-based stress management intervention (iSMI) among distressed managers compared with a attention control group (AC) with full access to treatment-as-usual. Method A total sample of 117 distressed managers, mainly employed in the healthcare, IT, communication and educational sector, were randomised to either iSMI (n=59) or an AC group (n=58). The iSMI consisted of eight modules including cognitive behavioural stress management and positive management techniques. Participants received a minimal and weekly guidance from a psychologist or master-level psychology student focusing on support, feedback and adherence to the intervention. Self-report data were assessed at pre, post and 6 months after the intervention. The primary outcome was perceived stress (Perceived Stress Scale-14). The secondary outcomes included mental and work-related health outcomes. Results Participants in the iSMI intervention reported significantly less symptoms of perceived stress (d=0.74, 95% CI 0.30 to 1.19) and burnout (d=0.95, 95% CI 0.53 to 1.37) compared with controls, at postassessment. Significant medium-to-large effect sizes were also found for depression, insomnia and job satisfaction. Long-term effects (6 months) were seen on the mental health outcomes. Conclusion This is one of the first studies showing that iSMIs can be an effective, accessible and potentially time-effective approach of reducing stress and other mental-related and work-related health symptoms among distressed managers. Future studies are needed addressing distressed managers and the potential of indirect effects on employee stress and satisfaction at work. PMID:28855344

  13. Risk of poor neonatal outcome at term after medically assisted reproduction: a propensity score-matched study.

    PubMed

    Ensing, Sabine; Abu-Hanna, Ameen; Roseboom, Tessa J; Repping, Sjoerd; van der Veen, Fulco; Mol, Ben Willem J; Ravelli, Anita C J

    2015-08-01

    To study risk of birth asphyxia and related morbidity among term singletons born after medically assisted reproduction (MAR). Population cohort study. Not applicable. A total of 1,953,932 term singleton pregnancies selected from a national registry for 1999-2011. None. Primary outcome Apgar score <4; secondary outcomes Apgar score <7, intrauterine fetal death, perinatal mortality, congenital anomalies, small for gestational age, asphyxia related morbidity, and cesarean delivery. The risks of birth asphyxia and related morbidity were calculated in women who conceived either through MAR or spontaneously (SC), with a subgroup analysis for in vitro fertilization (IVF). An additional propensity score matching analysis was performed with matching on multiple maternal baseline covariates (maternal age, ethnicity, socioeconomic status, parity, year of birth, and preexistent diseases). Each MAR pregnancy was matched to three SC controls. Relative to SC, the MAR singletons had an increased risk of adverse neonatal outcomes including Apgar score <4 (adjusted odds ratio [OR] 1.29; 95% CI, 1.14-1.46) and intrauterine fetal death (adjusted OR 1.61; 95% CI, 1.35-1.91). After propensity score matching, the risk of an Apgar score <4 was comparable between MAR and SC singletons (OR 0.99; 95% CI, 0.87-1.14). Cesarean delivery for both fetal distress and nonprogressive labor occurred more among MAR pregnancies compared with SC pregnancies. Term singletons conceived after MAR have an increased risk of morbidity related to birth asphyxia. Because this is mainly due to maternal characteristics, obstetric caregivers should be aware that the increased rates of cesareans reflect the behavior of women and physicians rather than increased perinatal complications. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  14. MORTALITY AFTER ACUTE MYOCARDIAL INFARCTION IN HOSPITALS THAT DISPROPORTIONATELY TREAT AFRICAN-AMERICANS

    PubMed Central

    Skinner, Jonathan; Chandra, Amitabh; Staiger, Douglas; Lee, Julie; McClellan, Mark

    2006-01-01

    Background African-Americans are more likely be seen by physicians with less clinical training or treated at hospitals with deficient times to acute reperfusion therapies. Less is known about differences in health outcomes. This paper compares risk-adjusted mortality following Acute Myocardial Infarction (AMI) between U.S. hospitals with high and low fractions of elderly black AMI patients. Methods and Results A prospective cohort study was performed for fee-for-service Medicare patients hospitalized for AMI during 1997–2001 (N = 1,136,736). Hospitals (N =4289) were classified into approximate deciles depending on the extent to which the hospital served the African-American population. The lowest category (12.5 percent of AMI patients) included hospitals without any African-American AMI admissions during 1997–2001. Decile 10 (10 percent of AMI patients) included hospitals with the highest fraction of black AMI patients (33.6 percent). The main outcome measures were 90-day and 30-day mortality following AMI. Patients admitted to hospitals disproportionately serving African-Americans experienced no greater level of morbidities or severity of the infarction. Yet hospitals in Decile 10 experienced risk-adjusted 90-day mortality rate of 23.7 percent (95% CI: 23.2–24.2) compared to 20.1 percent (95% CI: 19.7–20.4) in Decile 1 hospitals. Differences in outcomes between hospitals were not explained by income, hospital ownership status, hospital volume, Census region, urban status, or hospital surgical treatment intensity. Conclusions Risk-adjusted mortality following AMI is significantly higher in U.S. hospitals that disproportionately serve African-Americans. A reduction in overall mortality at these hospitals could reduce dramatically black-white disparities in health care outcomes. PMID:16246963

  15. Gynecomastia in Patients with Prostate Cancer: A Systematic Review

    PubMed Central

    Cormio, Luigi; Palangi, Lina; Lewin, Richard; Santanelli di Pompeo, Fabio; Elander, Anna

    2015-01-01

    Introduction Gynecomastia and/or mastodynia is a common medical problem in patients receiving antiandrogen (bicalutamide or flutamide) treatment for prostate cancer; up to 70% of these patients result to be affected; furthermore, this can jeopardise patients’ quality of life. Aims To systematically review the quality of evidence of the current literature regarding treatment options for bicalutamide-induced gynecomastia, including efficacy, safety and patients’ quality of life. Methods The PubMed, Medline, Scopus, The Cochrane Library and SveMed+ databases were systematically searched between January 1, 2000 and December 31, 2014. All searches were undertaken between January and February 2015. The search phrase used was:”gynecomastia AND treatment AND prostate cancer”. Two reviewers assessed 762 titles and abstracts identified. The search and review process was done in accordance with the PRISMA statement. The PICOS (patients, intervention, comparator, outcomes and study design) process was used to specify inclusion criteria. Quality of evidence was rated according to GRADE. Main Outcome Measures Primary outcomes were: treatment effects, number of complications and side effects. Secondary outcome was: Quality of Life. Results Eleven studies met the inclusion criteria and are analysed in this review. Five studies reported pharmacological intervention with tamoxifen and/or anastrozole, either as prophylactic or therapeutic treatment. Four studies reported radiotherapy as prophylactic and/or therapeutic treatment. Two studies compared pharmacological treatment to radiotherapy. Most of the studies were randomized with varying risk of bias. According to GRADE, quality of evidence was moderate to high. Conclusions Bicalutamide-induced gynecomastia and/or mastodynia can effectively be managed by oral tamoxifen (10–20 mg daily) or radiotherapy without relevant side effects. Prophylaxis or therapeutic treatment with tamoxifen results to be more effective than radiotherapy. PMID:26308532

  16. Treatment outcome of selective digestive decontamination and enteral nutrition in patients with severe acute pancreatitis.

    PubMed

    Sawa, Hidehiro; Ueda, Takashi; Takeyama, Yoshifumi; Yasuda, Takeo; Shinzeki, Makoto; Matsumura, Naoki; Nakajima, Takahiro; Matsumoto, Ippei; Fujita, Tsunenori; Ajiki, Tetsuo; Fujino, Yasuhiro; Kuroda, Yoshikazu

    2007-01-01

    Sepsis due to infected pancreatic necrosis is the most serious complication in the late phase of severe acute pancreatitis (SAP). Bacterial translocation from the gut is thought to be the main cause of pancreatic infection. The possibility has recently been reported that selective digestive decontamination (SDD) and enteral nutrition (EN) may alleviate the complications and reduce the mortality rate in patients with SAP. We analyzed the treatment outcome of SDD and EN in patients with SAP. We divided 90 patients with SAP into three groups: SDD(-)EN(-),group A; SDD(+)EN(-), group B; and SDD(+)EN(+), group C. Clinical outcome was analyzed retrospectively. The effect of SDD was compared in groups A and B, and the effect of EN was compared in groups B and C. The background of patients was not significantly different between the groups. SDD reduced the incidence of organ dysfunction (from 70% to 59%) and the mortality rate (from 40% to 28%), but the differences were not significant. EN reduced the incidence of infected pancreatic necrosis (from 31% to 24%) and the frequency of surgery for pancreas (from 28% to 18%), and further reduced the mortality rate (from 28% for SDD to 16%), but the differences were not significant. The peripheral lymphocyte count was significantly increased in patients with EN. SDD and EN did not significantly affect the treatment outcome in SAP. However, the results in this study raise the possibility that SDD and EN may decrease the complications and reduce the mortality rate in SAP. The efficacy of SDD and EN for SAP should be evaluated in a randomized controlled trial.

  17. Comparing the quality of preconception care provided in healthcare centers in Mashhad in 2012.

    PubMed

    Sardasht, Fatemeh Ghaffari; Shourab, Nahid Jahani; Jafarnejad, Farzaneh; Esmaily, Habibollah

    2015-01-01

    Improving the quality of healthcare services is considered as the main strategy to improve maternal and neonatal health outcomes. Providing appropriate healthcare for mothers and their newborn children is facilitated significantly by considering the mothers' health and welfare before pregnancy occurs. Therefore, the aim of this study was to compare the quality of preconception care provided to women of reproductive age provided by five health centers in Mashhad in 2012 and 2013. Multi-stage sampling was used to select the participants in this descriptive study. As a result, 360 women of reproductive age and 39 healthcare providers from 24 healthcare centers in Mashhad were selected to participate. The data gathering tool was a checklist based on the Donabedian model that includes the three dimensions of structure, process, and outcome. The data were analyzed by SPSS software (version 11.5), Kruskal-Wallis tests, ANOVA, and Spearman rank correlation. The results showed that preconception care at the 24 healthcare centers had essentially the same conditions. But in the process and outcome components, the quality of the preconception care at five of the health centers was significantly different (p=0.008). The highest quality of care processes was identified at health center number 3. The difference in the component of outcomes being followed up by the healthcare providers at five of the health centers was statistically significant (p=0.000); however, there were no significant differences found among the satisfaction and awareness of the women who participated at the five health centers. The results showed that the performance of health personnel in providing preconception care and providing follow-up care was not satisfactory.

  18. Tranexamic acid for traumatic brain injury: a systematic review and meta-analysis.

    PubMed

    Zehtabchi, Shahriar; Abdel Baki, Samah G; Falzon, Louise; Nishijima, Daniel K

    2014-12-01

    The antifibrinolytic agent tranexamic acid (TXA) has demonstrated clinical benefit in trauma patients with severe bleeding, but its effectiveness in patients with traumatic brain injury (TBI) is unclear. We conducted a systematic review to evaluate the following research question: In ED patients with or at risk of intracranial hemorrhage (ICH) secondary to TBI, does TXA compared to placebo improve patients' outcomes? MEDLINE, EMBASE, CINAHL, and other databases were searched for randomized controlled trial (RCT) or quasi-RCT studies that compared the effect of TXA to placebo on outcomes of TBI patients. The main outcomes of interest included mortality, neurologic function, hematoma expansion, and adverse effects. We used "Grading quality of evidence and strength of recommendations" to assess the quality of trials. Two authors independently abstracted data using a data collection form. Results from studies were pooled when appropriate. Of 1030 references identified through the search, 2 high-quality RCTs met inclusion criteria. The effect of TXA on mortality had a pooled relative risk of 0.64 (95% confidence interval [CI], 0.41-1.02); on unfavorable functional status, a relative risk of 0.77 (95% CI, 0.59-1.02); and on ICH progression, a relative risk of 0.76 (95% CI, 0.58-0.98). No serious adverse effects (such as thromboembolic events) associated with TXA group were reported in the included trials. Pooled results from the 2 RCTs demonstrated statistically significant reduction in ICH progression with TXA and a nonstatistically significant improvement of clinical outcomes in ED patients with TBI. Further evidence is required to support its routine use in patients with TBI. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. A tailored implementation strategy to reduce the duration of intravenous antibiotic treatment in community-acquired pneumonia: a controlled before-and-after study.

    PubMed

    Engel, M F; Bruns, A H W; Hulscher, M E J L; Gaillard, C A J M; Sankatsing, S U C; Teding van Berkhout, F; Emmelot-Vonk, M H; Kuck, E M; Steeghs, M H M; den Breeijen, J H; Stellato, R K; Hoepelman, A I M; Oosterheert, J J

    2014-11-01

    We previously showed that 40 % of clinically stable patients hospitalised for community-acquired pneumonia (CAP) are not switched to oral therapy in a timely fashion because of physicians' barriers. We aimed to decrease this proportion by implementing a novel protocol. In a multi-centre controlled before-and-after study, we evaluated the effect of an implementation strategy tailored to previously identified barriers to an early switch. In three Dutch hospitals, a protocol dictating a timely switch strategy was implemented using educational sessions, pocket reminders and active involvement of nursing staff. Primary outcomes were the proportion of patients switched timely and the duration of intravenous antibiotic therapy. Length of hospital stay (LOS), patient outcome, education effects 6 months after implementation and implementation costs were secondary outcomes. Statistical analysis was performed using mixed-effects models. Prior to implementation, 146 patients were included and, after implementation, 213 patients were included. The case mix was comparable. The implementation did not change the proportion of patients switched on time (66 %). The median duration of intravenous antibiotic administration decreased from 4 days [interquartile range (IQR) 2-5] to 3 days (IQR 2-4), a decrease of 21 % [95 % confidence interval (CI) 11 %; 30 %) in the multi-variable analysis. LOS and patient outcome were comparable before and after implementation. Forty-three percent (56/129) of physicians attended the educational sessions. After 6 months, 24 % (10/42) of the interviewed attendees remembered the protocol's main message. Cumulative implementation costs were 5,798 (20/reduced intravenous treatment day). An implementation strategy tailored to previously identified barriers reduced the duration of intravenous antibiotic administration in hospitalised CAP patients by 1 day, at minimal cost.

  20. Outcome analysis of individualized vestibular rehabilitation protocols

    NASA Technical Reports Server (NTRS)

    Black, F. O.; Angel, C. R.; Pesznecker, S. C.; Gianna, C.

    2000-01-01

    OBJECTIVE: To determine the outcome of vestibular rehabilitation protocols in subjects with peripheral vestibular disorders compared with normal and abnormal control subjects. STUDY DESIGN: Prospective study using repeated measure, matched control design. Subjects were solicited consecutively according to these criteria: vestibular disorder subjects who had abnormal results of computerized dynamic posturography (CDP) sensory organization tests (SOTs) 5 and 6 and underwent rehabilitation; vestibular disorder subjects who had abnormal results of SOTs 5 and 6 and did not undergo rehabilitation; and normal subjects (normal SOTs). SETTING: Tertiary neurotology clinic. SUBJECTS: Men and women over age 18 with chronic vestibular disorders and chief complaints of unsteadiness, imbalance, and/or motion intolerance, and normal subjects. INTERVENTIONS: Pre- and post-rehabilitation assessment included CDP, vestibular disability, and activities of daily living questionnaires. Individualized rehabilitation plans were designed and implemented to address the subject's specific complaints and functional deficits. Supervised sessions were held at weekly intervals, and self-administered programs were devised for daily home use. MAIN OUTCOME MEASURES: CDP composite and SOT scores, number of falls on CDP, and self-assessment questionnaire results. RESULTS: Subjects who underwent rehabilitation (Group A) showed statistically significant improvements in SOTs, overall composite score, and reduction in falls compared with abnormal (Group B) control groups. Group A's performances after rehabilitation were not significantly different from those of normal subjects (Group C) in SOTs 3 through 6, and close to normal on SOTs 1 and 2. Subjects in Group A also reported statistically significant symptomatic improvement. CONCLUSIONS: Outcome measures of vestibular protocol physical therapy confirmed objective and subjective improvement in subjects with chronic peripheral vestibular disorders. These findings support results reported by other investigators.

  1. Association of Exposure to Di-2-Ethylhexylphthalate Replacements With Increased Insulin Resistance in Adolescents From NHANES 2009–2012

    PubMed Central

    Trasande, Leonardo

    2015-01-01

    Context: Di-isononyl phthalate (DINP) and di-isodecyl phthalate (DIDP) are environmental chemicals increasingly used to replace di-2-ethylhexylphthalate (DEHP) and commonly found in processed foods. Phthalate exposures, in particular DEHP, have been associated with insulin resistance in adolescents, but there are no data regarding the two substitutes, DINP and DIDP. Objective: This study aimed to examine associations of DINP, DIDP, and DEHP with insulin resistance outcomes. Design, Setting, and Participants: This was a cross-sectional analysis of 2009–2012 National Health and Nutrition Examination Surveys (NHANES) composed of 356 fasting 12–19-year-olds. Main Outcome Measures: Insulin resistance as a categorical outcome expressed as homeostatic model assessment of insulin resistance (HOMA-IR), using a cut point of 4.39 to define insulin resistance. We also examined continuous HOMA-IR as an outcome in secondary analyses. Results: Controlling for demographic and behavioral factors, diet, age, body mass index, and urinary creatinine, for each log increase in DINP metabolite, a 0.08 (P = .001) increase in HOMA-IR was identified. Compared with the first tertile of DINP (23.4% adjusted prevalence), the third tertile was associated with a 34.4% prevalence (95% confidence interval [CI], 27.3–41.6%; P = .033) of insulin resistance. Similarly, compared with the first tertile of DEHP (20.5% adjusted prevalence), the third tertile had 37.7% prevalence (95% CI 29.8–45.6%; P = .003). Conclusions: Urinary DINP concentrations were associated with increased insulin resistance in this cross-sectional study of adolescents. The previously identified association of DEHP with insulin resistance was also confirmed. Further, longitudinal studies are needed to confirm these associations, with the possibility to assess opportunities for intervention. PMID:25993640

  2. Multimodal data and machine learning for surgery outcome prediction in complicated cases of mesial temporal lobe epilepsy.

    PubMed

    Memarian, Negar; Kim, Sally; Dewar, Sandra; Engel, Jerome; Staba, Richard J

    2015-09-01

    This study sought to predict postsurgical seizure freedom from pre-operative diagnostic test results and clinical information using a rapid automated approach, based on supervised learning methods in patients with drug-resistant focal seizures suspected to begin in temporal lobe. We applied machine learning, specifically a combination of mutual information-based feature selection and supervised learning classifiers on multimodal data, to predict surgery outcome retrospectively in 20 presurgical patients (13 female; mean age±SD, in years 33±9.7 for females, and 35.3±9.4 for males) who were diagnosed with mesial temporal lobe epilepsy (MTLE) and subsequently underwent standard anteromesial temporal lobectomy. The main advantage of the present work over previous studies is the inclusion of the extent of ipsilateral neocortical gray matter atrophy and spatiotemporal properties of depth electrode-recorded seizures as training features for individual patient surgery planning. A maximum relevance minimum redundancy (mRMR) feature selector identified the following features as the most informative predictors of postsurgical seizure freedom in this study's sample of patients: family history of epilepsy, ictal EEG onset pattern (positive correlation with seizure freedom), MRI-based gray matter thickness reduction in the hemisphere ipsilateral to seizure onset, proportion of seizures that first appeared in ipsilateral amygdala to total seizures, age, epilepsy duration, delay in the spread of ipsilateral ictal discharges from site of onset, gender, and number of electrode contacts at seizure onset (negative correlation with seizure freedom). Using these features in combination with a least square support vector machine (LS-SVM) classifier compared to other commonly used classifiers resulted in very high surgical outcome prediction accuracy (95%). Supervised machine learning using multimodal compared to unimodal data accurately predicted postsurgical outcome in patients with atypical MTLE. Published by Elsevier Ltd.

  3. Open Reduction and Internal Fixation versus Non-Surgical Treatment in Displaced Midshaft Clavicle Fractures: A Meta-Analysis.

    PubMed

    Ahmed, Abdulaziz F; Salameh, Motasem; AlKhatib, Nidal; Elmhiregh, Aissam; Ahmed, Ghalib O

    2018-04-17

    To compare open reduction and internal fixation (ORIF) and non-surgical treatment outcomes in displaced midshaft clavicle fractures. PubMed, MEDLINE, EMBASE, Web of Science, Cochrane Library, and ClinicalTrials.gov were searched in September 2017. Inclusion criteria were randomized controlled trials reporting nonunion, shoulder functional outcomes, and subsequent surgery rates or pain scores. We excluded studies with patients younger than 16 years, maximum follow-up less than nine months, and inaccessible full text. Extracted data included the first author, publication year, number of patients, number of nonunions, Constant scores, disabilities of the arm, shoulder and hand (DASH) scores, number of subsequent surgeries, and pain measured using the visual analogue analog scale. The risk ratio (RR) of nonunion was 0.15 (95% confidence interval [CI], 0.08, 0.31) in ORIF compared with that of non-surgical treatment. Constant and DASH scores were significantly better in ORIF up to 6 months. The mean difference (MD) in DASH scores at 12 months was statistically insignificant in both treatments (MD, -4.19; 95% CI, -9.34, 0.96). Constant scores remained significant in ORIF (MD, 4.39; 95% CI, 1.03, 7.75). Subsequent surgeries and pain scores were similar in both treatments. Significant reduction in nonunions and favorable early functional outcomes are associated with ORIF. Nevertheless, late functional outcomes, subsequent surgeries, and pain scores are similar to those of non-surgical treatment. Although patients treated with ORIF mainly had subsequent elective plate removals; non-surgically treated patients had more surgical fixations for nonunions. As a result, there remains inconsistent evidence regarding the best treatment for displaced midshaft clavicle fractures. Therapeutic Level I.

  4. A randomised trial of povidone-iodine to reduce visual impairment from corneal ulcers in rural Nepal

    PubMed Central

    Katz, J; Khatry, S K; Thapa, M D; Schein, O D; Kimbrough Pradhan, E; LeClerq, S C; West , K P

    2004-01-01

    Aim: To assess whether povidone-iodine provided any benefit over and above a standard regimen of antibiotic therapy for the treatment of corneal ulcers. Methods: All patients diagnosed with corneal ulcers presenting for care at a primary eye care clinic in rural Nepal were randomised to a standard protocol of antibiotic therapy versus standard therapy plus 2.5% povidone-iodine every 2 hours for 2 weeks. The main outcomes were corrected visual acuity and presence, size, and position of corneal scarring in the affected eye at 2–4 months following treatment initiation. Results: 358 patients were randomised and 81% were examined at follow up. The two groups were comparable before treatment. At follow up, 3.9% in the standard therapy and 6.9% in the povidone-iodine group had corrected visual acuity worse than 20/400 (relative risk (RR) 1.77, 95% confidence interval (CI) 0.62 to 5.03). 9.4% in the standard therapy and 13.1% in the povidone-iodine group had corrected visual acuity worse than 20/60 (RR 1.39, 95% CI 0.71 to 2.77), and 17.0% and 18.8% had scars in the visual axis in each of these groups, respectively (RR 1.11, 95% CI 0.67 to 1.82). Conclusions: A small proportion of patients with corneal ulceration treated in this setting had poor visual outcomes. The addition of povidone-iodine to standard antibiotic therapy did not improve visual outcomes, although this design was unable to assess whether povidone-iodine on its own would have resulted in comparable visual outcomes to that of standard therapy. PMID:15548795

  5. An intervention to improve program implementation: findings from a two-year cluster randomized trial of Assets-Getting To Outcomes

    PubMed Central

    2013-01-01

    Background Studies have shown that communities have not always been able to implement evidence-based prevention programs with quality and achieve outcomes demonstrated by prevention science. Implementation support interventions are needed to bridge this gap between science and practice. The purpose of this article is to present two-year outcomes from an evaluation of the Assets Getting To Outcomes (AGTO) intervention in 12 Maine communities engaged in promoting Developmental Assets, a positive youth development approach to prevention. AGTO is an implementation support intervention that consists of: a manual of text and tools; face-to-face training, and onsite technical assistance, focused on activities shown to be associated with obtaining positive results across any prevention program. Methods This study uses a nested and cross-sectional, cluster randomized controlled design. Participants were coalition members and program staff from 12 communities in Maine. Each coalition nominated up to five prevention programs to participate. At random, six coalitions and their respective 30 programs received the two-year AGTO intervention and the other six maintained routine operations. The study assessed prevention practitioner capacity (efficacy and behaviors), practitioner exposure to and use of AGTO, practitioner perceptions of AGTO, and prevention program performance. Capacity of coalition members and performance of their programs were compared between the two groups across the baseline, one-, and two-year time points. Results We found no significant differences between AGTO and control group’s prevention capacity. However, within the AGTO group, significant differences were found between those with greater exposure to and use of AGTO. Programs that received the highest number of technical assistance hours showed the most program improvement. Conclusions This study is the first of its kind to show that use of an implementation support intervention-AGTO -yielded improvements in practitioner capacity and consequently in program performance on a large sample of practitioners and programs using a randomized controlled design. ClinicalTrials.gov identifier NCT00780338 PMID:23924279

  6. Adherence to Antitumor Necrosis Factor Use Recommendations in Spondyloarthritis: Measurement and Effect in the DESIR Cohort.

    PubMed

    Harvard, Stephanie; Guh, Daphne; Bansback, Nick; Richette, Pascal; Saraux, Alain; Fautrel, Bruno; Anis, Aslam H

    2017-10-01

    To evaluate a classification system to define adherence to axial spondyloarthritis (axSpA) anti-tumor necrosis factor (anti-TNF) use recommendations and examine the effect of adherence on outcomes in the DESIR cohort (Devenir des Spondylarthropathies Indifférenciées Récentes). Using alternate definitions of adherence, patients were classified as adherent "timely" anti-TNF users, nonadherent "late" anti-TNF users, adherent nonusers ("no anti-TNF need"), non-adherent nonusers ("unmet anti-TNF need"). Multivariate models were fitted to examine the effect of adherence on quality-adjusted life-years (QALY), total costs, and nonbiologic costs 1 year following an index date. Generalized linear regression models assuming a γ-distribution with log link were used for costs outcomes and linear regression models for QALY outcomes. Using the main definition of adherence, there were no significant differences between late anti-TNF users and timely anti-TNF users in total costs (RR 0.86, 95% CI 0.54-1.36, p = 0.516) or nonbiologic costs (RR 0.72, 95% CI 0.44-1.18, p = 0.187). However, in the sensitivity analysis, late anti-TNF users had significantly increased nonbiologic costs compared with timely users (RR 1.58, 95% CI 1.06-2.36, p = 0.026). In the main analysis, there were no significant differences in QALY between timely anti-TNF users and late anti-TNF users, or between timely users and patients with unmet anti-TNF need. In the sensitivity analysis, patients with unmet anti-TNF need had significantly lower QALY than timely anti-TNF users (-0.04, 95% CI -0.07 to -0.01, p = 0.016). The effect of adherence to anti-TNF recommendations on outcomes was sensitive to the definition of adherence used, highlighting the need to validate methods to measure adherence.

  7. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

    PubMed

    Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

    2015-09-11

    Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of the first studies focusing on the individual components of combined goal setting and reward structures in a factorial design to increase walking. The trial is expected to produce results useful to future research interventions and perhaps industry initiatives, primarily focused on mHealth, goal setting, and those looking to promote behavior change through performance-based incentives. ClinicalTrials.gov NCT02053259; https://clinicaltrials.gov/ct2/show/NCT02053259 (Archived by WebCite at http://www.webcitation.org/6b65xLvmg).

  8. Adolescent Abstinence and Unprotected Sex in CyberSenga, an Internet-Based HIV Prevention Program: Randomized Clinical Trial of Efficacy

    PubMed Central

    Ybarra, Michele L.; Bull, Sheana S.; Prescott, Tonya L.; Korchmaros, Josephine D.; Bangsberg, David R.; Kiwanuka, Julius P.

    2013-01-01

    Context Cost-effective, scalable programs are urgently needed in countries deeply affected by HIV. Methods This parallel-group RCT was conducted in four secondary schools in Mbarara, Uganda. Participants were 12 years and older, reported past-year computer or Internet use, and provided informed caregiver permission and youth assent. The intervention, CyberSenga, was a five-hour online healthy sexuality program. Half of the intervention group was further randomized to receive a booster at four-months post-intervention. The control arm received ‘treatment as usual’ (i.e., school-delivered sexuality programming). The main outcome measures were: 1) condom use and 2) abstinence in the past three months at six-months' post-intervention. Secondary outcomes were: 1) condom use and 2) abstinence at three-month's post-intervention; and 6-month outcomes by booster exposure. Analyses were intention to treat. Results All 416 eligible youth were invited to participate, 88% (n = 366) of whom enrolled. Participants were randomized to the intervention (n = 183) or control (n = 183) arm; 91 intervention participants were further randomized to the booster. No statistically significant results were noted among the main outcomes. Among the secondary outcomes: At three-month follow-up, trends suggested that intervention participants (81%) were more likely to be abstinent than control participants (74%; p = 0.08), and this was particularly true among youth who were abstinent at baseline (88% vs. 77%; p = 0.02). At six-month follow-up, those in the booster group (80%) reported higher rates of abstinence than youth in the intervention, no booster (57%) and control (55%) groups (p = 0.15); they also reported lower rates of unprotected sex (5%) compared to youth in the intervention, no booster (24%) and control (21%) groups (p = 0.21) among youth sexually active at baseline. Conclusions The CyberSenga program may affect HIV preventive behavior among abstinent youth in the short term and, with the booster, may also promote HIV preventive behavior among sexually active youth in the longer term. Trial Registration NCT00906178. PMID:23967069

  9. The "ComPAS Trial" combined treatment model for acute malnutrition: study protocol for the economic evaluation.

    PubMed

    Lelijveld, Natasha; Bailey, Jeanette; Mayberry, Amy; Trenouth, Lani; N'Diaye, Dieynaba S; Haghparast-Bidgoli, Hassan; Puett, Chloe

    2018-04-24

    Acute malnutrition is currently divided into severe (SAM) and moderate (MAM) based on level of wasting. SAM and MAM currently have separate treatment protocols and products, managed by separate international agencies. For SAM, the dose of treatment is allocated by the child's weight. A combined and simplified protocol for SAM and MAM, with a standardised dose of ready-to-use therapeutic food (RUTF), is being trialled for non-inferior recovery rates and may be more cost-effective than the current standard protocols for treating SAM and MAM. This is the protocol for the economic evaluation of the ComPAS trial, a cluster-randomised controlled, non-inferiority trial that compares a novel combined protocol for treating uncomplicated acute malnutrition compared to the current standard protocol in South Sudan and Kenya. We will calculate the total economic costs of both protocols from a societal perspective, using accounting data, interviews and survey questionnaires. The incremental cost of implementing the combined protocol will be estimated, and all costs and outcomes will be presented as a cost-consequence analysis. Incremental cost-effectiveness ratio will be calculated for primary and secondary outcome, if statistically significant. We hypothesise that implementing the combined protocol will be cost-effective due to streamlined logistics at clinic level, reduced length of treatment, especially for MAM, and reduced dosages of RUTF. The findings of this economic evaluation will be important for policymakers, especially given the hypothesised non-inferiority of the main health outcomes. The publication of this protocol aims to improve rigour of conduct and transparency of data collection and analysis. It is also intended to promote inclusion of economic evaluation in other nutrition intervention studies, especially for MAM, and improve comparability with other studies. ISRCTN 30393230 , date: 16/03/2017.

  10. A Randomized Controlled Trial to Compare Computer-assisted Motivational Intervention with Didactic Educational Counseling to Reduce Unprotected Sex in Female Adolescents.

    PubMed

    Gold, Melanie A; Tzilos, Golfo K; Stein, L A R; Anderson, Bradley J; Stein, Michael D; Ryan, Christopher M; Zuckoff, Allan; DiClemente, Carlo

    2016-02-01

    To examine a computer-assisted, counselor-guided motivational intervention (CAMI) aimed at reducing the risk of unprotected sexual intercourse. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: We conducted a 9-month, longitudinal randomized controlled trial with a multisite recruitment strategy including clinic, university, and social referrals, and compared the CAMI with didactic educational counseling in 572 female adolescents with a mean age of 17 years (SD = 2.2 years; range = 13-21 years; 59% African American) who were at risk for pregnancy and sexually transmitted diseases. The primary outcome was the acceptability of the CAMI according to self-reported rating scales. The secondary outcome was the reduction of pregnancy and sexually transmitted disease risk using a 9-month, self-report timeline follow-back calendar of unprotected sex. The CAMI was rated easy to use. Compared with the didactic educational counseling, there was a significant effect of the intervention which suggested that the CAMI helped reduce unprotected sex among participants who completed the study. However, because of the high attrition rate, the intent to treat analysis did not demonstrate a significant effect of the CAMI on reducing the rate of unprotected sex. Among those who completed the intervention, the CAMI reduced unprotected sex among an at-risk, predominantly minority sample of female adolescents. Modification of the CAMI to address methodological issues that contributed to a high drop-out rate are needed to make the intervention more acceptable and feasible for use among sexually active predominantly minority, at-risk, female adolescents. Copyright © 2016 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

  11. Cost-Effectiveness of Tolvaptan in Autosomal Dominant Polycystic Kidney Disease

    PubMed Central

    Erickson, Kevin F.; Chertow, Glenn M.; Goldhaber-Fiebert, Jeremy D.

    2014-01-01

    Background: In the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes (TEMPO) trial, tolvaptan significantly reduced expansion of kidney volume and loss of kidney function. Objective: To determine how benefits observed in the TEMPO trial might relate to longer-term health outcomes such as progression to end-stage renal disease (ESRD) and mortality in addition to its cost-effectiveness. Design: A decision-analytic model. Data Sources: Published literature. Target Population: Persons with early Autosomal Dominant Polycystic Kidney Disease (ADPKD). Time Horizon: Lifetime. Perspective: Societal. Interventions: We compared a strategy where patients receive tolvaptan therapy until death, development of ESRD, or liver complications to one where they do not receive tolvaptan. Outcome Measures: Median age at ESRD onset, life expectancy, discounted quality-adjusted life years (QALYs) and lifetime costs (in 2010 USD), and incremental cost-effectiveness ratios. Results of Base Case Analysis: Tolvaptan prolonged the median age at ESRD onset by 6.5 years and increased life expectancy by 2.6 years. At a drug cost of $5,760 per month, tolvaptan cost $744,100 per QALY gained compared to standard care. Results of Sensitivity Analysis: For patients with ADPKD progressing more slowly, tolvaptan’s cost per QALY gained was even higher. Limitations: Although the TEMPO trial followed patients for 3 years, our main analysis assumed that the clinical benefits of tolvaptan persisted over patients’ lifetimes. Conclusions and Relevance: Assuming that tolvaptan’s benefits persist longer term, the drug may slow progression to ESRD and reduce mortality. However, barring an approximately 95% reduction in the price of tolvaptan, its cost-effectiveness does not compare favorably with many other commonly accepted medical interventions. PMID:24042366

  12. A randomized trial comparing treatments for varicose veins.

    PubMed

    Brittenden, Julie; Cotton, Seonaidh C; Elders, Andrew; Ramsay, Craig R; Norrie, John; Burr, Jennifer; Campbell, Bruce; Bachoo, Paul; Chetter, Ian; Gough, Michael; Earnshaw, Jonothan; Lees, Tim; Scott, Julian; Baker, Sara A; Francis, Jill; Tassie, Emma; Scotland, Graham; Wileman, Samantha; Campbell, Marion K

    2014-09-25

    Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain. In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success. After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (P<0.001); the frequency of serious adverse events (approximately 3%) was similar among the groups. Measures of clinical success were similar among the groups, but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group (P<0.001). Quality-of-life measures were generally similar among the study groups, with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

  13. Ground reaction forces on stairs. Part II: knee implant patients versus normals.

    PubMed

    Stacoff, Alex; Kramers-de Quervain, Inès A; Luder, Gerhard; List, Renate; Stüssi, Edgar

    2007-06-01

    The goal of this study was to compare selected parameters of vertical ground reaction forces (GRF) of good outcome patients with different prosthesis designs with a matched control group during level walking, stair ascent and descent. Forty subjects, 29 with three main implant designs (including four subjects with a passive knee flexion restriction), and 11 healthy controls were measured with 8-10 repetitions. Vertical ground reaction forces were measured during two consecutive steps with force plates embedded in the walkway and the staircase. Defined parameters of the force signals were used to compare the results of the test groups. The results show, that, postoperatively, good outcome patients produce gait patterns of the vertical ground reaction force which are comparable to normal healthy subjects with the exception of a few distinct differences: a significant reduction (p<0.05) in the vertical loading on the operated side during level walking at take-off, at weight acceptance and take-off during stair ascent of the normal stair. During stair descent, the patients did not reduce load on the operated side, but increased load variation and side-to-side asymmetry; thus, the mechanical loads on the implants were high, which may be important information with respect to loading protocols of knee implant simulators. No systematic differences in any of the test parameters were found between posterior cruciate-retaining (LCS MB and Innex CR) versus non-retaining (LCS RP and Innex UCOR) implant designs. The restricted group showed significant reductions (p<0.05) of several loading parameters as well as an increased side-to-side asymmetry. About one third of the force parameters of the good outcome patients showed a side-to-side asymmetry between two consecutive steps, which was over a proposed level of acceptance.

  14. Cost-effectiveness of counselling, graded-exercise and usual care for chronic fatigue: evidence from a randomised trial in primary care.

    PubMed

    Sabes-Figuera, Ramon; McCrone, Paul; Hurley, Mike; King, Michael; Donaldson, Ana Nora; Ridsdale, Leone

    2012-08-20

    Fatigue is common and has been shown to result in high economic costs to society. The aim of this study is to compare the cost-effectiveness of two active therapies, graded-exercise (GET) and counselling (COUN) with usual care plus a self-help booklet (BUC) for people presenting with chronic fatigue. A randomised controlled trial was conducted with participants consulting for fatigue of over three months' duration recruited from 31 general practices in South East England and allocated to one of three arms. Outcomes and use of services were assessed at 6-month follow-up. The main outcome measure used in the economic evaluation was clinically significant improvements in fatigue, measured using the Chalder fatigue scale. Cost-effectiveness was assessed using the net-benefit approach and cost-effectiveness acceptability curves. Full economic and outcome data at six months were available for 163 participants; GET = 51, COUN = 58 and BUC = 54. Those receiving the active therapies (GET and COUN) had more contacts with care professionals and therefore higher costs, these differences being statistically significant. COUN was more expensive and less effective than the other two therapies. The incremental cost-effectiveness ratio of GET compared to BUC was equal to £987 per unit of clinically significant improvement. However, there was much uncertainty around this result. This study does not provide a clear recommendation about which therapeutic option to adopt, based on efficiency, for patients with chronic fatigue. It suggests that COUN is not cost-effective, but it is unclear whether GET represents value for money compared to BUC. Clinical Trial Registration number at ISRCTN register: 72136156.

  15. Vertebral Derotation by Vertebral Column Manipulator Improves Postoperative Radiographs Outcomes of Lenke 5C Patients for Follow-up of Minimum 2 Years.

    PubMed

    Huang, Zifang; Wang, Qifei; Yang, Junlin; Yang, Jingfan; Li, Fobao

    2016-04-01

    This was a retrospective study. The aim of this study was to compare radiographic outcomes of Lenke 5C adolescent idiopathic scoliosis (AIS) patients treated by vertebral column manipulator (VCM) or simple rod derotation (SRD) maneuver. The direct vertebral rotation (DVR) technique has demonstrated better rotational and coronal correction than SRD, but clinical radiographic outcomes for Lenke 5C AIS following DVR using a VCM derotational device have not been described. A retrospective study was carried out in 39 Lenke 5C AIS patients treated by VCM (n=20) or SRD (n=19) techniques between April 2008 and June 2011. All patients had complete clinical record and radiographic data. Nine radiographic variables were collected and compared at 3 time points (preoperative, immediate postoperative, and minimum 2-year follow-up) between both groups. Scoliosis was successfully corrected in both groups. All patients obtained good coronal and sagittal balance, and no severe complications occurred. The postoperative apical rotation corrective rate of the VCM and SRD groups were 55.1% and 25.5%, respectively (P < 0.05). Lowest instrumented vertebra and stable vertebra (LIV-SV) was statistically significant between the VCM and SRD groups, the mean values were 1.2 ± 0.4 level and 0.7 ± 0.5 level (P < 0.05). The main curve corrective rates and LIV-tilt angle correction rates were not significantly different between groups, but it showed a spontaneous correction for the coronal LIV-tilt angle for both groups at the last follow-up. VCM improved postoperative apical axial rotational correction and lessened the lumbar fusion segment compared with the SRD technique, which might have a potential trend to reserve lumbar mobility.

  16. Clinical and bacteriological outcome of different doses and duration of pivmecillinam compared with placebo therapy of uncomplicated lower urinary tract infection in women: The LUTIW project

    PubMed Central

    Ferry, Sven A.; Holm, Stig E.; Stenlund, Hans; Lundholm, Rolf; Monsen, Tor J.

    2007-01-01

    Objective To analyse associations between symptoms and bacteriuria in uncomplicated lower urinary tract infection in women (LUTIW) and to evaluate outcome of therapy with three different regimens of pivmecillinam or placebo. Design Prospective, multicentre, randomized, double-blind, and placebo-controlled therapy study. Symptoms registered at inclusion, during therapy and at follow-up visits after 8–10 and 35–49 days. Significant bacteriuria defined according to current European guidelines. Setting A total of 18 primary healthcare centres in northern Sweden. Subjects Women aged 18 years and above with symptoms of urgency, dysuria, supra pubic or loin pain. Main outcome measures Symptoms and bacteriuria at inclusion and course of symptoms, bacteriuria, and their combinations during and post-therapy. Results At inclusion, no associations or significant differences were found between symptom scores and bacteriuria, bacterial counts, or species. The 884 patients (77%) with significant bacteriuria were followed up. All pivmecillinam therapies were superior to placebo (p < 0.001). From day six until first follow-up, the mean values of all symptoms were higher and the bacteriological cure was lower at first follow-up in the three days (84%) compared with the seven days regimens (93–94%, p < 0.001). At final follow-up clinical cure was similar in all pivmecillinam regimens (65–72%) as was bacteriological cure (83–89%). Pivmecillinam had few low to mild adverse reactions, comparable to placebo. Conclusions Symptoms are not conclusive for diagnosis of LUTIW. Pivmecillinam therapies are superior to placebo and seven days regimens are more efficient than three days. Pivmecillinam 200 mg×2×7 days is recommended as a first-line therapy for LUTIW. PMID:17354160

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

    PubMed

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

    2017-04-01

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

  18. Communication between South Asian patients and GPs: comparative study using the Roter Interactional Analysis System

    PubMed Central

    Neal, Richard D; Ali, Nasreen; Atkin, Karl; Allgar, Victoria L; Ali, Shahid; Coleman, Tim

    2006-01-01

    Background The UK South Asian population has poorer health outcomes. Little is known about their process of care in general practice, or in particular the process of communication with GPs. Aim To compare the ways in which white and South Asian patients communicate with white GPs. Design of study Observational study of video-recorded consultations using the Roter Interactional Analysis System (RIAS). Setting West Yorkshire, UK. Method One hundred and eighty–three consultations with 11 GPs in West Yorkshire, UK were video-recorded and analysed. Results Main outcome measures were consultation length, verbal domination, 16 individual abridged RIAS categories, and three composite RIAS categories; with comparisons between white patients, South Asian patients fluent in English and South Asian patients non-fluent in English. South Asians fluent in English had the shortest consultations and South Asians non-fluent in English the longest consultations (one-way ANOVA F = 7.173, P = 0.001). There were no significant differences in verbal domination scores between the three groups. White patients had more affective (emotional) consultations than South Asian patients, and played a more active role in their consultations, as did their GPs. GPs spent less time giving information to South Asian patients who were not fluent in English and more time asking questions. GPs spent less time giving information to South Asian patients fluent in English compared with white patients. Conclusions These findings were expected between patients fluent and non-fluent in English but do demonstrate their nature. The differences between white patients and South Asian patients fluent in English warrant further explanation. How much of this was due to systematic differences in behaviour by the GPs, or was in response to patients' differing needs and expectations is unknown. These differences may contribute to differences in health outcomes. PMID:17132355

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

    PubMed Central

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

    2017-01-01

    Abstract Background: One of the perceived major drawbacks of minimally invasive techniques has always been its cost. This is especially true for the robotic approach and is one of the main reasons that has prevented its wider acceptance among hospitals and surgeons. The aim of our study was to evaluate the clinical outcomes and economic impact of robotic and open liver surgery in a single institution. Methods: Sixty-eight robotic and 55 open hepatectomies were performed at our institution between January 1, 2009 and December 31, 2013. Demographics, perioperative data, and postoperative outcomes were collected and compared between the two groups. An independent company performed the financial analysis. The economic parameters comprised direct variable costs, direct fixed costs, and indirect costs. Results: Mean estimated blood loss was significantly less in the robotic group (438 versus 727.8 mL; P = .038). Overall morbidity was significantly lower in the robotic group (22% versus 40%; P = .047). Clavien III/IV complications were also lower, with 4.4% in the robotic versus 16.3% in the open group (P = .043). The length of stay in the intensive care unit (ICU) was shorter for patients who underwent a robotic procedure (2.1 versus 3.3 days; P = .004). The average total cost, including readmissions, was $37,518 for robotic surgery and $41,948 for open technique. Conclusions: Robotic liver resections had less overall morbidity, ICU, and hospital stay. This translates into decreased average costs for robotic surgery. These procedures are financially comparable to open resections and do not represent a financial burden to the hospital. PMID:28186429

  20. The Effects of Highly Challenging Balance Training in Elderly With Parkinson's Disease: A Randomized Controlled Trial.

    PubMed

    Conradsson, David; Löfgren, Niklas; Nero, Håkan; Hagströmer, Maria; Ståhle, Agneta; Lökk, Johan; Franzén, Erika

    2015-10-01

    Highly challenging exercises have been suggested to induce neuroplasticity in individuals with Parkinson's disease (PD); however, its effect on clinical outcomes remains largely unknown. To evaluate the short-term effects of the HiBalance program, a highly challenging balance-training regimen that incorporates both dual-tasking and PD-specific balance components, compared with usual care in elderly with mild to moderate PD. Participants with PD (n = 100) were randomized, either to the 10-week HiBalance program (n = 51) or to the control group (n = 49). Participants were evaluated before and after the intervention. The main outcomes were balance performance (Mini-BESTest), gait velocity (during normal and dual-task gait), and concerns about falling (Falls Efficacy Scale-International). Performance of a cognitive task while walking, physical activity level (average steps per day), and activities of daily living were secondary outcomes. A total of 91 participants completed the study. After the intervention, the between group comparison showed significantly improved balance and gait performance in the training group. Moreover, although no significant between group difference was observed regarding gait performance during dual-tasking; the participants in the training group improved their performance of the cognitive task while walking, as compared with the control group. Regarding physical activity levels and activities of daily living, in comparison to the control group, favorable results were found for the training group. No group differences were found for concerns about falling. The HiBalance program significantly benefited balance and gait abilities when compared with usual care and showed promising transfer effects to everyday living. Long-term follow-up assessments will further explore these effects. © The Author(s) 2015.

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