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Age Nutrition Chirugie (ANC) study: impact of a geriatric intervention on the screening and management of undernutrition in elderly patients operated on for colon cancer, a stepped wedge controlled trial
No full textAbstract
Background
Undernutrition prior to major abdominal surgery is frequent and increases morbidity and mortality, especially in older patients. The management of undernutrition reduces postoperative complications. Nutritional management should be a priority in patient care during the preoperative period. However undernutrition is rarely detected and the guidelines are infrequently followed. Preoperative undernutrition screening should allow a better implementation of the guidelines.
Methods/design
The ANC ( \u201cAge Nutrition Chirurgie\u201d ) study is an interventional, comparative, prospective, multicenter, randomized protocol based on the stepped wedge trial design. For the intervention, the surgeon will inform the patient of the establishment of a systematic preoperative geriatric assessment that will allow the preoperative diagnosis of the nutritional status and the implementation of an adjusted nutritional support in accordance with the nutritional guidelines. The primary outcome measure is to determine the impact of the geriatric intervention on the level of perioperative nutritional management, in accordance with the current European guidelines. The implementation of the intervention in the five participating centers will be rolled-out sequentially over six time periods (every six months). Investigators must recommend that all patients aged 70\ua0years or over and who are consulting for a surgery for a colorectal cancer should consider participating in this study.
Discussion
The ANC study is based on an original methodology, the stepped wedge trial design, which is appropriate for evaluating the implementation of a geriatric and nutritional assessment during the perioperative period. We describe the purpose of this geriatric intervention, which is expected to apply the ESPEN and SFNEP recommendations through the establishment of an undernutrition screening and a management program for patients with cancer. This intervention should allow a decrease in patient morbidity and mortality due to undernutrition.
Trial registration
This study is registered in ClinicalTrials.gov NCT02084524 on March 11, 2014 (retrospectively registered)
Systematic review and network meta-analysis of tedizolid for the treatment of acute bacterial skin and skin structure infections caused by MRSA
No full textAbstract
Background
Tedizolid, the active moiety of tedizolid phosphate, is approved in the United States, the European Union, Canada and a number of other countries for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). This network meta-analysis (NMA) evaluates the comparative effectiveness of tedizolid and other antibacterials indicated for the treatment of ABSSSI caused by MRSA.
Methods
Systematic review of 10 databases was undertaken to inform an NMA to estimate the relative effectiveness of tedizolid and established monotherapy comparators (ceftaroline, daptomycin, linezolid, teicoplanin, tigecycline, vancomycin) for treating MRSA-associated ABSSSI. Randomized controlled trials enrolling adults with ABSSSI or complicated skin and skin structure infections caused by suspected/documented MRSA were eligible for inclusion. Networks were developed based on similarity of study design, patient characteristics, outcome measures and available data. Outcomes of interest included clinical response at end of therapy (EOT), post-therapy evaluation (PTE) or test-of-cure assessment and treatment discontinuations resulting from adverse events (AEs). Bayesian NMA was conducted for each outcome using fixed-effects and random effects models.
Results
Literature searches identified 3,618 records; 15 trials met the inclusion criteria and were considered suitable for NMA comparison. In fixed-effects models, tedizolid had higher odds of clinical response at EOT (odds ratio [OR], 1.7; credible interval, 1.0, 3.0) and PTE than vancomycin (OR, 1.6; credible interval, 1.1, 2.5). No differences in odds of clinical response at EOT or PTE were observed between tedizolid and other comparators. There was no evidence of a difference among treatments for discontinuation due to AEs. Results from random effects and fixed-effects models were generally consistent.
Conclusions
Tedizolid was superior to vancomycin for clinical response at EOT and PTE. There was no evidence of a difference between tedizolid and other comparators and no evidence of a difference between tedizolid and all comparators when evaluating discontinuation due to AEs. These findings suggest that tedizolid provides an alternative option for the management of serious ..
Sex with sweethearts: Exploring factors associated with inconsistent condom use among unmarried female entertainment workers in Cambodia
No full textAbstract
Background
Despite the success in promoting condom use in commercial relationships, condom use with regular, noncommercial partners remains low among key populations in Cambodia. This study explores factors associated inconsistent condom use with sweethearts among unmarried sexually active female entertainment workers (FEWs).
Methods
In 2014, the probability proportional to size sampling method was used to randomly select 204 FEWs from entertainment venues in Phnom Penh and Siem Reap for face-to-face interviews. Multivariate logistic regression analysis was conducted to examine independent determinants of inconsistent condom use.
Results
Of total, 31.4% of the respondents reported consistent condom use with sweethearts in the past three months. After adjustment, respondents who reported inconsistent condom use with sweethearts remained significantly less likely to report having received any form of sexual and reproductive health education (AOR\u2009=\u20090.49, 95% CI\u2009=\u20090.22\u20130.99), but more likely to report having been tested for HIV in the past six months (AOR\u2009=\u20092.19, 95% CI\u2009=\u20091.03\u20134.65). They were significantly more likely to report having used higher amount of alcohol in the past three months (AOR\u2009=\u20091.29, 95% CI\u2009=\u20091.01\u20131.99) and currently using a contraceptive method other than condoms such as pills (AOR\u2009=\u20094.46, 95% CI\u2009=\u20091.34\u201310.52) or other methods (AOR\u2009=\u20099.75, 95% CI\u2009=\u20092.07\u20139.86).
Conclusions
The rate of consistent condom use in romantic relationships among unmarried FEWs in this study is considerably low. The importance of consistent condom use with regular, non-commercial partners should be emphasized in the education sessions and materials, particularly for FEWs who use non-barrier contraceptive methods
Clinical and microbiologic characteristics of cefotaxime-non-susceptible Enterobacteriaceae bacteremia: a case control study
No full textAbstract
Background
Cefotaxime plays an important role in the treatment of patients with bacteremia due to Enterobacteriaceae , although cefotaxime resistance is reported to be increasing in association with extended-spectrum \u3b2-lactamase (ESBL) and AmpC \u3b2-lactamase (AmpC).
Methods
We conducted a case-control study in a Japanese university hospital between 2011 and 2012. We assessed the risk factors and clinical outcomes of bacteremia due to cefotaxime-non-susceptible Enterobacteriaceae (CTXNS-En) and analyzed the resistance mechanisms.
Results
Of 316 patients with Enterobacteriaceae bacteremia, 37 patients with bacteremia caused by CTXNS-En were matched to 74 patients who had bacteremia caused by cefotaxime-susceptible Enterobacteriaceae (CTXS-En). The most common CTXNS-En was Escherichia coli (43%), followed by Enterobacter spp. (24%) and Klebsiella spp. (22%). Independent risk factors for CTXNS-En bacteremia included previous infection or colonization of CTXNS-En, cardiac disease, the presence of intravascular catheter and prior surgery within 30\ua0days. Patients with CTXNS-En bacteremia were less likely to receive appropriate empirical therapy and to achieve a complete response at 72\ua0h than patients with CTXS-En bacteremia. Mortality was comparable between CTXNS-En and CTXS-En patients (5 vs. 3%). CTXNS-En isolates exhibited multidrug resistance but remained highly susceptible to amikacin and meropenem. CTX-M-type ESBLs accounted for 76% of the \u3b2-lactamase genes responsible for CTXNS E. coli and Klebsiella spp. isolates, followed by plasmid-mediated AmpC (12%). Chromosomal AmpC was responsible for 89% of CTXNS Enterobacter spp. isolates.
Conclusions
CTXNS-En isolates harboring ESBL and AmpC caused delays in appropriate therapy among bacteremic patients. Risk factors and antibiograms may improve the selection of appropriate therapy for CTXNS-En bacteremia. Prevalent mechanisms of resistance in CTXNS-En were ESBL and chromosomal AmpC
Monophylogenetic HIV-1C epidemic in Ethiopia is dominated by CCR5-tropic viruses\u2013an analysis of a prospective country-wide cohort
No full textAbstract
Background
CCR5 coreceptor using HIV-1 subtype C (HIV-1C) has been reported to dominate the Ethiopian epidemic. However, almost all data have been obtained from two large cities in the central and north-west regions and recent data is lacking.
Methods
Plasma were obtained from 420 treatment-na\uefve patients recruited 2009\u20132011 to a large country-wide Ethiopian cohort. The V3 region was sequenced and the co-receptor tropism was predicted by the clinical and clonal models of the geno2pheno tool at different false positive rates (fpr) and for subtype. In an intention to treat analysis the impact of baseline tropism on outcome of antiretroviral therapy was evaluated.
Results
V3 loop sequencing was successful in 352 (84%) patients. HIV-1C was found in 350 (99.4%) and HIV-1A in two (0.6%) patients. When comparing the geno2pheno fpr10% clonal and clinical models, 24.4% predictions were discordant. X4-virus was predicted in 17.0 and 19.0%, respectively, but the predictions were concordant in only 6%. At fpr5%, concordant X4-virus predictions were obtained in 3.1%. The proportion of X4-tropic virus (clonal fpr10%) increased from 5.6 to 17.3% ( p \u2009<\u20090.001) when 387 Ethiopian V3 loop sequences dated from 1984 to 2003 were compared with ours. In an intention to treat analysis, 67.9% reached treatment success at month 6 and only 50% at month 12. Only age and not tropism predicted therapy outcome and no difference was found in CD4+ cell gain between R5-tropic and X4-tropic infected patients. At viral failure, R5 to X4 switch was rare while X4 to R5 switch occurred more frequently (month 6: p \u2009=\u20090.006; month 12: p \u2009=\u20090.078).
Conclusion
The HIV-1C epidemic is monophylogenetic in all regions of Ethiopia and R5-tropic virus dominates, even in patients with advanced immunodeficiency, although the proportion of X4-tropic virus seems to have increased over the last two decades. Geno2pheno clinical and clonal prediction models show a large discrepancy at fpr10%, but not at fpr5%. Hence further studies are needed to assess the utility of genotypic tropism testing in HIV-1C. In ITT analysis only age and not tropism influenced the outcome
The impact of national prenatal screening on the time of diagnosis and outcome of pregnancies affected with common trisomies, a cohort study in the Northern Netherlands
No full textAbstract
Background
To evaluate the impact of the introduction of prenatal screening on time of detection and pregnancy outcome for trisomy 21 (T21), trisomy 18 (T18) and trisomy 13 (T13).
Methods
We performed a retrospective, population-based cohort study in the Northern Netherlands including 503 trisomy cases born between 2005 and 2012. Screening tests and invasive procedures, timing of diagnosis and pregnancy outcome were compared between the period before (2005\u20132006) and after introduction (2007\u20132012) using X
2
tests.
Results
There was an increase in proportion of women who had a prenatal screening and/or invasive test, from 62% in 2005\u20132006 to 84% in 2010\u20132012 ( p \u2009<\u20090.01), while the proportion of prenatally diagnosed cases did not change (60% overall). In women\u2009<\u2009=35\ua0years 47% of the cases were diagnosed prenatally vs 73% in women >35\ua0years ( p \u2009<\u20090.01). More T13/T18 cases were diagnosed <24\ua0weeks after introduction (62% vs 84%; p \u2009<\u20090.01). In T13/T18 intra-uterine death decreased (26% vs 15%), while terminations increased: 55% vs 72%.
Conclusion
The introduction of prenatal screening had limited impact on the time of detection and outcome of the most common trisomies. The introduction of the 20-week anomaly scan has resulted in more trisomy cases diagnosed <24\ua0weeks and a shift from fetal death to terminations
Protein kinase C inhibitor G\uf66976 but not G\uf66983 induces the reversion of E- to N-cadherin switch and metastatic phenotype in melanoma: identification of the role of protein kinase D1
No full textAbstract
Background
Melanoma is a highly metastatic type of cancer that is resistant to all standard anticancer therapies and thus has a poor prognosis. Therefore, metastatic melanoma represents a significant clinical problem and requires novel and effective targeted therapies. The protein kinase C (PKC) family comprises multiple isoforms of serine/threonine kinases that possess distinct roles in cancer development and progression. In this study, we determined whether inhibition of PKC could revert a major process required for melanoma progression and metastasis; i.e. the E- to N-cadherin switch.
Methods
The cadherin switch was analyzed in different patient-derived primary tumors and their respective metastatic melanoma cells to determine the appropriate cellular model (aggressive E-cadherin-negative/N-cadherin-positive metastasis-derived melanoma cells). Next, PKC inhibition in two selected metastatic melanoma cell lines, was performed by using either pharmacological inhibitors (G\uf66976 and G\uf66983) or stable lentiviral shRNA transduction. The expression of E-cadherin and N-cadherin was determined by western blot. The consequences of cadherin switch reversion were analyzed: cell morphology, intercellular interactions, and \u3b2-catenin subcellular localization were analyzed by immunofluorescence labeling and confocal microscopy; cyclin D1 expression was analyzed by western blot; cell metastatic potential was determined by anchorage-independent growth assay using methylcellulose as semi-solid medium and cell migration potential by wound healing and transwell assays.
Results
G\uf66976 but not G\uf66983 reversed the E- to N-cadherin switch and as a consequence induced intercellular interactions, profound morphological changes from elongated mesenchymal-like to cuboidal epithelial-like shape, \u3b2-catenin translocation from the nucleus to the plasma membrane inhibiting its oncogenic function, and reverting the metastatic potential of the aggressive melanoma cells. Comparison of the target spectrum of these inhibitors indicated that these observations were not the consequence of the inhibition of conventional PKCs (cPKCs), but allowed the identification of a novel serine/threonine kinase, i.e. protein kinase C\u3bc, also known as protein kinase D1 (PKD1), whose specific inhibition allows the reversion of the metastatic phenotype in aggressive melanoma.
Conclusion
In conclusion, our study suggests, for the first time, that while ..
Solitary plasmacytoma: population-based analysis of survival trends and effect of various treatment modalities in the USA
No full textAbstract
Background
Solitary plasmacytoma (SP) is a localized neoplastic plasma cell disorder with an annual incidence of less than 450 cases. Given the rarity of this disorder, it is difficult to conduct large-scale population studies. Consequently, very limited information on the disorder is available, making it difficult to estimate the incidence and survival rates. Furthermore, limited information is available on the efficacy of various treatment modalities in relation to primary tumor sites.
Methods
The data for this retrospective study were drawn from the Surveillance, Epidemiology and End Results (SEER) database, which comprises 18 registries; patient demographics, treatment modalities and survival rates were obtained for those diagnosed with SP from 1998 to 2007. Various prognostic factors were analyzed via Kaplan-Meier analysis and log-rank test, with 5-year relative survival rate defined as the primary outcome of interest. Cox regression analysis was employed in the multivariate analysis.
Results
The SEER search from 1998 to 2007 yielded records for 1691 SP patients. The median age at diagnosis was 63 years. The patient cohort was 62.4% male, 37.6% female, 80% Caucasian, 14.6% African American and 5.4% other races. Additionally, 57.8% had osseous plasmacytoma, and 31.9% had extraosseous involvement. Unspecified plasmacytoma was noted in 10.2% of patients. The most common treatment modalities were radiotherapy (RT) (48.8%), followed by combination surgery with RT (21.2%) and surgery alone (11.6%). Univariate analysis of prognostic factors revealed that the survival outcomes were better for younger male patients who received RT with surgery ( p \u2009<\u20090.05). Additionally, patients who received neoadjuvant RT had increased survival rates compared to those receiving adjuvant RT (86% vs 73%, p \u2009<\u20090.05). Furthermore, the analyses revealed that 5-year survival rates for patients with axial plasmacytoma were superior when RT was combined with surgery ( p \u2009<\u20090.05). In the multivariate analysis, age <60 years and treatment with either RT or surgery showed superior survival rates. Progression to multiple myeloma (MM) was noted in 551 patients. Age >60 years was associated with a lower 5-year survival in patients who progressed to MM compared to those who were diagnosed initially with MM (15.1 vs 16.6%). Finally, those who received RT and progressed to MM still had a higher chance of survival than those who were diagnosed with MM initially and treated with RT/surgery (21.8% vs 15.9%, p \u2009<\u20090.05).
Conclusions
A review of the pertinent literature indicates that we provided the most comprehensive population-based analysis of SP to date. Moreover, our ..
S2O \u2013 A software tool for integrating research data from general purpose statistic software into electronic data capture systems
No full textAbstract
Background
Data capture for clinical registries or pilot studies is often performed in spreadsheet-based applications like Microsoft Excel or IBM SPSS. Usually, data is transferred into statistic software, such as SAS, R or IBM SPSS Statistics, for analyses afterwards. Spreadsheet-based solutions suffer from several drawbacks: It is generally not possible to ensure a sufficient right and role management; it is not traced who has changed data when and why. Therefore, such systems are not able to comply with regulatory requirements for electronic data capture in clinical trials. In contrast, Electronic Data Capture (EDC) software enables a reliable, secure and auditable collection of data. In this regard, most EDC vendors support the CDISC ODM standard to define, communicate and archive clinical trial meta- and patient data. Advantages of EDC systems are support for multi-user and multicenter clinical trials as well as auditable data. Migration from spreadsheet based data collection to EDC systems is labor-intensive and time-consuming at present. Hence, the objectives of this research work are to develop a mapping model and implement a converter between the IBM SPSS and CDISC ODM standard and to evaluate this approach regarding syntactic and semantic correctness.
Results
A mapping model between IBM SPSS and CDISC ODM data structures was developed. SPSS variables and patient values can be mapped and converted into ODM. Statistical and display attributes from SPSS are not corresponding to any ODM elements; study related ODM elements are not available in SPSS. The S2O converting tool was implemented as command-line-tool using the SPSS internal Java plugin. Syntactic and semantic correctness was validated with different ODM tools and reverse transformation from ODM into SPSS format. Clinical data values were also successfully transformed into the ODM structure.
Conclusion
Transformation between the spreadsheet format IBM SPSS and the ODM standard for definition and exchange of trial data is feasible. S2O facilitates migration from Excel- or SPSS-based data collections towards reliable EDC systems. Thereby, advantages of EDC systems like reliable software architecture for secure and traceable data collection and particularly compliance with regulatory requirements are achievable
Improving the knowledge of labour and delivery nurses in India: a randomized controlled trial of mentoring and case sheets in primary care centres
No full textAbstract
Background
Birthing in health facilities in India has increased over the last few years, yet maternal and neonatal mortality rates remain high. Clinical mentoring with case sheets or checklists for nurses is viewed as essential for on-going knowledge transfer, particularly where basic training is inadequate. This paper summarizes a study of the effect of such a programme on staff knowledge and skills in a randomized trial of 295 nurses working in 108 Primary Health Centres (PHCs) in Karnataka, India.
Methods
Stratifying by district, half of the PHCs were randomly assigned to be intervention sites and provided with regular mentoring visits where case sheet/checklists were a central job and teaching aid, and half to be control sites, where no support was provided except provision of case sheets. Nurses\u2019 knowledge and skills around normal labour, labour complications and neonate issues were tested before the intervention began and again one year later. Univariate and multivariate analyses were conducted to examine the effect of mentoring and case sheets.
Results
Overall, on none of the 3 measures, did case sheet use without mentoring add anything to the basic nursing training when controlling for other factors. Only individuals who used both case-sheets and received mentoring scored significantly higher on the normal labour and neonate indices, scoring almost twice as high as those who only used case-sheets. This group was also associated with significantly higher scores on the complications of labour index, with their scores 2.3 times higher on average than the case sheet only control group. Individuals from facilities with 21 or more deliveries in a month tended to fare worse on all 3 indices. There were no differences in outcomes according to district or years of experience.
Conclusions
This study demonstrates that provision of case sheets or checklists alone is insufficient to improve knowledge and practices. However, on-site mentoring in combination with case sheets can have a demonstrable effect on improving nurse knowledge and skills around essential obstetric and neonatal care in remote rural areas of India. We recommend scaling up of this mentoring model in order to improve staff knowledge and skills and reduce maternal and neonatal mortality in India.
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