Trend In Favour Research Articles

A phase III, multicentre, randomised, investigator-masked, cross-over, comparative, non-inferiority trial evaluating the efficacy and tolerability of generic preservative-free Latanoprost (Polpharma S.A.) compared to Xalatan® (Pfizer) in patients with ocular hypertension or primary open-angle glaucoma

BackgroundPrimary open-angle glaucoma (POAG), often associated with increased intraocular pressure (IOP), can lead to permanent damage of the optic nerve, concomitant visual field loss, and blindness. Latanoprost, a prostaglandin F2α analogue, reduces IOP and is used to treat glaucoma. In this clinical trial, we evaluated the efficacy of Latanoprost Polpharma, a generic preservative-free latanoprost 0.05 mg/ml eye drops solution, in lowering IOP when compared to the originator Xalatan® (latanoprost 0.005% ophthalmic solution, Pfizer).MethodsThis was a Phase III, multicentre, randomized, investigator-masked, cross-over, comparative, non-inferiority trial carried out in 5 sites in Hungary and Russia. The primary endpoint was to evaluate the non-inferiority of the test product when compared to the reference product with respect to the differences in the mean diurnal IOP on Day 1 (baseline) and Day 29. The secondary endpoints included efficacy, ocular tolerance, safety, and usability. We recruited adult patients (18–75 years) with open-angle glaucoma or ocular hypertension.ResultsForty-nine patients were randomised and received at least one dose of the test or reference product. A virtually identical reduction of the mean diurnal IOP of 7.04 ± 2.14 mmHg or 7.17 ± 2.11 mmHg was found after treatment with test or reference product, respectively (N = 44). In the intention to treat analysis, the reduction was 7.29 ± 2.53 mmHg (95% CI: 6.55–8.04) or 7.43 ± 2.78 mm Hg (95%CI: 6.61–8.24) after treatment with test or reference product, respectively (N = 47). There were no serious adverse events.ConclusionsLatanoprost Polpharma was shown to be non-inferior to Xalatan®. Both investigational products were equally well tolerated and safe. The data show a trend in favour of the test product with regards to the severity of hyperaemia and to the velocity of remission of ocular discomfort. Latanoprost Polpharma, being preservative-free, also avoids the cytotoxicity of benzalkonium chloride, the side effects of which may affect patient compliance and lower the quality of life.Trial registrationThe study had the ethical and regulatory approval from the National Institute of Pharmacy and Nutrition (OGYEI, OGYEI/41,779- 11/2018) and the Ethics Committee for Clinical Pharmacology (KFEB) of Hungary and from the Ministry of Healthcare of the Russian Federation (MOH of Russia) prior to the beginning of the study (642/25.12.2018) (clinical trial identification number: 848,300,144/0103/1 - POP03; IND number/EudraCT number: 2018-001727-39).

The impact of ambient temperature and powertrains of SUVs on the environment in Slovakia during the use phase

This study compares different powertrains of sport utility vehicles (SUVs) with respect to ambient temperature and energy mix in Slovakia using the well-to-wheel (WTW) Life Cycle Assessment (LCA) method. Battery electric vehicles (BEV), plug-in hybrid electric vehicles (PHEV), and petrol and diesel vehicles were assessed and compared. The WTW study was conducted in SimaPro software assessing electricity/petrol/diesel production, transport, and use (energy conversion in the vehicle), with impact categories being climate change, particulates, NOx emissions, ionizing radiation, and fossil resource scarcity depending on the season (summer and winter). The results indicate that for Slovak conditions, BEV generally had the lowest environmental impact in both seasons studied. The only exceptions were ionizing radiation, which is clearly caused by the high share of nuclear power in the Slovak energy mix, and NOx emissions, which are caused by the combustion of biomass for electricity generation. The other impact categories were dominated by vehicles with an internal combustion engine. The results of emissions from fuel production are also given for each impact category. The transportation of fuel did not exceed the value of 1% for any impact category or for any powertrain. The conclusions of the study support the global trend in favour of vehicle electrification as an important way to reduce the negative environmental impacts of internal combustion engine vehicles in Slovakia.

Harmonization of Homologous Recombination Deficiency testing in Ovarian Cancer: results from the MITO16A/MaNGO-OV2 trial

BackgroundHomologous Recombination Deficiency (HRD) status predicts response to treatment with poly(ADP-ribose) polymerase inhibitors in Ovarian Cancer (OC) patients. The Myriad myChoiceCDx Assay is approved by Food and Drug Agency for the HRD assessment.Here we compared the HRD status obtained by three commercial panels with the results from Myriad reference test. MethodsThe HRD analysis was performed on DNA from formalin-fixed and paraffin-embedded tumor samples of 100 untreated OC patients for which Myriad assay results were available, using TruSight Oncology 500 HRD assay (Illumina), Oncomine Comprehensive Assay Plus (Thermo Fisher Scientific) and SOPHiA DDM HRD solution panel (SOPHiA Genetics). ResultsA good overall concordance with the reference method was demonstrated at three different levels: BRCA mutational status (from 94.4% to 97.7%), the genomic instability value (from 88.2% to 95.3%) and for the HRD status (from 90.4% to 97.6%). Moreover, a trend in favour of HRD positive patients for response rate, progression-free survival and overall survival similar to Myriad was observed for all three tests. DiscussionOur data suggest the feasibility of commercial testing for assessing HRD status, with a good concordance with the reference method and association with clinical outcome.

A single-center analysis of lung transplantation outcomes in recipients aged 70 or older.

As life expectancies continue to increase, a greater proportion of older patients will require lung transplants (LTs). However, there are no well-defined age cutoffs for which LT can be performed safely. At our high-volume LT center, we explored outcomes for LT recipients ≥70 years old versus <70 years old. This is a retrospective single-center study of survival after LT among older recipients. Data were stratified by recipient age (≥70 years old versus <70 years old) and procedure type (single versus double lung transplant). Demographics and clinical variables were compared using Chi-square test and two sample t-test. Survival was assessed by Kaplan-Meier curves and compared by log-rank test with propensity score matching. 988 LTs were performed at our center over 10 years, including 289 LTs in patients ≥70 years old and 699 LTs in patients <70 years old. The recipient groups differed significantly by race (p < 0.0001), sex (p = 0.003), and disease etiology (p < 0.0001). Older patients were less likely to receive a double lung transplant compared to younger patients (p < 0.0001) and had lower rates of intraoperative cardiopulmonary bypass (p = 0.019) and shorter length of stay (p = 0.001). Both groups had overall high 1-year survival (85.8% versus 89.1%, respectively). Survival did not differ between groups after propensity matching (p = 0.15). Our data showed high survival for older and younger LT recipients. There were no statistically significant differences observed in survival between the groups after propensity matching, however, a trend in favour of younger patients was observed.

Optimal Percutaneous Treatment Approach to Unprotected Ostial Left Anterior Descending Artery Disease: A Meta-Analysis and Systematic Review

The optimal management strategy for significant unprotected ostial left anterior descending artery (LAD) disease remains undefined. Merits of the two most common percutaneous approaches are considered in this quantitative synthesis. A meta-analysis was performed to compare ostial stenting (OS) and crossover stenting (CS) in the treatment of unprotected ostial LAD stenosis. The primary outcome is the disparity in target lesion revascularisation (TLR). The Mantel-Haenszel method was employed with random effect model, chosen a priori to account for heterogeneity among the included studies. Seven studies comprising 1,181 patients were included in the analyses. Of these, 482 (40.8%) patients underwent CS. Overall, there was a statistically significant trend in favour of CS (odds ratio 0.51, 95% confidence interval 0.30-0.86, p=0.01) with respect to the rate of TLR at follow-up. This remained true when TLR involving the left circumflex artery (LCx) was considered, even when there was a greater need for unintended intervention to the LCx during the index procedure (odds ratio 6.68, 95% confidence interval: 1.69-26.49, p=0.007). Final kissing balloon inflation may reduce the need for acute LCx intervention. Imaging guidance appeared to improve clinical outcomes irrespective of approach chosen. In the percutaneous management of unprotected ostial LAD disease, CS into the left main coronary artery (LMCA) appeared to reduce future TLR. Integration of intracoronary imaging was pivotal to procedural success. The higher incidence of unintended LCx intervention in the CS arm may be mitigated by routine final kissing balloon inflation, although the long-term implication of this remains unclear. In the absence of randomised trials, clinicians' discretion remains critical.

Results of Treatment Approaches in Myeloid Neoplasms According to TP53 Allelic Status (Multi-hit vs Monoallelic), a Real World Analysis

INTRODUCTION: Myeloid neoplasms with mutated TP53 (MN-TP53) represent a unique category in the 2022 International Consensus Classification (ICC) of Myeloid Neoplasms. This entity has an exceedingly poor prognosis with the available standard therapies, and clinical trials with novel drugs show limited benefits. Recently, it has been shown that TP53 multi-hit alterations may confer even worse prognosis, compared to the monoallelic status, in myelodysplastic syndromes. However, multi-hit status has not been analysed in all MN-TP53 subtypes. Elucidating this difference and its association with responses to treatment becomes essential from a clinical perspective. Therefore, our aim was to analyse whether the allelic status of TP53 in our cohort has an impact on therapeutic outcomes. METHODS: We retrospectively collected data from four institutions, between September 2011 and February 2023. Inclusion criteria were: 1) patients diagnosed with MN-TP53; 2) available information to categorize them into multi-hit or monoallelic group according to ICC 2022; and 3) eligible for treatment. The primary endpoint was to describe the outcomes, in terms of overall response rate (ORR) and overall survival (OS), of MN-TP53 according to TP53 status (multi-hit vs monoallelic) and treatment. RESULTS: A total of 105 patients diagnosed with MN-TP53 were identified. Eighty-seven were eligible for treatment and included in the analysis. Sixty-nine patients were identified as multi-hit, and 18 as monoallelic. Table 1 summarises patient's demographics and clinical characteristics. The median OS of the entire cohort was 7 months (range 0-141); while it was 6 months (0-141) for the multi-hit group and 8.5 months (0-44) for the monoallelic group; (p=0.23) (Figure 1). In both groups, most of the patients received non-intensive treatment as first line (1L) (40 patients [58%] in multi-hit group vs 14 [78%] in monoallelic), followed by intensive treatment (17 patients [25%] in multi-hit group vs 2 patients [11%] in monoallelic) and hypomethylating agent plus venetoclax (12 [17%] in multi-hit vs 2 [11%] in monoallelic). The overall response rate (ORR) was 43% for patients with multi-hit TP53 status and 67% for those with monoallelic status (p=0.38) . Correspondingly, 29% and 11% were not evaluated after 1L due to death or poor general condition. Progression after 1L of treatment was seen in 55% of patients with multi-hit TP53 status and in 43% of cases with monoallelic status (p=0.11). The subgroup analysis of the multi-hit cohort revealed no significant difference in response between intensive and non-intensive treatment (p=0.09). Nevertheless, there is a trend in favour of non-intensive treatment, including hypomethylating agents plus venetoclax (p=0.18). Allogeneic hematopoietic stem cell transplant was performed in 12 patients (17%) in the multi-hit group and in 2 patients (11%) in the monoallelic group. CONCLUSION: In this study, no difference in terms of OS was evidenced when comparing patients according to the type of TP53 status (multi-hit vs monoallelic). However, a trend to higher ORR and lower rate of progression was observed in the monoallelic group after 1L, which should be confirmed in further analysis. Concerning the TP53 multi-hit subgroup, we have not found any benefit on using intensive treatment in terms of ORR compared to non-intensive approach.

ZAP (Zero-Fluoro - ALARA Procedures) EP: A UK Tertiary Centre Safety and Efficiency Evaluation

Abstract Background 3D mapping facilitates zero-fluoro (ZF) and as-low-as-reasonably-achievable (ALARA) procedures which allows for minimizing exposure to harmful radiation and maximizing lead-free time in the EP lab. Objective Safety, efficiency, radiation time and dose exposure was assessed in a consecutive unselected supraventricular tachycardias (SVT) cohort. Methods Retrospective and prospective analysis comparing procedure time, complications and radiation dose and time between ZAP (ZF, ALARA) and non-ALARA cases was performed between January 2021 to August 2022. Radiation exposure was expressed as dose-area product (DAP). We included AVNRTs, accessory pathway (AP) ablations and EP studies. Results A total of consecutive 279 patients were included, of which 116 were ZAP (40 were ZF cases) and 163 non-ALARA. Median age was 52.5 for ZAP and 47.5 for non-ALARA patients. In specific, 131 AVNRT ablations (50 ZAP, 81 non-ALARA), 45 AP ablations (23 ZAP, 22 non-ALARA) and 103 EP studies (43 ZAP, 60 non-ALARA) were included. A comparative analysis of DAP between ZAP and non-ALARA cohort in both AVNRT ablations and EP studies demonstrated statistical significance with corresponding values of 3.15±4.4 vs. 6.04±7.5 Gy.cm2 (p=0.001) and 1.94±1.8 vs. 3.78±3.9 Gy.cm2 (p=0.024) (Figure 1). Significantly shorter fluoroscopy duration was also noted 6.07±6 vs. 12.44±7.5 min (p&amp;lt;0.001; AVNRT) and 4.23±4.2 vs. 6.16±4.1 min (p=0.01; EPS). For AP ablations there was a trend in favour of ZAP but not significant difference (DAP: 8.52±7.7 vs. 10.65±9 Gy.cm2, p=0.43; fluoroscopy duration: 12.12±8.7 vs. 15.9±8.3 min, p=0.33) (Figure 1). This might be attributed to the relatively smaller number of AP cases. Complication rates and procedure time were not different between ZAP and non-ALARA cases. Conclusion Lower fluoroscopy time with reduced radiation exposure is seen in ZAP cases compared to non-ALARA procedures for AVNRT ablations and EP studies. Future ICE navigation in complex cases may further reduce fluoroscopy need.Figure 1

Small bite versus large bite stitching technique for midline laparotomy wound closure: A systematic review and meta-analysis.

Mass closure with a continuous suture using large bite stitching technique has been widely accepted for midline laparotomy wound closures. However, emerging evidence suggests the use of small bite technique to reduce rates of incisional ventral hernia, surgical site infection (SSI) and burst abdomen. This meta-analysis aims to compare small versus large bite stitching techniques to assess complication rates in midline laparotomy wound closures. A comprehensive multi-database search (OVID EBM Reviews, OVID Medline, EMBASE, Scopus) was conducted from database inception to 11th October 2021 according to PRISMA guidelines. We included studies comparing post-operative complication rates of small bite versus large bite stitching techniques for midline laparotomy wound closure. Extracted data was pooled for meta-analysis evaluating rates of incisional ventral hernia, SSI and burst abdomen. We included five randomized controlled trials (RCT) in the meta-analysis and three prospective cohort studies for qualitative analysis. A total of 1977 participants composed of 961 small bite and 1016 large bite technique patients were included from the five RCTs. There was a significant reduction in the rates of incisional ventral hernia and SSI with the small bite stitch technique with odds ratios (OR) of 0.39 (95% CI [0.21-0.71]) and 0.68 (95% CI [0.51-0.91]) respectively, and a trend in favour of reduced incidence of burst abdomen with OR of 0.60 (95% CI [0.15-2.48]). Small bite stitch technique in midline laparotomy wound closure may be superior over conventional mass closure using the large bite stitch technique, with statistically significant lower rates of incisional ventral hernia and SSI.

Interventions to increase help-seeking for mental health care in low- and middle-income countries: A systematic review.

Mental health problems are a significant and growing cause of morbidity worldwide. Despite the availability of evidence-based interventions, most people experiencing mental health problems remain untreated. This treatment gap is particularly large in low- and middle-income countries (LMIC) and is due to both supply-side and demand-side barriers. The aim of this systematic review is to identify and synthesise the evidence on interventions to improve help-seeking for mental health problems in LMICs. The protocol was registered a priori (Registration number: CRD42021255635). We searched eight databases using terms based on three concepts: 'mental health/illness' AND 'help-seeking' AND 'LMICs'; and included all age groups and mental health problems. Forty-two papers were eligible and included in this review. Intervention components were grouped into three categories following the steps in the help-seeking process: (1) raising mental health awareness among the general population (e.g., distribution of printed or audio-visual materials), (2) identification of individuals experiencing mental health problems (e.g., community-level screening or detection), and (3) promoting help-seeking among people in need of mental health care (e.g., sending reminders). The majority of interventions (80%) included components in a combination of the aforementioned categories. Most studies report positive outcomes, yet results on the effectiveness is mixed, with a clear trend in favour of interventions with components from more than one category. Ten out of 42 studies (24%) yielded a statistically significant effect of the intervention on help-seeking; and all targeted a combination of the aforementioned categories (i.e., raising awareness, identification and help-seeking promotion). Only six studies (14%) focused on children and adolescents. Due to the limited number of robust studies done in LMICs and the heterogeneity of study designs, outcomes and components used, no definite conclusions can be drawn with regards to the effects of individual strategies or content of the interventions.

Association between catheter ablation of atrial fibrillation and mortality or stroke

ObjectiveCatheter ablation of atrial fibrillation effectively reduces symptomatic burden. However, its long-term effect on mortality and stroke is unclear. We investigated if patients with atrial fibrillation who undergo catheter ablation...

Rethinking the dominant modernist planning narrative: Investigating pedestrianisation in Europe, 1960s–1970s

This article intends to discuss the 1970s as a breaking point in both urban and transport history. The dominant narrative of urban planning sets two periods after 1945 in opposition: the post-war modernist and car-oriented city on the one hand, and on the other hand the (more) sustainable and pedestrian-oriented city that supposedly started to arise in the 1980s. This time frame reveals the importance given to the narrative of the avant-garde, the great intellectual figures, and the national policies in urban history. The paper decentres the investigation into the history of pedestrianisation in Europe and highlights how “anonymous” city engineers and local urban planners produced alternative pathways to modernisation as early as the 1950s. The European municipal movement for pedestrianisation appears as the missing link between the radical functionalist approach of post-war modern planning, and the present trend in favour of public space and walkability.

Effect evaluation of a vocational rehabilitation program for young adults with chronic physical conditions at risk for unemployment: A controlled clinical trial

Background The work participation of young adults with chronic physical conditions lag behind compared to healthy age-mates. ‘At Work’ is a vocational rehabilitation intervention provided by occupational therapists, that supports them for entering the competitive labour market after graduating post-secondary education. Aim To evaluate the effects of ‘At Work’ on self-efficacy, work-ability and employment status as compared to usual care. Materials and methods In total, 88 young adults were included in a multicentre controlled trial; 49 entered ‘At Work’, 39 received usual care. GEE-analyses were applied. Results Scores on all outcome measures substantially improved over time in the intervention group, but no significant effects were found as compared to the control group. The effect on general self-efficacy showed a positive trend in favour of the intervention group. Conclusions and significance Unlike previous study results pointing to positive outcomes of At Work’, the current study did not support the effectiveness of this program on work-related self-efficacy, work-ability and paid employment, as compared to usual care. Yet, we did find an indication for positive intervention effect on general self-efficacy, which is known to be an important capacity to achieve social participation.

War Against the Tamil Tigers: How Did Sri Lanka Win?

The final Eelam War that was fought during 2006 to 2009, the Sri Lankan State for the first time in the history witnessed the crystallisation of the trends in favour of it against the Tamil tigers or LTTE (Liberation Tigers of Tamil Eelam, also known as Tamil Tigers). With gradual liberation of north and eastern territory first that where under the clutches of LTTE for long and later dislodging Tigers’ command control, in three years’ timeline the Sri Lankan Armed Forces (SLAF) annihilated the Tigers entirely in May 2009. The victory of the SLAF brought three decade long armed conflict to an end that caused the death of over 100,000 and displacement of millions. While noticing the progress of the security forces and the way things unfolded, the pertinent questions that arise are: How did the Mahinda Rajapaksa government won the war? Was there a game plan with the government since the beginning of Eelam War IV? If so, what was that strategy? If not, how did they go ahead? Although there was no explicit publicly pronounced strategy by the Sri Lankan government for dislodging the Tigers but it appears their evolved game plan was broadly centered around ten points. They were: one, winning local constituency support; two, silence critics; three, build strong military, four, entice Karuna, five, shed conventional military methods; six, shrivel Tigers territories; seven, keep in loop but deter India; eight, diplomatic neutralise West; nine, curb Tigers’s international network; and finally, liquidate Tigers’ top leadership. The paper analyzes these aspects in details in this paper. Keywords: Sri Lanka, LTTE, Tamil Tigers, Eelam, Rajapaksa

Environmental and Economic Analyses of TIG, MIG, MAG and SMAW Welding Processes

Metal welding processes, and electric arc welding in particular, constitute a key link in a production chain comprising a large number of companies. This fact, in addition to a growing trend in favour of more in-depth environmental analysis and control of industry, and the need to continue affording due consideration to the economic aspect set the stage for this study. Herein, an environmental and economic analysis is conducted of four types of electric arc welding: TIG welding with and without filler, MIG, MAG, and SMAW welding. Different types of materials are examined such as carbon steel, stainless steel, and aluminium, thus the results generate relevant comparative information on the economic and environmental impacts of choosing one type of welding over another. To this end, an experimental study was carried out: 480 test specimens were welded using different welding technologies. A series of data was collected during the welding process to inform an environmental analysis based on a Life Cycle Analysis and an economic study. The most salient results include that the TIG welding process with filler generated the greatest environmental impact due to its higher consumption of shielding gas. On the other hand, the SMAW process demonstrated the best environmental performance as categories such as Global Warming Potential; CO2 emissions dropped by 93.29%. A key factor is the final indicator of human health, where, once again, TIG technology had the worst results, in contrast to SMAW technology, wherein impact decreased by 93.08%. On the other hand, the use of TIG technology implies a higher economic cost due to a 61.36% increase in welding time compared to the average welding technology.

Exploring the effect of case management in homelessness per components: A systematic review of effectiveness and implementation, with meta-analysis and thematic synthesis.

Exploring the effect of case management in homelessness per components: A systematic review of effectiveness and implementation, with meta-analysis and thematic synthesis.

Leflunomide treatment for patients hospitalised with COVID-19: DEFEAT-COVID randomised controlled trial

ObjectiveTo evaluate the clinical efficacy and safety of leflunomide (L) added to the standard-of-care (SOC) treatment in COVID-19 patients hospitalised with moderate/critical clinical symptoms.DesignProspective, open-label, multicentre, stratified, randomised clinical trial.SettingFive...

Multiwavelength analysis of Galactic Supernova Remnants

The origin of Galactic Cosmic Rays (CRs) and the possibility of Supernova Remnants (SNRs) being potential CR accelerators is still an open debate. The charged CRs can be detected indirectly by the γ-ray observatories through the π 0 production and consequent decay, leading to the generation of high-energy γ-rays. The goal of the study is to identify qualitative and quantitative trends in favour of hadronic scenario and search for SNRs which could be potential accelerators up to PeV energies (PeVatrons).We have performed a Multiwavelength (MWL) study using different radiative models to evaluate the hadronic contribution. The spectral energy distributions (SEDs) of selected SNRs are modeled using the Naima [1] package. Two different radiative scenarios are considered, pure leptonic and lepto-hadronic scenarios and different methods are used to evaluate their importance.This study shows that the lepto-hadronic scenario is favored for most SNRs. Two particular indicators of hadronic contribution come from the data around the π 0 production threshold and the data above a few TeV. The hard rise at the π 0 production threshold cannot be explained by leptonic processes. More data in this region would be valuable for these studies. For some SNRs, an important hadronic contribution is observed up to a few TeV, thus making them promising PeVatron candidates. In this high-energy region where the leptonic processes are expected to be suppressed, more data is required to help distinguish between the leptonic and hadronic origin of γ-ray emission. In the future, we intend to use the obtained model parameters to simulate data for CTA and assess its capability to identify PeVatrons.

Quality of life after radical treatment for muscle invasive bladder cancer: A systematic review and meta-analysis.

489 Background: Radical cystectomy (RC) with or without perioperative chemotherapy is considered the standard treatment option for Muscle invasive bladder cancer (MIBC), despite poor oncological outcomes. However, RC is often burdened by significant impact on quality of life (QoL); Continence preserving methods (e.g continent cutaneous urinary diversion and orthotopic neobladder-ONB), have been proposed as alternatives to improve the postoperative QoL, but real benefit of these approaches is questioned. Bladder sparing approach, such as trimodal therapy (TMT) emerged as an alternative to surgery. Aiming to assess the impact of these treatment options from the patients’ perspective, we undertook a systematic review and meta-analysis of literature, focusing on studies specifically reporting QoL data about each of the above mentioned approaches. Main purpose of this review is to compare available treatment options from the QoL point of view and highlight the potential advantage of a bladder sparing approach if compared to different postoperative urinary diversion methods. Methods: A systematic review was carried out including all prospective and retrospective studies enrolling patients treated with radical intent for non-metastatic MIBC from 1999 to 2021 (either RC or TMT). All studies included specifically reported QoL for one of the main treatment approaches explored (RC followed by ileal conduit urinary diversion-ICUD, ONB or TMT). Review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement Results: Fifty studies were included in the final analysis, assessing QoL after RC followed by ICUD or ONB in 6 and 15 cases, respectively. Six studies addressed QoL after TMT. ICUD vs ONB and TMT vs ICUD/ONB comparisons were carried out in 21 and 1 studies, respectively. Pooled analysis for EORTC QLQ- C30 and BLM-30 questionnaires showed that ONB yielded a significant advantage if compared to ICUD only for Physical Functioning (pooled mean standardized difference -0.73 SD, p-value 0.019, I 2 =93%) and for Emotional Functioning (pooled mean standardized difference -0.16 SD, p-value 0.029, I 2 =0%). A trend in favour of higher mean reported values after TMT for Global Health Score, Physical Functioning and Role Functioning was found, if compared to both RC approaches. Conclusions: Significant benefit for ONB if compared to ICUD was detected only for specific subdomains of QoL questionnaires. No direct comparison with TMT is available, but data suggest advantage of this approach if compared to both reconstructive scenarios. These data should be used in clinical practice to help well informed patients decision about local treatment choice.

Microbiota signatures and mucosal healing in the use of enteral nutrition therapy v. corticosteroids for the treatment of children with Crohn's disease: a systematic review and meta-analysis.

Corticosteroids (CS) and exclusive and partial enteral nutrition (EEN and PEN) are effective therapies in paediatric Crohn's disease (CD). This systematic review of randomised controlled trials (RCT) and cohort studies analyses the impact of EEN/PEN v. CS on intestinal microbiota, mucosal healing as well as other clinically important outcomes, including clinical remission, relapse, adherence, adverse events and health-related quality of life (HRQL) in paediatric CD. Three RCT (n 76) and sixteen cohort studies (n 1104) compared EEN v. CS. With limited available data (one RCT), the effect on intestinal microbiome indicated a trend towards EEN regarding Shannon diversity. Based on two RCT, EEN achieved higher mucosal healing than CS (risk ratio (RR) 2·36, 95 % CI (1·22, 4·57), low certainty). Compared with CS, patients on EEN were less likely to experience adverse events based on two RCT (RR 0·32, 95 % CI (0·13, 0·80), low certainty). For HRQL, there was a trend in favour of CS based on data from two published abstracts of cohort studies. Based on thirteen cohort studies, EEN achieved higher clinical remission than CS (RR 1·18, 95 % CI (1·02, 1·38), very low certainty). Studies also reported no important differences in relapse and adherence. Compared with CS, EEN may improve mucosal healing with fewer adverse events based on RCT data. While limited data indicate the need for further trials, this is the first systematic review to comprehensively summarise the data on intestinal microbiome, mucosal healing and HRQOL when comparing enteral nutrition and CS in paediatric CD.

Perceptions regarding open science appraised by editors of scholarly publications published in Spain

AbstractPillars of open science are often included within the editorial policies of scholarly journals, including policies on open access publication, availability of underlying research data, preprints and open peer review. The aim of this paper is to examine and analyse perceptions and editorial practices related to open access, preprints, open research data and open peer review, from the perspective of editors of scientific journals published in Spain, to gain an insight into editorial policies related to open science. Results and data were obtained by a combined method of online interviews and an online questionnaire. The online survey was sent to editors from journals indexed in the Dulcinea directory, which at the time of the study included 1875 academic journals. A total of 420 responses (22.4%) were obtained. The results indicated that 92% of the journals were open access journals, 2% of the journals conducted open peer review, 15% of the journals had instructions to allow archiving preprints, and out of 375 responses, only 59 journals (16%) reported having a policy on underlying research data. Based on these results, there is a trend in favour of open access, but the perceived barriers to open peer review outweighed the advantages. There is also some reluctance to allow preprints to be made available. This concern might be because editors want authors and readers to read and cite the contents published in their journals, rather than their preprint versions.