International Prospective Registry Research Articles

Effectiveness, safety and implementation results of the strategies aimed at the safe prescription of medications in university hospitals in adult patients. Systematic review

Introduction: A broad range of practices aimed at improving the effectives and safety of this process have been documented over the past few years.
 Objective: to establish the effectiveness, safety and results of the implementation of these strategies in adult patients in university hospitals.
 Methodology: A review of systematic reviews was conducted, in addition to a database search in the Cochrane Library of Systematic Reviews, Embase, Epistemonikos, LILACS and gray literature. Any strategy aimed at reducing prescription-associated risks was included as intervention. This review followed the protocol registered in the International Prospective Registry of Systematic Reviews (PROSPERO): CRD42020165143.
 Results: 7,637 studies were identified, upon deleting duplicate references. After excluding records based on titles and abstracts, 111 full texts were assessed for eligibility. Fifteen studies were included in the review. Several interventions grouped into 5 strategies addressed to the prescription process were identified; the use of computerized medical order entry systems (CPOE), whether integrated or not with computerized decision support systems (CDSS), was the most effective approach.
 Conclusions: The beneficial effects of the interventions intended to the prescription process in terms of efficacy were identified; however, safety and implementation results were not thoroughly assessed. The heterogeneity of the studies and the low quality of the reviews, preclude a meta-analysis.

Clinical Outcomes of Patients with Anaplastic Large Cell Lymphoma, Anaplastic Lymphoma Kinase-Negative (ALCL, ALK-): Analysis of 203 Patients Prospectively Registered in the International T-Cell Project

Introduction: Anaplastic Large Cell Lymphoma, Anaplastic Lymphoma Kinase-negative (ALCL, ALK-) is a clinically aggressive lymphoid neoplasm with characteristic histologic and genetic features. The analysis from a retrospective International T-cell Lymphoma Project reported intermediate outcomes for ALCL, ALK- patients with 5-year event-free survival (EFS) and overall survival (OS) rates of 39% and 46%, respectively (Savage et al. Blood 2008 ). In this analysis, we sought to study clinical features and outcomes of 203 patients prospectively enrolled into the international T-cell lymphoma registry, the T-cell Project (TCP).Methods: The T-Cell Project prospectively registered consecutive patients with newly diagnosed peripheral T-cell lymphomas (PTCL) from 74 centres, in 14 countries, across 4 continents from Sep 2006 -Dec 2015. Demographic, clinical, and pathologic characteristics at the time of diagnosis, as well as treatment details and survival outcomes were collected. A key aim of this global collaborative project was to more precisely define clinical characteristics and outcome of patients with various subtypes of PTCL.Results: From a total of 1,429 evaluable PTCL cases, 203 (14.8%) were confirmed as ALCL, ALK- following international histopathologic panel review. As anticipated, these cases, as a proportion of all PTCL cases, varied across geographical regions (Asia 4.6%, South America 29.3%, U.S.A 12.7%, and Europe 14.7%). The median age at diagnosis was 55 (range, 18-89) years with a slight male predominance (63%). Stage III/IV disease was identified in 61% of patients, whilst bulky disease >5cm (25%) and BM involvement (9%) were uncommon. 65% of patients presented with low IPI score. Data on therapy was available in 155 (76%) patients, of whom 142 (92%) received chemotherapy (CHT) as part of first-line treatment. 23 (14.8%) patients additionally received concurrent or sequential radiotherapy (RT), whilst 12 patients (7.7%) underwent high-dose therapy as consolidation. Eleven (7%) patients received palliative care only. Of 142 patients treated with chemotherapy, 137 (96.5%) received anthracycline-containing regimens. There was no significant variation in anthracycline use by global geographic regions. The investigator-assessed overall response rate was 72%, with 84 (58%) patients achieving complete remission. With a median follow-up of 41 (range, 31-51) months, the median PFS (n=114) was 35 (95% CI 16-53) months, and 3-year and 5-year PFS rates were 48% and 40%, respectively. The median OS (n=203) was 52 (95% CI, 29-76) months, and 3-year and 5-year OS rates were 57% and 47%, respectively (Fig.1). At the time of data cut off, 84 (41%) patients died. Cause of death was most commonly attributable to lymphoma (72%) and infection (8%).Conclusions: This is the largest-to-date prospective international registry study of ALCL, ALK- patients describing epidemiology, clinical features, treatment approaches, and outcomes. With a mature follow-up, we report comparable results to previously reported from the retrospective International T-Cell Lymphoma Project. The long term survival rates after modern treatment approaches are disappointing with more than half of the patients not surviving past 5 years from diagnosis. This study underscores the urgent need for improved frontline therapies for ALCL, ALK- patients, and provides a robust platform for designing and interpreting future clinical trials. Recent results of incorporating novel CD30-targeting agent into initial therapy protocols are encouraging, and confirmatory randomized trial analysis is underway.Figure 1. Kaplan Meier estimates of overall (A) and progression-free (B) survival among ALCL, ALK- patients enrolled into the prospective TCP registry. [Display omitted] DisclosuresShustov:Celgene: Other: Publication assistance; Spectrum Pharmaceuticals: Consultancy, Research Funding. Horwitz:ADCT Therapeutics: Research Funding; Mundipharma: Consultancy; Kyowa-Hakka-Kirin: Consultancy, Research Funding; HUYA: Consultancy; Infinity/Verastem: Consultancy, Research Funding; Millenium/Takeda: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Forty-Seven: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Aileron Therapeutics: Research Funding; BMS: Consultancy. Radford:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Consultancy; Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Research Funding; Novartis: Speakers Bureau; Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Speakers Bureau; Seattle Genetics: Speakers Bureau; GSK: Equity Ownership; AstraZeneca: Equity Ownership. Chiappella:Nanostring: Speakers Bureau; Amgen: Speakers Bureau; Pfizer: Speakers Bureau; Celgene: Speakers Bureau; Roche: Speakers Bureau; Teva: Speakers Bureau; Janssen: Speakers Bureau. Federico:takeda: Honoraria, Research Funding.

Clinical Outcomes of Patients with Anaplastic Large Cell Lymphoma, Anaplastic Lymphoma Kinase-Positive (ALCL, ALK+): Data from 119 Patients Prospectively Registered in the International T-Cell Project

Introduction: Anaplastic Large Cell Lymphoma, Anaplastic Lymphoma Kinase-positive (ALCL, ALK+) is a clinically aggressive lymphoid neoplasm with reported outcomes that compare favorably to other peripheral T-cell lymphoma (PTCL) subtypes. Pathogenesis of ALCL, ALK+ has been linked to perpetual activation of the ALK-kinase and numerous downstream signaling molecular events, that result from the recurrent genetic alteration, t(2;5)(p23;q35), in the majority of cases. In this study, we sought to analyze demographic characteristics, presenting clinical features, and treatment outcomes of 116 patients with ALK+ ALCL prospectively enrolled into the international T-cell lymphoma registry, the T-cell Project (TCP).Methods: The T-Cell Project prospectively registered consecutive patients with newly diagnosed PTCLs from 74 centers, in 14 countries, across 4 continents from Sep 2006 -Dec 2015. A key aim of this global collaborative project was to more precisely define clinical characteristics and outcomes of patients with various PTCL subtypes.Results: From a total of 1,429 evaluable PTCL cases, 119 (8.3%) were confirmed as ALCL, ALK+ following international histopathologic panel review. As anticipated, these cases, as a proportion of all PTCL cases, varied across geographical regions (Asia 4.4%, South America 8.0%, U.S.A 9.3%, and Europe 9.1%). The median age at diagnosis was 34.5 (range, 18-84) years with a slight male predominance (58%). Stage III/IV disease was found in 68.7% patients, whilst bulky disease >10cm (8.4%) and bone marrow involvement (14.5%) were uncommon, and 78.6% of patients had low risk IPI score (0-1). Data on therapy was available in 81 (68%) patients, of whom 80 (99%) received chemotherapy (CHT) as part of first-line treatment. Ten patients (12.3%) additionally received concurrent or sequential radiotherapy (RT), whilst 4 patients (4.9%) underwent high-dose therapy as consolidation. One patient (1.2%) received palliative care only. Of 80 patients treated with chemotherapy, 76 (91%) received anthracycline-containing regimens. The investigator-assessed overall response rate was 82.6%, with 57 patients (71%) achieving complete remission. With a median follow-up of 28 (range, 19-37) months, the median PFS for (n=114) ALK+ ALCL patients was not reached, and 3-year and 5-year PFS rates were 66% (95% CI, 55-75) and 59% (95% CI, 47-70), respectively. The median OS (n=116) was not reached, and 3-year and 5-year OS rates were both 77% (95% CI, 66-85) (Fig.1). At the time of data cut off, 20 patients died. Cause of death was most commonly attributable to lymphoma (65%) and infection (15%).Conclusions: This is the largest prospective international registry study to-date of ALCL, ALK+ patients, describing epidemiology, clinical features, treatment approaches and clinical outcomes. The use of anthracycline-based CHT regimens remains a standard of care front-line approach across global geographic regions. With a median follow up of >2 years, we observed favorable OS outcomes compared to other PTCLs despite presence of advanced stage disease in the majority of patients. However, the rates of PFS leave room for improvement. These findings are consistent with previous report from the retrospective International T-cell Project. Incorporation of recently developed CD30-targeting and ALK-kinase targeting agents into front-line regimens is underway to further improve outcomes for high-risk patients.Figure 1. Kaplan-Meier estimates of overall (A) and progression-free survival (B) among ALCL, ALK+ patients enrolled into the prospective TCP registry. [Display omitted] DisclosuresShustov:Celgene: Other: Publication assistance; Spectrum Pharmaceuticals: Consultancy, Research Funding. Pileri:Takeda Pharmaceuticals: Speakers Bureau. Horwitz:Mundipharma: Consultancy; ADCT Therapeutics: Research Funding; Celgene: Consultancy, Research Funding; BMS: Consultancy; Millenium/Takeda: Consultancy, Research Funding; Kyowa-Hakka-Kirin: Consultancy, Research Funding; Aileron Therapeutics: Research Funding; Infinity/Verastem: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Forty-Seven: Consultancy, Research Funding; HUYA: Consultancy. Carson:Seattle Genetics: Honoraria. Federico:takeda: Honoraria, Research Funding.

Evaluation of the Effectiveness of Helicobacter pylori Eradication Regimens in Lithuania during the Years 2013-2020: Data from the European Registry on Helicobacter pylori Management (Hp-EuReg).

Background and Objectives: The prevalence of H. pylori in Eastern Europe remains quite high; however, there is insufficient data on the eradication regimens and their effectiveness. Therefore, the objective of the study was to evaluate the diagnostic methods and treatment of H. pylori infection as well as their adherence to Maastricht V/Florence consensus during the years 2013–2020 in Lithuania. Materials and Methods: Sub-study of the “European Registry on H. pylori Management” (Hp-EuReg), international multicenter prospective non-interventional registry of the routine clinical practice. Lithuanian data from the years 2013–2020 were analyzed for effectiveness on a modified intention-to-treat (mITT) basis. 2000 adult patients, diagnosed with H. pylori infection, were included. Data were compared to the European Maastricht V guidelines. Results: Triple-therapy was used in 90% of the cases. In 91% of the first-line prescriptions, standard triple therapy (STT) was used. The most common second-line treatment was a combination of PPI, amoxicillin and levofloxacin (PPI+A+L) (47%). The overall effectiveness in 552 cases valid for analysis was 90% by mITT. In first-line treatment, the STT effectiveness was 90% and second-line treatment with PPI+A+L achieved 92% by mITT. Increasing overall H. pylori eradication rates were observed: from 72% in 2013 to more than 90% in 2018–2020, as well as a shift from 7 to 10–14 days treatments duration throughout 2013–2020. Conclusions: In Lithuania, the prescribed eradication regimens for H. pylori were in accordance with the international guidelines but diagnostic methods and treatment duration only partially met Maastricht V/Florence guidelines. The eradication effectiveness was improved progressively during the years 2018–2020, reaching ≥90% cure rates.

P1051 - Magnetic Resonance guided adaptive Radiotherapy (MRgRT) for localised prostate cancer: The first result from a prospective international registry for the evidence-based Introduction of MRgRT

P1051 - Magnetic Resonance guided adaptive Radiotherapy (MRgRT) for localised prostate cancer: The first result from a prospective international registry for the evidence-based Introduction of MRgRT

Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for iron deficiency anemia in obstetric and gynecologic patients: A systematic review and meta-analysis.

Introduction:Iron deficiency anemia (IDA) is common among obstetric and gynecologic patients. This systematic review aimed to assess the comparative efficacy and safety of commonly used intravenous (IV) iron formulations, ferric carboxymaltose (FCM), and iron sucrose (IS) in the treatment of IDA in obstetric and gynecologic patients.Methods:We systematically searched PubMed, EMBASE, Cochrane CENTRAL, and Google Scholar for eligible randomized controlled trials (RCTs) comparing IV iron replacement using FCM and IS up to October 2019. The primary outcome was to compare the efficacy of FCM and IS, assessed by measuring serum hemoglobin (Hb) and ferritin levels before and after iron replacement. The secondary outcome was to compare the safety of FCM and IS, assessed by the incidence of adverse events during iron replacement. The meta-analysis was performed using RevMan 5.3.Results:We identified 9 RCTs with 910 patients (FCM group, n = 456; IS group, n = 454). Before iron replacement, FCM and IS group patients had similar baseline Hb (mean difference [MD], 0.04 g/dL; 95% confidence interval [CI], −0.07 to 015; I2 = 0%; P = 0.48) and ferritin levels (MD, −0.42 ng/mL; 95% CI, −1.61 to 0.78; I2 = 45%; P = 0.49). Following iron replacement, patients who received FCM had higher Hb (MD, 0.67; 95% CI, 0.25–1.08; I2 = 92%; P = 0.002) and ferritin levels (MD, 24.41; 95% CI, 12.06–36.76; I2 = 75%; P = 0.0001) than patients who received IS. FCM group showed a lower incidence of adverse events following iron replacement than IS group (risk ratio, 0.53; 95% CI, 0.35–0.80; I2 = 0%; P = 0.003). Serious adverse events were not reported in any group.Conclusion:FCM group showed better efficacy in increasing Hb and ferritin levels and a favorable safety profile with fewer adverse events compared with IS group for IDA treatment among obstetric and gynecologic patients. However, this meta-analysis was limited by the small number of RCTs and high heterogeneity.Trial registration:The review was prospectively registered with the International Prospective Registry of Systematic Reviews (https://www.crd.york.ac.uk/prospero/, registration number CRD42019148905).

Endoscopic enucleation of the prostate (EEP). The same but different\u2014a systematic review

PurposeVarious techniques for EEP exist. They differ by surgical steps and the source of energy. It is assumed that the latter is of minor importance, whereas adherence to the anatomical enucleation template determines the postoperative result. So far, no systematic review highlights the differences between the energy sources in use for anatomical EEP. This study will address selfsame topic.MethodsA systematic review of the literature was completed on September 1st, 2020. Studies comparing HoLEP, ThuLEP, DiLEP, or BipolEP with TUR-P providing 12 months of postoperative follow-up were included. Two frequentist network meta-analyses were created to compare the techniques of EEP indirectly.Results31 studies, including 4466 patients, were found eligible for our meta-analysis. Indirect pairwise comparison showed differences in surgery time between BipolEP and HolEP (MD − 16.72 min., 95% CI − 27.75 to − 5.69) and DiLEP and HoLEP (MD − 22.41 min., 95% CI − 39.43 to − 5.39). No differences in the amount of resected prostatic tissue, major and minor complications and postoperative catheterization time were found. The odds for blood transfusions were threefold higher for BipolEP than for HoLEP (OR 3.27, 95% CI 1.02–10.5). The difference was not statistically significant when comparing prospective trials and matched-pair analysis only (OR 3.25, 95% CI 0.94–11.18). The Qmax 12 months after surgery was 2 ml/sec. higher for BipolEP than for DiLEP (MD 2.00, 95% CI 0.17–3.84) and 1.94 ml/sec. lower for DiLEP than for HoLEP (MD − 1.94, 95% CI − 3.65 to − 0.22).ConclusionThe energy source used for EEP has an impact on the intervention itself. BipolEP promotes surgical efficiency; laser techniques lower the risk of bleeding.RegistryThis meta-analysis is registered in the PROSPERO international prospective register registry with the registration number CRD42020205836.

International Prospective Registry of Acute Coronary Syndromes in Patients With COVID-19

BackgroundPublished data suggest worse outcomes in acute coronary syndrome (ACS) patients and concurrent coronavirus disease 2019 (COVID-19) infection. Mechanisms remain unclear. ObjectivesThe purpose of this study was to report the demographics, angiographic findings, and in-hospital outcomes of COVID-19 ACS patients and compare these with pre–COVID-19 cohorts. MethodsFrom March 1, 2020 to July 31, 2020, data from 55 international centers were entered into a prospective, COVID-ACS Registry. Patients were COVID-19 positive (or had a high index of clinical suspicion) and underwent invasive coronary angiography for suspected ACS. Outcomes were in-hospital major cardiovascular events (all-cause mortality, re–myocardial infarction, heart failure, stroke, unplanned revascularization, or stent thrombosis). Results were compared with national pre–COVID-19 databases (MINAP [Myocardial Ischaemia National Audit Project] 2019 and BCIS [British Cardiovascular Intervention Society] 2018 to 2019). ResultsIn 144 ST-segment elevation myocardial infarction (STEMI) and 121 non–ST-segment elevation acute coronary syndrome (NSTE-ACS) patients, symptom-to-admission times were significantly prolonged (COVID-STEMI vs. BCIS: median 339.0 min vs. 173.0 min; p < 0.001; COVID NSTE-ACS vs. MINAP: 417.0 min vs. 295.0 min; p = 0.012). Mortality in COVID-ACS patients was significantly higher than BCIS/MINAP control subjects in both subgroups (COVID-STEMI: 22.9% vs. 5.7%; p < 0.001; COVID NSTE-ACS: 6.6% vs. 1.2%; p < 0.001), which remained following multivariate propensity analysis adjusting for comorbidities (STEMI subgroup odds ratio: 3.33 [95% confidence interval: 2.04 to 5.42]). Cardiogenic shock occurred in 20.1% of COVID-STEMI patients versus 8.7% of BCIS patients (p < 0.001). ConclusionsIn this multicenter international registry, COVID-19–positive ACS patients presented later and had increased in-hospital mortality compared with a pre–COVID-19 ACS population. Excessive rates of and mortality from cardiogenic shock were major contributors to the worse outcomes in COVID-19 positive STEMI patients.

Feasibility of achieving planned surgical margins in primary spine tumor: a PTRON study.

Oncological resection of primary spine tumors is associated with lower recurrence rates. However, even in the most experienced hands, the execution of a meticulously drafted plan sometimes fails. The objectives of this study were to determine how successful surgical teams are at achieving planned surgical margins and how successful surgeons are in intraoperatively assessing tumor margins. The secondary objective was to identify factors associated with successful execution of planned resection. The Primary Tumor Research and Outcomes Network (PTRON) is a multicenter international prospective registry for the management of primary tumors of the spine. Using this registry, the authors compared 1) the planned surgical margin and 2) the intraoperative assessment of the margin by the surgeon with the postoperative assessment of the margin by the pathologist. Univariate analysis was used to assess whether factors such as histology, size, location, previous radiotherapy, and revision surgery were associated with successful execution of the planned margins. Three hundred patients were included. The surgical plan was successfully achieved in 224 (74.7%) patients. The surgeon correctly assessed the intraoperative margins, as reported in the final assessment by the pathologist, in 239 (79.7%) patients. On univariate analysis, no factor had a statistically significant influence on successful achievement of planned margins. In high-volume cancer centers around the world, planned surgical margins can be achieved in approximately 75% of cases. The morbidity of the proposed intervention must be balanced with the expected success rate in order to optimize patient management and surgical decision-making.

Severe traumatic brain injury and hypotension is a frequent and lethal combination in multiple trauma patients in mountain areas \u2013 an analysis of the prospective international Alpine Trauma Registry

BackgroundHypotension is associated with worse outcome in patients with traumatic brain injury (TBI) and maintaining a systolic blood pressure (SBP) ≥110 mmHg is recommended. The aim of this study was to assess the incidence of TBI in patients suffering multiple trauma in mountain areas; to describe associated factors, treatment and outcome compared to non-hypotensive patients with TBI and patients without TBI; and to evaluate pre-hospital variables to predict admission hypotension.MethodsData from the prospective International Alpine Trauma Registry including mountain multiple trauma patients (ISS ≥ 16) collected between 2010 and 2019 were analysed. Patients were divided into three groups: 1) TBI with hypotension, 2) TBI without hypotension and 3) no TBI. TBI was defined as Abbreviated Injury Scale (AIS) of the head/neck ≥3 and hypotension as SBP < 110 mmHg on hospital arrival.ResultsA total of 287 patients were included. Fifty (17%) had TBI and hypotension, 92 (32%) suffered TBI without hypotension and 145 (51%) patients did not have TBI. Patients in group 1 were more severely injured (mean ISS 43.1 ± 17.4 vs 33.3 ± 15.3 vs 26.2 ± 18.1 for group 1 vs 2 vs 3, respectively, p < 0.001). Mean SBP on hospital arrival was 83.1 ± 12.9 vs 132.5 ± 19.4 vs 119.4 ± 25.8 mmHg (p < 0.001) despite patients in group 1 received more fluids. Patients in group 1 had higher INR, lower haemoglobin and lower base excess (p < 0.001). More than one third of patients in group 1 and 2 were hypothermic (body temperature < 35 °C) on hospital arrival while the rate of admission hypothermia was low in patients without TBI (41% vs 35% vs 21%, for group 1 vs 2 vs 3, p = 0.029). The rate of hypothermia on hospital arrival was different between the groups (p = 0.029). Patients in group 1 had the highest mortality (24% vs 10% vs 1%, p < 0.001).ConclusionMultiple trauma in the mountains goes along with severe TBI in almost 50%. One third of patients with TBI is hypotensive on hospital arrival and this is associated with a worse outcome. No single variable or set of variables easily obtainable at scene was able to predict admission hypotension in TBI patients.

Pregnancy outcomes in women with a systemic right ventricle and transposition of the great arteries results from the ESC-EORP Registry of Pregnancy and Cardiac disease (ROPAC)

ObjectiveCardiac disease is a major cause of maternal mortality. Data regarding pregnancy outcomes in women with a systemic right ventricle (sRV) are scarce. We studied pregnancy outcomes in women with...

Sutureless Valve in Repeated Aortic Valve Replacement: Results from an International Prospective Registry.

To report early and midterm results registry of patients undergoing repeated aortic valve replacement (RAVR) with sutureless prostheses from an international prospective registry (SURE-AVR). Between March 2011 and June 2019, 69 patients underwent RAVR with self-expandable sutureless aortic bioprostheses at 22 international cardiac centers. Overall mortality was 2.9% with a predicted logistic EuroSCORE II of 10.7%. Indications for RAVR were structural valve dysfunction (84.1%) and infective prosthetic endocarditis (15.9%) and were performed in patients with previously implanted bioprostheses (79.7%), mechanical valves (15.9%), and transcatheter valves (4.3%). Minimally invasive approach was performed in 15.9% of patients. Rate of stroke was 1.4% and rate of early valve-related reintervention was 1.4%. Overall survival rate at 1 and 5 years was 97% and 91%, respectively. No major paravalvular leak occurred. Rate of pacemaker implantation was 5.8% and 0.9% per patient-year early and at follow-up, respectively. The mean transvalvular gradient at 1-year and 5-year follow-up was 10.5 mm Hg and 11.5 mm Hg with a median effective orifice area of 1.8 cm2and 1.8 cm2, respectively. RAVR with sutureless valves is a safe and effective approach and provides excellent clinical and hemodynamic results up to 5 years.

Interim Analysis of Pregnancy Outcomes Following Exposure to Dimethyl Fumarate in a Prospective International Registry (1320)

Interim Analysis of Pregnancy Outcomes Following Exposure to Dimethyl Fumarate in a Prospective International Registry (1320)

Predictors of sexual violence among female students in higher education institutions in Ethiopia: A systematic review and meta-analysis.

BackgroundSexual violence is a profound social and public health problem in Ethiopia. Female students in institutions of higher education are highly vulnerable to sexual violence. Different studies conducted on sexual violence at higher education institutions lack consistency and inclusiveness. Thus, this systematic review and meta-analysis were conducted to estimate the lifetime and twelve-month prevalence, and predictors of sexual violence among female students in institutions of higher education in Ethiopia.MethodsThis study used a systematic review and meta-analysis of studies conducted from January 1, 2000, to June 1, 2020, in Ethiopia. This review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Electronic databases including PubMed, Cochrane Library, Hinari, Google Scholar, CINAHL, and Global Health were searched using relevant search terms. Meta-analysis was performed using STATA 14 software. The I2 statistics and Egger’s test were used to assess heterogeneity and publication bias, respectively. Forest plots were used to present the prevalence and odds ratio (OR) with a 95% confidence interval (CI).ResultsThis systematic review and meta-analysis included 10 studies, 5790 study participants. The pooled lifetime and twelve-month prevalence of sexual violence among female students in Ethiopia was 49.4% (95%CI: 37.87, 60.96) and 36.02% (95%CI: 26.42, 45.62) respectively. Rural residence (OR = 2.13;95%CI: 1.33, 3.42), alcohol drinking (OR = 2.03; 95%CI: 1.44, 2.87), and ever had a boyfriend (OR = 2.07; 95%CI: 1.32, 3.62) were factors associated with sexual violence.ConclusionsThe lifetime prevalence of sexual violence among female students in institutions of higher education in Ethiopia was high. Place of residence, alcohol drinking, and ever had a boyfriend were statistically significant factors of sexual violence. Life skill training and law enforcement are needed to control alcohol consumption. Additionally, more focused interventions should be done in rural settings.RegistrationThis systematic review has been registered in the International Prospective Registry of Systematic Review (PROSPERO) with a specific registration number CRD42020155894.

The 5 Pillars in Tourette Syndrome Deep Brain Stimulation Patient Selection: Present and Future.

The selection of patients with Tourette syndrome (TS) for deep brain stimulation (DBS) surgery rests on 5 fundamental pillars. However, the operationalization of the multidisciplinary screening process to evaluate these pillars remains highly diverse, especially across sites. High tic severity and tic-related impact on quality of life (first 2 pillars) require confirmation from objective, validated measures, but malignant features of TS should per se suffice to fulfill this pillar. Failure of behavioral and pharmacologic therapies (third pillar) should be assessed taking into account refractoriness through objective and subjective measures supporting lack of efficacy of all interventions of proven efficacy, as well as true lack of tolerability, adherence, or access. Educational interventions and use of remote delivery formats (for behavioral therapies) play a role in preventing misjudgment of treatment failure. Stability of comorbid psychiatric disorders for 6 months (fourth pillar) is needed to confirm the predominant impact of tics on quality of life, to prevent pseudo-refractoriness, and to maximize the future DBS response. The 18-year age limit (fifth pillar) is currently under reappraisal, considering the potential impact of severe tics in adolescence and the predictive effect of tic severity in childhood on tic severity when transitioning into adulthood. Future advances should aim at a consensus-based definition of failure of specific, noninvasive treatment strategies for tics and of the minimum clinical observation period before considering DBS treatment, the stability of behavioral comorbidities, and the use of a prospective international registry data to identify predictors of positive response to DBS, especially in younger patients.

Does nocturnal use of a complete denture interfere with the degree of obstructive sleep apnea? A systematic review and meta-analysis

The impact of a complete denture on obstructive sleep apnea is not well understood. Therefore, this study aimed to evaluate the relationship between nighttime use of complete dentures and obstructive sleep apnea and determine if wearing a complete denture during sleep changes the degree of obstructive sleep apnea. This systematic review followed the notification items for Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) andwas recorded in the International Prospective Registry of Systematic Reviews (PROSPERO) under number CRD42020183167. An electronic search in the PubMed/MEDLINE, Scopus, and Cochrane Library databases for articles published until September 2020 was conducted. The search strategy used the terms (complete denture OR denture OR edentulous OR edentulism) AND (quality of sleep OR sleep OR apnea OR obstructive sleep apnea). Only prospective, retrospective, controlled, and randomized clinical studies of patients wearing complete dentures, studies comparing sleep with and without the prosthesis, and studies in which patients were diagnosed with obstructive sleep apnea by polysomnography were included in the review. In total, four articles were selected for the qualitative and quantitative analyses. A total of 144 patients, with an average age of 60years, were studied. The meta-analysis showed that there was no statistical difference in the apnea-hypopnea index between using and not using the prosthesis during sleep. The use of complete dentures during sleep does not influence the degree of obstructive sleep apnea.

Effect of Sex on Outcomes of Coronary Rotational Atherectomy Percutaneous Coronary Intervention (From the European Multicenter Euro4C Registry)

Data regarding the potential influence of gender on outcomes of rotational atherectomy (RA) percutaneous coronary intervention (PCI) are scarce and conflicting. Using the Euro4C registry, an international prospective multicentric registry of RA PCI, we evaluated the influence of gender on clinical outcomes of RA PCI. Between October 2016 and July 2018, 966 patients were included. In them, 267 (27.6%) were females. Female patients were older than males (77.7 years old ± 9.8 vs 73.3 ± 9.5 years old respectively, p < 0.001) had a poorer renal function (43,1% of females had a GFR < 60 ml/min:1.73m² vs 30.4% of males, p < 0.001) and were more frequently admitted for an acute coronary syndrome (32.2% vs 22.3% p = 0.002). During RA procedure, women were less likely to be treated by radial approach (65.0% vs 74.4%, p = 0.004). In-hospital major adverse cardiac event rate-defined as cardiovascular death, myocardial infarction, stroke/transient ischemic attack, target lesion revascularization, and coronary artery bypass grafting surgery-was higher in the female group (7.1% vs 3.7%, p = 0.043). However, coronary perforation, dissection, slow/low flow and tamponade did not significantly differ in gender, neither did cardiovascular medications at discharge. At 1 year follow-up, rate of major adverse cardiac event was 18.4% in the female group vs 11.2% in the male group (adjusted Hazard Ratio 1.82 [1.24 to 2.67], p = 0.002). No significant bleeding differences were observed in gender, neither in hospital, nor during follow-up. In conclusion women had worse clinical outcomes following RA PCI during hospitalization and at 1 year follow-up than did men.

Room for Improvement in the Treatment of Helicobacter pylori Infection: Lessons from the European Registry on H. pylori Management (Hp-EuReg).

Managing Helicobacter pylori infection requires constant decision making, and each decision is open to possible errors. The aim was to evaluate common mistakes in the eradication of H. pylori, based on the "European Registry on Helicobacter pylori management". European Registry on Helicobacter pylori management is an international multicentre prospective noninterventional registry evaluating the decisions and outcomes of H. pylori management by European gastroenterologists in routine clinical practice. Countries recruiting more than 1000 patients were included (26,340 patients). The most common mistakes (percentages) were: (1) To use the standard triple therapy where it is ineffective (46%). (2) To prescribe eradication therapy for only 7 to 10 days (69%). (3) To use a low dose of proton pump inhibitors (48%). (4) In patients allergic to penicillin, to prescribe always a triple therapy with clarithromycin and metronidazole (38%). (5) To repeat certain antibiotics after eradication failure (>15%). (6) Failing to consider the importance of compliance with treatment (2%). (7) Not to check the eradication success (6%). Time-trend analyses showed progressive greater compliance with current clinical guidelines. The management of H. pylori infection by some European gastroenterologists is heterogeneous, frequently suboptimal and discrepant with current recommendations. Clinical practice is constantly adapting to updated recommendations, although this shift is delayed and slow.

Mastication in children and adolescents with overweight or obesity: a systematic review

ABSTRACT Studies have shown that changes in mastication are related to overweight in children and adolescents as these changes influence the increase in food consumption. The objective of this article was to characterize, through a systematic review, the mastication in children and adolescents with overweight or obesity. For this, two independent authors performed a systematic review of the electronic databases: Medical Literature Analysis and Retrieval System Online, Scopus, Cumulative Index to Nursing and Allied Health, Web of Science and Latin American and Caribbean Literature in Health Sciences. Masticatory characteristics were considered as primary outcomes; the methods of analyzing mastication, the physical characteristics of the foods/materials used in the analyses and the fasting time were considered as secondary outcomes. This review was prepared in accordance with the items of the preferential reports for systematic analysis and meta-analysis. The systematic review protocol was submitted to the International Prospective Registry of Systematic Reviews. Nine articles were included in this review. The reviewed articles suggest that children and/or adolescents with overweight or obese present masticatory damages because they have worse masticatory performance and altered orofacial myofunctional characteristics.

Pregnancy Outcomes in Women After Arterial Switch Operation for Transposition of the Great Arteries: Results From ROPAC (Registry of Pregnancy and Cardiac Disease) of the European Society of Cardiology EURObservational Research Programme.

BackgroundIn the past 3 decades, the arterial switch procedure has replaced the atrial switch procedure as treatment of choice for transposition of the great arteries. Although survival is superior after the arterial switch procedure, data on pregnancy outcomes are scarce and transposition of the great arteries after arterial switch is not yet included in the modified World Health Organization classification of maternal cardiovascular risk.Methods and ResultsThe ROPAC (Registry of Pregnancy and Cardiac disease) is an international prospective registry of pregnant women with cardiac disease, part of the European Society of Cardiology EURObservational Research Programme. Pregnancy outcomes in all women after an arterial switch procedure for transposition of the great arteries are described. The primary end point was a major adverse cardiovascular event, defined as combined end point of maternal death, supraventricular or ventricular arrhythmias requiring treatment, heart failure, aortic dissection, endocarditis, ischemic coronary events, and thromboembolic events. Altogether, 41 pregnant women (mean age, 26.7±3.9 years) were included, and there was no maternal mortality. A major adverse cardiovascular event occurred in 2 women (4.9%): heart failure in one (2.4%) and ventricular tachycardia in another (2.4%). One woman experienced fetal loss, whereas no neonatal mortality was observed.ConclusionsWomen after an arterial switch procedure for transposition of the great arteries tolerate pregnancy well, with a favorable maternal and fetal outcome. During counseling, most women should be reassured that the risk of pregnancy is low. Classification as modified World Health Organization risk class II seems appropriate.