Building a Prediction Model for Vacuum-Assisted Operative Vaginal Delivery Risk

Aim: The objective of this study was to evaluate the risk factors for operative vaginal delivery and to propose a new nomogram for predicting the risk. Methods: We retrospectively analyzed the data of 1,955 pregnancies that occurred in our clinic between the years 2007 and 2008. Included were singleton pregnancies with labor diagnosis after the 36th gestational week in which spontaneous or operative vaginal deliveries occurred. In this study, the operative delivery was carried out exclusively by vacuum extraction. Results: After univariate analysis and multivariate logistic regression stepwise model selection, maternal age, nulliparity, medically assisted procreation, gestational age at birth, male fetus, epidural analgesia and medical induction of labor were found to be the most predictive variables for operative vaginal delivery. Considering these factors we propose a new nomogram for an objectified determination of the risk of operative vaginal delivery. Conclusions: The new nomogram we propose could be an important tool for an objectified determination of the risk of operative vaginal delivery by vacuum extraction in individualized patient counseling

Produção de forragem e grãos de variedades de feijão-miúdo em consórcio com milho.

Espécies leguminosas tropicais são melhoradoras de solos, pela capacidade de fixação biológica de nitrogênio e pelo residual de fertilidade que permitem aos cultivos subsequentes. O feijãomiúdo é uma espécie que tem se destacado na região Sul do Brasil devido à sua multiplicidade de uso. Seu cultivo vem se difundindo rapidamente, principalmente nas bacias leiteiras, mas informações sobre seu cultivo e potencial de uso são escassos. Um experimento foi conduzido com o objetivo de avaliar a produção de forragem e grãos de quatro variedades de feijão-miúdo em cultivo consorciado com milho. Foram determinadas a densidade real de plantas e as produções de massa verde e seca totais e de massa seca de lâminas foliares, colmos e de grãos (kg ha-1) de feijão-miúdo, na ocasião da colheita do milho. Não foram verificadas diferenças estatísticas nas variáveis analisadas, devido, provavelmente, aos altos coeficientes de variação obtidos. Contudo, verificam-se diferenças numéricas expressivas entre os tratamentos. As produções podem ser consideradas satisfatórias para o sistema e região de cultivo, mas outros estudos deverão ser realizados para que sejam possíveis conclusões mais pontuais sobre as características das variedades de feijão-miúdo e seu cultivo consorciado com milho. Mesmo sem respaldo estatístico, podem ser destacadas as produções de massa seca total, de lâminas foliares e de grãos obtidas pela variedade Amendoim

Core outcome domains for early-phase clinical trials of sound-, psychology-, and pharmacology-based interventions to manage chronic subjective tinnitus in adults: the COMIT'ID study protocol for using a Delphi process and face-to-face meetings to establish consensus

Background: The reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound (e.g. loudness) to psychosocial impacts (e.g. quality of life). Even when considering one type of intervention strategy for subjective tinnitus, there is no agreement about what is critically important for deciding whether a treatment is effective. The main purpose of this observational study is therefore to develop Core Outcome Domain Sets for the three different intervention strategies (sound, psychological, and pharmacological) for adults with chronic subjective tinnitus that should be measured and reported in every clinical trial of these interventions. Secondary objectives are to identify the strengths and limitations of our study design for recruiting and reducing attrition of participants, and to explore uptake of the core outcomes. Methods: The ‘Core Outcome Measures in Tinnitus: International Delphi’ (COMIT’ID) study will use a mixed methods approach that incorporates input from healthcare users at the pre-Delphi stage, a modified three round Delphi survey and final consensus meetings (one for each intervention). The meetings will generate recommendations by stakeholder representatives on agreed Core Outcome Domain Sets specific to each intervention. A subsequent step will establish a common cross-cutting Core Outcome Domain Set by identifying the common outcome domains included in all three intervention-specific Core Outcome Domain Sets. To address the secondary objectives, we will gather feedback from participants about their experience of taking part in the Delphi process. We aspire to conduct an observational cohort study to evaluate uptake of the core outcomes in published studies at 7 years following core outcome set publication. Discussion: The COMIT’ID study aims to develop a Core Outcome Domain Set that are agreed as critically important for deciding whether a treatment for subjective tinnitus is effective. Such a recommendation would help to standardise future clinical trials worldwide and so we will determine if participation increases use of the core outcome set in the long term. Trial registration: This project has been registered in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative

Quantum encoding of dynamic directed graphs

In application domains such as routing, network analysis, scheduling, and planning, directed graphs are widely used as both formal models and core data structures for the development of efficient algorithmic solutions. In these areas, graphs are often evolving in time: for example, connection links may fail due to temporary technical issues, meaning that edges of the graph cannot be traversed for some time interval and alternative paths have to be followed. In classical computation graphs have been implemented both explicitly through adjacency matrices/lists and symbolically as ordered binary decision diagrams. Moreover, ad-hoc visit procedures have been developed to deal with dynamically evolving graphs. Quantum computation, exploiting interference and entanglement, has provided an exponential speed-up for specific problems, e.g., database search and integer factorization. In the quantum framework everything must be represented and manipulated using reversible operators. This poses a challenge when one has to deal with traversals of dynamically evolving directed graphs. Graph traversals are not intrinsically reversible because of converging paths. In the case of dynamically evolving graphs also the creation/destruction of paths comes into play against reversibility. In this paper we propose a novel high level graph representation in quantum computation supporting dynamic connectivity typical of real-world network applications. Our procedure allows to encode any multigraph into a unitary matrix. We devise algorithms for computing the encoding that are optimal in terms of time and space and we show the effectiveness of the proposal with some examples. We describe how to react to edge/node failures in constant time. Furthermore, we present two methods to perform quantum random walks taking advantage of this encoding: with and without projectors. We implement and test our encoding obtaining that the theoretical bounds for the running time are confirmed by the empirical results and providing more details on the behavior of the algorithms over graphs of different densities

Impact of social determinants on antiretroviral therapy access and outcomes entering the era of universal treatment for people living with HIV in Italy

Background: Social determinants are known to be a driving force of health inequalities, even in high income countries. Aim of our study was to determine if these factors can limit antiretroviral therapy (ART) access, outcome and retention in care of people living with HIV (PLHIV) in Italy. Methods: All ART naïve HIV+ patients (pts) of Italian nationality enrolled in the ICONA Cohort from 2002 to 2016 were included. The association of socio-demographic characteristics (age, sex, risk factor for HIV infection, educational level, occupational status and residency area) with time to: ART initiation (from the first positive anti-HIV test), ART regimen discontinuation, and first HIV-RNA < 50 cp/mL, were evaluated by Cox regression analysis, Kaplan Meier method and log-rank test. Results: A total of 8023 HIV+ pts (82% males, median age at first pos anti-HIV test 36 years, IQR: 29-44) were included: 6214 (77.5%) started ART during the study period. Women, people who inject drugs (PWID) and residents in Southern Italy presented the lowest levels of education and the highest rate of unemployment compared to other groups. Females, pts aged > 50 yrs., unemployed vs employed, and people with lower educational levels presented the lowest CD4 count at ART initiation compared to other groups. The overall median time to ART initiation was 0.6 years (yrs) (IQR 0.1-3.7), with a significant decrease over time [2002-2006 = 3.3 yrs. (0.2-9.4); 2007-2011 = 1.0 yrs. (0.1-3.9); 2012-2016 = 0.2 yrs. (0.1-2.1), p < 0.001]. By multivariate analysis, females (p < 0.01) and PWID (p < 0.001), presented a longer time to ART initiation, while older people (p < 0.001), people with higher educational levels (p < 0.001), unemployed (p = 0.02) and students (p < 0.001) were more likely to initiate ART. Moreover, PWID, unemployed vs stable employed, and pts. with lower educational levels showed a lower 1-year probability of achieving HIV-RNA suppression, while females, older patients, men who have sex with men (MSM), unemployed had higher 1-year risk of first-line ART discontinuation. Conclusions: Despite median time to ART start decreased from 2002 to 2016, socio-demographic factors still contribute to disparities in ART initiation, outcome and durability

Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

BACKGROUND: There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus. METHODS: Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded. RESULTS: Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used. CONCLUSIONS: Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments. PROSPERO REGISTRATION: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525. Registered on 12 March 2015 revised on 15 March 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1399-9) contains supplementary material, which is available to authorized users

Updates and Debate Concerning Margin Adequacy and Management following Breast-Conserving Surgery

Objective: Breast-conserving surgery (BCS) experienced a significant surge during the last decades due to the increase of early breast cancer detection. Central to the discussion is margin adequacy which represents one of the most significant predictive factors for local relapse. This paper aims to shed light on the problem of margins in breast surgery. Mechanism: We performed a systematic narrative review of the literature by conducting a search using Medline/PubMed, Scopus, and Embase. The following keywords were considered: "breast-conserving surgery"AND "margins"/"margin". Findings in Brief: In the case of invasive breast cancer, "no ink on tumor"can be considered an adequate margin, while for ductal carcinoma in situ (DCIS), a distance of 2 mm from tumor should be obtained. Many novel tools have been developed based both on the latest radiological imaging techniques and on the tissue expression of certain markers, with the aim of precise navigation of tumor excision and intraoperative evaluation of cavity excision margins. Oncoplastic surgery can be considered oncologically safe while improving the cosmetic outcome and patients' quality of life. The appropriate use of adjuvant treatments in the context of a multidisciplinary and personalized management of breast cancer is the only means to omit a second intervention in some carefully selected cases. Conclusions: Debate still exists concerning the definition of adequate clear margin following BCS for DCIS. Further studies are required to better assess multimodal treatment approaches in this condition