419 research outputs found

    Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement

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    Many questions regarding the clinical management of people experiencing pain and related health policy decision-making may best be answered by pragmatic controlled trials. To generate clinically relevant and widely applicable findings, such trials aim to reproduce elements of routine clinical care or are embedded within clinical workflows. In contrast with traditional efficacy trials, pragmatic trials are intended to address a broader set of external validity questions critical for stakeholders (clinicians, healthcare leaders, policymakers, insurers, and patients) in considering the adoption and use of evidence-based treatments in daily clinical care. This article summarizes methodological considerations for pragmatic trials, mainly concerning methods of fundamental importance to the internal validity of trials. The relationship between these methods and common pragmatic trials methods and goals is considered, recognizing that the resulting trial designs are highly dependent on the specific research question under investigation. The basis of this statement was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) systematic review of methods and a consensus meeting. The meeting was organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership. The consensus process was informed by expert presentations, panel and consensus discussions, and a preparatory systematic review. In the context of pragmatic trials of pain treatments, we present fundamental considerations for the planning phase of pragmatic trials, including the specification of trial objectives, the selection of adequate designs, and methods to enhance internal validity while maintaining the ability to answer pragmatic research questions

    Access to the World Health Organization-recommended essential diagnostics for invasive fungal infections in critical care and cancer patients in Africa: A diagnostic survey

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    Background: Invasive fungal infections (IFIs) contribute to significant morbidity and mortality among patients with haemato-oncological conditions, seriously ill hospitalised patients and those in intensive care (ICU). We surveyed for the World Health Organization-recommended essential diagnostic tests for IFIs in these risk groups in Africa. Methods: The Global Action For Fungal Infections (GAFFI) evaluated the different levels of access to both diagnostics for IFIs for populations in Africa, with the aim of building a comparative dataset and a publicly available interactive map. Data was collected through a validated questionnaire administered to a country leader in relevant topics (i.e., HIV, laboratory coordination) and/or Ministry of Health representatives and followed up with 2 rounds of validation by video calls, and later confirmation by email of findings. Results: Initial data was collected from 48 African countries covering 99.65 % of the population. Conventional diagnostics such as blood cultures, direct microscopy and histopathology were often used for diagnosis of IFIs in more than half of the facilities. Bronchoscopy was rarely done or not done in 20 countries (population 649 million). In over 40 African countries (population >850 million), Aspergillus antigen testing was never performed in either the public or private sectors. Computed tomography (CT) imaging is routinely used in 27 (56 %) of countries in the public sector and 21 44 %) in the private sector. However, magnetic resonance imaging remains relatively uncommon in most African countries. Conclusions: There are critical gaps in the availability of essential diagnostics for IFIs in Africa, particularly Aspergillus antigen testing and modern medical imaging modalities. Early diagnosis and commencement of targeted therapy of IFIs are critical for optimal outcomes from complex cancer therapies

    The Effect of Sliding Speed on the Tribological Properties of Ceramic Materials

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    Ceramics are considered to be candidate materials for galvanising pot bearing materials due to their excellent corrosion resistance in many molten metals. Galvanising pot roll bearings must have excellent wear resistance, and, therefore, it is important to understand the wear behaviour of prospective bearing materials. This study investigates the friction- and wear-resistant properties of select ceramics, namely, pure hBN, BN M26, AlN-BN, Macor, 3YSZ, Al2O3 and Si3N4. The ceramics were tested at different sliding speeds using a pin-on-disc device equipped with SiC pins. The lowest coefficient of friction (COF) achieved was below 0.1, and it was measured for pure hBN at a 3.14 m/min sliding speed. However, a wear scar analysis showed that the BN grades suffered from severe wear. The highest wear rate was obtained for BN M26 at a 9.42 m/min sliding speed and was equal to 17.1 × 10−6 mm3 N−1 m−1. It was shown that the wear coefficient of the tested ceramics varied exponentially with hardness. The lowest wear was observed on the 3YSZ, Al2O3 and Si3N4 ceramics, which showed no volume loss, and, for this reason, they can be potentially used as bearing materials in continuous galvanising lines

    Evaluating approaches for constructing polygenic risk scores for prostate cancer in men of African and European ancestry

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    Genome-wide polygenic risk scores (GW-PRSs) have been reported to have better predictive ability than PRSs based on genome-wide significance thresholds across numerous traits. We compared the predictive ability of several GW-PRS approaches to a recently developed PRS of 269 established prostate cancer-risk variants from multi-ancestry GWASs and fine-mapping studies (PRS269). GW-PRS models were trained with a large and diverse prostate cancer GWAS of 107,247 cases and 127,006 controls that we previously used to develop the multi-ancestry PRS269. Resulting models were independently tested in 1,586 cases and 1,047 controls of African ancestry from the California Uganda Study and 8,046 cases and 191,825 controls of European ancestry from the UK Biobank and further validated in 13,643 cases and 210,214 controls of European ancestry and 6,353 cases and 53,362 controls of African ancestry from the Million Veteran Program. In the testing data, the best performing GW-PRS approach had AUCs of 0.656 (95% CI = 0.635–0.677) in African and 0.844 (95% CI = 0.840–0.848) in European ancestry men and corresponding prostate cancer ORs of 1.83 (95% CI = 1.67–2.00) and 2.19 (95% CI = 2.14–2.25), respectively, for each SD unit increase in the GW-PRS. Compared to the GW-PRS, in African and European ancestry men, the PRS269 had larger or similar AUCs (AUC = 0.679, 95% CI = 0.659–0.700 and AUC = 0.845, 95% CI = 0.841–0.849, respectively) and comparable prostate cancer ORs (OR = 2.05, 95% CI = 1.87–2.26 and OR = 2.21, 95% CI = 2.16–2.26, respectively). Findings were similar in the validation studies. This investigation suggests that current GW-PRS approaches may not improve the ability to predict prostate cancer risk compared to the PRS269 developed from multi-ancestry GWASs and fine-mapping.</p

    Evaluating approaches for constructing polygenic risk scores for prostate cancer in men of African and European ancestry

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    International audienceGenome-wide polygenic risk scores (GW-PRSs) have been reported to have better predictive ability than PRSs based on genome-wide significance thresholds across numerous traits. We compared the predictive ability of several GW-PRS approaches to a recently developed PRS of 269 established prostate cancer-risk variants from multi-ancestry GWASs and fine-mapping studies (PRS269). GW-PRS models were trained with a large and diverse prostate cancer GWAS of 107,247 cases and 127,006 controls that we previously used to develop the multi-ancestry PRS269. Resulting models were independently tested in 1,586 cases and 1,047 controls of African ancestry from the California Uganda Study and 8,046 cases and 191,825 controls of European ancestry from the UK Biobank and further validated in 13,643 cases and 210,214 controls of European ancestry and 6,353 cases and 53,362 controls of African ancestry from the Million Veteran Program. In the testing data, the best performing GW-PRS approach had AUCs of 0.656 (95% CI = 0.635-0.677) in African and 0.844 (95% CI = 0.840-0.848) in European ancestry men and corresponding prostate cancer ORs of 1.83 (95% CI = 1.67-2.00) and 2.19 (95% CI = 2.14-2.25), respectively, for each SD unit increase in the GW-PRS. Compared to the GW-PRS, in African and European ancestry men, the PRS269 had larger or similar AUCs (AUC = 0.679, 95% CI = 0.659-0.700 and AUC = 0.845, 95% CI = 0.841-0.849, respectively) and comparable prostate cancer ORs (OR = 2.05, 95% CI = 1.87-2.26 and OR = 2.21, 95% CI = 2.16-2.26, respectively). Findings were similar in the validation studies. This investigation suggests that current GW-PRS approaches may not improve the ability to predict prostate cancer risk compared to the PRS269 developed from multi-ancestry GWASs and fine-mapping

    Reactions of industry and associated organisations to the announcement of the UK Soft Drinks Industry Levy: longitudinal thematic analysis of UK media articles, 2016-18

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    BACKGROUND: The UK Soft Drinks Industry Levy (SDIL) was announced in March 2016, became law in April 2017, and was implemented in April 2018. Empirical analyses of commercial responses have not been undertaken to establish the scale, direction or nuance of industry media messaging around fiscal policies. We aimed to develop a detailed understanding of industry reactions to the SDIL in publicly available media, including whether and how these changed from announcement to implementation. METHODS: We searched Factiva to identify articles related to sugar, soft-drinks, and the SDIL, between 16th March 2016-5th April 2018. Articles included were UK publications written in English and reporting a quotation from an industry actor in response to the SDIL. We used a longitudinal thematic analysis of public statements by the soft-drinks industry that covered their reactions in relation to key policy milestones. RESULTS: Two hundred and ninety-eight articles were included. After the announcement in March 2016, there was strong opposition to the SDIL. After the public consultation, evolving opposition narratives were seen. After the SDIL became law, reactions reflected a shift to adapting to the SDIL. Following the publication of the final regulations, statements sought to emphasise industry opportunities and ensure the perceived profitability of the soft drinks sector. The most significant change in message (from opposition to adapting to the SDIL) occurred when the SDIL was implemented (6th April 2018). CONCLUSION: Reactions to the SDIL changed over time. Industry modified its media responses from a position of strong opposition to one that appeared to focus on adaptation and maximising perceived profitability after the SDIL became law. This shift suggests that the forces that shape industry media responses to fiscal policies do not remain constant but evolve in response to policy characteristics and the stage of the policy process to maximise beneficial framing

    The effect of scrap originating trace elements on the properties of low alloyed steels

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    The present intention to reach fossil-free steel manufacturing will inevitably result in an increase in the use of steel scrap as a raw material for steel production. Consequently, the amounts of elements, seen as impurities, will increase in steels. This has already been seen in electric arc furnace (EAF) processed steels, where the Cu and Sn levels have doubled in some cases after 1980’s. This may cause problems, as it is well-known, that some impurity elements have harmful effects on the properties of steel. This has been widely studied in low-alloy steels containing chromium and molybdenum which are widely used in components for the petroleum and electrical power generation applications. However, limited number of studies have been performed on formable steel grades, and the published reports/articles have mostly concentrated on the effects of P and B. Thus, there is still a need to understand the roles of other impurity elements. In the present study, a formable C-Mn steels containing additions (either individually or in combination) of Cu and Sn is investigated. The samples were cold rolled and annealed following typical time-temperature profiles of modern continuous annealing lines. Mechanical and forming properties (incl. bending and cupping tests) are determined as well as elemental profile analysis is conducted. The results identify that minor additions of impurity elements, in this case Cu and Sn, does not affect the mechanical and forming properties of low alloyed formable steel grades considerably.publishedVersionPeer reviewe

    Reactions of industry and associated organisations to the announcement of the UK Soft Drinks Industry Levy: longitudinal thematic analysis of UK media articles, 2016-18.

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    Funder: British Heart FoundationFunder: Cancer Research UKFunder: Wellcome TrustBACKGROUND: The UK Soft Drinks Industry Levy (SDIL) was announced in March 2016, became law in April 2017, and was implemented in April 2018. Empirical analyses of commercial responses have not been undertaken to establish the scale, direction or nuance of industry media messaging around fiscal policies. We aimed to develop a detailed understanding of industry reactions to the SDIL in publicly available media, including whether and how these changed from announcement to implementation. METHODS: We searched Factiva to identify articles related to sugar, soft-drinks, and the SDIL, between 16th March 2016-5th April 2018. Articles included were UK publications written in English and reporting a quotation from an industry actor in response to the SDIL. We used a longitudinal thematic analysis of public statements by the soft-drinks industry that covered their reactions in relation to key policy milestones. RESULTS: Two hundred and ninety-eight articles were included. After the announcement in March 2016, there was strong opposition to the SDIL. After the public consultation, evolving opposition narratives were seen. After the SDIL became law, reactions reflected a shift to adapting to the SDIL. Following the publication of the final regulations, statements sought to emphasise industry opportunities and ensure the perceived profitability of the soft drinks sector. The most significant change in message (from opposition to adapting to the SDIL) occurred when the SDIL was implemented (6th April 2018). CONCLUSION: Reactions to the SDIL changed over time. Industry modified its media responses from a position of strong opposition to one that appeared to focus on adaptation and maximising perceived profitability after the SDIL became law. This shift suggests that the forces that shape industry media responses to fiscal policies do not remain constant but evolve in response to policy characteristics and the stage of the policy process to maximise beneficial framing.This project was funded by the NIHR Public Health Research programme (Grant Nos. 16/49/01 and 16/130/01). At the time this study was conducted TLP, CPJ, DP, JA, HF, OM & MW were also supported in part by: Programme grants to the MRC Epidemiology Unit from the Medical Research Council (grant No. MC_UU_12015/6 and MC_UU_00006/7); and the Centre for Diet and Activity Research (CEDAR), a UKCRC Public Health Research Centre of Excellence – funding from the British Heart Foundation, Cancer Research UK, the Economic and Social Research Council, the Medical Research Council, the National Institute for Health Research, and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration is gratefully acknowledged. The views expressed are those of the authors and not necessarily those of the any of the above named funders. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript

    Supporting adolescents’ participation in muscle-strengthening physical activity: protocol for the ‘Resistance Training for Teens’ (RT4T) hybrid type III implementation–effectiveness trial

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    Introduction In Australia, only 22% of male and 8% of female adolescents meet the muscle-strengthening physical activity guidelines, and few school-based interventions support participation in resistance training (RT). After promising findings from our effectiveness trial, we conducted a state-wide dissemination of the ‘Resistance Training for Teens’ (RT4T) intervention from 2015 to 2020. Despite high estimated reach, we found considerable variability in programme delivery and teachers reported numerous barriers to implementation. Supporting schools when they first adopt evidence-based programmes may strengthen programme fidelity, sustainability, and by extension, programme impact. However, the most effective implementation support model for RT4T is unclear.Objective To compare the effects of three implementation support models on the reach (primary outcome), dose delivered, fidelity, sustainability, impact and cost of RT4T.Methods and analysis We will conduct a hybrid type III implementation–effectiveness trial involving grade 9 and 10 (aged 14–16 years) students from 90 secondary schools in New South Wales (NSW), Australia. Schools will be recruited across one cohort in 2023, stratified by school type, socioeconomic status and location, and randomised in a 1:1:1 ratio to receive one of the following levels of implementation support: (1) ‘low’ (training and resources), (2) ‘moderate’ (training and resources+external support) or ‘high’ (training and resources+external support+equipment). Training includes a teacher workshop related to RT4T programme content (theory and practical sessions) and the related resources. Additional support will be provided by trained project officers from five local health districts. Equipment will consist of a pack of semiportable RT equipment (ie, weighted bars, dumbbells, resistance bands and inverted pull up bar stands) valued at ~$A1000 per school. Study outcomes will be assessed at baseline (T0), 6 months (T1) and 18 months (T2). A range of quantitative (teacher logs, observations and teacher surveys) and qualitative (semistructured interviews with teachers) methods will be used to assess primary (reach) and secondary outcomes (dose delivered, fidelity, sustainability, impact and cost of RT4T). Quantitative analyses will use logistic mixed models for dichotomous outcomes, and ordinal or linear mixed effects regression models for continuous outcomes, with alpha levels set at p&lt;0.025 for the outcomes and cost comparisons of the moderate and high support arms against the low support arm.Ethics and dissemination Ethics approval has been obtained from the University of Newcastle (H-2021-0418), the NSW Department of Education (SERAP:2022215), Hunter New England Human Research Ethics Committee (2023/ETH00052) and the Catholic Schools Office. The design, conduct and reporting will adhere to the Consolidated Standards of Reporting Trials statement, the Standards for Reporting Implementation Studies statement and the Template for Intervention Description and Replication checklist. Findings will be published in open access peer-reviewed journals, key stakeholders will be provided with a detailed report. We will support ongoing dissemination of RT4T in Australian schools via professional learning for teachers.Trial registration number ACTRN12622000861752

    Changes in soft drinks purchased by British households associated with the UK soft drinks industry levy: a controlled interrupted time series analysis

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    Objective To determine changes in household purchases of drinks 1 year after implementation of the UK soft drinks industry levy (SDIL).Design Controlled interrupted time series.Participants Households reporting their purchasing to a market research company (average weekly n=22 091), March 2014 to March 2019.Intervention A two-tiered tax levied on soft drinks manufacturers, announced in March 2016 and implemented in April 2018. Drinks with ≄8 g sugar/100 mL (high tier) are taxed at ÂŁ0.24/L, drinks with ≄5 to &lt;8 g sugar/100 mL (low tier) are taxed at ÂŁ0.18/L.Main outcome measures Absolute and relative differences in the volume of, and amount of sugar in, soft drinks categories, all soft drinks combined, alcohol and confectionery purchased per household per week 1 year after implementation.Results In March 2019, compared with the counterfactual, purchased volume of high tier drinks decreased by 140.8 mL (95% CI 104.3 to 177.3 mL) per household per week, equivalent to 37.8% (28.0% to 47.6%), and sugar purchased in these drinks decreased by 16.2 g (13.5 to 18.8 g), or 42.6% (35.6% to 49.6%). Purchases of low tier drinks decreased by 170.5 mL (154.5 to 186.5 mL) or 85.8% (77.8% to 93.9%), with an 11.5 g (9.1 to 13.9 g) reduction in sugar in these drinks, equivalent to 87.8% (69.2% to 106.4%). When all soft drinks were combined irrespective of levy tier or eligibility, the volume of drinks purchased increased by 188.8 mL (30.7 to 346.9 mL) per household per week, or 2.6% (0.4% to 4.7%), but sugar decreased by 8.0 g (2.4 to 13.6 g), or 2.7% (0.8% to 4.5%). Purchases of confectionery and alcoholic drinks did not increase.Conclusions Compared with trends before the SDIL was announced, 1 year after implementation, volume of all soft drinks purchased combined increased by 189 mL, or 2.6% per household per week. The amount of sugar in those drinks was 8 g, or 2.7%, lower per household per week. Further studies should determine whether and how apparently small effect sizes translate into health outcomes.Trial registration number ISRCTN18042742
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