bluuebunny/crossref_metadata_2025_split huggingface dataset:
Association between spinal curvature disorders and injury: a nationwide population-based retrospective cohort study
Authors: Kuo Yen-Liang , Chung Chi-Hsiang , Huang Tsai-Wang , Tsao Chang-Huei , Chang Shan-Yueh , Peng Chung-Kan , Cheng Wei-Erh , Chien Wu-Chien , Shen Chih-Hao 
Published: January 2019

ObjectivesInjury is an important issue in public health. Spinal curvature disorders are deformities characterised by excessive curves of the spine. The prevalence of spinal curvature disorders is not low, but its relationship with injury has not been studied. The aim of this study is to investigate whether spinal curvature disorders increase the risk of injury.DesignPopulation-based retrospective cohort study.SettingUsing data from the Taiwan National Health Insurance Research Database from 2000 to 2010.Participants and exposurePatients with spinal curvature disorders were selected using codes from the International Classification of Diseases, Ninth Revision, Clinical Modification. A cohort without spinal curvature was randomly frequency-matched to the spinal curvature disorders cohort at a ratio of 2:1 according to age, sex and index year.Primary outcome measuresThe risk of injury was analysed using Cox’s proportional hazards regression models adjusting for age, sex, comorbidities, urbanisation level and socioeconomic status.ResultsA total of 20 566 patients with spinal curvature disorders and 41 132 controls were enrolled in this study. The risk of injury was 2.209 times higher (95% CI 2.118 to 2.303) in patients with spinal curvature disorders than in the control group. The spinal curvature disorders cohort exhibited higher risk of developing injury compared with the control group, regardless of age, sex, comorbidities, urbanisation level and subgroup of spinal curvature disorders. Based on the subgroup analysis, the spinal curvature disorders cohort had higher risks of unintentional injury and injury diagnoses such as fracture, dislocation, open wound, superficial injury/contusion, crushing and injury to nerves and spinal cord compared with the control cohort.ConclusionsPatients with spinal curvature disorders have a significantly higher risk of developing injury than patients without spinal curvature disorders. Aggressive detection and management of spinal curvature disorders may be beneficial for injury prevention.
Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: study protocol for the DiaPROM randomised controlled trial pilot study
Authors: Haugstvedt Anne , Hernar Ingvild , Strandberg Ragnhild Bjarkøy , Richards David A , Nilsen Roy Miodini , Tell Grethe S , Graue Marit 
Published: January 2019

IntroductionAlthough diabetes distress is found to be associated with decreased glycaemic control among adults with type 1 diabetes, the psychological and emotional impact of living with the condition is often not recognised and often under-reported in diabetes care. Therefore, regular assessment of diabetes distress is recommended. Assessment of diabetes distress using patient-reported outcome measures (PROMs) in clinical practice has the potential to enhance care for people with diabetes by identifying problems and improving patient–clinician communication. In this study protocol, we describe a pilot randomised controlled trial (RCT) aiming to test the feasibility of all components of an empowerment-based intervention using PROMs as dialogue support in clinical diabetes consultations, and to address the uncertainties associated with running a fully powered evaluation study.Methods and analysisWe will undertake a two-arm pilot RCT of an intervention using the Problem Areas In Diabetes (PAID) scale in clinical diabetes consultations in order to conclude whether a fully powered trial is appropriate and/or feasible. The study will also include qualitative indepth interviews with participants and healthcare providers. Our objectives are to (1) evaluate the recruitment procedures and attrition rates; (2) evaluate the performance of the randomisation procedure; (3) evaluate the participants’ mean scores on the outcome measures before and after the intervention; (4) evaluate if the intervention consultations are acceptable and feasible; and (5) explore patients’ and healthcare providers’ experiences with the use of PAID as dialogue support and empowerment-based communication skills in clinical diabetes consultations. The quantitative data analysis includes descriptive statistics (frequencies, percentages, means, SD and CI). For the qualitative data, we will perform thematic analysis.Ethics and disseminationEthical approval has been obtained from the Western Norway Regional Committee for Medical and Health Research Ethics (2017/1506/REC west). We will present the findings from the study phases at national and international conferences and submit manuscripts to peer-reviewed journals and popular science journals.Trial registration numberNCT03471104; Pre-results.
Health-related quality of life and anxiety in the PAN-CAN lung cancer screening cohort
Authors: Taghizadeh Niloofar , Tremblay Alain , Cressman Sonya , Peacock Stuart , McWilliams Annette M , MacEachern Paul , Johnston Michael R , Goffin John , Goss Glen , Nicholas Garth , Martel Simon , Laberge Francis , Bhatia Rick , Liu Geoffrey , Schmidt Heidi , Atkar-Khattra Sukhinder , Tsao Ming-Sound , Tammemagi Martin C , Lam Stephen C 
Published: January 2019

ObjectivesThe impact of lung cancer screening with low-dose chest CT (LDCT) on participants’ anxiety levels and health-related quality of life (HRQoL) is an important consideration in the implementation of such programmes. We aimed to describe changes in anxiety and HRQoL in a high-risk Canadian cohort undergoing LDCT lung cancer screening.Methods2537 subjects who had 2% or greater lung cancer risk over 6 years using a risk prediction tool were recruited from eight centres across Canada in the Pan-Canadian Early Detection of Lung Cancer Study (2008–2010). We compared HRQoL and anxiety levels before and after screening of 1237 participants with LDCT (excluding a subset of 1300 participants who also underwent autofluorescence bronchoscopy screening), as well as after investigations performed because of a positive screening examination. The 12-item short-form Physical and Mental Component Scales (SF-12), EQ-5D-3L scores and State Trait Anxiety Inventory-State anxiety were used at each assessment.ResultsOverall, there were no clinically significant differences in HRQoL outcomes between baseline and each of the survey time points following initial screening. No mean change in anxiety in the overall cohort was noted following baseline LDCT, but more participants had clinically significant increase in anxiety versus decrease after baseline screening (increase >minimal clinically important difference (MCID) (n=180) vs decrease >MCID (n=50), p<0.001). This finding persisted but to a lesser degree at the 12 month time point (increase >MCID (n=146) vs decrease >MCID (n=87), p<0.001).ConclusionsCT screening for lung cancer has no major overall impact on HRQoL among participants, although a minority of participants (number-needed-to-harm=7 after baseline screening and 18 at 1 year) demonstrated clinically significant increased anxiety levels.Trialregistration numberNCT00751660; Results.
Oral cannabinoids in people living with HIV on effective antiretroviral therapy: CTN PT028—study protocol for a pilot randomised trial to assess safety, tolerability and effect on immune activation
Authors: Costiniuk Cecilia T , Saneei Zahra , Routy Jean-Pierre , Margolese Shari , Mandarino Enrico , Singer Joel , Lebouché Bertrand , Cox Joseph , Szabo Jason , Brouillette Marie-Josée , Klein Marina B , Chomont Nicolas , Jenabian Mohammad-Ali 
Published: January 2019

IntroductionDespite antiretroviral therapy (ART), people living with HIV have higher rates of non-infectious chronic diseases. These conditions are driven by relatively high levels of inflammation persisting on ART compared with uninfected individuals. Chronic inflammation also contributes to HIV persistence during ART. Cannabis when taken orally may represent a way to reduce inflammation and strengthen immune responses. Before planning large interventional studies, it is important to ensure that cannabis taken orally is safe and well tolerated in people living with HIV. We propose to conduct a pilot randomised trial to examine the safety and tolerability of cannabis oils containing tetrahydrocannabinol (THC) and cannabidiol (CBD) consumed orally in people living with HIV. We will also measure inflammatory markers, markers of HIV persistence in peripheral blood cells and changes in the gastrointestinal microbiome.Methods and analysisTwenty-six people living with HIV having undetectable viral load for at least 3 years will be randomised to receive TN-TC11LM (THC:CBD in 1:1 ratio) or TN-TC19LM (THC:CBD in 1:9 ratio) capsules daily for 12 weeks. Safety and tolerability of these capsules will be assessed through haematological, hepatic and renal blood tests, face-to-face interviews and questionnaires. Proportions of participants without any signs of significant toxicity (grades 0–2 scores on the WHO toxicity scale) and who complete the study, as well as scores on quality of life and mood will be examined using descriptive statistics. The effects on inflammatory markers, markers of peripheral blood reservoir size and effect on the composition of the gastrointestinal microbiome will be assessed before and after study completion.Ethics and disseminationThis study has been approved by the Research Institute of the McGill University Health Centre. A Data Safety Monitor will review safety information at regular intervals. The final manuscript will be submitted to an open-access journal within 6 months of study completion.Trial registration numberNCT03550352.
Towards sustainable healthcare system performance in the 21st century in high-income countries: a protocol for a systematic review of the grey literature
Authors: Braithwaite Jeffrey , Zurynski Yvonne , Ludlow Kristiana , Holt Joanna , Augustsson Hanna , Campbell Margie 
Published: January 2019

IntroductionThere is wide recognition that, if healthcare systems continue along current trajectories, they will become harder to sustain. Ageing populations, accelerating rates of chronic disease, increasing costs, inefficiencies, wasteful spending and low-value care pose significant challenges to healthcare system durability. Sustainable healthcare systems are important to patients, society, policy-makers, public and private funders, the healthcare workforce and researchers. To capture current thinking about improving healthcare system sustainability, we present a protocol for the systematic review of grey literature to capture the current state-of-knowledge and to compliment a review of peer-reviewed literature.Methods and analysisThe proposed search strategy, based on the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines, includes Google Advanced Search, snowballing techniques and targeted hand searching of websites of lead organisations such as WHO, Organisation for Economic Cooperation and Development, governments, public policy institutes, universities and non-government organisations. Documents will be selected after reviewing document summaries. Included documents will undergo full-text review. The following criteria will be used: grey literature document; English language; published January 2013–March 2018; relevant to the healthcare delivery system; the content has international or national scope in high-income countries. Documents will be assessed for quality, credibility and objectivity using validated checklists. Descriptive data elements will be extracted: identified sustainability threats, definitions of sustainability, attributes of sustainable healthcare systems, solutions for improvement and outcome measures of sustainability. Data will be analysed using novel text-mining methods to identify common concept themes and meanings. This will be triangulated with the more traditional analysis and concept theming by the researchers.Ethics and disseminationNo primary data will be collected, therefore ethical approval will not be sought. The results will be disseminated in peer-reviewed literature, as conference presentations and as condensed summaries for policy-makers and health system partners.PROSPERO registration numberCRD42018103076.
PreImplantation Trial of Histopathology In renal Allografts (PITHIA): a stepped-wedge cluster randomised controlled trial protocol
Authors: Ayorinde John OO , Summers Dominic M , Pankhurst Laura , Laing Emma , Deary Alison J , Hemming Karla , Wilson Edward CF , Bardsley Victoria , Neil Desley A , Pettigrew Gavin J 
Published: January 2019

IntroductionMost potential kidney transplant donors in the UK are aged over 60 years, yet increasing donor age is associated with poorer graft survival and function. Urgent preimplantation kidney biopsy can identify chronic injury, and may aid selection of better ‘quality’ kidneys from this group. However, the impact of biopsy on transplant numbers remains unproven. The PreImplantation Trial of Histopathology In renal Allografts (PITHIA) study will assess whether the introduction of a national, 24 hours, digital histopathology service increases the number, and improves outcomes, of kidneys transplanted in the UK from older deceased donors.Methods and analysisPITHIA is an open, multicentre, stepped-wedge cluster randomised study, involving all UK adult kidney transplant centres. At 4-monthly intervals, a group of 4–5 randomly selected clusters (transplant centres) will be given access to remote, urgent, digital histopathology (total intervention period, 24 months). The trial has two primary end points: it is powered for an 11% increase in the proportion of primary kidney offers from deceased donors aged over 60 years that are transplanted, and a 6 mL/min increase in the estimated glomerular filtration rate of recipients at 12 months post-transplant. This would equate to an additional 120 kidney transplants performed in the UK annually. Trial outcome data will be collected centrally via the UK Transplant Registry held by NHS Blood and Transplant (NHSBT) and will be analysed using mixed effects models allowing for clustering within centres and adjusting for secular trends. An accompanying economic evaluation will estimate the cost-effectiveness of the service to the National Health Service.Ethics and disseminationThe study has been given favourable ethical opinion by the Cambridge South Research Ethics Committee and is approved by the Health Research Authority. We will present our findings at key transplant meetings, publish results within 4 years of the trial commencing and support volunteers at renal patient groups to disseminate the trial outcome.Trial registrationnumberISRCTN11708741; Pre-results.
Place of death in a small island state: a death certificate population study
Authors: Jennings Nicholas , Chambaere Kenneth , Deliens Luc , Cohen Joachim 
Published: January 2019

ObjectivesLow/middle-income countries, particularly Small Island Developing States, face many challenges including providing good palliative care and choice in place of care and death, but evidence of the circumstances of dying to inform policy is often lacking. This study explores where people die in Trinidad and Tobago and examines and describes the factors associated with place of death.MethodsA population-level analysis of routinely collected death certificate and supplementary health data where the unit of analysis was the recorded death. We followed the Reporting of Studies Conducted Using Observational Routinely Collected Health Data reporting guidelines, an extension of Strengthening the Reporting of Observational Studies in Epidemiology, on a deidentified data set on decedents (n=10 221) extracted from International Statistical Classification of Diseases version 10 coded death records for the most recent available year, 2010.ResultsOf all deaths, 55.4% occurred in a government hospital and 29.7% in a private home; 65.3% occurred in people aged 60 years and older. Cardiovascular disease (23.6%), malignancies (15.5%) and diabetes mellitus (14.7%) accounted for over half of all deaths. Dying at home becomes more likely with increasing age (70–89 years (OR 1.91, 95% CI 1.73 to 2.10) and 90–highest (OR 3.63, 95% CI 3.08 to 4.27)), and less likely for people with malignancies (OR 0.85, 95% CI 0.74 to 0.97), cerebrovascular disease (OR 0.61, 95% CI 0.51 to 0.72) and respiratory disease (OR 0.74, 95% CI 0.59 to 0.91).ConclusionPlace of death is influenced by age, sex, race/ethnicity, underlying cause of death and urbanisation. There is inequality between ethnic groups regarding place of care and death; availability, affordability and access to end-of-life care in different settings require attention.
Electronic cigarettes in Italy: a tool for harm reduction or a gateway to smoking tobacco?
Authors: Liu Xiaoqiu , Lugo Alessandra , Davoli Enrico , Gorini Giuseppe , Pacifici Roberta , Fernández Esteve , Gallus Silvano 
Published: January 2019

IntroductionMore than a decade after electronic cigarettes (e-cigarette) hit the European market, we are still debating whether they may help or hinder tobacco control. It is therefore useful to explore the potential net effect of e-cigarette use in the general population.MethodsWe annually conduct a face-to-face survey on smoking in Italy on a representative sample of the general population aged 15 years or over (52.4 million). A total of 15 406 subjects were interviewed in 2014–2018. We investigated the consequences of using e-cigarettes on tobacco smoking behaviour among ever and regular e-cigarette users.ResultsIn all, 5.7% of our sample reported ever e-cigarette use. Multivariate analyses showed more use by men, ex-smokers and current smokers. E-cigarette use decreased with age and increased with education and calendar year. Only 1.1% of subjects were regular e-cigarette users. This prevalence rose from 0.4% in 2014–2015 to 1.8% in 2016–2017 and was 1.3% in 2018. Among 522 ever users, 13.2% stopped smoking after trying e-cigarettes and 22.2% started smoking or relapsed after using e-cigarettes. The corresponding estimates among regular users were 24.7% and 28.0%, respectively.ConclusionsAmong Italian e-cigarette users, those (re)starting smoking after using e-cigarettes outnumber those who stop smoking after using e-cigarettes. From a public health point of view, e-cigarettes may have an unfavourable net effect. Consequently, if we are not able to prevent sales of e-cigarettes to non-smokers, this product will more likely stimulate smoking tobacco than reduce harm.
Illicit tobacco trade in Georgia: prevalence and perceptions
Authors: Little Megan , Ross Hana , Bakhturidze George , Kachkachishvili Iago 
Published: January 2019

BackgroundIn lower-income and middle-income countries, limited research exists on illicit tobacco trade and its responsiveness to taxation. Tobacco taxes are critical in reducing tobacco consumption, thereby improving public health. However, the tobacco industry claims that tax increases will increase illicit tobacco trade. Therefore, research evidence on the size of the illicit cigarette market is needed in Georgia and other low-income and middle-income countries to inform tobacco tax policies.MethodsIn 2017, a household survey using stratified multistage sampling was conducted in Georgia with 2997 smokers, to assess illicit tobacco consumption. Smokers were asked to show available cigarette packs to the surveyors. These were examined for tax stamps and health warnings which allowed for an assessment of illegal cigarette consumption in Georgia.FindingsThe packs shown to surveyors suggest illicit cigarette trade is low (1.5%), although with regional differences, as illicit cigarette packs were present in 6% of the households in Zugdidi. Most illicit cigarettes were purchased at kiosks or informal outlets. This estimate might be conservative, as 28% of respondents did not show any packs to the surveyors.ConclusionsDespite recent tobacco tax increases, illicit cigarette trade in Georgia seems to be negligible. The market is more vulnerable to illicit cigarette trade close to the border with Abkhazia (near Zugdidi). Tighter control or ban of tobacco sales at kiosks and informal outlets may reduce illicit cigarette trade. Further investigation is planned to better understand why a large proportion of survey participants said they had no pack available at home.
MNK1/NODAL Signaling Promotes Invasive Progression of Breast Ductal Carcinoma In Situ
Authors: Guo Qianyu , Li Vivian Z. , Nichol Jessica N. , Huang Fan , Yang William , Preston Samuel E.J. , Talat Zahra , Lefrère Hanne , Yu Henry , Zhang Guihua , Basik Mark , Gonçalves Christophe , Zhan Yao , Plourde Dany , Su Jie , Torres Jose , Marques Maud , Habyan Sara Al , Bijian Krikor , Amant Frédéric , Witcher Michael , Behbod Fariba , McCaffrey Luke , Alaoui-Jamali Moulay , Giannakopoulos Nadia V. , Brackstone Muriel , Postovit Lynne-Marie , del Rincón Sonia V. , Miller Wilson H. 
Published: January 2019

Abstract

The mechanisms by which breast cancers progress from relatively indolent ductal carcinoma in situ (DCIS) to invasive ductal carcinoma (IDC) are not well understood. However, this process is critical to the acquisition of metastatic potential. MAPK-interacting serine/threonine-protein kinase 1 (MNK1) signaling can promote cell invasion. NODAL, a morphogen essential for embryogenic patterning, is often reexpressed in breast cancer. Here we describe a MNK1/NODAL signaling axis that promotes DCIS progression to IDC. We generated MNK1 knockout (KO) or constitutively active MNK1 (caMNK1)-expressing human MCF-10A–derived DCIS cell lines, which were orthotopically injected into the mammary glands of mice. Loss of MNK1 repressed NODAL expression, inhibited DCIS to IDC conversion, and decreased tumor relapse and metastasis. Conversely, caMNK1 induced NODAL expression and promoted IDC. The MNK1/NODAL axis promoted cancer stem cell properties and invasion in vitro. The MNK1/2 inhibitor SEL201 blocked DCIS progression to invasive disease in vivo. In clinical samples, IDC and DCIS with microinvasion expressed higher levels of phospho-MNK1 and NODAL versus low-grade (invasion-free) DCIS. Cumulatively, our data support further development of MNK1 inhibitors as therapeutics for preventing invasive disease.

Significance:
These findings provide new mechanistic insight into progression of ductal carcinoma and support clinical application of MNK1 inhibitors to delay progression of indolent ductal carcinoma in situ to invasive ductal carcinoma.