bluuebunny/crossref_metadata_2025_split huggingface dataset:
Nutritional impact on Immunological maturation during Childhood in relation to the Environment (NICE): a prospective birth cohort in northern Sweden
Authors: Barman Malin , Murray Fiona , Bernardi Angelina I , Broberg Karin , Bölte Sven , Hesselmar Bill , Jacobsson Bo , Jonsson Karin , Kippler Maria , Rabe Hardis , Ross Alastair B , Sjöberg Fei , Strömberg Nicklas , Vahter Marie , Wold Agnes E , Sandberg Ann-Sofie , Sandin Anna 
Published: October 2018

IntroductionPrenatal and neonatal environmental factors, such as nutrition, microbes and toxicants, may affect health throughout life. Many diseases, such as allergy and impaired child development, may be programmed already in utero or during early infancy. Birth cohorts are important tools to study associations between early life exposure and disease risk. Here, we describe the study protocol of the prospective birth cohort, ‘Nutritional impact on Immunological maturation during Childhood in relation to the Environment’ (NICE). The primary aim of the NICE cohort is to clarify the effect of key environmental exposures—diet, microbes and environmental toxicants—during pregnancy and early childhood, on the maturation of the infant’s immune system, including initiation of sensitisation and allergy as well as some secondary outcomes: infant growth, obesity, neurological development and oral health.Methods and analysisThe NICE cohort will recruit about 650 families during mid-pregnancy. The principal inclusion criterion will be planned birth at the Sunderby Hospital in the north of Sweden, during 2015–2018. Questionnaires data and biological samples will be collected at 10 time-points, from pregnancy until the children reach 4 years of age. Samples will be collected primarily from mothers and children, and from fathers. Biological samples include blood, urine, placenta, breast milk, meconium, faeces, saliva and hair. Information regarding allergic heredity, diet, socioeconomic status, lifestyle including smoking, siblings, pet ownership, etc will be collected using questionnaires. Sensitisation to common allergens will be assessed by skin prick testing and allergic disease will be diagnosed by a paediatrician at 1 and 4 years of age. At 4 years of age, the children will also be examined regarding growth, neurobehavioural and neurophysiological status and oral health.Ethics and disseminationThe NICE cohort has been approved by the Regional Ethical Review Board in Umeå, Sweden (2013/18-31M). Results will be disseminated through peer-reviewed journals and communicated on scientific conferences.
Decision-making on the location of care of the elderly: protocol for a systematic review of qualitative studies
Authors: Serrano-Gemes Gema , Serrano-del-Rosal Rafael , Rich-Ruiz Manuel 
Published: October 2018

IntroductionThe elderly must take part in the management of their own health. One of the aspects they should be able to decide on is the place where they want to live. The aim of this review is to synthetise qualitative evidence in order to understand how decisions are made on the location of care of the elderly.Methods and analysisSystematic review of qualitative studies. Six databases have been consulted: Web of Science, PubMed, Scopus, CINAHL Complete, PsycINFO and SciELO Citation Index (from the beginning to 29 November 2017). The inclusion criteria will be: studies that deal with the decision-making process on the location of care of the elderly (already experienced by the participants), original studies, qualitative or mixed-method studies and studies written in English or Spanish. The obtained results will be exported to the Zotero bibliography manager. The references will be reviewed by title and abstract and, later, the complete texts will be reviewed for their inclusion. A tool created for this study will be used to extract the data. The quality will be assessed withCritical Appraisal Skills Programme Español. The data synthesis will be carried out using the constant comparative method. All this process will be performed independently by two reviewers. Enhancing transparency in reporting the synthesis of qualitative research has been used to draw up this protocol.Ethics and disseminationThis protocol did not require ethical approval, since it is a protocol for a systematic review. The plans to disseminate our results include publishing a research paper in a high-impact journal in our study area. Also, if possible, our results will be presented in scientific conferences. Besides, the obtained results will complement and discuss the doctoral thesis of one of the authors of the review.PROSPERO registration numberCRD42018084826.
Protocol for a randomised, double-blind, placebo-controlled trial to explore the effect of tramadol in the prevention of postpartum depression (ETPPD)
Authors: Duan Guangyou , Wu Zhuoxi , Zhao Peng , Peng Jing , Chen Zhengqiong , Zhang Qingling , Xu Rufu , Li Hong 
Published: October 2018

IntroductionPostpartum depression is one of the most commonly experienced psychological disorders for women patients undergoing caesarean section, which accounts for about one-third of puerpera worldwide. Tramadol, a commonly used analgesic with an inhibitory effect on the reuptake of norepinephrine and serotonin, is an effective and well-tolerated agent for analgesia after caesarean section. Based on the role of changes in the postpartum levels of serotonin and norepinephrine in postpartum depression, we speculated that postoperative intravenous analgesia using tramadol may decrease the incidence of postpartum depression for caesarean patients. Therefore, this trial aimed to explore the effect of tramadol in the prevention of postpartum depression.Methods and analysisA randomised double-blind placebo-controlled trial will be performed and 1230 singleton parturients will be randomised to receive patient-controlled intravenous analgesia with tramadol or hydromorphone, or patient-controlled epidural analgesia with ropivacaine. The primary outcome of this trial will be the incidence of postpartum depression at 4 weeks after the caesarean section, together with the collection of the relevant data during hospitalisation and at 3 months after the caesarean section. Subgroup data according to the preoperative depression score will be analysed. Demographic characteristics, postoperative analgesic effects and postoperative recovery score will also be summarised and presented.Ethics and disseminationThe current trial protocol was approved by the Institutional Ethics Committee of Xinqiao Hospital (ID: 2017–026), Third Military Medical University, Chongqing, China. The results of this trial will be disseminated at scientific meetings and in a peer-reviewed journal.Trial registration numberNCT03309163; Pre-results.
Late-life suicidal behaviours among new users of antidepressants: a prospective population-based study of sociodemographic and gender factors in those aged 75 and above
Authors: Hedna Khedidja , Andersson Sundell Karolina , Hensing Gunnel , Skoog Ingmar , Gustavsson Sara , Waern Margda 
Published: October 2018

ObjectiveTo investigate sociodemographic and gender factors associated with suicide and suicide attempts among new users of antidepressants aged 75 and above.DesignRegister-based cohort study.SettingNational population-based cohort of Swedish residents aged ≥75 years.Participants185 225 patients who initiated antidepressant medication between 1 January 2007 and 31 December 2013 were followed until 31 December 2014.Main outcome measuresSuicide and suicide attempts. Fine and Gray regression models were used to analyse the sociodemographic factors (age, country of birth, marital status, education level, last occupation, income and social allowance) associated with suicidal behaviours in the entire cohort and by gender.ResultsDuring follow-up, 295 suicides and 654 suicide attempts occurred. Adjusted sub-hazard ratios (aSHRs) for suicide were lower among older age groups (aSHR 0.73, 95% CI 0.53 to 0.99 for those 85–89 years; and aSHR 0.53, 95% CI 0.33 to 0.86 for those ≥90 years). A similar pattern was observed for suicide attempts. Suicide attempts were more common among those born in foreign countries (aSHR 1.58, 95% CI 1.16 to 2.15 for those born in another Nordic country; and aSHR 1.43, 95% CI 1.06 to 1.93 for those born in non-Nordic countries). In the gender-stratified analyses, being single or divorced, and born in another Nordic country was associated with a higher risk of suicide among men. Educational and occupational history and being born in a non-Nordic country influenced risk of suicidal behaviours in women.ConclusionSuicidal behaviours occurred more commonly among new users who were ‘younger’ old adults and those with foreign background, suggesting that those groups might require greater support when initiating antidepressant therapy. Our findings suggest the need for gender-specific, multifaceted approaches to the prevention of suicidal behaviours in late life.
The PIPc Study—application of indicators of potentially inappropriate prescribing in children (PIPc) to a national prescribing database in Ireland: a cross-sectional prevalence study
Authors: Barry Emma , Moriarty Frank , Boland Fiona , Bennett Kathleen , Smith Susan M 
Published: October 2018

ObjectivesEvidence is limited regarding the quality of prescribing to children. The objective of this study was to apply a set of explicit prescribing indicators to a national pharmacy claims database (Primary Care Reimbursement Service) to determine the prevalence of potentially inappropriate prescribing in children (PIPc) in primary care.Primary and secondary outcomes measuresTo determine the overall prevalence of potentially inappropriate prescribing (PIP) in children in primary care. To examine the prevalence of PIPc by gender.Design and settingCross-sectional study. Application of indicators of commission of PIP and omission of appropriate prescribing to a national prescribing database in Ireland.ParticipantsEligible children <16 years of age who were prescribed medication in 2014.ResultsOverall prevalence of PIPc by commission was 3.5% (95% CI 3.5% to 3.6%) of eligible children <16 years of age who were prescribed medication in 2014. Overall prevalence of PIPc by omission was 2.5% (95% CI 2.5% to 2.6%) which rose to 11.5% (95% CI 11.4% to 11.7%) when prescribing of spacer devices for children with asthma was included. The most common individual PIPc by commission was the prescribing of carbocisteine to children (3.3% of eligible children). The most common PIPc by omission (after excluding spacer devices) was failure to prescribe an emollient to children prescribed greater than one topical corticosteroid (54% of eligible children). PIPc by omission was significantly higher in males compared with females (relative risk (RR) 1.3; 95% CI 1.0 to 1.7) but no different for PIPc by commission (RR 1.0; 95% CI 0.7 to 1.6).ConclusionThis study shows that the overall prevalence of PIP in children is low, although results suggest room for improved adherence to asthma guidelines.
Disclosure of payments by pharmaceutical companies to healthcare professionals in the UK: analysis of the Association of the British Pharmaceutical Industry’s Disclosure UK database, 2015 and 2016 cohorts
Authors: Mulinari Shai , Ozieranski Piotr 
Published: October 2018

ObjectivesTo analyse the section of Disclosure UK that pertains to healthcare professionals (HCPs) in order to provide insight into the database’s structure and content and suggest ways to improve its transparency.Design and participantsCohort study of drug companies and HCPs in the 2015 and 2016 versions of Disclosure UK.ResultsCompanies report transfers of value (ToVs) to named HCPs or, where an HCP declines to consent, in aggregate. Only a limited number of variables describe the recipient HCP and the ToV, precluding refined analyses. In 2015, 107 companies reported 54 910 ToVs worth ₤50 967 728. In 2016, 109 companies reported ToVs but spending decreased by 7.3%. The spending was concentrated: the top 10 spenders reported about 50% of the total value, with consultancy-related payments comprising over 70%, and the rest being costs for events. In 2015, 55.5% (30 478) of ToVs worth ₤24 428 619 (47.9%) were disclosed at the individual HCP level, increasing to 64.5% (32 407) and ₤28 145 091 (59.2%) in 2016. Despite increased individual-level disclosure in 2016, the median number of ToVs reported by each company at the individual level was only 57.7%, with 25% of companies reporting less than 38.6%. We found little agreement (62%–48% in 2015 and 46%–30% in 2016) between HCP consent rates that we calculated based on information in the database and those provided by companies.ConclusionsKey deficiencies in Disclosure UK include: insufficient information on payments and recipients, a relatively low HCP consent rate for individual-level disclosure, differences in consent rates across companies and payment types, and reporting ambiguities or inconsistencies. We employ these findings to develop recommendations for improving transparency, including an easily interpretable consent rate statistic that allows for comparison across years, firms and countries. If deficiencies remain unresolved, the UK should consider introducing legislation requiring mandatory disclosure to allow for adequate tracking of industry payments.
Emergency hospital care for adults with suspected seizures in the NHS in England 2007–2013: a cross-sectional study
Authors: Dickson Jon Mark , Jacques Richard , Reuber Markus , Hick Julian , Campbell Mike J , Morley Rebeka , Grünewald Richard A 
Published: October 2018

AimsTo quantify the frequency, characteristics, geographical variation and costs of emergency hospital care for suspected seizures.DesignCross-sectional study using routinely collected data (Hospital Episode Statistics).SettingThe National Health Service in England 2007–2013.ParticipantsAdults who attended an emergency department (ED) or were admitted to hospital.ResultsIn England (population 2011: 53.11 million, 41.77 million adults), suspected seizures gave rise to 50 111 unscheduled admissions per year among adults (≥18 years). This is 47.1% of unscheduled admissions for neurological conditions and 0.71% of all unscheduled admissions. Only a small proportion of admissions for suspected seizures were coded as status epilepticus (3.5%) and there were a very small number of dissociative (non-epileptic) seizures. The median length of stay for each admission was 1 day, the median cost for each admission was £1651 ($2175) and the total cost of all admissions for suspected seizures in England was £88.2 million ($116.2 million) per year. 16.8% of patients had more than one admission per year. There was significant geographical variability in the rate of admissions corrected for population age and gender differences and some areas had rates of admission which were consistently higher than the average.ConclusionsOur data show that suspected seizures are the most common neurological cause of admissions to hospital in England, that readmissions are common and that there is significant geographical variability in admission rates. This variability has not previously been reported in the published literature. The cause of the geographical variation is unknown; important factors are likely to include prevalence, deprivation and clinical practice and these require further investigation. Dissociative seizures are not adequately diagnosed during ED attendances and hospital admissions.
Geriatric CO-mAnagement for Cardiology patients in the Hospital (G-COACH): study protocol of a prospective before-after effectiveness-implementation study
Authors: Deschodt Mieke , Van Grootven Bastiaan , Jeuris Anthony , Devriendt Els , Dierckx de Casterlé Bernadette , Dubois Christophe , Fagard Katleen , Herregods Marie-Christine , Hornikx Miek , Meuris Bart , Rex Steffen , Tournoy Jos , Milisen Koen , Flamaing Johan 
Published: October 2018

IntroductionAlthough the majority of older patients admitted to a cardiology unit present with at least one geriatric syndrome, guidelines on managing heart disease often do not consider the complex needs of frail older patients. Geriatric co-management has demonstrated potential to improve functional status, and reduce complications and length of stay, but evidence on the effectiveness in cardiology patients is lacking. This study aims to determine if geriatric co-management is superior to usual care in preventing functional decline, complications, mortality, readmission rates, reducing length of stay and improving quality of life in older patients admitted for acute heart disease or for transcatheter aortic valve implantation, and to identify determinants of success for geriatric co-management in this population.Methods and analysisThis prospective quasi-experimental before-and-after study will be performed on two cardiology units of the University Hospitals Leuven in Belgium in patients aged ≥75 years. In the precohort (n=227), usual care will be documented. A multitude of implementation strategies will be applied to allow for successful implementation of the model. Patients in the after cohort (n=227) will undergo a comprehensive geriatric assessment within 24 hours of admission to stratify them into one of three groups based on their baseline risk for developing functional decline: low-risk patients receive proactive consultation, high-risk patients will be co-managed by the geriatric nurse to prevent complications and patients with acute geriatric problems will receive an additional medication review and co-management by the geriatrician.Ethics and disseminationThe study protocol was approved by the Medical Ethics Committee UZ Leuven/KU Leuven (S58296). Written voluntary (proxy-)informed consent will be obtained from all participants at the start of the study. Dissemination of results will be through articles in scientific and professional journals both in English and Dutch and by conference presentations.Trial registration numberNCT02890927.
Trends in the socioeconomic patterning of overweight/obesity in India: a repeated cross-sectional study using nationally representative data
Authors: Luhar Shammi , Mallinson Poppy Alice Carson , Clarke Lynda , Kinra Sanjay 
Published: October 2018

ObjectivesWe aimed to examine trends in prevalence of overweight/obesity among adults in India by socioeconomic position (SEP) between 1998 and 2016.DesignRepeated cross-sectional study using nationally representative data from India collected in 1998/1999, 2005/2006 and 2015/2016. Multilevel regressions were used to assess trends in prevalence of overweight/obesity by SEP.Setting26, 29 and 36 Indian states or union territories, in 1998/99, 2005/2006 and 2015/2016, respectively.Participants628 795 ever-married women aged 15–49 years and 93 618 men aged 15–54 years.Primary outcome measureOverweight/obesity defined by body mass index >24.99 kg/m2.ResultsBetween 1998 and 2016, overweight/obesity prevalence increased among men and women in both urban and rural areas. In all periods, overweight/obesity prevalence was consistently highest among higher SEP individuals. In urban areas, overweight/obesity prevalence increased considerably over the study period among lower SEP adults. For instance, between 1998 and 2016, overweight/obesity prevalence increased from approximately 15%–32% among urban women with no education. Whereas the prevalence among urban men with higher education increased from 26% to 34% between 2005 and 2016, we did not observe any notable changes among high SEP urban women between 1998 and 2016. In rural areas, more similar increases in overweight/obesity prevalence were found among all individuals across the study period, irrespective of SEP. Among rural women with higher education, overweight/obesity increased from 16% to 25% between 1998 and 2016, while the prevalence among rural women with no education increased from 4% to 14%.ConclusionsWe identified some convergence of overweight/obesity prevalence across SEP in urban areas among both men and women, with fewer signs of convergence across SEP groups in rural areas. Efforts are therefore needed to slow the increasing trend of overweight/obesity among all Indians, as we found evidence suggesting it may no longer be considered a ‘diseases of affluence’.
International phase I study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q)
Authors: Klassen Anne F , Kaur Manraj , Johnson Natasha , Kreukels Baudewijntje PC , McEvenue Giancarlo , Morrison Shane D , Mullender Margriet G , Poulsen Lotte , Ozer Mujde , Rowe Will , Satterwhite Thomas , Savard Kinusan , Semple John , Sørensen Jens Ahm , van de Grift Tim C , van der Meij-Ross Maeghan , Young-Afat Danny , Pusic Andrea L 
Published: October 2018

IntroductionA critical barrier to outcome assessment in gender-affirming healthcare is the lack of a specific patient-reported outcome measure (PROM). This phase I protocol describes an international collaboration between investigators in Canada, Denmark, the Netherlands and the USA who have coalesced to develop a new PROM (ie, the GENDER-Q) to evaluate outcomes of psychological, hormonal and surgical gender-affirming treatments.Methods and analysisThis phase I study uses an interpretive description approach. Participants aged 16 years and older seeking any form of gender-affirming treatments in centres located in Canada, Denmark, the Netherlands and the USA will be invited to take part in qualitative interviews. Participants will review BREAST-Q and FACE-Q scales hypothesised to contain content relevant to specific gender-affirming treatments. Interviews will elicit new concepts for additional scale development. Each interview will be digitally recorded, transcribed and coded. The main outcome of this phase I study will be the development of a conceptual framework and set of scales to measure outcomes important to evaluating gender-affirming treatments. To this end, analysis will be used to add/drop/revise items of existing scales to achieve content validity. For new concepts, coding will assign top-level domains and themes/subthemes to participant quotes. Codes will be used to develop an item pool to inform scale development. Draft scales will be shown to transgender and gender diverse persons and experts to obtain feedback that will be used to refine and finalise the scales. The field-test version of the GENDER-Q will be translated by following rigorous methods to prepare for the international field-test study.Ethics and disseminationThis study is coordinated at McMaster University (Canada). Ethics board approval was received from the Hamilton Integrated Ethics Board (Canada), the Medical Ethical Committee at VUmc (The Netherlands) and Advarra (USA). Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.